health research authority meaning

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The Health Research Authority (HRA) protects and promotes the interests of patients and the public in health research.

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Research and Development
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Health Research Authority (HRA) Approval or NHS Permission

Health Research Authority Approval is the process for research in the NHS in England.

It comprises a review by an NHS Research Ethics Committee (REC) (where required) as well as an assessment of regulatory compliance, and study-wide research governance checks undertaken by dedicated HRA staff.

It replaces the need for research governance review by the Clinical Research Network, or each participating NHS organisation. This allows the participating NHS organisations to focus their resources on assessing, arranging and confirming their capacity and capability to deliver the study.

HRA Approval applies only to the NHS in England . The HRA has compatibility arrangements in place with the national NHS permissions coordinating functions in Northern Ireland, Scotland and Wales that mean that the HRA will share information with those national coordinating functions to benefit study set-up in participating NHS/HSC organisations across the UK where applicable.

If your study involves recruitment of NHS patients, staff, premises, resources (pharmacy, radiology or laboratories) or data/tissue you will need to have HRA Approval in place.

Additionally you will need to work with the OUH R&D Team to confirm local capacity and capability to carry out your project at Oxford University Hospitals NHS Foundation Trust.

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Research is indispensable for resolving public health challenges – whether it be tackling diseases of poverty, responding to rise of chronic diseases, or ensuring that mothers have access to safe delivery practices.

Likewise, shared vulnerability to global threats, such as severe acute respiratory syndrome, Ebola virus disease, Zika virus and avian influenza has mobilized global research efforts in support of enhancing capacity for preparedness and response. Research is strengthening surveillance, rapid diagnostics and development of vaccines and medicines.

Public-private partnerships and other innovative mechanisms for research are concentrating on neglected diseases in order to stimulate the development of vaccines, drugs and diagnostics where market forces alone are insufficient.

Research for health spans 5 generic areas of activity:

measuring the magnitude and distribution of the health problem;
understanding the diverse causes or the determinants of the problem, whether they are due to biological, behavioural, social or environmental factors;
developing solutions or interventions that will help to prevent or mitigate the problem;
implementing or delivering solutions through policies and programmes; and
evaluating the impact of these solutions on the level and distribution of the problem.

High-quality research is essential to fulfilling WHO’s mandate for the attainment by all peoples of the highest possible level of health. One of the Organization’s core functions is to set international norms, standards and guidelines, including setting international standards for research.

Under the “WHO strategy on research for health”, the Organization works to identify research priorities, and promote and conduct research with the following 4 goals:

Capacity - build capacity to strengthen health research systems within Member States.
Priorities - support the setting of research priorities that meet health needs particularly in low- and middle-income countries.
Standards - develop an enabling environment for research through the creation of norms and standards for good research practice.
Translation - ensure quality evidence is turned into affordable health technologies and evidence-informed policy.
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Regulatory approvals and governance

You need to seek regulatory approval for your research project and register it with an appropriate database. You also need to adhere to the highest standards of research governance.

You should write and publish a protocol for your NIHR-funded research project.

For clinical trials, you must publish trial protocols within 12 months from completing the primary study.

Guidance templates

The Health Research Authority (HRA) has produced guidance and templates to help researchers develop high-quality protocols for submission for ethical and other approvals. The templates contain all the elements that review bodies consider to help applicants provide all the information required in their protocol.

See protocol information on the HRA website

Medicinal products

For qualitative research and for clinical trials of investigational medicinal products, you’ll need to look at specific protocol guidance and templates .

The SPIRIT Statement provides evidence-based recommendations for the minimum content of a clinical trial protocol and the template is in line with these guidelines and all regulatory requirements.

See further guidance on Clinical Trials Toolkit .

The Health Research Authority (HRA) needs to approve most NIHR-funded research projects. The HRA oversees ethical, governance and legal aspects of research in England.

Researchers can apply for HRA approval for their research through the Integrated Research Application System (IRAS) .

IRAS is a single system for applying for the permissions and approvals for health and social care research in the UK. The system:

enables you to enter the information about your project once, instead of duplicating information in separate application forms
uses filters to ensure that the data collected and collated is appropriate to the type of study, and consequently the permissions and approvals required
helps you to meet regulatory and governance requirements.

Planning a multicentre study?

The Health Research Authority has a Research Passport system that allows you to move easily between NHS Trusts without requiring HRA approval at each organisation.

Study registration

Clinical trials.

You need to register NIHR-funded clinical trials before the first participant receives an intervention.

In most cases you should register clinical research studies with the International Standard Randomised Controlled Trial Number Register (ISRCTN) , which is our registry of choice.

However, you can register with another registry if required to do so by a regulator or if another registry is more appropriate.

You only need to register once.

Updating registry information

You should update registry information regularly, following the guidelines from the relevant NIHR team and ISRCTN (or relevant registry). This includes any changes to recruitment data and key outcomes.

Read more in the NIHR policy on clinical trial registration and disclosure of results .

Systematic reviews - register on PROSPERO database

If your project includes a systematic review in the protocol, you need to register your protocols on the PROSPERO database .

PROSPERO is an international database of prospectively registered systematic reviews in health and social care. Registration advice is provided in the documentation supplied by your programme as part of the application, contracting and start-up processes.

Research projects we fund must:

follow the UK Policy Framework for Health and Social Care Research . It outlines the principles of good practice in the management and conduct of health and social care research in the UK
comply with the Concordat to support Research Integrity and, if relevant, in accordance with the Governance Arrangements for Research Ethics Committees (GAfREC) .

Pharmaceutical product trials - guidance

The I nternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines provide advice on governance of pharmaceutical product trials.

Steering committees

You also need to set up a steering committee. The committee provides overall supervision for a project on behalf of the project sponsor and project funder, and ensures that the project is conducted to rigorous governance standards.

These committees are variously known as a:

Trial Steering Committee
Study Steering Committee
Programme Steering Committee
Research Steering Group

depending on the type of research and the NIHR research programme. For some types of research, a Data Monitoring Committee is also required.

Please see our research governance guidelines for more information on steering committees.

Programme Grants for Applied Research (PGfAR)

Research funded through Programme Grants for Applied Research (PGfAR) Programme should be overseen by a Programme Steering Committee .

Trial management

You should appoint a dedicated trial manager.

This generic job description can support you in hiring a trial manager. Please let us know about any appointments you make.

Patient consent

People who are invited to take part in health and care research must give informed consent before being enrolled. For consent to be considered both legal and ethical it must be:

given by a person with capacity
voluntarily given, with no undue influence
given by someone who has been adequately informed
a fair choice

We expect that research we fund or support follows best practice in consent and the preparation of information for participants.

See informing participants and seeking consent on the HRA website

Protecting personal data

Researchers and study coordinators must comply with General Data Protection Regulation (GDPR) with respect to processing personal data, such as from research participants.

See GDPR guidance for researchers and study coordinators on the HRA website .

Read more about requirements around research governance on our policies and guidelines page .

Health Research Authority (HRA) and NHS Research Ethics Service

The roles of hra and nhs rec in clinical research ethics approval.

Any research project that involves recruitment of NHS patients, staff, premises, resources (pharmacy, radiology or laboratories) or data/tissue in England must go through the HRA approval process.

HRA approval brings together the assessment of governance and legal compliance with the independent opinion provided through the NHS Research Ethics Committee (NHS REC). More information about the Health Research Authority (HRA) approval is available on the HRA website and on the IRAS website .

Additionally you will need to work with the NHS Trust R&D office(s) to confirm local capacity and capability to carry out your project at NHS site(s). If your lead site is the Oxford University Hospitals NHS Foundation Trust, please contact the OUH R&D department for further information and advice.

Application process

Any application that is to be submitted to the HRA and NHS REC (where required) must be prepared using the Integrated Research Application System (IRAS) . Clear instructions as to how to complete the form, with question-specific guidance, is available on the IRAS website . CTRG staff will be happy to provide advice.

Forms are web-based and can be worked on repeatedly prior to submission. Documents to submit to the HRA are itemised on a checklist provided on IRAS. CTRG needs to review all documents prior to submission. Please allow sufficient time for this and do not book a slot until advised by CTRG to do so.

Once CTRG have approved your application you will need to submit the application via the IRAS system. This will then be directed within the HRA to the REC and the HRA approval process.

RGEA TEAM

Public Health

45 CFR 164.512(b) ( Download a copy in PDF ) Background The HIPAA Privacy Rule recognizes the legitimate need for public health authorities and others responsible for ensuring public health and safety to have access to protected health information to carry out their public health mission. The Rule also recognizes that public health reports made by covered entities are an important means of identifying threats to the health and safety of the public at large, as well as individuals. Accordingly, the Rule permits covered entities to disclose protected health information without authorization for specified public health purposes. In addition, if a covered entity engages a business associate to assist in a specified public health activity, the business associate’s written agreement with the covered entity should identify these activities, and the business associate may make the disclosure for public health reasons in accordance with its written agreement.

New - OCR Issues Guidance on HIPAA, Health Information Exchanges, and Disclosures of Protected Health Information for Public Health Purposes

OCR has issued guidance on how the Health Insurance Portability and Accountability Act of 1996 (HIPAA) permits covered entities and their business associates to use health information exchanges (HIEs) to disclose protected health information (PHI) for the public health activities of a public health authority (PHA). The guidance provides examples relevant to the COVID-19 public health emergency on how HIPAA permits covered entities and their business associates to disclose PHI to an HIE for reporting to a PHA conducting public health activities.

Guidance on HIPAA, Health Information Exchanges, and Disclosures of Protected Health Information for Public Health Purposes - December 18, 2020
Press Release

How the Rule Works

General Public Health Activities . The Privacy Rule permits covered entities to disclose protected health information, without authorization, to public health authorities who are legally authorized to receive such reports for the purpose of preventing or controlling disease, injury, or disability. This would include, for example, the reporting of a disease or injury; reporting vital events, such as births or deaths; and conducting public health surveillance, investigations, or interventions. See 45 CFR 164.512(b)(1)(i). Also, covered entities may, at the direction of a public health authority, disclose protected health information to a foreign government agency that is acting in collaboration with a public health authority. See 45 CFR 164.512(b)(1)(i). Covered entities who are also a public health authority may use, as well as disclose, protected health information for these public health purposes. See 45 CFR 164.512(b)(2).

A “public health authority” is an agency or authority of the United States government, a State, a territory, a political subdivision of a State or territory, or Indian tribe that is responsible for public health matters as part of its official mandate, as well as a person or entity acting under a grant of authority from, or under a contract with, a public health agency. See 45 CFR 164.501. Examples of a public health authority include State and local health departments, the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention, and the Occupational Safety and Health Administration (OSHA). Generally, covered entities are required reasonably to limit the protected health information disclosed for public health purposes to the minimum amount necessary to accomplish the public health purpose. However, covered entities are not required to make a minimum necessary determination for public health disclosures that are made pursuant to an individual’s authorization, or for disclosures that are required by other law. See 45 CFR 164.502(b).

For disclosures to a public health authority, covered entities may reasonably rely on a minimum necessary determination made by the public health authority in requesting the protected health information. See 45 CFR 164.514(d)(3)(iii)(A). For routine and recurring public health disclosures, covered entities may develop standard protocols, as part of their minimum necessary policies and procedures, that address the types and amount of protected health information that may be disclosed for such purposes. See 45 CFR 164.514(d)(3)(i).

Other Public Health Activities. The Privacy Rule recognizes the important role that persons or entities other than public health authorities play in certain essential public health activities. Accordingly, the Rule permits covered entities to disclose protected health information, without authorization, to such persons or entities for the public health activities discussed below.

Child abuse or neglect. Covered entities may disclose protected health information to report known or suspected child abuse or neglect, if the report is made to a public health authority or other appropriate government authority that is authorized by law to receive such reports. For instance, the social services department of a local government might have legal authority to receive reports of child abuse or neglect, in which case, the Privacy Rule would permit a covered entity to report such cases to that authority without obtaining individual authorization. Likewise, a covered entity could report such cases to the police department when the police department is authorized by law to receive such reports. See 45 CFR 164.512(b)(1)(ii). See also 45 CFR 512(c) for information regarding disclosures about adult victims of abuse, neglect, or domestic violence.
Collecting or reporting adverse events (including similar reports regarding food and dietary supplements), product defects or problems (including problems regarding use or labeling), or biological product deviations;
Tracking FDA-regulated products;
Enabling product recalls, repairs, replacement or lookback (which includes locating and notifying individuals who received recalled or withdrawn products or products that are the subject of lookback); and
Conducting post-marketing surveillance. See 45 CFR 164.512(b)(1)(iii). The “person” subject to the jurisdiction of the FDA does not have to be a specific individual. Rather, it can be an individual or an entity, such as a partnership, corporation, or association. Covered entities may identify the party or parties responsible for an FDA-regulated product from the product label, from written material that accompanies the product (know as labeling), or from sources of labeling, such as the Physician’s Desk Reference.
Persons at risk of contracting or spreading a disease. A covered entity may disclose protected health information to a person who is at risk of contracting or spreading a disease or condition if other law authorizes the covered entity to notify such individuals as necessary to carry out public health interventions or investigations. For example, a covered health care provider may disclose protected health information as needed to notify a person that (s)he has been exposed to a communicable disease if the covered entity is legally authorized to do so to prevent or control the spread of the disease. See 45 CFR 164.512(b)(1)(iv).
Workplace medical surveillance. A covered health care provider who provides a health care service to an individual at the request of the individual’s employer, or provides the service in the capacity of a member of the employer’s workforce, may disclose the individual’s protected health information to the employer for the purposes of workplace medical surveillance or the evaluation of work-related illness and injuries to the extent the employer needs that information to comply with OSHA, the Mine Safety and Health Administration (MSHA), or the requirements of State laws having a similar purpose. The information disclosed must be limited to the provider’s findings regarding such medical surveillance or work-related illness or injury. The covered health care provider must provide the individual with written notice that the information will be disclosed to his or her employer (or the notice may be posted at the worksite if that is where the service is provided). See 45 CFR 164.512(b)(1)(v).

OCR HIPAA Privacy December 3, 2002 Revised April 3, 2003

Other Public Health Resources

View our Frequently Asked Questions
View CDC Guidance on the HIPAA Privacy Rule and Public Health

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What is Public Health Authority FAQ

Public health authority refers to a government body’s (usually a health or public health department or agency) legal ability to further public health by using tools such as community engagement, data collection, scientific research, laws and regulations, enforcement, and the many methods of sharing information and guidance with those who need it most.

Public health agencies use their authority for more than preventing epidemics and the spread of disease, they serve many other critical functions, such as preventing injuries, testing children for lead exposure, promoting healthy behaviors, responding to disasters, advancing health equity and more.

Below are frequently asked questions about what public health authority is exactly, and why it’s so critically important.

What is the practice of public health?

Practicing “ public health ” means protecting and promoting the health and well-being of all people by improving the ways our whole community influences our lives, including during crises: from ensuring that water, air, and food are safe, to controlling the spread of infectious diseases.

What is public health authority?

“ Public health authority ” refers to a government body’s—usually a health or public health department or agency—legal ability to further public health by using tools such as data collection, scientific research, laws and regulations, enforcement, community-engaged processes, and the many methods of sharing information and guidance with those who need it most.

It makes sense that our community influences our health outcomes; where do “the social determinants of health” come in?

The term “ social determinants of health ” describes non-medical factors in our daily lives that have a huge influence on our health, such as “employment, income, housing, transportation, childcare, education, discrimination, and the quality of the places where people live, work, learn, and play.” That definition includes our whole community and the different opportunities it provides to different people to be healthy and well.

What is health equity , and why does it come up so often in public health?

More than merely offering public health services to all, “health equity” strives to meet each person and each community where they are, supporting their health according to their different goals and needs, and different starting places. Health equity is the state in which “everyone has a fair and just opportunity to be as healthy as possible.”

What are some of the best examples of using public health authority to improve health equity?

Some common examples of public health successes include:

vaccines that have saved countless lives and eradicated deadly illnesses;
inspections that ensure what we eat and drink is clean and safe;
rules to protect clean air in our restaurants, workplaces, and neighborhoods; and
regulations that require life-saving technologies, like seatbelts, for everyone and not just those who can afford them.

Public health successes aimed at improving health equity by focusing on community-wide determinants of health include:

laws to protect workers and consumers from companies that treat people unfairly, secure minimum wages and paid leave, and restrict misleading marketing;
agreements to secure community-wide broadband access, bringing work, education, and health care opportunities with it; and
zoning and other policies that protect and promote safe, stable, housing, like proactive rental inspections (to regularly check home safety and fix issues before they become problematic) and inclusionary zoning (to ensure housing options for community members at a range of income levels).

How are public health agencies organized?

Government bodies with public health authority sit at every level of government: federal, tribal, state, and local. They include agencies such as the CDC and local health departments. State public health authority is generally shared with local governments, in different ways depending on the state.

State agencies often oversee or support local agencies and may implement population-based public health services like disease tracking and epidemiology. Local agencies tend to coordinate local public health services like inspections, immunizations, and disease screening. Some local agencies provide public health services to such a large population that their capacity resembles, or may even surpass, that of many state agencies.

What are some other ways public health agencies use their authority to help advance public health?

State and local public health agencies can engage in a wide range of activities to promote public health, such as monitoring population health; creating, championing, or implementing policies, plans, or laws; utilizing legal and regulatory actions; and improving and innovating through evaluation, research, and quality improvement. For more information on these and other types of public health activities, please see the 10 Essential Public Health Services framework .

What’s happening to public health authority in the wake of COVID response efforts?

Most states and decisionmakers have supported and improved public health’s response to COVID-19, reducing the cost—in both lives and dollars—of the pandemic . But some anti-regulatory decisionmakers (legislators, legislatures, and judges) have challenged and curbed state and local public health authority , limiting how agencies can respond to COVID-19, as well as future outbreaks, other public health emergencies, and even day-to-day local public health needs.

How are legislatures proposing to limit public health authority?

Some state legislatures have restricted, or proposed to restrict, public health authority by, for example: (1) preempting (i.e., prohibiting) certain lower-level government actions; (2) broadening exemptions from life-saving public health measures to include “personal belief” objections; and (3) shifting authority away from public health officials and staff, subjecting urgent public health activities to unwieldy political processes.

How are courts limiting public health authority?

Some courts have decided to narrow their interpretation of the scope of public health authority and emergency powers delegated by legislatures to public health agencies. Some have also backtracked on their historical deference to public health expertise and science as tools to inform balanced responses to complex, rapidly changing health crises.

How does limiting public health authority impact the practice of public health?

Rolling back public health authority changes the practice of public health in significant ways, including by wrestling control away from the officials closest to the communities they serve, hampering effective responses to rapidly evolving public health emergencies, and elevating politics over public health expertise and evidence-based decision making.

How does limiting public health authority impact the health of our communities and health equity?

By thwarting public health officials’ ability to respond quickly and effectively to identified community needs, reactionary rollbacks in public health authority jeopardize the health of our communities and further compound existing community health inequities.

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Institute of Medicine (US) Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule; Nass SJ, Levit LA, Gostin LO, editors. Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research. Washington (DC): National Academies Press (US); 2009.

Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research.

Hardcopy Version at National Academies Press

3 The Value, Importance, and Oversight of Health Research

The previous chapter reviewed the value of privacy, while this chapter examines the value and importance of health research. As noted in the introduction to Chapter 2 , the committee views privacy and health research as complementary values. Ideally, society should strive to facilitate both for the benefit of individuals as well as the public.

In addition to defining health research and delineating its value to individuals and society, this chapter provides an overview and historical perspective of federal research regulations that were in place long before the Privacy Rule was implemented. Because a great deal of medical research falls under the purview of multiple federal regulations, it is important to understand how the various rules overlap or diverge. The chapter also explains how the definition of research has become quite complex under the various federal regulations, which make a distinction between research and some closely related health practice activities that also use health data, such as quality improvement initiatives.

The chapter also reviews the available survey data regarding public perceptions of health research and describes the importance of effective communication about health research with patients and the public.

CONCEPTS AND VALUE OF HEALTH RESEARCH

Definitions

Under both the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the Common Rule, “research” is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” This is a broad definition that may include biomedical research, epidemiological studies, 1 and health services research, 2 as well as studies of behavioral, social, and economic factors that affect health.

Perhaps the most familiar form of health research is the clinical trial, in which patients volunteer to participate in studies to test the efficacy and safety of new medical interventions. But an increasingly large portion of health research is now information based. A great deal of research entails the analysis of data and biological samples that were initially collected for diagnostic, treatment, or billing purposes, or that were collected as part of other research projects, and are now being used for new research purposes. This secondary 3 use of data is a common research approach in fields such as epidemiology, health services research, and public health research, and includes analysis of patterns of occurrences, determinants, and natural history of disease; evaluation of health care interventions and services; drug safety surveillance; and some genetic and social studies ( Lowrance, 2002 ; Lowrance and Collins, 2007 ).

The Importance of Health Research

Like privacy, health research has high value to society. It can provide important information about disease trends and risk factors, outcomes of treatment or public health interventions, functional abilities, patterns of care, and health care costs and use. The different approaches to research provide complementary insights. Clinical trials can provide important information about the efficacy and adverse effects of medical interventions by controlling the variables that could impact the results of the study, but feedback from real-world clinical experience is also crucial for comparing and improving the use of drugs, vaccines, medical devices, and diagnostics. For example, Food and Drug Administration (FDA) approval of a drug for a particular indication is based on a series of controlled clinical trials, often with a few hundred to a few thousand patients, but after approval it may be used by millions of people in many different contexts. Therefore, tracking clinical experience with the drug is important for identifying relatively rare adverse effects and for determining the effectiveness in different populations or in various circumstances. It is also vital to record and assess experience in clinical practice in order to develop guidelines for best practices and to ensure high-quality patient care.

Collectively, these forms of health research have led to significant discoveries, the development of new therapies, and a remarkable improvement in health care and public health. 4 Economists have found that medical research can have an enormous impact on human health and longevity, and that the resulting increased productivity of the population contributes greatly to the national economy ( Hatfield et al., 2001 ; Murphy and Topel, 1999 ) in addition to the individual benefits of improved health. If the research enterprise is impeded, or if it is less robust, important societal interests are affected.

The development of Herceptin as a treatment for breast cancer is a prime example of the benefits of research using biological samples and patient records ( Box 3-1 ) ( Slamon et al., 1987 ). Many other examples of findings from medical records research have changed the practice of medicine as well. Such research underlies the estimate that tens of thousands of Americans die each year from medical errors in the hospital, and research has provided valuable information for reducing these medical errors by implementing health information technology, such as e-prescribing ( Bates et al., 1998 ; IOM, 2000b ). This type of research also has documented that disparities in health care and lack of access to care in inner cities and rural areas result in poorer health outcomes ( Mick et al., 1994 ). Furthermore, medical records research has demonstrated that preventive services (e.g., mammography) substantially reduce mortality and morbidity at reasonable costs ( Mandelblatt et al., 2003 ), and has established a causal link between the nursing shortage and patient health outcomes by documenting that patients in hospitals with fewer registered nurses are hospitalized longer and are more likely to suffer complications, such as urinary tract infections and upper gastrointestinal bleeding ( Needleman et al., 2002 ). These findings have all informed and influenced policy decisions at the national level. As the use of electronic medical records increases, the pace of this form of research is accelerating, and the opportunities to generate new knowledge about what works in health care are expanding ( CHSR, 2008 ).

Examples of Important Findings from Medical Database Research. Herceptin and breast cancer: Data were collected from a cohort of more than 9,000 breast cancer patients whose tumor specimens were consecutively received at the University (more...)

Advances in health information technology are enabling a transformation in health research that could facilitate studies that were not feasible in the past, and thus lead to new insights regarding health and disease. As noted by the National Committee on Vital and Health Statistics, “Clinically rich information is now more readily available, in a more structured format, and able to be electronically exchanged throughout the health and health care continuum. As a result, the information can be better used for quality improvement, public health, and research, and can significantly contribute to improvements in health and health care for individuals and populations” ( NCVHS, 2007a ). The informatics grid recently developed with support from the National Cancer Institute (Cancer Biomedical Informatics Grid, or caBIG) is an example of a how information technologies can facilitate health research by enabling broader sharing of health data while still ensuring regulatory compliance and protecting patient privacy ( Box 3-2 ).

caBIG (Cancer Biomedical Informatics Grid). The National Cancer Institute’s caBIG Data Sharing and Intellectual Capital Workspace’s mission is to enable all constituencies in the cancer community—including researchers, physicians, (more...)

Science today is also changing rapidly and becoming more complex, so no single researcher or single site can bring all the expertise to develop and validate medical innovations or to ensure their safety. Thus, efficient sharing of information between institutions has become even more important than in previous eras, when there were fewer new therapies introduced. The expansion of treatment options, as well as the escalating expense of new therapies, mandates greater scrutiny of true effectiveness, 5 once efficacy has been demonstrated. This requires registries of patient characteristics, outcomes, and adverse events. Large populations are required to facilitate comparison of patient populations and to calculate risk/benefit estimates. For example, INTERMACS 6 (Interagency Registry for Mechanically Assisted Circulatory Support) is a national registry for patients who are receiving mechanical circulatory support device therapy to treat advanced heart failure. This registry was devised as a joint effort of the National Heart, Lung and Blood Institute, Centers for Medicare & Medicaid Services, FDA, clinicians, scientists and industry representatives. Analysis of the data collected is expected to facilitate improved patient evaluation and management while aiding in better device development. Registry results are also expected to influence future research and facilitate appropriate regulation and reimbursement of such devices. Similarly, the Extracorporeal Life Support Organization (ELSO), 7 an international consortium of health care professionals and scientists who focus on the development and evaluation of novel therapies for support of failing organ systems, maintains a registry of extracorporeal membrane oxygenation and other novel forms of organ system support. Registry data are used to support clinical practice and research, as well as regulatory agencies. Another example is the database developed by the United Network for Organ Sharing (UNOS) for the collection, storage, analysis and publication of data pertaining to the patient waiting list, organ matching, and transplants. 8 Launched in 1999, this secure Internet-based system contains data regarding every organ donation and transplant event occurring in the United States since 1986.

Information-based research, such as research using health information databases has many advantages (reviewed by Lowrance, 2002 ). It is often faster and less expensive than experimental studies; it can analyze very large sets of data and may detect unexpected phenomena or differences among subpopulations that might not be included in a controlled experimental study; it can often be undertaken when controlled trials are simply not possible for ethical, technical, or other reasons, and it can be used to study effectiveness of a specific test or intervention in clinical practice, rather than just the efficacy as determined by a controlled experimental study. It can also reexamine data accrued in other research studies, such as clinical trials, to answer new questions quickly and inexpensively. However, information-based research does have limitations. Often it has less statistical rigor than controlled clinical studies because it lacks scientific control over the original data collection, quality, and format that prospective experimental research can dictate from the start. In addition to these scientific limitations, because of its relational and often distant physical separation from the data subjects, and the sheer volume of the records involved, obtaining individual consent for the research can be difficult or impossible.

Advances in information-based medical research could also facilitate the movement toward personalized medicine, which will make health research more meaningful to individuals. The goal of personalized medicine is to tailor prevention strategies and treatments to each individual based on his/her genetic composition and health history. In spite of the strides made in improving health through new treatments, it is widely known that most drugs are effective in only a fraction of patients who have the condition for which the drug is indicated. Moreover, a small percentage of patients are likely to have adverse reactions to drugs that are found to be safe for the majority of the population at the recommended dose. Both of these phenomena are due to variability in the patient population. Revolutionary advances in the study of genetics and other markers of health and disease are now making it possible to identify and study these variations, and are leading to more personalized approaches to health care—that is, the ability to give “the appropriate drug, at the appropriate dose, to the appropriate patient, at the appropriate time.” Achieving the goals of personalized medicine will lead to improvements in both the effectiveness and the safety of medical therapies.

Public Perceptions of Health Research

A number of studies have been undertaken to gauge the public’s attitude toward research and the factors that influence individuals’ willingness to participate in research. The surveys reviewed in this chapter focus on interventional clinical trials. A review of survey questions to gauge the public willingness to allow their medical records to be used in research can be found in Chapter 2 .

The Public Values Health Research

A number of studies suggest that most Americans have a positive view of medical research and believe that research is beneficial to society. A recent Harris poll found that nearly 80 percent of respondents were interested in health research findings, consistent with previous survey results ( Westin, 2007 ). A study in 2005 compiled data from 70 state surveys and 18 national surveys and found that the majority of Americans believe maintaining world leadership in health-related research is important. Seventy-eight percent of respondents said that it is very important, and 17 percent said that it is somewhat important. Only 4 percent of Americans reported that maintaining world leadership in health-related research is not impor tant ( Woolley and Propst, 2005 ). Similar results were found in a 2007 survey—76 percent of respondents reported that science plays a very important role in our health, and 78 percent reported that science plays a very important role in our competitiveness ( Research!America, 2007 ).

The Virginia Commonwealth University 2004 Life Sciences Survey also found that most Americans have a positive view of research. In this study, 90 percent of respondents agreed that developments in science have made society better; 92 percent reported that “scientific research is essential for improving the quality of human lives”; and 84 percent agreed that “the benefits of scientific research outweigh the harmful results” ( NSF, 2006 ).

Overall Experience When Participating in Research

Little is known about the attitudes of individuals who have actually participated in medical research. However, the available evidence suggests that most research participants have positive experiences. A recent Harris Poll found that 13 percent of respondents had participated in some form of health research, and 87 percent of those felt comfortable about their experience ( Westin, 2007 ). In a study focused on cancer, 93 percent of respondents who participated in research reported it as a very positive experience; 76 percent said they would recommend participation in a clinical trial to someone with cancer. Most physicians surveyed in this study stated that they believe clinical trial participants receive the best possible care, and have outcomes at least as good as patients receiving standard cancer treatment ( Comis et al., 2000 ). Another study found that 55 percent of individuals who participated in a research study would be willing to participate again in a future research study ( Trauth et al., 2000 ).

Willingness to Participate in Research

Public opinion surveys indicate that a majority of Americans are willing to participate in clinical research studies. In 2001, a compilation of studies commissioned by Research!America found that 63 percent of Americans would be willing to participate in a clinical research study ( Woolley and Propst, 2005 ). This percentage has remained stable over time. A 2007 Research!America survey also found that 63 percent of Americans would be very likely to participate in a clinical research study if asked ( Research!America, 2007 ); 68 percent of respondents reported that their desire to improve their own health or the health of others was a major factor in deciding whether to participate in a clinical research project ( Research!America, 2007 ).

Other surveys also suggest that willingness to participate in research focused on specific diseases is quite high. In one survey, the percentage of respondents indicating a willingness to participate in a medical research study was 88 percent for cancer, 86 percent for heart disease, 83 percent for a noncurable fatal disease, 79 percent for addiction, 78 percent for depression, and 76 percent for schizophrenia ( Trauth et al., 2000 ). Respondents with greater knowledge of how research is conducted were more willing to participate ( Trauth et al., 2000 ). Another study found that 8 of 10 Americans would consider participating in a clinical trial if faced with cancer. More than two-thirds of respondents said they would be willing to participate in a clinical trial designed to prevent cancer ( Comis et al., 2000 ).

Americans also seem to be very supportive of medical research that relies on genetic data. A 2007 survey found that 93 percent of Americans supported the use of genetic testing if the information collected is used by researchers to find new ways to diagnose, prevent, or treat disease ( Genetics & Public Policy Center, 2007 ). Two separate surveys found that 66 percent of Americans would be willing to donate their genetic material for medical research ( Genetics & Public Policy Center, 2007 ; Research!America, 2007 ). However, despite this apparent positive view of genetic research, 92 percent of Americans reported they were concerned about their genetic information being used in a “harmful way” ( Genetics & Public Policy Center, 2007 ).

Many factors, in addition to concerns about privacy and confidentiality ( Genetics & Public Policy Center, 2007 ; Research!America, 2007 ), may influence an individual’s willingness to participate in a medical research study. The Trauth survey found that individuals with higher income levels, with a college or graduate degree, or with children were more likely to participate in research. Age affected willingness to participate: 57 percent of respondents ages 18–34 were willing to participate in research, but only 31 percent of respondents ages 65 or older were willing ( Trauth et al., 2000 ).

Other factors that potentially influence an individual’s willingness to participate in research are race and ethnicity. It is well documented that minorities participate in health research at a much lower percentage than white Americans. Many cultural, linguistic, and socioeconomic barriers could be responsible for this difference ( Giuliano et al., 2000 ), and study results have been variable on this issue. Several studies suggest that the low participation rates by racial and ethnic minority groups are due to their strong distrust of the medical research community compared to the general population ( Braunstein et al., 2008 ; Corbie-Smith et al., 1999 ; Farmer et al., 2007 ; Grady et al., 2006 ; Shavers et al., 2002 ).

However, other evidence suggests that the low percentage of minorities participating in research is related to minority groups’ lack of access to the research community ( Brown et al., 2000 ; Wendler et al., 2006 ; Williams and Corbie-Smith, 2006 ). Thus, it is likely that the low number of minority individuals participating in medical research is at least partly due to recruitment techniques that are ineffective for minority populations.

The survey that focused on cancer research suggests that one of the main reasons why individuals do not participate in research is lack of knowledge about the availability of clinical trials. In a survey of nearly 6,000 cancer patients, 85 percent said they were unaware of the opportunity to participate in a clinical trial. Respondents who did participate said they did so because of one of the following beliefs: (1) trials provide access to the best quality of care (76 percent), (2) their participation would benefit future cancer patients (72 percent), (3) they would receive newer and better treatment (63 percent), and (4) participation would get them more care and attention (40 percent) ( Comis et al., 2000 ).

A recommendation from a physician can also impact participation. In the United States, 48 percent of respondents to one survey reported that a physicians’ recommendation would be a major factor in deciding whether to take part in a research study. Nearly three-fourths of respondents also cited an institution’s reputation as a key factor to consider when deciding whether to participate in a study ( Research!America, 2007 ). Twenty percent of respondents in an Italian public survey indicated that the presence of a physician as a reference during a research study influenced their willingness to participate ( Mosconi et al., 2005 ).

In sum, surveys indicate that the vast majority of Americans have a positive view of medical research, believe that research is beneficial to society, and are interested in health research findings. Although little is known about the attitudes of individuals who have actually participated in medical research, the available evidence suggests that most research participants have positive experiences. Surveys also suggest that a majority of Americans are willing to participate in clinical research studies. Similar to the findings in Chapter 2 , surveys indicate that many factors, in addition to concerns about privacy and confidentiality, can potentially influence an individual’s willingness to participate in medical research, including the type of research and personal characteristics such as health status, age, education, and race. Notably, respondents with greater knowledge of how research is conducted were more willing to participate in research.

OVERSIGHT OF HEALTH RESEARCH

Historical Development of Federal Protections of Health Information in Research

The development of international codes, federal legislation, and federal regulation of human subjects often occurred in response to past abuses in biomedical experiments (reviewed by Pritts, 2008 ) ( Box 3-3 ). The most well-known examples included (1) reported abuses of concentration camp prisoners in Nazi experiments during World War II, and (2) the Tuskegee syphilis study begun in 1932, in which researchers withheld effective treatment from affected African American men long after a cure for syphilis was found. Most of the current principles and standards for conducting human subjects research were developed primarily to protect against the physical and mental harms that can result from these types of biomedical experiments. Therefore, they focus on the principles of autonomy and consent. Although the standards apply to research that uses identifiable health information, research based solely on information is not their primary focus.

The Basis for Human Subjects Protections in Biomedical Research. Nuremberg Code The Nuremberg Code, created by the international community after the Nazi War Crimes Trials, is generally seen as the first codification (more...)

In the United States, perhaps the most influential inquiry into the protection of human subjects in research was the Belmont Report. The Belmont principles have been elaborated on in many settings, and served as the basis for formal regulation of human subjects research in the United States. In general, states do not directly regulate the activity of most researchers ( Burris et al., 2003 ). However, the Belmont Commission’s recommendations were reflected in the Department of Health and Human Services’ (HHS’s) Policy for Protection of Human Subjects Research, Subpart A of 45 C.F.R. 46 (“Subpart A”) in 1979. 9 These protections were considered a benchmark policy for federal agencies, and in December 1981, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research recommended 10 that all federal departments and agencies adopt the HHS regulations. 11

In 1982, the President’s Office of Science and Technology Policy appointed a Committee for the Protection of Human Research Subjects to respond to the recommendations of the President’s commission. The committee agreed that uniformity of federal regulations on human subjects protection is desirable to eliminate unnecessary regulations and to promote increased understanding by institutions that conduct federally supported or regulated research. As a result, in 1991, other federal departments and agencies joined HHS in adopting a uniform set of rules for the protection of human subjects of research, identical to Subpart A of 45 C.F.R. 46, which is now informally known as the “Common Rule.” Eighteen federal agencies have now adopted the Common Rule as their own respective regulations.

Overview of the Common Rule

The Common Rule governs most federally funded research conducted on human beings and aims to ensure that the rights of human subjects are protected during the course of a research project. The Common Rule stresses the importance of individual autonomy and consent; requires independent review of research by an Institutional Review Board (IRB); and seeks to minimize physical and mental harm. Privacy and confidentiality protections, although not defined in a detailed and prescriptive manner, are included as important components of risk in research.

The framework for achieving the goal of protecting human subjects is based on two foundational requirements: the informed consent of the research participant and the review of proposed research by an IRB. This section describes some of the basic parameters of the Common Rule (reviewed by Pritts, 2008 ). Particular provisions that interact with the HIPAA Privacy Rule are described in more detail in Chapter 4 .

Scope of the Common Rule

In general, the Common Rule applies only to research on human subjects that is supported by the federal government. 12 As noted previously, research is defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” 13

Under the Common Rule, a “human subject” is defined as “a living individual about whom an investigator … conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.” Private information is considered to be personally identifiable if the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

The Common Rule applies to most human subjects research conducted using federal funds, but its influence is broader because most institutions that accept federal funds sign an agreement (a Federalwide Assurance or FWA) with HHS to abide by the Common Rule requirements in all research, regardless of funding source. Nonetheless, some privately funded human subjects research is conducted outside the purview of federal regulation ( Goldman and Choy, 2001 ; Williams, 2005 ). Companies and other organizations may voluntarily choose to apply the Common Rule to their research projects, and many do. However, research projects in which compliance is voluntary are not subject to oversight or disciplinary action by HHS ( Goldman and Choy, 2001 ; Williams, 2005 ).

Informed Consent 14

The Common Rule requires that a researcher obtain informed consent (usually in writing) from a person before he/she can be admitted to a study ( Williams, 2005 ). Informed consent is sought through a process in which a person learns key facts about a research study, including the potential risks and benefits, so that he/she can then agree voluntarily to take part or decide against it.

The Common Rule informed consent regulations focus primarily on the elements and documentation of informed consent rather than on the process used to obtain it. As to the process, the regulations require that informed consent be sought only under circumstances that provide the prospective subject with adequate opportunity to consider whether to participate. The Common Rule requires that information pertaining to informed consent be given in language understandable to the subject, and that the consent does not imply that the subject is giving up his/her legal rights or that the investigator is released from liability for negligence during the conduct of the study. 15

The Common Rule also specifies a number of elements that must be provided when informed consent is sought. These elements include:

an explanation of the purposes of the research,
the expected duration of the subject’s participation,
the potential risks and benefits of the research,
how confidentiality will be maintained,
the fact that participation is strictly voluntary, and
who the subject can contact to answer questions about the study or about his/her rights as a research participant.

In certain limited circumstances, the Common Rule allows an informed consent to be for unspecified future research. For example, under the Common Rule an informed consent can be used to obtain a person’s permission to study personally identifiable information maintained in a repository for future, unspecified research purposes ( HHS, 2003 ).

For the most part, the required elements of an informed consent address all types of research, although some are more relevant to biomedical research (e.g., the consent must include a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject). One required element of informed consent is particularly relevant to research involving personally identifiable health information. The Common Rule requires an informed consent to include a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. 16

Institutional Review Boards

Adopting the principles of the Belmont Report, the Common Rule requires that protocols for human subjects research be reviewed by an IRB ( Box 3-4 ) before research may begin. 17 The IRB must meet certain membership requirements, including having members with different expertise and at least one member who is not affiliated with the investigator’s institution. The Common Rule specifies which level of IRB review is needed for various types of research and provides criteria for the IRB to consider during the review. Although the Common Rule does not specify the procedures an IRB must follow in its review of protocols, it does require the IRB to have written procedures for how it will review protocols and document IRB decisions.

Institutional Review Boards. According to the Department of Health and Human Services (HHS) Institutional Review Board (IRB) guidebook, “the IRB is an administrative body established to protect the rights and welfare of human research subjects (more...)

The Common Rule requires that an IRB determine the following factors are satisfied to approve proposed research:

Risks to subjects are minimized;
Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result;
The selection of subjects is equitable;
Informed consent will be sought in accordance with the rules and will be documented;
When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects; and
When appropriate, adequate provisions are in place to protect the privacy of subjects and to maintain the confidentiality of data. 18

An IRB may waive the requirement to obtain informed consent or approve an alteration of the consent form for some minimal risk research. The IRB may also waive the requirement for signed consent in certain circumstances. 19

Anonymized Data

As noted above, the Common Rule considers use of “private identifiable information” to be human subjects research. Data are considered personally identifiable if the identity of the subject is or may be readily ascertained by the investigator or associated with the information accessed by the researcher. 20 However, the Common Rule exempts from its requirements research that involves:

[T]he collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. 21

Otherwise identifiable data may be deidentified or “anonymized” for purposes of the Common Rule if it is coded and certain other conditions are met ( HHS, 2004 ). Under Guidance issued by the Office for Human Research Protection, information is “coded” if identifying information (such as name or Social Security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (the code), and a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimen.

Research involving only coded private information or specimens is not considered to involve human subjects under the Common Rule if the following conditions are met:

The private information or specimens were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals; and
—The key to decipher the code is destroyed before the research begins;
—The investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, until the individuals are deceased;
—IRB-approved written policies and operating procedures for a repository or data management center prohibit the release of the key to investigators under any circumstances, until the individuals are deceased; or
—Other legal requirements prohibit the release of the key to the investigators, until the individuals are deceased.

Under this standard, when a researcher accesses or receives data that have been coded and does not have access to the identifying key, the research is not considered human subjects research and is not subject to the Common Rule’s requirements of informed consent or IRB review and approval of protocol.

Enforcement of the Common Rule

The Common Rule requirements for informed consent do not preempt any applicable federal, state, or local laws that require additional information to be disclosed to a subject in order for informed consent to be legally effective. 22

Federal funding can be suspended or withdrawn from an institution when it is found to be in material violation of the Common Rule. 23 There is no authority to impose penalties directly on individual researchers for violations. Neither does the Common Rule expressly provide a research participant with a private right of action. It should be noted, however, that recent cases indicate that courts may be willing to hold an institution liable under common law negligence theories where the approved informed consent form is determined to be less than adequate ( Shaul et al., 2005 ). 24

FDA Protection of Human Research Subjects

Some health research is also subject to FDA regulations. The FDA is charged by statute with ensuring the protection of the rights, safety, and welfare of human subjects who participate in clinical investigations 25 involving articles subject to the Federal Food, Drug, and Cosmetic Act 26 (the Act), as well as clinical investigations that support applications for research or marketing permits for products regulated by the FDA, including drugs, medical devices, and biological products for human use ( Box 3-5 ).

FDA Protection of Human Subjects Regulations. The Food and Drug Administration (FDA) Protection of Human Subjects Regulations aim to protect the rights of human subjects enrolled in research involving products that the FDA regulates (i.e., drugs, medical (more...)

In January 1981, the FDA adopted regulations governing informed consent of human subjects 27 and regulations establishing standards for the composition, operation, and responsibilities of IRBs that review clinical investigations involving human subjects. 28 At the same time, HHS adopted the Common Rule regulations on the protection of human research subjects. 29 The FDA’s regulations were harmonized with the Common Rule in 1991 to the extent permitted by statute. Key differences between FDA and HHS regulations include that the FDA does not allow for waiver or alteration of informed consent and requires that subjects be informed that the FDA may inspect their medical records. In addition, studies of efficacy based solely on medical records research are not permitted to support registration. Remaining differences in the rules are due to differences in the statutory scope or requirements ( Lee, 2000 ).

DISTINGUISHING HEALTH RESEARCH FROM PRACTICE

The Common Rule and Privacy Rule make a somewhat artificial distinction between health research and some closely related health care practices, such as public health practice, quality improvement activities, program evaluations, 30 and utilization reviews, 31 all of which may involve collection and analysis of personally identifiable health information. However, determining which activities meet the definition of “research” is a major challenge for IRBs, Privacy Boards, 32 investigators, and health care practitioners because neither the regulations nor their interpretations by HHS provide clear guidance on how to distinguish research from activities that use similar techniques to analyze health information ( IOM, 2000a ).

It is important for IRBs and Privacy Boards to correctly distinguish among activities that are or are not subject to the various provisions of the Privacy Rule and the Common Rule. Only research requires formal IRB or Privacy Board review and informed consent. 33 Inappropriate classification of an activity as research can make it difficult or impossible for important health care activities, such as public health practice and quality improvement, to be undertaken. On the other hand, failure to correctly identify an activity as research could potentially allow improper disclosure of personally identifiable health information without sufficient oversight.

Thus, standard criteria are urgently needed for IRBs and Privacy Boards to use when making distinctions between health research and related activities, and the committee recommends that HHS consult with relevant stake holders to develop such standard criteria. HHS is aware of this need, and created a working document titled “What Is Research?” However, the work on this project apparently has been delayed for unknown reasons ( NCURA, 2007 ). 34 As described below, a number of other models have already been proposed to help determine whether activities should be classified as research in the fields of public health and quality improvement, and these could be instructive for developing HHS guidance. Any criteria adopted by HHS should be regularly evaluated to ensure that they are helpful and producing the desired outcomes.

The following sections describe some ongoing efforts to develop such criteria in the fields of public health and quality improvement. The intent of the committee is not to endorse these particular models, but rather to illustrate the challenges associated with making these distinctions and establishing standard criteria.

Public Health Practice Versus Public Health Research

The Belmont Report defined health practice as “interventions designed solely to enhance the well-being of the person, patient or client, and which have reasonable expectation of success” ( CDC, 1999 ). To apply this definition to “public” health practice, the targeted beneficiary of the intervention must be expanded to include benefit to the community, rather than just a particular person. Neither the Common Rule nor the Privacy Rule provides a specific definition for public health research; rather public health research is included in the general definition of research. However, the Privacy Rule regulates public health practice differently from public health research (see Chapter 4 ).

An early model for distinguishing public health research from public health practice focused on the intent for which the activity was designed, noting that the intent of public health research is to “contribute to or generate generalizable knowledge,” while the intent of public health practice is to “conduct programs to prevent disease and injury and improve the health of communities” ( Snider and Stroup, 1997 ). The Centers for Disease Control and Prevention developed a similar method with an expanded assessment of intent. For example, the model posits that in public health research, the intended benefits of the project extend beyond the study participants, and the data collected exceed the requirements for the care of the study participants. But for public health practice, the intended benefits of the project are primarily for the participants in the activity, or for the participants’ community, and the only data collected are those needed to assess or improve a public health program or service, or the health of the participants and their community. The model also assumes that public health practice is based on well-established medical interventions and is nonexperimental ( CDC, 1999 ). However, these models both have been criticized as too subjective and too dependent on the opinion of the person conducting the activity ( Gostin, 2008 ; Hodge, 2005 ).

A new, more comprehensive model incorporating much of the previous two was recently proposed as a more objective checklist to be used by IRBs, Privacy Boards, and interested parties ( Hodge, 2005 ; Hodge and Gostin, 2004 ). The foundations for this model are specific definitions of public health research: “the collection and analysis of identifiable health data by a public health authority for the purpose of generating knowledge that will benefit those beyond the participating community who bear the risks of participation,” and public health practice: “the collection and analysis of identifiable health data by a public health authority for the purpose of protecting the health of a particular community, where the benefits and risks are primarily designed to accrue to the participating community.”

The model is based on two primary assumptions. First, the actor performing the activity in question is a governmental public health official, agent, agency, or entity at the federal, tribal, state, or local level. Second, the activity in question involves the acquisition, use, or disclosure of personally identifiable health data. The model is then divided into two stages. Stage 1 is applied to all activities, and can be used to distinguish practice from research in the easiest cases. Stage 2 is only applied to those cases that are hard to distinguish, and where Stage 1 failed to lead to a definitive IRB/Privacy Board decision ( Box 3-6 ).

A Model for Distinguishing Public Health Practice from Research. Stage 1 Public health practice:

Quality Improvement Versus Health Research

Quality improvement has been defined as “systematic, data-guided activities designed to bring about immediate, positive change in the delivery of health care in a particular setting” ( Baily, 2008 ). Quality improvement activities do not require IRB or Privacy Board approval under the Common Rule or the Privacy Rule, which classify quality improvement as a component of health care operations. 35

However, in many cases, it is difficult for health care providers, IRBs, and Privacy Boards to determine whether a particular activity is purely for quality improvement, or whether it also entails research. One survey 36 exploring opinions in the health care community about the need for IRBs to review various quality-related activities found that physicians conducting quality improvement were less likely than IRB chairs to believe that IRB review was required for a given hypothetical activity, or that informed consent was necessary ( Lindenauer et al., 2002 ). Recently, a highly publicized case has again brought the issue to the forefront for all the stakeholders ( Box 3-7 ).

A Case Study of Quality Improvement and Research. Peter Pronovost of Johns Hopkins University (JHU) led a quality improvement effort at 103 intensive care units (ICUs) in Michigan hospitals to reduce the number of catheter-related bloodstream infections. (more...)

Some members of the health care community have proposed requiring that all prospective quality improvement activities go through external review ( Bellin and Dubler, 2001 ), while others have outlined specific criteria to differentiate quality improvement activities from research.

For example, Casarett and colleagues developed a two-part test to identify quality improvement activities. The first test is whether the majority of patients are expected to benefit directly from “the knowledge to be gained” from the initiative. This means that the patients must actually benefit from the knowledge learned during the evaluation, not just from being a recipient of the protocol itself. If the patients are generally expected to directly benefit from the knowledge gained during the activity, then the activity is quality improvement. If not, the activity is research. The second test is whether the participants would be subjected to additional risks or burdens, including the risk of privacy breach, beyond the usual clinical practice in order to make the results of the initiative generalizable. If yes, then the initiative should be reviewed as research ( Casarett et al., 2000 ).

More recently, the Hastings Center published a report exploring the similarities and differences between research and quality improvement. The report emphasized three fundamental characteristics of quality improvement and three fundamental characteristics of research. The authors argue that individuals have a responsibility to participate in the quality improvement activities because all patients have an interest in receiving high-quality medical care, and the success of a quality improvement activity depends on the cooperation of all patients. In addition, the report notes that quality improvement activities are a low risk to the patient, so there is little justification for not participating. The report also assumes that quality improvement activities are based on existing knowledge about human health and should lead to immediate local improvements in the provision of medical care.

In contrast, the report notes that participation in research should be voluntary, and decisions to participate should be based on researchers’ full disclosure of all the potential risks and benefits. In addition, the authors assert that research is designed to create new knowledge about human health, rather than relying solely on existing knowledge, and that most research does not result in any direct benefit to the institution where the research is being conducted.

The authors concluded that IRBs are not the appropriate body for the ethical oversight of quality improvement activities. They argue that IRBs unnecessarily impose high transaction costs on these activities because of the difference in the way they are conducted compared to research. For example, in research, any changes in methodology require further IRB approval. In contrast, quality improvement activities involve frequent adjustments in the intervention, measurement, and goals of the activity based on the experience of the investigators. Requiring the investigator to revisit an IRB every time a small adjustment is needed in such an activity significantly increases the amount of time and effort required to conduct the initiative and to produce meaningful data. Also, the investigators involved in quality improvement activities ordinarily are already involved in the clinical care of participants and bear responsibility for the quality and safety of an intervention. Thus, the authors argue that there is no need for the additional oversight by an IRB to protect participant safety.

Rather, the report recommended integrating the ethical oversight of quality improvement activities into the ongoing management of an institution’s health care delivery system, suggesting that oversight of quality improvement could be left with the managers of clinical care organizations, and that consent to receive treatment should include consent to participate in any quality improvement project that is minimal risk. However, the report stated that if a project has the characteristics of both quality improvement and research, the project should be reviewed as both human subjects research and quality improvement ( Baily et al., 2006 ; Lynn et al., 2007 ).

In response to the ongoing confusion over when quality improvement rises to the level of research and requires IRB review, the IOM jointly hosted a meeting with the American Board of Internal Medicine in May 2008 to discuss this issue. Key members of the quality improvement community attended, and short- and long-term solutions to this problem were proposed. However, no written report from this meeting was produced and no general consensus was reached.

THE IMPORTANCE OF EFFECTIVE COMMUNICATION WITH THE PUBLIC

As noted previously in this chapter, surveys indicate that the vast majority of Americans believe that health research is important and are interested in the findings of research studies. The majority of patients also appear to be willing to participate in health research, either by volunteering for a study to test a medical intervention or by allowing access to their medical records or stored biospecimens, under certain conditions. Their willingness to participate depends on trust in researchers to safeguard the rights and well-being of patients, including assurance of privacy and confidentiality, and the belief that it is a worthwhile endeavor that warrants their involvement. Yet patients often lack information about how research is conducted, and are rarely informed about research results that may have a direct impact on their health. The committee’s recommendations in this section are intended to address both the public’s desire for more information about health research and to help fulfill two of the committees overarching goals of the report: (1) improving the privacy and security of health information, and (2) improving the effectiveness of health research.

Disseminating Health Research Results

Ethicists have long suggested greater community involvement in health research studies, including more communication about research results (reviewed by Shalowitz and Miller, 2008a , b ). In addition, the IOM committee identified transparency—the responsibility to disclose clearly how and why personally identifiable information is being collected—as an important component of comprehensive privacy protections. A previous IOM report also recommended improved communication with the public and research participants to ensure that the protection process is open and accessible to all interested parties ( IOM, 2002 ). Effective communication would build the public’s trust of the research community and is consistent with the principles of fair information practices.

When patients consent to the use of their medical records in a particular study, health researchers should make greater efforts at the conclusion of the study to inform study participants about the results, and the relevance and importance of those results. Learning about clinically relevant findings from a study in which a patient has participated could make patients feel more integrated into the process and could encourage more to participate in future studies. A recent United Kingdom report on the use of personal data in health research concluded that public involvement in research is necessary for the success of information-based research, and that a public informed about the value of research is likely to have greater enthusiasm and confidence in research and the research community ( AMS, 2006 ). Moreover, direct feedback with study participants could lead to improved health care for the individuals if the results indicate that an altered course of care is warranted.

Nonetheless, there are multiple impediments, beyond cost, to providing meaningful feedback to participants. A summary of the results alone, while necessary and reasonable, can be seen as a token, and also raises questions about issues such as how best to write summaries, the stage at which results should be disseminated, and how to present research with uninformative outcomes. For example, one recent study found that sharing results directly with study participants was met with overwhelmingly favorable reactions from patients, but the study also revealed some obstacles ( Partridge et al., 2008 ). In a survey of women who had participated in a randomized trial of breast cancer therapy and had received a summary of the study results by mail, 95 percent reported that they were glad they received the results. Most respondents interpreted the results correctly, although incorrect interpretation of the results was associated with increased anxiety, as was dissatisfaction with treatment.

Although some guidelines for providing and explaining study results to research participants have been proposed, they differ in details because limited data are available on this subject, and thus standards are lacking ( Partridge and Winer, 2002 ; Partridge et al., 2008 ; Shalowitz and Miller, 2008b ; Zarin and Tse, 2008 ). Because transparency is best achieved by providing graded levels of information and guidance to interested parties ( IOM, 2002 ), it will be important to develop effective and efficient ways to communicate with various sectors of the population. A commitment to the principles of “plain language” 37 will be important. Broader adoption of electronic medical records may also be helpful in accomplishing this goal.

Research Registries

One way to make information about research studies more broadly available to the public is through registration of trials and other studies in public databases. HHS should encourage such registration of trials and other studies, particularly when research is conducted with an IRB/Privacy Board approved waiver of consent or authorization (see Chapter 4 ). Numerous clinical trial registries already exist, and registration has increased in recent years (reviewed by Zarin and Tse, 2008 ). In 2000, the National Library of Medicine established a clinical trials registry ( ClinicalTrials.gov ), which has expanded to include information from several other trial registries and to serve as the FDA-required site for submissions about clinical trials subject to the FDA databank requirement. The FDA Amendments Act of 2007 38 expanded the scope of required registrations at ClinicalTrials.gov and provided the first federally funded trials results database. It mandates registrations of controlled clinical investigations, except for Phase I trials, of drugs, biologics, and devices subject to FDA regulation.

A policy of the International Committee of Medical Journal Editors (ICMJE), adopted in fall 2005, also requires prospective trial registration as a precondition for publication ( DeAngelis et al., 2004 ). This policy led to a 73 percent increase in trial registrations of all intervention types from around the world ( Zarin et al., 2005 ). Nearly 45,000 trials had been registered by fall 2007.

However, although the development of such registries is an important first step toward providing high-quality clinical trial information to the public, no centralized system currently exists to disseminate information about clinical trials of drugs or other interventions, making it difficult for consumers and their health care providers to identify ongoing studies. The current statutory requirements for registration and data reporting in the United States are not as broad as the transnational policies of the ICMJE or the World Health Organization, which call for the registration of all interventional studies in human beings regardless of intervention type ( Laine et al., 2007 ; Sim et al., 2006 ). Moreover, noninterventional studies, such as observational studies that play an increasingly critical role in biomedical research, are not generally included in these databases. Because many noninterventional studies are conducted with an IRB/Privacy Board approved waiver of consent or authorization, including those studies in a registry could be an important method for increasing public knowledge of such studies.

Informing the Public About the Methods and Value of Research

As noted previously, clinical trials are the most visible of the various types of health research, but a great deal of information-based health research entails analysis of thousands of patient records to better understand human diseases, to determine treatment effectiveness, and to identify adverse side effects of therapies. This form of research is likely to increase in frequency as the availability of electronic records continues to expand. As we move toward the goal of personalized medicine, research results will be even more likely to be directly relevant to patients, but more study subjects will be necessary to derive meaningful results.

However, many patients probably are not aware that their medical records are being used in information-based research. For example, the recent study that used focus groups to examine the views of veterans toward the use of medical records in research found that the majority of participants (75 percent) were not aware that “under some circumstances, [their] medical records could be used in some research studies without [their] permission,” despite the fact that a notice of privacy practices, which included a statement that such research could occur, had been mailed to all participants less than a year prior to the study ( Damschroder et al., 2007 ).

Moreover, surveys show that many patients desire not only notice, but also the opportunity to decide whether to consent to such research with medical records. Those surveys further indicate that patients who wish to be asked for consent for each study are most concerned about the potentially detrimental affects of inappropriate disclosure of their personally identifiable health information, including discrimination in obtaining health or life insurance or employment.

As noted in Chapter 2 , strengthening security protections of health data should reduce the risk of security breaches and their potential negative consequences, and thus should help to alleviate patient concerns in this regard. But educating patients about how health research is conducted, monitored, and reported on could also help to ease patient concerns about privacy and increase patients’ trust in the research community, which as noted above is important for the public’s continued participation in health research. For example, datasets are most often provided to researchers without direct identifiers such as name and Social Security number. Furthermore, identifiers are not included in publications about research results. Also, under both the Privacy Rule and the Common Rule, a waiver of consent and authorization is possible only under the supervision of an IRB or Privacy Board, and a waiver is granted only when the research entails minimal risk and when obtaining individual consent and authorization is impracticable (see the previous section and also Chapter 4 ). Finally, professional ethics dictate that researchers safeguard data and respect privacy.

Conveying the value of medical records research to patients will be important. Surveys show that people are more supportive of research that is relevant to them and their loved ones. At the same time, educational efforts should stress the negative impact of incomplete datasets on research findings. Representative samples are essential to ensure the validity and generalizability of health research ( Box 3-8 ), but datasets will not represent the entire population if some people withhold access to their health information.

Selection Bias in Health Research. When researchers are required to obtain consent or authorization to access each individual’s medical record for a research study, it is likely that individuals’ willingness to grant access will not be (more...)

In addition, an educated public could also decrease the potential for biased research samples. A universal requirement for consent or authorization in medical records research leads to incomplete datasets, and thus to biased results and inaccurate conclusions. Some large medical institutions with a strong research history and reputation (e.g., Mayo Clinic) can obtain authorization and consent rates as high as 80 percent, but the 20 percent who refuse have distinct demographic and health characteristics. In fact, even a refusal rate of less than 5 percent can create selection bias in the data ( Jacobsen et al., 1999 ; see Chapter 5 for more detail). Conveying to the public the importance of health care improvements derived from medical records research and stressing the negative impact of incomplete datasets on research findings may increase the public’s participation in research and their willingness to support information-based research that is conducted with IRB or Privacy Board oversight, under a waiver of patient consent or authorization.

Numerous examples of important research findings from medical records research would not have been possible if direct patient consent and authorization were always required ( Box 3-1 ). For example, analysis of medical records showed that infants exposed to diethylstilbesterol (DES) during the first trimester of pregnancy had an increased risk of breast, vaginal, and cervical cancer as well as reproductive anomalies as adults. Similarly, studies of medical records led to the discovery that folic acid supplementation during pregnancy can prevent neural tube defects.

Thus, HHS and the health research community should work to edu cate the public about how research is done and the value it provides. All stakeholders, including professional organizations, nonprofit funders, and patient organizations, have different interests and responsibilities to make sure that their constituencies are well informed. For example, the American Society of Clinical Oncology and the American Heart Association already have some online resources to help patients gather information about research that may be relevant to their conditions. But coordination and identification of best practices by HHS would be helpful, and research is needed to identify which segments of the population would be receptive to and benefit from various types of information about how research is done and its value in order to create and implement an effective plan.

Greater use of community-based participatory research, in which community-based organizations or groups bring community members into the research process as partners to help design studies and disseminate the knowledge gained, 39 could help achieve this goal. These groups help researchers to recruit research participants by using the knowledge of the community to understand health problems and to design activities that the community is likely to value. They also inform community members about how the research is done and what comes out of it, with the goal of providing immediate community benefits from the results when possible.

CONCLUSIONS AND RECOMMENDATIONS

Based on its review of the information described in this chapter, the committee agreed on a second overarching principle to guide the formation of recommendations. The committee affirms the importance of maintaining and improving health research effectiveness. Research discoveries are central to achieving the goal of extending the quality of healthy lives. Research into causes of disease, methods for prevention, techniques for diagnosis, and new approaches to treatment has increased life expectancy, reduced infant mortality, limited the toll of infectious diseases, and improved outcomes for patients with heart disease, cancer, diabetes, and other chronic diseases. Patient-oriented clinical research that tests new ideas makes rapid medical progress possible. Today, the rate of discovery is accelerating, and we are at the precipice of a remarkable period of investigative promise made possible by new knowledge about the genetic underpinnings of disease. Genomic research is opening new possibilities for preventing illness and for developing safer, more effective medical care that may eventually be tailored for specific individuals. Further advances in relating genetic information to predispositions to disease and responses to treatments will require the use of large amounts of existing health-related information and stored tissue specimens. The increasing use of electronic medical records will further facilitate the generation of new knowledge through research and accelerate the pace of discovery. These efforts will require broad participation of patients in research and broad data sharing to ensure that the results are valid and applicable to different segments of the population. Collaborative partnerships among communities of patients, their physicians, and teams of researchers to gain new scientific knowledge will bring tangible benefits for people in this country and around the world.

Surveys indicate that the majority of Americans believe that health research is important, are interested in the findings of research studies, and are willing to participate in health research. But patients often lack information about how research is conducted and are rarely informed about research results that may have a direct impact on their health. Effective communication could build the public’s trust of the research community, which is important because trust is necessary for the public’s continued participation in research. Moreover, direct feedback could lead to improved health care for study participants if the results indicate that an altered course of care is warranted.

Thus, the committee recommends that when patients consent to the use of their medical records in a particular study, health researchers should make greater efforts when the study ends to inform study participants about the results, and the relevance and importance of those results. Broader adoption of electronic health records may be helpful in accomplishing this goal, but standards and guidelines for providing and explaining study results to research participants or various sectors of the public are needed.

HHS should also encourage registration of trials and other studies in public databases, particularly when research is conducted with an IRB/Privacy Board approved waiver of consent or authorization, as a way to make information about research studies more broadly available to the public. Numerous clinical trial registries already exist, and registration has increased in recent years, but no centralized system currently exists for disseminating information about clinical trials of drugs or other interventions, making it difficult for consumers and their health care providers to identify ongoing studies. Moreover, noninterventional studies, such as observational studies that play an increasingly critical role in biomedical research, are not generally included in these databases. Because many noninterventional studies are conducted with an IRB/Privacy Board approved waiver of consent or authorization, including such studies in a registry could be an important method for increasing public knowledge of those studies.

Interventional clinical trials are the most visible of the various types of health research, but a great deal of information-based health research entails analysis of thousands of patient records to better understand human diseases, to determine treatment effectiveness, and to identify adverse side effects of therapies. This form of research is likely to increase in frequency as the availability of electronic health records continues to expand. As we move toward the goal of personalized medicine, research results will be even more likely to be directly relevant to patients, but more study participants will be necessary to derive meaningful results.

However, many patients are likely not aware that their medical records are being used in information-based research, and surveys show that many patients desire not only notice, but also the opportunity to decide about whether to consent to such research with medical records. As noted in Chapter 2 , strengthening security protections of health data should reduce the risk of security breaches and their potential negative consequences, and thus should help to alleviate patient concerns in this regard. But educating patients about how health research is conducted, monitored, and reported could also increase patients’ trust in the research community. Thus, HHS and the health research community should work to educate the public about how research is done.

It will also be important for HHS and researchers to convey the value of health care improvements derived from medical records research, and to stress the negative impact of incomplete datasets on research findings. Representative samples are essential to ensure the validity and generalizability of health research, but datasets will not be representative of the entire population if some people withhold access to their health information. A universal requirement for consent or authorization in information-based research may lead to incomplete datasets, and thus to biased results and inaccurate conclusions. Numerous examples of important research findings from medical records research would not have been possible if direct patient consent and authorization were always required.

To ensure that beneficial health research and related activities continue to be undertaken with appropriate oversight under federal regulations, it will be important for HHS to also provide more guidance on how to distinguish the various activities. The Privacy Rule makes a distinction between health research and some closely related endeavors, such as public health and quality improvement activities, which also may involve collection and analysis of personally identifiable health information. Under the Privacy Rule (as well as the Common Rule), these activities, which aim to protect the public’s health and improve the quality of patient care, are considered health care “practice” rather than health research. Therefore, they can be undertaken without consent or authorization, or an IRB/Privacy Board waiver of consent or authorization. However, it can be a challenge for IRBs and Privacy Boards to distinguish among activities that are or are not subject to the various provisions of the Privacy Rule and the Common Rule, and inappropriate decisions may prevent important activities from being undertaken or could potentially allow improper disclosure of personally identifiable health information.

To address these difficulties, a number of models have been proposed that outline the criteria IRBs and Privacy Boards should use to distinguish practice and research. For example, one recent model provides a detailed checklist for IRBs and Privacy Boards to use in determining whether an activity is public health research and required to comply with the research provisions of the Privacy Rule, or public health practice that does not need IRB/Privacy Board review. The committee believes that standardizing the criteria is essential to support the conduct of these important health care activities.

Thus, HHS should convene the relevant stakeholders to develop standard criteria for IRBs and Privacy Boards to use when making decisions about whether protocols entail research or practice. There should be flexibility in the regulation to allow important activities to go forward with appropriate levels of oversight. Also, it will be important to evaluate whether these criteria are effective in aiding IRB/Privacy Board reviews of proposed protocols, and whether they lead to appropriate IRB/Privacy Board decisions.

These changes suggested above could be accomplished without any changes to HIPAA by making them a condition of funding from HHS and other research sponsors and by providing some additional funds to cover the cost.

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Research!America. America speaks: Poll summary. Vol. 7. Alexandria, VA: United Health Foundation; 2007.
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Shaul RZ, Birenbaum S, Evans M. Legal liability in research: Early lessons from North America. BMC Medical Ethics. 2005; 6 (4):1–4. [ PMC free article : PMC1182131 ] [ PubMed : 15953387 ]
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Epidemiology is the study of the occurrence, distribution, and control of diseases in populations.

Health services research has been defined as a multidisciplinary field of inquiry, both basic and applied, that examines the use, costs, quality, accessibility, delivery, organization, financing, and outcomes of health care services to increase knowledge and understanding of the structure, processes, and effects of health services for individuals and populations ( IOM, 1995 ).

The National Committee on Vital and Health Statistics has noted that “secondary uses” of health data is an ill-defined term, and urges abandoning it in favor of precise description of each use ( NCVHS, 2007a ). Thus, the committee chose to minimize use of the term in this report.

See Standards for Privacy of Individually Identifiable Health Information, 64 Fed. Reg. 59918, 59967 (preamble to rule proposed November 3, 1999) for a discussion on the benefits of health records research.

Effectiveness can be defined as the extent to which a specific test or intervention, when used under ordinary circumstances, does what it is intended to do. Efficacy refers to the extent to which a specific test or intervention produces a beneficial result under ideal conditions (e.g., in a clinical trial).

See http://www .intermacs.org .

See http://www .elso.med.umich.edu .

See http://www .unos.org/Data .

The Department of Health, Education and Welfare (now HHS) had previously issued policy and guidance on the protection of human subjects. See Williams (2005) .

In its report “First Biennial Report on the Adequacy and Uniformity of Federal Rules and Policies, and their Implementation, for the Protection of Human Subjects in Biomedical and Behavioral Research, Protecting Human Subjects.”

45 C.F.R. part 46 (2005).

See 45 C.F.R. § 46.101 (2005).

See 45 C.F.R. § 46.102(d) (2005).

This section on informed consent is based largely on a Congressional Research Service report ( Williams, 2005 ), as adapted by Pritts (2008) .

See 45 C.F.R. § 46.116 (2005).

See 45 C.F.R. § 46.116(b) (2005).

See 45 C.F.R. § 46.103 (2005).

See 45 C.F.R. § 46.111 (2005). There are additional factors if the study includes subjects who are likely to be vulnerable to coercion or undue influence.

See 45 C.F.R. § 46.116(d); 46.117(c) (2005).

See 45 C.F.R. § 46.102(f) (2005).

See 45 C.F.R. § 46.101(b)(4) (2005).

See 45 C.F.R. § 46.116(e) (2005).

See 45 C.F.R. § 46.123 (2005).

See also Grimes v. Kennedy Krieger Institute , 782 A. 2d 807 (Md. Ct. App. 2001); Gelsinger v. University of Pennsylvania (Philadelphia County Court of Common Pleas filed September 18, 2000), available at http://www .sskrplaw.com /links/healthcare2.html .

The FDA has defined “clinical investigation” to be synonymous with “research.”

The Food, Drug, and Cosmetic Act Section 505(i), 507(d), or 520(g) of 21 U.S.C. 355(i), 357(d), or 360j(g) (1972).

See 21 C.F.R. part 50 (2008); 46 Fed. Reg. 8942 (1981).

See 21 C.F.R. part 56 (2008); 46 Fed. Reg. 8958 (1981).

See 45 C.F.R. part 46 (2005); 46 Fed. Reg. 8366 (1981).

The Centers for Disease Control and Prevention defines program evaluation as the “systematic investigation of the merit, worth, or significance of organized public health action,” noting that such evaluations are “systematic ways to improve and account for public health actions by involving procedures that are useful, feasible, ethical, and accurate.” They can be based on goals, processes, outcomes, or value ( http://www .cdc.gov/mmwr /preview/mmwrhtml/rr4811a1.htm ).

The Utilization Review Accreditation Commission defines utilization review as “the evaluation of the medical necessity, appropriateness, and efficiency of the use of health care services, procedures, and facilities under the provisions of the applicable health benefits plans” ( http://www .urac.org/about/ ).

Another type of oversight board defined by the Privacy Rule. See Chapter 4 .

Under the Privacy Rule, consent is referred to as authorization. See Chapter 4 .

Personal communication, C. Heide, Office for Civil Rights, HHS, May 29, 2008.

The Privacy Rule defines the term “health care operations” by listing a number of specific activities that qualify as health care operations. These include “conducting quality assessment and improvement activities, population-based activities relating to improving or reducing health care costs, and case management and care coordination.” See 45 C.F.R. § 164.501 (2006).

A total of 444 surveys were mailed to the medical directors of quality improvement and IRB chairs at hospitals with 400 or more beds that belong to the Council of Teaching Hospitals of the Association of American Medical Colleges, and to the editors of all U.S.-based medical journals that publish original research and appear in the Abridged Index Medicus. 236 surveys were returned, for a 53 percent response rate. The survey consisted of six brief scenarios that asked respondents to determine whether the described project needed IRB review and informed consent.

See http: //plainlanguage.gov/index.cfm .

FDA, Public Law 110–85 § 801 (2007).

See http://www .ahrq.gov/research/cbprrole .htm .

Cite this Page Institute of Medicine (US) Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule; Nass SJ, Levit LA, Gostin LO, editors. Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research. Washington (DC): National Academies Press (US); 2009. 3, The Value, Importance, and Oversight of Health Research.
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Fact-checking warnings from Democrats about Project 2025 and Donald Trump

This fact check originally appeared on PolitiFact .

Project 2025 has a starring role in this week’s Democratic National Convention.

And it was front and center on Night 1.

WATCH: Hauling large copy of Project 2025, Michigan state Sen. McMorrow speaks at 2024 DNC

“This is Project 2025,” Michigan state Sen. Mallory McMorrow, D-Royal Oak, said as she laid a hardbound copy of the 900-page document on the lectern. “Over the next four nights, you are going to hear a lot about what is in this 900-page document. Why? Because this is the Republican blueprint for a second Trump term.”

Vice President Kamala Harris, the Democratic presidential nominee, has warned Americans about “Trump’s Project 2025” agenda — even though former President Donald Trump doesn’t claim the conservative presidential transition document.

“Donald Trump wants to take our country backward,” Harris said July 23 in Milwaukee. “He and his extreme Project 2025 agenda will weaken the middle class. Like, we know we got to take this seriously, and can you believe they put that thing in writing?”

Minnesota Gov. Tim Walz, Harris’ running mate, has joined in on the talking point.

“Don’t believe (Trump) when he’s playing dumb about this Project 2025. He knows exactly what it’ll do,” Walz said Aug. 9 in Glendale, Arizona.

Trump’s campaign has worked to build distance from the project, which the Heritage Foundation, a conservative think tank, led with contributions from dozens of conservative groups.

Much of the plan calls for extensive executive-branch overhauls and draws on both long-standing conservative principles, such as tax cuts, and more recent culture war issues. It lays out recommendations for disbanding the Commerce and Education departments, eliminating certain climate protections and consolidating more power to the president.

Project 2025 offers a sweeping vision for a Republican-led executive branch, and some of its policies mirror Trump’s 2024 agenda, But Harris and her presidential campaign have at times gone too far in describing what the project calls for and how closely the plans overlap with Trump’s campaign.

PolitiFact researched Harris’ warnings about how the plan would affect reproductive rights, federal entitlement programs and education, just as we did for President Joe Biden’s Project 2025 rhetoric. Here’s what the project does and doesn’t call for, and how it squares with Trump’s positions.

Are Trump and Project 2025 connected?

To distance himself from Project 2025 amid the Democratic attacks, Trump wrote on Truth Social that he “knows nothing” about it and has “no idea” who is in charge of it. (CNN identified at least 140 former advisers from the Trump administration who have been involved.)

The Heritage Foundation sought contributions from more than 100 conservative organizations for its policy vision for the next Republican presidency, which was published in 2023.

Project 2025 is now winding down some of its policy operations, and director Paul Dans, a former Trump administration official, is stepping down, The Washington Post reported July 30. Trump campaign managers Susie Wiles and Chris LaCivita denounced the document.

WATCH: A look at the Project 2025 plan to reshape government and Trump’s links to its authors

However, Project 2025 contributors include a number of high-ranking officials from Trump’s first administration, including former White House adviser Peter Navarro and former Housing and Urban Development Secretary Ben Carson.

A recently released recording of Russell Vought, a Project 2025 author and the former director of Trump’s Office of Management and Budget, showed Vought saying Trump’s “very supportive of what we do.” He said Trump was only distancing himself because Democrats were making a bogeyman out of the document.

Project 2025 wouldn’t ban abortion outright, but would curtail access

The Harris campaign shared a graphic on X that claimed “Trump’s Project 2025 plan for workers” would “go after birth control and ban abortion nationwide.”

The plan doesn’t call to ban abortion nationwide, though its recommendations could curtail some contraceptives and limit abortion access.

What’s known about Trump’s abortion agenda neither lines up with Harris’ description nor Project 2025’s wish list.

Project 2025 says the Department of Health and Human Services Department should “return to being known as the Department of Life by explicitly rejecting the notion that abortion is health care.”

It recommends that the Food and Drug Administration reverse its 2000 approval of mifepristone, the first pill taken in a two-drug regimen for a medication abortion. Medication is the most common form of abortion in the U.S. — accounting for around 63 percent in 2023.

If mifepristone were to remain approved, Project 2025 recommends new rules, such as cutting its use from 10 weeks into pregnancy to seven. It would have to be provided to patients in person — part of the group’s efforts to limit access to the drug by mail. In June, the U.S. Supreme Court rejected a legal challenge to mifepristone’s FDA approval over procedural grounds.

WATCH: Trump’s plans for health care and reproductive rights if he returns to White House The manual also calls for the Justice Department to enforce the 1873 Comstock Act on mifepristone, which bans the mailing of “obscene” materials. Abortion access supporters fear that a strict interpretation of the law could go further to ban mailing the materials used in procedural abortions, such as surgical instruments and equipment.

The plan proposes withholding federal money from states that don’t report to the Centers for Disease Control and Prevention how many abortions take place within their borders. The plan also would prohibit abortion providers, such as Planned Parenthood, from receiving Medicaid funds. It also calls for the Department of Health and Human Services to ensure that the training of medical professionals, including doctors and nurses, omits abortion training.

The document says some forms of emergency contraception — particularly Ella, a pill that can be taken within five days of unprotected sex to prevent pregnancy — should be excluded from no-cost coverage. The Affordable Care Act requires most private health insurers to cover recommended preventive services, which involves a range of birth control methods, including emergency contraception.

Trump has recently said states should decide abortion regulations and that he wouldn’t block access to contraceptives. Trump said during his June 27 debate with Biden that he wouldn’t ban mifepristone after the Supreme Court “approved” it. But the court rejected the lawsuit based on standing, not the case’s merits. He has not weighed in on the Comstock Act or said whether he supports it being used to block abortion medication, or other kinds of abortions.

Project 2025 doesn’t call for cutting Social Security, but proposes some changes to Medicare

“When you read (Project 2025),” Harris told a crowd July 23 in Wisconsin, “you will see, Donald Trump intends to cut Social Security and Medicare.”

The Project 2025 document does not call for Social Security cuts. None of its 10 references to Social Security addresses plans for cutting the program.

Harris also misleads about Trump’s Social Security views.

In his earlier campaigns and before he was a politician, Trump said about a half-dozen times that he’s open to major overhauls of Social Security, including cuts and privatization. More recently, in a March 2024 CNBC interview, Trump said of entitlement programs such as Social Security, “There’s a lot you can do in terms of entitlements, in terms of cutting.” However, he quickly walked that statement back, and his CNBC comment stands at odds with essentially everything else Trump has said during the 2024 presidential campaign.

Trump’s campaign website says that not “a single penny” should be cut from Social Security. We rated Harris’ claim that Trump intends to cut Social Security Mostly False.

Project 2025 does propose changes to Medicare, including making Medicare Advantage, the private insurance offering in Medicare, the “default” enrollment option. Unlike Original Medicare, Medicare Advantage plans have provider networks and can also require prior authorization, meaning that the plan can approve or deny certain services. Original Medicare plans don’t have prior authorization requirements.

The manual also calls for repealing health policies enacted under Biden, such as the Inflation Reduction Act. The law enabled Medicare to negotiate with drugmakers for the first time in history, and recently resulted in an agreement with drug companies to lower the prices of 10 expensive prescriptions for Medicare enrollees.

Trump, however, has said repeatedly during the 2024 presidential campaign that he will not cut Medicare.

Project 2025 would eliminate the Education Department, which Trump supports

The Harris campaign said Project 2025 would “eliminate the U.S. Department of Education” — and that’s accurate. Project 2025 says federal education policy “should be limited and, ultimately, the federal Department of Education should be eliminated.” The plan scales back the federal government’s role in education policy and devolves the functions that remain to other agencies.

Aside from eliminating the department, the project also proposes scrapping the Biden administration’s Title IX revision, which prohibits discrimination based on sexual orientation and gender identity. It also would let states opt out of federal education programs and calls for passing a federal parents’ bill of rights similar to ones passed in some Republican-led state legislatures.

Republicans, including Trump, have pledged to close the department, which gained its status in 1979 within Democratic President Jimmy Carter’s presidential Cabinet.

In one of his Agenda 47 policy videos, Trump promised to close the department and “to send all education work and needs back to the states.” Eliminating the department would have to go through Congress.

What Project 2025, Trump would do on overtime pay

In the graphic, the Harris campaign says Project 2025 allows “employers to stop paying workers for overtime work.”

The plan doesn’t call for banning overtime wages. It recommends changes to some Occupational Safety and Health Administration, or OSHA, regulations and to overtime rules. Some changes, if enacted, could result in some people losing overtime protections, experts told us.

The document proposes that the Labor Department maintain an overtime threshold “that does not punish businesses in lower-cost regions (e.g., the southeast United States).” This threshold is the amount of money executive, administrative or professional employees need to make for an employer to exempt them from overtime pay under the Fair Labor Standards Act.

In 2019, the Trump’s administration finalized a rule that expanded overtime pay eligibility to most salaried workers earning less than about $35,568, which it said made about 1.3 million more workers eligible for overtime pay. The Trump-era threshold is high enough to cover most line workers in lower-cost regions, Project 2025 said.

The Biden administration raised that threshold to $43,888 beginning July 1, and that will rise to $58,656 on Jan. 1, 2025. That would grant overtime eligibility to about 4 million workers, the Labor Department said.

It’s unclear how many workers Project 2025’s proposal to return to the Trump-era overtime threshold in some parts of the country would affect, but experts said some would presumably lose the right to overtime wages.

Other overtime proposals in Project 2025’s plan include allowing some workers to choose to accumulate paid time off instead of overtime pay, or to work more hours in one week and fewer in the next, rather than receive overtime.

Trump’s past with overtime pay is complicated. In 2016, the Obama administration said it would raise the overtime to salaried workers earning less than $47,476 a year, about double the exemption level set in 2004 of $23,660 a year.

But when a judge blocked the Obama rule, the Trump administration didn’t challenge the court ruling. Instead it set its own overtime threshold, which raised the amount, but by less than Obama.

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Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research.

3 The Value, Importance, and Oversight of Health Research

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