National Bioethics Advisory Commission Recommendations on Research Involving Human Participants
Changes at the National Level
Recommendation 3.1: The federal oversight system should protect the rights and welfare of human research participants by requiring 1) independent review of risks and potential benefits; and 2) informed consent. Protection should be available to participants in both publicly and privately sponsored research. Federal legislation should be enacted to provide such protection.
Recommendation 3.2: To ensure the protection of the rights and welfare of all research participants, federal legislation should be enacted to create a single, independent federal office, the National Office for Human Research Oversight (NOHRO), to lead and coordinate the oversight system. This office should be responsible for policy development, regulatory reform (see Recommendation 3.3), research review and monitoring, research ethics education, and enforcement.
Recommendation 3.3: A unified, comprehensive federal policy embodied in a single set of regulations and guidance should be created that would apply to all types of research involving human participants (see Recommendation 3.2).
Recommendation 3.4: Federal policy should cover research involving human participants that entails systematic collection or analysis of data with the intent to generate new knowledge. Research should be considered to involve human participants when individuals 1) are exposed to manipulations, interventions, observations, or other types of interactions with investigators; or 2) are identifiable through research using biological materials, medical and other records, or databases. Federal policy also should identify those research activities that are not subject to federal oversight and outline a procedure for determining whether a particular study is or is not covered by the oversight system.
Recommendation 3.5: Federal policy should require research ethics review that is commensurate with the nature and level of risk involved. Standards and procedures for review should distinguish between research that poses minimal risk and research that poses more than minimal risk. Minimal risk should be defined as the probability and magnitude of harms that are normally encountered in the daily lives of the general population (see Recommendation 4.2). In addition, the federal government should facilitate the creation of special, supplementary review bodies for research that involves novel or controversial ethical issues.
Review of Research
Recommendation 4.1: An analysis of the risks and potential benefits of study components should be applied to all types of covered research (see Recommendation 3.4). In general, each component of a study should be evaluated separately, and its risks should be both reasonable in themselves as well as justified by the potential benefits to society or the participants. Potential benefits from one component of a study should not be used to justify risks posed by a separate component of a study.
Recommendation 4.2: Federal policy should distinguish between research studies that pose minimal risk and those that pose more than minimal risk (see Recommendation 3.5). Minimal risk should be defined as the probability and magnitude of harms that are normally encountered in the daily lives of the general population. If a study that would normally be considered minimal risk for the general population nonetheless poses higher risk for any prospective participants, then the institutional review board should approve the study only if it has determined that appropriate protections are in place for all prospective participants.
Recommendation 4.3: Federal policy should promote the inclusion of all segments of society in research. Guidance should be developed on how to identify and avoid situations that render some participants or groups vulnerable to harm or coercion. Sponsors and investigators should design research that incorporates appropriate safeguards to protect all prospective participants.
The Informed Consent Process
Recommendation 4.4: Federal policy should emphasize the process of informed consent rather than the form of its documentation and should ensure that competent participants have given their voluntary informed consent. Guidance should be issued about how to provide appropriate information to prospective research participants, how to promote prospective participants’ comprehension of such information, and how to ensure that participants continue to make informed and voluntary decisions throughout their involvement in the research.
Recommendation 4.5: Federal policy should permit IRBs in certain, limited situations (some studies using existing identifiable data or some observational studies) to waive informed consent requirements if all of the following criteria are met:
a) all components of the study involve minimal risk or any component involving more than minimal risk must also offer the prospect of direct benefit to participants;
b) the waiver is not otherwise prohibited by state, federal, or international law;
c) there is an adequate plan to protect the confidentiality of the data;
d) there is an adequate plan for contacting participants with information derived from the research, should the need arise;
e) in analyzing risks and potential benefits, the IRB specifically determines that the benefits from the knowledge to be gained from the research study outweigh any dignitary harm associated with not seeking informed consent.
Recommendation 4.6: Federal policy should require investigators to document that they have obtained voluntary informed consent but should be flexible with respect to the form of such documentation. Especially when individuals can easily refuse or discontinue participation, or when signed form might threaten confidentiality, IRBs should permit investigators to use other means of verifying that informed consent has been obtained.
Protecting Privacy and Confidentiality
Recommendation 4.7: Federal policy should be developed and mechanisms should be provided to enable investigators and institutions to reduce threats to privacy and breaches of confidentiality. The feasibility of additional mechanisms should be examined to strengthen confidentiality protections in research studies.
Development of a Research Agenda for Research Ethics
Recommendation 4.8: The federal government, in partnership with academic institutions and professional societies, should facilitate discussion about emerging human research protection issues and develop a research agenda that addresses issues related to research ethics.
Need for Education
Recommendation 5.1: All institutions and sponsors engaged in research involving human participants should provide educational programs in research ethics to appropriate institutional officials, investigators, IRB members, and IRB staff. Among other issues, these programs should emphasize the obligations of institutions, sponsors, IRBs, and investigators to protect the rights and welfare of participants. Colleges and universities should include research ethics in curricula related to research methods, and professional societies should include research ethics in their continuing education programs.
Recommendation 5.2: The federal government, in partnership with academic and professional societies, should enhance research ethics education related to protecting human research participants and stimulate the development of innovative educational programs. Professional societies should be consulted so that educational programs are designed to meet the needs of all who conduct and review research.
Certification and Accreditation
Recommendation 5.3: All investigators, IRB members, and IRB staff should be certified prior to conducting or reviewing research involving human participants. Certification requirements should be appropriate to their roles and to the area of research. The federal government should encourage organizations, sponsors, and institutions to develop certification programs and mechanisms to evaluate their effectiveness. Federal policy should set standards for determining whether institutions and sponsors have an effective process of certification in place.
Recommendation 5.4: Sponsors, institutions, and independent IRBs should be accredited in order to conduct or review research involving human participants. Accreditation should be premised upon demonstrated competency in core areas through accreditation programs that are approved by the federal government.
Ensuring Compliance
Recommendation 5.5: The process for assuring compliance with federal policy should be modified to reduce any unnecessary burden on institutions conducting research and to register institutions and IRBs with the federal government. The assurance process should not be duplicative of accreditation programs for institutions (see Recommendation 5.4).
Recommendation 5.6: Institutions should develop internal mechanisms to ensure IRB compliance and to ensure investigator compliance with regulations, guidance, and institutional procedures. Mechanisms should be put in place for reporting noncompliance to all relevant parties.
Managing Conflicts of Interest
Recommendation 5.7: Federal policy should define institutional, IRB, and investigator conflicts of interests, and guidance should be issued to ensure that the rights and welfare of research participants are protected.
Recommendation 5.8: Sponsors and institutions should develop policies and mechanisms to identify and manage all types of institutional, IRB, and investigator conflicts of interests. In particular, all relevant conflicts of interests should be disclosed to participants. Policies also should describe specific types of prohibited relationships.
Institutional Review Board Membership
Recommendation 5.9: Federal policy should establish standards and criteria for the selection of IRB members. The distribution of institutional review board members with relevant expertise and experience should be commensurate with the types of research reviewed by the IRB (see Recommendation 5.10).
Recommendation 5.10: IRBs should include members who represent the perspectives of participants, members who are unaffiliated with the institution, and members whose primary concerns are in nonscientific areas. An individual can fulfill one, two, or all three of these categories. For the purposes of both overall membership and quorum determinations 1) these persons should collectively represent at least 25% of the IRB membership; and 2) members from all of these categories should be represented each time an IRB meets (see also Recommendation 5.9).
Monitoring Ongoing Research
Recommendation 5.11: Federal policy should describe how sponsors, institutions, and investigators should monitor ongoing research.
Recommendation 5.12: Federal policy should describe clearly the requirements for continuing IRB review of ongoing research. Continuing review should not be required for research studies involving minimal risk, research involving the use of existing data, or research that is in the data analysis phase when there is no additional contact with participants. When continuing review is not required, other mechanisms should be in place for ensuring compliance of investigators and for reporting protocol changes or unanticipated problems encountered in the research.
Recommendation 5.13: Federal policy should clarify when changes in research design or context require review and new approval by an IRB.
Recommendation 5.14: The federal government should create a uniform system for reporting and evaluating adverse events occurring in research, especially in multisite research. The reporting and evaluation responsibilities of investigators, sponsors, IRBs, data safety and monitoring boards, and federal agencies should be clear and efficient. The primary concern of the reporting system should be to protect current and prospective participants.
Central or Lead Institutional Review Boards
Recommendation 5.15: In multisite research, federal policy should permit central or lead IRB review, provided that participants’ rights and welfare are rigorously protected.
Study of Research-Related Injury Compensation Issues
Recommendation 5.16: The federal government should study the issue of research-related injuries to determine if there is a need for a compensation program. If needed, the federal government should implement the recommendation of the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1982) to conduct a pilot study to evaluate possible program mechanisms.
Need for Resources
Recommendation 6.1: The proposed oversight system should have adequate resources to ensure its effectiveness and ultimate success in protecting research participants and promoting research:
a) funds should be appropriated to carry out the functions of the proposed federal oversight office as outlined in this report;
b) federal appropriations for research programs should include a separate allocation for oversight activities related to the protection of human participants;
c) institutions should be permitted to request funding for IRBs and other oversight activities;
d) federal agencies, other sponsors, and institutions should make additional funds available for oversight activities.
• The numbering of the recommendations corresponds with the chapters in which they appear in the preliminary report. Although the numbering of the recommendations might change in the final report, the content will remain the same. There are no recommendations made in chapters 1 and 2.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content