Responsibilities of Institutional Review Boards (IRBs)
IRB committees are authorized by the National Institutes of Health via the Office for Human Research Protection (OHRP), or by the Food and Drug Administration (FDA). Any institution that receives research funding from the federal government must have an IRB to review any research involving human subjects, even if the project itself is not specifically federally funded. IRBs are also highly recommended for privately funded research in order to establish safe, ethical protocols for the conduct of medical experiments with human subjects, and in order to produce safety data in anticipation of an FDA-approved clinical trial.
A Brief History of Human Research Protection
The modern codification of protections for human subjects began with the Nuremberg Code, which was developed after WWII by the Nuremberg Military Tribunal in response to human experimentation by the Nazis (see photo right). The first provision of the Code states that, “the voluntary consent of the human subject is absolutely essential.” This remains the cornerstone of ethical experiments using human subjects. Implicit in this basic concept is the subject’s comprehension of both the risks and benefits of an experimental procedure and his or her capacity to make an informed decision.
These principles were reinforced and further codified in 1964 by the World Medical Assembly with its Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects. It reiterated fundamentals such as the subject’s freedom to withdraw at any time, and the prerequisites of good research design and qualified investigators. The World Medical Assembly updated the Declaration in 1975 and 1989.
In the U.S., meanwhile, the National Institutes of Health introduced its Policies for the Protection of Human Subjects in 1966, policies which became enforceable regulations in 1974. Among other things, the regulations established the IRB as a mechanism to oversee the treatment of human subjects. The year 1974 also saw the passage of the National Research Act, which established a national commission to look into the treatment of patients in biomedical and behavioral research. Its recommendations were published in 1978 in “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.”
The Belmont Report set forth three guiding principles for the ethical conduct of research: Respect for Persons, Beneficence,
and Justice. Respect for Persons recognizes personal dignity; Beneficence stipulates that benefits should be maximized while risks minimized; and Justice requires that subjects be fairly selected.
These guidelines were further updated in 1981 by the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Its report—Protecting Human Subjects: The Adequacy and Uniformity of Federal Rules and their Implementation—further identified the issues to which investigators and IRBs should be sensitive in designing or reviewing research proposals.
Finally, in 1991, the Department of Health and Human Services, along with 16 other federal agencies that that conduct, support or regulate research with human subjects, adopted as regulation the Federal Policy for the Protection of Human Subjects (45 CFR 46). This common Federal Policy was created on the recommendation of the President’s Commission and was designed to make the regulations and guidelines for protecting human subjects uniform in all federal agencies and departments. While the FDA did not adopt the Policy in its entirety, it did make changes to its IRB regulations to correspond to the Federal Policy.
The Regulatory Requirements of Investigators
Investigators who wish to conduct research involving human subjects must obtain prior approval from an IRB by submitting the design and purpose of the research project, and they must meet the specific requirements for their particular research study once approved. They must also obtain prior approval for any modifications of previously approved research, including modifications to the informed consent process
Any physician, scientist, nurse, administrator, teacher or student who performs tasks involving research using human subjects is referred to as an ‘investigator’ by the HHS. When research studies are conducted by more than one investigator, then one investigator is designated the “principal investigator” with overall responsibilities for the study. In every research study using human subjects, investigators have certain responsibilities regarding the ethical treatment of human subjects. These responsibilities include obtaining voluntary, informed consent from the subjects in the research, obtaining information about the individuals being studied, and analyzing resulting data for research purposes.
During the course of their study, investigators must protect the rights and welfare of human subjects and as they carry out sound, ethical research consistent with the plans approved by an IRB. Investigators are also responsible for ongoing requirements in the conduct of approved research. These include:
- Ensuring that progress reports and requests for continuing review and approval are submitted to the IRB in accordance with the policies, procedures, and actions of the IRB as referenced in the OHRP-approved regulations:
45 CFR 46.103(b)(4)
45 CFR 46.109(e)
45 CFR 46.115(a)(1)
- Providing to the IRB prompt reports of any unanticipated problems involving risks to subjects or others as well as any serious or continuing noncompliance with the regulations or the requirements or determinations of the IRB:
45 CFR 46.103(b)(5)
- Keeping certain records as required by the HHS regulations for at least three years after completion of the study:
45 CFR 46.115(b)
Once the research study has been completed, investigators should notify the IRB of the study’s completion and file a completion report, after which they are no longer required to obtain continuing review and approval of that study by the IRB.
Once a study has been completed, investigators may keep the data they collected, including identifiable private data, if consistent with the IRB-approved research plan. Investigators should continue to honor any confidentiality protections of the data as well as any other commitments agreed to as part of the approved research, for example, providing information about the study results to research subjects.
Information on IRB, FDA and HHS research regulations
For further information on IRBs and the regulations that govern their purpose and conduct, you can access these links:
FDA Regulations for IRBs and Protection of Human Subjects in Clinical Trials: VISIT FDA
A Summary of the Regulations for IRBs by the HHS Office for Human Research Protections: VISIT OHRP
The HHS Code of Federal Regulations on the Protection of Human Subjects (45 CFR 46): VISIT HHS
The Specific FDA guidelines for IRBs and investigators: VISIT FDA