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The Institutional Review Board (IRB) is a critical component in the realm of clinical research. It is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction.
The IRB is guided by ethical principles outlined in the Belmont Report: respect for persons, beneficence, and justice. These principles are applied through a rigorous review process, ensuring that the risks to subjects are minimized, the benefits are maximized, and the selection of subjects is equitable.
History and Legal Framework of IRB
The establishment of Institutional Review Boards (IRBs) was a response to historical abuses in human subjects research. The most notorious of these was the Tuskegee Syphilis Study, which led to the National Research Act in 1974 and the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
The Commission produced the Belmont Report, which outlined the ethical principles for conducting research involving human subjects. The U.S. Department of Health and Human Services (HHS) codified these principles into regulations, known as the Common Rule, which governs all federally funded research involving human subjects.
IRB Composition
An IRB is composed of at least five members with varying backgrounds to promote complete and adequate review of research activities. The IRB must be sufficiently qualified through the experience and expertise of its members, and the diversity of its members, including consideration of race, gender, and cultural backgrounds, and sensitivity to community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.
At least one member of the IRB should be a scientist, at least one member should be a non-scientist, and at least one member should be unaffiliated with the institution. This diverse composition ensures a comprehensive review of research activities from multiple perspectives.
IRB Review Process
The IRB review process begins when a researcher submits a protocol for review. The protocol includes a detailed description of the research plan, the qualifications of the research team, the methods for obtaining informed consent, and the risks and benefits of the research.
The IRB reviews the protocol to ensure that it meets the ethical principles outlined in the Belmont Report. The IRB can approve the protocol, require modifications, or disapprove the protocol. The IRB also has the authority to monitor the progress of approved research through continuing review.
Types of Review
There are three types of IRB review: exempt, expedited, and full board. Exempt review is for research involving minimal risk and falls within certain categories defined by the regulations. Expedited review is for research involving minimal risk and falls within certain categories defined by the regulations, but requires review by one or more IRB members. Full board review is for research that does not qualify for exempt or expedited review and requires review by the entire IRB at a convened meeting.
The type of review required depends on the nature of the research and the level of risk to the subjects. Regardless of the type of review, the IRB must ensure that the ethical principles of the Belmont Report are upheld.
Role of IRB in Clinical Research
The primary role of the IRB in clinical research is to protect the rights and welfare of human subjects. The IRB achieves this by reviewing research protocols to ensure that the risks to subjects are minimized, the benefits are maximized, and the selection of subjects is equitable.
The IRB also plays a critical role in ensuring informed consent. The IRB reviews the informed consent process and documents to ensure that subjects are given adequate information, that they understand the information, and that they voluntarily agree to participate.
Informed Consent
Informed consent is a process, not just a form. It involves providing potential subjects with adequate information about the research, ensuring that they understand the information, and obtaining their voluntary agreement to participate. The IRB reviews the informed consent process and documents to ensure that they meet these requirements.
The informed consent document must include a description of the research, the risks and benefits, the voluntary nature of participation, and the subject’s rights. The document must be written in language that is understandable to the subject. The IRB also reviews any changes to the informed consent document during the course of the research.
Challenges and Controversies
While the IRB plays a critical role in protecting human subjects, it is not without its challenges and controversies. One of the main challenges is the balance between protecting human subjects and facilitating research. Some critics argue that the IRB process is too burdensome and slows down research. Others argue that the IRB does not do enough to protect human subjects.
Another challenge is the potential for conflicts of interest. IRB members may have personal or financial ties to the research they are reviewing. The regulations require that IRB members with a conflict of interest be excluded from the review, but identifying and managing conflicts of interest can be challenging.
Future Directions
The field of human subjects research is constantly evolving, and the IRB must evolve with it. New technologies, such as genomics and big data, pose new ethical challenges. The IRB must be prepared to address these challenges while continuing to uphold the ethical principles of the Belmont Report.
There is also a trend towards more community involvement in the IRB process. This involves including community members in the IRB review process and seeking community input on research priorities. This approach recognizes that the community is a key stakeholder in human subjects research and should have a voice in the process.
Conclusion
The Institutional Review Board (IRB) plays a critical role in protecting the rights and welfare of human subjects in clinical research. Through a rigorous review process, the IRB ensures that the ethical principles of the Belmont Report are upheld. Despite the challenges and controversies, the IRB remains a cornerstone of ethical research involving human subjects.
As the field of human subjects research continues to evolve, so too will the role of the IRB. It will continue to face new ethical challenges and will need to adapt to meet these challenges. However, the core mission of the IRB, to protect human subjects, will remain the same.
