The IRB has an ethical obligation to review the design or other aspects of a study that may affect the scientific quality of the protocol. The following sections from internationally recognized ethical guides state that ethical research requires that:
- the study is designed to minimize the risks to subjects and
- the potential risks of the research are justified by the potential benefits.
The Ethical Codes:
Nuremberg Code (1949)
Several sections including the following address the question.
Point 3. “The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.”
Declaration of Helsinki (2000)
Several sections including the following address the question.
- Section 11. “Medical Research involving human subjects must conform to generally accepted scientific principles and be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and when appropriate, animal experimentation.”
- Section 18. “Medical research involving human subjects should only be conducted if the importance of the objective outweighs the inherent risks and burdens to the subject. This is especially important when the human subjects are healthy volunteers.”
- Section 29. “The benefits, risks, burdens, and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic or therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists.”
Federal Research Regulations
DHHS and corresponding FDA Sections (21 CFR 56.111).
45 CFR 46.111 Criteria for IRB approval of research.
In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:
- Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
- 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. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
Guidelines
Robert J. Amdur in Ch. 5-2 “Evaluating Study Design and Quality” in IRB Management and Function by Elizabeth A. Bankert and Robert J. Amdur notes the references above and offers the following guidelines to IRBs when evaluating a study’s scientific design and benefit from the perspective of risk to participants.
The IRB should use independent judgment and common sense. For example if the design of a student research project for a course is flawed but creates no effective risk to subjects, there is no ethical basis for the IRB to require revisions for approval. There are only educational reasons to suggest changes.
The IRB should NOT approve a study without requiring revisions if:
- revising the design will decrease the risks to participants in a meaningful way without a major compromise to the persuasiveness of the study results; OR
- the study design is “so flawed that the value of the study results will be almost zero.” In this case, even though the risks may be low if the potential benefit is zero, the overall risk/benefit ratio would be unacceptable; OR
- the study involves a meaningful risk and asks a question that was already answered in earlier research or “not important” to the field of scientific inquiry.
Policies and Procedures
UConn IRB, Submission to the IRB, Scientific Review