Per U.S. Department of Health and Human Services (DHHS) and the Federal Drug Administration (FDA) regulations (45 CFR 46.111 and 21 CFR 56.111) two of the required criteria for granting IRB approval of the research are:
- Risks to subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and 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 Committee will 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.
Researchers can minimize risk if they:
- Provide complete information in the protocol regarding the experimental design and the scientific rationale underlying the proposed research, including the results of previous animal and human studies.
- Justify the study plan planned and how it will create generalizable knowledge of any significance.
- Cite or reference previous research (or literature review) that supports the study design and purpose (including any known risks from similar studies).
- Assemble a research team with sufficient expertise and experience to conduct the research.
- Ensure that the projected sample size is sufficient to yield useful results.
- Collect data from standard-of-care procedures to avoid unnecessary risk, particularly for invasive or risky procedures (e.g., spinal taps, cardiac catheterization).
- Incorporate adequate safeguards into the research design such as an appropriate data safety monitoring plan, the presence of trained personnel who can respond to emergencies, and procedures to protect the confidentiality of the data (e.g., encryption, codes, and passwords).
- Elaborate on the safety plan and precautions for engaging the population of interest.
- Describe how the study team will face known problems like serious adverse events or the loss of a team member.
- As relevant, include a research ramp-down, or ramp-up plan if there is an emergency.
A risk-benefit analysis compares the social, emotional, physical, (and other) risks of a situation and (potential direct or indirect) benefits. The risk-benefit analysis is used to determine whether a study protocol is justified or if the risks are too high (or uncertain). A risk-benefit analysis happens everyday with most human interactions. However, from an IRB ​perspective, documenting how risks will be mitigated and the researcher’s qualifications and plans to protect the rights and welfare of a human subject in a study will determine whether a protocol submission is approved.