In accordance with CFR 46.111
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
- 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 to 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 the 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 responsibilities.
- Selection of subjects is equitable. In making this assessment the IRB should consider the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
- Informed consent is sought from each prospective subject or the subject’s legally authorized representative in accordance with and to the extent required by 45 CFR 46.116.
- Informed consent is documented in accordance with and to the extent required by 45 CFR 46.116.
- When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
- When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- The IRB will make every effort to ensure that both the mental and physical well-being of the subjects are adequately protected and establish procedures to ensure the maintenance of proper records, the protection of anonymity, and the confidentiality of all data collected.
- The IRB will determine whether risks to subjects are reasonable relative to the anticipated benefits. The IRB shall not allow the use of human subjects in poorly designed projects that are unlikely to elicit meaningful results.
- Ensure informed consent of subjects will be obtained through appropriate methods. The IRB will ensure that written consent is obtained from all subjects unless waived in accordance with CFR 46.117.
IRB Considerations for All Submissions
For all reviews, the IRB will:
- Consider the qualifications and professional development of the Principal Investigator and relate them to the degree of protocol complexity and risk to human subjects.
- Instruct investigators to prepare protocols, with complete descriptions of the proposed research.
- The research plan must include provisions for the adequate protection of the rights and welfare of prospective subjects and ensure that pertinent laws and regulations are observed.
- Samples of informed consent must be included with protocols.
- Investigators are responsible for obtaining informed consent and ensuring that no human subject will be involved in the research before consent is obtained.
- Ensure that the research plan addresses quality assurance standards set by the institution as well as applicable external standards.
- Ensure that appropriate reviews for scientific merit be conducted before the research is approved.
- Ensure that mechanisms be in place for monitoring the progress of the research.
Additional IRB Considerations for Non-Exempt Submissions
In addition, for non-exempt research the IRB must:
- Review the proposal at a convened meeting
- Evaluate the procedures:
- How are subjects recruited?
- Are subjects equitably selected?
- What are the risks and are they minimized?
- Do the benefits outweigh the risks?
- Evaluate the consent process
- Will subjects be fully informed of procedures and risks?
- Is consent written in appropriate understandable language?
- Is the subject’s voluntary consent and withdrawal explained fully?
- How is informed consent obtained?
- Evaluate the Informed Consent Form