The Review Process
Basic Expectations: It is expected that research design will satisfy the following the following two criteria:
- Risk: Research procedures should be designed so as to ensure that subjects are not exposed to physical, psychological, or social risks significantly in excess of that normally encountered in daily life. Any possible risks imposed must be weighed against the scientific importance and the potential benefits of the research. Specifically, risks of harm to human subjects must be (1) of no greater probability or magnitude than those encountered in daily life or during performance in routine physical or psychological examination or tests; or (2) reasonable in relation to expected benefits of the research and minimized by the use of the safest procedures. The review process is dependent on the amount of risk involved in regard to the human subjects.
- Confidentiality: Research procedures shall not disclose confidential information, including names and/or salient identifying characteristics, to other than the investigator(s) and their research staff. Further adequate provisions must be made to protect the confidentiality of information that is to be retained over an extended period.
- Exemptions from IRB Consideration: For projects associated with university courses, if the identity of a research subject is sufficiently protected and the subject is at minimal risk, an exception may be granted. All submissions for exempt status will receive special attention by the Chair if a protected population is included in the study.
- Expedited Review: An expedited review is a review by a subcommittee of the IRB consisting of the chair of the IRB and two other members of the IRB for research that involves no more than minimal risk, protected populations, or to review minor revisions in previously approved research, or review revisions for proposals that were approved but require revision. The subcommittee meets as needed to perform expedited reviews. An initial discussion of a project proposal with the IRB chair will determine whether an expedited or full review is necessary.
- Limited Review: Verifies conditions for certain exemptions are met. HHS maintains a list of these criteria allowing certain research to undergo the Expedited review mechanism, unless the reviewer determines that the study involves more than minimal risk. If so, the rationale must be documented.
- Full Review: A full review is a review of a project proposal by the entire IRB. This will be conducted for research that involves greater than minimal risk, or when the research is of a psychological nature.
- Documentation: Results of reviews will be documented under the supervision of the IRB Chair. Records will be retained according to VCSU records management schedule. Researchers and supervising advisors, if appropriate, will be notified according to established VCSU timelines. The IRB reserves the right to seek clarification or additional materials from the researcher. Absence of required documentation upon initial submission may delay the review.
Monitoring of Ongoing Research
The IRB shall maintain ongoing review of nonexempt human research with respect to subjects' rights. Monitoring procedures shall be arranged at the time of the review on a case-by-case basis. No continuing review is required for research eligible for expedited or limited review or for studies that have completed interventions and only involve analyzing data or accessing follow-up clinical data. IRB can override this and require continuing review, but this must be documented.