The Review Process
Investigators must receive IRB approval before they start their research. The review of fully-prepared applications can take as long as eight weeks to complete for projects involving higher levels of risk, and researchers should not expect the review of any application to take less than two weeks. Students applying for Summer Research Opportunites, in need of IRB review and approval, are required to submit a completed application and supporting materials no later than April 1 regardless of the level of review. The IRB does not meet during summer months, so applications for faculty research that will take place during the summer should be filed before May 1 if they require expedited review, and before April 15 if they require full review (see definitions below).
Investigators must submit the completed application with details about the proposed research, including the scholarly rationale for the project, its potential risks and benefits, an outline of research procedures, procedures for informed consent, and measures for protecting privacy and confidentiality. All applicable documentation requested in the checklist for supporting materials—such as survey instruments, consent forms, and associated grant applications—must be included with the application. A research project submitted to the IRB will be assessed at one of three levels of review:
- The IRB may deem it exempt from further IRB review;
- the IRB may deem it qualified for expedited review (that is, review by a subcommittee of the whole committee); or
- the IRB may determine that the application requires full IRB review at a meeting of the entire committee.
When reviewing applications to determine the appropriate level of review as well as to determine whether the researcher's procedures adequately protect the participants in the research, the IRB considers the following questions (among others):
- Are the risks to subjects reasonable in relation to anticipated benefits to subjects (if any) and/or others? Are the risks reasonable and in relation to the importance of the knowledge that may be expected to result?
- Does the research involve the collection of data or recording of behavior which, if known outside the research context, could reasonably place subjects at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, or reputation?
- Does the research involve prisoners, pregnant women, seriously ill, or mentally or cognitively compromised adults as subjects?
- Does the research involve deception, and if there is deception, when and how will subjects be debriefed?
- How will the researcher secure the informed consent from the subjects?
- Are any of the subjects of the research under 18 years of age?
- Is participation in the research potentially distressing to subjects? Might participation cause psychological or social harm? Has the researcher designed adequate measures for minimizing these risks and for addressing them, should they occur?
When proposals are reviewed by the IRB, three outcomes are possible:
- a protocol may be approved with no further action from the investigator;
- a protocol may be approved contingent on additional conditions determined by the IRB; and
- a protocol may be denied approval by the IRB, in which case the research cannot be initiated by the investigator. The IRB provides the reasons for the denial in writing.
The investigator then can respond either in writing or in person at the next meeting of the IRB. IRB approval is typically in effect for one year. During that period, investigators must request approval from the IRB for any modifications to the project, except those necessary to eliminate apparent immediate hazards to subjects. Typical modifications include both minor revisions (e.g., changes in contact information on consent forms, additions or deletions of staff, additions or deletions of questions in a survey) and substantive revisions (e.g., changes to the recruitment plan, adding a research site, or changing the principal investigator). Any unanticipated problems involving risks to subjects or others must be promptly reported to the IRB. If the investigator wishes to continue the research beyond the approval expiration date, he or she must re-submit the proposal and a progress report to the IRB for a continuation of the approval.