There are three types of review paths for an IRB application: Full Board, Expedited, and Exempt. Decisions to determine the type of review are based on the following:
- Whether an activity is research that must be reviewed by the IRB
- Whether the research may qualify for an exempt determination
- Whether the review may be performed using expedited procedures
- Whether informed consent, or its documentation, may be waived
IRB Regulated Research Review ensures:
- Risks to the subjects are minimal, and are reasonable in relation to anticipated benefits
- The subject selection is equitable
- Privacy of participation and confidentiality of data are protected
- Informed consent processes meet federal regulatory and/or SEKESC requirements
Per SEKESC IRB policy, PIs are to submit an Exemption Application Form for review and final determination by the IRB. Projects that meet the criteria for a federal exempt category may be granted a determination of exemption by the IRB.
Research involving prisoners or certain types of research with children (e.g. surveys, interviews/observations of public behavior where the investigator interacts with the children) does not qualify for exemption.
Federal regulations (45 CFR 46.110) authorize the use of an expedited review process for:
- Minimal risk human subjects research that meets one or more of the OHRP Expedited Review Categories
- Minor IRB Amendments based on recommendations for approval by the full board
- Applications qualifying for expedited review are accepted and reviewed on a continuing basis
Expediting reviewers are the IRB Chair and at least one other experienced IRB member. The expediting reviewers have the authority to make a determination or to refer a submission for full board review for the multiple purposes (e.g., clarification, expertise), including in cases of disapproval. Only the full board has the authority to disapprove a study.
Full Board Review
Federal regulations and institutional policy require an IRB Full Board Review for applications where the research involves more than minimal risk to human subjects or has been referred to the committee by an expedited reviewer or the Chair. Regardless of risk level, the SEKESC IRBs may require full board review when the research involves:
- Vulnerable populations, particularly prisoners
- Sensitive topics, including illegal behaviors which may require an NIH Certificate of Confidentiality (CoC) to protect subject data from compelled disclosure
- Research involving genetic testing
- A complex research design requiring the expertise of multiple board members to evaluate
Applications requiring full board review are sent to the next meeting of the convened IRB once it has been determined ready by the IRB chair and/or designee. Investigators will be invited for presentation at the full board meeting and to answer questions from the board. PI’s are dismissed prior to the board’s discussion and voting. At the conclusion of the meeting, the board votes and issues a determination to deny or approve.