Types of Review Categories
Projects exempt from full board review (i.e., qualifies for review by the chair and one other board member) include:
- Research conducted in educational settings, involving normal educational practices, for the purpose of publication or presentation
- Research involving the use of educational tests, survey, interview procedures, or observation of public behavior by adults (unless subject’s confidentiality is questionable)
- Research involving the study or collection of existing data that is publicly available
- Research that is anonymous with no more than minimal risk (“anonymous” means that there is no way for anyone, including members of the research team, to link the research participant to the data she provided. “Minimal risk” means no more risk than is encountered in everyday life.)
- Research that does not involve children or other vulnerable groups
- Research that does not contain questions of sensitive matters
If the chair and another HSRB committee member concur that the research project is exempt from full board review, the Principal Investigator will be informed in writing and the project will be assigned an HSRB number.
If there are stipulations, they will be specified in a letter to the Principal Investigator and must be addressed before the project can be approved and assigned an HSRB number. Research projects deemed exempt from full board review are generally reviewed within one week of submission.
Expedited review projects (i.e., reviewed by the chair and two other board members) include:
- Research that involves deception, is not anonymous, or involves more than minimal risk, that also does not qualify for a full-board review
- Research involving voice recordings or moderate exercise by subjects
- Research in which there are minimal questions about drug use and/or sexual orientation where the subject’s anonymity is protected
If the project is eligible for expedited review, the chair will assign the application to two reviewers. The reviewers may approve the proposal (with or without stipulations), make a recommendation, or call for full board review.
If there are stipulations, they will be specified in a letter to the Principal Investigator and they must be addressed before the project can be approved and assigned an HSRB number. Research projects deemed expedited are generally reviewed within one week of submission.
Full Board Review projects includes:
- Research involving vulnerable people as subjects (including, but not limited to, children, prisoners, pregnant women, undocumented immigrants, developmentally disabled individuals, anyone unable to provide their own informed consent)
- Research involving deception, purposeful creation of anxiety, shock, or any form of punishment
- Research involving extensive questioning about drug use, sexual orientation and/or sexual experience
- Research involving sexually explicit materials or questions
Any project seeking or having been granted external funding must obtain full board review and approval.
If the reviewers or the chair decide that the project should receive full board review, the chair will convene a special meeting to review the proposal. The board members or the researcher can request that s/he be present at the meeting of the HSRB when his/her project is being considered.
The board members may approve the application as submitted, approve it with stipulations, or disapprove it. The action of the HSRB will be reported in writing to the Principal Investigator. Any stipulations must be addressed before the project can be approved and assigned an HSRB number. Research projects requiring full board review are generally reviewed within two weeks of submission.