Outside the context of an IRB meeting, there are two categories of reviewers that determine whether a human subjects research proposal at Alverno is exempt from IRB review:
- RRC Decentral Reviewers
- IRB Direct-Certified Reviewers
All reviewers of exempt studies affirm that they will refrain from participating in exempt determinations when they may have a conflict of interest.
RRC Decentral Reviewers, as their name implies, make determinations for exempt requests in the context of a particular Research Review Committee. Generally, they review research proposals by Master's students in the particular school. These reviewers are assigned and receive training by the Research Review Committee for the particular school. These reviewers:
- Always use the General Request for Exemption Determination form
- May only waive informed consent for anonymous surveys
- May only conduct exempt reviews for members of the Alverno community
IRB Direct-Certified Reviewers make exempt determinations outside of the context of one of Alverno’s RRCs and address special circumstances. These include the following:
- Exempt determinations where no appropriate RRC exists
- Exempt determinations that use the Streamlined Alverno Educator Request for Educational Research Exemption
- Exempt determinations for research proposed by researchers not affiliated with Alverno College (external researchers)
- Exempt determinations that include a request for waiver or altering of Informal Consent and/or its documentation
The following Alverno-affiliated individual is an IRB Direct-Certified Reviewer
- Paul Smith (IRB Chair)
Submissions can be made directly to these reviewers, with the IRB Chair copied on both the original submission and the completion of the review.
EXEMPT RESEARCH Research determined through an IRB sanctioned request for exemption to fit within specific categories of minimal risk research that are articulated in federal regulations. Once a research study is determined to be exempt, data collection may begin, which is why it is said to be exempt from IRB review.