DETERMINATION OF HUMAN SUBJECT RESEARCH (HSR)

Occasionally a sponsor or vendor wants verification from an impartial source that activities do not require IRB review or approval. This is a one-time determination and is not subject to continuing review. If activities change during the project, a new determination request would be required.  A request for a determination that a project is not human subject research by E&I is made using E&I Form 11.  

GENERAL APPROVAL

A federal grant application must be subject to IRB review before it is funded, but at that time there is usually no money and often no specifics.  Grants often describe sequential studies, some of which must be fairly amorphous until the initial studies are complete. Nevertheless, funding agencies require IRB approval of grant applications. The IRB will consider acceptance of the grant with the caveat that no activity is allowed until a protocol is approved.  E&I offers general approvals of grant applications using E&I Form 10. 

EXEMPTION FROM IRB REVIEW

Some human subject research is either so common or such a low perceived risk that it does not require review by an IRB. The exemption is from IRB review but is not from ethical conduct or, where needed, appropriate consent. To qualify, all of the procedures in the study under consideration must qualify under the categories allowed in the regulations. Continuing review is not required, but a requirement for follow-up such as a one year “check in” to assure that the activity is on-going and continues to merit the exemption may be applied. Consideration of exemption may be made by the E&I administration or board using E&I Form 12.  

IRB REVIEW

There are two methods allowed for IRB review.  Both require the reviewers to apply the same criteria to all aspects of the study; the protocol, consent forms, recruitment materials, qualifications of investigators etc. 

EXPEDITED PROCESS

Activities that are either repetitive or a low perceived risk do not necessarily need the attention of the full board. Expedited review is performed by one or two experienced members who may approve, ask questions, or refer the project to the full board. "Expedited" review does not necessarily ensure a faster determination, especially when the full board meets frequently.  The expedited process may be used for:

• Initial review of a project when ALL of the activities in the application are found to create less than a minimal risk of harm and all of the procedures fit in one or more of the expedited review categories (E&I Form 22); or
• Continuing review of a study that was originally full board if it meets categories 8 or 9; or

• A minor modification to an already approved study. Minor is undefined and the trend among IRBs is to be more conservative in the evaluation of what constitutes a minor change. Any change that does not alter or that reduces risk is likely to be a minor change, as would new advertising copy, or pre-arranged changes, or reviews of new investigators.

IRB REVIEW - FULL BOARD PROCESS

All other applications must be reviewed by the full board at a convened meeting with enough circulation time to allow members to fully consider the proposal.