FAQ - The HRRC Review & Approval Process
The HRRC staff performs an administrative review of the submitted protocol, and assigns members of the board to review the protocol on a rotating basis and in accord with their areas of expertise. Investigators are notified as soon as possible of the decisions relating to their protocol (i.e. request for revisions or approval).
Note: The HRRC Office makes the initial decision about what type of review is necessary; the IRB may request more extensive review.
Research which is neither exempt nor expedited requires the full board category of review. All research which does not clearly fit into exempt or expedited categories of review should be submitted to the HRRC, assuming it will need full board review.
As part of the risk-benefit analysis, the HRRC must be concerned with the design of the research. If the research is poorly designed, and the information to be gained is likely to have little or no value, the HRRC cannot justify any risks or inconveniences to the subject. Sometimes members of the HRRC are able to suggest modifications to the research design which reduce the level of risk and/or increase the benefits to the subjects.
Exempt protocols are reviewed by the HRRC Office and one additional committee member. If protocols submitted as exempt do not meet exemption criteria they will be subjected to either expedited or full review. Protocols that are approved as exempt do not require formal renewal, but do submit annual updates and protocol completion reports when the project is finished.
Remember, no research may begin until the HRRC has given your research protocol full approval. All protocols submitted undergo an initial administrative review. If changes to the protocol are requested, the Principle Investigator is responsible for a timely response. The protocol is then submitted for review by one or more HRRC board members. Exempt and expedited review is usually complete within 2 weeks. Full board review can take one month or longer to complete. Responses to tabling decisions for required modifications or information requested are typically reviewed within one week.
All changes to a research protocol must be approved before the change is incorporated into the protocol. These proposed changes should be submitted to the HRRC office on the change in protocol form that is found on the HRRC website.
The HRRC issues approvals for up to but not exceeding one calendar year from the date the protocol was initially approved. The termination date of that approval period is specified on the approval letter. If subject enrollment, data collection or data analysis needs to continue beyond that termination date, a continuing review (CR) form must be submitted for review and approval. It is important that the CR approval process be completed prior to the expiration date of the initial approval, or subject enrollment and data collection must cease. In general, CR takes less than 2 weeks to process.
Page last modified August 17, 2010