The RPP 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 RPP Office makes the initial decision about what type of review is necessary; the HRRC may request more extensive review.
Research which is not eligible for any of the six exempt categories nor the nine expedited categories requires a full board review at a regularly convened meeting.
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, any risks or inconveniences to the subject cannot be ethically justified. As a professional courtesy sometimes the HRRC may suggest modifications to the research design to reduce the level of risk and/or increase the benefits to the subjects.
Exempt protocols are reviewed by the HRRC Office staff. If protocols submitted as exempt do not meet exemption criteria they will be upgraded by the staff member to either expedited or full review. Protocols that are determined to be exempt do not require an annual review or re-approval.
All research protocols undergo an initial administrative review by trained and experienced RPP staff. If missing documentation or changes to the protocol are requested, the Principle Investigator is responsible for a timely response. If the protocol submission is complete and is determined to be exempt, a response time of 3 days is typical.
If the protocol requires expedited review and response time of three weeks is typical due to the additional considerations and multiple reviewers required.
Study materials for all full board reviews must be complete, have authorizing official approval, and be submitted at least eight (8) working days before the scheduled board meeting. Responses to the review are usually available within a week following the meeting. If an approval decision is deferred for required modifications or clarifications, the review of changes will be conducted at the next regularly scheduled board meeting following receipt of all required materials and authorizations, if any.
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 RPP office on the change in protocol (CIP) form that is found on the HRRC website and the IRBNet document library.
Exempt protocols are not approved but rather determined to be exempt. That determination never expires and does not require annual updating unless significant changes to the study are being considered or planned.
Eligible expedited protocols may be approved for up to two calendar years from the date the protocol was initially approved as specified on the approval letter. Certain restrictions apply. See HRRC policy #121. If subject enrollment, data collection or data analysis needs to continue beyond that termination of approval date, a continuing review (CR) form must be submitted for review. It is important that the CR review process be completed prior to the expiration date of the current approval, or subject enrollment and data collection must immediately cease and the RPP office contacted at 331-3197 or firstname.lastname@example.org
Continuing review applications require a comprehensive review of the study materials and progress and therefore take approximately the same amount of time to process as initial review. The maximum approval period is two years. Certain restrictions apply. See HRRC policy #121