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Human Subjects Review Program

The HSRC Review Process

Introduction

When a research protocol and application materials are submitted to the Human Subjects Review program office, the administrator will review the protocol submission and determine whether it is Exempt from Further Institutional Review, or requires either a Minimal Risk ("expedited") or Full Board Review. If the protocol is, in fact, exempt, the principal investigator will receive a letter of institutional approval indicating that the research is exempt from review. Following receipt of this letter, the investigator may implement the study-related procedures. 

NOTE: Recruitment activities are considered study-related procedures and thus, cannot begin until after institutional approval has been obtained.

Research protocols that do not meet the requirements for an exemption will be reviewed in one of two ways: 1) If the research protocol is eligible for a minimal risk review, the investigator's materials will be reviewed by a subcommittee of HSRC members. Although minimal risk or "expedited" review usually takes less time than a full board review, it is only available to research activities meeting specific criteria. 2) Protocols not eligible for an expedited review will be reviewed by the full board at a convened meeting.

Review Process

1. Carefully evaluate whether or not the proposed study meets the criteria for exemption, minimal risk, or full board review.  Student investigators should work closely with the faculty sponsor to help determine the type of review required.

2. Complete the CITI training.  Make sure CITI training has been completed by or certification is current for all co-investigators and the faculty sponsor (if applicable).

3. Submit all protocols for human subjects research using IRBManager, an online system for submitting and managing IRB-related study records.

Every attempt will be made to provide feedback to the investigator as soon as possible after submitting application materials. Depending on the workload and completeness of submitted materials, review and processing times may take up to three weeks for exemptions and up to 8 weeks for minimal risk and full board protocols.

Consultations with the Human Protections Administrator are encouraged for clarification of any aspect of the review process, both prior to initiating a review and during the review.  Advance consultations can often reduce the amount of time needed for the researcher to prepare the submission materials as well as the time for a proposal to receive approval.  Contact the HSRC office to make an appointment for consultation.

 

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