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| THE HUMAN RESEARCH PROTECTION PROGRAM |
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THE COMMITTEE ON HUMAN RESEARCH APPLYING TO THE CHR General Instructions: Renewal Application (Continuing
Review)
• Brief Overview How Often Renewal is Required: Re-review of all projects involving human subjects is required at least annually (see 45 CFR 46.109(d) (DHHS) and 21 CFR 56.109(d) (FDA))
The CHR may require more frequent review. At UCSF, studies that have been certified as Exempt from CHR review must have the exemption renewed at least every three years. Re-review is often referred to as “Continuing Review.” Renewal Reminders and Notices: As a courtesy, the Committee on Human Research (CHR) office sends out renewal reminders twelve and eight weeks before studies expire. Additional warnings are sent within a week of a study’s expiration and 6 weeks following the expiration. However, it is ultimately the investigator's responsibility to initiate a renewal application, allowing sufficient time for the review and re-approval process to be completed before the current approval expires. As an additional aid, investigators can review of listing of their studies on Research Online and sort the studies by expiration date. If Approval Expires, ALL ACTIVITIES INVOLVING SUBJECTS MUST STOP. The only exception is that activities needed for participant safety should continue. No new subjects may be enrolled. If any project activity—even activity required for participant safety—occurs or continues after the expiration date, the investigator is out of compliance with both federal regulations and university policy. Retrospective approval for work done after the expiration date cannot be granted.
Combining Modifications with Renewals Combined Form: Modifications may be made at the same time as a scheduled renewal. All renewals, whether or not they include major or minor modifications, should be submitted using the form Status Report for Renewals and Major Modifications (Continuing Review). Caution: Delayed approval and study expiration may happen if the CHR finds problems with a modification that has been combined with a renewal. If a study’s expiration date is close, you should seriously consider not submitting a possibly controversial modification until after the renewal has been approved. See General Instructions: Modification Request for additional guidance on when to submit modifications. Specific Submission Requirements for CHR Renewal Applications (Continuing Review) The specific submission requirements are available on the Renewals and Major Modifications Submission Checklist. For ALL Renewals (and Major Modifications) - please note incomplete submissions will not be assigned to a CHR meeting agenda
Use Most Recent Versions: All of the documents submitted with a renewal application should be the most recent versions approved by the CHR. For example, if the CHR has approved a modified consent form since the initial approval, submit the modified version approved by the CHR, not the initial version. Base any Modifications on the Most Recent Versions: Base any modifications on the version of a document most recently approved by the CHR. Avoid using earlier versions that may not include your recently approved modifications.
Questionnaires/Instruments: Previously approved questionnaires or instruments should be submitted only if modifications are being proposed. Any new instruments should be submitted (unless they are commonly known to experts in your field, in which case they only need to be described in your application). Do Not Include Extraneous Materials: Do not attach previous approval letters or other old correspondence with the CHR. The extra reading material is not needed by reviewers. Applications for renewal of approval should be forwarded to the Committee on Human Research, Box 0962 (San Francisco, CA 94143). They also can be dropped off at the CHR office at Laurel Heights, Suite 315. For additional information, please call the CHR office at 476-1814 or email the CHR.
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