HSC Procedure for Full Review

HSC Procedure for Full Review

Full Review Procedures

Full review:

Research that involves more than minimal risk (see Section V) qualifies for Full Committee Review. This means that all HSC members will review the protocol and make a decision based on the entire committee’s input. The committee will conduct continuing review of this research at intervals appropriate to the degree of risk, but not less than once a year, and shall also have authority to observe or have a third party observe the consent process and the research.


SAMPLE MEMORANDUM

TO:

FROM: UCAR Human Subjects Committee

OHRP IRB Number: IRB00006222 (U Corp. for Atmospheric Rsch)

Assurance Number: FWA00012567

DATE:

SUBJECT: Human Subjects Committee Review #2012-23 for study “ Study Name” (UCAR Proposal Number:  )

REVIEW: Full Review and Approval pursuant to 45 CFR Part 690.111

The Human Subjects Committee (HSC) conducted a full committee review of the study protocol and related documents for “<Study Name>” and met with the Researcher on <date>.  At that time, after discussion with the Researcher, including more details about <details here> the Committee requested:

·         <list here; could include revised Informal Consent Form, etc>.

The Researcher has provided the revised  <docs list here>  to the committee.  As such, the HSC approves under 45 CFR 690.111. The protocol is approved for a maximum of one year from this date of approval, or the completion of the project (whichever comes first).   

You, the Researcher, are required to update the HSC annually as to the status of this project; this may include submitting an updated study protocol.  The Researchers is also required to update the HSC at any time if any of the aspects of your study that involve human subjects changes.  The UCAR HSC's approval of this study is for human subjects research purposes only and in no way reflects any management opinion about the study or its potential results.

We appreciate your conscientious adherence to the requirements of human subjects research.  If you have any questions about this process, or if you need assistance at any time, please feel free to contact the HSC (hsc@ucar.edu) or visit our website at /human-subjects-committee/human-subjects-research.

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