Human Research Review Committee
(HRRC-IRB)
Supported by the
Human Research Protections Office
| HRRC Home > Forms > Submitting a Continuation, Closure, or Reactivation > Reactivation of a study |
Request for Reactivation of a study
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Items Required for Reactivation of a properly closed study |
Items Required for Reactivation of a non-compliance closed study | |
| To reactivate a properly closed study, it must have not been closed for more than 6 months. If closure was more than 6 months ago, you will need to submit a new study application. | Non-compliance closed studies are those in which the HRRC approval period has expired. NOTE: The HRRC requires complete progress report submissions at least 30 days prior to the expiration date in order to insure review and approval. | |
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ü Current Protocol (electronic Document) reflecting amendments and changes previously approved by the HRRC. Protocol Guidelines.
ü Attachment 1 reflecting all current investigators on this study. |
ü Current Protocol (electronic Document) reflecting amendments and changes previously approved by the HRRC. Protocol Guidelines. |
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| Items Required if applicable to Study | Items Required if applicable to Study | |
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ü Current Consent/Assent form (Word Document; single-spaced; 12 pt font) [For studies with continuing enrollment]
ü Current HIPAA form
ü Summary of any proposed changes to Protocol, Consent/Assent, and/or HIPAA (If numerous changes are proposed, please submit one clean copy and one marked copy of each document)
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ü Last Signed Consent/Assent form (Used to enroll last subject in this review period - black out participant's name and signature - leave dates legible). Scan into a .pdf for email, or fax 505/272-0803.
ü Last Signed HIPAA form (Used to enroll last subject in this review period - black out participant's name and signature - leave dates legible; Same subject as Consent). Scan into a .pdf for email, or fax 505/272-0803.
ü Current Consent/Assent form (Word Document; single-spaced; 12 pt font) [For studies with continuing enrollment]
ü
Sponsorship Information Form
and if applicable $750 Review Fee
ü If Sponsored/funded: Supporting Documentation that Sponsor/funding agency has been notified of the lapse in approval period
ü Any Abstracts or Publications published since the last HRRC review.
ü Multi-Center Trial Reports since last HRRC Review
ü Data Safety Monitoring Board Reports since last HRRC Review
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ACCEPTABLE METHODS OF SUBMISSION FOR AMENDMENTS, PROGRESS REPORTS, and REACTIVIATIONS:
When you have the above documents ready to send you have three options to get them to us with a signature.
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Email: Reactivation form and all required documents may be emailed to HRRC@salud.unm.edu from the Principal Investigator's email address, we will consider this a signed document. OR
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Fax: If documents are emailed from an email address other than the PIs, the signature page with the PI signature should be faxed to 505-272-0803 immediately after the email is sent. OR
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Scan: If You have scanning abilities, scan the complete document with the signature into a .pdf and email it to HRRC@salud.unm.edu OR
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Deliver: You may also deliver the signed progress report to the HRRC Office and email the required electronic documents.
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