Human Research Review Committee
(HRRC-IRB)
Supported by the
Human Research Protections Office
| HRRC Home > Forms > Submitting a New Research Study > Full Committee Review Research |
Full Committee Review Research Submissions
1 copy of each of the following documents (except where noted) should be delivered to our office. You can also view/print this checklist from a word document.
Items Required for EVERY Full Committee Study - All forms are in MS Word except where noted
ü Department Review Form - To be completed by head of department submitting the study
ü The following PDF forms must be filled out by every investigator listed on attachment 1, as well as the Principal Investigator
Conflict of Interest Statement for UNM Employees
OR
Conflict of Interest Statement for non-UNM Employees
ü One of the Following (3 copies):
-
Investigators Protocol: Guidelines for developing the Protocol
-
NIH Grant Application (If study is supported by NIH, a copy of the grant application must be submitted)
-
Cooperative Group Protocol
-
Sponsor's Protocol (for commercially sponsored studies)
Items Required if applicable to Expedited Study - All forms are in MS Word except where noted
ü Any Applicable Attachments:
ü Sponsorship Information Form and if applicable $2,000 Application Fee
ü DHHS approved sample Consent Form
ü Radiation Control Human Uses Subcommittee Approval Letter
ü All Questionnaires, surveys, etc.
ü All recruitment materials and advertisements
ü (3 Copies) Investigator's Brochure or device manual (for commercially sponsored studies)
ü (3 Copies) Sponsor's non-significant risk determination (if device study and no IDE was submitted to FDA)
ü Documentation from the sponsor or FDA verifying the IND number for this research. This may include any of the following:
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FDA Letter
-
Sponsor Letter
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IND number is in protocol or other sponsor-generated document
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Other as described in Attachment 9
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