The University of New Mexico

Quick Links

    Physical Address:
    BMSB B71
    Camino de Salud
    Albuquerque, NM 87106
    Mailing Address:
    MSC:08-4560
    1 University of New Mexico
    Albuquerque, N.M. 87131-0001
    Office Hours:
    Monday - Friday 8am to 5pm
    Email: HRPO@Salud.unm.edu
    Phone: (505) 272.1129
    Fax: (505) 272.0803

 Submissions to the HRPO for Review

Instructions:

      Download the most current version:
      Complete all sections of the application and relevant attachment(s);
      Signature is REQUIRED
      Submit application & relevant attachment(s) to HRPO@salud.unm.edu
      Email Submission to HRPO

NOTE: Incomplete submissions to the HRPO will not be accepted. Please make sure ALL relevant review materials are submitted together.

Guidance: Submissions

2/1/2012 The Electronic Submissions Guidance Document supersedes all guidance for submission requirements on current HRRC and IRB Forms.

This document contains current Submission Checklists for ALL types of submissions =)

It is the responsibility of the Principal Investigator to submit relevant IRB Review Documents to the HRPO prior to starting the Human Subjects Research.

Levels of Review

Exempt: less than minimal risk.
Expedited: minimal risk.
Full Committee: greater than minimal risk.

For more information about the levels of review, please check out the HRP Training program. If you need help with determining which new study application to complete, please use the FAQ program found on the FAQ page or check out this Review Level Worksheet.

For information regarding facilitated reviews, please visit the CIRB Facilitated Review Process page from the NCI CIRB website.

Types of Submissions

  New Study

    All research activities involving humans must be reviewed and approved by the HRRC or IRB. Review board members need to be given enough detailed information about a proposed study in order to effectively make their determination. The Principal Investigator should submit a new study application, protocol, and any other relevant documents as required. No research activities can begin until the Principal Investigator receives an official letter of approval from the HRRC or IRB.
  Amendment

    When any document or procedure within an HRRC or IRB approved research study is revised, the Principal Investigator needs to submit an Amendment Request form and all relevant documents to the HRPO for HRRC or IRB review and approval. This process needs to occur prior to implementation of the proposed changes.
  Continuation or Reactivation

    Previously approved Full Committee and Expedited research must undergo annual continuing review. Approval must be granted prior to the study expiration date to avoid a lapse. It is the Principal Investigator's responsibility to submit a Continuation Request and all relevant documents to the HRPO for HRRC or IRB review and approval at least 45 days prior to the study expiration date. This is to ensure that the HRRC or IRB has enough time to carry out the continuing review. Please note that reminder notices of expiration are a courtesy; the Principal Investigator is responsible for keeping track of the study approval period to avoid non-complaince closure.
    A study that has either expired or closed can be reactivated within 6 months of the expiration date. The Principal Investigator needs to submit a Reactivation Request and all relevant documents to the HRPO for HRRC or IRB review and approval within this timeframe. Studies closed longer than 6 months must be formally closed the the HRRC or IRB. If the PI wishes to continue with the study, a New Study Application will need to be submitted to the HRPO with all applicable fees.
  Closure

    A study can be formally closed to the HRRC or IRB when data analysis has been completed OR data analysis continues on de-identified data only. The Principal Investigator needs to submit a closure report and all relevant documents to the HRPO for HRRC or IRB review and approval for closure prior to the study expiration date.
  Events, Unanticipated Problems, and Complaints

    The HRPO does not require reporting of events unless they are:
      Unanticipated
      Caused harm or placed a person at increased risk of harm
      AND are more likely than not related to the research
    Investigators should keep a log at their research site, to track non-reportable events. The completed tracking log for non-reportable events will provide documentation of the investigator’s assessment of whether events are or are not reportable.

    If an event is assessed to meet all three criteria, then an Event Form must be completed by the investigator and submitted to HRPO. HRRC no longer accepts IND safety reports that do not meet reporting criteria with exception of a few required by sponsors for administrative purposes.

    Other events including protocol violations, incorrect consent procedures, etc. may also be reportable to the HRRC or IRB.

    If an event, unanticipated problem, or complaint needs to be reported to the HRPO, please complete the Event Form.


Submission Fast-Track

The HRPO may fast-track an HRRC or IRB review of certain submissions if the welfare of the participant or patient is involved. Please note that this is not a standard process and failure to properly plan does not constitute a fast-track submission. If your submission requires urgent HRRC or IRB approval, please complete the Fast-Track Request Form.