UNM IRB approval

Template Letter
v.0.14

HRP-510-HRRC_TEMPLATE_LETTER_Approval
Approved By:

Date:

Human Research Review Committee
Human Research Protections Office
April 13, 2015
Kimberly Page, PhD, MPH
MSC10 550
1 University of New Mexico
Albuquerque, NM 87106
505-272-2520
[email protected]
Dear Dr. Page:
On 3/3/2015, the HRRC reviewed the following submission:
Type of Review:
Title of Study:
Investigator:
Study ID:
Submission ID:
Funding:
Funding Source ID:
Grant ID:
IND, IDE, or HDE:

Initial Study
Hepatitis Treatment and Integrated Prevention
Kimberly Page, PhD, MPH
14-313
14-313
CDC
5U18PS004568-02
3T910
None

Submission Summary: Initial Study
Documents Approved: Protocol v03/12/2015
Combined Consent/HIPAA Form v03/12/2015
H-TIPS Appendix 1-Survey v04/07/2015
H-TIPS Appendix 2-HCF Reinfection Interview Guide v12/08/2014
H-TIPS Appendix 3-Study Timelines v12/08/2014
H-TIPS Appendix 4-Study Visit Reminders v12/08/2014
Flyer v04/10/2015
Patient Authorization for Discloure of PHI submitted 01/29/2015
Review Category: Full Committee
Determinations/Waivers: Requires a signed Consent form.
HIPAA Authorization on record; signed HIPAA required.
Consent and HIPAA included in same document.
Submission Approval Date: 3/3/2015
Approval End Date: 3/2/2016
Effective Date: 4/13/2015
The HRRC approved the study from 3/3/2015 to 3/2/2016 inclusive. If modifications were required
to secure approval, the effective date will be later than the approval date. The “Effective Date”

The University of New Mexico • MSC08 4560 • 1 University of New Mexico • Albuquerque, NM 87131-0001 • Phone 505.272.1129 • Fax 505.272.0803 • hsc.unm.edu/som/research/hrrc •
BMSB B71

Page 1 of 2

Template Letter
v.0.14

HRP-510-HRRC_TEMPLATE_LETTER_Approval
Approved By:

Date:

4/13/2015 is the date the HRRC approved your modifications and, in all cases, represents the date
study activities may begin.
Before 3/2/2016 or within 45 days of study closure, whichever is earlier, you are required to submit
a continuing review. You may submit a continuing review by navigating to the active study and
clicking the “Create Modification / CR” button.
Please use the consent documents that were approved and stamped by the HRRC. The stamped and
approved consents are in a comment within the submission covered by this approval letter.
This determination applies only to the activities described in this submission and does not apply
should you make any changes to these documents. If changes are being considered and there are
questions about whether HRRC review is needed, please submit a study modification to the HRRC
for a determination. A change in the research may disqualify this research from the current review
category. You can create a modification by clicking Create Modification / CR within the study.
In conducting this study, you are required to follow the Investigator Manual dated July 31, 2012
(HRP-103), which can be found by navigating to the IRB Library.
Sincerely,

Mark Holdsworth, PharmD
Executive Chair

The University of New Mexico • MSC08 4560 • 1 University of New Mexico • Albuquerque, NM 87131-0001 • Phone 505.272.1129 • Fax 505.272.0803 • hsc.unm.edu/som/research/hrrc •
BMSB B71

Page 2 of 2