Attach 5 IRB Approval Letters

Human Research Review Committee
MSC 08 4560 BMSB Room B71
1 University of New Mexico~Albuquerque, NM 87131-0001
(505) 272-1129 Facsimile (505) 272-0803
http://hsc.unm.edu/som/research/hrrc/
07-Jun-2012
Lewis, Johnnye L, Ph.D.
College of Pharmacy
SUBJECT: HRRC Approval of Research - Amendment
Project Title: The Navajo Birth Cohort Study (A Prospective Birth Cohort Study Involving Environmental Uranium
Exposure in the Navajo Nation)
HRRC#: 11-310
Type of Review: Expedited Review
Approval Date: 06-Jun-2012
Expiration Date: 13-Jun-2013
Dear Dr. Lewis:
The Human Research Review Committee (HRRC) has approved* the above mentioned research protocol action based on
review of the following:
1. Investigator Protocol version 05/16/2012;
2. UNM HSC Mother's Consent version 05/16/2012;
3. UNM HSC Father's Consent version 05/16/2012;
4. Biological Specimen Table submitted 05/25/2012;
5. Food Frequency Questionnaire submitted 05/25/2012;
6. NBCS Eligibility Questionnaire submitted 05/25/2012;
7. Recruitment Materials submitted 05/25/2012;
8. Approval Process for future informational videos.
PI requests acknowledgment of the following:
1. Navajo HRRB Letter dated 04/19/2012;
2. NBCS Mother Consent Translational Guide submitted 05/25/2012;
3. Participant Timeline English version submitted 05/25/2012;
4. Initial Version Participant Timeline Navajo Translation Guide submitted 05/25/2012;
5. Initial Version HIPAA Navajo Translation Guide submitted 05/25/2012;
6. NBCS Introduction submitted 05/25/2012;
7. Reference Document for Malcolm Benally.

Consent Decision:
Amended consent(s) attached.
HIPAA Authorization on record; signed HIPAA required

VA Studies Only:

If a consent is required, we have attached a date stamped consent that must be used for consenting participants during the above
noted approval period.
If HIPAA Authorization is required, the HIPAA Authorization version noted above should be signed in conjunction with the
consent form.
This study is approved to enroll only the number of subjects listed in the application, current protocol and consent form(s). If the
PI wants to enroll additional subjects, it is the responsibility of the PI to submit an Amendment Request to the HRRC before the
approved number of enrolled subjects is exceeded. If increased enrollment is requested the application, protocol and/or consent
form(s) must also be amended to include the new target.
When consent is required, it is the responsibility of the Principal Investigator (PI) to ensure that ethical and legal informed consent
has been obtained from all research participants.
Sincerely,

Mark Holdsworth, PharmD
Executive Chair
Human Research Review Committee

* Under the provisions of this institution's Federal Wide Assurance (FWA00003255), the HRRC has determined that this proposal provides adequate safeguards for protecting the rights and
welfare of the subjects involved in the study and is in compliance with HHS Regulations (45 CFR 46), FDA Regulations (21 CFR 50, 56).