Att 5 - IRB Approval

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Centers for Disease Control
and Prevention (CDC)

Memorandum
Date
d

February 16th, 2012

From

James Peterson, PhD
IRB-D Administrator, Human Research Protection Office

Subject

CDC Approval of Reliance on a Non-CDC IRB for CDC Protocol #6149.0, "A Prospective Birth
Cohort Study Involving Environmental Uranium Exposure in the Navajo Nation"

To

Steve Dearwent, PhD
ATSDR/DHS
CDC's Human Research Protection Office reviewed and approved the request to allow reliance
on a non-CDC IRB for protocol #6149.0, “A Prospective Birth Cohort Study Involving
Environmental Uranium Exposure in the Navajo Nation” in accordance with 45 CFR 46.114.
The protocol has been reviewed and approved by the University of New Mexico Health Sciences
Center IRB for the maximum allowable period of twelve months and the IRB’s approval will
expire on 6/13/2012.
CDC study activities may begin with the following collaborators as current IRB approval
has been received by CDC’s Human Research Protection Office (HRPO):
1. Navajo Division of Health
2. Navajo Area Indian Health Service
If other institutions involved in this protocol are being awarded CDC funds through the CDC
Procurement and Grants Office (PGO), you are required to send a copy of this IRB approval to
the CDC PGO award specialist handling the award. You are also required to verify with the
award specialist that the awardee has provided PGO with the required documentation and has
approval to begin or continue research involving human subjects as described in this protocol.
As a reminder, the IRB must review and approve all human subjects research protocols at
intervals appropriate to the degree of risk, but not less than once per year. There is no grace
period beyond one year from the last IRB approval date. It is ultimately your responsibility to
submit your research protocol for continuation review and approval by the IRB along with
available IRB approvals from all collaborators. Please keep this approval in your protocol file as
proof of IRB approval and as a reminder of the expiration date. To avoid lapses in approval of
your research and the possible suspension of subject enrollment and/or termination of the
protocol, please submit your continuation request along with all completed supporting
documentation at least six weeks before the protocol's expiration date of 6/13/2012.
Any problems of a serious nature must be brought to the immediate attention of the CDC
IRB, and any proposed changes to the protocol should be submitted as an amendment to
the protocol for CDC IRB approval before they are implemented.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Centers for Disease Control
and Prevention (CDC)

If you have any questions, please contact your National Center Human Subjects Contact or the
CDC Human Research Protection Office (404) 639-4721 or e-mail: [email protected].
cc:
NCEH/ATSDR Human Subjects
Angela Ragin, PhD

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/
20-Jun-2011
Lewis, Johnnye L, Ph.D.
College of Pharmacy
SUBJECT: HRRC Approval of New Research Protocol
HRRC#: 11-310
Study Title: The Navajo Birth Cohort Study (A Prospective Birth Cohort Study Involving Environmental Uranium
Exposure in the Navajo Nation)
Type of Review: Full Committee Review
Approval Date: 17-Jun-2011
Expiration Date: 13-Jun-2012
Dear Dr. Lewis:
The Human Research Review Committee (HRRC) has reviewed and approved* the above-mentioned research
protocol including the following:
1. HRRC Application, revised, received 061711 & All attachments submitted 052411 unless noted below
2. Protocol, v061611
3. Biological Specimen Table, received 061711
4. Recruitment Flyer/Announcement, received 061711
5. Photography Consent, v061611
6. UNMHSC Consent/Assent Form-Mother v061611
7. UNMHSC Consent/Assent Form-Father v061611
8. UNMHSC HIPAA Authorization v061611
Note: Revisions requested by the Full Committee on 6/14/11 were received and reviewed using Expedited review
procedures.
ALSO NOTE: Navajo Nation IRB approval is required prior to beginning research. Please submit documentation of
approval once received. Also, it is acknowledged that the infants name cannot be included on the consent at the time
that the mothers consent is obtained. However, given the longitudinal nature of the study and the fact that the infant
will be followed for a period of time and will undergo study procedures, the infants identity should be captured on the
study documents such as the informed consent. As such, it is recommended to create a field for the infants name and
to add the name once the infant is born. This will allow for adequate documentation of the infant's identity as a study
subject. This recommendation can be incorporated with revisions made at the request of the Navajo Nation IRB and
submitted to the HRRC when Navajo Nation IRB Approval documentation is submitted as an amendment.

Consent decision:

Requires a signed consent form
HIPAA Authorization on record; signed HIPAA required
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, protocol and consentform(s). If
the PI wants to enroll additional subjects, it is the responsibility of the PI to submit an Amendment/Change 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.
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).