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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/
25-Mar-2008
McClain, Catherine, M.D.
Pediatrics Center for Development
SUBJECT: HRRC Approval of Research - Amendment
HRRC#: 06-001
Study: Evaluation of the "I Can Do It, You Can Do It" Program
Type of Review: Expedited Review
Approval Date: 25-Mar-2008
Expiration Date: 12-Dec-2008
Dear Dr. McClain:
The Human Research Review Committee (HRRC) has approved* the above mentioned research protocol
action based on review of the following:
Amendment Form dated 03/19/08Protocol Amendment, v 03/19/08
Informed Consent letter v 03/19/08

Consent Decision:
Waived the requirement to obtain a signed consent form
VA Studies Only:
Not applicable.
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/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.
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. A date stamped original of
the HRRC approved consent form(s) is attached to this correspondence, and copies should 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.

Sincerely,
Mark Holdsworth, Pharm.D., BCOP
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).