Va Form 10-1223 - Report Of Subcommittee On Human Studies
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1REPORT OF SUBCOMMITTEE ON HUMAN STUDIES
Project/Program Title
Principal Investigator
VAMC
Review Date:
COMMITTEE FINDINGS:
1. The information given in the Informed Consent under the Description of Research
YES
by Investigator is complete, accurate, and understandable to a research subject or a
NO
surrogate who possesses standard reading and comprehension skills.
YES
2. The informed consent is obtained by the principal investigator or a trained and
NO
supervised designate under suitable circumstances.
YES
3. Every effort has been made to decrease risk to subject(s)?
NO
4. The potential research benefits justify the risk to subject(s)?
YES
NO
5. If subject is incompetent and surrogate consent is obtained, have all of the
following conditions been met; a) the research can’t be done on competent subjects;
YES
b) there is no risk to the subject, or if risk exists the direct benefit to subject is
NO
substantially greater; c) if an incompetent subject resists, he will not have to
participate; d) if there exists any question about the subject’s competency, the basis
for decision on competency has been fully described.
YES
6. If the subject is paid the payment is reasonable and commensurate with the
NO
subject’s contribution.
7. Members of minority groups and women have been included in the study
YES
population whenever possible and scientifically desirable.
NO
8. Comments: (Indicate if Expedited Review)
RECOMMENDATION:
APPROVE
DISAPPROVE/REVISE
SIGNATURE OF CHAIRMAN
DATE
10-1223
Page 1 of 1
VA FORM
DEC 2005
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