DOCUMENT 5
                                 
                           

TO:       Memorandum of Faculty Committee on Research

FROM:     Chairman, Faculty Committee on Research

DATE:     April 18, 1969


NIH Review of our Faculty Committee on Research:
     I thought you would be interested in the outcome of the
visit of Dr. mark Connor NIH representative from the
Institutional Relations Division.  He met with Dr. Orules and I
to review this institution's experiences with peer review of
USPHS supported faculty research.

Rejection of Grants on Moral Grounds:
     We learned that two applications received by NIH from this
institution have been rejected on ethical grounds.  Both had been
through this committee.  As far as I know, neither of the
principal investigators involved were notified of the reason of
the rejection by the NIH.  One of these grants was the total body
radiation study in the patients with malignancy.  I third
Cincinnati application under current review by the NIH is also
under scrutiny with respect to the morality of the proposed
investigation.  The latter project is the Kaplan/Schubert/Hug
protocol to study cardiomyopahy in children.

     NIH has set up a separate office, and Institutional
Relations Division under the direction of Dr. Donald Chalkey, to
deal with this general area.  Executive secretaries on NIH study
sections have been directed to report to this Institutional
Relations Division any grant applications which come under
criticism or serious question with respect to a moral issue.  IN
the future, NIH executive secretaries will be asked to notify the
principal investigator when his application has been rejected
because of a moral question or whatever possible, the executive
secretary will contact the P.I. to request supplementary
information from the local Faculty Committee on Research which
may be of help to the study section in judging the morality of
the proposed research.

General Consent Form
     The acceptability of our general consent form for human
volunteers participating in research was questioned.  You will
recall that current policy is to use the General Hospital
Admission Consent Form as the official volunteer consent form for
the institution; a copy is enclosed for your review.  Dr. Orules

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has asked that we review the use of this form.

     Reproduced below is a recent statement appearing in the
Public Affairs Newsletter of the American Federation for Clinical
Research in dealing with the question of patient consent.

     NIH GOING "BY THE BOOK" IN REQUIRING PATIENT CONSENT

     Some grant applications for research projects with human
subjects have failed to obtain their awards for lack of
acceptable assurances of adherence to required patient consent
procedures, and "a small percentage of grantees" have
subsequently "caused problems," after filing acceptable
assurances, according to Dr. Donald Chalkey, NIH Institutional
Relations Officer.

     Grantees are frequently checked on compliance with patient
consent and other standards by reference to the local review
committee which is required to be established by the grantee
institution before the grant is awarded.  Such committees are
composed of nonmedical community leaders as well as institutional
and professional people.

     So far, Dr. Chalkey estimates that only 60 of 1400 approved
institutions have been questioned regarding compliance with
patient consent procedures.

cc:  Dean Orulee