ATTACHMENT 6:

LETTER FROM NIH LEGAL ADVISOR TO DIRECTOR, CLINICAL CENTER,
DECEMBER 5, 1952
                        OFFICE MEMORANDUM

TO:       Distribution                       September 3, 1963

FROM:     T. L. Shipman, M.D., Health Division Leader

SUBJECT:  ADMINISTRATION OF TRACER DOSES TO HUMANS FOR
          EXPERIMENTAL PURPOSES

SYMBOL:   H

In a memo dated July 12, 1956, I established the ground rules
which would, of necessity, be followed in all experimental
procedures involving the administration of tracer doses of
radioactive isotopes to human volunteers.  I would here like to
restate these rules:

     1.   Each experiment which requires the administration of
tracer doses to human volunteers must have the written approval
of the Health Division Leader or his Alternate.

     2.   The request for such approval must contain a statement
as to the maximum dose to be administered, together with a
statement as to the maximum permissible dose for such material.

     3.   All subjects will be bona fide volunteers who are fully
informed as to the procedure to be carried out.

     4.   The administration of any such doses shall be carried
out only under the immediate and direct supervision of a
physician licensed to practice medicine in the State of New
Mexico.

The only thing which has changed since this SOP was prepared is
the fact that for the first time since 1947 Group H-4 will not
have a licensed physician on its staff.  For this reason it will
be necessary if any such work is to be done to require the
collaboration of the physicians on the staff in Group H-2.  It is
particularly important that section 4 above be followed to the
letter in the event of any subcutaneous or intravenous
administration of all materials.

Generally speaking, Wright Langham has blanket authority to
approve or disapprove such procedures, although all proposals in
any way out of the ordinary have been discussed with me.

                                   REPOSITORY ___________________
                                   COLLECTION ___________________
                                   BOX No. ______________________

TO:       DISTRIBUTION                       September 3, 1963

Section 2 above, however, must be carried out with each proposal
for experiments involving humans with the required statement kept
on file in the H-4 Group Office.


                                   T. L. SHIPMAN, M.D.
                                   Health Division Leader


TLS/de

Distribution:  Wright H. Langham, H-4
               Group H-4 Section Leaders
               Harry O. Whipple, M.D.
               Paul L. Flynn, M.D., H-2
               Duane Drake, M.D., H-2



                  Mr. Rouke - 136, Bldg. 1, NIH

                                   FEDERAL SECURITY AGENCY
                                   Office of the Administrator
                                   Office of the General Counsel


                                        ILLEGIBLE
     Dr. John A. ILLEGIBLE                   December 5, 1952
     Director, Clinical Center

     Mr. Edward J. Rourke
     Legal Adviser, ILLEGIBLE
     Office of General Counsel
     Research - Clinical Investigations - Administrative Methods
     to Assure Patient Participant on Fully Informed and
     Voluntary Basis

     At your invitation, I presented to the Medical Board of the
Clinical Center on December 2 a proposal that, in view of several
factors in some degree peculiar to the Clinical Center, it would
be advisable from the legal point of view among others to adopt
certain procedures relating to patient admission that are more
formal than might otherwise be considered necessary.  It was thus
proposed in particular to secure from patients as a uniform
practice a written statement, signed preferably before admission,
indicating the patient's awareness and acceptance of the nature
of the particular investigation in which he was to participate
and acceptance of any particular inconvenience of risk inherent
in his participation.  I offered to prepare, for further
consideration by the several institutes, samples of such a
statement drafted to cover projects that the Institutes plan for
early activation.

     I think it fair to say that of the members of the Medical
Board that expressed their views, and most did so, all rejected
such a proposal.  The rejection was use, as I understand it, not
to any particular detail but rather it more basic objection to
written, as compared to oral, statements.  There was apparently,
therefore, no objection to providing the patient with enough
information to permit him to exercise an informed choice of
participation or refusal as long as not reduced to writing his
signature.

     I will not burden you ILLEGIBLE with repetition of the
factors that in my judgment make it advisable to use statements
subscribed by the patient.  I note only that the reasons for the
use of "consent" forms for standard surgical procedures, a
practice your Board apparently accepts, apply in my opinion with
greater force to clinical investigations.  On the other hand, the
methods to be used to assure that patient participation is on an
informed and voluntary basis are matters of administrative
choice, since no pertinent law precludes the National Institutes
of Health from undertaking either the risks of liability arising
from use of oral rather than written evidence, or the risks to
affective administration arising from the use of other then the
best record to demonstrate that a policy of proceeding only on
the basis of informed consent has been carried out.  I would like
to suggest, however, that whatever be the decision, the matter is
of such importance to the NIH from the point of view of legal
liability that Dr. ILLEGIBLE be at least informed.
     Members of the Medical Board did discuss the possibility
that special occasions would arise when it would be advisable to
have a statement signed by the patient.  It is not yet clear what
the criteria would be on the basis for which such situations
would be identified.  The discussion suggested that one of them
would be where harmful consequences to the patient could not be
excluded in advance with assurance.  It may be that you will want
to secure a degree of uniformity in Clinical Center
administration by developing criteria, acceptable to the
Institutes, for identifying such situation so that special
precautions can then be used.  If so, I would be glad to work
with any officer or group you may designate for this purpose.

     In view of the Medical Board's basic reaction to my initial
proposal and its apparent preferences for a selective approach, I
suggest that it would serve no useful purpose to undertake at
this time a draft of sample statements appropriate for general
use upon patient admission.  I would be glad, of course, to
assist any project director if it be decided that his project is
of such nature that a statement signed by the patient is
advisable.

     A copy of this memorandum is being forwarded to Dr. Wilder
for his information in his capacity as Chairman of the Committee
on Principles Governing Clinical Research.

                              Richard J. Rourke