HEW DRAFT PROPOSED REPORT ON S. 2579, A BILL 'TO AMEND THE PUBLIC HEALTH SERVICE ACT TO ESTABLISH THE PRESIDENT'S COMMISSION FOR THE PROTECTION OF HUMAN SUBJECTS OF BIOMEDICAL AND BEHAVIORAL RESEARCH, AND FOR OTHER PURPOSES.'

• Document Type: CREST
• Collection: General CIA Records
• Document Number (FOIA) /ESDN (CREST): CIA-RDP81M00980R001100010048-7
• Release Decision: RIPPUB
• Original Classification: K
• Document Page Count: 6
• Document Creation Date: December 20, 2016
• Document Release Date: December 15, 2006
• Sequence Number: 48
• Publication Date: April 4, 1978
• Content Type: MEMO

OFFICE OF MANAGEMENT AND BUDGET
WASHINGTON, D.G. 20503
April 4, 1978
LEGISLATIVE REFERRAL MEMORANDUM
TO: . Legislative Liaison
Department of Defense
Veterans Administration
Central Intelligence agency
National Science Foundation
Office of Science and
Technology Policy
Department of Justice
Officer
Department of Energy
National Aeronautics and
Space Administration
Environmental Protection
Agency
Department of Agriculture
SUBJECT: HEW draft proposed report on S. 2579, a bill
"To amend the Public Health Service Act to
establish the President's Commission for the
Protection of Human Subjects of Biomedical and
Behavioral Research, and for other purposes."
The office of Management and Budget requests the views of
your agency on the above subject before advising on its
relationship to the program of the President, in accordance
with OMB Circular A-19.
A response to this request for your views is needed
no later than noon Thursday, April ? '6', 1978, (Subcommittee
markup of S. 2579 is scheduled or Friday a.m., April 7).
Questions should be referred to John Lively
(395-4794 ) or to Jim Stimpson
the legislative analyst in this office.
( 395-3736 ) ,
Naomi R. Sweeney, for
Assistant Director for
Legislative Reference
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EXECUTIVE OFFICE OF THE PRESIDENT [[JJ
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 !s e-.: U-1 ~L.. - DEPARTMENT OF HEAL 1 H. ESL
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The Honorable Harrison A. 'ill ll7 =-s
Chairman, Committer on Haan. Resources .
United States Senate
Washington, H. C... 205M
..Mr_ chain.
'T . is. In, response to your requests for:-a- report*on -S- 2579, al b#1.1 i
Cosaisaion for the Protection of 1'w n Sub j ects . of. ;Bio dic al and ,.:: -'. `?
"To amend the "Publ Health Seruice -Ac- to -establish the -President 'S'
~enaviora.~ sears
Pa -sumary. -. I rt t=*grees v th the purposes -of the -bill az
Is-prepared to receend that it :be- meted.,. provided that `several
.:.a ~ ... ~~ ~C ~ =v?ae^' that it s appropriate ?r,-r.
public adv3. so ry b ,te . o Su rsi oe ~ . to pars s' of ,
depart ent err agency i to e cueraL Coveru :t ;. We tb efors
ze riew apet-if is programs and make _r etero ati ors - coal r:+n them
1802(b)(2)) i hich authorize the proposed -President's: .ssioa to
all prov.or of . S~: I . p artice ly section
aid. be- dileteci. Fuatbe czre, t ..bii~= is + uire the .Pxesid.ec '
i n to separately a se =each of sow -Federal. agencies
-engaged,.:1n research involving humm subjects. This -requirement is
inconsistent with recooendac1ons made by the existing National
.. -Co=acission for the Protection o?."" Runau Sup t acts -of-'El medical and
Behavioral Research that "Pe eiai law sboui4 be.-aacted or--a=ended
-to authorize the Secretary of Health, __P +statian 11 Welfare to
.-: - pr gate regulations icxg-revieew.cf all research involving
- tan. subjects that is subject to Federal, --regulations: " i'`he
.Dent believes that S,7579 -should be aaersued -to incorporate
the recut endatiorxs of the ational Coe .ssion. --Additional sugges-
t ons for azan ent are en t {maned belcwm
S. 2579 contains the following provisions
(1) The bill would establish a President's Co fission to be co=Posed
of eleven members appointed by the President with the advice and
consent of the Senate. Five members of the Coiarission are to be
especially qualified by virtue of their experience and background in
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Page 3 -.The Honorable Harrison A. Williams
are trade to a particular department or agency, that department. or--
agency crust publish the report in the Federal Register within 60
days and provide opportunity for public comment. 4:ithin 180 days
of the date of publication. in the Federal Le ister, the depart ent
or agency rat take appropriate action or publish in the Federal
Register a notice that it deem such action inappropriate. Annual
reports. to the President and appropriate Congressional Co mittees
are required. Tile reports are to indicate "the recommendations
made by the-President's Com`aission and tine subsequent -.actions of
the af.#ected. department or agency..
(8) Other.. provisions of the bid call for the establishment of ethics
advisory boards in each executive or millzzxy department to advise
each department head with respect to ethical l and moral -issues..
These boards are to coordinate-their practices and. agenda with the
(9) Finally, ? 4e b ll inulw e adi ig&5trat N . provisio :g fc i- the
conduct of the President's fission's business and repeals corn-
flictino pro': isio s of the Kati ; Research .Act z=: the Public Health
Service Act.
The Department is in full. agrees ent with' the intent of S. 2379 to
;evaluate policies pertaining to, human subjects of biomedical and
behavioral- research, and to evaluate the implications of genetic
- - -testing, counseling, -and education prograar..:,
We cannot help but question, her ever-, whether a Co aission for the,
protection of human subjects will be-qualified to address question
pertaining to analysis of scientific-and -.technological-advances,
the principles governing the use of technology in medical practice,-
public attitudes toward such advances, and evaluation of re-source
allocation decisions.
Certain of these charges, including those relating to the definition
of death 'and the ele-nts of informed consent in the delivery of
health services, are matters which are being addressed by the carts
and legislatures of the several -states aaong those matters
reserved to their jurisdiction by the 10th Amendmenr. It would.
appear that the opportunity for the President's Ca,=zzission to make
a significant contribution in these areas nay be lizited. Further-
re, the expertise needed to carry out such studies =ay be very
different from that required to evaluate safeguards of the rights
and veil-being of human subjects. The stated qualifications for
ezbership on the Cozzission do not seem to be well suited to these
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Page '* - The honorable Harrison A. Williams
Similarly, the Dc t artrent agrees with the intent of S. 2579 to develop
a uniform policy throughout the Federal Government for the protection
of hu=.an research subjects. On the basis of its earlier efforts
involving eleven Federal. agencies to develop such, a policy, the
Department can attest to the general recognition and acceptance within
the executive branch of a need for such a mechanism. The Department's
eficrts to this end were halted because section 202 of F.L. 93-348,
the National Research Act, required the National Commission for the
Protection of }tu.:.an Subjects to study how a uniform Federal policy
could best be accomplished. The National Co=fission recently com-
pleted its study of this matter and has recon.;,,ended that HEW take the
lead in developing such a policy. Initial steps to i=ple r the
recorr.endations a the Co_.issien have already been taken. As currently
drafted, S. 2579 proposes a much more diffuse approach than that
expressed in the National Co~.^ission's recoendations. Where the