searched in the project. Psychoneuroimmunology
and the connections between psychological stress and
immune compromise shall also be studied.
(E) A diversity of theories should be developed
and tested through both laboratory experiments and
epidemiological research, including careful examina-
tion of cases of people with HIV and AIDS and
interviews with people with HIV and AIDS and their
care providers including but not limited to primary
care clinicians, gynecologists, nutritionists, alter-
native or holistic practitioners, and mental health
workers.
(F) All research funded in this Act shall be con-
ducted in conformity with the ethics and privacy of
current medical research.
(G) Researchers shall study epidemiological and
blood studies of long-term survivors from diverse
populations to attempt to isolate the factors that
have sustained them.
(H) Consideration shall be given to the
hypotheses and results obtained in other countries.
Researchers from other countries shall be invited to
participate in the project. This may include agree-
ments with another country to reassign particular
researchers to the project for an indefinite commit-
ment. The project’s progress shall not await the con-
clusion of such international agreements.
(2) The project’s study of AIDS pathogenesis
and manifestations must focus on all populations of
people with AIDS and HIV. Equal consideration
shall be given to the differences between these popu-
lations as to their similarities or norms. This in-
cludes, but is not limited to people of all age groups
(including children and seniors), gender, sexual ori-
entation, women (regardless of reproductive health
status), gay men, lesbians, people of color (of var-
ious affected national-cultural groups), injection
drug users, prison inmates, people with hemophilia
and people with inadequate medical care or nutrition
(or both), and persons with disabilities and chronic
conditions related to AIDS.
(3) Basic science investigations and therapeutic
results shall be geared to people at every point on
the spectrum of AIDS and HIV—from the sickest to
the healthiest. Saving people considered near death
must be considered as important as early interven-
tion.
(4) Information generated by the project shall
be made freely available worldwide to researchers,
health care providers, people with AIDS and HIV
and their advocates as soon as it is available, with-
out being inhibited by professional publication prac-
tices. Funds shall be available as needed for the dis-
semination and translation of project materials.
(5) Curatives and therapies ultimately released
due primarily to project research shall not result in
financial gain to any private organization, and shall
be made available to all affected people worldwide
regardless of ability to pay. The project shall be re-
sponsible for establishing a mechanism for inter-
national funding and distribution of any such
curatives.
SEC. 4. EFFICIENT AND COOPERATIVE MANAGEMENT OF
PROJECT.
(a) GOVERNING COUNCIL.—
(1) IN GENERAL.—The project under section 2
shall be governed by, not merely advised by, a coun-
cil composed of scientists and clinicians representing
divergent approaches, and people with AIDS and
HIV, and their advocates, from all affected commu-
nities. This council shall set policy and oversee re-
search priorities, ethical standards, conflict of inter-
est rules and hiring of researchers, and administra-
tors.
(2) CERTAIN
AUTHORITIES.—The Secretary
shall ensure that the following requirements are met
with respect to the council under paragraph (1):
(A) The council shall be composed of sci-
entists representing divergent approaches, clini-
cians with both research and community-based
experience and people with AIDS and HIV and
their advocates.
(B) The council shall have at least 21
members in order to adequately represent di-
verse communities, opinions and disciplines.
People with AIDS and HIV from diverse com-
munities shall be in the majority to ensure that
the project staff are ultimately accountable to
people directly affected by the course and out-
come of the research. Council members shall
step down and be replaced by new members on
a regular basis.
(C) The Council shall set policy for and
oversee research priorities. It shall develop
guidelines for and oversee the hiring of primary
research staff, ensuring both high quality (sci-
entific credentials and experience) and a diver-
sity of disciplines and perspectives (including
alternative’’ or holistic approaches). Having
pursued specific AIDS theories shall not be a
necessary prerequisite for hiring. The Council
shall have the power to create new research po-
sitions when necessary and to remove scientists
from their positions after due process and ap-
propriate review of their work.
(D) The Council shall be charged with
evaluating the work of the project, as well as
the pace of the research, to ensure that it
matches the urgency of the epidemic. Initially,
and throughout the life of the project, the
Council, in cooperation with the primary re-
search staff, shall solicit and evaluate theories
developed outside the project. It shall direct the
project scientists to evaluate and respond to de-
serving proposals and to devise new research
plans where desirable.
(E) The Council shall adopt strict, detailed
codes governing medical ethics and conflicts of
interest and shall monitor compliance with
these codes. Project scientists shall report di-
rectly to the council about the progress of their
work in a manner to be determined by the
council. The Council shall report to the Presi-
dent through the liaison about the progress of
the project.
(F) Council meetings, including those at
which all decisions are made, shall be public
and shall be held at least quarterly, with time
allotted for public comment. In addition, the
Council shall hold an annual public hearing on
its priorities and progress. A complete report of
the project’s goals and accomplishments shall
be updated by the Council, submitted to the
President and released to the public at least
once quarterly. The Council shall evaluate its
structure and process at least once per year and
make changes which allow it to function more
effectively.
(G) Members of the Governing Council will
not be paid employees of the project. However,
the Governing Council will be provided with an
operating budget, including but not limited to,
the following purposes: Support staff; creation
and dissemination of reports and other mate-
rials; funds for transportation and other per
diem expenses; and funds for convening public
meetings.
(b) REQUIREMENTS.—The Governing Council, in car-
rying out the project under section 2, shall ensure that
the following requirements are met:
(1) The project shall establish a primary loca-
tion for its work, in an area with a high incidence
of AIDS. All primary research staff shall work at
that 
location; 
contributing 
researchers 
located
around the world shall interact via video teleconfer-
encing, an international computer network, and reg-
ularly scheduled face-to-face meetings.
(2) The National Institutes of Health’s existing
AIDS research programs shall be maintained. All
National Institutes of Health basic science research
supplementary to that done by the project shall be
performed cooperatively with the project in coordina-
tion with the Office of AIDS Research.
(3)(A) All primary research staff and adminis-
trators shall be financially compensated only by the
project and may not have conflicts of interests with
private or public organizations (including but not
limited to universities, pharmaceutical companies,
and private research organizations).
(B) All primary research staff and administra-
tors shall be required to suspend their relationship
with any private or public organizations for the du-
ration of their association with the project. These re-
quirements shall include full-time, part-time, or con-
sultant positions with a private or public organiza-
tion or other government agencies, and the suspen-
sion would include employment, consulting or board
membership fees, and stock or business ownership.
(C) The Governing Council members shall be
required to suspend their relationship with for-profit
organizations which represent a conflict of interest.
(4) The project shall be funded by public, not
private monies. Appropriations for the project shall
not be diverted from other health research, health
care, or human service programs.
(5) The project shall, in addition to basic re-
search investigations, operate an on-site clinic to
conduct small scale research trials with human par-
ticipants if such trials are crucial for testing
hypotheses related to its basic research.
(c) COORDINATING
COMMITTEE.—The Governing
Council shall ensure that a coordinating committee is es-
tablished for the project under section 2, in accordance
with the following:
(1) The community of scientists selected for the
project shall elect three of their members to serve as
the coordinating committee for the project, and de-
termine whether these positions should be perma-
nent or rotating.
(2) The coordinating committee shall be respon-
sible for facilitating communication among the dif-
ferent scientists working on the project, for evaluat-
ing the progress of its work, and for convening the
entire staff on a regular schedule (or when nec-
essary) to evaluate the progress of the project as a
whole, identify gaps in research, reevaluate the
project’s direction, and to consider newly developed
theories emanating from both within and outside the
project.
(3) The coordinating committee shall also be re-
sponsible for keeping the Governing Council in-
formed of the progress of the project’s work, at
times and in a manner to be determined by the Gov-
erning Council. The coordinating committee shall
also make decisions regarding the hiring of research
associates, technical staff, purchases of equipment
and other day-to-day needs.
(4) The first task of the coordinating committee
shall be to facilitate a preliminary review of all exist-
ing pathogenesis hypotheses, as well as other rel-
evant information about AIDS pathogenesis. At the
end of this review, which shall last no longer than
3 months, the primary research staff shall collec-
tively develop plans for evaluating and testing each
of the viable hypotheses, including timelines for eval-
uating the progress of this work, and submit these
plans to the Governing Council for review and com-
ments.
(d) SELECTION OF GOVERNING COUNCIL.—
(1) IN GENERAL.—The Secretary of Health and
Human Services (HHS) shall convene a national
AIDS congress to make recommendations to the
President for selecting the Governing Council. The
AIDS congress will meet only once, and for the sole
purpose of nominating the initial Governing Council.
The Secretary of HHS shall solicit nominations from
a wide variety of sources, including, but not limited
to, each of the following: AIDS activist groups;
health care providers; AIDS advocacy organizations;
AIDS service organizations; community-based AIDS
research organization; biomedical researchers and
nonmainstream (including alternative or holistic)
medical organizations; and health care planning
agencies, who shall send their nominations for the
Governing Council to the AIDS congress. The AIDS
congress will make recommendations to the Presi-
dent for the Governing Council. The President shall
select the Governing Council based on the rec-
ommendations of the AIDS congress. The AIDS
congress will consist of 2 representatives chosen by
each of the HIV health services planning councils
under section 2602(b) of the Public Health Service
Act, chosen in a forum that is open to the public by
each of the HIV planning councils. The President
shall widely publicize the request for nominations.
(2) DATE CERTAIN FOR SELECTION.—In keep-
ing with the emergency nature of this project, the
nomination and selection process must be completed
within 3 months of the enactment of this Act.
SEC. 5. EXTRAORDINARY POWERS.
In carrying out the project under section 2, the Gov-
erning Council shall have extraordinary powers to carry
out the following:
(1)(A) Utilize, in cooperation with the agencies,
any and all existing United States Government fund-
ed research entities nationwide (including but not
limited to the AIDS Clinical Trial Group (ACTG),
the Community Program for Clinical Research on
AIDS (CPCRA)), and their facilities to clinically
test promising cures developed on the basis of its re-
search and to direct the manner in which such re-
search shall proceed, including staffing, participants,
location, and timing. Such research shall be funded
by the project.
(B) The project shall design its own protocols
and work with these existing clinical trial programs
to develop research designs and methods appropriate
to the project’s goals, assuring that data gathered
by the NIH would accurately reflect the use of these
compounds in all populations and stages of illness.
(C) The project shall provide funding for these
clinical trials of its own compounds. In areas of con-
flict, the project shall have the power to implement
its goals.
(2) Exercise the right of eminent domain to
carry out the following:
(A)(i) Obtain from public and private orga-
nizations, with just compensation, samples of
all potential curatives and all data (excluding
medical records) regarding their development
(including safety and efficacy data) as well as
other 
information, 
materials, 
or 
products
deemed crucial to the project, but protect the
privacy of research subjects and the researcher
over which the project will be exercising the
right of eminent domain. The project shall use
(C) If, however, a company refuses to co-
operate with the project by not releasing needed
data, or by withholding samples of requested
compounds, whether under development or not,
the project is authorized to use powers of emi-
nent domain to procure samples and data. The
project shall have the power to obtain the pat-
ents of such compounds if, after reasonable at-
tempts at cooperation, it finds that a company
will not develop a promising compound accord-
ing to an approved timeframe by the coordinat-
ing committee. After notification by the project
that this power will be used, a company shall
have 30 days in which to develop, for the
project’s approval, a plan for accelerated devel-
opment of the compound to avoid losing exclu-
sive rights to the patent. Unless said companies
adhere to an approved timeframe and are forth-
coming with their data as such work proceeds,
then the project can implement clinical testing
for potential curatives by private companies.
(D) Use existing pharmaceutical company
facilities (with just compensation) for the pro-
duction of promising curatives to be utilized in
project research and, if effective, to produce
such curatives in sufficient amounts to be dis-
seminated to all people needing them.
SEC. 6. PLANNING FUNDS.
Funds shall be allocated immediately to be used for
planning of the project under section 2 (including creating
facilities, selection of staff, funding, structure, and sched-
ules), so that the project can begin functioning as soon
as is possible.
SEC. 7. REAUTHORIZATION OF PROJECT.
After 5 years of operation, the Congress shall have
the power to reauthorize the project under section 2.
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HR 4370 IH——2