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PROCEDURES FOR USE OF HUMANS AS RESEARCH SUBJECTS
IN THE EXTRAMURAL RESEARCH PROGRAM
I.
Purpose: This is to establish uniform procedures and respon-
sibility for review of the use of
humans as research subjects,
negotiation of provisions, and administration of research projects
in the extramural program. Wherever the term "contractor" appears
it shall also mean grantee and other Government agency.
II.
References
1.
45 CFR 46 HHS Regulation on Protection of Human Subjects;
2.
£
10 U. S. C. Section
980 Limitations on Use of Humans as
Experimental Subjects;
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3.
21 CFR 312 Investigational Drugs and Vaccines;
4.
21 CFR 812 Investigational Medical Devices;
5.
21
CFR
56.111 (a) (3)
Advertisement Guidelines
for the
Recruiting of Research Subjects;
6.
DOD
Directive
6465.2
Organs and Tissues Obtained from
Autopsy ;
7.
DOD Directive
3216.2
Protection
of Human
Subjects in
DOD-Supported Research;
8.
Federal Acquisition
Regulation (FAR) 52. 228-7 Insurance
Liability to Third Persons and FAR 31.109 Advance Agreements;
1
9.
USAMRDC Regulation 70-25
Use
of
Human
Subjects
in
Research, Development, Testing and Evaluation;
10. USAMRDC Broad Agency Announcement (BAA) ;
11. Army Regulation 340-21 The Army Privacy Program; and
12. Federal Acquisition Regulations (FAR) Part 24 Protection
of
Privacy and Freedom
of
Information,
52. 224-1 Privacy
Act
Notification, and 52.224-2 Privacy Act.
III.
Objectives :
1.
Safeguarding
the rights and welfare of human subjects
participating in research and development supported by contracts,
grants and orders awarded by U. S. Army Medical Research and
SOP 8
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Development Command (USAMRDC) is of utmost concern to the Command,
and is primarily the responsibility of the contractor or recipient
who receives or is accountable to USAMRDC for the funds awarded for
the support of the project.
However, the sensitivity of such
research necessitates
that
the Command exercise prudence in its
oversight responsibilities.
The
procedures employed shall be
flexible and tailored to the requirements of the specific acquisi-
tion.
2.
It is the policy of USAMRDC that the Department of Health
and
Human
Services (HHS) Regulation on Protection of Human Sub-
jects, Food and Drug Administration Regulations on Investigational
Drugs and Vaccines and Investigational
Medical Devices, and
Advertisement Guidelines for the Recruiting of Research Subjects
shall be adhered to by USAMRDC contractors and recipients, with the
addition of the following specific DOD/USAMRDC requirements.
a. Informed consent must be obtained in advance from the
subject, or
in the case of research intended to be beneficial to
the subject, the informed consent of
the subject or a legal
representative of the subject must be obtained in advance.
b. Contractors and recipients shall provide all neces-
sary medical care to research subjects for injury or disease which
is the proximate result of participation in the research.
c.
Anatomical Substances (organs, tissues, or tissue
fluids) obtained from autopsy shall not be used for research or
investigational purposes without the expressed consent of the next
of kin.
It should be noted that a general autopsy consent may not,
in itself, be sufficient.
If autopsy tissue is to be used, the
protocol should include a copy of the consent form used to obtain
the tissue.
d.
Anatomical Substances (organs, tissues, or tissue
fluids) obtained from a
surgical procedure shall not be used for
research or investigational purposes without the expressed consent
of the patient or patient's legal representative.
It should be
noted that a consent
to perform surgery may not, in itself, be
sufficient. If excised tissue is to be used, the protocol should
include a copy of the consent form used to obtain the tissue.
e.
Anatomical
substances linked by identifiers to a
particular person and used for research shall be donated for the
purpose of research, and shall be lawfully acquired.
The donor
shall be the person from whom the substance is removed or, in the
event of death or legal disability of the person from whom the
substance is removed, the next of kin or legal representative of
such person.
Donation shall be made by written consent and the
donor shall relinquish all ownership and/or rights to the sub-
stance.
If excised or autopsy tissue is to be used, the protocol
should include a copy of the consent form used to obtain the
tissue.
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f.
Prisoners of war shall not be used as research
subjects.
g .
Use of prisoners as research subjects shall follow 45
CFR 46, Subpart C.
h. Studies
conducted outside the U.S., its territories
or possessions, which
involve the use of non-U.S. citizens as
subjects, in addition
to compliance with 45 CFR 46 and above
special DoD and USAMRDC requirements, shall comply with the laws,
customs, and practices of the country in which the study is to be
conducted. The minimum standards to be adhered to are contained in
the Declaration of Helsinki (Tab D).
The research proposal
submitted for approval will document this action.
In exceptional
circumstances
where
laws, customs or practices of the country
involved take exception to
particular procedural
requirements of
this provision
(as, for
example, the documentation of informed
consent or the procedures
by which it is obtained), specific
approval
will be obtained
from the Commander, U.S. Army Medical
Research
and
Development Command as an integral part of the
proposal review and approval process.
i.
None of these provisions apply to epidemiological
surveys involving no more than minimal risk.
j.
The USAMRDC may inspect contractor records concerning
human use.
IV.
Goals:
1.
The Human Use Review and Regulatory Affairs Office
(SGRD-HR) shall be
responsible
for all
aspects of the USAMRDC
extramural program
involving
the use of humans in research and
testing, and use
of human
anatomical
substances.
SGRD-HR is
specifically responsible for:
a.
Review of any proposal and consent form, contract,
subcontract, grant, intragovernmental transfer of funds order, or
modification which involve the use of humans or human anatomical
substances. Review shall ensure:
(1) that applicable DOD directives, Army Regulations,
FDA and HHS regulations, and public laws will be complied with;
(2) that appropriate validation of the human use
process has occurred, and;
(3) that the recipient or contractor has an assurance
of compliance with 45 CFR 46 satisfactory to the HHS, or has
provided sufficient information for negotiation with the USAMRDC of
a special assurance of compliance.
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b. Development, in coordination
the U.S. Army
Medical
Research
Acquisition Activity
( SGRD-RMA) ,
of special
provisions to be included in RFPs, contracts, and grants. Develop-
ment,
in coordination
with
the
Acquisition Management Office
(SGRD-ACQ), of special provisions to be
included in the BAA and
intragovernmental transfer of fund orders.
c. Participating in negotiations
£
(in conjunction with
SGRD-RMA or SGRD-ACQ) with prospective contractors for the develop-
ment of
special assurance of compliance with HHS 45 CFR 46. The
SGRD-HR shall be the final approval authority for special assuran-
ces.
d.
Review and approval of
proposals recommended for
inclusion in the competitive range as
a result of solicitations,
and its accompanying consent
form.
Where applicable, advertise-
ments used to recruit subjects will be reviewed.
e. Assuring
that
all
parties
(e.g., contracting
officer's representative (COR), Project Manager and Product Manager
( PM) , SGRD-ACQ, AMLO, and SGRD-RMA)
are kept informed regarding
issues relative to the use of humans.
f. Monitoring contracts, grants, and orders funded by
USAMRDC by means of documentation review or site survey (pre- and
post-award) as required.
g. Receiving reports of research related illnesses or
injuries from principal investigators.
2.
The SGRD-RMA
shall be
responsible for
the following
concerning the use of
humans as
research subjects or the use of
human anatomical substances :
a.
Negotiation, in conjunction with
SGRD-HR, of special
assurances of compliance with regulations with prospective contrac-
tors.
b. Development, in coordination with SGRD-HR, of special
provisions to be included in RFPs and contracts.
When
assigned
contract
administration,
assuring
compliance with contract terms.
d.
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Approval of use of
prisoners as
research subjects,
after
review and approval of
the
Command
Judge Advocate and
SGRD-HR.
3.
The SGRD-ACQ shall
be
responsible
for
the following
concerning the use of humans as research subjects:
a. Issuing required changes to this procedure.
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b.
Negotiation, in
conjunction with SGRD-HR, of special
assurances of compliance
with
regulations
with
other Government
agencies.
c.
Development, in coordination with SGRD-HR, of special
provisions to be included
in intragovernmental
transfer
of fund
orders.
d.
Approval of
use
of prisoners as research subjects,
after
review
and
approval
of
the
Command Judge
Advocate and
SGRD-HR.
e.
Administration of
intragovernmental orders to assure
compliance with the order.
4. The U.S. Army Medical Materiel Development Activity shall
assist and participate with SGRD-HR, SGRD-RMA, and SGRD-ACQ on all
matters pertaining to the use of
humans as research subjects in
programs under their cognizance.
5.
The Office of
the
Command Judge Advocate shall advise
SGRD-HR, SGRD-RMA, and SGRD-ACQ on all legal matters pertaining to
the use of humans
as research
subjects or the use of anatomical
substances.
6. The appointed COR through the AMLO or PM shall assist and
participate with SGRD-RMA, SGRD-HR, and SGRD-ACQ in administration
of contracts, grants, and intragovernmental orders.
V.
Procedures :
1. Proposed contracts, RFPs, and proposals received under
the
BAA,
and proposals
from other Government agencies which are
recommended for funding shall be reviewed by SGRD-HR prior to
submission to SGRD-RMA for procurement or to SGRD-ACQ
for intra-
government transfer of funds.
a .
Clarifications or changes to proposals received in
response to the
BAA or
from
other Government agencies
is the
responsibility of
SGRD-HR.
Copies
of all
correspondence will be
provided the affected AMLO.
b.
Clarification or changes in RFPs and contracts is the
responsibility of
SGRD-HR.
All communications with the contractor
will be through SGRD-RMA.
2.
To permit timely award of the contract, the
9
use
USAMRDC Form
and
documentation may be submitted by SGRD-HR to SGRD-RMA or
SGRD-ACQ, even though all issues relating
to
the
of human
subjects have not been resolved, on the condition that the Prohibi-
tion of Use of Human Subjects
provision will
be included in the
contract, grant, or order.
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specific RFPs
a.
Comments on proposals submitted
in
response
to
shall be provided by SGRD-HR to SGRD-RMA prior to
negotiation
by SGRD-RMA
with organizations in the competitive
range. SGRD-HR shall provide SGRD-RMA recommendations for negotia-
tion of provisions to be included in contracts to be awarded as the
result of other than full and open competition, and provisions for
changes or tasks after contract award.
b. Upon receipt of required information, SGRD-HR shall
review and approve the appropriate provision in the contract,
grant, or order.
c. SGRD-HR
will review and approve task order protocols
in accordance with the provisions of the contract.
d. Upon resolution of all issues involving
the use of
humans
in research, the clause entitled "Use of Human Subjects,
Investigational Drugs, and Investigational Medical Devices" (TAB B)
will be included in the contract.
3.
Compliance by subcontractors
with
45 CFR 46 and these
procedures is the responsibility
of the
prime contractor, subject
to the following:
a.
Subcontracts shall contain the prime contract clause
Prohibition of Use of Human Subjects (Tab A) or Use of Human
Subjects, Investigational
Drugs, and Investigational Medical
Devices (Tab B). The proposed subcontract and assurance of
compliance with 45 CFR 46 satisfactory to the HHS, or sufficient
information for negotiation with USAMRDC of a special
assurance of
compliance, shall be submitted to SGRD-RMA for review and approval
by SGRD-HR prior to award of the subcontract, or use of humans as
research subjects.
b. The SGRD-RMA will obtain comments and approval of
SGRD-HR prior to SGRD-RMA
approval of the subcontract or use of
humans, or negotiation of a special assurance with the subcontrac-
tor.
c.
The prime contractor shall
be
involved with and
participate in all discussions and negotiation.
Responsibility for
compliance with 45 CFR 46 and this procedure shall be the
responsibility
of
the prime
contractor
and
subcontractor (s)
utilizing humans
as research subjects.
Subcontractors shall have
Institutional Review Boards and follow
45 CFR 46, except under
unusual circumstances where SGRD-HR
and SGRD-RMA (or SGRD-ACQ)
approve the prime's assuming responsibility for the subcontractor
in this regard.
4. The requirement for site visits, extent of examination of
records, and discussions with researchers and research subjects
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shall, except under unusual
circumstances, be coordinated between
SGRD-HR, the assigned administrative contracting office (ACO) (or
SGRD-ACQ), AMLO, and the COR or PM. Copies of correspondence and
telephone memoranda shall be exchanged between SGRD-HR, ACO (or
SGRD-ACQ) and the COR and AMLO or PM to assure awareness of human
use issues. If the ACO, in consultation with SGRD-HR, determines
that the contractor is not in compliance with the requirements of
the provisions in Tab B, the ACO may suspend work and further
payment until corrections are made by the contractor.
5.
All contracts, grants, and intragovernmental orders which
involve the use of humans shall:
a.
Contain the provision (Tab A) to prohibit the use of
humans as research subjects, or
b. Contain the provision (Tab B) governing
the use of
human subjects, investigational drugs or vaccines, and investiga-
tional medical devices, and/or
c.
Contain the provision (Tab C) governing
the use of
donated anatomical substances,
d. Be reviewed and approved by SGRD-JA prior to award,
e. Be reviewed and approved by SGRD-HR prior to award.
6. Due to the fact that DA policy requires the contractor to |
provide necessary medical care of research subjects, requests may
be made by prospective contractors for assurance of future funding
for certain liabilities, as set out in FAR 52.228-7(c) (2). Since
the Government's liability is subject to the availability of funds
at the time the contingency occurs, to cover such a contingency, an
advance agreement (pursuant to FAR
31.109) may be negotiated to
recognize costs,
associated with
such medical care, which exceed
those covered by
the contractor's
insurance required by the
contract. Such allowable costs, however, may not exceed the total
amount of funds obligated by the Government to the contract. It is
the responsibility of the contractor to initiate a specific request
for funds to pay premiums for additional insurance coverage, or the
costs of
medical care required as a result of research performed
under the contract. Approval of
the Secretary of
the Army to
indemnify a contractor against unusually hazardous risks may be
requested pursuant to DOD FARS 235.070.
Such requests shall only
be made after receipt of proof the risk cannot be compensated by
insurance or otherwise.
7. a. It is the policy of the USAMRDC that whenever the use
of volunteers exists in USAMRDC sponsored research, data sheets are
to be completed on all volunteers for entry in the USAMRDC's
Volunteer Registry data base. SGRD-HR may, on request, exempt this
requirement for studies which the IRB has determined to be minimal
risk. The intent of the data base is two fold:
first, to readily
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answer questions
concerning
an individual's participation
in
research conducted or sponsored by the USAMRDC; and
second, to
ensure that the USAMRDC can exercise its "duty to warn." The "duty
to warn" is an obligation to ensure that
research volunteers are
adequately informed concerning the risks
involved with their
participation in research, and to provide
them
with any newly
acquired
information that may affect their well-being when that
information becomes available. The duty to warn
exists even after
the volunteer
has completed his or her participation in research.
To accomplish this, a system must be established
which will permit
the identification of volunteers who have participated in research
conducted or sponsored by the USAMRDC. The data base must contain
items of personal information, for example, name, Social Security
number, etc., which subjects it to the provision of the Privacy Act
of 1974 (Reference 11.).
b.
For each subject enrolled in
a study a Volunteer
Registry Data Sheet (USAMRDC Form 60-R), TAB E, is to be completed.
The principal investigator is to complete Part A of Form 60-R;
after which, Form 60-R is to be provided to volunteers for comple-
tion at the time of consent.
The information collected is then
sent to SGRD-HR upon completion of the research or upon expiration/
termination of the contract, whichever occurs first. Data sheets
collected on volunteers participating in task orders are to be
submitted to SGRD-HR
upon completion of each task order. The
information is stored in the USAMRDC Headquarters data base for a
minimum of 75 years.
c. Information
stored in the Volunteer Registry data
base will
be disclosed
in accordance with Reference 10, and the
privacy Act of 1974.
Upon written or oral requests, persons on
whom data is collected,
or his or her designated agent or legal
guardian may have access to the record pertaining to that individ-
ual contained in the Volunteer Registry data base. Only authorized
staff of the HURRAO may have access to information entered in and
information selected from the Volunteer Registry data base.
d. The record system name and notice number for the
Volunteer Registry data base is Medical Research Volunteer Regist-
ry, AD 1304-22a DASG, as published in the Federal Register/VOL. 51,
No. 125/Monday, June 30, 1986.
8.
Research and development conducted outside the U.S. utilizing
investigational drugs, vaccines, and devices is subject to the same
safety reviews and regulatory procedures as research and develop-
ment conducted within the U. S.
Initial dose ranging, toxicity and
safety studies . (Phase I studies) will only be conducted within the
U.S.
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Prohibition of Use of Human Subjects
Notwithstanding any other provisions
contained
£
in this
contract
or
incorporated
by reference herein, the contractor is
expressly forbidden to use or subcontract for the use of human
subjects
in any manner whatsoever.
In the performance of this
contract, the contractor agrees not to come into contact with, use
or employ, or subcontract for the use or employ of any human
subjects for research, experimentation, tests or other treatment
under the scope of work as set out in the contract without express
written approval from the contracting officer.
Tab A
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Use of Human Subjects, Investigational Drugs and Vaccines, and
Investigational Medical Devices
a.
Definitions
(1) Subject at risk
means any individual
who may be
exposed to the possibility of injury, including physical, psycho-
logical, or social injury, as a
consequence of participation as a
subject in any research, development, or related activity which
departs from the application
of
those established and accepted
methods necessary
to
meet
his needs, or which increases the
ordinary risks
of daily
life,
including the recognized risks
inherent in a chosen occupation or field of service.
1
(2) Investigational drugs and vaccines means a drug or
vaccine that may be considered investigational when the composition
is such that:
under
(a)
Its proposed use is not recognized for the use
the conditions prescribed; or its proposed use is not
recommended
or suggested in its approved labeling.
Experts
qualified by scientific training and experience evaluate the safety
and effectiveness of drugs and vaccines to make this determination.
(b)
Its use has become recognized as investigation-
al, as a result of studies to determine its safety and effective-
ness for use under such conditions (21 CFR 312) .
(3) Investigational medical devices means a device that
is not generally used in the diagnosis, cure, mitigation, treatment
or prevention of disease in humans, and recognized as safe and
effective. Research is usually, but not necessarily,
initiated to
determine if the device is safe or effective (21 CFR 812).
b.
None of these provisions applies
to
epidemiological
surveys which involve no more than minimal risk.
c.
Requirements for the Use of Humans
(1) Safeguarding the rights and welfare
of
subjects at
risk .
in
activities
supported by this contract is primarily the
responsibility of the contractor.
Compliance with
this contract
will
in no way render inapplicable pertinent federal, state, or
local laws or regulations.
In order to provide for the adequate
discharge of this institutional responsibility, it is the policy of
the U.S. Army Medical
Research and Development Command (USAMRDC)
that no activity involving human subjects under this contract shall
be undertaken unless an Institutional Review Board (IRB) has
reviewed and approved such activity.
TAB B
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(2) The institution shall have provided to USAMRDC a
written assurance that it will abide
by the policy for the pro-
tection of human subjects as contained in 45 CFR 46. When an
institution has an assurance of compliance satisfactory to the
Department of Health and
Human Services (HHS), evidence of IRB
approval of the study shall have been accomplished by submission to
USAMRDC of an executed HHS Form 596. For an institution without a
HHS approved assurance of compliance, an assurance concerning the
protection of human subjects
shall have been negotiated with the
USAMRDC contracting officer, and IRB approval given.
(3) In addition to the requirements of Title 45, Part 46
of the CFR, the following
shall apply to all USAMRDC contracts
supporting research, development, and related activities:
(a) Informed consent must be obtained in advance from
a subject at risk, or in the case
of research
intended to be
beneficial to the subject, a legal
representative of the subject
may give informed consent in advance of the research.
(b) The contractor shall provide
for all necessary
medical care of subjects at risk for injury or disease which is the
proximate result of participation in the research.
(c) Prisoners of war shall
not be used under any
circumstances.
(d) Use of prisoners as research subjects shall have
been specifically approved by the USAMRDC contracting officer.
(e) Studies conducted outside the United States, its
territories
or possessions,
which involve the use of non-U.S.
citizens as subjects, in addition to compliance with 45 CFR 46 and
special DOD
requirements, shall comply with all laws, customs, and
practices of the country
in which
the study is to be conducted.
The minimum
standards
to
be adhered to are contained in The
Declaration of Helsinki.
The research proposal
submitted for
approval will
document this action.
In exceptional circumstances
where laws, customs
or practices
of
the country
involved take
exception to particular procedural
requirements of this provision
(as, for example, the documentation
of.
informed consent
or the
procedures by which it is obtained), specific approval will be
obtained from the
Commander, U. S.
Army Medical Research
and
Development Command
as an integral part of the proposal review and
approval process.
(4) In accordance
with
21
CFR
56.111(a) (3), IRBs are
responsible for reviewing
the methods
used by investigators to
recruit subjects. One method of recruiting subjects is through
advertisements which should be seen as an extension of the informed
consent. IRB review of advertisements is necessary to ensure that
the information is not misleading to subjects. The FDA has
established guidelines on advertisement for research subjects.
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Generally, the FDA
believes that any
advertisement to recruit
subjects should be limited to:
(a) The name and address of the principal investi-
gator;
(b) The purpose of the research and, in summary form,
the eligibility criteria that will be used to admit subjects into
the study;
(c) A straightforward and truthful description of the
benefits (e.g., payments or free
treatment)
to the subject from
participation in the study;
(d) The location of
the research and the person to
contact for further information.
(5) In addition to the requirements noted above, a copy
of the protocol and informed consent for each phase of a study will
be forwarded to the Commander, U.S. Army Medical Research and
Development Command, ATTN:
SGRD-HR, Fort Detrick, Frederick, MD
21701-5012. If available, a copy of the local IRB review and
approval should be provided.
Research involving the use of human
subjects may not commence
until approved
by
the contracting
officer.
d.
Requirements for the Use of Investigational Drugs and
Vaccines
The contractor shall comply with 21 CFR 312 for the study
and evaluation of those new drugs restricted by the Federal Food,
Drug, and Cosmetic Act.
The drug shall be used by, or under the
supervision of an investigator pursuant to an Investigational New
Drug Application ( IND) .
A copy of the current applicable forms as
related under Part 312 shall have been provided with the contrac-
tor's proposal.
℮
Requirements for
the
Use of
Investigational
£
Medical
Devices
The contractor shall comply with 21 CFR 812 for the study
and evaluation, of those devices which are not generally recognized
as safe and/or effective, intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in, or research on
humans. Should the contractor propose to use an investigational
device in the research, he shall provide with his proposal a copy
of Food and Drug Administration (FDA) approval of,
or grant of
waiver for, use of an investigational device exemption (IDE).
f.
Requirements for Reporting and Documentation:
(1) Immediate telephone notification shall be given to
the USAMRDC Human Use Review and Regulatory Affairs Office of any
significant adverse reactions.
( Telephone weekdays, Area
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Code 301/663-2165; nights, weekends, and holidays, the Duty Officer
Telephone Area Code 301/ 663-7114.)
(2) Copies of all documents presented or required for
initial
and continuing review by the IRB, e.g., Board minutes
pertaining only to the
contract, record of subject's consent,
transmittals
on actions,
instructions, and conditions resulting
from IRB deliberations addressed to the activity director, are to
be retained by the contractor for at least three years after
completion of the research. All documents shall be accessible for
inspection during normal working hours, by the USAMRDC contracting
officer or authorized representative.
(3) Information on volunteers used
in research sponsored
by USAMRDC
will be entered in the USAMRDC Volunteer Registry data
base.
The data base is required to ensure that USAMRDC can readily
exercise
its "duty to warn"
individuals of any newly acquired
information which may affect their well-being,
even after partici-
pation in the research.
The
SGRD-HR
may, on request of the
contractor, exempt the research from
this
requirement; such
exemption may only be granted for studies which the local IRB has
determined to be minimal risk.
The Volunteer
Registry Data Sheet
USAMRDC
Form 60-R (Tab E)
is
to be completed at the time the
subject consents to participate and is entered into the study. The
forms
shall be submitted
to
the HURRAO upon completion of the
research project or upon expiration/termination of the contract,
whichever occurs first. The USAMRDC will retain information in the
data base for 75 years. Persons on whom data is collected, or a
designated representative or legal guardian, may have access to the
record pertaining to that individual.
(4) Except as otherwise provided by law, information in
the records
or possession of the contractor which refers to or can
be identified with
a particular subject may not be disclosed
except :
(a) with the consent of the subject or his legally
authorized representative, or
(b) as may be necessary for the USAMRDC to carry out
its legal responsibilities.
(5) Upon expiration or termination of this contract, a
list of all unused test material shall be
provided to the USAMRDC
contracting officer.
(6) The contractor shall immediately notify the USAMRDC
contracting officer, by telephone, of inquiries
outside the
Department of Defense concerning the use of human subjects
under this contract. In addition, the contracting officer shall be
notified as soon as possible of inspections of the facility or
contract protocols by the FDA.
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1990
g .
Subcontracts. Compliance by subcontractors with Code of
Federal Regulations 45 CFR 46 and this contract provision is the
responsibility of the prime contractor. All subcontracts which
contain this contract provision shall be approved by the contract-
ing officer prior to award.
The requirements of paragraph c(2)
above shall apply to subcontractors.
h.
If at any time during performance of this contract, the
contracting officer determines, in consultation with the USAMRDC
Human Use Review and Regulatory Affairs Office, that the contractor
is not in compliance with any of the requirements and/or standards
stated in paragraphs c, d, and e above, the contracting officer may
immediately suspend, in whole or in part, work and further payments
under this contract until the contractor corrects such noncompli-
ance. Notice of the suspension may be communicated by telephone
and confirmed in writing.
If the contractor fails to complete
corrective action within
the period of time designated in the
contracting officer's written notice of suspension, the contracting
officer may terminate this contract in whole or in part, and the
contractor's name may be removed from the list of those contractors
with approved policies on the use of human subjects.
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4
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Use of Anatomical Substances
2 5 JUN 1990
Any anatomical substance (organs, tissues, or tissue fluids)
linked by identifiers to a particular person and used for research
under this contract shall be donated for the purpose of research or
investigation.
The
donor
shall be the person
from
whom the
substance is removed or, in the event of death or legal disability
of the person from
whom the substance is removed, the next of kin
or legal representative of such person. Donation shall
be made by
written consent and shall relinquish all ownership and/or rights to
the substance. All human anatomical substance
used
in research
under this contract shall be lawfully acquired.
It should be noted
that a general autopsy consent form or a consent to perform surgery
in and of themselves, may not be adequate.
If excised or autopsy
tissue is to be used, the protocol should
include a copy of the
consent form used to obtain the tissue.
Tab C
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2 5 JUN 1990
THE DECLARATION OF HELSINKI
1.
BASIC PRINCIPLES
a.
Biomedical research involving human subjects must conform
to generally accepted scientific principles and should be based
on adequately performed laboratory and animal experimentation and
on a thorough knowledge of the scientific literature.
b.
The design and performance of each experimental procedure
involving human subjects should be clearly formulated in an
experimental protocol which should be transmitted to a specially
appointed independent committee for consideration, comment, and
guidance.
c.
Biomedical research involving human subjects should be
conducted only by scientifically qualified persons and under the
supervision of a clinically competent medical person. The
responsibility for the human subject must always rest with a
medically qualified person and never rest on the subject of the
research, even though the subject has given his or her consent.
d.
Biomedical research involving human subjects cannot
legitimately be carried out unless the importance of the
objective is in proportion to the inherent risk to the subject.
e.
Every biomedical research project involving human
subjects should be preceded by careful assessment of predictable
risks in comparison with foreseeable benefits to the subject or
to others.
Concern for the interests of the subject must always
prevail over the interests of science and society.
f.
The right of the research subject to safeguard his or her
integrity must always be respected. Every precaution should be
taken to respect the privacy of the subject, and to minimize the
impact of the study on the subject's physical and mental
integrity and on the personality of the subject.
g .
Doctors should abstain from engaging in research projects
involving human subjects unless they are satisfied that the
hazards involved are believed to be predictable.
Doctors should
cease any investigation if the hazards are found to outweigh the
potential benefits.
h. In publication of the results of his or her research, the
doctor is obliged to preserve the accuracy of the results.
Reports of experimentation not in accordance with the principles
laid down in this Declaration should not be accepted for
publication.
Tab D
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i. In any research on human beings, each potential subject
must be adequately informed of the aims, methods, anticipated
benefits and potential hazards of the study and the discomfort it
may entail. He or she should be informed that he or she is at
liberty to abstain from participation in the study and that
he or she is free to withdraw his or her consent to participation
at any time. The doctor should then obtain the subject's given
informed consent, preferably in writing.
j.
When obtaining informed consent for the research project,
the doctor should be particularly cautious if the subject is in a
dependent relationship to him or her or may consent under duress.
In that case the informed consent should be obtained by a doctor
who is not engaged in the investigation and who is completely
independent of this official relationship.
k.
In case of legal incompetence, informed consent should be
obtained from the legal guardian in accordance with national
legislation. Where physical or mental incapacity makes it
impossible to obtain informed consent, or when the subject is a
minor, permission from the responsible relative replaces that of
the subject in accordance with national legislation.
1. The research protocol should always contain a statement
of the ethical considerations involved and should indicate that
the principles enunciated in the present Declaration are complied
with.
2.
MEDICAL RESEARCH COMBINED WITH PROFESSIONAL CARE
(CLINICAL RESEARCH)
a.
In the treatment of the sick person, the doctor must be
free to use a new diagnostic and therapeutic measure, if in his
or her judgment it offers hope of saving life, reestablishing
health, or alleviating suffering.
b. The potential benefits, hazards and discomforts of a new
method should be weighed against the advantages of the best
current diagnostic and therapeutic methods.
c.
In any medical study, every patient -- including those of a
control group, if any -- should be assured of the best proven
diagnostic and therapeutic methods.
d. The refusal of the patient to participate in a study must
never interfere with the doctor-patient relationship.
e. If the doctor considers it essential not to obtain
informed consent, the specific reasons for this proposal should
be stated in the experimental protocol for transmission to the
independent committee.
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f. The doctor can combine medical research with professional
care, the objective being the acquisition of new medical
knowledge, only to the extent that medical research is justified
by its potential diagnostic or therapeutic value for the patient.
3.
NON-THERAPEUTIC BIOMEDICAL RESEARCH INVOLVING HUMAN SUBJECTS
(NON-CLINICAL BIOMEDICAL RESEARCH)
a. In the purely scientific application of medical research
carried out on a human being, it is the duty of the doctor to
remain the protector of the life and health of that person on
whom biomedical research is being carried out.
b. The subjects should be volunteers -- either healthy persons
or patients for whom the experimental design is not related to
the patient's illness.
c. The investigator or the investigating team should
discontinue the research if in his or her or their judgment it
may, if continued, be harmful to the individual.
d.
In research on man, the interest of science and society
should never take precedence over considerations related to the
well-being of the subject.
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VOLUNTEER REGISTRY DATA SHEET
2 5 JUN 1990
-
THIS FORM . IS AFFECTED BY THE PRIVACY "ACT OF 1974
1. AUTHORITY: 5 USC 301: 10 USC 1071-1090; 14 USC 3101; BO 9397
2. Principal and Routine Purposes: To document participation in research conducted or sponsored by the U.S. Army Medical
Research and Development Command. Personal information will be used for identification and location of participants.
3. Mandatory or Voluntary Disclosure: The furnishing of the SSN is mandatory and necessary to provide identification
and to contact you if future information indicates that your health may be adversely affected.
Failure to provide the information may preclude your participation in the research study
PART A-INVESTIGATOR INFORMATION
(To Be Completed By Investigator)
PLEASE PRINT, USING INK OR BALLPOINT PEN
1. Study NR:
2. Protocol Title:
3. Contractor (Laboratory/Institute Conducting Study):
4. Study Period: From: 01/
1
To: 15/
1
(DAIMOIYR)
(DAIMOIYR)
5. Principal/Other Investigator(s) Names(s)
6. Location/Laboratory
(1)
(Last)
(First)
(MI)
(2)
(3)
/
PART B-VOLUNTEER INFORMATION
(To Be Completed By Volunteer)
PLEASE PRINT, USING INK OR BALLPOINT PEN
7. SSN:
1
1
8. Name:
(Last)
(First)
(MI)
9. Sex: M_F_
10. Date of Birth:
1
11. * MOS/Job Series:
12. * Rank/Grade:
13. Permanent Home Address (Home of Record) or Study Location Address:
(Street)
(P.O. Box/Apartment No.)
(City)
(Country)
(State)
(Zip Code)
(
)
-
(Perm Home Phone No)
14. * Local Address (If Different From Permanent Address):
(Street)
(P.O. Box/Apartment No.)
(City)
(Country)
(State)
(Zip Code)
)
(Local Phone No)
5 .* Military Unit:
Zip Code:
Organization:
Post:
Duty Phone No.
(
-
-
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TAB E
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PART C-ADDITIONAL INFORMATION
(To Be Completed By Investigator)
PLEASE PRINT, USING INK OR BALLPOINT PEN
-
16. Location of Study:
17. Is Study Completed: Y_ N_
Did volunteer finish participation: Y
Z
If YES, Date finished:
(DAIMOIYR)
If NO, Date withdrawn:
Reason withdrawn:
(DAIMOIYR)
18. Did Any Serious or Unexpected Adverse Incident or Reaction Occur: Y __ N __ If YES, Explain:
19 .* Volunteer Followup:
Purpose:
Date:
1
1
(DAIMOIYR)
Was contact made: Y_N_ If No action taken, explain:
20 .* Hard Copy Records Retired: Place:
File NR:
21 .* Product Information:
Product:
Manufacturer:
Lot NR:
Expiration Date:
NDA NR:
IND/IDE NR:
*Indicates that item may be left blank if information is unavailable or does not apply.
Entries must be made for all other items.
.
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