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DoD 5240.1.
DEPARTMENT OF DEFENSE
PROCEDURES GOVERNING THE
ACTIVITIES OF
DOD INTELLIGENCE COMPONENTS
THAT AFFECT UNITED STATES PERSONS
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DECEMBER 1982
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· DoD 5240.1-R
-PROCEDURE -13 .- EXPERIMENTATION ON HUMAN SUBJECTS FOR INTELLIGENCE PURPOSES
A. APPLICABILITY
--
This procedure applies to experimentation on human subjects if such experi-
mentation is conducted by or on behalf of a DoD intelligence component. This
procedure does not apply to experimentation on animal subjects.
R.
EXPLANATION OF UNDEFINED TERMS
-
1. Experimentation in this context means any research or testing activ-
ity involving human subjects that may expose such subjects to the possibility
of |permanent or temporary injury (including physical or psychological damage
and damage to the reputation of such persons) beyond the risks of injury to
which/such subjects are ordinarily exposed in their daily lives.
2. Experimentation is conducted on behalf of a DOD intelligence com-
ponent if it is conducted under contract to that component or to another DoD
component for the becefit of the intelligence component or at the request of
such a component regardless of the existence of a contractual relationship.
3.
Human subjects in this context includes any person whether or not
such person is a United States person.
C.
PROCEDURES
le Experimentation on human subjects conducted by or on behalf of a Dob
intelligence component may be undertaken only with the informed . cunsent ... of. the
subject, in accordance with guidelines issued by the Department of Health and
Human Services, setting out. conditions that safeguard the welfare of such sub-
jects.
2.
DoD intelligence components nay not engage in or contract for experi-
mentation on human subjects withont approval of the Secretary or Deputy Secre-
tary of Defense, or the Secretary or Under Secretary of a Military Department,
as appropriate.
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AR 381-10
February 1982
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pence components to state and local laws en.
svement authorities only when lives are ca.
c'estred and only pursuant to a request by F'h.
til of such authority. Such requests must ...
proved by the Secretary of Under Secretary
. he Army. Under these circumstances expert
i gonnel may be provided to sach agency pre.
dod participation in law enforcement acti i.
... is limited as follows :
(«) Only personnel with technical skills
." readily available to such law enforcement
atorities, which can be utilized to proveit
. th or serious injury, na; be p" wided ;
(b) Provision of such personel will lv
mited to that necessary to prevent the deat !!
serious injury that is threatened. but in it
:
shall such assistance be provided for more
!. : : 72 hours;
(c) Such personnel are not used to ar.
preload persons who are suspected of con ...
acting, or who are about to commit, a cri in,
. i
(d) Use of such pers onel does not vie ..
1.1. the Posse Comitatus Act.
(3) Emergency assistrice. In emergency
tions, where life is endangered, the requer
r. Ared in (1) and (2) above may be ona.
is. vided that it is reduced to writing and sub
cipal to BQDA (DAMI-CH ) within 72 hours
'T; r- life is endangered, doabi as to the legal
't and propriety of the requested assistance
der this procedure should be resolved in favor
> providing the assistance.
": 17. Procedure 17. Assignment of intelligence
,Tsonnel to other agencies, a. Applicability
" arope. This procedure applies to the as-
I went of DA intelligence personnel to other
saudies within the federal government. This
morodure does not apply to ---
( 1) Assignment to state or local govern ..
Miel .... corporations or other private organiza.
2) Assignment to another agency with :
amelligence community when part of the
ve of the assignment is to gain experience
„od showledge about the activities of the other
@petey. (Reporting or repart in this context
operation or personnel of an agency that is not
available publicly.)
h. Policy. Employees of Army intelligence
components who are assigned to work for and
under the direction of another agency of the
federal government will conduct themselves
for the duration of their assignment as if they
were employees of that agency. Any responsi-
bilities to provide information to or services
for DA will be stated expressly and made a part
of the terms of the assignment.
c. Procclares.
(1) Assignment of employees of Army in.
ich gence components to other agencies within
ih federal government is governed by DOD
Directive 1000.17. The memorandum of agree-
mont concerning such assignment and required
by subsection D(6) (c) (1 ) of the Directive shall
in lade --
(@) An identification of the Artry intel-
ligence component from which the employee
has been assigned by DA.
(b) A statement delincating the em-
loyer's responsibilities, if any, for reporting
to the DA about mettere that come to the ent-
poyec's attention while on assignment outside
the Department.
(2) Other than is permitted by the terms
of the memorandum of agreement pursuant to
DoD Directive 1000.17, an employee of an Army
intelligence component on assignment to an-
other agency of the federal government may not
report to any Army component the operations
of personnel of the agency to which the em-
ployre is assigned.
(3) After completion of an assignment to
another agency of the federal government and
retarn to DA, an employee remains under the
same restrictions, as to reporting, that applied
when the employee was on auch assignment.
2-18. Procedure 18. Experimentation en human
subjects. a. Applicability and scope.
(1) This procedure applies to experimen-
tation on human subjects if such experimenta-
tion is conducted by or on behalf of any Army
intelligence component. This procedure coes not
app'y to experimentation on animal subjects.
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AR 381-10
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a research, development, or related activn. that
maay expose an individual to the possibility of
injury (including physical, psychological, or
social injury ) that increases the ordinary risks
of daily life for the subject (including the rec-
ognized risks inherent in a chosen occupation
or field of service), or that temporarily ad-
versely affects a person's mental or physical
condition.
(3) Experimentation is conducted "on be-
half of" an Army intelligence component if it is
conducted under contract to that component or
to another Army component for the benefit of
the intelligence component, or at the request of
such a component regardless of the existence
of a contractual relationship.
(4) Human subjects in this context in-
cludes any person regardless of whether the
person qualifies as & US person.
. Policy. Army intelligence components may
conduct experimentation on human subjects
only when an important foreign intelligence or
CI purpose is to be served, only after the in-
formed consent of the subject has been obtained
in writing, and only in accordance with guide-
lines issued by the Department of Health and
Human Services setting out conditions that
safeguard the welfare of the subjects, and other
applicable regulations.
c. Procedure. Army intelligence components
may not engage in or contract for experimen-
tation on human subject: without prior ap.
proval of the Secretary or Under Secretary of
the Army.
2-19. Procedure 19. Special activities. a. Ap-
plicability and scope.
(1) This procedure applies to the conduct
and support of special activities by Azmy intel-
ligence components. This procedure also applies
to other Army components that provide support
for special activities conducted by Dob) intel-
ligence components and other agencies within
the Intelligence Community. These procedures
do not apply to ---
(a) Diplomatie or military attache ac-
tivities conducted by DOD.
telligence ;
(c) Any functions in support of the
collection and production intelligence; or
(d) The conduct of special activities by
the military services in armed conflict or to
military deception operations targeted, for mili.
tary purposes, against a hostile foreign power.
(2) Conspiracy in this context has che
same meaning as in the criminal law context
and requires an overt act. Neither the term
"assassination" nor the term "conspire" in-
clude military or civilian measures against on-
going international terrorist activities (which
is a defined term (see glossary) and should be
construed strictly), aircraft hijackings, or in
response to danger of substantial physical harm
to any person. These terms do not apply to
actions of the military services in the execu-
tion of lawfully ordered military operations.
(3) Diplomatic and minlary attache activ-
ities means the representational, information
gathering, and reporting activities performed
by diplomatic and military attache personnel
abroad.
(4) Production of intelligence means the
process of developing "inteligence products"
which is a defined term. (see glossary ).
(5) Special activities mean activities con-
dueled abroad in support of national foreign
policy objectives that are designed to further
official US programs and policies abroad; that
are planned and executed so that the role of the
United States Government is not apparent, or
acknowledged publicly and functions in support
of such activities, but not including diplomatic
and military attache activities or the collection
and production of intelligence or related sup.
port functions.
(6) Support, when used in this context,
means the provision of assistance in the form
of transportation, training, supplies, equipment
or expert personnel.
b. Policy. No Army intelligence componenta
will participate in the conduct or support of
special activities. No other Army componet
will provide support for special activities excet
upon the specific direction of the Secretary er
Under Secretary of the Army and the Secretar.
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DEPARTMENT OF THE ARMY
UNITED STATES ARMY INTELLIGENCE AND SECURITY COMMAND
Arlington Hall Station
Arlington, Virginia
22212
.
USAINSCOM Regulation 15-3
24 February 1984
Boards, Commissions and Committees
HIGH PERFORMANCE REVIEW PROCEDURES
ParAng 1982 and 1983, in keeping with the US Army Intelligence and Security
Cor mand (INSCOM) goal of "extraordinary performance," and seeking to move the
ccomand to a level which exceeds commonly defined parameters of performance,
+ !. c INSCOM conducted a study of high performing organizations and programs in
the public and private sectors. Several technologies, management techniques,
training experiences and programs were identified for further evaluation with
respect to their potential to contribute to the development of extraordinary
individual and unit performance within the Command. This regulation contains
INFCOM policies and guidance for that evaluation, establishes procedures for
the use of INSCOM personnel as volunteers in evaluating and implementing high
performing human systems and provides guidance for commanders and supervisors
in further implementing and evaluating those high performing hunan systems.
Supplementation of this regulation is permitted only after prior approval has
been obtained from this Headquarters, ATTN:
IASJA.
Paragraph
Page
Purpose
1-1
1-1
Applicability
1-2
1-1
References
1-3
1-1
Scope
1-4
1-1
Exemptions
1-5
1-2
Explanation of terms and abbreviations
1-6
1-3
CHAPTER 2
RESPONSIBILITIES
..
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2-1
2-1
Commanders and Staff Element Heads
2-2
2-1
INSCOM Human Technology Review Board (HTRB)
2-3
2-1
Chairperson of the HIRB
--
2-4
2-2
Executive Secretary of the HTRB
2-5
2-2
Regular HTRS Membership
2-6
2-2
Ex Officio HTRR Membership
2-7
2-3
A.i hoc ITRB Membership
2-8
2-3
Principal investigator
2-9
2-3
Members of volunteer recruiting teams
2-10
2-4
Medical monitor
2-11
2-4
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CHAPTER 1
GENERAL INFORMATION
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Approving officials
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USAINSCOM Regulation 15-3
24 February 1984
Paragraph
Pare
CHAPTER 3
POLICIES
General
3-1
3-1
Approval
3-2
3-3
Risk determinations
3-3
3 - 1
Risk versus benefit
3-4
3. 1
Moral, ethical and legal concepts
3-5
3-1.
Fully informed subjects
3-6
3.1
Use of non-US citizens
3-7
3-1
Use of prisoners of war and decalnees
3-8
3-1
Medical care
3-9
3-1
Stated objectives
3-10
3. 1
Physical and mental suffering
3-11
3-1
Qualifications of investigators
3-12
3 -?
Minors
3-13
3-2
Recruiting of volunteers
3-14
3 ---
Protocol guidance
3-15
3 -.
CHAPTER 4
PROCEDURAL GUIDANCE
Technical reports
4-1
4 .1
Advising the Medical Research
and Development Command
1
4-2
4-1
Informed consent
4-3
Minimum standards
4-4
More than minimal risk
4-5
Contractors or vendors
4-6
Requests for exceptions
4-7
Expedited review categories
4-8
Expedited review procedures
4-9
CHAPTER 5
INSCOM HUMAN TECHNOLOGY REVIEW BOARD ( HTRB) ACTIVITIES
Composition of the HTRB
5-1
5-1
General criteria for membership
5-2
5-1
General committee activities
5-3
5-1
Avoiding possible conflicts of interest
5-4
Criteria for INSCOM HTRB approval
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5-5
5-1
Special considerations of sensitivity
5-6
5-2
Suspension or termination of a project
5-7
5-7
Records
5-8
5-3
APPENDICES
A - Terms and Abbreviations
A- :
B - Format for Preparation of a Research Protocol
C - Volunteer Agreement, Part :
C-1
D - Volunteer Agreement, Part 3
Dri
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Chapter 1
GENERAL INFORMATION
i ...
Purpose.
This regulation contains INSCOM policies and guidance for the
evaluation and implementation of high performing human systems within the com-
mand,
It
a .
Promulgates procedures and guidance for the use of INSCOM personnel
volunteers in the evaluation of high performing human systems;
as
b.
Establishes and implements a review process which is consistent with
AR 70-25;
C.
Insures the continued evaluation of INSCOM activities to assure that
the provisions of AR 70-25 are being followed;
d. ' Establishes procedures to obtain a health hazard assessment prior to
approving an INSCOM protocol issued as required herein; and
e. Promulgates INSCOM policies and procedures to assure that "NSCOM com-
ponents do not engage in or contract for experimentation on human subjects in
violation of Procedure 13, AR 381-10.
:- 2.
Applicability.
This regulation applies to all elements of the INSCOM.
1-3.
References.
a .
AR 70-25, Use of Volunteers as Subjects of Research -
b .
AR 381-10, US Army Intel! Igence Activities.
c.
AR 70-31, Standards for Technical Reporting.
Scope.
---
a.
Nothing in this regulation Is intended to supersede requirements for
health hazard or other safety reviews required by any other regulations or di-
rectives.
b. The procedures, policies and guidance contained in this regulation
percain to the following:
(1)
Behavioral studies, research and/or testing involving human sub-
jects, regardless of whether conducted by INSCOM, a contractor, or other agency
utilizing INSCOM funds.
(2)
Incluston of human subjects, whether as the direct or indirect
of ject of research, regardless of the level or risk Involved, in the devolop-
m .ve, testing or study of matters associated with the missions and functions of
1
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USAINSCOM Regulation 15-3
24 February
the INSCOM, or the application of non-traditional ideas and technologies tr
achieving high performance of human resources.
(3) The investigation of programs and technologies to enhance orgas-
izational and individual excellence where such investigation involves the in-
clusion of human subjects as their object.
1-5. Exempt tons .
a. Research, testing and studies in which human subjects are involved In
one or more of the following categories are exempt from this regulation.
(1) Bonafide activities under the sponsorship of another Department:
of the Army component and involving surveys or interviews where all of the fol-
lowing conditions exist:
(a) Responses are recorded In such a way that subjects canre:
be identified directly or indirectly.
(b) The subject's responses, If they become known, would ri
place the subject at risk of criminal or civil liability or damage the sub-
ject's financial or social standing or employability.
(c) The activity does not real with sensitive aspects of the
subject's own behavior, such as illegal conduct, drug use, sexual behavior, ("
use of alcohol.
(2) Research which involves the use of educational tests, provi,
the data is recorded in such a way that the subject cannot be identified
rectly or indirectly.
(3) Research in non-INSCOM educational settings which involve noras!
educational practices, such as --
(a) Regular and special educational strategies.
(b) The effectiveness or the comparison among techniques of in-
struction, curricula, or classroom methods.
(4) Follow-up debriefings, interviews, tests, or evaluations to de.
termine how well participants have learned the information or skills transmic
ted by training or instructional activities previously attended by the subjec:
thereof .
b. Exemptions of other activities from this regulation, even where such
activities may be exempted from other similar regulations or directives, shal:
not be considered valid for INSCOM purposes less and until confirmed by the
INSCOM Human Technology Review Board as prescribed elsewhere in this regular
tion.
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Chapter 2
RESPONSIBILITIES
2-1.
Approving officials.
The Commanding General, the Deputy Commander, In-
L:lligence, and the Deputy Commander, Support, are the designated INSCOM ap-
proving officials. Only these officials may approve the use of human subjects
In research.
2-2. Commanders and Staff Element leads. Commanders at all levels within the
!"SCOM, heads of Headquarters stiff elements, office chiefs and program direc-
roors (hereinafter referred to only as commanders and staff element heads) are
responsible within their respective functional areas for --
a .
Insuring that the provisions of this regulation are institutionalized
into their organizational procedures and practices.
b.
Insuring that no persons engage in or contract for experimentation
Involving human subjects without the express approval of an INSCOM approving
D'ficial.
2-3.
INSCOM Human Technology Review Board (HTRB).
The INSCOM HTRB is respon-
sible for
--
-
a.
Observing written procedures for the following:
(1) Initial and continuing review of research, including the reports
of findings and actions to the investigator and the approving official.
(2)
Determination of those projects which must be ··-
(a)
Reviewed more often than annually.
(b)
Verified from sources other than the investigators that no
svertal changes have occurred since the previous HTRB review.
(3)
Prompt reporting to the HTRB of proposed changes in the re-
rch, and to the HlTRB and approving official of unexpected problems involving
risks to the subjects or others.
b.
Insuring that changes In approved projects (during the period for
wilich approval has already been given) are not initiated without HTRB review,
except to eliminate immediate hazards to a subject.
c. Reviewing proposed protocols at meetings attended by a majority of
rombers except when an expedited review is used. For the protocol to be ap-
proved, it will receive the approval of a majority of those members present.
d.
Reporting to the CG any serious or continuing noncompliance with HERB
requirements and determinations found by investigators.
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USAINSCOM Regulation 15-3
24 February 1994
e .
Conducting a continuous review of research studies at Intervals pro-
per to the degree of risk, but not less than duce pet year,
f. Insuring the observation by a chire party of the consent process ar '
each investigation, as appropriate.
Recommending safeguards or specii conditions to a protocol.
Why 1
such recommendations are made, the approving, official may take the followin;
action:
col.
(1)
Not reduce the safeguards or conditions, and approve the protr -
(2)
Require additional safeguards .
(3)
Disapprove the protocol.
(4) Refer the protocol to a higher echelon approving authority fo -
action and review.
2-4. Chairperson of the HTRB. The DCSPEM is designated Chairperson and a reg-
ular member of the TRB and is responsible for chairing HTRB meetings, keepin;
the CG informed of HTRB activities, and recommending approval/disapproval of
HTRB regular members to the CG.
2-5.
Executive Secretary of the HTRB.
The UCSPPM will designate a member
his staff to be the Executive Secretary of the HTRB.
The Executive Secretir
of the HTRB Is responsible for --
1
a .
Insuring that the responsibilities of the HTRB prescribed in para -
graph 2-3 are carried out.
b.
Preparing and distributing the agenda for each meeting to all HTRU
members.
c.
Insuring that all HTRB members are afforded the opportunity to com-
ment on HTRB actions conducted under expedited review procedures.
2-6.
Regular HITRB membership. The INSCON DOSOPS, DCSPER, DCSSYS, SJA, Command
Chaplain and DARCOM LNO, are each responsible for nomination of an individu:)
to serve as a regular member of the HTRB.
Nominees may be from their respec-
tive staffs, subordinate command functional counterpart staffs, or may be the
nominating element head. Nominations will be submitted to the HTRB Chairperson
(DCSPPM) for approval/disapproval by the CG.
Nominations may be by letter, DE
or message, and will contain the Information required by paragraph a, below.
a. Nominees will be identified by name, carned degrees, current position:
and duties, and experience, such as board cotsifications and licenses. The in-
formation in the nomination will be complete enough to describe each member's
chief expected contributions to HTRB reviews.
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USAINSCOM Regulation 15-3
Nominees will normally be military officers in the grade of 0-5, or
"bove, or civilian employees, GS-13 or above. Nominees will have diverse back-
¿rounds to insure thorough review of research studies involving human volun-
teers as research jub jects .
Nondiees should be of varied racial and cultural
backgrounds. Nominees should have displayed sensitivity to such issues as con-
munity attitudes, and respect for advice and counsel and for the rights and
welfare of human subjects.
c. Confirmed nominees will serve as HTRB members for an indefinite term,
and will be expected to have final authority to speak on behalf of their activ-
ity.
7-7.
Ex officio HTRB membership. The incumbents of the following positions
& Ill serve as ex officio, non-voting members of the HTRB:
a. Chief, CENTEX.
b., 'Command Psychologist.
c. Chief, Human Technology Office.
d.
Chief, Public Affairs Office.
2-3.
Ad hoc HTRB membership.
The following will serve as ad hoc members of
the INSCOM HTRB:
2.
The Staff Advisor for Scientific and Cryptologic Affairs.
b. A physician, as approved by an INSCOM approving official (para 2-1).
Physician nominees for ad hoc membership will be provided as requested by the
Chairperson.
2-9.
Principal investigator.
The principal investigator for each project
covered by this regulation is responsible for --
a. Maintaining adequate records on the following:
(1) Receipt, storage, use and disposition of all investigational ma-
Cerials and devices,
(2)
Case histories that record all observations and other data im-
portant to the study.
(3)
Volunteer agreement documents.
b. Preparing progress reports, Including annual reports, as determined
by the approving authority and the INSCOM HTRB.
c. Promptly notifying the approving authority, through the INSCOM HTRB,
of any adverse effects caused by the research.
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24 February 19%.
d.
Insuring that the research has been approved by the proper authority
and the INSCOM HTR3 before starting, changing or extending a study.
e.
Insuring that all subjects, including those used as controls or the !:
representatives, are fully informed of the nature of the research to Inclu ..
potential risks to the subject.
f. Insuring that investigational materials and devices are administered
only to subjects under his or her personal supervision and that of a previously
approved associate investigator.
g. Insuring that volunteer recruiting teams are briefed as to the nature
of the research and the ethical principles in this and related regulations.
2-10. Members of volunteer recruiting teams.
Members of volunteer recruiting
teams are responsible for ---
a.
Establishing volunteer requirements prior to recruitment.
b.
Undertaking recruiting in a morally, ethically and legally acceptab !..
manner.
2-11. Medical monitor.
The medical monitor of each project is responsible fr
and is hereby delegated the authority to telainite the effort if --
a.
Subjects are at risk of life or 11: ..
b. It appears the risk is significantly greater than anticipated at th ..
time of review and approval of the project.
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USAINSCOM Regulation 15-C
Chapter 3
POLICIES
3-1.
General.
Experimentation Involving human technology or human subjects
conducted by or on behalf of any .NSCOM component may be undertaken only with
informed consent of the subject, and in recordance with guidelines issued
hy the Department of Health and Human Services (DHHS), setting out conditions
that safeguard the welfare of such subjects. The provisions of this regulation
varstitute INSCOM implementation c' those guidelines.
Approval .
INSCOM components nay not engage in or contract any research
er testing involving human subjects without advance approval through the INSCOM
: TAB by an INSCOM approving offici .: ", or higher level official, where appropri-
This approval is required regardless of the degree of risk involved.
3-3.
Risk determinations. The INSCOM ATAB will render all risk determinations
regarding INSCOM research or testing involving human subjects.
Risk versus benefit.
The Goeree of potential ris': involved in any pro-
pet will never exceed the expected benefits of that effort.
3 -5.
Moral, ethical and legal concepts.
The moral, ethical and legal concepts
on the use of human subjects will be followed as outlined in this regulation.
Voluntary consent of each human subjec: is essential. Military personnel are
fot subject to the Uniform Code of Military Justice (UCMJ) for choosing not to
fixe part as human subjects.
Fully Informed subjects. Only persons who are fully informed and volun-
teer to take part may be used as human subjects in INSCOM research and testing
activities.
3-7.
Use of non-US citizens. Research may be conducted outside the US that
(wolves non-US citizens; however, all requirements of this regulation applic-
.le to human subjects shall be equally applicable to non-US citizen human sub-
Pets.
Use of prisoners of war and detainces.
The use of prisoners
of war and
arainees as human research subjects is prohibited.
Medical care.
Volunteers will be authorized all necessary medical care
fur injury or disease that is the proximate result of taking part in approved
INSCOM research or testing activities.
3.10.
Stated objectives.
Each project will be designed to achieve its stated
of jectives. The proposed nomber of subjects will be the minimum needed to In-
that statistically significant results are obtained.
" -: 1.
Physical and rental suffering. Bach project will be conducted in such a
planer
as
to avoid unnecessary physical and mental suffering.
Preparations
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will be made and adequate facilities provided to protect the subject and fn-
vestigators against all foreseeable injuries, disabilities, or death. A pro
ject will not be conducted if any reason extats to believe that death or Injury
will result. The degree of potential risk will never exceed the expected ben ? -
fits of the project.
-. . .
3-12.
Qualifications of investigators.
Only persons judged qualified by the
appropriate approving authority will conduct human subject studies. The phys -
cian responsible for the health and welfare of the subject may or may not
the principal investigator. The physician is authorized to stop the project
any time he or she believes that injury, disability or death may result.
3-13.
Minors.
Minors may not be involved is human research subjects without
advance approval in each case by the INSCOM HIRB.
3-14.
Recruiting of volunteers. Volunteer recuiting will be accomplished
personnel responsible for the conduct of the particular project, or as othe
wise specifically approved by the INSCOM HTR3.
3-15. Protocol guidance.
a.
Each approved protocol will be reviewed at least annually and on
continuing basis as determined by the INSCOM HTRB.
Annually means once each
12-month period.
b.
The decision as to whether a research protocol involves more th ..
minimal risk shall be made by the INSCOM ATRB.
c.
The research protocol will be prepared in accordance with the i -
structions contained at appendix B.
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Chapter 4
PROCEDURAL GUIDANCE
4-1.
Technical reports.
Technical reports will be prepared as prescribed in
AR 70-31 and follow the format of MIL-STD-847A.
When applicable, these reports
will contain the following statement :
For the protection of human subjects, the
investigators have adhered to the policies
of AR 70-25 concerning the use of volunteers
as research subjects.
4-2.
Advising the Medical Research and Development Command.
Two copies of
technical reports of study will be forwarded to the Commander, US Army Medical
Research and Development Command, ATTN:
SGRD-HR, Fort Detrick, Frederick,
Maryland
21701.
When HQDA approval, or higher, is required, information
copies of material forwarded for approval will also be furnished to the office
above. These will include as a minimum, two copies of the protocol, a copy of
the volunteer agreement and all minutes of INSCOM HTRB meetings reviewing the
proposed project.
4-3.
Informed consent.
Subjects will be given adequate time to review and un .-
derstand all information before agreeing to take part in a project. The volur-
teer agreement documents will be written in language that is easily understood
by the subject. The documents listed below will be discussed with each subject
before his or her acceptance.
a. The Volunteer Agreement ( append'x C) .
b. The Explanation Portion of the Volunteer Agreement ( appendix D) .
4-L.
Minimum standards.
The laws, customs and practices of the country in
which the research is conducted will take precedence over procedures' required
by this regulation, where applicable. The project must meet the sane standards
of ethics and safety, however, that apply within the US involving US citizens.
When standards vary, the more stringent will apply. A minimum age of 18 is re-
quired for US citizens taking part in research conducted outside the US, re-
gardless of the laws of the country in which the effort is being undertaken.
4-5.
More than minimal risk.
--
When It has been determined that the risk in a
human subjects study is more than minimal, then advance approval is required
through HQDA (DAMI-CI) by the Secretary or Under Secretary of the Army. In ad-
dition, a medical monitor shall be recommended by the INSCOM HTRB and approved
by the CG.
4-6.
-
Contractors or vendors.
Contractors or vendors holding approved DRUS
assurance of compliance shall be considered In compliance with this regulation.
In the absence of such an assurance, a special assurance will be negotiated
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with the contractor or vendor.
In all cases, however, the INSCOM HTRB must ap -
prove the INSCOM participation in or utilization of such contractors or ven-
dors.
4-7. Requests for exceptions.
Requests for exceptions to this regulation will
be submitted to the INSCCM HIRB Chairperson (DCSPPM) with full justification.
4-8. Expedited review categories.
Categories which may be processed in the
expedited review procedures are as follows :
a. Recording of data from subjects who are 18 years of age or older,
using non-invasive procedures routinely employed in clinical practice.
This
category does not Include exposure to electromagnetic radiation outside the
visible range (e.g., X-rays, microwaves). It does include --
(1) The use of physical sensors that are applied either to the sur-
face of the body or at a distance and do not Involve input of matter or signif -
icant amounts of energy into the subject or an invasion of the subject's pri-
vacy.
(2)
Such procedures as --
(a) Weighing.
(b)
Electrocardiogra
(c)
Electroencephalography.
(d)
Thermography.
(e)
Detection of naturally occurring radioactivity,
(f)
Diagnostic echography.
(g)
Electroretinography.
b.
Voice recordings made for research purposes such as investigations of
speech defects, improvement in language utilization, etc.
c.
Moderate exercise of healthy volunteers.
d.
Study of existing data, documents, records, pathological specimens,
or diagnostic specimens.
e .
Minor changes in previously approved research during the period for
which approval has been authorized.
4-9.
Expedited review procedures.
Under an expedited review procedure, the
HTRB Chairperson, or one or more HTRR reviewers designated by the chairperson,
may carry out the review. These reviewers may exercise all of the authorities
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o. the HTRB except that of disapproval, which may only be exercised as pre-
geribed elsewhere in this regulation.
a. When the expedited review procedure is used, the reviewers will fur-
nish complete copies of all their actions and related materials (e.g., research
plan, protocol, etc. ) to all other members of the HTRB. The HTRB Chairperson
will submit a written report of capedited review actions to the CG within ten
working days of approval action.
b. An expedited review procedure may be restricted or suspended to pro-
tect the rights or welfare of subjects at any time based upon either direction
of an approving official or request by any member of the HITRB.
..
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Chapter 5
INSCOM HUMAN TECHNOLOGY REVIEW BOARD ACTIVITIES
..
Composition of the HTRB.
Membership in the INSCOM HTRB will consist of
the chairperson; at least six other regular members, appointed by the CG from
song the nominations submitted in accordance with paragraph 2-6 and 2-8,
"hove, or from other sources; an executive secretary; and such other ex officio
and ad hoc members as prescribed in chapter 2, above. One regular member will
he not affiliated with the INSCON and not part of the Immediate family of a
person affiliated with the INSCOM.
5.2.
General criteria for membership. At least one member of the HTRB will be
frem a profession/position/activity primarily concerned with the welfare of hu-
min persons. At least ore member will be non-scientific, such as a lawyer,
ethicist or member of the clergy. THE INSCOM HTRB may invite persons with spe-
clal competence to assist in the review of complex issues that require exper-
tise beyond that available on the HTRB.
These persons normally will not vote,
unless he or she is serving as the non-INSCOM member of the HTRB.
5-3.
General committee activities. Each regular and ad hoc committee member
shall have one equal vote, and the entire committee will be vested with the ie-
2ponsibility to determine if a proposed activity is acceptable. Acceptability
will be in terms of Army Medical Cepartment (AMEDD) commitments and regula-
tions, applicable law, standards of conduct and practice, and with full consid-
eration for the particularly sensitive nature of the INSCOM's role as an intel-
licence component .
a.
At least five voting members will be required to constitute a quorum
it bach committee meeting.
b.
All actions of the committee will be by majority vote of members
present .
Avoiding possible conflicts of Interest.
a .
Except to provide Inforan! to requested by the HTRB, no INSCOM HIRB
Myaber may take part in a review of any project which is sponsored by that nem-
bor's organization or office of employment or assignment, or in which there may
otherwise be a conflict or appearance of a conflict of interest.
b. The intended approving official may not be a member of the HTRE. The
Approving official may not approve research for which he or she is also a prin-
cijal or associate investigator. A higher echelon of command must review and
approve such projects.
5-5.
Criteria for INSCOM HTRB approval.
a .
In evaluating the risks and benefits for projects under considera-
-ion, the INSCOM HTRB should consider only those that may result from that
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particular project, unless a clear linkice has been established to other p:
jects.
b. To approve an effort covered by this regulation, the INSCOM HT33 1:
determine that all of the requirements below are met.
(1)
Risks to subjects are minimized by using procedures that x: : -
(a) Consistent with sound investigation design and do not : "".
essarily expose subjects to risk.
(b)
Already being used on subjects for diagnosis or treFunc ..
when appropriate.
(2)
Risks to subjects are reasonable in relation to --
(a) Anticipated benefits, if any, to the subjects.
(b)
The importance of the knowledge that may be expected
result.
(3) In making an assessment for the selection of subjects, the spo
sor has adequately considered --
(a) The purpose of the investigation.
(b) The setting in which the research investigation will te ce
ducted.
(4)
Informed consent will be secured from each subject.
(5)
Informed consent will be properly documented.
(5)
The protocol takes adequate provisions for monitoring
collected to Insure the safety of the subjects.
(7) Adequate provisions exist to protect the privacy of subjec
to maintain the confidentiality of data when appropriate.
5-6. Special considerations of sensitivity. Some or all of the subjects .
vulnerable to special considerations of sensitivity because of past asstgr int
affiliations, etc. In such cases, additional safeguards will be included
protect the rights and welfare of these subjects. In no instance wiil :
INSCOM be a party to any research which Involves the use of persons with dice
or severe physical or mental illness, c: those who are economically or educ ..
tionally disadvantaged.
5-7.
Suspension or termination of a proiect.
a. The INSCOM will suspend or terminate a project that --
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(1)
Is not being conducted according to the HTRB's requirements.
(2)
Has been associated with unexpected harm to the subjects.
b. Suspensions or terminations of a project will include a statement of
the reasons for the HTRB's action, and will be reported within 24 hours to the
principal investigator and the approving official.
5~8.
Records.
-------
a. The HTRB executive secretary will prepare and maintain adequate docu-
ments on HTRB activities, includins, ---
(1) Copies of all proposals reviewed, scientific evaluations that
accompany the proposals, approved sample consent documents, progress reports
Submitted by investigators, and reports of injuries and adverse reactions.
(2)
Minutes of HTRB meetings showing attendance; actions taken by
the INSCOM HTRB; the vote of these actions, including the number of members
voting for, against, and abstaining a decision; the basis for requiring changes
or disapproving a project; and a written summary of the discussion of contro-
verted issues and their resolution.
(3)
Records of continuing review activities.
(4)
Copies of all correspondence between the HTRB and project inves-
: motors.
(5) A current list of BIRB members. Members will be Identified by
1. we, earned degrees, representative capacity and experience, such as board
Certifications and licenses.
The information will be complete enough to des-
cribe each member's chief expected contributions to HTRB reviews. Any employ-
mit or other relationship between members and the INSCOM will be noted.
(6)
Written procedure: , Including agendas, expedited review proce-
'ures, etc., for the HTRB.
(7) Statements of significant new findings.
b.
The records required by this regulation will be retained permanently
unjer AR 340-18-13.
Such records will be reasonably accessible for inspection
aile copying by authorized DA personnel and representatives of the Federal Food
hou Drug Administration.
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USAINSCOM Regulation 15-3
APPENDIX A
TERMS AND ABBREVIATIONS
Section I - Terms
A-1.
Approving official. The INSCOM Commanding General, Deputy Commander, In-
telligence, Deputy Commander, Support, or higher level official, who has been
delegated authority to approve the use of human subjects in research.
A-2.
Associate investigator. A person who may be deeply involved in the exe-
curion of research but does not have overall primary responsibility.
A-3.
Consent. The legally effective agreement to take part as a human sub-
ject. The agreement may pertain to one's own participation or be in behalf of
another person. Three terms associated with this meaning that distinguish be-
tween the' legal validity of such: agreements 'are subject consent, permission,
and assent. These terms are defined below.
Subject consent.
Agreement by an adult person who has autonomous
legal capacity to consent to taking part as a human subject. This form of con-
sent pertains only to adults who have not lost their legal capacity to consent.
b. Permission. Agreement ty a "legally authorized representative" for
taking part as a human subject of another person who does not possess autono-
ruas legal capacity to consent in his or her own behalf. A legally authorized
representative is a person or judicial body authorized under applicable law to
Brant permission (also known as third-party consent).
c. Agsent. The affirmative agreement to take part as a human subject by
a person not possessing autonomous legal capacity to consent in his or her own
benalf, but who is capable of understanding what is proposed and able to ex-
press an opinion as to willingness to participate. Assent is concurrence in
what is proposed, but is not a substitute for subject consent because, unlike
consent, assent has no legal effe.c.
A-4. Experimentation. Any research or testing activity involving; human sub-
jects that may expose such subjects to the possibility of permanent or tempor-
ary injury (including physical or psychological damage and damage to the repu-
( :tion of such persons) beyond the risks of injury to which such subjects are
ordinarily exposed in their daily lives.
A-5.
Expedited review procedures. Those procedures used In research involving
no more than minimal risk and those used for minor changes in approved investi-
gations. These procedures minimize time required for review.
A-D.
Health care practitioner. An individual trained to interact with pa-
-
cleats to provide diagnostic er treatment procedures within established profes-
sional standards.
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A-7. Human subject. Any person, whether or not such person is a US citizen,
about whom ant investigator conducting research. testing or studies obtains dati
through interaction with that person. Both physical procedures and manipula-
tions of the subject or the subject's environment are included. Human subject :
may be thought of as direct objects when the research is to determine the e" -
fects of a new system on man (for example, the psychological effects of a par-
ticular inteccogation technique on an individu .. 1) or as indirect objects when a
test is conducted to determine how man affects the ultimate performance of a
system (doctrine, concepts, training progra:is) .
A-8. Human Technology Review Board (HT3B). A body set up to provide Initial
and continuing review of research involving tie use of human subjects. HT3
fulfills all the functions of a human use committee as described in AR 70-2).
It is fundamentally similar to an Institutional Review Board (IRB) discussed !"
guidelines issued by the DHIS for human research, but has somewhat different
authority as compared to an IRB. Within DOC, authority to approve the use ci
human subjects in research is vested in commanders. In the INSCOM it is vested
in the CG, and has been delegated to the DCC-I and DCG-S for matters under
their respective functional control.
Approving officials act on recommend .--
tions of validly constituted HTREs.
Outside DOD, IRBs tend to be vested wi. :
this authority.
A-9. Legally authorized representative. A person or judicial or other body
authorized under applicable law to consent on behalf of a prospective subjec :
to the subject taking part in the procedures involved in the research.
A-10.
Medical monitor. This person is a military or Department of the Army
civilian physician who is responsible for observing human subjects during the
conduct of research.
A-11. Minimal risk. When used in the context of this regulation, this means
that the risks of harm anticipated in the proposed research are not greater,
considering probability and magnitude, than those ordinarily encountered In
daily life or during the performance of routine physical or psychological exam-
inations or tests.
A-12. Principal investigator. A person, regardless of title, who is primarily
responsible for the actual execution of the research.
A-13.
Protocol. The written, detailed plan by which research is to be co .
ducted. The plan contains, as a minimum, discussion of --
a. The objectives of the project.
b.
The information to be collected.
c.
The means by which it will be collected and evaluated.
d. An assessment of potential risks and benefits to subjects.
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e.
Safety measures,
f.
Other means to be used to reduce the risks to subjects.
A -14.
Research.
A systematic investigation designed to develop or contribute
to general knowledge concerning military or intelligence problems.
The term
-
does not include individual or group training of personnel such as combat read-
iness, effectiveness, proficiency or fitness exercises.
This definition is
um.ique to this regulation and is not Intended to identify an effort for funding
under appropriations intended for Research, Development, Test and Evaluation
I.DTE).
"Research" in the sense applied in this regulation will be funded
hvording to the project, effort, etc., to which it applies.
Research and development.
Any scientific inquiry, investigation, or
.Ildation performed or directed to test hypotheses or develop concepts con-
ceraing physical or biological principals or laws. Research is a major explor-
ation of 'the unknown and contains unpredictable elements. Development , usually
is confined to the qualification or elaboration of known principals.
1-6.
Systematic Investigation.
A formal inquiry generally described in a
protocol that sets forth explicit objectives and formal procedures designed to
reach chose objectives. The term includes clinical investigations, but does
art include post-training or post-therapeutic inquiries intended only to evalu-
ate individual progress or responsiveness to training or therapy.
A -: 7.
Test and evaluation.
An effort or assessment to validate proposed or
existing standards or concepts of performance, either of humans or of material.
A-18.
Test participants.
Humans directly involved in test and evaluations,
but who are not themselves the direct object of such activities. Generally,
test participants are not regarded as receiving any direct benefits as a result
of their participation in the test (for example, a new doctrine or training
concept ).
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Section II - Abbreviations
ACSI
Department of the Army Assistant
Chief o: Staff, Intelligence
AMED
Army Medical Department
ARI
US Army Research Institute for the
Behavioral and Social Sciences
CENTEX
The INSCOM Center for Excellence
CFR
Code of Federal Regulations
D:
Department of the Army
:
DARCOM
US Army Materiel Development and
Research Command
DOSPER-
The INSCOM Deputy Chief of Staff for
Personnel
DOSPPM-
The INSCOM Deputy Chief of Staff
for Flans, Programs and Modernization
DOSOPS
Th INACOM Deputy Chief of Staff
for Operations
D'INS
Department of Health and Human Services
HPTF-
The INSCOM High Performance Task
Force ( no longer constituted)
HTRB
The INSCOM Human Technology Review Boar !
INSCOM-
US Arm: Intelligence and Security
Comman:1
MACOM
Ma Jor Army command
SJA
The INSCOM Staff Judge Advocate
TSG
The Surgeon General of the Army
United States
US
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APPENDIX 3
FORMAT FOR PREPARATION OF A RESEARCH PROTOCOL
.
Section I.
GENERAL INFORMATION
Project title. (Enter complete project title - if this is an amendment co
an existing project, identify by indicating "Amendment No.
to" immediately
preceding the title).
2. ' Investigators.
a.
Principal investigator.
(Enter full name, rank, title, organization
and telephone number).
b.
Associate investigators.
( Identify all associate investigators and
area of the project for which each is responsible.
Include full name, rank,
title, organization and telephone number for each) .
3.
Location of the project. ( Identify all locations at which the project will
be carried out and specify which portions will be done at each location and who
-
is the point of contact at each location.
Include telephone number for POC),
4.
Period covered by the project.
(Give month and year of expected start and
completion dates).
Section II
INTRODUCTION
5.
Synopsis.
a. (Enter a short, one-page or one-paragraph, summary of the proposed pro-
ject, similar to the abstract of a scientific paper) .
b. (Enter a list and brief description of safety measures for human sut-
jects involved in the project).
6.
Medical application.
(Explain briefly the medical importance, including
psychological considerations, and possible usefulness of the project).
7.
Objectives.
(State briefly but specifically the objectives of the pro-
ject .
Include items below, where applicable).
3 .
Study design. (Double-blind, crossover, etc. ).
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b.
Technologies to be employed. (List. the generic technologies to be em-
ployed in the project).
C .
Type of population involvel. ( list the subject population to be ob-
' erved ) .
9.
Stacus. (State what has been accomplished or published in the proposed
gres of study and describe how this project will relate to, differ from and/or
advance that which has already been accomplished).
9.
Bibliography. (List all references used in preparing the protocol).
10.
Authority. (Cite the specific authority for the INSCOM to engage in this
project. Indicate date of approval, and if not yet approved, indicate specific
approval authority needed for this project.
Identify any POC in approval au-
thority's organization with whom coordination has been effected.
Section III
PROTOCOL PLAN
11.
General approach.
a .
£
(Outline expected accomplishments in sufficient detail to show a clear
course of action).
b. (Include discussion of the technological validity of the proposed re-
search procedures) .
c. (List the chronological steps to be taken) ..
12.
Project subjects .
(Give as a minimum the Information below) .
-
a .
Number of subjects.
( Indicate the total number of subjects expected to
complete the study) .
b.
Age range.
c.
Sex .
-
d.
Inclusion criteria.
( State specific and detailed reasons for inclusion
of subjects by class, or individually, as appropriate) .
e.
Diagnostic criteria for entry.
f. Evaluations before entry.
( Include any physical or psychological
axa :: .
Inations, medical history, etc., which is to be done on each subject before
entry Into the project) .
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g .
Exclusion criteria.
( Include a complete list detailing the subjects,
-
diseases, medications, etc., which constitute the criteria for exclusion from
the project) .
h.
Source of
subjects.
(Describe briefly where subjects will be ob-
Gained).
1 ..
Subject identification. (Describe code system, if any, which will be
(sed in the project).
1.
Subject assessment .
(Describe the methods used to assign or allocate
:: : object of this research to particular subjects) .
k.
Risks and benefits.
(Discuss the analysis of risks and benefits
to
"si jects and to those conducting th: research) .
1.
Minimization of risks. (Discuss the precautions to be taken to mini-
mize or eliminate risks to subjects and those conducting the research).
m .
Corrective actions. (Describe hypothesized adverse reactions and cor-
rective accions expected to be taken if such adverse reactions occur) .
n.
Special equipment.
(Describe any special medical or nursing care or
equipment needed for subjects admitted to the project).
13.
Project technologies.
--------
a .
(State the complete name and description of all technologies to be
used, including procedures for their application) .
( Identify the source of all technologies and related Items, devices,
List all components and manufacturing and quality control plans/
procedures, where applicable).
etc.
c. ( Identify the methodology for application, if different from procedures
described above).
d. (State the schedule, administration and duration of each aspect of the
. ject ) .
(Describe in detail accompanying devices and their Intended use. Iden-
tify whether these are classified as medical devices and whether the medical
devices amendment to the Federal Food, Drug and Cosmetic Act applies) .
f. (Discuss labeling to medical devices, where applicable).
1 ..
Evaluations made during and following the project.
(A project schematic
may be included, or the items may
be listed as indicated below.
In either
case, it is Important to Identify the person who will perform each evaluation).
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a .
Specimens to be collected.
-
(1)
Schedule of collections.
(2)
Evaluations to be made on spectmns.
(3)
Storage. (If applicable, state where and if special condition:
are required
.5
(4)
Labeling and disposition.
-
(5)
Laboratories performing evaluations.
(6)
Special precautions.
b. Clinical/behavioral assessments. ( Include how adverse effects are :)
be recorded ) .
c.
Vital signs.
( State when desired and the frequency) .
d.
Follow-up procedures.
e .
Disposition of data. (State location and duration of storage. Incle l"
pertinent i formation regarding Privacy At and AR 381-10 considerations,
applicable) .
f.
Methods used for data collection. (State critical measurements used as
end points to characterize safety, efficacy or equivalency) .
15. Departure from protocol for individual subjects.
a.
When allowed. (Use flexible, but definite criteria. If none is to be
allowed, so state) .
b.
Who will be notified.
(Include both those regarding the individual
subject, if appropriate, and those elsewhere within the INSCOM.
Must notify ...
least the HTRB) .
1.6.
Adverse reactions. (Must correlate with paragraph 12m, above) .
a .
Definition of subject reactions.
b.
Immediate reporting procedures.
c.
Routine reporting procedures.
-
d.
Potential post-project adverse reactions.
-
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USAINSCOM Regulation 15-3
Section IV
ADMINISTRATION
1. . .
Modification of protocol.
(Describe the procedure to be followed to
codify, terminate or extend the protocol).
Disposition of unused project material. (Give a statement pertaining to
disposition of unused project material and devices, if applicable) .
19,
Publications and reports.
--
(Describe use, including potential restric-
tions, of information and publications and reports arising from the project).
20.
Funding. (Identify source of funds and any special or unusual funding tu-
plications ).
21, Medical monitor. (State the name and telephone number of medical monitor,
when applicable).
22.
Protocol review.
(Identify the human use committee or institutional re-
view board which will provide in1 :tal, continued and annual review of this pro-
'ccol).
(signature)
(Name, rank and organization of prison submitting protocol)
: : Lenature)
( ame, rank and organization of principal investigator)
--...
( Signature)
( Name, rank and organization of approving official)
Attachments
A - Proposed Volunteer Agreement
B - Proposed Explanation Portion of the Volunteer Agreement
C - Review of Scientific and Human Research Issues ( if applicable)
D - Biographic Sketch of principal and associate investigators
B -- 5
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USAINSCOM Regulation 15-3
APPENDIX C
VOLUNTEER AGREEMENT
Part A
I,
, having attained my eighteenth
( 13ch) birthday, and otherwise having full capacity to consent, do hereby vol-
-
onceer to participate in an investigation study entitled:
--
--------
and
imer the direction of
-
The implications of my voluntary participation; the nature, duration and
purpose, and the methods and means by which it Is to be conducted; and the in-
"onveniences and hazardo to be expected have been thoroughly explained to me by
, and are set forth in Part B of this
Agreement, which I have signed.
I have been given the opportunity to ask ques-
tlons concerning this investigativa study, and any such questions have been
answered to my full and complete satisfaction.
I understand that I may at any time during the course of this Investigative
study revoke my consent, and withdraw from the study without prejudice; how-
ever, I may be required to undergo certain further examinations, if, in the
opinion of competent authority, sich examinations are necessary for my health
or well being.
Signature
Date
Witness's Signature
Date
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USAINSCOM Regulation 15-3
24 February 1984
.
APPENDIX D
VOLUNTEER AGREEMENT
Part B
Explanation Portion of the Volunteer Agreement
1.
Project title.
(The title of the project and the place where it is to be
conducted).
2.
Principal investigator. (Must agree with the protocol).
3. Discussion. (A statement that the study involves research. An explanation
of the purpose of the study and the expected duration of the subject's partici --
pation. A description of the procedures to be followed. An identification of
any experimental procedures. A statement giving information about prior, simi-
lar, or related studies that provide the rationale for this project).
4.
Risks or discomforts. (A description of any reasonably foreseeable risks
or discomforts to the subject).
5.
Benefits. (A description of any benefits to the subject or to others that
may reasonably be expected from the study).
6.
Alternative procedures. (A disclosure of proper alternative procedures or
courses of. treatment, if applicable, that might be advantageous to the sub-
3.ct ) .
i. Confidentiality of records.
(A statement describing the extent, if any, to
which confidentiality of records identifying the subject will be maintained.
Also, if more than a minimal risk is involved, a statement that authorities
outside the US may Inspect the records).
Subject's rights. ( An explanation of whom to contact for answers to perti-
sont questions about the study and the subject's rights and whom to contact in
the event of study-related Injury to the subject).
9.
Voluntary participation. (A statement that
a.
Participation is voluntary.
b.
Refusal to participate will Involve no penalty or loss of benefits to
which the subject is otherwise entitled.
c .
The subject may discontinue participation at any time without penalty
or loss of benefits to which the subject is otherwise entitled).
Compensation and medical treatment. ( For a study involving more than min-
inil risk, an explanation as to whether any compensation and medical treatment
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24 February 198.
are available if injury occurs and, if so, what they consist of, or where fur -
ther information may be obtained).
1 :. Additional comments.
(When appropriate, one or more of the elements of
information below will also be given to each subject.
a.
A statement that a certain treatment of procedure may involve risks t.
the subject - or to the embryo or fetus If the subject Is or may become preg -
nint - that are currently unforeseeable.
b. The anticipated circumstances under which the subject's participation
may be terminated by the investigator without regard to the subject's consent .
c. Any additional costs to the subject that may result from participatie :
in the study.
d. The consequences of a subject's decision to withdraw from the study an:
procedures for the orderly end of the subject's participation.
e. A statement that new findings developed during the course of the study
which could affect the subject's willingness to continue will be given to th
subject.
f. The approximate number of subjects involved in the study.
g .
The precautions to be observed by the subject before and after the
study . )
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24 re Anprayed for Release 2000/08/08 : CIA-RDP96-00788R00M1500440004-8 15-3
The proponent of this regulation is the Staff Judge Advocate
Users are invited to forward comments and suggested improve-
ments on DA Form 2028 (Recommended Changes to Publications
and Blank Forms) to this Headquarters, ATTN: IASJA.
FOR THE COMMANDER :
OFFICIAL:
E/J. K.RAYNAK
Administrative Officer
LOUIS D. KIRK
Colonel, GS .
Chief of Staff
DISTRIBUTION:
A B C (2 cys)
Flus -
Staff Judge Advocate (30 cys)
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