USAINSCOM REGULATION 15-3: BOARDS, COMMISSIONS AND COMMITTEES HIGH PERFORMANCE REVIEW PROCEDURES

• Document Type: CREST
• Collection: STARGATE
• Document Number (FOIA) /ESDN (CREST): CIA-RDP96-00788R001500140005-7
• Release Decision: RIFPUB
• Original Classification: K
• Document Page Count: 35
• Document Creation Date: November 4, 2016
• Document Release Date: May 15, 2000
• Sequence Number: 5
• Publication Date: February 24, 1984
• Content Type: REGULATION

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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
Boards, Commissions and Committees
HIGH PERFORMANCE REVIEW PROCEDURES
24 February 1984
During 1982 and 1983, in keeping with the US Army Intelligence and Security
Command (INSCOM) goal of "extraordinary performance," and seeking to move the
command to a level which exceeds commonly defined parameters of performance,
the 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
INSCOM 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 human 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
Approving officials -------------------------------
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 HTRB ---------------------------
2-4
2-2
Executive Secretary of the HTRB ------------------
2-5
2-2
Regular HTRB Membership --------------------------
2-6
2-2
Ex Officio HTRB Membership ------------------------
2-7
2-3
Ad hoc HTRB 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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USAINSCO Regulation 15-3
CHAPTER POLICIES
24 February :1984
Paragraph Page
General ------------------------------------ ----- 3-1 3-1
Approval ----------------------------------------- 3-2 3-1
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 detainees ------------ 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 3-2
Minors ------------------------------------------- 3-13 3-2
Recruiting of volunteers ------------------------- 3-14 3-2
Protocol guidance -------------------------------- 3-15 3-2
Technical reports -------------------------------- 4-1 4-1
Advising the Medical Research
and Development Command ------------------------ 4-2 4-1
Informed consent -------------------------------- 4-3 4-1
Minimum standards -------------------------------- 4-4 4-1
More than minimal risk --------------------------- 4-5 4-1
Contractors or vendors --------------------------- 4-6 4-1
Requests for exceptions -------------------------- 4-7 4-2
Expedited review categories ---------------------- 4-8 4-2
Expedited review procedures ---------------------- 4-9 4-2
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 5-1
Criteria for INSCOM HTRB approval --------------- 5-5 5-1
Special considerations of sensitivity ------------ 5-6 5-2
Suspension or termination of a project ----------- 5-7 5-2
Records --------------------------------------- 5-8 5-3
A - Terms and Abbreviations -------------------------- -
A-1
B
- Format for Preparation of a Research Protocol-----
B-1
C
- Volunteer Agreement, Part A ----------------------
C-1
D
- Volunteer Agreement, Part B ----------------------
D-1
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24 February 1984 USAINSCOM Regulation 15-3
Chapter 1
1-1. 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
as volunteers in the evaluation of high performing human systems;
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 INSCOM com-
ponents do not engage in or contract for experimentation on human subjects in
violation of Procedure 13, AR 381-10.
1-2. 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 Intelligence Activities.
c. AR 70-31, Standards for Technical Reporting.
1-4. 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
pertain 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) Inclusion of human subjects, whether as the direct or indirect
object of research, regardless of the level or risk involved, in the develop-
ment, testing or study of matters associated with the missions and functions of
1-1
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24 February 1984
the INSCOM, or the application of non-traditional ideas and technologies in
achieving high performance of human resources.
(3) The investigation of programs and technologies to enhance organ-
izational and individual excellence where such investigation involves the in-
clusion f human subjects as their object.
1-5. Ex m tions.
h
waa LL
uman 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 cannot
be identfied directly or indirectly.
(b) The subject's responses, if they become known, would not
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 deal with sensitive aspects of the
subject's own behavior, such as illegal conduct, drug use, sexual behavior, or
use of alcohol.
the data
rectly or
(2) Research which involves the use of educational tests, provided
is recorded in such a way that the subjects cannot be identified di-
indirectly.
(3) Research in non-INSCOM educational settings which involve normal
educationial practices, such as --
(a) Regular and special educational strategies.
(b) The effectiveness or the comparison among techniques of in-
structions, curricula, or classroom methods.
(4) Follow-up debriefings, interviews, tests, or evaluations to de-
termine hpw well participants have learned the information or skills transmit-
ted by training or instructional activities previously attended by the subject
thereof.
b. ,Exemptions of other activities from this regulation, even where such
activities may be exempted from other similar regulations or directives; shall
not be considered valid for INSCOM purposes unless and until confirmed by the
INSCOM Hunan Technology Review Board as prescribed elsewhere in this regula-
tion.
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24 February 1984 USAINSCOM Regulation 15-3
1-6. Explanation of terms and abbreviations. The explanation of terms and ab-
breviations used in this regulation is contained in appendix A.
11111010
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24 February ' 1984
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Z4 February 1984 USAINSCOM Regulation 15-3
Chapter 2
RESPONSIBILITIES
2-1. Approving officials. The Commanding General, the Deputy Commander, In-
telligence, 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 Heads. Commanders at all levels within the
INSCOM, heads of Headquarters staff elements, office chiefs and program direc-
tors (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
official.
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
material changes have occurred since the previous HTRB review.
(3) Prompt reporting to the HTRB of proposed changes in the re-
search, and to the HTRB and approving official of unexpected problems involving
risks to the subjects or others.
b. Insuring that changes in approved projects (during the period for
which 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
members 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 HTRB
requirements and determinations found by investigators.
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e. Conducting a continuous review of research studies at intervals pro-
per to the degree of risk, but not less than once per year.
f. Insuring the observation by a third party of the consent process and
each investigation, as appropriate.
g. Recommending safeguards or special
such recommendations are made, the approving
action:
(1)
(4) Refer the protocol to a higher echelon approvine authority for
24 February 1984
conditions to a protocol. When
official may take the following
Not reduce the safeguards or conditions, and approve the proto-
(2) Require additional safeguards.
(3) Disapprove the protocol.
2-4. Chairperson of the HTRB. The DCSPPM is designated Chairperson and a reg-
ular member of the HTRB and is responsible for chairing HTRB meetings, keeping
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 DCSPPM will designate a member of
his staff to be the Executive Secretary of the HTRB. The Executive Secretary
of the HTRB is responsible for --
a. Insuring that the responsibilities of the HTRB prescribed in
ara-
p
graph 2-3 are carried out.
b. Preparing and distributing the agenda for each meeting to all HTRB
members.
c.
ment on H
Insuring that all HTRB members are afforded the opportunity to com-
1B actions conducted under expedited review procedures.
2-6. Regular HTRB membership. The INSCOM DCSOPS, DCSPER, DCSSYS, SJA, Command
Chaplain and DARCOM LNO, are each responsible for nomination of an individual
to serve as a regular member of the HTRB. Nominees may be from their respec-
tive staff, 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, DF
or message and will contain the information required by paragraph a, below.
at ominees will be identified by name, earned degrees, current position
and duties, and experience, such as board certifications 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
b. Nominees will normally be military officers in the grade of 0-5, or
above, or civilian employees, GS-13 or above. Nominees will have diverse back-
grounds to insure thorough review of research studies involving human volun-
teers as research subjects. Nominees should be of varied racial and cultural
backgrounds. Nominees should have displayed sensitivity to such issues as com-
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.
2-7. Ex officio HTRB membership. The incumbents of the following positions
will 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.
2-8. Ad hoc HTRB membership. The following will serve as ad hoc members of
the INSCOM HTRB:
a. 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.
2-49. 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-
terials 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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d.' Insuring that the research has been approved by the proper authority
and the FNSCOM HTRB before starting, changing or extending a study.
:e. Insuring that all subjects, including those used as controls or their
representatives, are fully informed of the nature of the research to include
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 r7search and the ethical principles in this and related regulations.
2-10. Members of volunteer recruiting teams. Members of volunteer recruiting
teams area responsible for
b.
manner.
Establishing volunteer requirements prior to recruitment.
Undertaking recruiting in a morally, ethically and legally acceptable
2-11. Medical monitor. The medical monitor of each project is responsible for
and is hereby delegated the authority to terminate the effort if --
Subjects are at risk of life or limb..
b. It appears the risk is significantly greater than anticipated at the
time of review and approval of the project.
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24 February 1984 USAINSCOM Regulation 15-3
Chapter 3
POLICIES
3-1. General. Experimentation involving human technology or human subjects
conducted by' or on behalf of any INSCOM component may be undertaken only with
the informed consent of the subject, and in accordance with guidelines issued
by the Department of Health and Human Services (DHHS), setting out conditions
that safeguard the welfare of such subjects. The provisions of this regulation
constitute INSCOM implementation of those guidelines.
3-2. Approval. INSCOM components may not engage in or contract any research
or testing involving human subjects without advance approval through the INSCOM
HTRB by an INSCOM approving official, or higher level official, where appropri-
ate. This approval is required regardless of the degree of risk involved.
3-3. Risk determinations. The INSCOM HTRB will render all risk determinations
regarding INSCOM research or testing involving human subjects.
3-4. Risk versus benefit. The degree of potential risk involved in any pro-
ject 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 subject is essential. Military personnel are
not subject to the Uniform Code of Military Justice (UCMJ) for choosing not to
take part as human subjects.
3-6. 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
involves non-US citizens; however, all requirements of this regulation applic-
able to human subjects shall be equally applicable to non-US citizen human sub-
jects.
3-8. Use of prisoners of war and detainees. The use of prisoners of war and
detainees as human research subjects is prohibited.
3-9. Medical care. Volunteers will be authorized all necessary medical care
for 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
objectives. The proposed number of subjects will be the minimum needed to in-
sure that statistically significant results are obtained.
3-11. Physical and mental suffering. Each project will be conducted in such a
manner as to avoid unnecessary physical and mental suffering. Preparations
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USAINSCOM' Regulation 15-3 24 February, 1984
will be made and adequate facilities provided to protect the subject and in-
vestigators against all foreseeable injuries, disabilities, or death. A pro-
ject will not be conducted if any reason exists to believe that death or injury
will result. The degree of potential risk will never exceed the expected bene-
fits of he project.
3-12. Qualifications of investigators. Only persons judged qualified by the
appropriate approving authority will conduct human subject studies. The physi-
cian responsible for the health and welfare of the subject may or may not be
the principal investigator. The physician is authorized to stop the project at
any time he or she believes that injury, disability or death may result.
3-13. M nors. Minors may not be involved as human research subjects without
advance pproval in each case by the INSCOM HTRB.
3-14. R4cruiting of volunteers. Volunteer recuiting will be accomplished by
personnel responsible for the conduct of the particular project, or as other-
wise specifically approved by the INSCOM HTRB.
3-15. Protocol guidance.
a.~ Each approved protocol will be reviewed at least annually and on a
continuing basis as determined by the INSCOM HTRB. Annually means once each
12-month,period.
b. 1 The decision as to whether a research protocol involves more than
minimal risk shall be made by the INSCOM HTRB.
- c. The research protocol will be prepared in accordance with the in-
structionp contained at appendix B.
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24 February 1984 USAINSCOM Regulation 15-3
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 volun-
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 (appendix C).
b. The Explanation Portion of the Volunteer Agreement (appendix D).
4-4. 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 same 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 DHHS
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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15-3
24 February, ,19$4
with the contractor o
I
r vendor.
In
all
cases, however,
the
INSCOM HTRB must ap-
prove th
INSCOM part
dors.
icipation
in
or
utilization of
such
contractors orven-
4-7. Requests for exceptions. Requests for exceptions to this regulation will
be submitted to the INSCOM HTRB 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 t,a 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) Electrocardiography.
(c) Electroencephalography.
(d) Thermography.
(e) Detection of naturally occurring radioactivity.
(f) Diagnostic echography.
(g) Electroretinography.
b.
speech de
Voice recordings made for research purposes such as investigations of
ects, improvement in language utilization, etc.
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 HTRB reviewers designated by the chairperson,
may carry out the review. These reviewers may exercise all of the authorities
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USAINSCOM Regulation 15-3
of the HTRB except that of disapproval, which may only be exercised as pre-
scribed 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 expedited 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 HTRB.
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4-4
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24 February 1984 USAINSCOM Regulation 15-3
Chapter 5
INSCOM HUMAN TECHNOLOGY REVIEW BOARD ACTIVITIES
5-1. 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
among the nominations submitted in accordance with paragraph 2-6 and 2-8,
above, 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
be not affiliated with the INSCOM 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
from a profession/position/activity primarily concerned with the welfare of hu-
man persons. At least one member will be non-scientific, such as a lawyer,
ethicist or member of the clergy. THE INSCOM HTRB may invite persons with spe-
cial 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 re-
sponsibility to determine if a proposed activity is acceptable. Acceptability
will be in terms of Army Medical Department (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-
ligence component.
a. At least five voting members will be required to constitute a quorum
at each committee meeting.
b. All actions of the committee will be by majority vote of members
present.
5-4. Avoiding possible conflicts of interest.
a. Except to provide information requested by the HTRB, no INSCOM HTRB
member may take part in a review of any project which is sponsored by that mem-
ber'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 HTRB. The
approving official may not approve research for which he or she is also a prin-
cipal 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-
tion, the INSCOM HTRB should consider only those that may result from that
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particular project, unless a clear linkage has been established to other pro-
jects.
b.i To approve an effort covered by this regulation, the INSCOM HTRB must
determin that all of the requirements below are met.
(1) Risks to subjects are minimized by using procedures that are --
essarily
(a) Consistent with sound investigation design and do not unnec-
expose subjects to risk.
(b) Already being used on subjects for diagnosis or treatment,
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 to
(3) In making an assessment for the selection of subjects, the spon-
sor has adequately considered --
(a) The purpose of the investigation.
(b) The setting in which the research investigation will be con-
(4) Informed consent will be secured from each subject.
(5) Informed consent will be properly documented.
(6) The protocol takes adequate provisions for monitoring the data
to insure the safety of the subjects.
(7) Adequate provisions exist to protect the privacy of subjects and
to mainta.n the confidentiality of data when appropriate.
5-6. Special considerations of sensitivity. Some or all of the subjects may be
vulnerable to special considerations of sensitivity because of past assignments,
affiliations, etc. In such cases, additional safeguards will be included to
protect the rights and welfare of these subjects. In no instance will the
INSCOM beja party to any research which involves the use of persons with acute
or severe physical or mental illness, or those who are economically or educa-
tionally disadvantaged.
5-7. Sus ension or termination of a project.
a. The INSCOM will suspend or terminate a project that --
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r 1
(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, including --
(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-
tigators.
(5) A current list of HTRB members. Members will be identified by
name, 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-
ment or other relationship between members and the INSCOM will be noted.
(6) Written procedures, including agendas, expedited review proce-
dures, etc., for the HTRB.
(7) Statements of significant new findings.
b. The records required by this regulation will be retained permanently
under AR 340-18-13. Such records will be reasonably accessible for inspection
and copying by authorized DA personnel and representatives of the Federal Food
and 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-
cution 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.
as 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 by a "legally authorized representative" for
taking part as a human subject of another person who does not possess autono-
mous 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
grant permission (also known as third-party consent).
c. Assent. 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
behalf, 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 effect.
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-
tation 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-6. Health care practitioner. An individual trained to interact with pa-
tients to provide diagnostic or 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 an investigator conducting research, testing or studies obtains data
through interaction with that person. Both physical procedures and manipula-
tions of the subject or the subject's environment are included. Human subjects
may be thought of as direct objects when the research is to determine the ef-
fects of ,e new system on man (for example, the psychological effects of a par-
ticular interrogation technique on an individual) or as indirect objects when a
test is conducted to determine how man affects the ultimate performance of a
system (doctrine, concepts, training programs).
A-8. Hunan Technology Review Board (HTRB). A body set up to provide initial
and continuing review of research involving the use of human subjects. HTRB
fulfills all the functions of a human use committee as described in AR 70-25.
It is fundamentally similar to an Institutional Review Board (IRB) discussed in
guidelines issued by the DHHS for human research, but has somewhat different
authority, as compared to an IRB. Within DOD, authority to approve the use of
human subects in research is vested in commanders. In the INSCOM it is vested
in the CCU, and has been delegated to the DCG-I and DCG-S for matters under
their respective functional control. Approving officials act on recommenda-
tions of validly constituted HTRBs. Outside DOD, IRBs tend to be vested with
this authority.
A-9. Legally authorized representative. A person or judicial or other body
authorize under applicable law to consent on behalf of a prospective subject
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 hysician 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. Prtocol. The written,
detailed
plan by which
research
is
to be con-
ducted.
T
h
a plan contains, as
a minimum,
discussion of
--
a.
The objectives of the
project.
b.
The information to be collected.
c. rhe means by which it will be collected and evaluated.
d. An assessment of pote
ntial 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
unique to this regulation and is not intended to identify an effort for funding
under appropriations intended for Research, Development, Test and Evaluation
(RDTE). "Research" in the sense applied in this regulation will be funded
according to the project, effort, etc., to which it applies.
A-15. Research and development. Any scientific inquiry, investigation, or
validation performed or directed to test hypotheses or develop concepts con-
cerning 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.
A-16. Systematic investigation. A formal inquiry generally described in a
protocol that sets forth explicit objectives and formal procedures designed to
reach those objectives. The term includes clinical investigations, but does
not include post-training or post-therapeutic inquiries intended only to evalu-
ate individual progress or responsiveness to training or therapy.
A-17. 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 ---- ------- ------------- ---------
CENTEX-------------- ------- ----------
CFR------ --------------- ------------
DA-----------------------------------
DARCOM-------------------------------
DCSPER-------------------------------
DCSPPM-------------------------------
DCSOPS------------------------------
DHHS--------------------------------
HPTF---------------------------------
SJA----------------------------------
TSG----------------------------------
Us-------- ---------------------------
24 February 1984
Department of the Army Assistant
Chief of Staff, Intelligence
Army Medical Department
US Army Research Institute for the
Behavioral and Social Sciences
The INSCOM Center for Excellence
Code of Federal Regulations
Department of the Army
I
US Army Materiel Development and
Research Command
The INSCOM Deputy Chief of Staff for
Personnel
The INSCOM Deputy Chief of Staff
for Plans, Programs and Modernizatiop
The INSCOM Deputy Chief of Staff
for Operations
Department of Health and Human Services
The INSCOM High Performance Task
Force (no longer constituted)
The INSCOM Human Technology Review Board
US Army Intelligence and Security
Command
Major Army command
The INSCOM Staff Judge Advocate
The Surgeon General of the Army
United States
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APPENDIX B
FORMAT FOR PREPARATION OF A RESEARCH PROTOCOL
1. Project title. (Enter complete project title - if this is an amendment to
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).
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 sub-
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).
a. Study design. (Double-blind, crossover, etc.).
B-1
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b. Technologies to be employed. (List the generic technologies to be em-
ployed in the project).
c. ~ype of population involved. (List the subject population to bel ob-
served).
8. Stat s. (State what has been accomplished or published in the proposed
area of s udy 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.
a. (outline expected accomplishments in sufficient detail to show a clear
c
f action`
ourse o
b. (Include discussion of the technological validity of the proposed re-
search procedures).
c. (List the chronological steps to be taken).
12. Pro ct sub ects. (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 exam-
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-
tained).
i. Subject identification. (Describe code system, if any, which will be
used in the project).
J. Subject assessment. (Describe the methods used to assign or allocate
the object of this research to particular subjects).
k. Risks and benefits. (Discuss the analysis of risks and benefits to
subjects and to those conducting the 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 actions expected to be taken if such adverse reactions occur).
no 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).
b. (Identify the source of all technologies and related items, devices,
etc. List all components and manufacturing and quality control plans/
procedures, where applicable).
c. (Identify the methodology for application, if different from procedures
described above).
d. (State the schedule, administration and duration of each aspect of the
project).
e. (Describe in detail accompanying devices amd 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).
14. Evaluations made during and following the project. (A project schematic
may be included, or the items may he listed as indicated below. In either
case, it is important to identify the person who will perform each evaluation).
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1) Schedule of collections.
2) Evaluations to be made on specimens.
24 February 1984
3) Storage. (If applicable, state where and if special conditi
o ns
are required.)
4) Labeling and disposition.
(:5) Laboratories performing evaluations.
(6) Special precautions.
b. linical/behavioral assessments. (Include how adverse effects are to
be recorded).
c. V tal signs. (State when desired and the frequency).
d. F llow-u procedures.
I
e. Disposition of data. (State location and duration of storage. Include
pertinent information regarding Privacy Act and AR 381-10 considerations, if
applicable).
f. thods 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. 4ho will be notified. (Include both those regarding the individual
subject, if appropriate, and those elsewhere within the INSCOM. Must notify at
least the HTRB).
16. Adverse reactions. (Must correlate with paragraph 12m, above).
a. D$finition of subject reactions.
b. I ediate reporting procedures.
c. Routine reporting procedures.
d. Potential post-project adverse reactions.
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24 February 1984 USAINSCOM Regulation 15-3
Section IV
ADMINISTRATION
17. Modification of protocol. (Describe the procedure to be followed to
modify, terminate or extend the protocol).
18. 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 im-
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 initial, continued and annual review of this pro-
tocol).
(Signature)
(Name, rank and organization of person submitting protocol)
(Signature)
(Name, rank and organization of principal investigator)
(Signature)
(Name, rank and organization of approving official)
~0/
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
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24 February-1984
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24 February 1984 USAINSCOM Regulation 15-3
APPENDIX C
VOLUNTEER AGREEMENT
Part A
I, , having attained my eighteenth
(18th) birthday, and otherwise having full capacity to consent, do hereby vol-
unteer to participate in an investigation study entitled:
, and
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-
conveniences and hazards 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-
tions concerning this investigative 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, such examinations are necessary for my health
or well being.
Signature Date
Witness's Signature Date
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.
USAINSCOM Regulation 15-3
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-
ject).
7. 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).
8. Subject's rights. (An explanation of whom to contact for answers to perti-
nent 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).
10. Compensation and medical treatment. (For a study involving more than min-
imal risk, an explanation as to whether any compensation and medical treatment
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24 February 1984
are available if injury occurs and, if so, what they consist of, or where fur-
ther information may be obtained).
11. Additional comments. (When appropriate, one or more
information below will also be given to each subject.
a. Al statement that a certain treatment or procedure
the subject - or to the embryo or fetus if the subject is
nant - that are currently unforeseeable.
of the elements of
may involve risks to
or may become preg-
b. The anticipated circumstances under which the subject's participation
may be terminated by the investigator without regard to the subject's consent.
c. Achy additional costs to the subject that may result from participation
i
n tie stdy.
d. The consequences of a subject's decision to withdraw from the study and
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 the
subject.
f. Tle 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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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.
OFFICIAL:
KRAANAK
Alministrative Officer
DISTRIBUTION:
A B C (2 cys)
Plus -
Staff Judge Advocate (30 cys)
LOUIS D. KIRK
Colonel, GS
Chief of Staff
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