_ Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 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 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 CHAPTER 1 GENERAL INFORMATION PULPOSE meer rrr rt tr ern rr rena 1-1 1-1 Applicability --e~eq-- eee nnn rrr rrr nr rrr 1-2 1-1 References serrate nr errr rrr 1-3 1-1 SCOPCG momma ttt rrr era 1-4 1-1 Exemptions --- ste s ett en rrr rrr rrr a 1-5 1-2 Explanation of terms and abbreviatLons---------~--- 1-6 1-3 CHAPTER 2 RESPONSIBILITIES Approving offictals --o ope --- nner renner rrr nn 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 -----3~n eee nnn nnn 2-4 2-2 Executive Secretary of the HTRB ------------------— 2-5 2-2 Regular HTRB Membership ---sre eres eer nn errr 2-6 2-2 Ex Officio HTRB Membership -----93r-- errr en rrr rn 2-7 2-3 Ad hoc HTRB Membership 2-9-3939 errr 2-8 2-3 Principal investigator ------3s ener ren 2-9 2-3 Members of volunteer recruiting teams ------------- 2-10 2-4 Medical monttor qe ec cs ose n sree rrr rr 2-11 2-4 Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7
Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 USAINSCOM Regulation 15-3 CHAPTER 3 CHAPTER 4 CHAPTER 5 APPENDICE GVaAwWP 24 February 1984 | Paragraph Page POLICIES General -------~------------~---------—----------. 3-1 Approval ------~----------~------------------~---~ 3-2 Risk determinations ----------------~~--..--....-~ 3-3 Risk versus benefit -----~------~~-——~.--.-.....~. 3=4 Moral, ethical and legal concepts ---~------------- 3-5 Fully informed subjects -------------------~-~-- — 3-6 Use of non-US citizens ---------------~---------~~ 3-7 Use of prisoners of war and detainees -~~--------- 3-8 Medical care ---------------~--------~~-—.---~~--~~ 3-9 Stated objectives ---------~------—-~~-—-.--...-.. -- 3-10 ‘Physical and mental suffering ---------------~-~—-— 3-11 Qualifications of investigators -~----------------- 3-12 Minors ---<~------------------------------------~-~ 3-13 Recruiting of volunteers -------------------~~-~~~~ 3-14 Protocol guidance ~-----------------—-~---.----~.~. 3-15 PROCEDURAL GUIDANCE Technical reports -----------~---~--~-----~---—---- 4-1 Advising the Medical Research and Development Command -----~-------~----------- 4-2 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 INSCOM HUMAN TECHNOLOGY REVIEW BOARD (HTRB) ACTIVITIES Composition of the HTRB ---~---------------~-----.. 5-1 General criteria for membership ------------------ 5-2 General committee activities --------------~~..... 5-3 Avoiding possible conflicts of interest ---------- 5-4 Criteria for INSCOM HIRB approval ----~------------ 5-5 Special considerations of sensitivity ------------ 5-6 Suspension or termination of a project ----------- 5-7 ReCOrd8 s-<- een nn nn ee 5-8 Terms and Abbreviations -------~-----—~—.--~-~-.... Format for Preparation of a Research Protocol----- Volunteer Agreement, Part A --------------~~-----.- Volunteer Agreement, Part B --<---—---------~---~= ti Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 * is4 | ol i ee WWwWWWWW Ww 1: itt td t tet tf NNNN PE eRe PP eR PEP Peeoe T rae PRR EE Se NNN He ee Ep ; wa an WN NR Re ee oii hia
ry Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 24 February 1984 | USAINSCOM Regulation 15-3 Chapter 1 GENERAL INFORMATION 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; @.« 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 Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7
Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 s USAINSCOM Regulation 15-3 24 February 1984 the INSCOM, or the application of non-traditional ideas and technologies in achieving high performance of human resources. Lge / | €3) The investigation of programs and technologies to enhance organ- izational and individual excellence where such investigation involves the in- clusion of human subjects as their object. 1-5. Exemptions. | : 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 compenent 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 identified 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. | (2) Research which involves the use of educational tests, provided the data is recorded in such a way that the subjects cannot be identified di- rectly or indirectly. | (3) Research in non-INSCOM educational settings which involve normal 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 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 Human Technology Review Board as prescribed elsewhere in this regula- tion. | 1-2 Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 » a a |
Tm ° Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 L ‘ t t 24 February 1984 USAINSCOM Regulation 15-3 wy 1-6. Explanation of terms and abbreviations. The explanation of terms and ab- breviations used in this regulation is contained in appendix A. , ww wy 1-3 Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7
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Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 24 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. be 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. ce.» 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. 2=1 Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7
Approv: USAINSCOM e. per to the f. each inves g- such recommendations action: col. action and 2-4, HTRB regul 2=5 * Exe his staff of the HTRB is responsible for -—- ute Ae graph 2-3 bd. members. Co Chairperson of the HTRB. ular member of the HTRB and is responsible for chairing HTRB meetings, the CG informed of HTRB activities, ed For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 Regulation 15-3 24 February 1984 Conducting a continuous review of research studies at intervals pro~ degree of risk, but not less than once per year. Insuring the observation by a third party of the consent process and tigation, as appropriate. Recommending safeguards or special conditions to a protocol. When are made, the approving official may take the following (1) Not reduce the safeguards or conditions, and approve the proto- (2) Require additional safeguards. (3) Disapprove the protocol. ° (4) Refer the protocol to a higher echelon approving authority for review. | The DCSPPM is designated Chairperson and a reg- keeping and recommending approval/disapproval of ar members to the CG. utive Secretary of the HTRB. The DCSPPM will designate a member of to be the Executive Secretary of the HTRB. The Executive Secretary Insuring that the responsibilities of the HTRB prescribed in para- are carried out. Preparing and distributing the agenda for each meeting to all HTRB Insuring that all HTRB members are afforded the opportunity to con- ment on HTRB 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. tive staff nominating (DCSPPM) -f or message Nominees may be from their respec-— 8, subordinate command functional counterpart staffs, or may be the element head. Nominations will be submitted to the HTRB Chairperson or approval/disapproval by the CG. Nominations may be by letter, DF » and will contain the information required by paragraph a, below. a» Nominees will be identified by name, earned degrees, current position and duties formation chief expe and experience, such as board certifications and licenses. The in- in the nomination will be complete enough to describe each member's cted contributions to HTRB reviews. 2-2 Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7
wy & Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 24 February 1984 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 hack- 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. be. Command Psychologist. ce. 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. 2-9. 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- 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. 2-3 Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7
Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 _ USAINSCOM Regulation 15-3 i d. and the INSCOM HTRB before starting, changing or extending a study. Be 24 February 1984 Insuring that the research has been approved by the proper authority 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. £. Insuring that investigational materials and devices are administered only to subjects under his or her personal supervision and that of a previously approved ‘Be associate investigator. _ 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 —— Ge b. manner » Establishing volunteer requirements prior to recruitment. Undertaking recruiting in a morally, ethically and legally acceptable edical monitor. The medical monitor of each project is responsible for and is hereby delegated the authority to terminate the effort if -- ae . »b. Subjects are at risk of life or limb.. It appears the risk is significantly greater than anticipated at the time of review and approval of the project. 2-4 = For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7
ad rs Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 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 3-1 Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7
Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 . USAINSCOM Regulation 15-3 will be apptopria 24 February 1984 made and adequate facilities provided to protect the subject and in- vestigators against all foreseeable injuries, disabilities, or death. ject will will result. fits of the project. A: pro- not be conducted if any reason exists to believe that death or injury The degree of potential risk will never exceed the expected bene- alifications of investigators. Only persons judged qualified by the te 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. any time 3-13. M advance a The physician is authorized to stop the project at he or she believes that injury, disability or death may result. | nors. Minors may not be involved as human research subjects without pproval in each case by the INSCOM HTRB. 3-14. Recruiting of volunteers. Volunteer recuiting will be accomplished by personnel responsible for the conduct of the particular project, or as other- wise spec a. continuin 12-month De minimal r L Ce struction ifically approved by the INSCOM HTRB. Protocol guidance. Each approved protocol will be reviewed at least annually and on a g basis as determined by the INSCOM HTRB. Annually means once each period. | The decision as to whether a research protocol involves more than isk shall be made by the INSCOM HTRB. The research protocol will be prepared in accordance with the in- s contained at appendix B. 3-2 Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7
Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 * 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-CL) 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 4el Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7
Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 USAINSCOM ) with the c prove the dors. 4-7, Requests for exceptions. _ be submitter 24 February. 1984 ontractor or vendor. In all cases, however, the INSCOM HTRB must ap- INSCOM participation in or utilization of such contractors or ven- Regulation 15-3 Requests for exceptions to this regulation will ed to the INSCOM HTRB Chairperson (DCSPPM) with full justification. Categories which may be processed in the 4-8, Expedited review categories. expedited review procedures are as follows: ae. using non-invasive procedures routinely employed in clinical practice. Recording of data from subjects who are 18 years of age or older, This category does not include exposure to electromagnetic radiation outside the visible ra face of th nge (e-g-, X-rays, microwaves). It does include -—- (1) The use of physical sensors that are applied either to the sur- e 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. b. speech def Ce de or diagnos ee (2) Such procedures as -~ (a) Weighing. (b) Electrocardiography. (c) Electroencephalography. (d) Thermography. (e) Detection of naturally occurring radioactivity. (£) (g) Voice recordings made for research purposes such as investigations of ects, improvement in language utilization, etc. Diagnostic echography. Electroretinography. Moderate exercise of healthy volunteers. Study of existing data, documents, records, pathological specimens, tic specimens. Minor changes in previously approved research during the period for which approval has been authorized. 4-9 . HTRB Chatr whay carry Expedited review rocedures. Under an expedited review procedure, the person, or one or more HTRB reviewers designated by the chairperson, out the review. These reviewers may exercise all of the authorities 4-2 Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 am,
ed Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 : 24 February 1984 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. 4-3 Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7
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* Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 24 February 1984 USAINSCOM Regulation 15-3 a 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 men- 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 5-1 Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7
Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 | ‘ . USAINSCOM Regulation 15-3 24 February 1984 THIS PAGE INTENTIONALLY LEFT BLANK | “~ - ~ Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7
ed Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 : 24 February 1984 USAINSCOM Regulation 15-3 APPENDIX A TERMS AND ABBREVIATIONS Section I - Terms A-l. 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. © ae 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). ce. 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. A-1 Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7
_ system (doctrine, concepts, training programs). Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 USAINSCOM Regulation 15-3 24 February 1984 “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 a 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 A-8. Human 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 subjects in research is vested in commanders. In the INSCOM it is vested in the CG, and has been delegated to the DCG-I and DCC-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. An9. woael ty authorized representative. A person or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject taking part in the procedures involved in the research. eet a ee eee ree ec emimm te  c wo re : 4 '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 con-~ ducted. the plan contains, as a minimum, discussion of -- a» The objectives of the project. b. The information to be collected. ¢. The means by which it will be collected and evaluated. d. An assessment of potential risks and benefits to subjects. A-2 Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7
Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 . 24 Fébruary 1984 USAINSCOM Regulation 15-3 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). Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7
Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 USAINSCOM Regulation 15-3 - 24 February 1984 -,. ! Section II - Abbreviations ACSI ----------------~--- Department of the Army Assistant Chief of Staff, Intelligence AME Dom nnn nnn nn ne nn nnn Army Medical Department AR Lowen nn nnn nnn enn US Army Research Institute for the Behavioral and Social Sciences CENTEX----~-~~-------~—-~--~..----_..-- The INSCOM Center for Excellence CPRe nan nn nnn nnn nn ne Code of Federal Regulations Darn ner nnn nanan nnn nn = Department of the Army DARCOM-------------------=-=—-—.--..- US Army Materiel Development and Research Command DCSPER-------~-~------=-----~-.--_-_. The INSCOM Deputy Chief of Staff for. Personnel DCSPPM---~------~--------------—.--- The INSCOM Deputy Chief of Staff , for Plans, Programs and Modernization -~ DCSOPS----~------------ Se a tn emcee The INSCOM Deputy Chief of Staff for Operations DHHS-~-~-~---=---~----------——------. Department of Health and Human Services HPT P wen nnn nn nn oo The INSCOM High Performance Task Force (no longer constituted) HT RB on nna a ne = The INSCOM Human Technology Review Board INSCOM----=--~--~-------.----------... US Army Intelligence and Security Command MACOM~----=-—~~~—==-=-——--—--- = = Major Army command | SJA ttm nner ne nnn nen The INSCOM Staff Judge Advocate TS Gren nnn nnn nnn nnn ne ne The Surgeon General of the Army | US ern e nnn nnn nn nn nn ne United States a A-4 Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7
a Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 1 £ ws’ ‘24 February 1984 USAINSCOM Regulation 15-3 APPENDIX B FORMAT FOR PREPARATION OF A RESEARCH PROTOCOL Section I GENERAL INFORMATION 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. ae 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 ww 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 IT 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). be (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 profject).: 7. Objectives. (State briefly but specifically the objectives of the pro- ject. Include items below, where applicable). a. Study design. (Double-blind, crossover, etc.)- rw B-1 Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7
! i Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 | USAINSCOM Regulation 15~3 THIS PAGE INTENTIONALLY LEFT BLANK B-6 Approved For Release 2000/08/08 : CIA-RDP96-00788R001500140005-7 24 February 1984 _