# I. 

# 

# 

# INTRODUCTION

> The purpose of protocol review guidelines is to describe the procedure
> for review of human subjects protocols submitted to the Army Surgeon
> General's Human Subjects Research Review Board (HSRRB). This review
> should ensure that the protocol is in compliance with applicable human
> subjects protection regulations and ethical guidelines.

# II. 

# RESPONSIBILITIES

> A. All human subjects protection and regulatory affairs scientists in
> the Office of Regulatory Compliance and Quality (RCQ) are responsible
> for review of intramural and extramural human subjects protocols in
> accordance with the procedure outlined in this SOP.
>
> B. For each protocol submitted to the HSRRB, the human subjects
> protection or regulatory affairs scientist who is assigned as the
> reviewer for the protocol is responsible for completing the HSRRB
> Protocol Checklist. The reviewer is responsible for updating the
> checklist when the Principal Investigator (PI) submits a revised
> protocol.
>
> C. The Acting Chair, HSRRB is responsible for approving the protocol
> review before protocol recommendations are given to the PI and before
> the protocol is submitted to the HSRRB for review. The Acting Chair
> may delegate this duty to the Alternate Acting Chair or Vice Acting
> Chair as needed.

# III. PROCEDURES

> The reviewer should enter the HSRRB Log No., name of PI, and date the
> checklist is completed or updated and sign in the space provided for
> "Reviewer's Signature." The reviewer should review each element of the
> checklist, check the appropriate box (Yes, No, or NA), and make
> written comments as needed. This checklist is designed to facilitate
> writing recommendations for changes to the protocol that the PI needs
> to make and/or additional information that the PI needs to provide. If
> a revised protocol contains significant changes, a new checklist
> should be used to review the revised protocol. An explanation of each
> element of the checklist follows:
>
> A. Protocol Title. The same protocol title should be used on all
> protocol related documents. The protocol should reference the overall
> research proposal if the protocol is part of a multi-protocol research
> proposal. (AR 70-25, Appendix B-1)
>
> B. Scientific Review. Documentation of review and approval of the
> protocol by a committee designated to assess the scientific merit of
> the protocol should be provided. Enter the date of approval in the
> \"Comments\" section of the checklist. If scientific review comments
> are provided, review the comments and ensure that they have been
> addressed. Protocol amendments that involve a significant change to
> the study design should have accompanying documentation that a
> committee designated to assess scientific merit approved the
> amendment. The scientific review requirement is applicable to all new
> protocol submissions. (32 C.F.R. § 219.115(a)(1); AR 70-25, 2-9c.(6),
> AR 70-25, 3-2c.(3); AR 70-25, Appendix B-17; OTSG 15-2, 6.a.(2))
>
> C. Institutional Committee(s) Review. Institutional committee reviews
> may involve review by the Radiation Control Committee, BioSafety
> Committee, BioMedical Engineering Committee and/or others.
> Documentation of review by a radiation control committee is required
> for protocols that involve the use of radiation. If applicable, as in
> gene therapy protocols, review by the BioSafety Committee should be
> performed. If applicable, record the date of approval in the
> \"Comments\" section of the checklist. If a report is available,
> review recommendations and actions taken by the investigator in
> response to recommendations. Otherwise, check the column marked
> \"NA\". (AR 70-25, 3-2c.(4))
>
> D. IRB/HURC Approval.
>
> 1\. Assurance Validation. All institutions participating in the
> proposed research must have an Assurance with the Health and Human
> Services Office of Human Research Protection (OHRP) or the DOD (DOD
> Directive 3216.2). If the institution has an OHRP Multiple Project or
> Federal Wide Assurance or a DOD Multiple Project Assurance, record the
> Assurance number in the \"Comments\" section of the checklist. If the
> institution does not currently hold an Assurance, the institution must
> apply for a DOD Single Project Assurance or OHRP Federal Wide
> Assurance. Provide the investigator with the appropriate instructions.
> See the Assurance SOP for further information on Assurance
> requirements. (AR 70-25, 3-2k.; DOD Guidance Memorandum, (10 June
> 1993))
>
> 2\. Documentation of IRB approval of the protocol must be provided
> prior to submission to the HSRRB. This documentation should be
> provided in the form of a letter from the IRB chair or designee and
> should include the level of risk as determined by the local IRB.
> Meeting minutes may also serve as documentation of protocol approval.
> Confirm that the assigned IRB/HURC number and title of the protocol
> are consistent with the IRB/HURC number and title stated in the
> IRB/HURC approval notice and/or minutes. Identify the date the
> Continuing Review Report is due as designated by the local IRB/HURC.
> Amendments to the protocol also require similar documentation of IRB
> approval. Record the date of IRB approval in the \"Comments\" section
> of the checklist. (32 C.F.R. § 219.111; 21 C.F.R. § 56.109; 21 C.F.R.
> § 56.115; AR 70-25, Appendix B-15; AR 70-25, Appendix B-17; AR 70-25,
> Appendix C-2)
>
> 3\. The assigned IRB number and the title of the protocol should be
> consistent with the IRB number and protocol title in the IRB approval
> letter.
>
> 4\. The approval letter from the IRB of Record should include the risk
> level assigned to the protocol. (AR 70-25, 3-1e.)
>
> 5\. The IRB of Record should specify the date by which the continuing
> review report is due. (AR 70-25, 3-2e.(1)(f); OTSG 15-2, 7.)
>
> E. Study Location. The location(s) where the study is to be conducted
> should be stated in the protocol. The name of the institution and
> address and contact information for the point of contact at each study
> site should be specified. (AR 70-25, Appendix B-3)
>
> F. Protocol Timeline. The investigator should specify the amount of
> time required to conduct the study, the time commitment required for
> study subjects, and any special constraints on the start or completion
> dates of the study. (AR 70-25, Appendix B-4)
>
> G. Description of Protocol Drug or Device. The protocol should
> identify the name of the drug or device to be used in the study, the
> type of drug or device, and the status of the product, (e.g.,
> approved, cleared, or investigational). The Classification of the
> device as Class I, II or III should be declared in the protocol. (AR
> 70-25, Appendix B-5; Review of IND Protocols SOP (2002); Review of
> Medical Device Protocols SOP (2002))
>
> H. Purpose. The protocol should include a description of the purpose
> of the study and the research objectives, questions, and/or
> hypotheses. (AR 70-25, Appendix B-5)
>
> I. Research Design.
>
> 1\. The research design should be specified (i.e., observational,
> experimental, cross-sectional, longitudinal, etc.). (AR 70-25,
> Appendix B-5; AR 70-25, Appendix B-6)
>
> 2\. Subject Identification. If unique identifiers or a specific code
> system will be used to identify subjects, this process should be
> described in the protocol. (AR 70-25, Appendix B-5; AR 70-25, Appendix
> B-6)
>
> 3\. Subject Assignment. If a randomization process or other procedures
> are used for subject group assignment, this process should be
> described in the protocol. (AR 70-25, Appendix B-5; AR 70-25, Appendix
> B-6)
>
> J. Study Population and Sample.
>
> 1\. Target Population. The population from which subjects will be
> recruited should be identified. Subject selection should be equitable.
> The protocol should indicate the age range of subjects, with
> justification of any age limitations provided. Studies should include
> both men and women unless the subject of the research is gender
> specific (e.g. Prostate Cancer, Pregnancy) or an adequate
> justification for exclusion is provided in the protocol. Consider the
> impact of the research on minors and women of childbearing potential.
> Exclusion of certain racial or ethnic groups must be justified. (AR
> 70-25, Appendix B-5; AR 70-25, Appendix B-6)
>
> 2\. Sample Size Justification. An appropriate sample size
> justification must be included in the protocol to ensure that the
> sample size is appropriate to meet the objectives of the study. The
> protocol should specify the approximate number of subjects that will
> be enrolled. If the protocol involves multiple sites, the number
> enrolled at each site should be stated in the protocol. (AR 70-25,
> 3-1h.)
>
> 3\. Sampling Method. The protocol should describe the methods for
> obtaining subjects. (e.g., convenience, simple random, stratified
> random) (AR 70-25, Appendix B-6)
>
> 4\. Inclusion and Exclusion Criteria. Any inclusion or exclusion
> criteria should be stated in the protocol. Ensure that exclusions are
> justified. Also assess whether additional inclusion or exclusion
> criteria should be recommended based on the nature and procedures
> involved in the protocol. Diseases, medications, and groups of
> subjects that should be excluded should be clearly stated. A lack of
> animal data does not constitute a valid reason for restricting entry
> of women of childbearing potential into a study. If pregnancy is
> contraindicated while on protocol, a pregnancy-testing plan should be
> included. Testing should be performed within a 48-hour window of the
> contraindicated procedure. Plans for follow-up, particularly if the
> subject withdraws from the study should be included as well as what
> management measures will be employed if pregnancy should occur. (AR
> 70-25, Appendix B-6)
>
> 5\. Pregnant Women, Human Fetuses and Neonates Involved in Research.
> All research involving pregnant women, human fetuses, neonates of
> uncertain viability, or nonviable neonates conducted or supported by
> the Department of Defense must comply with Subpart B, 45 C.F.R. §
> 46.204 along with other applicable requirements found in 32 C.F.R. §
> 219 and AR 70-25, Appendix B-6. Refer to HSRRB Clause 9.01, *Pregnancy
> Prevention*.
>
> 6\. Biomedical and Behavioral Research Involving Prisoners as
> Subjects. All biomedical and behavioral research conducted or
> supported by the Department of Defense involving prisoners as subjects
> must comply with Subpart C, 45 CFR 46. 306 along with other applicable
> requirements found in 32 CFR 219 and AR 70-25. Nothing in 45 CFR 46
> Subpart C shall be construed as indicating that compliance with the
> procedures set forth herein will authorize research involving
> prisoners as subjects, to the extent such research is limited or
> barred by applicable State or local law. (32 C.F.R. § 219.111(b); AR
> 70-25, Appendix C-4c.; OTSG 15-2, Appendix B-3)
>
> K. Recruitment and Informed Consent Process.
>
> 1\. Recruitment of Subjects. The recruitment process should be clearly
> described in the protocol, and all recruitment materials must be
> submitted for review. The recruitment methods should not be coercive
> and should accurately reflect the research. The research team is best
> qualified to recruit and should be the primary recruiter whenever
> possible. Advertisements may include the name and address of the
> clinical investigator, purpose of the research, summary of eligibility
> criteria, a straightforward and truthful description of benefits,
> location of the research, and the person to contact for further
> information. Ensure that advertisements are not misleading. See the
> Recruitment SOP for further information on review of recruitment
> material. (21 C.F.R. § 312.7; AR 70-25, 3-1p.; OTSG 15-2, Appendix
> B-1; FDA Information Sheets (1998))
>
> 2\. Informed Consent Process. The informed consent process must be
> described in the protocol. This description should include who is
> responsible for providing informed consent and should allow sufficient
> time for the subject to consider participation. Coercion and undue
> influence should be minimized, and the subject should be given the
> opportunity to ask questions. (32 C.F.R. § 219.116; AR 70-25, 3-1a.;
> AR 70-25, 3-1f.; AR 70-25, 3-1j.; OTSG 15-2, 6.a.(5);OTSG 15-2,
> 6.a.(8); OTSG 15-2, 6.a.(9))
>
> 3\. Intent to Benefit. If the investigator plans to enroll subjects
> not capable of providing his or her own consent, there should be a
> clear intent to benefit each subject participating in the study. 10
> United States Code 980 requires that \"funds appropriated to the
> Department of Defense may not be used for research involving a human
> being as an experimental subject unless (1) the informed consent of
> the subject is obtained in advance; or (2) in the case of research
> intended to be beneficial to the subject, the informed consent may be
> obtained from a legal representative of the subject.\" If subjects not
> capable of providing their own consent are being enrolled in the
> study, there must be a clear intent to benefit each subject. Benefits
> to the subject should be clearly defined in the protocol. (10 USC 980;
> AR 70-25, 3-1o.; OTSG 15-2, 6.a.(5); HSRRB Clause 6.01, *10 USC 980*)
>
> 4\. Consent of Legally Authorized Representative. If subjects cannot
> give their own consent to participate in the study, a description of
> the informed consent process and plan for consent of the individual's
> legally authorized representative to be obtained prior to
> participation must be described in the protocol. (AR 70-25, 3-1o.(3);
> OTSG 15-2, 6.a.(8))
>
> 5\. Consent for Medical or Surgical Procedures. Copies of procedural
> consent forms for standard procedures performed as part of the
> research study must be provided. In order to make an accurate risk
> assessment, as required by OTSG 15-2, the risks of all procedures that
> will occur, whether for standard of care, or for research purposes
> only should be considered to assess the cumulative effect of the
> research on the subject. Risks that are associated with standard of
> care procedures that are being performed over the course of the
> research do not need to appear in the research consent form, but when
> a procedural consent is required, a copy of that consent form should
> be provided. This will allow the Board to assess whether the research
> adds significant risk considering the procedural risks to which the
> subject will also be subjected. Note that institutions will differ in
> which procedures require written consent, but an attempt should be
> made to obtain the procedural consent forms when possible. (OTSG 15-2,
> 6.a.(1))
>
> L. Data Collection. The protocol should include descriptions of all
> data collection procedures to be used during the conduct of the study.
>
> 1\. Screening Procedures. If screening procedures are required for
> inclusion in the study, the tests, evaluations, and diagnostic
> criteria should be explained in the protocol. If screening tests are
> required for inclusion in the trial, the diagnostic criteria for entry
> should be stated in the protocol. Ensure that the diagnostic criteria
> are appropriate for the protocol. Assess whether additional criteria
> for entry should be recommended. All evaluations prior to entry should
> be clearly stated in the protocol. These could include x-rays,
> physical exams, medical history, hematology, blood chemistry,
> urinalysis, or other tests as appropriate. Ensure that the informed
> consent process for the subject will been completed prior to
> performing study screening activities. (AR 70-25, Appendix B-6; AR
> 70-25, Appendix B-7)
>
> 2\. Laboratory Evaluations. If laboratory evaluations are required as
> part of the protocol, complete the following section. If no laboratory
> testing is performed, check \"NA\" on the Protocol Checklist. (AR
> 70-25, Appendix B-6; AR 70-25, Appendix B-7)
>
> a\. Specimens to be collected, schedule and amount. All specimens that
> will be collected for research purposes must be clearly stated in the
> protocol. The collection schedule and amount of material collected
> must also be clearly described. This may be represented using a table
> or schematic for more involved protocols.
>
> b\. Evaluations to be made. All evaluations that will be made as part
> of the research study should be stated in the protocol. Copies of all
> data collection forms should be provided. Where appropriate, normal
> values should be stated in the protocol.
>
> c\. Storage. Specimen storage must be described in the protocol, to
> include where, how long, any special conditions required, labeling and
> disposition.
>
> d\. Labs performing evaluations and special precautions. The
> laboratory performing each evaluation should be clearly identified in
> the protocol, as well as any special precautions that should be taken
> in handling the samples. Special precautions that should be taken by
> the subject before, during, or after the laboratory procedure should
> be clearly defined. If transport of samples is required, provisions
> for ensuring proper storage during transport should be included in the
> protocol.
>
> 3\. Clinical Assessments. If clinical assessments are required as a
> part of the research study, complete item 11 a-c. Otherwise, enter
> \"NA\" for these items on the Protocol Checklist. (AR 70-25, Appendix
> B-7; AR 70-25, Appendix B-11)
>
> a\. Schedule of clinical evaluations and follow-up procedures. The
> schedule of all clinical evaluations to be performed as part of the
> research study, as well as all follow-up procedures should be clearly
> outlined in the protocol (i.e., when vital signs are required, and the
> frequency). This may be represented using a table or schematic for
> more involved protocols.
>
> b\. A description of how adverse events will be recorded should be
> included when appropriate. (AR 70-25, Appendix B-9; HSRRB Policy
> Memorandum, *Reporting to the HSRRB Unanticipated Problems Involving
> Risks to Subjects or Others* (27 February 2002))
>
> c\. Disposition of clinical data. Location and duration of storage,
> and disposition of all clinical data, both hard and soft copy, should
> be described in the protocol.
>
> 4\. Methods used for data collection. All methods used for data
> collection should be described in the protocol. Copies of data
> collection forms and any test instruments administered should be
> provided. Data collection forms should be adequate and accurate
> according to the data collection plan described in the protocol.
> Whenever possible, identifiers should be removed from data collection
> forms. Critical measurements used as endpoints should be identified.
> (AR 70-25, Appendix B-6; AR 70-25, Appendix B-7; AR 70-25, Appendix
> B-9; AR 70-25, Appendix B-11; OTSG 15-2, 6.a.(6); OTSG 15-2, 6.a.(7))
>
> M. Data Management.
>
> 1\. Data Analysis. The data analysis plan should be described in the
> protocol and should be consistent with the study objectives. (AR
> 70-25, Appendix B-6; AR 70-25, Appendix B-7)
>
> 2\. Disposition of Data. The plan for the disposition of the data,
> both hard copy and electronic copy, should be described in the
> protocol. This description should include where, how and by whom data
> will be stored and the length of time the data will be stored. (AR
> 70-25, Appendix B-6; AR 70-25, Appendix B-7; OTSG 15-2, 6.a.(6); OTSG
> 15-2, 6.a.(7))
>
> 3\. Confidentiality. The protocol should explain all measures taken to
> protect the confidentiality of research subjects and study data. Any
> strategy to protect the privacy and confidentiality of study records,
> particularly those containing identifying information should be
> addressed. Complete confidentiality cannot be guaranteed for Active
> duty personnel in intramural research. Assess the need for a
> Certificate of Confidentiality. (AR 70-25, Appendix B-6; AR 70-25,
> Appendix B-7; AR 70-25, Appendix E-7; OTSG 15-2, 6.a (6); OTSG 15-2,
> 6.a.(7)).
>
> 4\. The protocol should contain a statement that informs the subject
> that representatives of the U.S. Army Medical Research and Materiel
> Command are eligible to review research records as a part of their
> responsibility to protect human subjects in research. Refer to the
> HSRRB Clause 11.01, *Review of Research Records*. (AR 70-25, Appendix
> E-7; OTSG 15-2, 6.a.(7))
>
> N. Risks/Benefits Assessment.
>
> 1\. Risks. The protocol should clearly state all research risks in the
> protocol. Research risks include any risks that the subject is
> subjected to as a result of participation in the protocol. Consider
> psychological, legal, social, and economic risks as well as physical
> risks. If the risks are unknown, this should be stated in the
> protocol. If applicable, any potential risk to the study personnel
> should be stated. (AR 70-25, Appendix B-6; OTSG 15-2, 6.a.(1); OTSG
> 15-2, 6.a.(3))
>
> 2\. Precautions. The protocol should state the measures that are taken
> to minimize or manage the risks to subjects and to study personnel.
> (AR 70-25, Appendix B-6)
>
> 3\. Special Care Needs. A description of a corrective action plan, if
> necessary, should be included in the protocol. Planned responses such
> as toxicity grading scales, stopgaps, and safeguards should be
> considered in the protocol. Any special medical care or equipment
> needed for subjects enrolled in the study should be described in the
> protocol. The clinical site must have adequate personnel and equipment
> to respond to adverse events. (AR 70-25, Appendix B-6)
>
> 4\. Benefits. Any benefits to the subject should be clearly stated in
> the protocol. Benefits to society may be considered as well. Ensure
> that the benefits are not overstated in the protocol and that
> compensation is not stated as a benefit. The protocol should address
> the risk-benefit ratio of the study. If the subject will not derive
> any benefits from participation, this should be stated in the
> protocol. An intent to benefit subjects in the study must be described
> if subjects cannot provide their own consent prior to enrollment in
> the study. (AR 70-25, Appendix B-6)
>
> O. Study Personnel.
>
> 1\. A biographical sketch or curriculum vita for the principal
> investigator, associate investigators, and medical monitor should
> indicate that they have the appropriate background to carry out their
> roles in the study. MRMC 40-68 also requires that for studies
> involving the use of investigational products, the investigator should
> have training in Good Clinical Practices. See IND or Medical Device
> Checklist. (AR 70-25, Appendix B-17d.)
>
> 2\. The roles and responsibilities of study personnel should be
> described in the protocol. Ensure that research personnel conducting
> the research are appropriate for their assigned roles and
> responsibilities. (AR 70-25, 3-1p.; AR 70-25, 3-1q.)
>
> 3\. Conflict of Interest. The Investigator(s) must declare any
> significant financial interest with a research sponsor, and any other
> significant financial interest that may reasonably appear to affect or
> be affected by the research. The disclosure statement must be in
> writing. Any measures in place for eliminating, managing or reducing
> conflict of interest must be described. Elements described in HSRRB
> Policy Memorandum "Prohibition Against Conflict of Interest for
> Investigators" should be evaluated for compliance with HSRRB policy.
> (HSRRB Policy Memorandum, *Prohibition Against Conflict of Interest
> for Investigators* (13 March 2002))
>
> 4\. Medical Monitor. A Medical Monitor must be assigned to all
> \"greater than minimal risk\" studies. The medical monitor must be
> named in the protocol, and the role of the medical monitor in the
> study must be described. This individual should be a physician or
> other individual qualified to monitor the study, other than the
> Principal Investigator, not associated with the protocol, able to
> provide medical care to research subjects for conditions that may
> arise during the conduct of the study, and who will monitor the
> subjects during the conduct of the study. The medical monitor should
> not be under the supervision of the principal investigator or other
> investigators or research staff. The HSRRB may approve exceptions. The
> medical monitor is required to review all serious and
> unexpected/unanticipated adverse events (per ICH definitions)
> associated with the protocol and provide an unbiased written report of
> the event within 10 calendar days of the initial report. At a minimum,
> the medical monitor should comment on the outcomes of the adverse
> event (AE) and relationship of the AE to the test article. The medical
> monitor should also indicate whether he/she concurs with the details
> of the report provided by the study investigator. HSRRB Clause
> "Medical Monitor Requirement" may be provided to investigators for
> guidance. (AR 70-25, 2-9e.; AR 70-25, 3-1r.; AR 70-25, 3-2e.(2)(c); AR
> 70-25, Appendix B-14; HSRRB Policy Memorandum, *Use of Medical
> Monitors* (13 March 2002))
>
> 5\. The Medical Monitor's role is appropriately described, and the
> Medical Monitor has no apparent conflict of interest. (AR 70-25,
> 2-9e.; AR 70-25, 3-1q.; AR 70-25, Appendix B-14; HSRRB Policy
> Memorandum, *Use of Medical Monitors* (13 March 2002))
>
> P. Modification of the Protocol. The protocol should describe the
> steps that must be taken if modification, termination, or extension of
> the protocol is necessary. The process should include approval of
> changes by the local IRB and the HSRRB prior to implementation, unless
> required to eliminate apparent immediate hazards. (AR 70-25, 2-9c.(6);
> AR 70-25, Appendix B-10)
>
> Q. Protocol Departure. If appropriate, the protocol should describe
> the procedure to be followed if departure from the protocol should
> occur. This description should include the process for notifying the
> local IRB and HSRRB regarding the occurrence of a departure from the
> protocol. The protocol should address when departures will be allowed,
> present flexible but definite criteria, and include who will be
> notified in the event of a departure from the protocol (e.g., subject,
> HURC/IRB, Approving Official, etc). (AR 70-25, Appendix B-8)
>
> R. Withdrawal from the Protocol.
>
> 1\. Subjects may discontinue participation at any time without penalty
> or loss of benefits to which the subject is otherwise entitled. If
> appropriate, the protocol should describe the consequences of a
> subject's decision to withdraw from the study and the procedure in
> place to support an orderly end of the subject's participation. (32
> C.F.R. § 219.116(b)(4); AR 70-25, Appendix E-9; AR 70-25, Appendix
> E-11d.)
>
> 2\. The anticipated circumstances under which the subject's
> participation may be terminated by the investigator should be
> addressed. (32 C.F.R. § 219.116(b)(2); AR 70-25, Appendix E-11b.)
>
> S. Adverse Event Reporting. A plan for reporting serious and
> unexpected or unanticipated events to the subject must be described in
> the protocol. The language contained in HSRRB Clause "Reporting of
> Serious and Unexpected Adverse Events", must be present in all
> protocols. Exception to this requirement can be made for research
> categories that are exempt from the Common Rule (32 C.F.R. §
> 219.101(b)). Refer to the HSRRB Clauses for approved language.
> Consider the appropriate need for use of an Adverse Event/Death Event
> Reporting Form. (AR 70-25, 2-9c.(4); AR 70-25, Appendix B-9; OTSG
> 15-2, 4.e.(2); HSRRB Policy Memorandum, *Reporting to the HSRRB
> Unanticipated Problems Involving Risks to Subjects or Others* (21
> February 2002))
>
> T. Medical Care for Research Related Injury. Medical care for research
> related injuries must be provided to subjects at no cost to them.
> Ensure that there is no language in the protocol stating that this
> medical care will not be provided. Refer to HSRRB Clause "Medical Care
> for Research Related Injury" for suggested language for the consent
> form. (AR 70-25, 3-1k.)

U.  Volunteer Registry Data Base Requirements. The Volunteer Registry
    Database Requirement must be described in "greater than minimal
    risk" intramural protocols. Refer to HSRRB Clause "Volunteer
    Registry Data Base Requirement" for suggested language. (AR 70-25,
    Appendix H)

# I. REFERENCES

> 10 United States Code (U.S.C.) 980, *Current Law for DOD Medical
> Research.*
>
> 21 Code of Federal Regulations (C.F.R.) § 50, *Protection of Human
> Subjects* (1980).
>
> 21 C.F.R. § 56, *Institutional Review Boards* (1981).
>
> 32 C.F.R. § 219, *Protection of Human Subjects* (1999).
>
> Department of Defense (DOD) Directive 3216.2, *Protection of Human
> Subjects and Adherence to Ethical Standards in DOD Supported Research*
> (25 March 2002).
>
> DOD Guidance Memo (10 June 1993).
>
> Army Regulation (AR) 40-7, *Use of Investigational Drugs and Devices
> and the Use of Schedule I Controlled Drug Substances* (4 January
> 1991).
>
> AR 70-25, *Use of Volunteers as Subjects of Research* (25 January
> 1990).
>
> Office of The Surgeon General (OTSG) Regulation 15-2, *Human Subjects
> Research Review Board* (11 January 1989).
>
> International Conference on Harmonization of Technical Requirements
> for Registration of Pharmaceuticals for Human Use (ICH) *Guideline for
> Good Clinical Practice* (9 May 1997).
>
> HSRRB Clauses:
>
> 1.02, *Reporting of Serious and Unexpected Adverse Events.*
>
> 2.01, *Volunteer Registry Data Base Requirements.*
>
> 3.01, *Medical Care for Research Related Injury.*
>
> 4.01, *Sample Donation.*
>
> 5.01, *Certification of Consent Form Translation.*
>
> 6.01, *10 United States Code (USC) 980.*
>
> 7.01, *Definition: Adverse Events.*
>
> 8.02, *Medical Monitor Requirement.*
>
> 9.01, *Pregnancy Prevention.*
>
> 10.01, *Investigational New Drug.*
>
> 11.01. *Review of Research Records.*
>
> 12.01, *Participation.*
>
> 13.01, *Responsibilities of Principal Investigator to the Surgeon
> General* .
>
> []{.mark}
>
> HSRRB Policy Memorandum, *Prohibition Against Conflict of Interest for
> Investigators* (13 March 2002).
>
> HSRRB Policy Memorandum, *Reporting to the HSRRB Unanticipated
> Problems Involving Risks to Subjects or Others* (27 February 2002).
>
> HSRRB Policy Memorandum, *Use of Medical Monitors* (13 March 2002).