Future Uses of the Department of Defense Joint Pathology Center Biorepository (2012) / Chapter Skim
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Appendix C: DoD Instruction 3216.02 Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research
Appendix C: DoD Instruction 3216.02 Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research
Pages 145-178
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Chapter 3 of the report discusses this and other military rules addressing human subjects research and privacy.
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All such activities must include both systematic investigation designed to develop or contribute to generalizable knowledge AND involve a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or about whom identifiable private information is obtained. All activities meeting both of these conditions will hereinafter be referred to as "research involving human subjects" in this Instruction.
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. The definitions of research involving a human being as an experimental subject and research involving human subjects are different; see the Glossary for an explanation.
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Public Law 107-347, "Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA) ," December 17, 2002 (l)
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DoD Directive 5240.01, "DoD Intelligence Activities," August 27, 2007 DoDI 3216.02, November 8, 2011
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g. Work with the DoD Components supporting international research involving human subjects to resolve conflicts between this Instruction, including its references, and other applicable foreign laws and requirements.
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HEADS OF THE OSD AND DoD COMPONENTS. The Heads of the OSD and DoD Components that conduct or support research involving human subjects covered by this Instruction shall: a.
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c. Establish and maintain a DoD assurance and other appropriate Federal assurances, if the institution is engaged in non-exempt research involving human subjects (see Glossary)
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Direct each institution within the DoD Component conducting or supporting research involving human subjects to establish an HRPP that is compliant with this Instruction and the DoD Component's HRPP management plan.
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If the institution does not have a Federal assurance, the institution must provide either a DoD assurance to the DoD Component supporting the research or a Federal wide assurance to HHS, Office for Human Research Protections. Alternatively, if the institution does not have a Federal assurance, the researcher may use an Individual Investigator Agreement to associate with an institution having a Federal assurance and thus fulfill the requirement of conducting non-exempt research involving human subjects under an approved Federal assurance.
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(4) A DoD institution that does not meet the criteria for requiring a Federal assurance but conducts only exempt research involving human subjects or supports research involving human subjects must have an HRPP approved by its DoD Component that includes relevant policies and procedures to ensure compliance with this Instruction.
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of Reference (c) to review minimal risk, non-exempt research involving human subjects using materials (e.g., data, documents, records, or specimens)
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(d) The DoD Component must conduct an appropriate administrative review of the research involving human subjects to ensure it is in compliance with DoD policies and procedures prior to the DoD institution's engagement in the research.
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(2) The DoD Component administrative review must be conducted before the research involving human subjects can begin to ensure compliance with all applicable regulations and policies, including any applicable laws and requirements and cultural sensitivities of a foreign country if conducted in a foreign country.
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They are not required to comply with provisions of this Instruction either solely directed to actions of the DoD Components or specifically limited to DoD-conducted research involving human subjects.
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EDUCATION AND TRAINING. The DoD Components shall ensure that all DoD personnel involved in the conduct, review, or approval of research involving human subjects, including the non-affiliated and prisoner representative members on the DoD IRB, receive initial and continuing education and training in compliance with the standards set forth by ASD(R&E)
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. Investigators, IRBs, IOs, and DoD Component personnel reviewing research protocols shall consider the need for appropriate similar safeguards for other vulnerable populations, such as: research involving human subjects and investigators in supervisor-subordinate relationships, human subjects with decisional or mental impairments, human subjects with a physical disability, or any other kind of human subjects in circumstances that may warrant provision of additional protections.
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(3) Research involving human subjects using fetal tissue shall comply with sections 289g289g-2 of Reference (j)
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For all DoD conducted or -supported research involving human subjects, the applicable DoD Component office conducting the reviews identified in paragraphs 3.b.
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The IRBs of DoD institutions or HRPOs may require Principal Investigators to confirm that a Service member's commander supports the member's participation in DoD supported research involving human subjects.
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DoD Civilians shall follow their organization's policies regarding the requirement to obtain permission to participate in research involving human subjects.
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RESEARCH MONITOR a. For DoD-conducted research involving human subjects determined by the IRB to involve more than minimal risk to human subjects (as defined in section 219.102(i)
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The DoD Components shall establish procedures to protect human subjects from medical expenses (not otherwise provided or reimbursed) that are the direct result of participation in DoD-conducted non-exempt research involving human subjects that involves more than minimal risk.
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(2) When DoD personnel are conducting the research involving human subjects at the collaborating institution and the Department of Defense does not have the primary involvement, the DoD Components are not required to have procedures to protect human subjects from medical expenses.
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b. Non DoD-Conducted Research Involving Human Subjects (1)
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Submission for approval shall be from the Head of the OSD or DoD Component conducting or supporting the non-exempt research involving human subjects. The request shall be coordinated with the ASD(R&E)
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A DoD Component or a contractor, grantee, or other non-Federal entity conducting DoD-supported research involving human subjects may request from the National Institutes of Health (NIH) of the Department of HHS a Certificate of Confidentiality pursuant to section 241(d)
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b. The DoD Components shall also retain records regarding the oversight of DoD Component-supported research involving human subjects for at least 3 years after the completion of the research, HRPP education or training program, or other action relevant to the HRPP.
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Research involving human subjects conducted in foreign countries may be subject to additional national and local requirements.
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classified research involving human subjects. Research involving human subjects where the protocol or other information required by the IRB for review and oversight or required or provided by the research subjects includes classified information, as defined in Reference (q)
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commits to a Federal department or agency their compliance with the requirements set forth in the Common Rule. Institutions engaged in non-exempt research involving human subjects conducted or supported by the Department of Defense or other Federal departments and agencies that have adopted the Common Rule must have a
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An entity that is not part of the Department of Defense. non-exempt research involving human subjects.
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An activity, for research purposes, where there is an intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of the intervention or interaction. Research involving a human being as an experimental subject is a subset of research involving human subjects.
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. This definition does not include activities that are not considered research involving human subjects, activities that meet the exemption criteria at section 219.101(b)
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