The information in this Guide is intended for University of Iowa (UI) investigators engaged in research involving human subjects and that is supported by, or is in collaboration with, the U.S. Department of Defense (DoD). The information presented here applies to all biomedical and social/behavior human subjects research involved with a DoD component.
Research activities which include “both a 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 identifiable private information” will hereinafter be referred to as “research involving human subjects.” (DoD Instruction, Glossary - DoD-supported research involving human subjects) [1]
Research with the DoD may involve duties and obligations in addition to those required by the UI IRB. Each component of the DoD may also have specific requirements for the application review process. The responsibility for upholding these requirements is shared among researchers, the IRB/HSO, the UI, and the DoD.
Please see Appendix I for a list of DoD components and Appendix II for a list of selected laws and regulations applicable to DoD-supported research. In this document, ‘DoD Instruction’ refers to DoD Instruction 3216.02, November 8, 2011, and specifically to Enclosure 3 thereof unless otherwise noted.
This Guide is intended only as a general reference. It is important to check with the DoD contact for specific details or with questions about the particular study.
The University of Iowa operates a centralized program to review and approve all research
involving human subjects through the Office of the Vice President for Research. Before a research
project involving human subjects is initiated, it must be reviewed and approved by an Institutional
Review Board (IRB). While the principal investigator has primary responsibility for the conduct of
the study, the University of Iowa IRBs are responsible for protecting the rights and welfare of study
participants. Through its Federalwide Assurance, the University is held accountable to federal
agencies that have established guidelines for the use of human subjects in research.
Research under the direction of the VAHCS, or research that involves VAHCS patients requires review and approval by IRB-03 and the VAHCS Research and Development Committee (R&D Committee). Completion of the University of Iowa IRB-03 review and associated IRB findings and actions is documented on a VA form 10-1223, an IRB approval letter, and IRB minutes for full board studies. This documentation is sent to the VAHCS research office and VA Principal Investigator.
The VAHCS R&D Committee does not share its deliberations with IRB-03 unless there are specific subject protection issues raised by the committee. Should such issues arise, the R&D Committee notifies the IRB in writing following its deliberations. If the IRB agrees that the issue(s) are related to subject protection, the IRB will require the Principal Investigator to revise the application to address the identified issue(s). The Principal Investigator notifies the R&D Committee when any study, including those involving investigational drugs, has been terminated. Once IRB-03 and the VAHCS R&D Committee have reviewed and approved the new research project, the Human Subjects Office releases the project to the Principal Investigator.
This booklet, prepared by the Human Subjects Office/IRB, provides guidance to University of Iowa investigators who may be uncertain if their study meets the definitions of human subjects research stated in the federal regulations (45CFR46.102). The HSO/IRB recognizes that the definition may not always provide a straightforward answer.
Do I need IRB Review? Is This Human Subjects Research? A Guide for Investigators offers investigators an explanation of the definitions as well as examples of studies that do or do not qualify as human subjects research. For further information, please refer to the Resources section in the back of this booklet. Credit is given to the University of Southern California Office for the Protection of Research Subjects (OPRS) for the concept and as a primary source of information. Credit is also given to the IRB Chairs and HSO staff for their contributions to this booklet.
The VA Privacy Officer helps to ensure that researchers and the IRB implement the VA’s privacy policies at the local level. The VA Privacy Officer reviews all IRB-03 submissions. For additional information about the role of Privacy Officers visit the US Department of Veterans Affairs Privacy Service website.
Research involves the DoD when:
DoD policies do not apply when US military personnel incidentally participate as subjects in a study that is not DoD-supported and US military personnel are not the intended target population.
Research projects involving human subjects require review and
approval by an Institutional Review Board. The mission of the University of Iowa Institutional Review Boards is to assure that the rights and welfare of human subjects are adequately protected in research. The IRB is charged with the responsibility of reviewing and overseeing human subjects research conducted under the aegis of The Office of the Vice President of Research. The first question a researcher should consider with respect to IRB review is whether the research project fits the definition of human subjects research. In light of the mission to protect human subjects, and the potential regulatory consequences of not obtaining IRB review and approval, the investigator should choose to err on the side of caution and consult the IRB Chair or the IRB Chair Designee when he/she is uncertain whether the study is human subjects research or not.
The VA Information Security Officer must review all human use protocols to ensure compliance with information security standards as defined by the VA. For additional information about the role of the Information Security Officer visit the Office of Information Security’s website
Federal Regulations define research as “a systematic investigation, including development, testing, and
evaluation, designed to develop or contribute to generalizable knowledge1 ” (45CFR46.102(d)). As described in the Belmont [2]Report [2]2 “...the term 'research' designates an activity designed to test a hypothesis or answer a research question(s) [and] permit conclusions to be drawn... Research is usually described in a formal protocol that sets forth an objective and a set of procedures to reach that
objective.” “Research” generally does not include operational activities such as defined practice activities in public
health, medicine, psychology, and social work (e.g., routine outbreak investigations and disease monitoring) and studies for internal management purposes such as program evaluation, quality assurance, quality improvement, fiscal or program audits, marketing studies or contracted-for services. However, some of these activities may include or constitute research in circumstances where there is a clear intent to contribute to generalizable knowledge.
**Information within this booklet is defined under OHRP federal regulations only. For activities that involve clinical investigations covered under FDA regulations involving human subjects require IRB review.
"Generalizable knowledge" is information where the intended use of the research findings can be applied to populations or situations beyond that studied.
The Belmont Report [2] is a statement of ethical principles (including beneficence, justice, and autonomy) for human subjects research by the U.S. Department of Health, Education, and Welfare.
The VA Research Compliance Officer is responsible for monitoring the research conduct and documentation of VA investigators.
Researchers should expect and plan for additional costs, actions, and documentation that may be associated with DoD-supported research. For example, when a scientific reviewer is required, costs for the reviewer should be included when developing the application. Consider the following when planning to do research with the DoD:
The DoD requires training in human subjects research. In addition to the CITI course required by the UI, the Navy requires additional certification modules offered through the CITI program. For directions on how to access these modules, see Training Requirements on this page [3].
Check with the DoD representative to determine if other training is needed or if current training should be recertified. Rules and regulations specific to the Navy and the Marines may be found in SECNAVINST 3900.39D [4].
The Army and Navy require independent scientific review and approval of nonexempt research prior to IRB review of new applications and substantive modifications. The review may be conducted by the funding agency (including the DoD), through the use of an established internal review mechanism in the PI’s school or department, or via an ad hoc scientific review by the researcher’s chair or dean.
When scientific review is required, the PI must provide documentation to the IRB upon submission of the initial IRB application or substantive amendments. Scientific review must demonstrate that the research uses procedures consistent with sound research design and is likely to yield the expected results and should include an assessment of the following:
The name and qualifications of the reviewer(s) should be included as part of the review.
At the UI, the requirement for scientific review will be met by the Departmental Executive Officer’s (DEO’s) signature on the Assurance submitted by the PI as part of the IRB submission. The form for documenting scientific review is incorporated with the Assurances.
Research involving surveys or interviews with DoD military or civilian personnel or their families may require DoD approval. Check with the DoD contact to determine if there are additional requirements and whether the approval is required before or after IRB review.
Investigators doing research with the Navy may not be designated as sponsors of an Investigational New Drug (IND) or Investigational Device Exemptions (IDE). Only the Surgeon General, Commanders, and Commanding Officers may be sponsors. (SECNAVINST 3900.39D(6)(h). Research Involving the Use of Investigational Test Articles.) [4]
A human subject is defined by Federal Regulations as “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”
(45 CFR 46.102(f)(1),(2))
Living individual – The specimen(s)/data/information must be collected from or be about live subjects. Research on cadavers, autopsy specimens or specimens/information from subjects now deceased is not human subjects research.
“About whom” – a human subject research project requires the
data received from the living individual to be about the person.
Intervention includes physical procedures, manipulations of thesubject, manipulations or changes of the subject's environment for research purposes. (i.e. for example, venipuncture, exercise, use of a computer mouse) Interaction includes communication between the investigator and the subject. This includes face-to face, mail, and phone interaction as well as other modes of communication, such as completion of a questionnaire, survey, interview procedures, or focus groups.
Identifiable private information3 “includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation is taking place,” (such as a public restroom) “and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a health care record).” (45 CFR 46.102(f)(2)) “Identifiable” means the information contains one or more data elements that can be combined with other reasonably available information to identify an individual (e.g. Social Security #).
Observational studies of public behavior (including television and open internet chat rooms) do not involve human subjects as defined when there is no intervention or interaction with the subjects and the behavior is not private. Also, studies based on data collected for non-research purposes may not constitute human subjects research if individuals are not identifiable (e.g. data such as service statistics, school attendance data, crime statistics, or election returns). Studies based on data that are individually identifiable but are also publicly available may not constitute human subjects research. However, the term “publicly available” is intended to refer to record sets that are truly readily available to the broad public, such as census data, or federal health, labor, or educational statistics. It is fair to say the IRB may make a final determination of whether or not a specific set of data meets the requirements of publicly available.
Researchers must take caution since disclosure of private information may place the subjects at risk of criminal or civil liability and/or damage their financial standing, employability, or reputation.
Certain studies may have the characteristics of human subjects research but may not meet the regulatory definition. Studies which meet the definition require IRB review. There are three categories to be considered:
Any investigator who is unsure of whether his/her proposal constitutes “human subjects research” should contact the IRB office or submit an online “Human Subjects Research Determination” through HawkIRB. https://hawkirb.research.uiowa.edu/hawkirb [5]
The IRB Chair and/or their designee will determine if the study meets the definition of human subjects research. Federal regulations do not allow investigators to make this determination themselves. If a study does not qualify as human subjects research, HawkIRB will issue a memo stating that the project does not require IRB review or approval. When a “Human Subjects Research Determination” is submitted through HawkIRB, a determination memo will be sent to the investigator via email. NOTE: Grant offices, faculty advisors, or publications may require a formal determination from the IRB/designee.
After the completed IRB review and approval, the application must be submitted to the applicable DoD Human Research Protection Office (HRPO) for administrative review. The HRPO may require changes to the research. Research must not begin before this review is completed.
Studies that fit any of the categories below typically do not need IRB review.
Course work as part of a Master’s Theses, Dissertation, or other Honor’s Program would not fall under this category.
According to 32 CFR § 219.101 [9], research involving non-U.S. citizens may be conducted outside the United States. However, in the conduct of such research, the laws, customs, and practices of the country in which the research is conducted or those required by this regulation, whichever are more stringent, will take precedence. The research must meet the same standards of ethics and safety that apply to research conducted within the United States involving U.S. citizens, and will be conducted in accordance with applicable international agreements.
The PI is responsible for determining whether the sponsoring DoD component requires an additional ethics review by the host country or a local DoD IRB with host country representation. The Navy requires that international research involving human subjects who are not U.S. citizens or DoD personnel, conducted outside the United States, its territories and possessions, requires permission of the host country. The laws, customs, and practices of the host country and those required by the instruction will be followed. An ethics review by the host country, or local Naval IRB with host country representation, is required. (SECNAVINST 3900.39D (6)(i). International Research.) [4]
Studies that utilize test subjects or their specimens for new devices, products, drugs, or materials.
Studies that collect data through intervention or interaction with individuals. Examples of this type of research include drug trials, internet surveys about alcohol consumption, studies that involve deception, research involving risky behaviors or attitudes, and open-ended interviews with minors that contribute to generalizable knowledge.
Studies using private information that can be readily identified with individuals, even if the information was not collected specifically for the study in question.
Studies that use bodily materials such as cells, blood, urine, tissues, organs, hair, or nail clippings, even if one did not collect these materials for the study. However, such research may be considered exempt or not human subjects research if the materials/data are coded and the investigator does not have access to the coding systems. Guidance on research involving coded private information or biological specimens is available on the web at:(http://www.hhs.gov/ohrp/humansubjects/policy/engage08.pdf [10].)
Studies that produce generalizable knowledge about categories or classes of subjects from individually identifiable information.
Studies that use human beings to evaluate environmental alterations, for example, weatherization options or habitat modifications to their living or working space or test chamber.
Collaborating institutions in multi-site research must have a federalwide assurance. Investigators must provide documentation of IRB approval or an IRB Authorization Agreement [11] for collaborators. The roles and responsibilities of each institution must be specified in any such Agreement, along with a statement by which the parties agree to comply with any special DoD requirements.
How to submit a Human Subject’s Research Determination form:
Note: To access the Request for Human Subjects Determination application, you must login to HawkIRB and click the “Human Subjects Research Determination” tab located in the black and gold tool bar after log in.
WHOM TO CONTACT
Human Subjects Office [19]
University of Iowa
600 Newton Rd
105 Hardin Library for the Health Sciences (HLHS)
Iowa City, IA 52242
Phone: 319-335-6564 Fax: 319-335-7310
Email: irb@uiowa.edu [6]
Force Health Protection is the healthcare program designed to meet the actual, anticipated, or potential needs of military personnel in relation to military missions. When using an IND under a force health protection program, the DoD Components involved in implementation shall provide prior notice to personnel receiving the drug or biological product and provide all pertinent clinical information to health care providers who administer the IND. (DoD Instruction 6200.02, February 27, 2008, E4.7 Training and Risk Communication) [20]
Certain types of research are prohibited by the DoD and/or the UI:
Generally, an IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waive the requirement to obtain informed consent under 32 CFR §§ 219.116 (c) and (d). These are also the conditions under which an IRB may waive consent for DoD-conducted and DoD-supported research involving human subjects.
Research Involving a Human Being as an Experimental Subject is an activity for research purposes, where there is an intervention or interaction with a human being for the primary purpose of obtaining data regarding the effect of the intervention or interaction. (DoD Instruction, Glossary) [1]
The definition of research involving a human subject as an experimental subject is a subset of but is not the same as the definition of research involving human subjects. When the research meets the Glossary definition of research involving a human being as an experimental subject, informed consent must be obtained in advance from the experimental subject or the subject’s legal representative consistent with 32 C.F.R. part 219 [24] if the subject cannot consent. If consent is to be obtained from the experimental subject’s legal representative, the IRB must have first determined that, consistent with 32 C.F.R. part 219, the research is intended to benefit the individual subject. (DoD Instruction, 9.b. Unique Limitations on Waiver of Informed Consent) [1]
The requirement of paragraph 9.b. of DoD Instruction may be waived by the Assistant Secretary of Defense for Research and Engineering (ASD(R&E)) if all the following conditions are met:
The DoD requires that pregnant women/fetuses/neonates, prisoners, and children have the protections of the Common Rule subparts B, C, and D. (45 C.F.R. part 46) [25] There are also protections for the cognitively impaired, those with mental illness or physical disabilities, or other circumstances that may require special protection.
In addition to the vulnerable populations with which researchers may be familiar, the Navy also includes severely ill patients, employer/employee, student/teacher, supervisor/subordinate, and deployed personnel as among the groups that may require additional protection. (SECNAVINST 3900.39D November 6, 2006 – 6. Policy (a)(6) Vulnerability and Additional Protections) [26]
For research involving a human being as an experimental subject, informed consent must be obtained from the subject or subject’s Legally Authorized Representative (LAR).
If consent is to be obtained from a LAR, the IRB must have first determined that, consistent with 32 C.F.R. part 219, the research is intended to benefit the individual subject. (DoD Instruction, 9.c. Unique DoD Limitations on Waiver of Informed Consent) [1]
The IRB understands that the selection of human subjects must reflect gender and minority participation in DoD-conducted or supported clinical research involving human subjects and shall comply with Public Law 103-160, Section 252 [27] – Inclusion of Women and Minorities in Clinical Research Projects. The requirement to include women and minorities may be waived by the Secretary of Defense or the DoD component if it is determined that the project is 1) inappropriate with respect to the health of the subjects, 2) is inappropriate with respect to the purpose of the research, or 3) is inappropriate under such other circumstances as the Secretary of Defense or DoD component may designate.
Risk is minimal where the probability and magnitude of physical or psychological harm is that which is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons. (45 CFR § 46.303(d)) [28]
When evaluating risk for DoD-supported research, “the phrase ‘ordinarily encountered in daily life or during the performance of routine physical or physiological examinations or tests’ in the definition of minimal risk shall not be interpreted to include the inherent risks certain categories of human subjects face in their everyday life. For example, the risks imposed in research involving human subjects focused on a special population should not be evaluated against the inherent risks encountered in their work environment (e.g., emergency responder, pilot, soldier in a combat zone) or having a medical condition (e.g., frequent medical tests or constant pain).” (DoD Instruction, 6.b. Selection of Human Subjects and Evaluating Risk, Evaluating Risk) [1]
Research that is greater than minimal risk requires that the IRB approve a research monitor by name. A research monitor is an individual with expertise consonant with the nature of risk(s) identified within the research protocol and whose role is to protect the safety and well-being of human subjects. (DoD Instruction, Glossary) [1] The monitor is independent of the team conducting the research involving human subjects. The monitor’s duties may include observing recruitment, enrollment procedures, and the consent process; reviewing safety monitoring and overseeing data collection and analysis. The monitor may discuss the research protocol with the investigator, interview subjects, and has the authority to take the steps necessary to protect the safety and well-being of human subjects by stopping research in progress until the IRB can assess the monitor’s report. The monitor has the responsibility to promptly report observations and findings to the IRB or other designated official and the HRPO. (DoD Instruction, 8. Research Monitor) [1]
The researcher must identify the monitor by name, provide a written summary of the monitors’ duties, authorities and responsibilities, and the selection must be approved by the IRB. More than one monitor may be appointed by the IRB for the same project and a monitor may be appointed even if the research is deemed to be no more than minimal risk.
The university policy regarding restricted access research is available in the University of Iowa Operations Manual Part II Chapter 27.2.
The Common Rule [29] does not require payment or reimbursement of medical expenses, provision of medical care, or compensation for research-related injuries. For studies that involve more than minimal risk, informed consent requires an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained. (32 CFR § 219.116(a)(6) [30]). Every Navy research project involving greater than minimal risk shall include an arrangement for emergency treatment and necessary follow-up of any research-related injury. (SECNAVINST 3900.39D [4](6)(a)(5)). The IRB application for Navy projects must specify (a) whether any compensation is available if injury occurs and (b) a plan for emergency treatment and necessary follow-up of any research related injury.
The age of majority in Iowa is eighteen. (Iowa Code § 599.1) [31] For the purpose of participating in DoD-supported or conducted research, active duty service members and reserve component members are considered to be adults. If a subject is an active duty service member or reserve component member in a federal duty status, that person is considered for purposes of this Guide to be an adult, even if the person is under eighteen. (DoD Instruction, 12. Service Members and Their Status as Adults) [1]
Military personnel may need command approval before participating in human subjects research because some research may impact readiness in the field. As part of the IRB review, investigators will be asked to provide documentation of command approval. The UI IRB requires that the documentation be in the form of an attached letter of agreement, indicating that the PI\team has permission to conduct research at the location.
Care must be taken to assure that officers and senior non-commissioned officers do not influence the decision of subordinates to participate in human subjects research and are not present during recruiting. In addition, if recruiting superior officers, they must be recruited in a separate session from their subordinates. The HawkIRB application documents military status of research team members who will obtain consent in order for the IRB to assess this requirement.
For research that has been determined by the IRB to be more than minimal risk and where recruiting is conducted in a group setting, an ombudsman must be present to ensure that information is clearly, accurately and adequately presented and that the voluntary nature of participation is emphasized. The ombudsman may be the same person that the IRB appointed as the research monitor. (DoD Instruction 7.e. DoD Personnel as Subjects (1) Military Personnel as Subjects, (a), (b), (c), and (d).) [1]
DoD civilian personnel that are recruited for research have the same protections as military personnel [32]. The requirement for an ombudsman is at the discretion of the IRB.
The sponsor-investigator must provide reports to the FDA as described above.
The sponsor-investigator must allow FDA employees access to all records and reports at their request.
The DoD has very specific requirements regarding compensation paid to DoD employees, whether they are active duty military or DoD civilian employees (DoD Instruction, 11. Compensation to Human Subjects for Participation in Research) [1]. Investigators who plan to compensate subjects may need to ask subjects about their military status in order to comply with the requirements below. Investigators should describe their plan for this assessment of military status in the IRB application.
On-duty federal personnel including military members:
Off-duty federal personnel including military members:
Non-federal personnel:
The IRB and the PI are required to report certain events to the HRPO. The following occurrences involving a DoD-supported research protocol must be reported to the DoD within 30 days of the event:
Generally, research records should be kept for the length of time required by UI or federal policy, usually 3-6 years after the completion of the research. However, individual DoD components may have additional requirements, including the transfer of records to the DoD component. There should also be a research record retained at UI unless there is an executable data usage agreement specifying otherwise. Retained records shall be made accessible for inspections and copying by authorized representatives of the DoD.
Components are entities within the DoD - the Office of the Secretary of Defense, the Military Departments, the Office of the Chairman of the Joint Chiefs of Staff and the Joint Staff, the Combatant Commands, the Office of the Inspector General of the Department of Defense, the Defense Agencies, the DoD Field Activities, and all other organizational entities within the DoD. Components include:
UI DoD/Navy Addendum
DoD/DoN Addendum to FWA expires 7/19/18.
DoD Regulations and Guidance
32 CFR part 219, Protection of Human Subjects [24]
10 USC 980, Limitations on the Use of Humans as Experimental Subjects [33]
Department of Defense Instruction 3210.7, Research Integrity and Misconduct [34]
DoD Component Requirements
Department of Defense, Office of the Secretary of Defense for Personnel and Readiness
Department of the Army
Information for Investigators, April 15, 2013 [36]
AR 70--‐25, Use of Volunteers as Subjects of Research, January 25, 1990 [37]
AR 40--‐38, Clinical Investigation Program, September 1, 1989 [38]
Department of the Navy
SECNAV Instruction 3900.39D, Human Research Protection Program, November 6, 2006 [4]
Department of the Navy, Training and Education Guidance [40]
Marine Corps Survey Program [41]
Department of the Air Force
Air Force Instruction 40--‐402, Protection of Human Subjects in Research [42]
This is not an authoritative list of all regulations or guidance that may apply to DoD-supported human subjects research. Check with the DoD contact for more information.
The Human Subjects Office gratefully acknowledges the University of Michigan Office of Research for permission to use much of the information produced in this Guide.
Approved by:
HSO Director, Michele Countryman 4/25/16
IRB Primary Chair, J. A. Bertolatus 4/26/16
Institutional Official, Heather Gipson 4/20/16
Links:
[1] http://www.dtic.mil/whs/directives/corres/pdf/321602p.pdf
[2] http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
[3] https://hso.research.uiowa.edu/irb-04-department-defense
[4] http://www.med.navy.mil/bumed/humanresearch/Documents/HRPP/Resources/ReferenceMaterial/SECNAVINST%203900-39D%20-%206%20Nov%2006.pdf
[5] https://hawkirb.research.uiowa.edu/hawkirb
[6] mailto:irb@uiowa.edu
[7] http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html#c1
[8] http://www.hhs.gov/ohrp/policy/cdebiol.pdf
[9] https://www.gpo.gov/fdsys/pkg/CFR-2011-title32-vol2/pdf/CFR-2011-title32-vol2-sec219-101.pdf
[10] http://www.hhs.gov/ohrp/policy/engage08.html
[11] https://hso.research.uiowa.edu/b-multi-center-studies-0
[12] http://www.hhs.gov/ohrp/
[13] http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html
[14] http://www.hhs.gov/ohrp/index.html
[15] http://www.FDA.gov
[16] http://www.hhs.gov/ohrp/humansubjects/index.html
[17] http://www.hhs.gov/ohrp/policy/biodata/index.html
[18] http://www.usc.edu/admin/provost/oprs/
[19] https://hso.research.uiowa.edu/
[20] http://www.dtic.mil/whs/directives/corres/pdf/620002p.pdf
[21] http://www.dtic.mil/whs/directives/corres/pdf/231001e.pdf
[22] http://opsmanual.uiowa.edu/community-policies/research/principles-governing-access-research-information
[23] https://www.gpo.gov/fdsys/pkg/USCODE-1997-title50/pdf/USCODE-1997-title50-chap32-sec1520a.pdf
[24] https://www.gpo.gov/fdsys/pkg/CFR-2013-title32-vol2/pdf/CFR-2013-title32-vol2-part219.pdf
[25] http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
[26] http://fas.org/irp/doddir/navy/secnavinst/3900_39d.pdf
[27] https://www.gpo.gov/fdsys/pkg/USCODE-2011-title10/html/USCODE-2011-title10-subtitleA-partIV-chap139-sec2358.htm
[28] http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.303
[29] http://www.hhs.gov/ohrp/humansubjects/commonrule/
[30] https://www.gpo.gov/fdsys/pkg/CFR-2011-title32-vol2/pdf/CFR-2011-title32-vol2-sec219-116.pdf
[31] https://www.legis.iowa.gov/docs/code/599.pdf
[32] https://hso.research.uiowa.edu/military-participants
[33] http://mrmc.amedd.army.mil/assets/docs/orp/title10_USC_980.pdf
[34] http://www.dtic.mil/whs/directives/corres/pdf/321007p.pdf
[35] http://www.health.mil/Policies?query=05-003&daterange=2005-2009
[36] http://mrmc.amedd.army.mil/assets/docs/orp/hrpo_information_for_investigators_050712.pdf
[37] http://www.apd.army.mil/pdffiles/r70_25.pdf
[38] http://www.apd.army.mil/pdffiles/r40_38.pdf
[39] http://www.apd.army.mil/pdffiles/r40_7.pdf
[40] http://www.onr.navy.mil/About-ONR/compliance-protections/Research-Protections/Research-Protection-Training-References.aspx
[41] http://www.med.navy.mil/bumed/humanresearch/Documents/HRPP/Resources/DONHRPPGuidance/MCO%205300.18%20USMC%20Survey%20Order%20dtd%2021%20May%202015.pdf
[42] http://www.wpafb.af.mil/shared/media/document/AFD-070319-050.pdf