Monitoring Report for UI Research Supported by the Department of Defense

Information

IRB ID #
PI Name

Study Information

Study Overview

Institution ID #
WIRB Protocol ID #
PI Name
Study Title

Monitoring Information

Date Monitored
Monitor
Chair of Record
- Herb Berger, MD
- J. Andrew Bertolatus, MD
- Dixie Ecklund, RN, MSN, MBA
- John Wadsworth, PhD
- Janet Williams, PhD, RN, FAAN
- Catherine Woodman, MD

DoD Components

Additional DoD Components
Select all applicable DoD components.
- Air Force
- Army
- DoD, not otherwise specified
- Marines
- Navy
- Other
- Under Secretary of Defense for Personnel and Readiness
Specify
Has the PI completed the applicable assurance document(s) for this study?
Select all applicable assurance documents.
- DoD
- DoN
- DoA
- IDE
- IND

Required Actions

Required Actions
Required Actions

Department of Defense Requirements

1. Testing Chemical or Biological Warfare Agents

a. Does this study involve testing of chemical or biological warfare agents?
Research involving human subjects for testing of chemical or biological warfare agents is generally prohibited by section 1520a of title 50, United States Code (USC), subject to possible exceptions for research for prophylactic, protective, or other peaceful purposes. DoDI 3216.02 (4)(c)
Comment
Comments
Findings
Findings

2. Research Conducted Outside the US

a. Is the PI conducting any part of this study outside of the United States?
i. Do the IRB minutes document compliance with any applicable national or local requirements and considerations of cultural sensitivities?
Comment
When the research is conducted outside of the United States, it must also comply with applicable requirements of the foreign country and its national laws and requirements. In the event of an unresolved conflict between DoDI 3216.02, including its references, and other applicable laws and requirements such that compliance with both is impossible, the requirements most protective of the human subject shall be followed. DoDI 3216.02 (4)(e)

Research may be conducted outside the United States that involves non-U.S. citizens. 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 regulations, 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. 32 CFR 219.101
Comments
Findings
Findings

3. Requirements for a Federal Assurance

a. Does the institution conducting the non-exempt research involving human subjects have a Federal assurance appropriate for the research being conducted?
Comment
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. DoDI 3216.02 2(a)(2)(a)

The non-DoD institution engaged in DoD-supported non-exempt research involving human subjects shall comply with the terms of its Federal assurance, applicable sections of DoD Instruction 3216.02, and relevant policies of the supporting DoD Component. DoDI 3216.02 2(a)(2)(b)
b. If the study was reviewed by a non-UI IRB, is there a DoD Institutional Agreement for IRB Review on file for the reviewing IRB?
When any institution relies on another upon institution's IRB, there must be a written agreement defining the responsibilities and authorities of each organization in complying with the terms of each institution's Federal assurance and this instruction (e.g., an Institutional Agreement for IRB review).

The existence of a DOD Institutional Agreement for IRB review or a similar agreement will satisfy the Federal assurance requirements at sections 32 CFR 219.103(b)(2)-(5). DODI 3216.02 2(a)(3)(b)
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4. Research Involving Human Subjects Conducted by a Non-DoD Institution

a. Has the Institution complied with the terms of the Defense Federal Acquisition Regulation Supplement (DFARS) clause (or comparable language) used in the agreement with the DoD Component supporting the research? DoDI 3216.02 (4)(b)(1).
Comment
b. Did the IRB consider the scientific merit of the research?
When a non-DoD institution is conducting non-exempt research involving human subjects, the IRB must consider the scientific merit of the research as required by 32 CFR 219.111.

The IRB may rely on outside experts to provide an evaluation of the scientific merit. DoDI 3216.02 (4)(b)(2)
Comment
c. Has the PI received confirmation from the appropriate DoD HRPO that they have performed an administrative review of the IRB approved research and granted their approval for the study to proceed?
If the non-DoD institution determines the activity is non-exempt research involving human subjects, the HRPO must perform an administrative review of the research before the activities that involve human subjects can begin (e.g., human subject recruitment and data collection).
DoDI 3216.02 (4)(c)(2).
Comment
d. Has the PI agreed to provide details of IRB approved modifications and the outcomes of continuing reviews to the appropriate DoD HRPO in a timely manner?
Comment
e. Has the institution engaged in the research agreed to promptly notify the appropriate DoD HRPO (Human Research Protections Office) of the items listed below in a timely manner? --If the IRB used to review and approve the research changes to a different IRB. --When the institution is notified by any Federal department or agency or national organization that any part of its HRPP is under investigation for cause involving a DoD-supported research protocol. --All UPIRTSOs, suspensions, terminations, and serious or continuing noncompliance regarding DoD-supported research involving human subjects. DoDI 3216.02 (4)(b)(4)
Comment
Comments
Findings
Findings

5. Education and Training

a. Has the PI and research team completed CITI training?
All investigators conducting human subjects research at the University Iowa are required to complete an educational program and become 'certified' in human subjects protections through the Collaborative Institutional Training Initiative Program (CITI).
b. Is Force Health Protection education and training documented?
When using an IND under a Force Health Protection program, the DoD Components involved in implementation shall, consistent with 10 US Code 1107, 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 (E4.7. Training and Risk Communication).

Education and training for investigational agent use for Force Health Protection is required by DoD Instruction 6200.02, "Use of Investigational New Drugs for Force Health Protection."
Comment
c. Has the DoD Component required you to complete an additional training?
Comment
Comments
Findings
Findings

6. Selection of Human Subjects and Evaluating Risk

a. Does the intended subject population include men, women, AND minorities?
The selection of human subjects reflecting gender and minority participation in DoD-conducted or supported clinical research involving human subjects shall comply with Section 252 of Public Law 103-160. A waiver of this requirement may be granted by the Head of the Office of the Secretary of Defense (OSD) or DoD Component.
DoDI 3216.02 (6)(a) and HR 2401 Section 252
Comment
Comments
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7. Additional Protections for Human Subjects

a. Does the research involve pregnant women, fetuses, or neonates as subjects?
i. Did the IRB document the study's compliance with 45 CFR 46, Subpart B?
Comment
Research involving pregnant women, fetuses, or neonates as human subjects must meet the additional relevant protections of subpart 45 CFR 46, Subpart B.

Fetal tissue research supported or conducted by the DoD shall comply with USC 289-289g-2
b. Does the research involve prisoners?
i. Did the IRB document the study's compliance with 45 CFR 46, Subpart C?
Comment
ii. Was the IRB reviewing the study composed of at least one prisoner advocate?
Comment
iii. Have any previously enrolled subjects become prisoners during the course of the study?
1. Was this reported to the IRB?
Comment
When a previously enrolled human subject becomes a prisoner and the relevant research protocol was not reviewed and approved by the IRB in accordance with the requirements of subparagraphs 7.b.(1) and (2) of this section, the principal investigator shall promptly notify the IRB.
DoDI 3216.02 (7)(b)(3)
Research involving human subjects that includes prisoners must meet the additional relevant protections of 45 CFR 46, Subpart C.

Research intending to include prisoners as subjects cannot be reviewed by the IRB through an expedited review procedure.
DoDI 3216.02 (7)(b)(1)(b)
c. Does the research involve detainees?
Research involving a detainee, as defined in DoD Directive 2310.01E, as a human subject is prohibited. One exception applies for IND/IDE given with consent and under same conditions/standard of care as offered to members of U.S. Military Services.
DoDI 3216.02 (7)(c)(1 & 2)
Comment
d. Does the research involve children?
i. Did the IRB document the studies compliance with 45 CFR 46, Subpart D?
Comment
Research involving children as human subjects must meet the additional relevant protections of 45 CFR 46, Subpart D.
e. Does the research involve other vulnerable populations?
i. Did the IRB consider the need for similar safeguards?
Comment
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
- Any other kind of human subjects in circumstances that may warrant provision of additional protections.

As appropriate, qualified individuals (e.g., research monitors, ombudsperson, advocates) may be appointed to perform oversight functions or assist the human subjects.

DoDI 3216.02 (7)
f. Does the research involve military personnel?
i. Does recruitment occur in a group setting?
a. Did the IRB appoint an ombudsperson? (Required for greater than minimal risk when recruitment occurs in a group setting).
Comment
1. Did the IRB determine appointing an ombudsperson was not appropriate? (Determination required for no greater than minimal risk when recruitment occurs in groups).
Comment
Comment
ii. How do you ensure supervisors of service members are not present during recruitment and consent?
iii. How do you minimize coercion in the consent process?
Ensure additional protections for military research subjects to minimize undue influence.
- Service members must follow their command policies to obtain command permission to participate in research involving human subjects while on-duty.
- Superiors (e.g., military and civilian supervisors, unit officers, and noncommissioned officers (NCOs)) are prohibited from influencing the decisions of their subordinates regarding participation as subjects.
- Superiors of Service members in the chain of command must not be present at any human subject recruitment sessions or during the consent process in which members of units under their command are afforded the opportunity to participate as human subject.
- When applicable, the superiors so excluded shall be afforded the opportunity to participate as human subjects in a separate recruitment session.
- For greater than minimal risk research when recruitment occurs in a group setting, the IRB shall appoint an ombudsperson.
- For research determined to be no greater than minimal risk and when recruitment occurs in a group setting, the IRB shall determine when it is appropriate to appoint an ombudsperson.

DoDI 3216.02 7(e)(1)(d)
g. Does the research involve DoD civilians as subjects?
i. Does recruitment occur in a group setting?
Comment
a. Did the IRB appoint an ombudsperson? (Required for greater than minimal risk when recruitment occurs in a group setting?
Comment
b. Did the IRB determine appointing an ombudsperson was not appropriate? (Determination required for no greater than minimal risk when recruitment occurs in groups).
Comment
ii. How do you ensure supervisors of DoD civilians are not present during recruitment and consent?
iii. How do you minimize coercion in the consent process?
- Supervisors (e.g., military and civilian supervisors or anyone in the supervisory structure) are prohibited from influencing the decisions of their subordinates regarding participation as subjects in research involving human subjects covered by this Instruction

Supervisors (e.g., military and civilian supervisors or anyone in the supervisory structure) shall not be present at any human subject recruitment session or during the consent process in which DoD civilians under their supervision are afforded the opportunity to participate as human subjects.

When applicable, supervisors so excluded shall be afforded the opportunity to participate as human subjects in a separate recruitment session.

For research involving civilians as human subjects and when recruitment occurs in a group setting, the IRB shall discuss appointing an ombudsperson.

The decision to require the appointment of an ombudsperson should be based in part on the human subject population, the consent process, and the recruitment strategy.

DoDI 3216.02 7(e)(2)(d)
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8. Research Monitor

a. Does the study involve more than minimal risk to subjects?
i. Is the study DoD-conducted or DoD-supported?
a) Did the IRB approve an independent research monitor by name?
b) Did the IRB approve a written summary of the monitor's duties, authorities, and responsibilities?
c) Did the IRB communicate with the research monitor to confirm their duties, authorities, and responsibilities?
Comment
For DoD-conducted research involving human subjects determined by the IRB to involve more than minimal risk to human subjects (32 CFR 219.102(i)) and, to the extent provided pursuant to 32 CFR Parts 22, 37, and 219, and 48 CFR 235, comparable DoD-supported research, the IRB shall approve an independent research monitor by name.
DoDI 3216.02 (8)(a).
The IRB must approve a written summary of the monitor's duties, authorities, and responsibilities. The IRB or HRPP official shall communicate with the research monitors to confirm their duties, authorities, and responsibilities.
DoDI 3216.02 (8)(a)(3).
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9. Unique DoD Limitations on Waiver of Informed Consent

a. Does this study have a Waiver of Consent?
i. Is this study funded by the DoD?
a. Does it meet the definition* of research involving a human being as an experimental subject?
Comment
b. Was the waiver granted by the Secretary of Defense?
Comment
c. Was the waiver determination appropriately documented in the IRB minutes or granted by the ASD(R&E) or their delegate?
Comment
Conditions under which an IRB may waive informed consent for DoD-conducted and DoD-supported research involving human subjects and research meeting the definition* of research involving a human being as an experimental subject are under DoDI 3216.02.

When the research meets the 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 CFR 219.116(c) and (d) if the subject cannot consent.

Conditions under which informed consent for DoD-funded research involving a human being as an experimental subject* can be waived by the Secretary of Defense are under 10 USC 980 and are applicable only to DoD-funded research. (10 USC 980 does not apply unless research meets this definition).

Additional conditions under which informed consent can be waived by the Assistant Secretary of Defense for Research and Engineering (ASD(R&E)) or an appropriate delegate are under DoDI 3216.02 (9)(a-c).

*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.
DoDI 3216.02 (9)(a-c)
b. Does this study obtain consent from a legally authorized representative?
i. Does it meet the definition* (see above) of research involving a human being as an experimental subject?
a. Did the IRB determine that the research is intended to be beneficial to the individual experimental subject?
Comment
b. Was a waiver granted by the ASD(R&E) or their delegate?
Comment
Comment
If consent is to be obtained from the experimental subject's (see definition* above) legal representative, the research must intend to benefit the individual subject

The determination that research is intended to be beneficial to the individual experimental subject must be made by an IRB consistent with part 32 CFR 219.

The requirement may be waived by the ASD(R&E) or an appropriate delegate under specific conditions described under DoDI 3216.02 (9)(c)(1-3).
DoDI 3216.02 (9)(b&c).
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10. Protecting Human Subjects from Medical Expenses if Injured

a. Did the IRB determine that this study involves more than minimal risk?
i. Does the informed consent document include an explanation of whether compensation and medical care are available if injury occurs?
For research involving more than minimal risk, informed consent must include 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 can be obtained.
32 CFR 219.116(a)(6)
Comment
b. Is this study DoD-Supported Research?
Payment or reimbursement of medical expenses, provision of medical care, or compensation for research-related injuries is not required.
DoDI 3216.02 (10)(a)
Comment
c. Is this study DoD-Conducted Research which involves more than minimal risk? (This may apply to a multi-site study where the coordinating center is a DoD component and the UI one of its sites).
i. Does the informed consent document explain how the subject will be protected from medical expenses that are the direct result of their participation in the research?
Comment
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.

This requirement does not apply when the Department of Defense is supporting the research but is not engaged in the non-exempt research involving human subjects (i.e., when the non-exempt research involving human subjects is performed solely by non-DoD institutions).
DoDI 3216.02 (10)(b)
d. Is this study DoD-Collaborative Research?
i. Will DoD personnel be conducting study procedures?
a. Does the DoD have primary involvement?
1. Does the informed consent document explain how the subject will be protected from medical expenses that are the direct result of their participation in the research?
Comment
When collaborating with a non-DoD institution, the DoD Components shall establish procedures comparable to those required for DoD-Conducted research to protect human subjects from medical expenses (not otherwise provided or reimbursed) that are the direct result of participation in non-exempt research involving human subjects and that are a direct result of activities performed by DoD personnel. This does not apply to expenses resulting from the injury due to actions performed by the non-DoD institution(s).

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.

DoDI 3216.02 (10)(c)(1-3)
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11. Compensation to Human Subjects for Participation in Research

a. Is the study's compensation plan in compliance with the DoD requirement? DoDI 3216.02 (11)(a&b)
Comment
Subjects who are on-duty Federal personnel (civil servants or Service members):
May be compensated up to $50 for each blood draw.
May not be compensated for general research participation, even if the research is not Federally funded or conducted.
Subjects who are off-duty Federal personnel (civil servants or Service members)
May be compensated up to $50 for each blood draw if the research is Federally funded. If the research is not Federally funded, the human subjects may be compensated for blood draws in reasonable amounts as approved by the IRB (i.e., >$50)
Additionally, off-duty Federal personnel may be compensated for research participation other than blood draws as approved by the IRB according to local prevailing rates and the nature of the research.
Payment to off-duty Federal personnel for general research participation must not be directly form a Federal source (payment from a Federal contractor or other non-Federal source is permissible).
Subjects who are not Federal personnel
May be compensated up to $50 for each blood draw and may be compensated for participation in DoD-supported research for other than blood draws in a reasonable amount as approved by the IRB according to local prevailing rates and the nature of the research.
Payment for general research participation may come directly from a Federal or non-Federal source.
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12. Service Members and Their Status as Adults

a. Does the study include Service members, students at Service Academies, or trainees who are under 18 years of age?
i. Did the IRB consider the recruitment process and the need to include such members as subjects?
Comment
When Service members are under 18 years of age, students at Service Academies, or trainees, the IRB shall carefully consider the recruitment process and the necessity to include such members as human subjects.
DoDI 3216.02 (12)
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13. Classified Research Involving Human Subjects

a. Does this study involve classified research?
Comment
i. Does the informed consent document identify the Department of Defense as such supporting institutions? (If no more than minimal risk or exception granted by Secretary of Defense, N/A)
Comment
ii. Does the informed consent document include a statement that the research is classified and an explanation of the impact of the classification?
Comment
b. Did the IRB use a full board review process?
Comment
c. Did the IRB determine and document whether potential human subjects need access to classified information to make a valid, informed consent decision?
Comment
University of Iowa policy prohibits UI faculty, staff, administrative officers, or students from utilizing University facilities for the purpose of engaging in secret research. As used in this policy, "secret research" includes activities designated as "classified" by the Federal government. (UI Operations Manual, 27.2(b)).

Waivers of informed consent are prohibited (DoDI 3216.02 (13)
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Additional DoD Components

14. Additional DoD Components

Additional DoD Components involved in research
Army

1. Responsibilities of the Principal Investigator (see Assurance Document)

2. Clinical Investigations

a. Does this study involve the use of an IND or IDE?
- IND
- IDE
- No
i. Is the investigator designated as a sponsor for the IND/IDE?
ii. All research involving the use of investigational test articles shall comply with FDA regulations (21 CFR 50, 56, 312, 812, 600). These requirements are addressed in the applicable assurance documents.
b. Does this study involve the use of a Surgeon General-sponsored, FDA regulated investigational product?
i. Is this study being conducted in an Active Army Medical Treatment Facility (MTF) or Dental Treatment Facility (DTF)?
a. Has the study been through the required Army approvals and FDA submissions?
Research conducted in an MTF/DTF may not begin until the protocol has been -
(1) Reviewed (scientifically and ethically) and approved at the first level that IRB endorsement can be given (that is, at the MTF/DTF where the investigation will be conducted or at the RMC of which the MTF/DTF is a part).
(2) Approved by the MTF/DTF commander and the RMC commander where the research will be conducted.
(3) Reviewed by the AMEDDC&S, Clinical Investigation Regulatory Office (MCCS-GCI), 1608 Stanley Road, Fort Sam Houston, TX 78234-5055.
(4) Forwarded to Commander, USAMMDA (MCMR-UMR), Fort Detrick, MD 21702-9240.
(5) Reviewed and approved by the USAMRMC ORP in accordance with USAMRMC policy requirements specified in AR 70-25.
(6) Submitted to the FDA by the Director, DRAC as part of an IND application. Per FDA Form 1571 (Investigational New Drug Application), a clinical investigation may not begin until 30 days after FDA's receipt of the new IND or IDE unless FDA notifies the sponsor that the study may begin.

AR 40-7 3-2a.
ii. Is this study being conducted or managed by a research, development, test and evaluation (RTD&E) organization?
a. Has the study been through the required Army approvals and FDA submissions?
Research conducted or managed by an RDT&E organization either within or outside of a DoD facility may not begin until the protocol has been -
(1) Reviewed (scientifically and ethically) and approved.
(2) Approved by the commander of the facility where the research will be conducted.
(3) Forwarded to Commander, USAMMDA (MCMR-UMR), Fort Detrick, MD 21702-9240.
(4) Reviewed and approved by the USAMRMC ORP in accordance with USAMRMC policy requirements specified in AR 70-25.
(5) Submitted to the FDA by the Director, DRAC acting as sponsor's representative. Per FDA Form 1571, a clinical investigation may not begin until 30 days after FDA's receipt of the new IND unless the FDA notifies the sponsor that the study may begin.
(6) Approved by the Director, DRAC who must determine that all of the sponsor's responsibilities have been met before the study may begin.

AR 40-7 3-2b.
c. Does this study involve the use of an other-than-Department-of-the-Army-sponsored, FDA regulated investigational product?
i. Is this study being conducted in an Active Army Medical Treatment Facility (MTF) or Dental Treatment Facility (DTF)?
a. Has the study been through the required Army approval?
Research conducted in an MTF/DTF may not begin until the protocol has been -
(1) Reviewed (scientifically and ethically) and approved at the MTF/DTF where the investigation will be conducted or at the RMC of which the MTF/DTF is a part.
(2) Approved by the MTF/DTF commander and the RMC commander where the research will be conducted.
(3) Reviewed and approved by the AMEDDC&S, Clinical Investigation Regulatory Office (MCCS-GCI), 1608 Stanley Road, Fort Sam Houston, TX 78234-5055.

AR 40-7 3-3a
ii. Is the research being conducted using research, development, test and evaluation (RTD&E)-managed resources?
a. Has the study been through the required ORP approval?
Research conducted using RTD&E-managed resources may not begin until the protocol has been forwarded to the Office of Research Protections (MCMR-ZB-P), 504 Scott Street, Fort Detrick, MD 21702-5012 for review and approval.
AR 40-7 3-3b.
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3. Additional Requirements and Considerations

a. Did the IRB make and document the determinations listed below?
Required IRB Determinations mentioned in AR 70-25 3-1g and 3-1e.
i. Research using human subjects is conducted in such a manner that risks to the subject are minimized and reasonable in relation to anticipated benefits.
ii. The determination of level of risk in a research protocol will be made by an IRB.
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Navy/Marines

1. Policy

a. Has the UI Institutional Official completed initial and ongoing research ethics and human subjects protections training?
b. Has the IRB Chair completed initial and ongoing research ethics and human subjects protections training?
c. Have the HSO administrators named on the DoD Addendum to the FWA completed initial and ongoing research ethics and human subjects protections training?
d. Has the principal investigator completed initial and ongoing research ethics and human subjects protections training?
SECNAVINST 3900.39D 6(a)(2) and DON HRPP Training and Education Guidance
All personnel involved in reviewing, approving, supporting, conducting, managing, or over-seeing research involving human subjects must complete initial and ongoing research ethics and human subject protections training appropriate to each individual's level of involvement, duties, and responsibilities. SECNAVINST 3900,39D 6(a)(2).

Recommended Refresher training or repeat initial training every three years. DON HRPP Training and Education Guidance.
e. Does the non-DoD Institution engaged in research have a current Surgeon General of the Navy (Navy SG) approved, DoD Navy Assurance on file?
A Department of Defense (DoD) Navy Assurance is a document originated by the institution engages in human subject research that states that it will comply with federal, DoD, and DoN requirments for human subjects protections. The DoD Navy Assurance is reviewed and approved by the Surgeon General of the Navy (Navy SG). Key requirements of the DoD Navy Assurance are completion of research ethics training, designation of IRB(s) to review research protocols, and the institution's plan for monitoring its human research.
SECNAVINST 3900.39D 6(a)(4)(b).
f. Have all key personnel disclosed any conflict of interests?
g. Are all persons involved in review and approval of the protocol free of any conflicts of interest?
Conflict of interest can be defined as any situation in which financial or personal interests may compromise or present the appearance of compromising an individual's or group's judgment in conducting, reviewing, approving, managing, and supporting research. Investigators, key research personnel, IRB members, and other personnel must disclose all conflicts of interest, including any financial interests for themselves, spouses, and dependent children. No personal shall be involved in any review or approval of a protocol when there may be a conflict of interest.
SECNAVINST 3900.39D 6(b).
h. Do study procedures include surveys with DoN military members, their families, or Navy civilian personnel?
i. Has the Navy Survey and Approval been obtained?
Surveys, other than those executed entirely within the command, typically required Navy Survey Review and Approval per OPNAVINST 5300.8c (Coordination and Control of Personnel Surveys). The Navy Survey Approval Manager may require IRB review of the survey instrument prior to granting approval. This applies to all surveys of DoN military members and their families and Navy civilian personnel.
SECNAVINST 3900-39D 6(e).
i. Is any part of this study conducted outside of the United States?
i. Was an ethics review by the host country or local Naval IRB with host country representation conducted?
Research involving human subjects who are not U.S. citizens or DoD personnel, conducted outside the United States and its territories and possessions, requires permission of the host country. The laws, customs, and practices of the host country and those required by this 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).
ii. Was an IND/IDE filed with the FDA?
An IND application or an IDE must be filed with the FDA whenever research involving human subjects is conducted outside the United States with drugs, devices, or biologics, which would require filing of an IND or an IDE if the research were conducted in the United States.
SECNAVIST 3900-39D 6(h).
j. Does the Institution agree to review, take appropriate action, and report the findings of all investigations of allegations of non-compliance with human subjects research to the Navy Surgeon General and appropriate sponsors?
The Naval command or activity with responsibility for the research will review all allegations of non-compliance with human subject protections and take action if appropriate. Report the initiation of all investigations and report results regardless of the findings to the Navy SG and appropriate sponsors.
SECNAVINST 3900-39D 6(k).
k. Does the Institution agree to review, take appropriate action, and report the findings of all investigations of allegations of research misconduct to the Navy Surgeon General and appropriate sponsors?
The Naval command or activity with responsibility for the research will review all allegations of research misconduct and take action if appropriate. Report the initiation of all investigators and report results regardless of the findings to the Naval SG and appropriate sponsors.
SECNAVINST 3900-39D 6(l)
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2. Responsibilities

a. Does the Institution agree to report the following to the DoN HRPP Office and appropriate sponsors?
i. All suspensions or terminations of previously approved DoN-supported research protocols.
ii. The initiation and results of investigations of alleged non-compliance with human subject protections.
iii. Unanticipated problems involving risks to subjects or others, or serious adverse events in DoN-supported research.
iv. All audits, investigations, or inspections of DoN-supported research protocols.
v. All audits, investigations, or inspections of the institution's HRPP conducted outside entities (e.g., the FDA or OHRP).
vi. Significant communication between institutions conducting research and other federal departments and agencies regarding compliance and oversight.
v. All restrictions, suspensions, or terminations of institutions' assurances.
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Air Force

1. Assurances

a. Has The University of Iowa provided written assurance to the sponsoring Air Force institution that it will abide by the policy for the protection of human subjects as stated in AFI 40-402?
Any organization applying for a contract to conduct research involving a human subject must provide a written assurance that will abide by the policy for protection of human subjects as states in this instruction. Written assurance may be provided to the sponsoring Air Force institution using Optional Form (OF) 310. If the organization has an approved multiple-project assurance on file with the Department of Health and Human Services (DHHS), as described in 32 CFR 219.103(a), the organization must annotate this on OF 310.
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2. Record Keeping

a. Does the principal investigator agree to comply with the above record keeping requiremetns?
i. Documents the medical and dental care given to the subject as part of the study. Give a copy of the ICD to the subject and adhere to local policy for ICD filing requirements. AFI 40-402 (2.7.6).
ii. Performs and supervises the conduct of the investigation and records data relating to the investigation as required. The Principal Investigator (PI) must provide research records, in accordance with local policy, to the institution upon completion of the research project or upon reassignment, whichever comes first. AFI 40-402 (4.7.5).
ii. Maintains study records (signed informed consent documents, IRB communications, approvals, amendments, continuing reviews, etc.) while affiliated with the institution. Upon reassignment or closure of the study, the PI will transfer said records to the institution. AFI 40-402 (2.7.15).
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3. Reporting Requirements

a. Does the principal investigator agree to comply with the following reporting requirements?
i. The contracting agency must notify the Clinical and Biomedical Research and Development Division of all reported contractor unanticipated deviations from the approved protocol and reports of serious unanticipated adverse events. AFI 40-402 (4.1.7.1).
ii. Notify the US Air Force contracting agency and obtain IRB approval prior to implementation of any changes to the protocol. AFI 40-402 (4.1.7)
iii. For protocols involving more than minimal risk, the investigator will submit to the sponsoring Air Force organization a copy of (AFI 40-402 (4.1.8)):
A. Documentation of protocol review
B. Documentations of IRB approval.
C. Records of the conduct of the study.
D. Subject Consents.
E. Results of the study.
iv. Submits continuing reviews and final report as required by the IRB. The Principal Investigator is responsible to inform the IRB of change in his/her status and to arrange for a new Principal Investigator who is approved by the IRB to continue the project, or to request closure of the protocol. All publications will be submitted to the IRB for inclusion in the protocol records. AFI 40-402 (2.7.8).
v. Reports serious adverse events, (expected or unexpected), to the IRB Chairperson or designee within five duty days of the event's discovery using FDA MedWatch Form 3500 or equivalent. AFI 40-402 (2.7.9).
vi. Provides follow-up to the IRB in accordance with local IRB policy for adverse event reporting. Coordinating the findings of adverse events with the medical monitor and proposes protocol change to the IRB as needed to minimize risk to other subjects. AFI 40-402 (2.7.10).
vii. Principal Investigators of study projects awarded Healthy Communities Research Program funding will provide a technical and accounting report to the Clinical and Biomedical Research and Development Division (of the AFMOA/SGOT) annually. AFI 40-402 (5.2.2).
b. Is the research conducted on an Air Force installment?
i. Does the PI have the written permission of the commander?
In order to conduct research on an Air Force installation, the investigator must obtain written permission from the wing/base or hospital commander in accordance with local policy.
AFI 40-402 (4.2.4).
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4. Investigational New Drugs and Investigational Device Exemptions

a. Does this study involve the use of an IND or IDE?
- IND
- IDE
- No
i. Has the PI included the IND/IDE number in the protocol?
The PI verifies that an IND or IDE is appropriately coordinated with the FDA according to 21 CFR and the IND/IDE number is included in the research protocol document. Maintains records and submits reports required by the FDA, when conducting studies as part of an IND or IDE.
AFI 40-402 (4.2.4).
ii. Was at least one voting IRB member a physician?
A physician who is a voting member of the IRB must be present when an Investigational New Drug (IND) or Investigational Device Exemption (IDE) protocol is reviewed.
AFI 40-402 (2.6.3).
b. All research involving the use of investigational test articles shall comply with FDA regulations (21 CFR 50, 56, 312, 812, 600). Does the PI agree to comply with the following requirements as applicable?
General responsibilities of investigators conducting research with an IDE (21 CFR 812.100) or an IDE (21 CFR 312.60)
a. Ensure that the investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs/devices under investigation.
b. The investigator shall obtain the informed consent of each human subject to whom the drug is administered/device is used (with the exception of emergency research provided in 21 CFR 50.24)
Specific responsibilities of investigators conducting research with an IDE (21 CFR 812.110)
a. Awaiting approval. An investigator may determine whether potential subjects would be interested in participating in an investigation, but shall not request written informed consent of any subject to participate, and shall not allow any subject to participate before obtaining IRB and FDA approval.
b. Compliance. An investigator shall conduct an investigation in accordance with the signed agreement with the sponsor, the investigational plan, this part and other applicable FDA regulations, and any conditions of approval imposed by an IRB or FDA.
c. Supervising device use. An investigator shall permit an investigational device to be used only with the subjects under the investigator's supervision. An investigator shall not supply an investigational device to any person not authorized under this part to receive it.
d. Financial disclosure. A clinical investigator shall disclose to the sponsor sufficient accurate financial information to allow the applicant to submit complete and accurate certification or disclosure statements. The investigator shall promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following the completion of the study.
e. Disposing of device. Upon completion or termination of a clinical investigation or the investigator's part of an investigation, or at the sponsor's request, an investigator must return to the sponsor any remaining supply of the device or otherwise dispose of the device as the sponsor directs.
f. If the PI is a sponsor-investigator, requirements under 21 CFR 812.43 must also be met, including having all investigators sign an agreement which includes the elements of 21 CFR 812.43(c) prior to participating in the study.
Additional responsibilities of the investigator for an IND/Schedule I Controlled Substances study (21 CFR 312, Subpart D).
a. Conduct the study in accordance with the relevant, current protocol(s) and only make changes in a protocol after notifying the sponsor, except when necessary to protect the safety, rights, or welfare of subjects.
b. Agree to personally conduct or supervise the described investigation(s).
c. Agree to inform any patients, or any persons used as controls, that the drugs are being used for investigational purposes, and ensure that the requirements relating to obtaining informed consent and IRB review and approval are met.
d. Agree to report to the sponsor adverse experiences that occur in the course of the investigation(s) in accordance with 21 CFR 312.64.
e. Read and understand the information in the Investigator's Brochure, including the potential risks and side effects of the drug.
f. Agree to ensure that all associates, colleagues, and employees assisting in the conduct of the study are informed about their obligations in meeting the above commitments.
g. Agree to maintain adequate and accurate records and to make those records available for inspection in accordance with appropriate FDA regulations.
h. Ensure that the IRB will be responsible for the initial and continuing review and approval of the clinical investigation.
i. Agree to promptly report to the IRB all changes in the research activity and all unanticipated problems involving risks to human subjects or others.
j. Additionally, the investigator will not make any changes in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects.
k. Agree to comply with all other requirements regarding the obligations of clinical investigators and all other pertinent requirements in 21 CFR 312.
l. If the PI is a sponsor-investigator, all sponsor obligations described under 21 CFR 312, Subpart D must also be met by the PI.
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5. Emergency Medical Research

a. Does this study involve the use of emergency drugs or devices?
i. Has the investigator reported an emergency use of drugs or devices to the IRB?
For investigators using emergency drugs or devices the using physician is the agent reponsible for following the FDA-prescribed requirements and must comply with all FDA procedural requirements (specified in 21 CFR 50, 56, 312, 812) for emergency use of an Investigational Drug or Device. Consistent with 10 USC 980, under no circumstances can waiver of documentation of informed consent be granted (21 CFR 50.24 does apply to emergency research conducted in the USAF).
AFI 40-402 (2.7.12).
ii. Has documentation of consent been obtained from the subject or their LAR?
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6. Injury and Adverse Events

a. Does the PI have written procedures for reporting adverse events to the US Air Force contracting agency?
Investigators must have written procedures for notifying the US Air Force contracting agency of any misadventure or unanticipated adverse medical event that coincides with or possibly results from using human subjects in a US Air Force-sponsored research protocol.
AFI 40-402 (4.1.7).
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7. Medical Monitor

a. Did the IRB determine the research to be greater than minimal risk?
i. Is the medical monitor identified in the informed consent document?
The IRB appoints an independent medical monitor by name when the IRB determines the research to be greater than minimal risk. The IRB is responsible for determining the extent of active involvement required by the medical monitor. This determination will be based upon the severity of potentially adverse events and the probability that such events may occur. Ensures the Medical Monitor is identified in the consent document.
AFI 40-402 (2.6.11).
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8. Subjects

a. Is this study recruiting active duty personnel?
i. Did the PI consult with the subject to determine whether participation would affect their performance of duties?
- Yes
- No
- Yes, Reg
- No, Reg
The investigator, in consultation with the subject, should determine whether participation in a study would affect the ability of the subject to mobilize for readiness, perform duties, or to be available for duty. Normally, fi their participation could affect their performance, they should not be considered as a subject.
AFI 40-402 (3.2.1).
b. Is this study recruiting a mentally disabled or institutionalized mentally infirm person?
i. Has the subject or their LAR given legally effective consent?
ii. Is the proposed study concerned with a particular impairment that inflicts the subject?
a. Has prior testing proved the risk to be acceptable?
iii. Did the IRB determine there is a direct potential benefit to the subject?
iv. Is the study about the effect of institutionalized life on the subject?
v. Can the information be obtained from any other class of subject?
A mentally disabled or institutionalized mentally infirm person may not participate as a test subject, unless the study would be impossible or meaningless if such subjects were excluded. The investigator may not use any such person as a test subject purely for the sake of convenience.

A mentally disabled or institutionalized mentally infirm person may not participate as a test subject unless:
i. The subject has given legally effective consent, or the subject's legal guardian has given effective third party consent, according to local law.
ii. The proposed study is concerned with one or more of the following:
a. The diagnosis, treatment, prevention, or etiology of a particular impairment that inflicts the subject.
b. Any other condition from which the subject is suffering, provided there is a direct potential benefit to the subject, and prior testing has proved the risk to the acceptable.
c. The effect of institutional life on the institutionalized mentally infirm subject, and involves no appreciable risk to the subject.
d. The information which cannot be obtained from any other class of subjects.
e. If the mentally disabled, or institutionalized mentally infirm person appears to have sufficient mental capacity to comprehend what is proposed and is able to express his or her willingness to participate, the investigator should obtain consent.
c. Is this study recruiting prisoners?
A prisoner may not participate as a human subject unless the proposed protocol is concerned with the diagnosis, treatment, prevention, or etiology of a particular impairment that afflicts the prisoner and unless the prisoner may derive a direct potential benefit.
AFI 40-402 (3.2.4).
d. Is this study recruiting minors?
i. Did the IRB determine the study has the intent to benefit the subject?
Minors may be used as subjects only when the protocol is intended to be of benefit to the subject and consent is obtained from the subject or the subject's legal guardian. In both cases, the investigator must solicit the assent of the minor as well as the consent of one or both parents or guardians.
AFI 40-402 (3.2.2).
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9. Survey Research

a. Does this study administer surveys?
b. Does the study obtain informed consent?
c. Does this study administer attitude and opinion surveys to Air Force military and civilian members, their families, and retired members? AFI 40-402 (3.4.3).
i. Was OMB approval granted?
Attitude and opinion surveys must be conducted IAW (AFI 36-2601), Air Force Personnel Survey Program, February 1, 1996. Surveys within the Air Force at more than one base are to be approved by HQ AFPC/DPSAS, Randolph AFB, TX, IAW the Paperwork Reduction Act. Title 44, United States Code, Chapter 35. Any non exempts survey conducted outside of the Air Force requires Office of Management and Budget (OMB) approval IAW Chapter 35 of Public Law 96-551, Paperwork Reduction Act.
Surveys which collect data through intervention or interaction with the subject or surveys which contain identifiable private information are not exempt and require IRB approval and informed consent.
AFI 40-402 (3.4.2).
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10. Informed Consent Requirements

a. Does the PI agree to comply with the following Informed Consent Requirements?
i. A written legal review of the Informed Consent Document must be obtained prior to IRB approval. AFI 40-402 (3.5.3)
ii. Retain copies of the IRB approved consent documents and legal review in the protocol records.
iii. Provide a copy of the consent document to the subjects. AFI 40-402 (3.5.4).
iv. When a consent form is required, the subject must sign the consent form in the presence of at least one witness, who attests to the subject's consent and attests to the subject's signature by signing in the place provided. (Attachment 4).
v. Assent of a minor must be obtained when appropriate. AFI 40-402 (3.5.2).
Surgeon General's Research Oversight Committee (SGROC)
b. Did the IRB determine that the study was greater than minimal risk?
i. Was the protocol sent to the AFMSA/SGRC?
ii. Did the SGROC review and approve the protocol prior to implementation?
The SGROC must review and approve all greater than minimal risk protocols prior to initiation.

One exception, the investigator may enroll subjects into local IRB and Medical Facility Commander (MTF/CC) approved cooperative oncology studies prior to submitting the protocols to the Clinical and Biomedical Research and Development Division (AFMOA/SGOT) and the SGROC.

Protocols that are determined by the IRB to be no more than minimal risk to the subject must be sent to Air Force Medical Support Agency/Surgeon General's Research and Compliance Office (AFMSA/SGRC), which shall conduct audits in order to ensure compliance.

Minimal risk studies may begin upon local IRB and Commander/AIO approval.

Protocols that are determined to be exempt by the IRB Chair of designee must be evaluated using written criteria, reported to the AFMSA/SGRC, and documented in the IRB minutes and in section 8 of the OF 310.
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11. Air Force Collaborations

a. Is this study a collaborative investigation with the Air Force?
i. Does the protocol have an Air Force PI?
ii. Was the protocol reviewed by a military IRB?
iii. Was the protocol reviewed by the facility commander/authorized institutional official (RDT&E facilities)?
iv. Was the protocol reviewed by the Surgeon General's Research Oversights Committee?
Collaborative studies with non-Air Force federal agencies or civilian organizations that use SGROC funds must have an Air Force PI or associate investigator. The protocol must be reviewed by a military IRB, approved by the facility commander/AIO and reviewed by the SGROC as appropriate.
AFI 40-402 (4.2.5).
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12. Conflict of Interest

a. Does the PI agree to following requirement? AFI 40-402 (11.1).
i. To avoid any appearance of a conflict of interest or violation of supplemental income rules, Air Force medical personnel assigned to or employed at the MTF and conducting research protocol under the AFI 40-402 may not engage in off-duty employment, or otherwise be compensated by non-Air Force sources, in connection with their work on such clinical investigations.
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Under Secretary of Defense for Personnel and Readiness

1. HA Policy: 50-003

a. Has the institution submitted assurances of compliance to the appointed official within the office of the USD (P&R) designated to accept assurances indicating that the institution will strictly follow all principles, policies, and procedures specified in HA Policy: 05-003?
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2. Data and Safety Monitoring

a. Does this study have a Data Monitoring Committee?
i. Has the PI followed recommendations the DMC has made?
Upon recommendation of an IRB, activities under the purview of USD (P&R) will use as appropriate a Data Monitoring Committee (DMC) to regularly review accumulating clinical research data.

This may require commitment of support resources for an existing or newly formed DMC. After appropriate analysis of data, the DMC may advise the sponsor and human subject research protection officials regarding the continuing safety of the subjects, as well as the continuing validity of research, and make recommendations

In accordance with established practice, sponsoring activities will be final arbiters of whether to engage a DMC and actions to take on DMC recommendations. However, following a DMC's recommendations ins the presumptive course of action.
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3. Medical Monitor

a. Does the study being reviewed involve more than minimal risk to subjects?
i. Was an independent medical monitor appointed by name?
ii. Is the medical monitor capable of overseeing the progress of the research protocol?
iii. Is the medical monitor independent of the research team?
iv. Does the medical monitor possess sufficient experience to serve as the subject advocate?
For research involving more than minimal risk to subjects as defined in 32 CFR 219.102(i), an independent medical monitor shall be appointed by name.

Medical monitors shall be physicians, dentists, psychologists, nurses, or other healthcare providers capable of overseeing the progress of research protocols, especially issues of individual subject/patient management and safety.

Medical monitors shall be independent of the investigative team and shall possess sufficient educational and professional experience to serve as the subject/patient advocate.
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DoD, not otherwise specified
Other
Specify
None
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15. Additional DoD Monitoring

Post Approval Monitoring and Education visit

1. Record Keeping

a. Does the PI agree to comply with the following record keeping requirements? DoDI 3216.02 (15)
i. All institutions engaged in DoD conducted or supported research involving human subjects are required to retain records for at least 3 years after the completion of the research.
Comment
ii. Research involving human subjects may be covered by other Federal regulations that impose longer record keeping requirements.
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iii. The DoD Components may rely on the non-DoD institutions to keep the required records that were generated by the institution, or the DoD Components may make arrangements to transfer the records.
Comment
iv. Health Insurance Portability and Accountability Act documentation is required to be retained for 6 years (in accordance with DoD 6025.18-R).
Comment
v. Records maintained by non-DoD institutions that document compliance or noncompliance with this Instruction shall be made accessible for inspection and copying by authorized representatives of the Department of Defense at reasonable times and in reasonable manner as determined by the supporting DoD Component.
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2. Noncompliance with DoD Instruction 3216.02

a. Does the PI agree to comply with the following requirements? DoDI 3216.02 (16)
i. The DoD Components shall respond to allegations of noncompliance. For allegations that involve more than one DoD Component or a non-DoD institution, the involved institutions will jointly determine and assign executive responsibility for responding to the allegation(s).
Comment
ii. For allegations involving a non-DoD institution, the DoD Component supporting the research involving human subjects shall ensure the allegation is properly investigated and reported to the DoD Component.
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iii. All findings of serious or continuing noncompliance that have been substantiated by inquiry or investigation shall be reported to the Assistant Secretary of Defense for Research and Engineering (ASD(R&E)) in a timely manner.
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3. Applicability to Other Requirements

a. Does the research involve the administration of surveys to or interviews of DoD personnel (military or civilian)?
i. Were the surveys or interviews approved by the Department of Defense?
Survey research involves research where DoD personnel and civilian personnel (working with the DoD) are asked to complete surveys; not when researchers funded by the DoD are conducting survey research on non-DoD personnel (DoDI 1100.13 Surveys of Military Personnel). Survey requirements are different depending on the branch of the DoD.
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4. Additional DoD Components

a. Are additional DoD Components involved in research?
Army

1. Responsibilities of the Principal Investigator

a. Investigators will maintain records in accordance with AR-25-400-2, which are pertinent to the research conducted. Does the principal investigator agree to comply with the following record keeping requirements? AR 70-25 3-2j & AR 70-25 2-9c.
i. Documentation of approval to conduct the study.
ii. A copy of the approved protocol or test plan.
iii. All subject's signed informed consent documents.
iv. A summary of the results of the research, including any untoward reactions or occurrences.
v. Case histories that record all observations and other data important to the study.
vi. Receipt, storage, use, and disposition of all investigational drugs, devices, controlled drug substances, and ethyl alcohol.
b. Does the principal investigator agree to comply with the following reporting requirements? AR 70-25 2-9c.
i. Notify the approving authority, through the medical monitor, and the IRB, of adverse effects caused by the research per reporting requirements.
ii. Report serious and/or unexpected adverse experiences involving the use of an investigational device or drug to the sponsor and the FDA.
iii. Apprise the IRB of any investigator's noncompliance with the research.
iv. Prepare and submit progress reports, including annual reports, as determined by the approving authority and regulatory agencies.
v. Prepare and file an investigator sponsored IND or IDE as approrpriate.
c. Does the PI agree to comply with the following Army requirements? AR 70-25 2-9c.
i. Prepare a protocol following the policies and procedures in accordance with the regulations.
ii. Ensure that the research has been approved by the proper review committee(s) before starting, changing, or extending the study.
iii. Ensure that a new PI is appointed if the previously appointed PI cannot complete research.
iv. Seek IRB approval for other investigators to participate in the research.
d. Does this study involve attitude or opinion surveys of Army personnel (military or civilian) to be used for policy and program evaluation and decision making in the Office of the Secretary of the Army (OSA) and Army staff?
i. Has U.S. Army Personnel Center (MILPERCEN) approval been obtained?
Investigators will ensure that research involving attitude or opinion surveys are approved in accordance with AR 600-46 (12).

All surveys of Army personnel will be approved by MILPERCEN prior to administration. AR 600-46 10.
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2. Clinical Investigations

a. Does this study involve the use of an IND or IDE?
- IND
- IDE
- No
i. Is the investigator designated as a sponsor for the IND/IDE?
ii. All research involving the use of investigational test articles shall comply with FDA regulations (21 CFR 50, 56, 312, 812, 600). These requirements are addressed in the applicable assurance documents.
General responsibilities of investigators conducting research with an IDE (21 CFR 812.100).
The investigation was conducted according to the signed investigator statement, the investigational plan, and applicable regulations.
The rights, safety, and welfare of subjects were protected under my care.
The devices under investigation were controlled.
The informed consent of each human subject on whom the device was used was obtained (with the exception of emergency research protocol provided in 21 CFR 50.24).
Specific responsibilities of investigators conducting research with an IDE (21 CFR 812.110).
Awaiting approval. An investigator may determine whether potential subjects would be interested in participating in an investigation, but shall not request the written informed consent of any subject to participate, and shall not allow any subject to participate before obtaining IRB and FDA approval.
Compliance. An investigator shall conduct an investigation in accordance with the signed agreement with the sponsor, the investigational plan, this part and other applicable FDA regulations, and any conditions of approval imposed by an IRB or FDA.
Supervising device use. An investigator shall permit an investigational device to be used only with subjects under the investigator's supervision. An investigator shall not supply an investigational device to any person not authorized under this part to receive it.
Financial disclosure. A clinical investigator shall disclose to the sponsor sufficient accurate financial information to allow the applicant to submit complete and accurate certification or disclosure statements. The investigator shall promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following completion of the study.
Disposing of device. Upon completion or termination of a clinical investigation or the investigator's part of an investigation, or at the sponsor's request, an investigator must return to the sponsor any remaining supply of the device or otherwise dispose of the device as the sponsor directs.
General responsibilities of investigators conducting research with an IND (21 CFR 312.60).
The investigation was conducted according to the signed investigator statement, the investigational plan, and applicable regulations.
The rights, safety, and welfare of the subjects under my care were protected.
The study drug under investigation were controlled.
The informed consent of each human subject to whom the study drug was administered was obtained (with the exception of emergency research protocol provided in 21 CFR 50.24).
Additional responsibilities of investigators conducting research with an IND (21 CFR 312).
The study was conducted in accordance with the relevant, current protocol(s) and only made changes in the protocol after notifying the sponsor, except when necessary to protect the safety, rights, or welfare of subjects.
I personally conducted or supervised the described investigation(s).
Any subjects, or any persons used as controls were informed that the drugs were being used for investigational purposes, and that the requirements relating to obtaining informed consent and IRB review and approval were met.
Adverse experiences that occurred in the course of the investigation(s) were reported to the sponsor in accordance with 21 CFR 312.64.
All associates, colleagues, and employees that assisted in the conduct of the study were informed about their obligations in meeting the above commitments.
Adequate and accurate records were maintained and made available for inspection in accordance with appropriate FDA regulations.
I ensured that the IRB was held responsible for the initial and continuing review and approval of the clinical investigation.
All changes in the research activity and all unanticipated problems involving risks to human subjects or others were promptly reported to the IRB.
No changes in the research were made without IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects.
I have agreed to comply with all other requirements regarding the obligations of clinical investigators and all other pertinent requirements in 21 CFR 312.
b. Does this study involve the use of a Surgeon General-sponsored, FDA regulated investigational product?
i. Is this study being conducted in an Active Army Medical Treatment Facility (MTF) or Dental Treatment Facility (DTF)?
a. Has the study been through the required Army approvals and FDA submissions?
Research conducted in an MTF/DTF may not begin until the protocol has been -
(1) Reviewed (scientifically and ethically) and approved at the first level that IRB endorsement can be given (that is, at the MTF/DTF where the investigation will be conducted or at the RMC of which the MTF/DTF is a part).
(2) Approved by the MTF/DTF commander and the RMC commander where the research will be conducted.
(3) Reviewed by the AMEDDC&S, Clinical Investigation Regulatory Office (MCCS-GCI), 1608 Stanley Road, Fort Sam Houston, TX 78234-5055.
(4) Forwarded to Commander, USAMMDA (MCMR-UMR), Fort Detrick, MD 21702-9240.
(5) Reviewed and approved by the USAMRMC ORP in accordance with USAMRMC policy requirements specified in AR 70-25.
(6) Submitted to the FDA by the Director, DRAC as part of an IND application. Per FDA Form 1571 (Investigational New Drug Application), a clinical investigation may not begin until 30 days after FDA's receipt of the new IND or IDE unless FDA notifies the sponsor that the study may begin.

AR 40-7 3-2a.
ii. Is this study being conducted or managed by a research, development, test and evaluation (RTD&E) organization?
a. Has the study been through the required Army approvals and FDA submissions?
Research conducted or managed by an RDT&E organization either within or outside of a DoD facility may not begin until the protocol has been -
(1) Reviewed (scientifically and ethically) and approved.
(2) Approved by the commander of the facility where the research will be conducted.
(3) Forwarded to Commander, USAMMDA (MCMR-UMR), Fort Detrick, MD 21702-9240.
(4) Reviewed and approved by the USAMRMC ORP in accordance with USAMRMC policy requirements specified in AR 70-25.
(5) Submitted to the FDA by the Director, DRAC acting as sponsor's representative. Per FDA Form 1571, a clinical investigation may not begin until 30 days after FDA's receipt of the new IND unless the FDA notifies the sponsor that the study may begin.
(6) Approved by the Director, DRAC who must determine that all of the sponsor's responsibilities have been met before the study may begin.

AR 40-7 3-2b.
c. Does this study involve the use of an other-than-Department-of-the-Army-sponsored, FDA regulated investigational product?
i. Is this study being conducted in an Active Army Medical Treatment Facility (MTF) or Dental Treatment Facility (DTF)?
a. Has the study been through the required Army approval?
Research conducted in an MTF/DTF may not begin until the protocol has been -
(1) Reviewed (scientifically and ethically) and approved at the MTF/DTF where the investigation will be conducted or at the RMC of which the MTF/DTF is a part.
(2) Approved by the MTF/DTF commander and the RMC commander where the research will be conducted.
(3) Reviewed and approved by the AMEDDC&S, Clinical Investigation Regulatory Office (MCCS-GCI), 1608 Stanley Road, Fort Sam Houston, TX 78234-5055.

AR 40-7 3-3a
ii. Is the research being conducted using research, development, test and evaluation (RTD&E)-managed resources?
a. Has the study been through the required ORP approval?
Research conducted using RTD&E-managed resources may not begin until the protocol has been forwarded to the Office of Research Protections (MCMR-ZB-P), 504 Scott Street, Fort Detrick, MD 21702-5012 for review and approval.
AR 40-7 3-3b.
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3. Additional Requirements and Considerations

a. Does the PI agree to comply with the Army requirements listed below?
Recruitment and Consent. AR 70-25 3-1a, d, f, j, p and AR 70-25 2-9d.
i. Only persons who are fully informed and volunteer in advance to take part may be used as subjects in research; except, when the measures used are intended to be beneficial to the subject, and informed consent is obtaining in advance from a legal representative on the subject's behalf.
ii. Any tissue or body fluid linked by identifiers to a particular person, obtained by surgical or diagnostic procedure and intended for use in research will be donated for such purpose. The donor will be the person from whom the tissue or fluid is removed or, in the event of death or legal disability of that person, the next of kin or legal representative of such person. Donation is made by written consent and relinquishes ownership and/or rights to the tissue or fluid. Consent to donate will not preclude payment for such donation.
iii. Moral, ethical, and legal concepts on the use of human subjects will be followed as outlined in AR 70-25. Voluntary consent of the human subject is essential.
iv. Military personnel are not subject to punishment under the Uniform Code of Military Justice for choosing not to take part as a human subject. Further, no administrative sanctions will be taken against military or civilian personnel for choosing not to participate as human subjects.
v. Volunteers are given adequate time to review and understand all information before agreeing to take part in a study.
vi. The personnel responsible for the conduct of the research are the best qualified to recruit volunteers for a study and should be the primary recruiters whenever possible.
vii. Members of volunteer recruiting teams will: establish volunteer requirements prior to recruitment; coordinated recruiting activities with unit commanders (if applicable); and undertake recruiting in a moral, ethical, and legal manner.
b. Does the PI agree to comply with the Army requirement listed below?
Risks and Benefits to Subjects
i. The research is conducted in such a manner as to avoid unnecessary physical and mental suffering. Preparations are made and adequate facilities provided to protect the subject and investigators against all foreseeable injuries, disabilities, or death. Such research is not to be conducted if any reason exists to believe that death or injury will results.
ii. Volunteers are authorized all necessary medical care for injury or disease that is a proximate result of their participation in research.
iii. Information obtained during, or as a result of, an epidemiological assessment interview with a HIV serum positive member of the Armed Forces may not be used to support any adverse personnel action against the member.
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Navy/Marines

1. Policy

i. Does this study involve the use of an IND or IDE?
- IND
- IDE
- No
i. Is the investigator designated as a sponsor for the IND/IDE?
FOR NAVY RESEARCH, INVESTIGATORS MAY NOT BE DESIGNATED AS SPONSORS, ONLY THE SG, COMMANDERS, AND COMMANDING OFFICERS.
ii. All research involving the use of investigational test articles shall comply with FDA regulations (21 CFR 50, 56, 312, 812, 600). The PI has agreed to comply with the requirements listed on the applicable assurance documents.
General responsibilities of investigators conducting research with an IDE (21 CFR 812.100) or an IDE (21 CFR 312.60)
a. Ensure that the investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs/devices under investigation.
b. The investigator shall obtain the informed consent of each human subject to whom the drug is administered/device is used (with the exception of emergency research provided in 21 CFR 50.24)
Specific responsibilities of investigators conducting research with an IDE (21 CFR 812.110)
a. Awaiting approval. An investigator may determine whether potential subjects would be interested in participating in an investigation, but shall not request written informed consent of any subject to participate, and shall not allow any subject to participate before obtaining IRB and FDA approval.
b. Compliance. An investigator shall conduct an investigation in accordance with the signed agreement with the sponsor, the investigational plan, this part and other applicable FDA regulations, and any conditions of approval imposed by an IRB or FDA.
c. Supervising device use. An investigator shall permit an investigational device to be used only with the subjects under the investigator's supervision. An investigator shall not supply an investigational device to any person not authorized under this part to receive it.
d. Financial disclosure. A clinical investigator shall disclose to the sponsor sufficient accurate financial information to allow the applicant to submit complete and accurate certification or disclosure statements. The investigator shall promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following the completion of the study.
e. Disposing of device. Upon completion or termination of a clinical investigation or the investigator's part of an investigation, or at the sponsor's request, an investigator must return to the sponsor any remaining supply of the device or otherwise dispose of the device as the sponsor directs.
f. If the PI is a sponsor-investigator, requirements under 21 CFR 812.43 must also be met, including having all investigators sign an agreement which includes the elements of 21 CFR 812.43(c) prior to participating in the study.
Additional responsibilities of the investigator for an IND/Schedule I Controlled Substances study (21 CFR 312, Subpart D).
a. Conduct the study in accordance with the relevant, current protocol(s) and only make changes in a protocol after notifying the sponsor, except when necessary to protect the safety, rights, or welfare of subjects.
b. Agree to personally conduct or supervise the described investigation(s).
c. Agree to inform any patients, or any persons used as controls, that the drugs are being used for investigational purposes, and ensure that the requirements relating to obtaining informed consent and IRB review and approval are met.
d. Agree to report to the sponsor adverse experiences that occur in the course of the investigation(s) in accordance with 21 CFR 312.64.
e. Read and understand the information in the Investigator's Brochure, including the potential risks and side effects of the drug.
f. Agree to ensure that all associates, colleagues, and employees assisting in the conduct of the study are informed about their obligations in meeting the above commitments.
g. Agree to maintain adequate and accurate records and to make those records available for inspection in accordance with appropriate FDA regulations.
h. Ensure that the IRB will be responsible for the initial and continuing review and approval of the clinical investigation.
i. Agree to promptly report to the IRB all changes in the research activity and all unanticipated problems involving risks to human subjects or others.
j. Additionally, the investigator will not make any changes in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects.
k. Agree to comply with all other requirements regarding the obligations of clinical investigators and all other pertinent requirements in 21 CFR 312.
l. If the PI is a sponsor-investigator, all sponsor obligations described under 21 CFR 312, Subpart D must also be met by the PI.
Comments
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Findings

2. Responsibilities

a. Did the PI submit the following items to the DoN HRPP Office? SECNAVINST 3900-39D 8(d)(1)(a-f).
i. An appropriate institutional assurance (e.g., a FWA or DoD assurance) or an application for a DoD Navy Assurance.
ii. Written acknowledgement that the institution will comply with the references DoDI 3216.02, 32 CFR 219, and when applicable 21 CFR 50, 56, 312, 812, and 600.
iii. Documentations of the IRB's initial and continuing review and approval.
iv. IRB-approved informed consent form, except when not required consistent with law and regulation.
v. IRB-approved research protocol.
vi. Documentations of completed research ethics and human subject protections training by the principal investigator.
b. Did the institution agree to report the following to the DoN HRPP Office and appropriate sponsors?
i. All suspensions or terminations of previously approved DoN-supported research protocols.
ii. The initiation and results of investigations of alleged non-compliance with human subject protections.
iii. Unanticipated problems involving risks to subjects or others, or serious adverse events in DoN-supported research.
iv. All audits, investigations, or inspections of DoN-supported research protocols.
v. All audits, investigations, or inspections of the institution's HRPP conducted outside entities (e.g., the FDA or OHRP).
vi. Significant communication between institutions conducting research and other federal departments and agencies regarding compliance and oversight.
vii. All restrictions, suspensions, or terminations of institutions' assurances.
Comments
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Signatures

I have reviewed the information provided on this checklist.
IRB Chair/HSO Executive Director

Monitoring Report for UI Research Supported by the Department of Defense

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Study Overview

Monitoring Information

DoD Components

Required Actions

1. Testing Chemical or Biological Warfare Agents

2. Research Conducted Outside the US

3. Requirements for a Federal Assurance

4. Research Involving Human Subjects Conducted by a Non-DoD Institution

5. Education and Training

6. Selection of Human Subjects and Evaluating Risk

7. Additional Protections for Human Subjects

8. Research Monitor

9. Unique DoD Limitations on Waiver of Informed Consent

10. Protecting Human Subjects from Medical Expenses if Injured

11. Compensation to Human Subjects for Participation in Research

12. Service Members and Their Status as Adults

13. Classified Research Involving Human Subjects

14. Additional DoD Components

1. Responsibilities of the Principal Investigator (see Assurance Document)

2. Clinical Investigations

3. Additional Requirements and Considerations

1. Policy

2. Responsibilities

1. Assurances

2. Record Keeping

3. Reporting Requirements

4. Investigational New Drugs and Investigational Device Exemptions

5. Emergency Medical Research

6. Injury and Adverse Events

7. Medical Monitor

8. Subjects

9. Survey Research

10. Informed Consent Requirements

11. Air Force Collaborations

12. Conflict of Interest

1. HA Policy: 50-003

2. Data and Safety Monitoring

3. Medical Monitor

15. Additional DoD Monitoring

1. Record Keeping

2. Noncompliance with DoD Instruction 3216.02

3. Applicability to Other Requirements

4. Additional DoD Components

1. Responsibilities of the Principal Investigator

2. Clinical Investigations

3. Additional Requirements and Considerations

1. Policy

2. Responsibilities

Signatures

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