Northwestern University – Institutional Review Board Office

Supplement for Research Projects Funded by the

Department of Defense (DoD)

Please use this form only when:

  • The study receives funding from or is supported by the Department of Defense (DoD)

1. Principal Investigator Name:

2. Project Title:

3. IRB Study Number: STU

4. This form is an attachment to a new study or existing study (select one)

Instructions:

  • Handwritten or incomplete forms will not be accepted
  • Complete all applicable sections of this form and do not leave any blanks unless directed
  • Within eIRB, upload a copy of the completed form in the same section as the protocol.
  1. Department of Defense Components and Involvement
  1. What component(s) of the United States Department of Defense (DoD) are involved in this research?

Check all that apply:

Navy

Army

US Army Corps of Engineers

Air Force

National Guard

Marines

Other: specify

  1. How is the Department of Defense (DoD) involved in your research? Check all that apply:

The research is funded by a component of DoD

The research involves cooperation, collaboration, or other type of agreement with a component of DoD

The research uses property; facilities, or assets of a component of DoD

The subject population will intentionally include personnel (military and/or civilian) from a component of DoD, or data or specimens from DoD personnel

  1. For research that is funded by a DoD component, provide the following information:
  1. Name of specific funding agency or program: specify
  2. Title of the grant or contract: specify
  3. Award number: specify
  4. Name of lead research on the grant or contract: specify
  1. Submission Requirements
  1. Are the investigator and research staff aware of the specific DoD requirements and have they been educated about these requirements?

Yes N/A

  1. Submit the following required documentation with your eIRB submission. Check the box to confirm the materials will be included with the submission.

- Principal Investigator and co-investigator’s CVs

- Data collection forms / case report forms

  1. When conducting multisite research, a formal agreement is required to specify the rolesand responsibilities of each party including a Statement of Work (SOW) and specific assignment of responsibilities. Confirm the agreement has been/will be executed:

Yes N/A

  1. Prohibitions or limitations related to DoD research.

Review and check each of the following to acknowledge that you are aware of, and will comply with, these limitations:

Captured or detained personnel

The research described here complies with Department of Defense Directive 3216.02 which prohibits research involving prisoners of war. This includes any person captured, detained, held, or otherwise under the control of DoD personnel (military and civilian, or contractor employee). Such persons include enemy prisoners of war, civilian internees, retained persons, lawful and unlawful enemy combatants. Such persons do not include DoD personnel being held for law enforcement purposes.

Waiver of consent

A waiver of the requirement for informed consent is not allowed for research involving DoD and that involves an intervention or interaction with a human being as an experimental subject, which means for the primary purpose of obtaining data regarding the effect of the intervention or interaction except as follows:

  • For research intended to be beneficial to the subject, if the subject lacks capacity, due to age, condition, or other reason, to make a decision about participation, consent may be provided by a legal representative of the subject.
  • The requirement for prior informed consent may be waived by the Head of the Office of the Secretary of Defense OSD and DoD component with respect to a specific research project to advance the development of a medical product necessary to the Armed Forces, if the research may directly benefit the subject and the research is carried out in accord with all other applicable laws and regulations.
  • This prohibition does NOT apply to screening (sometimes called “pre” screening) of records for the purpose of identifying possible subjects. It also does not apply to retrospective records reviews. The IRB can grant a waiver of consent for such activities.

Classified research, sensitive but unclassified research, or controlled unclassified information

The research described here does not involve classified, sensitive but unclassified research, or controlled unclassified information. Such research requires special University review and approval.

Testing of chemical or biological agents

The research described here does not involve the testing of chemical or biological agents, subject to possible exceptions for research for prophylactic, protective, or other peaceful purposes.

  1. Training Requirements

In addition to satisfying Northwestern University human subject’s training requirements, all personnel who conduct, review, oversee, support, or manage human subject’s research must also meet DoD training requirements. The DoDand Department of Navy training modules are available through CITI. If unsure which modules should be completed, please contact the program officer for specific information about their respective education requirements and obtain documentation confirming the requirements.

Review the statements below and select the option that best applies to your study.

  1. DoD training certificate of completion is submitted and uploaded to eIRB. Documentation is provided for the Principal Investigator, all co-investigators, staff, and collaborators who will be directly involved with human subjects

Attached N/A

  1. Documentation of the training requirement for the DoD component that is funding the research, if other than DoN or Under Secretary of Defense (Personnel and Readiness), is attached. [Note: This can typically be obtained from the Program Officer.]

Attached N/A

  1. By checking this box, I agree to comply with the requirements for the lead researcher/principal investigator and all others directly involved in this human subjects research to obtain training in the protection of human research subjects, as required by the DoD component providing funding for the research.

Attached N/A

  1. Research Procedures
  1. Surveys

Most DoD components have specific language and administration requirements related to survey, questionnaires and interviews with DoD personnel. Please consult with your DoD component agency and respond to the following:

  1. Will surveys or questionnaires be administered to or interviewsconducted with DoD personnel and/or their families?

Yes N/A

  1. If yes, of the items listed below, select the option which best fits your study:

I have been advised that additional survey/interview approval by the DoD component is not required. (submit documentation)

I have submitted documentation of the DoD component’s approval of the survey/interview.

I have been advised by the DoD component to obtain IRB approval first, then submit the survey/interview for approval by my DoD component. (submit documentation)

  1. Diminished capacity
  1. Does the research involve consent by a legally authorized representative (LAR) on behalf of a subject who lacks capacity (due to age, condition, or other reason) to make a decision regarding consent to participate in the research?

Yes N/A

  1. If “YES”, DoD policy states that the IRB must determine that the research is intended to be beneficial to individual subjects. Please describe the benefits expected for individual subjects in the text box below: describe
  1. Level of Risk

Does the research involve more than minimal risk to subjects?

“Minimal risk” is defined as: The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. This definition 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, solder in a combat zone) or having a medical condition (e.g., frequent medical tests or constant pain).

Yes No

If the answer is “YES” (i.e., the study is greater than minimal risk), complete all items in the Medical Research Monitor Section.

  1. MedicalResearch Monitor

For research involving more than minimal risk, an independent medical monitor must be appointed by name by the Investigator or the IRB (a monitor may also be appointed for minimal risk research at the discretion of the PI or IRB). 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, may be the medical monitor. The monitor must also be independent of the study team and should possess sufficient educational and professional experience to serve as the subject/patient advocate.

Depending on the nature of the study, the medical monitor may be assigned to assess one or more of the following phases of the research project: subject recruitment, subject enrollment, data collection, or data storage and analysis. At the discretion of the IRB, the medical monitor may be assigned to discuss research progress with the lead researcher, interview subjects, consult on individual cases, or evaluate adverse event reports.

All items below must be satisfied before the IRB can grant full approval.

Medical Monitor Information:

  1. Identify the medical research monitor: monitor's name

Select “a” or “b” below, as applicable:

  1. - The monitors’ curriculum vitae is attached, describing the monitor’s educational and research credentials and experience, and any other pertinent qualifications. The IRB cannot grant final and full approval until the IRB has received and reviewed the monitor’s curriculum vitae.
  2. - The monitor’s curriculum vitae will be provided to the IRB by the following date:date
  1. Describe the monitor’s role by indicating what will be monitored.Check all that apply:

- Subject recruitment and consent

- Subject enrollment

- Study procedures

- Confidentiality

- Adverse events and protocol deviations/violations

- Data and specimen collection

- Data and specimen storage

- Data analysis

- Other: specify here

  1. Select the activities the monitor will perform. Check all that apply:

- Discuss research progress with the lead researcher.

- Interview some or all subjects.

- Consult on individual cases.

- Evaluate adverse event reports.

- Other: specify here

  1. Confirm the monitor’s independence and authority. Attest to each of the following statements by checking each box.

The monitor:

- Is independent of the research team.

- Possesses sufficient educational and professional experience to serve as a subject advocate.

- Will promptly report discrepancies or problems to the IRB.

- Has the authority to stop the research in progress, remove individual subjects from the research, and take whatever steps are necessary to protect the safety and well-being of the subjects until the IRB can assess the monitor’s report.

- Has an IRB approved written summary of duties, authorities, and responsibilities based on specific risks or concerns about the research

- Will be named in the research protocol

- Is identified in the Confidentiality section of the consent form(s) (if the Monitor will have access to individually identifiable data)

- Is listed as the monitor in the Research Personnel application page of the e-IRB application

  1. Letter from monitor accepting the role. Select the appropriate option.

- A letter from the monitor accepting the role is attached. The letter should confirm their authorities, responsibilities, and duties.

- A letter from the monitor, accepting the role, will provide to the IRB by this date: date

  1. Handling of Research Related Injury

All DoD-related research involving greater-than-minimal risk must have an arrangement for emergency treatment and necessary follow-up of any research-related injury. Describe your arrangement in the text box (or state Not Applicable if study is minimal risk):

  1. Subject Recruitment / Protections for Military Personnel
  1. All of the following protections are required for research involving military personnel that is greater than minimal risk (Note- for minimal risk research, the IRB may still require that an ombudsman be appointed) . Check all that apply:

- N/A as study is minimal risk

- Military personnel are not an intended population.

- The individual’s decision about participation has not been influenced by unit officers or senior noncommissioned officers (NCOs).

- Unit officers and senior NCOs will be excluded from solicitation/recruitment/consent sessions for units under their command.

- Separate recruitment/consent sessions for officers and NCOs excluded from sessions held for their units will be offered.

- An ombudsperson not connected in any way to the research or to the unit will be present to monitor group recruitment briefings where a percentage of the unit is being recruited to participate as a group, to monitor that the voluntary nature of individual participants is adequately stressed and that the information provided about the research is adequate and true.

  1. If additional protections for military personnel will be implemented, please specify below:
  1. Subjection Compensation

Complete the items below:

  1. Compensation rule(s) for on duty Federal personnel

On duty Federal personnel, who participate in research conducted by a non-DoDinstitution, may be compensated up to $50 for each blood draw whether or not the research is Federally funded. Federal personnel participating as research subjects may only be compensated for blood draws and may not be otherwise compensated for general research participation. Confirm that the protocol is compliant with this requirement:

Yes N/A

  1. Compensation rule(s) for off duty Federal personnel
  1. Off duty Federal personnel, who participate as research subjects in Federally funded research, may be compensated up to $50 for each blood draw. If the research is not federally funded, subjects may be compensated a reasonable amount for blood draws. Confirm that the protocol is compliant with this requirement:

Yes N/A

  1. Off duty Federal personnel can may receive compensation for other forms of research participation; however, payment must not be directly from a Federal source (payment from a Federal contractor or other non-Federal source is permissible). Confirm that the protocol is compliant with this requirement:

Yes N/A

  1. Compensation rule(s) for non-Federal personnel:
  1. Non-Federal personnel participating as a research subject in DoD funded research may be compensated up to $50 for each blood draw. Confirm that the protocol is compliant with this requirement:

Yes N/A

  1. Non-Federal personnel may be compensated for other forms of research activities. Payment can come directly from a Federal or non-Federal source. Confirm that the protocol is compliant with this requirement:

Yes N/A

  1. International Research
  1. Does the research involve Human Subjects who are not U.S. citizens or personnel of the DoD, and is it conducted outside the United States, its territories and its possessions?

Yes N/A

  1. If “yes”, confirm each item below is true (all items must be checked):
  1. The permission of the host country has been obtained
  2. The laws, customs, and practices of the host country and the United States will be followe
  3. An ethics review by the host country, or local IRB with host country representation, will take place

Air Force

This section should be completed only for research that involves the Air Force. Go to the next section if the research does not involve the Air Force.

A. Review and check each of the following to acknowledge that you are aware of, and will comply with, these limitations:

  1. Yes N/A Subjects who are military or civilian employees or members of any Air Force component: The researcher will consult with each subject to determine whether participation in the research would affect the subject’s ability to mobilize for readiness, to perform duties, or to be available for duty. Normally, if participation could affect these abilities, the subject should not be considered for participation in the research. (Air force Instruction 40-402, section 3.2.1.)
  1. Yes N/A Research-related medical emergencies: Apparatus, instruments, and personnel will be available to deal with medical emergencies related to the research. (Air Force Instruction 40-402, section 2.7.11.)
  1. Yes N/A Minors: Minors may be used as subjects only when the research is intended to be of benefit to the subjects and satisfies one of the following set of conditions. (Air Force Instruction 40-402, section 3.2.2.)
  • Involves no more than minimal risk to subjects; or
  • Presents greater than minimal risk but presents the prospect of direct benefit for individual subjects and the IRB finds that:
  • The risk is justified by the anticipated benefit to the subject
  • The relationship of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches.
  1. Yes N/A Mentally disabled persons: A mentally disabled or institutionalized mentally infirm person may not participate as a subject, unless the study would be impossible or meaningless if such subjects were excluded. (Air Force Instruction 40-402, section 3.2.3.) In addition:
  • The subject must give legally effective consent, or the subject’s legal guardian must give effective consent, according to local law.
  • The proposed research must be concerned with one or more of the following:
  • The diagnosis, treatment, prevention, or etiology of a particular impairment that inflicts the subjects.
  • Any other condition from which the subjects are suffering, provided there is a direct potential benefit to the subjects and prior testing has proved the risk to be acceptable.
  • The effect of institutional life on the institutionalized mentally infirm subjects, and involves no appreciable risk to the subjects.
  1. Yes N/A Prisoners: A prisoner may not participate as a subject unless the proposed research 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. (Air Force Instruction 40-402, section 3.2.4.)
  1. Yes N/A Surveys: Surveys which collect data through interaction or interaction with the subject or surveys which contain identifiable private information are not exempt and require IRB approval and informed consent. (Air Force Instruction 40-402, section 3.4.2.)

B. The IRB is required to specify the research focus area(s) of your study, from the following Air Force-specific options. Check all that you believe apply to your research. You must select at least one category.