Researcher Responsibilities Acknowledgement

OMB Control Number 0720-0042

Expiration Date: xx-xx-xxxx

Office of the Under Secretary of Defense (Personnel & Readiness)

Researcher Responsibilities

The public reporting burden for this collection of information is estimated to average 30 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden, to the Department of Defense, Washington Headquarters Services, Executive Services Directorate, Information Management Division, 4800 Mark Center Drive, East Tower, Suite 03F09, Alexandria, VA 22350-3100 (0720-0042. Respondents should be aware that notwithstanding any other provision of law, no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number.

PLEASE DO NOT RETURN YOUR RESPONSE TO THE ABOVE ADDRESS.

Responses should be sent to Dr. Patrice Robinson-Haley, 7700 Arlington Blvd, Suite 5101, Fall Church, VA 22042

Privacy Act Statement

This statement serves to inform you of the purpose for collecting your personal information and how it will be used.

AUTHORITY: 10 U.S.C. 136, Under Secretary of Defense for Personnel and Readiness; 32 CFR Part 219, Protection of Human Subjects; DoD Directive 5136.01, Assistant Secretary of Defense for Health Affairs (ASD(HA)); and DoD Instruction 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research.

PURPOSE: To collect information from you in order to ensure that you are properly trained and qualified to conduct DoD-supported research involving human subjects.

ROUTINE USES: Your records may be disclosed outside of DoD in accordance with the DoD Blanket Route Uses published at http://dpclo.defense.gov/privacy/SORNs/blanket_routine_uses.html and as permitted by the Privacy Act of 1974, as amended (5 U.S.C. 552a(b)

SYSTEMS OF RECORDS NOTICE: http://dpcld.defense.gov/Privacy/SORNsIndex/DOD-wide-SORN-Article-View/Article/570681/edha-18/

DISCLOSURE: Voluntary. However, failure to provide the requested information may result in you not being eligible to conduct DoD-supported research involving human subjects.

RECORDS RETENTION AND DISPOSITION: In accordance with the OUSD(P&R) Records Retention and Disposition Schedule, records must be deleted/destroyed 10 years after completion or termination of the research protocol

The Office of the Under Secretary of Defense for Personnel and Readiness requires that all research investigators (principal investigators as well as associate investigators) engaged in research with one of its institutions explicitly acknowledge and accept responsibility for protecting the rights and welfare of human research subjects as stated therein.

1. I understand that the rights of the subjects take precedence over the needs of the research and I will protect the rights of human research subjects and will comply with the following: the Belmont Report, 32 CFR 219; 10 USC 980; DoDI 3216.02; where applicable 45 CFR 160 and 164; where applicable 45 CFR 46 (Subparts B, C, and D) under the authority of the DoD; and other Federal, State and local laws as they may relate to proposed human subjects research.

2. I am aware of the Joint Ethics Regulation, DoDI 5500.7-R, specifically areas addressing investigators relationships with sponsoring companies including monies received for research protocols. I understand that financial and other conflicts of interest must be reported to the EDO and/or IRB.

3. I understand that I must have either (a) a written exemption determination from my Exemption Determination Official (EDO) (b) an approval letter from a DoD IRB, or (c) written DoD concurrence with a nonfederal IRB review prior to initiating research.

4. I shall promptly report to the approving authority (EDO or IRB) proposed changes in a research activity and shall ensure that such changes in approved research, during the period for which approval has already been given, are not initiated without proper authority review and approval except when necessary to eliminate apparent immediate hazards to the subject.

5. I will ensure that all subjects, or their representatives, are fully informed of the nature of the research to include potential risks to subjects and I will obtain informed consent from each as required.

6. I will maintain study records for 3 years after the study is closed or for 6 years if the study is regulated by the Health Insurance Portability and Accountability Act.

7. I will respect the privacy of subjects. I shall protect confidential information given to me and advise subjects in advance of any limits upon my ability to ensure that the information will remain confidential.

8. I am aware and will complete the training required by the OUSD(P&R) HRPP prior to initiating research.

9. I will report immediately to the approving authority (EDO or IRB) any unanticipated problems involving risks to subjects or others in research.

Applicable to Biomedical Research Investigators

1. I understand and accept the responsibility for protecting the rights and welfare of human research subjects under the FDA regulations 21 CFR 50, 21 CFR 54, and 21 CFR 56 if applicable.

2. I will not enroll a subject into a study until the study has been approved by the appropriate authority and, when appropriate, the subject's primary care physician has granted approval for him/her to enter a study.

3. I am responsible for assuring the quality of each subject's consent in accordance with current federal regulations. This will include ensuring that any "designee" who obtains consent on my behalf is completely conversant with the protocol and is qualified to perform this responsibility.

4. I will maintain a Study File that must be kept for three years following completion of the study if no IND/IDE used. If IND medication or IDE appliances are used, the file must be kept for 2 years after FDA approval and can then be destroyed; or if no application is filed or approved, until 2 years after the study is discontinued and FDA notified.

5. I will report immediately to the IRB any unanticipated adverse events.

With my signature, I acknowledge that I have read and understand the responsibilities stated above and will comply with them. I understand that if I fail to comply with any of these responsibilities, all protocols for which I am an investigator may be suspended.

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Investigator Signature Date

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Mailing Address

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Phone Number Email Address

Version: 1 November 2013