In This Section      
 

JHM IRB Consent Language Requirements for Department of Defense (DoD)-Funded Research

December 2020

The information provided in this document is for DoD-sponsored studies.

For all participants in DoD-funded research, the informed consent documents must include the following:

Section of the Consent

What is Required?

Sponsor/Supporter/Funded By:

(located on p. 1 of the written and oral consent templates; see links to templates on last page below)

  • Be sure that Department of Defense (DoD) is listed as the sponsor.  If a specific DoD-component (e.g. U.S. Army Medical Research and Materiel Command (USAMRMC)) is indicated, specify its name as well.

What treatment costs will be paid if you are injured in this study?

  • In the payment for injury section of the consent, the JHM IRB standard institutional federal injury/indemnification language should be included for DoD-sponsored studies not conducted by a DoD Principal Investigator and not conducted at an official DoD site.

  • For greater than minimal risk research, add the following language: "If you are injured you may, for the duration of the study, be eligible for health care services for research-related injuries at a military treatment facility, and this eligibility for health care services extends beyond your participation in the study to such time after the study has ended."

How will your privacy be maintained and how will the confidentiality of your data be protected?

  • In the HIPAA section of the consent add the following language:

    • "The Department of Defense (DoD) will have access to records for audit purposes."

  • If funded specifically by the USAMRMC, use instead:

    • "The Department of Defense (DoD) and the U.S. Army Medical Research and Materiel Command (USAMRMC) will have access to records for audit purposes."

 

IN ADDITION:

For participants who are DoD-affiliated personnel, the informed consent documents must include the following if implicated:

Section of the Consent

What is Required?

What are the risks or discomforts of the study?

  • If the research includes any risks to DoD-affiliated personnel’s fitness for duty (e.g. health, availability to perform job, data breach), you must include language informing them about these risks and that they should seek Command or Component guidance before participating.

  • If applicable, you must include any potential risks for the revocation of clearance, credentials, or other privileged access or duty.

If you have questions about whether these issues may be implicated for your study, you should consult with your funding source/the DoD’s Human Research Protection Official (HRPO).

JHM IRB Written Consent Template:

 

https://www.hopkinsmedicine.org/institutional_review_board/forms/JHMIRB_CombinedInformedConsent_Template_v16_FINAL.docx

JHM IRB Oral Consent Template:

https://www.hopkinsmedicine.org/institutional_review_board/forms/OralConsentScript.docx