UK Office of Research Integrity

IRB Application: Informed Consent/Assent Process

Department of Health and Human Services (DHHS)-approved protocol

If the research is a Department of Health and Human Services (DHHS)-approved protocol, (such as a National Institutes of Health (NIH) MULTICENTER CLINICAL TRIAL), the IRB should receive a copy of the DHHS-approved sample informed consent document. Any deletion or substantive modification of information concerning risks or alternative procedures contained in the sample informed consent document must be justified in writing by the investigator and approved by the IRB. For trials sponsored by the National Cancer Institute, investigators must forward copies of such IRB-approved changes, with their justifications, to the appropriate Cooperative Group headquarters. The DHHS-approved consent document and any justification for changes in the Risks and/or Alternatives sections should be submitted as part of the application packet.

[If you are proposing research that is a Department of Health and Human Services (DHHS)-approved protocol, please mark the applicable check box in the Additional Information section of your E-IRB application, and upload the document using the "Protocol/Product Attachments" button].


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