The University IRB applies all Department of Health and Human Services (DHHS) requirements for informed consent to greater than minimal risk research: DHHS general requirements (at 45 CFR 46.116) (see ...

UAB may be a participating site in a multi-site research study and rely on an external IRB. The external IRB may include an institutional IRB (e.g., Vanderbilt) or an independent IRB (e.g. WIRB or ...

The U.S. Food and Drug Administration (FDA) has published a final rule on “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations,” which permits ...

Note that all forms must be completed on a computer. No handwritten forms will be accepted for review. Before you take the time to prepare your application, you want to make sure the project you are ...

Department of Health and Human Services (DHHS) regulations for the protection of human participants require that informed consent information be presented in language understandable to the participant ...

The Food and Drug Administration (FDA) has issued a final rule, Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations, 1 which allows an ...

The UAB Institutional Review Board for Human Use (IRB) is a committee established under federal regulations for the protection of human subjects in research (45 CFR 46). Its purpose is to help protect ...

Exempt research does not require the informed consent to be documented (it is at the discretion of the researcher), but the Bowdoin IRB does expect that informed consent be provided to the ...

1. Investigators have not completed required CITI training courses/ modules. See the HRPP Required Training webpage for guidance. Note that if you have taken a CITI course elsewhere, you must ...

The Revised Common Rule requires all clinical trials to post an unsigned consent form on a publicly available website. The Revised Common Rule is in effect for studies approved on or after January 21, ...