Altering or Waiving Elements of Informed Consent/Waiver of Consent
The IRB may approve a consent procedure which omits or which alters some or all of the elements of informed consent. A Principal Investigator may request a waiver of one or more elements of informed consent by indicating this request to the IRB.
The regulations governing waiver of informed consent are found in 45CFR46.116 (DHHS), 21 CFR 50.23 and 21CFR50.24 (FDA) ,and 32CFR219.116 (DoD). Regulations regarding waiver of HIPAA authorization are found in 21CFR164 (HIPAA).
In addition, if Protected Health Information (PHI) (health information with identifiers) will be obtained, HIPAA (21CFR160 and 164) regulations must be met in order to waive HIPAA authorization. At UVa, the HIPAA authorization is embedded in our consent forms.
- Because the UVa agreement with DHHS via the Federal Wide Assurance (FWA) states that we will follow DHHS regulations regardless of funding, a waiver of consent must always be reviewed and approved under the DHHS waiver regulations.
- If the protocol includes research on a drug, device or biologic, a waiver of consent must also be reviewed and approved under the FDA waiver regulations.
- If the protocol includes research of an in-vitro diagnostic device, additional information may be found in the FDA Guidance document " Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable"
- If the protocol is funded by the Department of Defense, the waiver of consent must also be reviewed and approved under DoD regulations.
The IRB carefully reviews such requests and determines whether alteration or waiver is appropriate and permissible in each situation.
The Privacy Rule also permits the IRB to alter the required form of authorization, if the IRB makes a separate set of findings and determines that the waiver criteria contained in the privacy rule are satisfied.
*Taken from UVa IRB-HSR Research Guidance