IRB Updates

The new, revised VHA Handbook 1200.05, “Requirements for the Protection of Human Subjects in Research,” has been released. The following changes to the conduct of research at the VA are now in effect:

• The PI must provide a signed statement at continuing review, certifying that all subjects entered onto the master list of subjects for the study signed an informed consent form prior to undergoing any study interactions or interventions, unless a waiver of consent is applicable. The SLC VA Research Review Committee (RRC) will be responsible for requesting and verifying this document upon continuing review; this form should NOT be attached to the IRB application. A template statement/form is available for PIs to use at:
  http://www.research.utah.edu/irb/forms/hipaa/pdf/VACertificationofInformedConsent-Jan11.pdf
• A witness signature and the PI signature are no longer required on VA consent documents. An updated VA Consent Template is available from the IRB at: http://www.research.utah.edu/irb/forms/hipaa/index.html. This change will be enforced for all new studies submitted on or after 2/5/2011, as well as at continuing review.
• The HIPAA Authorization section has been separated from the main consent. This means that participants must sign the document twice: once for consent and once for authorization. The VA Consent Template includes all sections and signature blocks for consent and authorization in one document, meaning that you do not need to upload two separate documents into ERICA; however the IRB will no longer use an approval stamp on the bottom of the HIPAA Authorization section. Because of the complexity of the template, be careful to follow the instructions included at the beginning and throughout the template. This change will be enforced for all new studies submitted on or after 2/5/2011, as well as at continuing review.
• The VA 10-1223 Form is no longer required. All new studies submitted to the IRB will not be required to submit a VA 10-1223 Form with the IRB application. Currently approved studies will not be required to remove the VA 10-1223 Form at continuing review.

For additional guidance regarding these new requirements, the following resources are available:

VHA 1200.05 Handbook: http://www.research.va.gov/pride/policy/default.cfm

VA HRPP Administrator
Phone: 801.582.1565 X4666

Institutional Review Board