New HIPPA Consent and Authorization Templates

The IRB released new consent and authorization templates March 14, 2007. New study applications submitted after March 19, 2007, must follow the template requirements. For studies with approved consent documents, these updates should be made at the time of continuing review. Please review the updates as outlined below and make any necessary revisions prior to submission of an application for continuing review.

Many of the changes to the template reflect information which has been requested in practice by the IRB but was not outlined on the template (e.g. list acceptable methods of birth control). The IRB has made an effort to provide better instructions and a more understandable format. Example text is more clearly differentiated. Instructions now note when a section or portion of a section may be omitted.

If your current consent document already includes the following information, no change is necessary. The template is a tool for investigators to include required elements of informed consent. We encourage the use of the template to prevent omission of required information.

HIPPA Consent and Authorization, Parental Permission and VA Consent

1. Confidentiality section:
   1. If the research is subject to FDA regulation, a statement must be included that notes the possibility that the FDA may inspect the records.
   2. If applicable, a description of the Certificate of Confidentiality and any voluntary disclosure plans by the investigator(s) should be included.
   3. If applicable, additional information must be disclosed if HIV testing or testing for any reportable disease (by Utah State law) will be performed as a result of study participation.
2. Person to Contact Section:
   1. Contact information must be provided for whom participants should contact with a research-related injury, including name(s), telephone number(s), and when the person(s) listed may be contacted.
   2. If applicable, contact information should be provided about who to contact if the participant has questions about the billing of costs in the study.
3. The Institutional Review Board statement has been revised to a lower reading level and included the IRB’s email address.
4. The University’s Liability Statement has been revised. The section is now entitled “Research-Related Injury” and provides flexibility for an explanation of who can provide care and who will be responsible for the cost of treatment.
5. For studies involving placebo or withheld treatment, instructions are included for providing the requisite information.
6. If applicable, information regarding reproductive risks, acceptable methods of birth control, and the action that will occur in the event of pregnancy is required.

Additional VA Consent Template Changes

• The Medical Treatment or Compensation for injury section has been revised. A statement is included regarding the VA’s authority to provide treatment. Also, if the study has a third party sponsor, an explanation of who will be responsible for the cost of treatment should be provided.
• The Costs and Compensation section provides better instruction regarding what information is required of VA studies.