June 19th, 2018
Effective June 2018, the University of Utah IRB (UUIRB) updated its screening and recruiting policies and procedures. The changes made are in Standard Operating Procedure 601: Screening, Recruiting and Advertising for Participant Enrollment and in the Investigator Guidance Series: Recruitment Methods. There are no changes to the ERICA application with regard to this update.
What is the change?
The UUIRB requires that investigators describe their plan for screening and recruiting of research participants. In practice, the UUIRB has not required a waiver of consent for recruitment with the exception of studies that are conducted at the VA (see below for more about the VA requirements). UUIRB written policy did not clearly outline this practice.
The IRB’s written policy now clearly states that written consent is not required for screening and recruiting. However, a HIPAA waiver of authorization for reviewing medical records should be requested for studies using medical records for screening and recruiting.
This policy clarification will not change how submissions are made by investigators. Plans for screening and recruiting of research participants will still need to be described in the ERICA application.
Minor revisions intended to ensure consistency were added to our written policy. Additionally, the following language was added to our written policy:
The University of Utah IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining eligibility of prospective subjects without the informed consent of the subject or the subject’s legally authorized representative if either of the following conditions are met:
- The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative; or
- The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
Why is this change being made?
In preparation for implementation of the revisions made to the Common Rule the University of Utah IRB clarified the written policy as described above. The effective date was originally set for January of 2018. However, the effective date was delayed. Because the changes do not alter how the University of Utah IRB was operating in practice, it was determined that rolling out the policy change prior to the implementation date of the revised Common Rule could be beneficial to the research community. The IRB’s written policy will now clearly describe the IRB process of approving screening and recruiting procedures in research proposals.
What if my study is conducted at the VA?
Since January 2017, the UUIRB has required that a “waiver of consent for recruitment only” be submitted for studies conducted at the VA when an investigator wishes to use medical records for screening and recruiting. As per VA request, this practice will continue. Once the revised Common Rule is effective, the requirement for a waiver of consent for recruitment only will no longer be requested for VA studies.
Where can I read the full revised policy?
You can find the UUIRB SOP 601: Screening, Recruiting and Advertising for Participant Enrollment on the Standard Operating Procedures page.
The revised version and a tracked copy of the Investigator Guidance Series: Recruitment Methods can be found on the Investigator Guidance Series (IGS) page.