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Changes to Screening and Recruiting Policies

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:

  1. The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative; or
  2. 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 (https://irb.utah.edu/guidelines/irb-sops.php). 

The revised version and a tracked copy of the Investigator Guidance Series: Recruitment Methods can be found on the Investigator Guidance Series (IGS) page (https://irb.utah.edu/guidelines/investigator.php). The revised version can also be found on the A-Z Index (https://irb.utah.edu/a-z.php).

  • GCP Training Requirements

    Effective January 1, 2017, the University of Utah IRB requires clinical investigators and staff listed on an IRB application funded by the NIH to have both human subjects training and GCP training before an IRB application will be approved.

  • IRB Staff Telephone Availability Interruption

    The IRB office is currently undergoing construction. Several of our staff members have moved to temporary accommodations away from their desks and usual telephones while the remodel is under way.

  • IRB Staff Changes

    Please join us in welcoming our new Panel 4 Coordinator.

  • Delayed Pre-Review Timelines

    Due to new staff onboarding and training currently happening at the IRB, as well as a greater than usual amount of applications submitted in recent weeks, we are running several days behind schedule on pre-reviews for all applications.

  • IRB Staff Changes

    We are excited to welcome a new Administrator to the IRB.

  • IRB Staff Changes

    We are happy to welcome a new IRB Coordinator. We are also pleased to announce that Jessica Loayza has joined the Administrator team.

  • Delayed Pre-Review Timelines

    Due to new staff onboarding and training currently happening at the IRB, as well as a greater than usual amount of applications submitted in recent weeks, we are running several days behind schedule on pre-reviews for all applications.

  • IRB Staff Changes

    We have added two new positions to the IRB.

  • IRB Staff Changes

    We are pleased to welcome a new Coordinator to the IRB.

  • IRB Staff Changes

    We are happy to welcome a new IRB Administrator to the New Study pre-review team.

  • IRB Updates

    Due to F&A increase to 36.5%, the IRB fee schedule is changing for industry-sponsored new studies, continuing reviews, and amendments. The new IRB fee schedule will be effective on July 1, 2016.

  • IRB Staff Changes

    Please join us in welcoming our new IRB Clerk.

  • RDRC-HUS Workflow for Amendments

    Effective 5/1/2016, the RDRC-HUS will now review all amendments related to radiation use within the ERICA system.

  • IRB Staff Changes

    Please join us in welcoming our newest IRB Administrator.

  • IRB Updates

    All studies conducted at Shriners Hospitals for Children in Salt Lake City are now required to obtain approval from Shriners Hospital leadership before the IRB will issue final approval of the study.

  • Institutional Conflict of Interest Policy

    Beginning January 15, 2016, the conflict of interest review process for all New Study applications will include a review for Institutional Conflicts of Interest (ICoI).

Last Updated: 6/26/18