HS-IRBs News April 2015

Health Sciences and Minimal Risk IRBs, IRB News / Volume 7, Number 4, April 2015

NEW: Pilot Testing a New Exemption Consent Template

The HS IRBs Office has developed a new consent template that can be used for exempt studies involving surveys, interviews, and/or focus groups.  We are looking for volunteers to pilot test the template and provide feedback.  Pilot testing involves using the template to create consent information for a new exemption application that involves surveys, interviews, and/or focus groups.  You may also provide verbal feedback on what you think of the template.  Of note, the new template may be used only with new exemption applications.

If your study team is preparing an IRB exemption application for this type of study and would like to try out the template, please email Sherry Holcomb (ssholcomb@medicine.wisc.edu).

NEW: Reliance Basics and Reliance Partners Pages 

As noted in the March newsletter, significant changes have been made to the multisite research resources on the HS IRBs website. These changes are being made to reflect the growing number of IRB reliance agreements in which the HS IRBs participate as well as updated resources regarding all aspects of IRB reliance. Part of this shift has included changing the name for the main multisite research page to Collaborative Research and Single IRB Review . This name change occurred to keep the HS IRBs website in step with national trends regarding how agreements among IRBs are described. Highlights of the new reliance pages include:

If you have questions about these changes or any IRB reliance issues, please contact the HS IRBs Reliance Team (irbreliance@medicine.wisc.edu).

Introducing the HS IRBs Reliance Team

Along with the changes to multisite and IRB reliance resources on the website, the HS IRBs offices now has a team of people to support study teams with IRB reliance issues. The team includes Mike Bingham, Molly Lumley, Carol Pech, and Brandy Stoffel. The Reliance Team is able to assist study teams with issues such as:

The Reliance Team encourages study teams to contact them with any questions about IRB reliance or multisite and collaborative research issues.

Reminder: NIH Genomic Data Sharing Policy Requirements

The National Institutes of Health (NIH) issued a Genomic Data Sharing Policy in 2008 that was updated January 25, 2015. This NIH Policy requires the submission of large-scale genomic data as well as relevant associated data to an NIH-designated data repository. This policy applies to all NIH-funded research that generates large-scale human or non-human genomic data as well as the use of these data for subsequent research. The policy defines large-scale data as including genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, metagenomic, epigenomic, and gene expression data. Further, the policy clarifies that its requirements apply irrespective of NIH funding level or funding mechanism (e.g., grant, contract, cooperative agreement, or intramural support).

Any investigator who is required or voluntarily wishes to submit data to an NIH repository must first obtain institutional certification to do so. The certification process requires the IRB to review the request to determine, among other things, whether the consent documents permit the retention of samples for future research and, if so, whether they limit the use of the samples in any way (e.g., samples were banked for a particular type of research). If the consent documents do not permit the retention of samples for future research, the IRB likely will require additional action before the samples can be sent to the NIH repository (e.g., contacting subjects for their permission). If the IRB determines that the initial consent forms are not consistent with submission of data to the NIH Repository, the data cannot be provided to the repository.

Any investigator conducting prospective research involving large-scale human genomic data should ensure the consent document informs participants of the intention to share genotype and phenotype information derived from their samples with the NIH repository, describes the information that will be shared, and describes the protections in place to protect their confidentiality. For more information about how the UW-Madison addresses this NIH policy, please see Guidance for the Implementation of NIH Genomic Data Sharing Policy for Human Data.

Upcoming ARROW Changes

Beginning in early May, ARROW will be updated to include the following changes:

ARROW Outages in May

Due to upgrades and maintenance, ARROW will be unavailable the following times:
We apologize for any inconvenience.

Questions? We're Here to Help!

Whether you have a question about a specific protocol, a general question about the submission process, or need clarification about research policy, we have several ways you can reach us.

  • Urgent issues (e.g., subject safety concerns), please call our main line (608-263-2362) and ask to speak with the staff reviewer on call for the day. Please do NOT use email for these kinds of questions.
  • General IRB questions, please call our main line (608-263-2362) to speak with the staff reviewer on call or email asktheirb@medicine.wisc.edu. These are the quickest ways to get help with general questions.
  • Specific questions regarding the status of your review and/or reviewer notes, please contact the staff reviewer assigned to your application.
  • Help with single IRB review and reliance questions, email irbreliance.wisc.edu.

  • Assistance with ARROW or technical questions, email askarrowirb@medicine.wisc.edu.
  • Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing join-hs_irbs_announcements@lists.wisc.edu.
  • WIRB updates, please sign up for the WIRB listsserv by emailing submitwirb@medicine.wisc.edu with a request to be put on the list.
  • Consultations: For investigators seeking assistance on a specific program or application, HS-IRBs staff are available for individual consultations. To request a consultation, complete the HS-IRBs Presentation and Consultation Request Form.
  • Presentations: The HS-IRBs office is available to provide the research community with presentations and trainings on a variety of topics. To request a presentation, complete the HS-IRBs Presentation and Consultation Request Form.