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 (email@example.com).
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:
- A new IRB Reliance Terms and Definitions glossary.
- Updated guidance on [Link for document 49389 is unavailable at this time.] .
- Updated guidance on when the HS IRBs will serve as IRB of record or cede IRB review to another IRB.
- A new Single IRB Review Partners page providing information on the IRB reliance partnerships in which the HS IRBs currently participate.
If you have questions about these changes or any IRB reliance issues, please contact the HS IRBs Reliance Team (firstname.lastname@example.org).
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:
- Identifying what IRB oversight requirements may apply to studies involving multiple sites or personnel outside the UW, including community partners.
- Assisting study teams with navigating the review process for different IRB reliance partnerships (e.g., WIC, Meriter).
- Facilitating the processing of IRB authorization and independent investigator agreements.
- Fostering collaborative research by coordinating communication with other institutions regarding IRB oversight issues.
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 RequirementsThe 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:
- The principal investigator (PI) and points of contact will still be listed on the first page of the application, but will no longer be able to be listed on the study team member access page of the initial review application. Any person listed as a PI or point of contact will still automatically have edit access rights to the IRB application and be able to be listed on the study team member roles page (e.g., where study teams list who obtains informed consent). This change is being made to avoid personnel being listed in more places in the application than necessary.
- Changes to the accounting point of contact will be able to be made as part of personnel changes rather than needing to be submitted with an expedited or full change of protocol.
ARROW Outages in MayDue to upgrades and maintenance, ARROW will be unavailable the following times:
- May 9th: 1PM to 5PM
- May 16th: 6AM to 6PM
- 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 email@example.com. 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 firstname.lastname@example.org.
- Assistance with ARROW or technical questions, email email@example.com.
- Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing firstname.lastname@example.org.
- 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.