HS-IRBs News August 2012
Health Sciences and Minimal Risk IRBs, IRB News / Volume 4, Number 8, August 2012
HS-IRBs Office Closed September 3rd
The HS-IRBs office will be closed for the Labor Day holiday on Monday, September 3rd. The ARROW helpline also will not be staffed on September 3rd.
New: Responsibilities for Study Teams When IRB Oversight Is Deferred
A new document has been added to the Multisite Research page on the HS-IRBs website that describes study team responsibilities for studies for which IRB oversight has been deferred to a non-UW-Madison IRB. Although such studies are overseen by a non-UW-Madison IRB, study teams still must follow applicable UW-Madison requirements, including:
- Following the requirements of UW-Madison ancillary committees (e.g., conflict of interest committee) as applicable
- Reporting funding changes to the IRB of record and providing Research and Sponsored Programs (RSP) with documentation that a study has been deferred to a non-UW-Madison IRB, if requested by RSP
- Potential unanticipated problems, serious adverse events, or noncompliance that occur at UW-Madison or UW Health sites must be reported to the Health Sciences IRBs in addition to the IRB of record
Please see Study Team Responsibilities When IRB Oversight Is Ceded to an External IRB for the complete list of study team
New Guidance: Timeframe for Submission of Changes of Protocol to the IRB
Because many study teams were not aware of the institutional policy that requires submission of changes of protocol from external sponsors to the IRB within 60 days of their receipt, the HS IRBs have issued the guidance document, Timeframe for Submission of Changes of Protocol to the IRB. This document describes when changes of protocol should be submitted to the IRB and the mechanisms for submission to the IRB if the change is the result of new information or was implemented prior to IRB approval in order to eliminate an apparent immediate hazard to subjects.
New: Who to Contact with Reportable Event Questions
Jessie Johnson is now serving as the IRB lead staff reviewer
for reportable events. Study teams with questions about reportable events
(e.g., noncompliance, new information reports, unanticipated problems) should contact Jessie directly rather than relying on the HS-IRBs general point
of contact system. Jessie can be reached
at 263-0385 and firstname.lastname@example.org.
New Guidance: Drug Shortages and Substitutions That Occur During the Conduct of Research Studies
The HS-IRBs have issued new guidance regarding IRB issues related to drug shortages or substitutions that can occur during a research study. Whether the IRB
needs to be informed of the drug shortage or substitution depends on whether
sites under UW-Madison purview will be affected. If UW-Madison sites are
affected, the guidance document describes how to report this information to the
IRB. Please see Guidance Regarding Drug Shortages and Substitutions that Occur During the Conduct of Research Studies for additional information.
SBS/ED IRBs Piloting ARROW
The SBS and ED IRBs are now piloting ARROW with a small number of study teams. Beginning October 1st, all study teams submitting to the SBS and ED IRBs will need to submit their applications through ARROW. No ARROW applications - other than from the pilot group - will be accepted by the SBS and ED IRBs prior to October 1st.
The SBS and EDIRBs also will have their own ARROW helpline and email address separate from the HS-IRBs helpline. For questions about SBS or ED IRB submissions in ARROW, please contact their helpline at 608-890-4898 or email@example.com.
Reminders about the Human Subjects Research Training Requirement
The HS-IRBs office has recently several questions about the human subjects research training requirement. The requirement for all study team members to complete human subjects research training has been in place since 2005 and has been part of the Summary of Investigator Responsibilities for at least as long. The requirement to check training in ARROW prior to submitting personnel changes and initial review applications is recent, but the requirement to have complete and current training is not.
Please see the Training & Education page for information on training requirements and links to the CITI module.
Revised Guidelines for Deferring IRB Review
The HS-IRBs guidelines for deferring IRB review have been revised to clarify several points, including when the HS-IRBs will not defer IRB review as well as what study teams need to do before submitting a deferral request. The guidelines also now include a new 2 month deadline for developing IRB deferral agreements from the date a deferral request is received. Please see Guidelines for Ceding IRB Review to an External IRB for more information. If you have questions about a deferral request, please contact Carol Pech or Molly Lumley.
Genetic Information and Nondiscrimination Act (GINA) Guidance
2008 a federal law called GINA was implemented. This law prohibits
discrimination in health coverage and employment based on genetic information,
but has some limits. Studies that involve genetic analysis should include
language about GINA and its protections and limitations in relevant consent
forms. The HS IRBs posted Genetic Information and Nondiscrimination Act (GINA) Guidance that explains GINA and includes required consent form language for studies that involve genetic research.
- 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 firstname.lastname@example.org. 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 email@example.com.
- Assistance with ARROW or technical questions, email firstname.lastname@example.org.
- Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing email@example.com.
- 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.