HS-IRBs News April 2013

Health Sciences and Minimal Risk IRBs, IRB News / Volume 5, Number 4, April 2013

HS-IRBs Staff Updates

Several HS-IRBs staff are currently on leave, including Molly Lumley, Anna Martin, and Brooke Mechelke. Submissions being reviewed by these staff members have been reassigned to other members of the HS-IRBs staff. If you have question about these submissions, please contact the staff reviewer listed in the submission workspace in ARROW. If you are not sure who to contact, please email asktheirb@medicine.wisc.edu for assistance.

ARROW Helpline Voicemail Support Ending April 29th

As previously announced, voicemail support for the HS-IRBs' ARROW helpline is being phased out. We will continue to provide email support for ARROW through askarrowirb@medicine.wisc.edu. ARROW guidance documents also are available on the Health Sciences IRBs ARROW Help page.

As of April 29th, voicemails to the ARROW helpline will no longer be accepted. All ARROW questions for the HS-IRBs should be directed to askarrowirb@medicine.wisc.edu. The ARROW helpline number will be disconnected in June.

If you have any questions about these changes to the ARROW helpline, please email Carol Pech (cap@medicine.wisc.edu).

New Guidance: Completing a Non-Exempt Medical Records Review Application

A new guidance document has been created for study teams to use when completing a non-exempt medical records review application in ARROW. Completing Non-exempt Medical Records Review applications in ARROW outlines specific questions pertinent to the non-exempt medical records application type and provides suggested responses to these questions. 

This guidance document is meant to be used for straightforward non-exempt medical records review studies. If study teams have a unique, complex, or multi-site records review study, the new guidance document may not address the specific aspects of the study that need to be communicated to the IRB. In these cases, please contact the HS IRBs Office directly for assistance. In addition, the guidance document includes suggested responses only. Study teams should use these responses as a starting point for answering the application questions. Any pertinent study-specific information must be incorporated into the responses by the study team.

WIRB Survey and Quality Improvement Project

Thank you to all who responded to the recent survey regarding WIRB review processes, both internal and external to the UW. The survey was part of our quality improvement efforts related to WIRB processes that was launched in February 2013. Your feedback will help shape the changes we make and what components of the process receive priority attention. We plan to have a follow-up to the survey later this year.

Several changes are already in progress that will be rolled out this year. Changes already implemented include those to the documentation of study personnel training as well as expanding the use of WIRB for phase I studies that are fully industry-sponsored.

Changes to Campus Policy on Existing Data Sets

The campus policy on existing data sets has been revised. Previously the policy provided a list of data sets that could be used for research without the need to obtain an exemption or approval from an IRB because the data from these sources did not meet the federal definition of research involving human subjects. Although this list is still available, the policy was broadened to outline the conditions under which the analysis of secondary data does not require prior IRB approval. IRB approval or exemption is not required in the following situations:

  1. The data sets are published and publicly available without restriction (e.g., data are published by a reputable source in a publicly-available journal, textbook or web-site) and neither the UW researcher nor any collaborating researcher on the project(s) has access to links that would connect the data to the individuals from whom they were derived.
  2. The data sets are publicly available to researchers and others, but the data holder requires a “responsible use statement” or similar attestation to ensure appropriate use and protection of the data. Such an agreement or attestation may be automated. In this case, neither the UW researcher nor any collaborating researcher on the project can have access to any links that would connect the data to the individuals from whom they were derived, nor may any researcher on the project attempt to re-identify any person from whom the data were derived.
  3. The researcher will obtain a data set available from a Federal or State agency and will enter into an agreement with the data provider that includes language that a) the data provided to the researcher does not contain any identifiers, including those specified under the HIPAA Privacy Rule; b) if the data are coded, the data provider will not release a link to the code to the researcher; and c) the researcher receiving the data set must agree to not attempt to re-identify any person from whom the data were derived.
Data satisfying one or more of the above criteria do not meet the definition of research involving human subjects under the federal Common Rule, 45 CFR Part 46 and UW-Madison policies, and, therefore, does not require IRB review. NOTE: Research projects that merge more than one data set in such a way that individuals may be identified are not covered by this policy and require prior IRB approval.

Revised Checklist of VA Regulations for IRB Review

If you are a member of a study team that works with research under VA purview, you may find it helpful to review the Checklist of VA Regulations for IRB Review. This checklist is used by the IRB when it reviews VA research to ensure that VA-specific requirements are met. This checklist also may help study teams identify and proactively address VA-specific requirements.

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.

  • For 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.
  • For 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.
  • For assistance with ARROW or technical questions, email askarrowirb@medicine.wisc.edu.
  • To receive the newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing join-hs_irbs_announcements@lists.wisc.edu.
  • To receive updates about WIRB, 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.

Keywords:newsletter, helpline, medical records, WIRB, existing data sets, datasets, VA checklist,   Doc ID:29468
Owner:Carol P.Group:Health Sciences IRBs
Created:2013-04-15 13:21 CDTUpdated:2015-06-09 16:14 CDT
Sites:Health Sciences IRBs
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