HS-IRBs News September 2015

Health Sciences and Minimal Risk IRBs, IRB News / Volume 7, Number 9, September 2015

Important: Proposed Changes to Human Subjects Research Regulations Announced

The Department of Health and Human Services has released its notice of proposed rulemaking (NPRM) regarding significant changes to the Common Rule, the federal regulations that govern human subjects research. The proposed revisions affect a broad range of research and study teams are encouraged to review the proposed changes and provide comments. The revised Common Rule and supporting documents are are available on the OHRP website.

The campus HRPP (Human Research Protection Program) is considering holding some information sessions for researchers regarding the proposed changes to the Common Rule. These will be announced in a future newsletter and via the HS IRBs listserv.

HS IRBs Office Staff Updates


  • Curtis Ryals, IRB staff reviewer, left the HS IRBs Office at the end of August. Curtis is focusing on completing his Master’s Degree in Bioethics from the Medical College of Wisconsin. We want to thank Curtis for all of his hard work with the HS IRBs Office and wish him all the best in his future endeavors.
  • Chelsea Dahmen, IRB staff reviewer, left the HS IRBs Office in mid-September. Chelsea has taken a position as the Compliance Manager for the UW Comprehensive Cancer Center. Many thanks to Chelsea for her service to the HS IRBs Office over the past few years, particularly as the ARROW specialist and then as a staff reviewer. We wish Chelsea all the best in her new position.

Filling In

  • We will be re-assigning Curtis' and Chelsea’s applications to other staff reviewers as needed. Questions about any IRB application items that Curtis or Chelsea previously reviewed can be directed to Gretchen Anding (gla@medicine.wisc.edu or 263-4170).

Reminder: Changes in Western IRB (WIRB) and UW IRB Fees

Dean Marc Drezner, Senior Associate Dean for Clinical & Translational Research in the School of Medicine and Public Health (SMPH), recently issued two memoranda regarding IRB fees. One memorandum describes changes to the WIRB fee process and the other provides clarifications regarding the School of Medicine and Public Health's IRB fee policy for studies reviewed by a UW Health Sciences IRB. These new fee schedules go into effect September 1, 2015 and apply only to NEW studies submitted for WIRB or UW IRB review. Please note while all studies that are fully industry-sponsored are charged a fee for IRB review, only certain studies conducted by investigators under their SMPH appointments are assessed an IRB review fee. The new IRB review fee memoranda, as well as prior fee schedules, are available on the IRB Fee Policy page of the HS IRBs' website. If you have questions about these changes, please contact the HS IRBs' fee point person, Faye Levine (263-4922).

New FAQ and Consent Template for Exempt Research Studies

Although not required by federal regulations, UW-Madison policy requires a consent process for exemptions when there is some kind of interaction with subjects, such as in most research involving interviews, surveys, or focus groups. This new FAQ describes how and when to get subjects’ consent for participation in exempt research. The FAQ also links to a new consent template designed for use with exempt research studies. The new FAQ and consent template are part of an ongoing effort by the HS IRBs Informed Consent Working Group to improve informed consent-related guidance for the research community.

Closing Studies at UW-Madison

A new Study Closure policy for human subjects research has been adopted by campus. This policy describes when studies that have been approved by an IRB should be closed and references two resources that may be helpful for researchers:

Reminder: HS IRBs Informed Consent Working Group Wants to Hear from You!

HS IRBs staff are working to revise and improve the informed consent form templates and informed consent-related guidance for the research community. We need your suggestions and ideas so we can create templates and guidance that are most helpful for you. Please provide your feedback and suggestions by emailing asktheirb@medicine.wisc.edu. Please include "informed consent feedback" in the subject line.

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, listserv, informed consent, closure, fees, common rule, NPRM, exempt   Doc ID:56472
Owner:Carol P.Group:Health Sciences IRBs
Created:2015-09-16 12:35 CDTUpdated:2015-10-20 13:55 CDT
Sites:Health Sciences IRBs
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