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.
- 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 (firstname.lastname@example.org 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 UW-Madison Fee Schedule 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:
- UW-Madison's [Link for document 34404 is unavailable at this time] that describes how research data are to be maintained, archived, and made available for review and use under the appropriate circumstances.
- A Research Close-Out Checklist that provides general guidance for researchers who may be leaving the University.
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 email@example.com. Please include "informed consent feedback" in the subject line.