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