HS-IRBs News December 2016
Health Sciences and Minimal Risk IRBs, IRB News / Volume 8, Number 12, December 2016
HS-IRBs Office ClosuresThe HS IRBs Office will be closed the following days in December and early January:
- December 26th: The office will be closed in observance of the Christmas holiday. WIRB offices will also be closed.
- January 2nd: The office will be closed in observance of the New Year's holiday. WIRB offices will also be closed.
New and Updated Guidance DocumentsThe Guidance and SOP Working Group (GSWG) has two new documents:
- Deception Guidance: While deception can be an effective tool for the conduct of research, it also raises ethical concerns with subject autonomy and respect for persons, as well as regulatory issues with informed consent requirements. The purpose of this new guidance document is to help researchers identify and plan for the use of deception in research.
- Updating Name and Contact Information in ARROW: This FAQ answers common questions posed by study teams regarding name changes, merging NetIDs, and email address updates.
Implementation Date Change for NIH Single IRB RequirementPer NOT-OD-17-027, the NIH requirement for single IRB review for multisite research funded by NIH will be effective September 25, 2017. This is a change from the previous May 25, 2017 implementation date. This policy will apply only to studies where the same research protocol is conducted at all study sites. Multisite studies currently ongoing will not need to comply with this policy until a competing renewal application is submitted. Guidance from NIH regarding key questions such as costs for single IRB review and what information about single IRB review needs to be included in grant applications and proposals is pending. The HS IRBs Office is very involved in the national discussions about implementation of this new policy, and we will provide further information when available. In the meantime, researchers are encouraged to contact the HS IRBs Reliance Team with any questions regarding IRB oversight for collaborative and multisite projects.
Improving IRB Processes for ResearchersAs part of our continuing efforts to improve processes within the HS IRBs Office, IRB staff will be part of a new Noncompliance/Corrective and Preventive Action Plan working group on campus. The group will also consist of members of ICTR and the Office of the Vice Chancellor for Research and Graduate Education (VCRGE). Goals will include developing resources for study teams that need to develop a corrective action plan since there is currently little guidance to conduct root cause analyses, etc. The group has drafted several documents as a starting direction for study teams that are struggling.
- Preventing Noncompliance Guidance: Achieving compliance can be difficult for even diligent study teams due to the highly technical nature of research and the involvement of research participants with complex medical or life situations.The purpose of this document is to outline steps that research teams should take throughout the life cycle of the study to prevent noncompliance.
- Investigating the Cause of Noncompliance and Implementing CAPA Plans Guidance: Corrective and Preventive Actions (CAPA) are developed and implemented for more significant or systematic noncompliance, once the root cause is known. This document provides guidance for study teams regarding how to develop a CAPA Plan.
- Developing an Internal Quality Assurance (QA) Program Guidance: Every study should have internal QA processes and procedures in place to ensure compliance with the research plan and subject safety while efficiently collecting high quality data. This document describes self-auditing and continuous improvement processes, and it lists UW-Madison resources to factor in a QA program.
CT.gov UpdateThe final NIH Policy requires studies that receive NIH funding in whole or in part and that meet the definition of a clinical trial need clinicaltrials.gov language included in the consent form as well as registration on the clinicaltrials.gov website. NIH defines a clinical trial as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” If you have questions about this requirement, please contact CT.gov Support, Office of Research Policy at 608-890-1241 or ClinicalTrials.gov_Support@research.wisc.edu.
- 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 email@example.com. 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 firstname.lastname@example.org.
- Assistance with ARROW or technical questions, email email@example.com.
- Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing firstname.lastname@example.org.
- 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.