HRPP Newsletter – Winter 2020
IRB Efficiency Project
The UW IRBs recently launched an IRB Efficiency Project (IEP) to implement key changes to the IRB review process. The purpose of these changes is to improve the efficiency and effectiveness of the UW IRBs. In addition, the project aims to reduce administrative burden for the research community, IRB members, and IRB staff, shorten IRB approval times, and improve the IRB experience overall. Project goals are described in greater detail on project goals page.
Recently members of the IEP team have analyzed results of the IEP Researcher Survey that was distributed this past fall and will serve as a baseline by which the project goals will be evaluated. Additionally over the past couple of months, IRB Staff have begun using the Huron Toolkit documents, a set of standard operating procedures, worksheet, and checklists, during IRB review. Please visit the project updates page for the most up-to-date information about the project. Researchers are encouraged to contact the IEP program managers with any questions they may have about the project (Thomas Bechert from Huron and Carol Pech from UW).
New Radiation Safety Webpage
Through working group meetings with representatives from the Office of Clinical Trials, Radiation Safety, UWHC, Office of Research Compliance, Radiology, RELIANT, and IRB Office, a new Environmental Health and Safety (EHS) webpage has been created for radiation safety review in human subjects research. The webpage is still under construction, but now contains the scope of review for Human Radiation Use Committee (HRUC), Radiation Drug Research Committee (RDRC), and WI DHS 157 variance (Appendix M), a flowchart for those reviews, contact information, consent form language, information about changes to approved studies, and more.
With the posting of this new webpage, study teams will have a comprehensive resource outlining when radiation safety review might be needed, who to contact, and how to submit that information. Note that the submission process is still under construction. In the interim, study teams can simply email the needed information to the group email address on the webpage.
New Guidance on External Sharing of Human Subjects Research Data
New Guidance on External Sharing of Human Subjects Research Data has been developed to provide clarity on the processes and agreements needed to share individual-level human subjects data with collaborators or data repositories outside the University of Wisconsin-Madison. This guidance contains information to consider both during the IRB protocol development stage and when working with your Departmental Research Administrator or Dean’s Office to obtain the appropriate agreement.
Professional Research Education Program (PREP) Updates
Looking for professional development opportunities? PREP, an education program for UW-Madison human subjects research personnel, has a broad collection of educational videos available for self-paced learning. PREP courses may also count for continuing education credits needed for professional certification organizations.
In addition, new live webinars are in development for 2021. Several courses are already available for registration on the OHRD Catalog:
• Feb. 2: Clinical Research Data Service — Resources for Counts and Recruitment
• Feb. 24: Engaging with LGBTQ+ Populations in Research
• April 15: Onboarding and Turnover
If you have questions about PREP or would like to receive email updates about upcoming PREP courses, please email Emily Putman-Buehler.
UW ClinicalTrials.gov Service Line
The UW has recognized the need for a centralized ClinicalTrials.gov (CT.gov) service to assist PIs with required CT.gov registration, maintenance, and results reporting process. You can contact the UW CT.gov Specialists at CT.gov_Help@clinicaltrials.wisc.edu. They have also created the Investigator Guidance to ClinicalTrials.gov document to familiarize study teams with this public database.
This service is free of charge to study teams who would like assistance.
What is ClinicalTrials.gov?
CT.gov is an online clinical study registry and results database for participants, their families, health-care professionals, researchers, and the public to access information about research studies involving human volunteers. The intention of CT.gov is:
- To fulfill an ethical obligation to participants, their families, and the research community by providing timely protocol amendments and meaningful results
- To connect participants with clinical trial opportunities
- To provide a public mechanism to identify and understand the evidence base for specific biomedical questions
- To improve the evidence base by addressing publication bias; a large percentage of non-favorable trial results are not reported or refused publication
- To promote scientific integrity and transparency
- To ensure appropriate allocation of research funds
- To help IRBs determine the appropriateness of a research study
UW Guidelines for ClinicalTrials.gov Records
The UW expects all clinical trials that are required by FDAAA Law, NIH Policy, and CMS Policy be registered, maintained in compliance, and that results be reported to CT.gov, as applicable:
- Requirement for trial registration is determined by the Principal Investigator in the IRB application via ARROW and subsequently audited by the VCRGE CT.gov Committee
- UW requires the Principal Investigator to be listed as the ClinicalTrials.gov Record Owner and the study’s Sponsor as the Responsible Party
If you would like to receive notifications for new HRPP Newsletters, you can subscribe to our distribution list by emailing HRPP@research.wisc.edu.
The two campus IRB offices maintain newsletters with information and announcements relevant to their researchers.