HRPP Newsletter September 2023
New HIPAA Guidance in Investigator Manual
The Investigator Manual has been updated to now include a comprehensive guide to HIPAA Processes and Documentation. This section includes information on remote authorization processes, when and how to request waivers of authorizations, and data use agreements, among others.
Interested in Serving on the IRB?
Do you have colleagues, friends, or family who may be interested in serving on the IRB? If so, please forward on our newly launched webpage for both UW-affiliated and unaffiliated individuals from the community who have an interest in IRB membership. Please also feel free to distribute to your departments/divisions/sections as we are always looking for new members!
Upcoming Education Opportunities
CTI: Clinical Research Q&A
9/14, 12:30-1:30pm, Online
Engage with leaders within the UW clinical research community at this open Q+A ‘Research Forum’. This is an opportunity to ask questions about clinical research-related topics such as the IRB, informatics, and clinical trials.
CTI: ClinicalTrials.gov Results Reporting
9/18, 12:00-1:00pm, Online
The UW ClinicalTrials.gov Service will review the requirements around whether summary results are due to ClinicalTrials.gov, the data that are expected to be reported, and a typical timeline for the results reporting process.
PREP: Multi-Site Research and Reliance Agreements: Factors for Serving and Ceding and the Communication and Processes Involved When Collaborating with External Research Partners
9/19, 11am-12pm, Online
The goal of this presentation is to inform research staff of the different factors that influence the IRB review of multi-site projects and trigger the need for reliance agreements. We will discuss what “reliance” means and the role of the Reliance Team in assisting study teams. This course will provide information regarding the single IRB (sIRB) application and its usefulness for multi-site projects. We will also discuss the importance of communication and responsibilities when participating in multi-site research. Finally, the course will provide the perspective of a study team utilizing UW-Madison as the reviewing IRB with a focus on how the study start-up process goes for a multi-site study and how to build relationships with study sites.
PREP: NIH Data Management and Sharing (DMS) Policy: Overview and Local Implementation
10/3, 11am-12pm, Online
NIH issued the Data Management and Sharing (DMS) policy to promote the sharing of scientific data. Effective for NIH grant applications starting January 25, 2023, this policy requires that researchers producing scientific data submit a DMS plan as part of their grant proposals. This presentation will provide an overview of the policy, the process for creating a DMS plan, and what to consider for IRB applications and informed consent documents. The presenters will highlight resources available at UW-Madison to help researchers carry out their obligations under the policy, including resources for writing DMS plans and identifying repositories within which to share data. There will also be time for Q&A.
IRB for Beginners Workshop
10/4, 2pm-3pm, Online
This workshop offers an overview of the IRB process and review procedures, including information on required training, steps to completing and submitting an IRB application with supporting documents, resources you can consult for more information, the IRB’s overall review process, and some tips and tricks to avoid delays in approval.
PREP: Perspectives on Diversity, Equity, and Inclusion for Recruitment and Retention
10/12, 11am-12pm, Online
This session will explore the methodology of a current pediatric research laboratory aiming to increase recruitment diversity. The presenter will detail the ongoing journey of broadening research opportunities for historically marginalized communities (HMC). Discussions will address potential barriers and facilitators of effective communication with families in a research setting. The presenter will identify opportunities to prioritize diversity, equity, and inclusion (DEI) in research recruitment, participation, and retention and will share the experience of building community partners, designing and distributing recruitment materials with the audience in mind, and review specific examples of DEI initiatives in recruitment and retention efforts.