Symposium for Research Administrators University of Wisconsin-Madison October 8 th , 2019 1
Na Navigating t g the R Road f from R m Research ch I Idea to to Human Subjects Study Activation Lisa Werning Lynn Haynes 2 University of Wisconsin - Madison
Key steps in Activation Pathway Study Inception Study Design Approvals • Novel idea • Protocol • IRB • Feasibility • HIPAA • Ancillary committees • Discover • Consent Form Funding • Other • Patient Opportunities requirements Materials • IRB Application 3 University of Wisconsin - Madison
Study Inception-Is this project fe feasible ? Patient Population Fiscal Credentials Components to Success Innovative Space and Novel 4 University of Wisconsin - Madison
Departmental Feasibility Attestation Best Case Scenario Usual Scenario Your Department’s Scenario 5 University of Wisconsin - Madison
Tr Training : HIPAA & Human Subjects Protection UW Biomedical, Social and Behavioral, and VA HIPAA training training Study team member training status (or in ARROW, click on “View Study Team Training”) 6 University of Wisconsin - Madison
Training Snapshot 7 University of Wisconsin - Madison
Training Snapshot Link directly to the required 8 training University of Wisconsin - Madison
IRB Application- Regulations and Policies (who says we have to do that?) Health Insurance Common Rule – Food & Drug Portability & most federally Administration Privacy Act (HIPAA) funded research (FDA) Privacy Rule Veterans UW-Madison Administration State Laws HRPP polices (VA) IRB guidance 9 University of Wisconsin - Madison
IRB Application Keys to Success - Help your investigator decide if their study needs IRB review and/or Oversight Research + Human Subjects = Oversight See: Activities Requiring oversight on HRPP web page Many studies are “not human subjects” or are “exempt” (per federal • definitions), but STILL NEED IRB review to make determination. Use the guidance and program evaluation self-certification tools • (HSIRBs or ED/SBS) to help decide if submission to IRB is required. 10 University of Wisconsin - Madison
Human Subjects Protocol Keys to Success- If you need a protocol - WRITE AN EXCELLENT PROTOCOL Many applications to HSIRBs need a formal written protocol • WHY? Because a protocol provides a comprehensive roadmap of the study for • all stakeholders. A reader should be able to conduct a study from start to finish based on the protocol. It is an account of study conduct and execution, including objectives, • design, procedures, measures, study management, data acquisition and analysis and ethical considerations. 11 University of Wisconsin - Madison
Human Subjects Protocol Keys to success- Know the difference between a Grant, Protocol and IRB application ü Grant describes the science ü Protocol is a roadmap of the implementation of the humans subjects research components of the grant ü IRB application is a collection and organization of key features of the protocol primarily addressing the protection of human subjects. Use templates – ICTR has a protocol development service and has • started to post templates. USE them to capture all appropriate information for your study. 12 University of Wisconsin - Madison
Step 1: Outline and Explain Study Procedures Focus application on activities subjects will undertake Describe activities – do not assume activities are universal Leave information on analysis in the protocol Use white space and headings University of Wisconsin - Madison
Step 2: Identify Risks of the Study Consider the risks posed to subjects by procedures AND analyses Describe physical risks and discomforts • Include common and rare but serious risks Describe psychosocial risks • Breach of confidentiality at a minimum! University of Wisconsin - Madison
Step 3: Describe Procedures to Minimize Risks Show the IRB how you are minimizing all risks Address both immediate risks and delayed risks Research Requirements ≠ Clinical Requirements University of Wisconsin - Madison
Step 4: Provide Justification Do not assume the IRB knows what you are doing or why When asked for justifications or explanations, provide them University of Wisconsin - Madison
Recent Changes to Reduce Administrative Burden University of Wisconsin - Madison
Funding and IRB Congruence • Certification is confirmation by PI to RSP Congruence (and RSP to NIH) that they have (or will no longer have for activities late in the project) IRB required, but approval for work proposed in the grant • RSP uses PLuS to confirm that the IRB certification of application in the WISPR record is IRB approval is approved. University of Wisconsin - Madison
How to Facilitate Certification and Release of Funding Add your IACUC/IRB protocols to WISPER records first. Use the new “chooser” to select all funding supporting the research. University of Wisconsin - Madison
New funding page University of Wisconsin - Madison
New funding page 21 University of Wisconsin - Madison
Study team activities In ARROW, the new chooser filters the funding for that PI, with the most recent proposals at the top. • If you do not see the expected funding, you can search by PI, MSN, grant number or title. • NOTE: for some studies (pilot awards from the cancer center or ICTR), study teams can select the primary grant (ie the Cancer Center grant or the CTSA award for ICTR) if that grant is ultimately supporting the project. University of Wisconsin - Madison
What happens at IRB? Administrative review will confirm that associated funding appears to be appropriate for the study (PI, grant title seems appropriate for the IRB application). Admin review may request information about peer review from study team for novel foundations. IRB does NOT need grant application or confirmation of approval/JIT materials University of Wisconsin - Madison
Ancillary Committees and Other Requirements to Consider Cybersecurity/ Protocol Review Research and Clinical Research Scientific Review Monitoring Sponsored Data Service Committee Committee Programs (RSP) (CRDS) OnCore/Ancillary Radioactive Drug Service VA R&D Research Review/Medicare Committee Committee (RDRC) Coverage 24 University of Wisconsin - Madison
25 University of Wisconsin - Madison
Resources • FAQ for scientific review: https://kb.wisc.edu/hsirbs/94085 • Changes to Congruence review: https://kb.wisc.edu/hsirbs/93382 • General Research questions: https://research.wisc.edu/ • HIPAA training: https://compliance.wisc.edu/hipaa/training/ • UW Biomedical, Social and Behavioral, and VA training: https://research.wisc.edu/compliance- policy/human-research-protection-program/hrpp-training/citi-human-subjects-protections-hsp- training-instructions/ • HS-IRB KB: https://kb.wisc.edu/hsirbs/ • Questions about Chooser: Andrew Drinkwater (Andrew.drinkwater@wisc.edu) • Questions about invoicing (industry sponsored studies): Vielska BRAUTIGAM ( vielska.brautigam@wisc.edu ) • Questions about certification/congruence requests: Lynn Haynes (Lynn.haynes@wisc.edu) University of Wisconsin - Madison
What Questions Do You Have? 27 University of Wisconsin - Madison
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