Symposium for Research Administrators University of - - PowerPoint PPT Presentation

Symposium for Research Administrators

University of Wisconsin-Madison October 8th, 2019

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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

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Key steps in Activation Pathway

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Study Inception

• Novel idea
• Feasibility
• Discover

Funding Opportunities Study Design

• Protocol
• HIPAA
• Consent Form
• Patient

Materials

• IRB Application

Approvals

• IRB
• Ancillary

committees

• Other

requirements

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Study Inception-Is this project fe

feasible?

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Patient Population Credentials Space Innovative and Novel Fiscal

Components to Success

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Departmental Feasibility Attestation

Best Case Scenario Usual Scenario Your Department’s Scenario

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Tr Training: HIPAA & Human Subjects Protection

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HIPAA training UW Biomedical, Social and Behavioral, and VA training Study team member training status (or in ARROW, click on “View Study Team Training”)

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Training Snapshot

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Training Snapshot

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Link directly to the required training

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IRB Application- Regulations and Policies

(who says we have to do that?)

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Common Rule – most federally funded research Food & Drug Administration (FDA) Health Insurance Portability & Privacy Act (HIPAA) Privacy Rule State Laws UW-Madison

HRPP polices IRB guidance

Veterans Administration (VA)

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IRB Application

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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.

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Human Subjects Protocol

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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.

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Human Subjects Protocol

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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.

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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

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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!

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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

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Step 4: Provide Justification

Do not assume the IRB knows what you are doing

• r why

When asked for justifications or explanations, provide them

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Recent Changes to Reduce Administrative Burden

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Funding and IRB Congruence

• Certification is confirmation by PI to RSP

(and RSP to NIH) that they have (or will have for activities late in the project) IRB approval for work proposed in the grant

• RSP uses PLuS to confirm that the IRB

application in the WISPR record is approved.

Congruence no longer required, but certification of IRB approval is

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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.

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New funding page

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New funding page

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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
• r 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.

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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

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Ancillary Committees and Other Requirements to Consider

Cybersecurity/ Clinical Research Data Service (CRDS) Scientific Review Committee Protocol Review Monitoring Committee Research and Sponsored Programs (RSP) Radioactive Drug Research Committee (RDRC) OnCore/Ancillary Service Review/Medicare Coverage VA R&D Committee

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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)

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What Questions Do You Have?

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