PREP Course 10: Electronic External Interests Review & The HRPP Review Process Presented by: Hallie Kassan Scott Beardsley Gerry Kassoff

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1 PREP Course 10: Electronic External Interests Review & The HRPP Review Process Presented by: Hallie Kassan Scott Beardsley Gerry Kassoff January 18,

2 CME Disclosure Statement The Northwell Health adheres to the ACCME s new Standards for Commercial Support. Any individuals in a position to control the content of a CME activity, including faculty, planners, and managers, are required to disclose all financial relationships with commercial interests. All identified potential conflicts of interest are thoroughly vetted by the Northwell Health for fair balance and scientific objectivity and to ensure appropriateness of patient care recommendations. Course Director and Course Planner, Kevin Tracey, MD and Tina Chuck, MPH have nothing to disclose. Hallie Kassan, Scott Beardsley and Gerry Kassoff have nothing to disclose. January 18,

3 Objectives Identify COI requirements in human subject research Review how our unique electronic platform and tiered review may be best utilized by researchers to reduce administrative burden January 18,

4 January 18,

5 Purpose of External Interests Review Promote objectivity and mitigate actual or perceived bias in research Provide guidance and education on how to comply with local policies and federal regulations Aid in maintaining the public trust in the mission of Northwell Health and its facilities. January 18,

6 January 18,

7 Paper Problems 1. Administrative Burden: High 2. Accessibility of information: Low 3. Opportunity for errors: High THE CHALLENGE: Build a more efficient process January 18,

8 Tiered Review Process 1. Admin review No significant financial interests reported 2. Expedited review Conducted by the COI Committee chair or a designee. 3. Full Committee review Reserved for cases where a standard management plan is inadequate or; When Northwell has a direct financial interest in the companies or products involved in research taking place at Northwell. January 18,

9 Going Electronic January 18,

Consistency across platforms COI Smart CMS Open Payments era

10 Compliance Pitfalls Minimum requirement is annual submission Updates must be submitted within 30 days of changes to your SFIs Consistency across platforms COI Smart CMS Open Payments era Commons COI submissions to industry sponsors and external IRBs January 18,

Audience Participation You are tasked with gathering all of the required information for your PI s progress report/continuing review submission to the IRB.

11 Audience Participation You are tasked with gathering all of the required information for your PI s progress report/continuing review submission to the IRB. The study is sponsored by AbbyZabby Pharma, Inc. The PI last submitted an external interest disclosure form via COI Smart 8 months ago, and has a management plan. You ask for a copy from the PI and it does not list AbbyZabby. Open Payments data was released four months ago and your PI is reported as accepting $100K in general payments last year from AbbyZabby. WHAT SHOULD YOU DO? January 18,

12 COI requirements for Clinical Research Protocols Must have current annual disclosure on file If disclosure is missing or expired: o For co-investigators they cannot participate in the study until the current disclosure is on file o For PIs study will not be approved until PI completes his/her disclosure. 12

13 Finding COI Disclosure Dates On Feinstein website: 13

14 How do I communicate my COI disclosure date to IRB/HRPP? COI disclosure dates are automatically loaded into IRBmanager Same fields exist any time you add personnel new studies, modifications or continuing review 14

15 What if someone on the study team has a management plan? Answer is yes Alerts HRPP staff to check MP in COI Smart HRPP staff confirm that MP is being applied correctly 15

16 Northwell IRB review of Management Plans (MPs) Review the MP as issued by the COI committee Determine if MP ok as is, or if extra precautions are necessary 16

17 External IRB review and Management Plans HRPP staff will perform the same COI review for studies that are being reviewed by an external IRB MP issued by COI Committee applies regardless of which IRB reviews your study. 17

18 Conflict Mitigation Possible Management Plans Remedies are based on the severity of the potential COI, level of risk of affected studies, and involvement of human subjects. Add language to the consent form Investigator cannot participate in obtaining consent Investigator cannot recruit for a study 18

19 Appeals If you do not agree with this management plan you may alternatively divest yourself of the interest or decline participation in studies involving these companies. If the individual disputes the terms and conditions of a management plan the case will be referred to the COI Committee for resolution. Study activities may not take place until the MP dispute has been resolved. 19

20 Thank you. Questions?? Contact: 20

PREP Course #11: Interactions with Industry What Most Docs Ask About

PREP Course #11: Interactions with Industry What Most Docs Ask About Presented by: Lou DiGiovanni, Corporate Compliance & Emmelyn Kim, Research Compliance January 23, 2018 1 CME Disclosure Statement The