Trinity Health of New England Corporation, Inc

Trinity Health Of New England Corporation, Inc.

Standard Conflict of Interest Management Plan for

Financial Interests in Research IRB TITL # E Individual w/SFI Sponsor Primary Dept. Affiliation PI Date of Plan

In view of my Financial Interest (FI) in (specify name of company and/or describe technology being evaluated),

Financial Interest >$5,000 and <$50,000

Financial Interest > $50,000

I agree to the following components of a plan to manage my conflict of interest with respect to the above-named protocol.

1. I will not serve as Principal Investigator (PI) on this protocol, although I may serve as a co-investigator. The PI selected must be approved by the IRB. As a co-investigator, I will be responsible for: (describe role on study).

2. I will not be involved in the recruitment of subjects.

3. I will not obtain the subjects' informed consent.

4. I will not solely obtain the subjects' informed consent and I will allow a clinical research nurse to be involved in the consent process.

5. I will not engage in the collection and recording of research data.

6. I will not be involved in clinical assessments of study eligibility criteria and intervention outcomes.

7. I will not participate in data and safety monitoring activities.

8. I will not participate in data analysis.

9. I will not solely be involved in the interpretation of study results, although I may be involved as part of a committee that evaluates study results. Final decisions about the

of 2 Trinity Health Of New England Corporation, Inc.

Standard Conflict of Interest Management Plan for

Financial Interests in Research appropriate interpretation and presentation of research results shall be the responsibility of the PI.

10. I will allow an independent Data and Safety Monitoring Board, or someone external to Saint Francis Care to oversee the conduct of the study, or evaluate study outcomes or adverse events.

11. The existence of my Financial Interest will be disclosed in the informed consent

12. I will disclose my financial interest to the appropriate co-Investigators, members of the research group, and students.

13. I will disclose the existence of my Financial Interest in any abstracts, presentations, press releases, or publications and in any proposals or applications for research funding related to the nature of that interest.

14. I will divestiture the financial interest to a permissible level.

Date Signature of investigator with FI

Date Signature of Chair of Financial Conflict Interest and Research Committee