Partners Conflict of Interest Policy and Reporting

October 11, 2012

Policies Governing Conflicts of Interest

• Partners Policy for Interactions with Industry and Other Outside Entities

• HMS Faculty Policy on Conflicts of Interest and Commitment

General Conflict of Interest Policies to Note

• Full-time HMS faculty are prohibited from serving in an executive position in a for-profit business engaged in commercial or research activities of a biomedical nature

• Board of director positions a position on the board of directors of the biomedical company will require Partners Committee on Conflict of Interest review. If a faculty member serves on the Board of Directors, member is not permitted to participate in clinical research on the technology owned or obligated to the company or receive sponsored research support from the company.

• Consulting agreements, consulting or other engagements with a pharmaceutical or medical device company, or vendor or potential vendors of partners require a written agreement. All personal consulting agreements must be reviewed by the institution to ensure compliance.

• Any engagement in outside activities must not be performed during regular hours at Partners, must not involve use of student or trainees, and must not involve the use of institutional funds or resources. All agreements must be for fair market value.

• Full-time faculty may not spend more than 20% of working time - not to exceed one day a week - on all outside activity.

• Gifts, participation in speakers bureaus are prohibited.

Specific changes to Research COI

• Effective August 24, 2012, Federal regulations surrounding research changed requirements for reporting on research conflicts of interest

• These requirements are mandated under federal law; we have no choice but to follow them

How it may impact you

If you have a grant application funded, you are subject to the rolling 12 months periods immediately!

If you have a collaborator who includes you on a NIH application and it is funded, you are then subject to these requirements

Definition of investigator is very broad (more to come)

New Research Requirements

What Research is Subject to the New Requirements?

• All research that is funded by the Public Health Service (this includes NIH)

• All research that is funded by foundations and other non-profits that have also chosen to follow the Federal Regs

• Partners has not extended the new requirements of the Federal Regs to any research funded by any other sources – so research funded by other government agencies (e.g., DOE, DOD), other non-profits or by industry is not subject to the new requirements

What Individuals are Affected by the New Regulations?

The regulations apply to “Investigators”• Investigators is defines as - PIs, PDs, key personnel,

and anyone else, regardless of title, who is responsible for the design, conduct, or reporting of research– Can include grad students, post-docs, collaborators, and others

• If you are responsible for the design, conduct or reporting of any research project funded by the Public Health Service or any foundation or non-profit that has chosen to adopt the Federal regulations, then these new requirements apply.

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What Must be Reported?

The Federal regs require Investigators to disclose to Partners their new Significant Financial Interests (including those of their spouse and dependent children) that are *related to their Partners responsibilities*

–Different standard from current NIH regs – “related to a particular research grant”

• What are my “Partners responsibilities?”• All of your hospital or other Partners activities, including research, clinical care, education and other

Partners activities, such as involvement in purchasing or serving on a Partners or hospital committee or board

• What is a “Significant Financial Interest (SFI)?”–Receipt by you or your spouse/dependent children of any of the following from a

non-Partners entity1. Income that exceeds *$5000* (changed from $10,000!), measured on rolling 12-

month basis – some exceptions2. Equity in a public company that exceeds $50003. Aggregated income + equity/ownership interest from a public company that

exceeds $5000, measured on a rolling 12-month basis4. ANY equity/ownership interest in a private company5. IP rights, upon receipt of income6. ALL reimbursed and “sponsored” travel expenses

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What Doesn’t Have to Be Reported

• Exceptions – things that don’t have to be reported–Salary, royalties, through the institution–Equity, and related income, in mutual funds, etc.–Income from seminars, lectures, or teaching engagements sponsored by, or payment of travel by:

• US government agencies• US institutions of higher education and research institutes

affiliated with them• Academic teaching hospitals• Medical centers NOTE: Professional Associations are NOT excluded !!

–Travel expenses paid directly by a company to Partners under a Partners agreement and not directly reimbursed by the company to the investigator

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11Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org | http://pulse.partners.org/OII/index.html 11

What is an SFI – Recap

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12Office for Interactions with Industry | 617-643-7752 | PHSOII@partners.org | http://pulse.partners.org/OII/index.html 12

What is an SFI – Recap

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When to Report

• Investigators must now UPDATE their disclosure WITHIN 30 DAYSWITHIN 30 DAYS of the acquisition or discovery of a new SFI– What is a “new” SFI?

NIH FAQ issued 5/18/12 – clarifies that a “new SFI” exists only when you receive/acquire, from the same outside entity, an SFI that is “a different type and nature” from what you have previously reported; or same type and nature from a different outside entity

• If an Investigator fails to report new SFI’s within 30 days, and the institution determines it is an FCOI:– Retrospective review must be conducted

120 days to determine whether there was bias Documentation of the review Update to PHS if any changes to a previously-submitted report

– If bias is found Notification to PHS Mitigation Report

How to Report

• Insight -– Same system as annual COI disclosures– Incorporates tracking tool for travel– Real time updates

• Your admin assistant has directions for this system but cannot enter for you

• If you think you may be subject to these please let me know!

Summary of Research Specific Changes• All research funded by Public Health Service (includes NIH) and certain Foundations, is subject to new requirement• Requires investigators to disclose to partners significant financial interests including those of spouse and

dependent children that are related to Partners responsibilities not just a particular research grant• Defines investigators as any and all individuals responsible for design and conduct or reporting of research so can

include postdocs, students etc.• Defines significant financial interest as the following

– Income that exceeds $5000 on rolling 12 month basis– Equity in a public company that exceeds $5000– Aggregated income plus equity/ownership interest from a public company that exceeds $5000 on a 12 month rolling basis– Any equity/ownership interest in a private company– IP rights upon receipt of income and– All reimbursed and sponsored travel expenses

• What does not need to be reported– Salary or royalties to come through Partners– Equity and/or income through mutual funds– Income from seminars, lectures or teaching engagements, sponsored by or payment of travel by US government, US institutes

of higher education, or academic teaching hospitals and medical centers. PLEASE NOTE: professional associations are NOT excluded

• Any significant financial interest must be reported within 30 days of the acquisition (30 day clock starts upon receipt of payment)

• If an investigator fails to report in a timely manner a retrospective review must be performed of activities over the previous 120 days