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ALBERT EINSTEIN HEALTHCARE NETWORKPOLICY AND PROCEDURE MANUAL

Effective Date: of 14

Department/Division: Research and Subject: Financial Disclosure Technology Development Policy for Investigators

Involved in Research Subject to Public Health Service Regulations

I. PURPOSE

The Albert Einstein Healthcare Network Financial Disclosure Policy for Investigators Involved in Research Subject to Public Health Service Regulations (“Policy”) defines the policies and procedures to identify and to manage, reduce or eliminate Financial Conflicts of Interest in relation to Research. This Policy will govern Research at all of the facilities of the Albert Einstein Healthcare Network (AEHN) that is subject to the requirements pertaining to objectivity in Research adopted by the Public Health Service (PHS) of the U.S. Department of Health and Human Services (DHHS).

II. POLICY

This Policy outlines the requirements for Investigators who are involved in Research funded or proposed for funding by the PHS (and any other organizations that require compliance with the PHS financial interest in research regulations) if any one of the following AEHN contacts exist: the Research: (a) is performed in whole or in part using AEHN facilities; (b) involves AEHN patients or other subjects of such Research who are enrolled at AEHN, or (c) is conducted by Investigators employed by AEHN whether or not AEHN patients or facilities are included.

This Policy is intended to meet federal regulations and the requirements of PHS to identify, manage, reduce, and eliminate any actual or potential Financial Conflicts of Interest that may be presented by a Financial Interest of any Investigator. All such persons must disclose any Financial Interest that they may have that is related to their Institutional Responsibilities.

III. CROSS-REFERENCE

The obligations of Investigators to report under this policy is in addition to the obligations that such persons may have under the Network’s Duality of Interest Policy to report actual or apparent dualities of interest.

IV. BACKGROUND





The Department of Health and Human Services (DHHS) and Public Health Services (PHS) published its final rule on Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors in the Federal Register Vol. 76 No. 165 p 53256-53293 on August 25, 2011 (42 CFR Part 50 and 45 CFR 94). It applies to any activity (described at 42 CFR 50.603) for which research funding is available from a PHS Awarding Component (e.g., NIH, SAMHSA, OPHS, HIS, HRSA, FDA, CDC and AHRQ) through a grant or cooperative agreement.

This Policy seeks to maintain a reasonable balance between AEHN's ability to identify and manage financial interests that may bias the Research, and minimize reporting and other burdens on the Investigators. In addition to the regulatory concerns relating to Investigators, AEHN has an obligation to investigate and make recommendations regarding any real or apparent Financial Conflicts of Interest surrounding the Research conducted by its Investigators or in its facilities, particularly where third party entity, controlled or represented by a person affiliated with AEHN, proposes to enter into a contract or arrangement, directly or indirectly, with AEHN regarding Research.

V. DEFINITIONS

A. Albert Einstein Healthcare Network (AEHN)- shall include the Einstein Medical Center – Philadelphia, Einstein Medical Center - Elkins Park. Einstein Medical Center – Montgomery, MossRehab, Belmont Center for Comprehensive Treatment, Germantown Community Health Services, Willowcrest, associated physician practice plans, and any other operating unit that becomes part of AEHN.

B. Financial Conflict of Interest - occurs when an Investigator has a Financial Interest that creates a perception of a divergence between an individual’s private interests and his or her professional obligations to AEHN such that an independent observer might reasonably question whether the individual’s professional actions or decisions are determined by considerations of personal gain, financial or otherwise. A Financial Conflict of Interest depends on the situation, and not on the character or actions of the individual(s).





C. Financial Interest- one or more of the following interests of the Investigator (and those of the Investigator’s spouse/domestic partner and dependent children) that reasonably appears to be related to the Investigator’s Institutional Responsibilities:

1) Any remuneration or honoraria received from a non-AEHN entity in the 12 months preceding the disclosure, including, but not limited to, compensation for speakers bureau or other lecture(s)/presentation(s), consulting, advising, participation on scientific advisory board or data safety monitoring board, paid authorship and expert witness testimony

2) Intellectual property rights and interests (e.g. patents, copyrights, and similar rights)

3) Ownership/equity interests, including, but not limited, to stock/options, bonds, dividends, annuities, commodity futures, real estate and any other business and/or partnership interests, etc. in any enterprise or non-AEHN entity

4) Any management position (e.g. director, officer, trustee, management employee) in a non-AEHN entity

5) Reimbursed or sponsored (i.e. paid for on the Investigator’s behalf but not reimbursed to Investigator so the exact monetary value may not be readily available) travel in the past 12 months. Disclosure of this interest will include the purpose and duration of the trip, the identity of the sponsor/organizer and the travel destination

The following items are NOT considered to be a Financial Interest:

1) Salary or other payments for services from AEHN to the Investigator if the Investigator is currently employed by AEHN;

2) Income from non-promotional, educational seminars, lectures, or teaching engagements sponsored and paid for by





governmental entities, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education

3) Income from service on advisory committees or review panels established by and paid for by a governmental entity

4) Income investment vehicles, such as from mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these investment vehicles

5) Travel that is reimbursed or sponsored by a government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education

D. Institutional Responsibilities – Any of the professional responsibilities of an Investigator conducted on behalf of the institution, including but not limited to, research, research consultation, teaching, clinical, administrative or professional duties performed on behalf of AEHN.

E. Investigator – Includes the principal investigator/project director, co-principal investigator(s), sub-investigator(s), study coordinator(s), research assistants/associates, research nurses, technical staff and any other person, including but not limited to residents, fellows, and students at AEHN, collaborators and consultants who are responsible for the design of a Research study; enroll research subjects (including obtaining subjects’ informed consent); make decisions related to eligibility to participate in the Research; perform activities related to collection of Research data or implementation of a Research intervention that are not considered part of their normal job responsibilities; analyze or report Research data; or submit manuscripts concerning the Research for publication. For purposes of this definition, “Investigator” includes both AEHN employees as well as non-employees, including





without limitation, volunteer physicians if such individuals perform such research utilizing AEHN facilities or patients and authorized volunteers of AEHN who are participating as a member of the research team on an AEHN research project. An Investigator who is an AEHN employee who conducts research at another institution also is subject to the disclosure responsibility set forth in this Policy. In this context, the term Investigator includes the Investigator’s spouse/domestic partner and dependent children/stepchildren.

F. Research - For the purpose of this Policy, this means all research conducted at or under the auspices of AEHN, whether it is internally funded or externally funded. This includes studies that: (a) are to be performed in whole or in part at AEHN; or (b) will involve AEHN patients, employees or other subjects enrolled at AEHN; or (c) will be conducted by Investigators employed by AEHN whether or not AEHN patients, employees or facilities are used.

VI. PROCEDURE

A. Investigator Reporting Responsibilities

A Financial Interest Disclosure form must be submitted under the following circumstances:

1. Upon submission of a grant application to any agency covered under PHS regulations or AEHN’s execution of a PHS-funded cooperative agreement/ sub award agreement or other agreement for PHS-regulated Research

2. Annually thereafter3. Whenever circumstances arise that either constitutes a new Financial Interest

or changes the facts applicable to a previously disclosed Financial Interest. Such a report must be submitted within 30 days of the change in circumstance.

4. Addition of a new Investigator who does not have a Financial Disclosure form on file to an ongoing project

The disclosure form will be submitted to the Director, Office of Research and





Technology Development (ORTD), who will then review any Financial Interest disclosed as provided in section VI.C below. One annual disclosure form will suffice to cover all on-going Research activities.

In those cases where it is determined that a Conflict of Interest exists, the Investigator cannot participate in the related Research activities until the he/she has agreed in writing to any management plan required by AEHN for this Research. An Investigator who has failed to report a Financial Interest that is determined to be related to Research will be subject to sanctions described in Section G and the retrospective review procedures described in Section H.

During the course of a given year, each Investigator who has an up-to-date Financial Interest Disclosure form on file with ORTD is required to either verify that the disclosures are up to date or submit an updated Financial Disclosure Form under the following circumstances:

1. Submission of a new PHS- regulated application or acceptance of a new PHS-regulated grant award

2. Submission of a new non-PHS regulated research application to the Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC)

3. At the time of continuing renewal of all ongoing Research4. Addition of a new Investigator to ongoing Research

It is the responsibility of the Principal Investigator or Project Director of a Research project to ensure that each Investigator working on/who will work on the project submits the Verification form and timely updates to a previously-submitted Financial Disclosure form as required.

The Verification form or updated Financial Interest Disclosure form will be submitted to the Director, ORTD or Research Compliance Officer, who will then review any Financial Interest disclosed as provided in section VI.E below.





B. Applicability to Subrecipients

For Research sponsored by PHS agency (or any other organization that requires compliance with the PHS financial interest in research regulations) that involves collaborators, consultants, subcontractors, subgrantees or subawardees (collectively “Subrecipients”) at other Institutions, AEHN requires a written agreement from Subrecipients that establishes whether AEHN’s policy or the Subrecipient organization’s policy shall apply to the Subrecipients. In all cases, AEHN must report to the PHS funding agency any Subrecipient Financial Conflicts of Interest prior to the execution of the subcontract if applicable or within 60 days of identification of a new Financial Conflict of Interest by the Subrecipient that arises during the term of the subcontract.

If the Subrecipient’s policy is used, the Subrecipient must certify that its Financial Conflict of Interest policy is compliant with 42 CFR Part 50 and 45 CFR Part 94 and it will be responsible for ensuring that the Subrecipient Institution and its Investigators comply with the federal regulations. Subrecipients must report to AEHN as the awardee Institution, any identified Financial Conflict of Interest within 10 business days of the management plan agreement with the Subrecipient’s Investigator, but no later than 45 days after identification of the Financial Conflict of Interest by the Subrecipient. The details of the Financial Conflict of Interest will be reported to the funding agency as required under applicable regulations or policies.

If AEHN’s policy is used, the Subrecipient must ensure that its Investigators submit the Financial Interest Disclosure form to AEHN prior to the time of application by AEHN or at the time the Subrecipient signs an institutional letter of support if during an on-going grant or contract.

C. Initial Review of Financial Interest Disclosure form

The Director, ORTD and Research Compliance Officer shall conduct an initial review





of the financial disclosure to determine if any Financial Interest disclosed by an Investigator is related to any Research projects that the Investigator is currently involved in or has submitted for funding and if so related, whether the Financial Interest could be viewed as a Financial Conflict of Interest. A Financial Interest will be considered related to a Research project when the Financial Interest could be affected by the Research project or is in an entity whose financial interest could be affected by the Research. A Financial Conflict of Interest will exist if the Financial Interest could directly affect the design, conduct or reporting of the Research.

D. Research Conflict of Interest Committee Review

If the initial determination is made that an Investigator may have an actual or potential Financial Conflict of Interest covered by this Policy, the disclosed information will be referred by the Director, ORTD to the AEHN Research Conflict of Interest Committee (RCOIC). Committee members are appointed by the Chief Operating Officer, with approval from the respective Department Chairmen. The RCOIC is composed of a minimum of 10 faculty members, one from each of the major clinical departments. A representative from AEHN Office of General Counsel will advise the RCOIC, but will not have a vote on the RCOIC.

The RCOIC will determine whether an actual or potential Financial Conflict of Interest exists and what conditions or restrictions if any should be imposed by AEHN to manage, to reduce or to eliminate an actual or potential Financial Conflict of Interest arising from a disclosure of Financial Interest. The RCOIC may make the following recommendations:

1) Public disclosure of all Financial Conflicts of Interest (e.g. when presenting or publishing the Research)

2) For Research involving human subjects, disclosure of all Financial Conflicts of Interest directly to participants

3) Appointment of an independent monitor capable of taking measures to protect the design, conduct and reporting of the Research against bias, or the appearance of bias, resulting from the Financial Conflict of Interest

4) Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the Research,





5) Divestiture by the Investigator of the Financial Interest, 6) Severance of relationships that create actual or potential Financial Conflict

of Interest, or 7) Modification of the Research plan.

If the RCOIC decides to impose any of the conditions or restrictions above, a Memorandum of Understanding (MOU) will be developed that details the steps that are to be taken to manage, to reduce, or to eliminate any actual or potential Financial Conflict of Interest. The MOU must be approved by a majority vote of the RCOIC.

E. Investigator Notification and Recommended Approval of Plan

Investigators will be notified by the Director, ORTD when a Financial Conflict of Interest exists and must be managed. The MOU will be sent to the Investigator for review and signature. If the Investigator wishes to appeal one or more terms in the MOU, an appeal may be made to the RCOIC within 10 days of receipt of the notification. Should the Investigator not file a written appeal with the RCOIC by such time, then the Investigator shall be considered to have waived his/her right to appeal and the determination by the RCOIC shall be final. If the Investigator’s appeal is denied by the RCOIC, then he/she may make a subsequent appeal to the Chief Operating Officer of AEHN. The Chief Operating Officer will notify the Investigator within 10 days as to whether the appeal is granted/denied or if a meeting will be scheduled to discuss the appeal. During the pendency of any appeal to the RCOIC or the Chief Operating Officer, the Investigator must either (a) agree to abide by the initial recommendations of the RCOIC; or (b) remove himself/herself from the Research; or (c) not expend any funds under any award from a sponsor for the conduct of the Research at issue.

The MOU must be signed by the Investigator and the Chairman of the RCOIC. Not less than once a year while the Research is continuing, the Investigator shall submit a statement to the RCOIC that he or she remains in compliance with the Memorandum of Understanding and no further conflicts have arisen that are not addressed by the original Memorandum of Understanding.

F. AEHN Reporting Responsibilities





Actual or potential Financial Conflicts of Interest are to be satisfactorily disclosed, managed, reduced, or eliminated in accordance with this Policy prior to accepting any award from a PHS-agency, and they will be disclosed to the sponsoring agency as required by the sponsor’s regulations or policies. Reports must be submitted to the applicable PHS-agency within sixty (60) days of the determination that a Financial Conflict of Interest exists. The Investigator’s timely cooperation with the efforts of the Director, ORTD and the RCOIC is needed to ensure timely reporting. Upon a failure to make timely reporting of a Financial Conflict of Interest to the PHS funding agency, AEHN is required under the PHS regulation to conduct a retrospective review of the Investigator’s Research activities as described under Section H.

In addition, if the Research involves human subjects, the AEHN Institutional Review Board (IRB) will be informed of the Financial Conflict of Interest and the Memorandum of Understanding to ensure that appropriate disclosure is included in the informed consent document provided to proposed participants of the Research. The outcome of any RCOIC reviews involving animal research will be communicated to the Institutional Animal Care and Use Committee (IACUC).

As required by federal regulations, AEHN shall report the following information regarding Financial Conflicts of Interest to the funding agency:

1) Project Number2) Principal Investigator3) Name of Investigator with the Financial Conflict of Interest4) Name of the entity with which the Investigator has a Financial

Conflict of Interest5) Nature of the Financial Interest (e.g. equity, consulting fee,

travel reimbursement, honorarium, etc.)6) Value of the Financial Interest or a statement that the interest

is one whose value cannot be readily determined through reference to public prices or other reasonable measure of fair market value

7) A description of how the Financial Interest related to the PHS-funded Research and the basis for AEHN’s determination that





the Financial Interest conflicts with such Research8) A description of the key elements of the Institution’s

management plan including:a. Role and principal duties of the conflicted Investigator

in the Researchb. Conditions of the management planc. How the management plan is designed to safeguard

objectivity in the Researchd. Confirmation of the Investigator’s agreement to the

management plan

e. How the management plan will be monitored to ensure Investigator compliance

f. Other information as needed or requested by the funding agency

Additionally, each award year AEHN must provide the funding agency with an annual Financial Conflict of Interest report that addressed the status of the Financial Conflict of Interest and any changes to the management plan for the duration of the project period (including extensions with or without funding). The annual Financial Conflict of Interest report shall specify whether the financial conflict is still being managed or explain why the Financial Conflict of Interest no longer exists. AEHN must submit the annual Financial Conflict of Interest report to the agency at the time of the progress report.

As required by federal regulations and upon written request, AEHN will provide written information to any requestor. Requests must be in writing and must identify the specific PHS project number. The request must include a named recipient and return address with a physical street address. P.O. boxes are not acceptable. AEHN will note in its written response that the information is current as of the date of the correspondence, and is subject to updates at least annually and within 60 days of AEHN’s identification of a new Financial Conflict of Interest, which must be requested under separate cover by





the requestor. The following information will be provided:

1) Project Number2) Name of the Investigator with a Financial Conflict of Interest;3) Investigator’s title and role with respect to the Research;4) Nature of the Financial Conflict of Interest (e.g. equity,

consulting fee, travel reimbursement, honorarium, etc.); and5) Value of the Financial Conflict of Interest (in ranges) or a

statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measure of fair market value

G. Violations of Policy

Whenever an Investigator has violated this Policy or the terms of the Memorandum of Understanding, the RCOIC shall recommend sanctions that may include disciplinary action ranging from a public letter of reprimand to dismissal and termination of employment or contracting relationship. If the violation results in collateral proceeding with Human Resources then the RCOIC shall defer a decision on sanctions until the Human Resources process is completed. The RCOIC’s recommendations on sanctions shall be presented to the Investigator’s cognizant department head, who in consultation with the Director, ORTD, Human Resources, and AEHN counsel shall enforce any disciplinary action.

H. Required Procedures for Failure to Comply with Policy or Management Plan

In addition to the sanctions listed in Section I, AEHN and Investigators are subject to the following procedures when a Financial Conflict of Interest is not identified or managed in a timely manner including failure by the Investigator to disclose a Financial Interest that is determined by ORTD to constitute a Financial Conflict of Interest; failure by AEHN to review or manage such a Financial Conflict of Interest; or failure by the Investigator to comply with a Financial Conflict of Interest management plan.





1) ORTD and the RCOIC must implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such Financial Conflict of Interest going forward

2) Within 120 days of AEHN’s determination of noncompliance, ORTD must complete a retrospective review of the Investigator’s Research activities to determine whether any Research conducted during the time period of noncompliance was biased in the design, conduct, or reporting of such Research.

3) ORTD must document the retrospective review and include, at minimum, the following information:

a) Sponsor identification numberb) Project titlec) Principal Investigator/Project Director d) Name of Investigator with the Financial Conflict of

Interest

e) Name of the entity with which the Investigator has a Financial Conflict of Interest

f) Reason(s) for the retrospective reviewg) Detailed methodology used for the retrospective

review (e.g. methodology of the review process, composition of the review panel, documents reviewed, etc.)

h) Findings of the reviewi) Conclusions of the review

4) Based on the results of the retrospective review, if appropriate, ORTD will update the previously submitted Financial Conflict of Interest report, specifying the actions that will be taken to manage the Financial Conflict of Interest going forward.





5) If the retrospective review finds bias, AEHN is required to notify the Research sponsor promptly and submit a mitigation report to the Research sponsor. The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the Research and AEHN’s plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g. impact on the Research; extent of harm done, including any qualitative and quantitative date to support any actual or future harm; analysis of whether the Research is salvageable, etc.). Thereafter, AEHN will submit to the sponsor annual reports. Depending on the nature of the Financial Conflict of Interest, AEHN may determine that additional interim measures are necessary with regard to the Investigator’s participation in the Research between the date that the Financial Conflict of Interest or the Investigator’s noncompliance is determined and the completion of ORTD’s retrospective review.

I. Training

Each Investigator must complete training related to the reporting requirements for Financial Interests prior to engaging in Research and at least every four years, and immediately under the designated circumstances:

1) When AEHN’s Policy changes in a manner that affects Investigator’s requirements

2) When a new Investigator is initially appointed to AEHN

3) When an Investigator is not in compliance with this Policy or a management plan related to his/her Research





J. Record Retention

Records of the Investigator including financial disclosure and the actions taken to manage actual or potential conflicts of interest are to be retained by ORTD until 3 years after the later of the termination or completion of the award to which they relate, date of submission of the submission of the final expenditure report if applicable, or the resolution of any government action involving those records.

Approved by: ____________________________Dated:______________ Director, ORTD, AEHN

Approved by: ____________________________ Dated: ______________ COO, AEHN

Approved by: ____________________________ Dated: ______________ President and CEO, AEHN

To be reviewed: Every three years

Policy Owner: Mary Klein, PhD

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