31.2.01 - Disclosure of Outside Interests Policy

Compliance and HIPAA: General Compliance

Last Updated: 03/20/2019

Original policy date: 04/15/2015

Applies to: Faculty, Staff, Residents & Clinical Postdoctoral Fellows, Postdoctoral Fellows, Students

 
I. Rationale
A.    Background. Baylor College of Medicine (BCM) acknowledges that collaboration across BCM departments and with outside entities is essential for advancing scientific innovation and academic excellence. However, in order to preserve the integrity of its educational and scientific activities, BCM will work to ensure that all Individuals adhere to the highest standards of professional and ethical conduct, and that such conduct is free from influence that might create or appear to create bias.
B.    Purposes. This policy establishes:
1.     A Culture of Disclosure. All Individuals must avoid actual and apparent conflicts of interest. All Covered Personnel and Investigators must disclose all Financial Interests and Significant Financial Interests as stated below. Disclosures may be shared with affiliate partners, regardless of the primary location of the Individual’s office, lab and/or practice.
3.     Deadlines for Disclosure.
a.     Within 30 days
1)    New employees who are Covered Personnel must complete their initial disclosures within 30 days of hire.
2)    Investigators must disclose any Significant Financial Interest, including any foreign (non-US) interest or activity that reasonably appears to be related to the Investigator’s Institutional Responsibilities before sponsored research proposal submission and thereafter within 30 days of acquiring or discovering the Significant Financial Interest.
b.     Annually –  
1)    Covered Personnel are required to disclose all Financial Interests on an annual basis.
2)    Investigators must annually confirm all Significant Financial Interests that reasonably appear to be related to the Investigator’s Institutional Responsibilities.
4.     Pre-Approval Requirements for Covered Personnel. Covered Personnel must seek pre-approval for certain Financial Interests with Industry from the appropriate Department Approver and Office of Compliance.
 
II. Stakeholders Affected by this Policy
Compliance with this policy is mandatory for all Individuals regardless of their geographic location.
 
III. Definitions
(a)   Conflict of Interest occurs when the private interests (financial or otherwise) of an Individual or members of their Immediate Family have the potential to bias or compromise an Individual’s obligations to the College such that an independent observer might reasonably question whether actions or decisions are being made in the best interest of the College. A Conflict of Interest may exist whether or not decisions are affected by a personal interest. In other words, the conflict does not depend on the person’s character or intent, but rather on the situation and appearance.
(b)   Consulting means providing expert advice or specialized knowledge of any kind to third-party professionals and/or organizations outside of the College.
(c)   Covered Personnel refers to any persons who are employed as full-time or part-time faculty members of BCM; residents; graduate students; fellows, including post-doctoral candidates; and staff members receiving Staff 1 or Staff 2 benefits.
(d)   Department Approver means the Department Chairperson and/or equivalent for staff, graduate students, residents, and fellows, or their designees.
(e)   DOI Portal means the tool utilized by the College to process the requirements of this policy.
1.     Financial Interest includes anything of value (cash or in-kind, unpaid appointments, and expectation to receive personal benefit) exceeding, except where noted below, $250 per occurrence that is/or appears to be related to an Individual’s Institutional Responsibilities and/or presents the appearance of a potential Conflict of Interest. Except as excluded in (f)(2) below, Financial Interests include:
Receipt of or the right or expectation to receive any income, whether in the form of a fee, salary, allowance, honorarium, forbearance, or forgiveness, including for Consulting, scientific advising, participation in speaking engagements, or serving as an expert/legal-medico expert;   
Business meals, travel and/or entertainment;
Gifts including, but not limited to, cash, electronic devices, services, promotional items, and hospitality (e.g., meals, tickets to sporting events, other forms of entertainment);
Equity interest in public or non-public entities (e.g., stock or other ownership interest), in any amount;
Trusts;
Interest in any healthcare-related venture (e.g., clinical practice, hospital, ambulatory surgical center, medical equipment, etc.);
Interest in real or personal property;
Any paid or unpaid professional services or personal services performed or products created for and/or sold to Industry and Other Entities, other than the College, including participation as a corporate officer, chair of a scientific advisory board or as a member of a Board of Directors. 
Intellectual Property right, dividend, or royalty payment or other interest derived from the licensing of Intellectual Property in any amount, including:
·         Intellectual Property rights and associated Financial Interests that are directly or indirectly related to the person’s Institutional Responsibilities; and
·         Intellectual Property belonging to a previous institution, employer, or any other third party, including but not limited to royalties, milestone payments, agreements to share in royalties, and materials, such as reagents, experimental animals, and cell lines.
·         Note: expired patents are excluded from this subsection.
Any paid or unpaid interest from a non-US foreign government, non-US foreign educational institutions or non-US foreign companies or entities;
Any interests described above which are held or received by Immediate Family of the Individual; and
Any other interest as determined by the College.
2.     Financial Interest does not include:
Income or interest in an investment vehicle, including mutual funds, retirement plans, trusts, managed investment accounts or other passive investments, where the Individual does not control investment decisions or does not have authority over the instrument;
Retirement plans, trusts, managed investment accounts or other passive investments, where the Individual does not control investment decisions or does not have authority over the instrument;
Stocks in publicly traded companies with a value less than $5,000 in the preceding 12 months prior to the time of disclosure; and
Reimbursement for expenses, including travel, lodging, and meals, if received directly from Other Entities when participating in an educational or CME activity. This exclusion does not apply to the following which must be disclosed:
·         Payments for speaking, consulting, or advisory activities received from Other Entities, a non-US foreign government, or a non-US foreign educational institution (see 31.2.04 - Healthcare Vendor Interactions Policy); or
·         Reimbursement of any expenses received from a non-US foreign government or a non-US foreign educational institution. 
(g)   Immediate Family includes the Individual’s spouse, spouse equivalent, and dependent children (natural or adopted).
(h)   Individual means any BCM faculty member, staff member, or current student.
(i)    Industry refers to any business or organization that provides or could provide the College with products or services that are pertinent to clinical care, academics, and/or research, including but not limited to: pharmaceuticals, devices, equipment, biotechnology products or processes, services, software, supplies, and biomedical investments; for-profit educational companies; representatives of such business, organization, or company; for-profit company or organizations, and any foundations sponsored by such business, organization, or company.
(j)    Intellectual Property has the same meaning as defined in BCM’s Policy on Patents and Other Intellectual Property (20.8.01). 
(k)   Institutional Responsibilities are work-related responsibilities, which may include research, research consultation, teaching, professional practice, clinical activities, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
(l)    Investigator is as defined in the Financial Interests in Research Manual. Any person who is responsible for (or has responsibilities in) the design, conduct or reporting of funded or proposed research.
(m) Other Entities includes but is not limited to other academic institutions, hospitals, health systems or other healthcare providers of any nature or type, as well as professional societies, associations, foundations, and organizations (e.g., charities).
(n)   Significant Financial Interest applies only to Investigators and is defined in the Financial Interests in Research Manual.
 
IV. Policy
1.     Avoiding Conflicts of Interest. All Individuals must avoid any activity or collaboration that may compromise or appear to compromise the integrity of BCM’s primary mission, or that may create a Conflict of Interest or the appearance of a Conflict. Individuals are responsible for maintaining objectivity during all educational, research and work activities conducted for the College and collaborations.
2.     Conducting Business with Government Entities/Personnel. Individuals involved in the administration of government contracts and/or interaction with government officials and employees must know and comply with any relevant federal, state and local laws and regulations that may differ from those that apply to other customers and suppliers.
 
1.     Speakers Bureaus. Activities in which Industry controls the content and/or materials are prohibited. Some pharmaceutical companies, device companies or other commercial entities maintain Speakers Bureaus and/or sponsor events and/or surveys designed to gather and disseminate information relating to their products and services. These companies often seek to hire Individuals associated with reputable academic institutions as lecturers because they are experts in particular areas and provide the company credibility. Because events sponsored by Industry generally do not provide the Individuals the opportunity to present their own materials, these events may be perceived as venues to influence participants, creating a perceived or actual bias and potentially jeopardizing the College’s mission.
2.     Referral of Patients for Healthcare Services. Referral of patients that violates any federal or state law (including, but not limited to, 42 USC §1320a-7b(b), commonly referred to as the Anti-Kickback Statute and 42 USC §1395 and its interpretive regulations, commonly referred to as Stark I and Stark II). See also BCM Healthcare Vendor Interactions Policy (31.2.04).
3.     College Affiliation and Resources. Permitting one’s College affiliation or resources to be used by Industry or Other Entities in connection with a marketing, investment or commercial venture. The College’s resources, space, facilities, and/or personnel may not be used by Individuals to benefit a Financial Interest.
4.     Commitment to the College. Individuals may not enter into any activity that would interfere with the Individual’s ability to perform his or her College duties.
5.     College Proprietary Information.
a.     Accepting any duties outside the College which may require or have the appearance of requiring Individuals to utilize proprietary or confidential information including, but not limited to, data, processes, procedures, or methods of the College and its affiliates, or of entities to which the College owes an obligation of confidence.
b.     Unless the Individual has sole proprietary rights (usually enforceable through copyright or patent), the College does not allow the use of knowledge gained through the Individual’s employment or contract with the College, which is not generally available to the public for non-College purposes. An Individual’s College-supported activities may not be used for personal gain.
c.     Individuals may not use or share Intellectual Property developed or acquired during their employment or affiliation with the College for the benefit of any Individual or entity outside the College unless permitted by applicable institutional policy and/or contract.
6.     Competing Business. Individuals having a Financial Interest in any business or entity which competes with the College, including third-party clinical practices, is prohibited. 
7.     Clinical Activity.  The practice of medicine outside the College and/or rendition of medical services for any other business is not permitted unless an exception is granted by BCM’s General Counsel’s Office.
8.     Interest in a Healthcare/Clinical Facility. Faculty having a Financial Interest in a healthcare facility operating in Harris County or the 7 counties contiguous to Harris County. 
9.     Purchasing. Individuals having a Financial Interest in any vendor to the College, shall not be involved in purchasing decisions involving that vendor (see Section IX, 03.1.01 and 03.2.01).
10. Gifts. Individuals are prohibited from accepting gifts from healthcare vendors, as described in the Healthcare Vendor Interactions Policy (31.2.04).
11. Regulatory and Policy Requirements.   Individuals are prohibited from entering into agreements with the intention of avoiding regulatory and policy oversight requirements.
 
C.    Disclosure Requirements Applying Only to Covered Personnel. In addition to compliance with Sections IV.A-B (above), Covered Personnel must disclose all Financial Interests as defined in this policy and respond appropriately when Conflicts of Interest arise.
1.     General Disclosure Requirements. Covered Personnel new to the institution must complete disclosure within 30 days of hire (see Section VIII.A, below). At a minimum, Covered Personnel must disclose and certify all Financial Interests on an annual basis.
2.     Interests Requiring Pre-Approval. Covered Personnel must obtain written approval from his or her Department Approver before obtaining the following Financial Interests or engaging in any of the following activities as an independent contractor, including, but not limited to:
a.     Consulting, Speaking Engagements, Scientific Advisory Boards for Industry, and other Industry Activities that Could Be Reasonably Related to an Individual’s BCM Responsibilities and/or a Potential or Apparent Conflict of Interest.
1)    Written authorization from the Department Approver must be obtained through the DOI Portal before engaging in any of the following activities:
a)    Speaking for an Industry-sponsored event. Covered Personnel may speak at an Industry-sponsored event only if the Covered Personnel retains full control and authority over the material, presents the material, and such communications and/or presentations are not subject to prior approval by any Industry interest other than approval for use of proprietary information;
b)    Serving on scientific advisory boards to review research on novel products;
c)     Serving on panels to review and objectively evaluate the data from clinical trials sponsored by Industry;
d)    Developing educational materials for websites that are directed towards the public for health promotion, explanation of diseases, and evidence-based diagnostic and therapeutic measures;
e)    Advising Industry about the structure of clinical trials;
f)      Advising Industry about the design, appropriate clinical use, or internal research on its products; and,
g)    Please consult the Interactions with Healthcare Vendor Interactions Policy (31.2.04) for additional requirements on Industry activities applicable to clinical faculty.
2)    Following authorization by the Departmental Approver, disclosure of the activity must be submitted together with signed copies of the contract/agreement and completed BCM Addendum for Consulting Relationships, Advisory Boards, and Speaking Engagements (see Section VIII.B), through the DOI Portal prior to engaging in the activity.
3)    Each requirement must be complete for the pre-approval process to be completed.
b.     Expert Witness, Medico/Legal Consultant. Consistent with the BCM Expert Witness Testimony or Legal Consulting and Fees Policy (21.1.05), before providing expert testimony or serving as a medico/legal consultant Covered Personnel must obtain pre-approval from the Office of Risk Management using the DOI Portal. Refer to Risk Management Guidance for additional information (see Section VIII.E, below).
 
D.    Disclosure Requirements for Investigators. Investigators must observe the following disclosure requirements:
1.     Investigators must disclose their Significant Financial Interests and those of Immediate Family Members.
2.     Investigators who are Covered Personnel must also observe all disclosure requirements required of Covered Personnel.
3.     Investigators must report within 30 days of discovering or acquiring a new Significant Financial Interest that would reasonably appear to be related to the Investigator’s Institutional Responsibilities. Please refer to and comply with all reporting requirements in the Financial Interests in Research Manual.
 
V. Responsibilities
A.    All BCM Individuals are responsible for complying with this policy, including where applicable, its disclosure requirements.
B.    Covered Personnel must disclose all Financial Interests and gifts as described above (see Section III.f), and obtain written pre-approval before participating in any activity or entering into any Financial Interest requiring pre-approval. Send questions or comments to Compliance@bcm.edu. Submit pre-approval requests thtough the DOI Portal (https://doi.bcm.edu).  
C.    Department Chairpersons/Administrators/Supervisors are responsible for communicating this policy to Individuals in their Departments. Department Approvers are responsible for review of annual disclosures and timely review and approval of pre-approval requests.
D.    The Office of Compliance is responsible for:
·         Periodic review and update of this policy (as needed) to reflect changes in Federal and State laws or BCM’s Code of Conduct;
·         Developing education materials to help Individuals comply with this policy (see Section VIII, below);
·         Timely review and approval or rejection of requests to engage with Industry; and
·         Verifying compliance with this policy.
 
VI. Procedures for Implementation and Review
A.    Disclosure of Financial Interests. Covered Personnel and Investigators shall disclose financial interests as required above using the DOI Portal.
B.    Disclosure of Activities Requiring Pre-Approval
1.     Covered Personnel shall submit all requests for activities requiring pre-approval to their Department Approver through the DOI Portal.  
2.     With the exception of Expert Witness and Medico/Legal Consulting, all Industry activities (e.g. Consulting, speaking, scientific advisory) must be formally documented in a contract/agreement. Prior to engaging in the activity, this contract must be signed by all parties and submitted to the Office of Compliance through the DOI Portal, along with an executed BCM Addendum for Consulting Relationships, Advisory Boards and Speaking Engagements (see Section VIII.B).
C.    Management of Financial Interests.
1.     Financial Interests of Covered Personnel. The President of the College shall appoint a Disclosure of Outside Interests Committee (DOIC), a subcommittee of the Executive Compliance Committee, which has the responsibility of administering and interpreting this policy, rendering advice about this policy and recommending changes as necessary. The DOIC and/or the President will approve any exceptions to this policy. The DOIC shall periodically report committee activities to the President, Executive Compliance Committee, and the Audit and Compliance Committee of the BCM Board of Trustees.
2.     Significant Financial Interests of Investigators. The Research Conflict of Interest Committee is an institutional committee formed to specifically oversee financial interests in research. It is appointed by and reports to the President and CEO through the Senior Vice President and Dean of Research. Any interest managed through this policy may also be subject to additional management plans.
D.    Disclosure Review.
1.     The Office of Compliance will evaluate all disclosures and forward a summary report to the Department Chair or equivalent for review and approval on an annual basis. A summary report will also be provided to the DOIC. The Department Approver will be asked to validate management plans, in accordance with the management plan strategies templates provided by the Office of Compliance. Any interests that fall outside of the management plan strategies will be drafted by the Office of Compliance with input from the Chair (or Administrator) and College leadership, as deemed appropriate.
2.     The Department Approver shall also review relationships, transactions or other events that fall outside of the management strategies. Subject to the authority of the DOIC, the Departmental Chair or equivalent will determine whether the relationship, transaction or other event should be eliminated or permitted, subject to a specific management plan. The Office of Compliance will formally monitor compliance with established management plans.
 
VII. Stakeholder Compliance
A.    Violators of this policy will be subject to disciplinary action under the College’s Progressive Discipline policy (02.5.18), up to and including termination of employment and/or employment contract with the College.
B.    Contact the Office of Compliance (Compliance@bcm.edu) or Office of Research (oor-rcs@bcm.edu) with questions about disclosure and/or the applicability of this policy to specific circumstances.
 
VIII. Tools
 
X. Applicable Laws, Regulations & Standards
A.    Laws & Regulations.
1.     Federal Anti-Kickback Statute and Regulations; 42 USC §1320a-7b(b) and 42 CFR 411.1001.952;
2.     Stark Law and Regulations; 42 USC §1395nn and 42 CFR 411.350-411.389;
3.     Texas Anti-Kickback law; Texas Occupations Code 102.001;
4.     Title 42 Code of Federal Regulations (CFR), Part 50, Subpart F for PHS grants or cooperative agreements (Revised 2011)
5.     Title 45 CFR Part 94 for PHS research contracts (Revised 2011) National Science Foundation (NSF) Chapter IV – Grantee Standards, Section A Conflict of Interest Policies
6.     FDA Regulations at 21 CFR Part 54
B.    Standards.
1.     Accreditation Standards of the Association for the Accreditation of Human Research Protection Programs (AAHRPP):
·   Standard 1.6.A. – Institutional Financial Conflicts of Interest (pg. 40);
·   Standard 1.6.B. – Investigators holding a Financial Interest (pg. 41-42).