As the ties between industry and academic medicine strengthen, and as translational research and the opportunities for technology transfer increase, so do the opportunities for real or apparent conflict between the personal financial interests of clinicians, educators and investigators and their professional responsibilities.
The College of Medicine is dedicated to maintaining transparency and full disclosure. It must fulfill the role of determining when actual or potential conflict of interest does exist. In these cases, the conflict of interest staff, and the Conflict of Interest Review Committee, are responsible for eliminating, reducing or managing the conflict in such a way as to encourage, support, and protect all legitimate research efforts as well as the integrity of our faculty.
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Conflict of Interest Program Overview
The Conflict of Interest Review Committee (CIRC) provides oversight for clinical, educational and research conflicts on the College of Medicine campus. The Committee is charged with determining whether an actual or perceived conflict of interest does exist between any significant financial interests reported by a faculty or staff member and their clinical, educational, research, or administrative responsibilities. When these conflicts, or potential conflicts, are found, it is the responsibility of this committee to oversee their management, in order to maintain the integrity of any faculty members’ professional responsibility. The Committee will attempt to recommend management of the conflict of interest, taking steps to reasonably eliminate bias in research, teaching or clinical care. If this cannot be accomplished, then the committee and the conflict of interest staff will suggest optimal ways to reduce, or even eliminate the conflict.
When any College faculty or staff member has disclosed a financial interest which may represent a conflict, they will be contacted by the Conflict of Interest Coordinator, who will obtain the necessary information regarding the conflict for discussion by the CIRC. The CIRC meets monthly, to discuss and resolve all cases brought before it. Faculty or staff members are encouraged to attend any meeting at which their interests will be discussed. In this way, information can be most easily shared with the committee, and the committee can make the most reasonable and informed decisions and recommendations.
The entire process of disclosure, reporting, conflict determination and management for the College of Medicine occurs on the COINS web-based Conflict of Interest Management System hosted by Penn State.
Detailed instructions for using COINS, as well as relevant disclosure information, are available on the COINS site’s main page.
Penn State Access ID
To enhance security, the Penn State Access ID, rather than the Penn State Health ePass ID, must be used to log in to COINS. Therefore, all faculty and administrative personnel will need to obtain their Penn State Access ID and password. This is not the same as the ePass ID used to sign in to Penn State Health’s network of systems, nor is it the same as the nine-digit Penn State ID on the back of your ID badge.
If you are not sure of your Penn State Access ID, you may look up your information in the Penn State Directory.
Resetting your Penn State Access ID Password
If you need to update, reset or activate your PSU Access Password, please visit accounts.psu.edu. If you require assistance in this process, you may contact the Penn State Health IS Service Desk at 833-577-4357. Please note that COI Program staff do not have access to this University account password and are not able to reset it.
Please be aware that PSU systems (including COINS) use a credential-specific Microsoft log-in screen, so you may need to sign out of your Penn State Health account and into your Penn State University (or use a different browser to prevent issues with the two separate log-ins).
For security purposes, Penn State requires two-factor authentication for all logins using the Penn State Access ID (whether you are logging in from campus or remotely). If you have not already set up two-factor authentication, you may do so here. Although Penn State uses the same Duo system as Penn State Health Milton S. Hershey Medical Center, you will still need to set up an additional PSU-specific authentication.
Conflict of Interest Guide
Maintaining trust and integrity and the ethical behavioral of investigators of the College of Medicine is a top priority for both our College and each individual faculty member. Penn State Policy AC47 outlines the general standards of professional ethics within the academic community. Violations of ethical standards, and University policy, must be considered to be a serious breach of the trust placed in each member of the faculty and staff. Any potential, or alleged, misconduct in research, including fabrication or falsification of data, plagiarism, disregard for the protection of human or animal subjects, as well as financial conflict of interest, will be investigated as outlined in Penn State Policy RP 02.
Who Must Disclose
- Investigators as defined by Penn State Policy RP 06: “Any University faculty, employee, or student who has the ability to make independent decisions related to the design, conduct or reporting of a University research project, but not including individuals who perform only incidental or isolated tasks related to the project.”
- Students include undergraduate, graduate, and postgraduate students, residents and fellows
- Any employee named as an investigator or co-investigator on the study protocol or grant application would be considered an “investigator” by definition for disclosure purposes
- A study’s principal investigator would have the responsibility to identify and name as a co-investigator in COINS any additional employees or students who they believe meet the definition of “investigator” for any funded or unfunded study conducted as part of their University employment
- In addition, all paid College of Medicine or Penn State Health Milton S. Hershey Medical Center employees with a College faculty appointment as determined by the Office of Faculty Affairs
- Including full-time and part-time employees
- Not including unpaid affiliate faculty members with prefix or suffix titles
- Not including occasional or PRN employees (less than 0.1 FTE), or those who have a primary job elsewhere
- The following designated administrators:
- CEO and Dean of the College of Medicine
- Executive Director of Penn State Health Milton S. Hershey Medical Center
- All persons reporting directly to CEO and Dean of the College of Medicine and/or
- Executive Leadership of Penn State Health Milton S. Hershey Medical Center, including Basic Science Academic Chairs, Clinical Academic Chairs, Institute and Center Directors
- Treasurer of Penn State Health Milton S. Hershey Medical Center
- Chief Financial Officer of Penn State Health Milton S. Hershey Medical Center
- Chief Compliance Officer for Penn State Health Milton S. Hershey Medical Center
- Clinical Department Administrators, Clinical Division Directors, and Center Directors
- All materials management/purchasing department employees
- Associate Dean for Research
- Associate Dean for Technology Development
What Must Be Disclosed
- All Significant Financial Interest of an investigator, faculty member or designated administrators (or their spouse and/or dependent children) that is related to their institutional responsibilities.
- A Significant Financial Interest is defined as financial interests consisting of one or more of the following interests of the Investigator, faculty member or designated administrator (and those of their spouse/partner and dependent children) that reasonably appear to be related to their institutional responsibilities:
- Publicly Traded Entity – a significant financial interest in a publicly traded entity exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure plus the value of any equity interest in the entity as of the date of the disclosure, when aggregated, exceeds $5,000. For the purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
- Non-Publicly Traded Entity – a significant financial interest exists when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest) in the entity or if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or
- Intellectual Property (IP) Rights and Interest – upon receipt of income related to such rights and interests that exceed $5,000 in the previous 12 months
- Human Subjects Research or Penn State-Related Purchasing Authority – Any financial interest in a for-profit entity or any intellectual property, regardless of income generated, if related to human subjects research conducted at Penn State or to Penn State purchasing authority
- Travel – the occurrence of any travel of the investigator, their spouse, or dependent children, for the last year from any one entity, exceeding $5,000 in the 12 months preceding disclosure, which is reimbursed or sponsored (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available) related to their institutional responsibilities
- Exceptions: Financial interests that do not require disclosure include:
- Salary, royalties, or other remuneration paid by the University (this includes any intellectual property rights assigned to the University and any agreements to share in royalties or licensing revenue related to the intellectual property rights);
- Income from investment vehicles, such as mutual funds and retirements accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
- Additional exceptions: for faculty members who are also investigators as defined above, all of the following are exempt from disclosure, as described in NIH 2011 regulations
- Income from seminars, lectures, or teaching engagements sponsored by a federal, state or local 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, within the United States, that is affiliated with an institution of higher education; or
- Income from service on advisory committees or review panels for a U.S. Federal, state, or local 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.
- Additional exceptions: for faculty members NOT considered investigators, all of the following are exempt from disclosure
- Any income for services provided to, or travel expenses from, non-profit entities including
- a U.S. federal, state, or local 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
- A foreign institution of higher education, academic teaching hospital, medical center, or research institute that is affiliated with an institute of higher education
- A non-profit 501(c)(6) professional association which is not a subsidiary of a for profit entity
- A charitable 501(c)(3) organization
- Any income for services provided to, or travel expenses from, non-profit entities including
When Must Disclosures be Made
- All investigators, faculty members and designated administrators are required to make a disclosure of all significant financial interest (SFI) on an annual basis.
- Financial interest disclosures each year are based upon the last calendar year (Jan. 1 to Dec. 31)
- A new disclosure or an update of an existing disclosure is required for all investigators, faculty members, and designated administrators prior to submitting an application for research funding, whenever the proposed Research is related to any new or previously disclosed SFI, and within 30 days of:
- Beginning employment with the University or Penn State Health Milton S. Hershey Medical Center in a job requiring disclosure
- When an SFI is acquired with a new entity not already included in your current COINS disclosure
- In cases of non-compliance
- As a part of the required annual disclosure
- In addition, all faculty members and administrators who are considered Investigators are required to disclose SFI within 30 days of acquiring, discovering or receiving any equity, income, intellectual property rights and interest and/or the occurrence of reimbursed or sponsored travel.
Public disclosure of financial conflicts of interest involving individual employees of the College of Medicine or PSHMC will be made only, as required in Federal PHS regulations (42 CFR, Part 50, Subpart F revised in 2011), for conflicts of interest involving studies funded by the Public Health Service (PHS).
Response to Requests for Public Information
The Conflict of Interest staff will respond via email or in writing to anyone requesting this information within 5 business days of receipt by the COI Program, for Financial Conflict of Interest involving PHS studies performed at Penn State Health Milton S. Hershey Medical Center.
The requestor will receive a letter from the COI program either providing the information below or specifying one of the following reasons it could not be provided:
- the individual for whom the information is requested is not a current Penn State Health Milton S. Hershey Medical Center/Penn State College of Medicine employee,
- the individual for whom the information is requested is not a PHS-funded investigator or the study requested is not funded by PHS, or
- the study for which information is requested was not performed at Penn State Health Milton S. Hershey Medical Center.
The information to be made public will include the following:
- The investigator’s name;
- Investigator’s title and role with respect to the research project;
- Name of the entity in which the significant financial interest is held;
- Nature of the significant financial interest; and
- Approximate dollar value of the significant financial interest or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.
If the investigator has no applicable conflict of interest, that information will be provided as well.
The investigator will be copied on this response.
A clinical conflict of interest can occur whenever a clinician, who has the ability to decide between competing products, devices, pharmaceuticals, or services in the management of their patients, has a financial interest in any one of these products. Risk of a conflict is particularly high when that financial interest could impact College of Medicine or Penn State Health purchasing decisions.
It is important that any significant financial interests which involve professional practice should be disclosed to the University. See the “Disclosure of Financial Interest” section of this page for details.
When graduate or medical students learn by working with, and observing, their faculty members and mentors, it is important that they have access to information regarding the faculty member’s significant financial interests which may impact on what they are being taught. Utmost care must be made to ensure that the performance of research is consistent with all procedures implemented to protect the integrity of student’s research and to ensure that the conflict has no influence on student’s progress.
It may be disruptive to disclose these interests each time a particular product of services is being discussed in the laboratory or clinic. Therefore, faculty would be encouraged to use a public location accessible to students, such as their faculty profile in Pure, to include relationships with private companies; such as consulting, membership on the board, or advising; as well as any equity interests such as patents; along with their other qualification and evidence of expertise in their field.
Significant financial interests which have any relationship to proposed research must be disclosed at the time the application is submitted to an external agency for funding, or when an application for that research project is made to the IRB (whether or not the study has external funding). If external funding is obtained for the project, the conflict must be reviewed, and managed, reduced, or eliminated, before any external funds would be received or spent.
The requirements for disclosure and management of conflict of interest for research come from the federal government, and need to be taken seriously in every instance.
Sheila Vrana, PhD, Associate Dean for Research, reviews applications for funded research projects. If any significant financial interests are disclosed, the Conflict of Interest Office will work with you to resolve them.
Disclosure with application for a research project
All sponsored project applications require the completion of an internal electronic form known as the ePIAF (Proposal Internal Approval Form). All investigators on the proposed project must electronically indicate on the ePIAF whether or not they have a significant financial interest in connection with the proposed project. Additionally, if the research project involves human subjects, the CATS IRB application also requires disclosure of any significant financial interest which may be related to that research. In either case, if an affirmative response has been made to a significant financial interest on either the ePIAF or the CATS IRB application, then additional information related to the disclosures would need to be submitted.
To make this disclosure, log into the electronic Conflict of Interest Disclosure System (COINS) and either make a new disclosure, or, if you have an existing disclosure, edit it to include new information.
More details regarding the federal requirements can be found on this page or by contacting the Office of Research Affairs.
Full-time faculty members may engage in consulting for private entities up to four days per month, with the understanding that it may not interfere with the performance of their University duties and the hope that the consulting will enhance their professional stature or academic proficiency. The nature of the consulting, and the necessary approvals and annual reporting, are more completely defined in Penn State Policy AC80.
In addition, any Penn State faculty or staff member requires approval of the University President before engaging in service, with personal compensation, for the Commonwealth of Pennsylvania, as specified in Penn State Policy HR-42.
External consulting may or may not be associated with financial conflict of interest depending on whether the financial interest is received from an external commercial entity. Medical liability testimony is a common area of external consulting that would not be considered a financial conflict of interest because it is considered a professional service.
Investigators considering starting a company or engaging in entrepreneurial activities should work with the following programs:
- Conflict of Interest Program (details on this page)
- Center for Medical Innovation
- College of Medicine Director of Accounting
- Consult with the Director of Accounting when considering any transactions involving your company and Penn State, including the purchase of products or services from your company, subcontracts or the use of Penn State equipment or facilities for company-related purposes. This person will assist in determining what additional steps may be necessary, such as competitive bids, fee schedules, or use of service agreements, and may refer you to other departments, such as the Office of Research Affairs.
- Email llong3pennstatehealth.psu.edu or call 717-531-7674
- Your Department Chair
- Your chair can address any concerns or questions you have regarding your time commitment to Penn State
Penn State Policies
- AC47 – General Standards of Professional Ethics (Formerly AD47)
- AC76 – Faculty Rights and Responsibilities
- AC80 – Private Consulting Practice
- AD83 – Institutional Financial Conflict of Interest
- HR42 – Payment of Personal Compensation by a State Agency or Department of the Commonwealth
- HR91 – Conflict of Interest
- IP06 – Technology Transfer and Entrepreneurial Activity (Faculty Research) (Formerly RA12)
- IPG03 (Guideline) – What to Expect When Licensing a Penn State Technology into a Start-Up Company (Formerly RAG14)
- RA06 – Small Business Innovation Research (SBIR) Collaboration
- RA07 – Small Business Technology Transfer (STTR) Collaboration
- RP02 – Addressing Allegations of Research Misconduct (Formerly RA10)
- RP06 – Disclosure and Management of Significant Financial Interests (Formerly RA20)
College of Medicine and Penn State Health Milton S. Hershey Medical Center Policies and Procedures
- A-60 HAM Conflict of Interest Policy (internal access only; login required)
- A-89 HAM Industry Relations Policy (internal access only; login required)
- Standard Operating Procedures Regarding Review and Management of Conflict of Interest (internal access only; login required)
- Standards of Practice Regarding Disclosure of Conflict of Interest (internal access only; login required)
- This information can also be found in the “Disclosure of Financial Interest” section of this page. A full PDF is available by emailing COIporgram@pennstatehealth.psu.edu.
- Title 45 Code of Federal Regulations (CFR), Part 94, Responsible Prospective Contractors
- Title 42 Code of Federal Regulations (CFR), Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought
- The U.S. Department of Health and Human Services (HHS) has issued a final rule in the Federal Register that amends the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94); see details
In order to to consolidate guidance found in other policies and standard operating procedures, the Conflict of Interest program created a set of administrative guidelines for managing conflicts of commitmment, outside business interests and non-PSU teaching activity.
See the full guidelines in the policy portal
(Penn State Health ePass login required)
To consolidate guidance found in the following policies and SOP:
- AD77 – Engaging in Outside Professional Activities
- AC80 – Outside Business Activities and Private Consulting
- Penn State College of Medicine (COM) Standards of Practice Regarding Conflicts of Interest
- Milton S. Hershey Medical Center (HMC) Industry Relations Policy
The criteria outlined in the policies and SOP listed above will be utilized to review faculty activities and approval will be considered on a case-by-case basis.
- All Penn State‐employed faculty (36‐ or 48‐week appointment), including Hershey Medical Center faculty and Penn State Health physicians involved in research, must adhere to the policies and SOP listed above.
- This does not include volunteer/adjunct faculty (clinical assistant, associate or full professors).
Pre-approval not required
The following activities do not require pre-approval by the department chair or dean, but may require annual disclosure:
- Giving a seminar or short course at another institution (less than one week)
- Serving on a doctoral or master’s committee at a U.S. institution, when any compensation is only for travel expenses and a small honorarium (less than $1,000)
- Any teaching that is not for academic credit, including professional education courses for licensing
- Any teaching that is not in the general area of expertise of Penn State appointment
- Presentations at professional meetings and other similar gatherings
- Peer review of articles and grant proposals
- Leadership positions in professional societies
- Preparation of scholarly publications
- Editorial services for educational or professional organizations
- Service on advisory committees or evaluation panels for government funding agencies, nonprofit foundations or educational organizations
- Service with accreditation agencies (e.g., AAALAC, AAHRPP, etc.)
- Conducting workshops for professional societies
- Expert witness testimony
Prior approval required
The following activities require written prior approval by the department chair (or dean, if faculty member is a department chair or institute director):
- Teaching/research appointments at another institution (e.g., visiting professorship) for longer than one week
- Teaching for credit at another institution of higher education
- Chairing PhD committees at another institution of higher education
- Holding an honorary chair at another institution
- Starting a company or assuming an executive/management position for a third-party entity
- Involving undergraduate or graduate students, or University staff, in Outside Business Activities (as defined in AC80)
- Global health trips for clinical purposes
- Any other private consulting activities not included as the list of activities that do not require preapproval by the department chair or dean (above)
Prohibited without prior approval
The following activities are prohibited without written prior approval by the department chair and dean:
- Exceeding the monthly or annual time limits for outside business activities
- All teaching or research engagements, appointments or affiliations with foreign institutions
The following activities are prohibited:
- Tenure at another institution of higher education
- Maintaining responsibility for a laboratory or research program at another institution of higher education (domestic or international)
- Private consulting involving presentations that are either not the work of the speaker or marketing/promotional in nature
Approval for activities will be collected via the College of Medicine Outside Business Activity Approval Form.
See form in policy portal
(Penn State Health ePass login required)
Additionally, any contracts, grants, or agreements related to a foreign appointment and/or employment with a foreign institution require institutional review and must be forwarded to firstname.lastname@example.org.
Relevant policies and descriptions
- This policy addresses conflict of commitment in the professional activities of faculty. Outside activities shall not adversely affect the University’s interests or mission, or require a significant commitment of an excessive amount of time, that interferes with an employee’s primary University responsibilities, or competes with coursework or services provided by the University.
- This policy defines Outside Business Activities as entrepreneurial or professional services, paid or unpaid, that are in the general area of expertise for which the faculty member is employed by the University but are beyond the scope of the individual’s University employment responsibilities.
COM Standards of Practice Regarding Disclosure of Conflict of Interest
(Penn State Health ePass login required)
- These standards incorporate the requirements of Penn State University policies regarding Conflict of Interest, (including RP06) for implementation at the College of Medicine.
Milton S. Hershey Medical Center (HMC) Industry Relations Policy
(Penn State Health ePass login required)
- This policy establishes guidelines for interactions with industry representatives. This policy is intended to cover interactions that involve marketing of products or services, on‐site training, and/or education. It applies to all health care professionals, including faculty, staff, administration, residents, students and trainees at HMC.
Last updated: August 2020
Help with COINS
Decision Tool: Should I disclosure reimbursed/sponsored travel in COINS?
Is the travel reimbursed/sponsored by a Federal, state, or local 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, within the United States, that is affiliated with an institution of higher education?
- Yes: No need to disclose the travel in COINS
- No: Is the travel paid for by a company related to any of my human subjects research or Penn State purchasing responsibility?
- Yes: Disclose the travel in COINS within 30 days
- No: Is the value of the reimbursed/sponsored travel from any one entity, over the course of 12 months, greater than $5,000?
- Yes: Disclose the travel in COINS within 30 days
- No: No need to disclose the travel in COINS
Guidance for Public Disclosure of Potential Conflicts of Interest in Research
This guide is meant to advise investigators on the specific requirements for public disclosure (in presentations, publications, informed consent form, etc.) when required in the management plan approved by the Penn State College of Medicine Conflict of Interest Review Committee (CIRC), addressing some frequently asked questions regarding the public disclosure process.
Public disclosure is a management plan element that serves to protect investigators and Penn State by identifying all potential financial interests that the investigator may have or appear to have in relation to their research, and making the interest subject to transparency. Providing a full disclosure of these facts helps to dispel any belief that financial interests or other commercial interests in technology are being hidden from the public eye. As has been demonstrated at several other institutions, complete transparency related to competing interests is extremely beneficial to investigators and their institutions. Management of potential conflicts of interest by mechanisms such as public disclosure allows College of Medicine investigators to continue in mutually beneficial commercial activities and industry partnerships that help to bring PSU’s exciting discoveries to the public benefit.
CIRC encourages investigators to contact the committee via the College of Medicine Conflict of Interest Program office (COIProgram@pennstatehealth.psu.edu or 717-531-0003 ext. 283526) with any questions about this guidance or to discuss particular management plans.
When is public disclosure required?
Public disclosure is required in any public presentations (see definitions below) of data from research that is related to the investigator’s financial interests. The statement must be included as applicable for all authors on the publication or presentation.
Note that it is the responsibility of each author with a financial interest to ensure that these public disclosures are included in relevant public presentations.
Public presentations include conferences, lectures, abstracts, oral or poster presentations, journal articles, including review articles, letters to the editor, etc.
Research related to the investigator’s financial interests is exemplified by any research project that:
- Is fully or partially sponsored by the company in which the investigator has a financial interest
- Involves technology licensed to or owned by the company in which the investigator has a financial interest (including manufacturers of the investigational product used in the research)
- Any other research projects not covered above where the conduct or outcome of the research may appear to affect the company in which the investigator has a financial interest (including financial interests in companies that are direct competitors with the sponsor of the research or the manufacturer of the investigational product).
Note: All research potentially related to the investigator’s financial interests must be disclosed to CIRC via COINS (https://coins.psu.edu). The investigator’s related financial interest must also be indicated on the Internal Approval Form (IAF) and CATS IRB submission, as applicable, for all potentially-related research.
How is the public disclosure statement to be incorporated in presentation materials?
A public disclosure statement should be included in any journal article, Powerpoint or other presentation slides or documents, posters, etc. presenting research related to the potential conflict as described above.
- Investigators should follow the journal or scientific organization’s policy for submission of financial disclosure information.
- If the journal or meeting host does not have a policy, the investigator should include a disclosure of their financial interests in a letter to the editor or meeting organizer and should indicate that Penn State requires a statement of these financial interests in the publication or presentation. It is the investigator’s responsibility to assure that the statement is included in the final publication.
- If the journal has a template (such as a statement or form) to use for the financial disclosure, it is appropriate to use that template instead of the recommended language listed below. This does not need to be submitted for review by CIRC.
- The statement may be placed in any location in the article, slide, or poster presentation as preferred by the investigator. It only needs to be included in one location (not on every slide).
What if the journal or scientific meeting host’s financial disclosure requirements are different than Penn State’s?
So long as the public disclosure occurs, the exact wording and placement of that disclosure is very negotiable. Although the investigator must complete any financial disclosure statements required by the journal or by the meeting host, he or she must also include a public disclosure statement in the article or presentation materials as described above. If the journal or meeting host wishes to modify the wording approved by the CIRC, that is fine.
PSU understands that there are differing definitions of “significant financial interest” (SFI) among universities and journals. Penn State College of Medicine’s definition is in keeping with the preponderance of current national guidance. We recognize that it may be more stringent in some cases, but less stringent in others. Please see the resources below that include examples of some journals’ COI policies and reports from national organizations that provide an overview of SFI definitions used at other academic medical centers and at various journals.
What happens if an investigator fails to include the public disclosure statement as required?
Upon annual monitoring of the investigator’s management plan, the COI Monitor requests information from each investigator for evidence of the public disclosure statements he/she has made.
Investigators will be required to contact the journal to publish an erratum for any missing or inadequate disclosure statement noted in the Monitor’s reviews. It is recommended that investigators confirm with the publisher, immediately before publication, that the correct disclosure statement is present. Additional corrective actions may also be required for non-compliance with management plan requirements.
Recommended Financial Conflict of Interest Disclosure Language
Disclosure in Publications/Presentations
- I have a financial interest in [insert entity name], which could potentially benefit from the results of this research.
- I have a financial interest in [insert entity name], a company which [describe activities, e.g., markets, develops, licenses] the technology [described, utilized, tested] in this research, and which could potentially benefit from the results for this research.
- I have a financial interest in [insert entity name], a company which could potentially benefit from the results of this research. This interest has been reviewed by the University in accordance with its Individual Conflict of Interest policy, for the purpose of maintaining the objectivity and integrity of research at The Pennsylvania State University.
Disclosures in Consent Forms for Human Research Subjects
Please defer to the IRB for any additional guidance regarding consent disclosure language.
- [Name of investigator], a member of the research personnel on this study, serves [insert type of relationship, e.g., as a paid consultant, on the advisory board, as a paid speaker] for the sponsor. This financial interest has been reviewed by the Penn State Institutional Review Board and Conflict of Interest Review Committee. If you would like more information, please contact the College of Medicine Conflict of Interest Program at 717-531-0003, ext. 283526.
- [Name of investigator], a member of the research personnel on this study, [owns/has applied for] a patent on the new [test, drug, treatment] being studied. Research studies like the one you are thinking about joining are done to determine whether the new [test, drug, treatment] is safe and effective. If research shows the new [test, drug, treatment] is safe and effective, [name of investigator] would receive a part of the profits from any sales of this [test, drug, treatment]. This financial interest has been reviewed by the Penn State Institutional Review Board and Conflict of Interest Review Committee. If you would like more information, please contact the College of Medicine Conflict of Interest Program at 717-531-0003, ext. 283526.
- This research study is designed to test a product made by [sponsor]. [Name of investigator] has an investment in [sponsor], such as stock. The amount of money the investment is worth might be affected by the results of this study. This means that [name of investigator] could gain or lose money depending on the results of this study. This financial interest has been reviewed by the Penn State Institutional Review Board and Conflict of Interest Review Committee. If you would like more information, please contact the Conflict of Interest Program at 717-531-0003, ext. 283526.
If Penn State has ownership, consultative or financial relationships with the sponsor:
The Penn State Institutional Review Board has reviewed the possibility of financial benefit. If you would like more information, please ask the investigators or the study coordinator.
The Penn State Institutional Review Board has reviewed the possibility of financial benefit. If you would like more information, please ask the investigators or the study coordinator.
Disclosures in University Press Releases
Sample Journal and Professional Organization COI Policies:
The Physician Payment Sunshine Act
The Physician Payment Sunshine Act, part of the Affordable Care Act, was passed by Congress in 2010. The program’s goal is to increase public awareness of financial relationships between drug and device manufacturers and health care providers, primarily physicians and teaching hospitals.
Under the Sunshine Act, manufacturers of drugs, medical devices, biological or medical supplies, and group purchasing organizations, are required to report all financial transactions/transfers of value to physicians and teaching hospitals. Ownership and investment interests of physicians and their immediate family members in these companies are also reportable. Manufacturers are required to submit the compiled reports to the Center for Medicare and Medicaid Services (CMS) on an annual basis. The information will then be made available on a public, searchable website. The program implementing the requirements of the Act is called “Open Payments” and will be administered by CMS.
Physicians and teaching hospitals do not have any reporting obligations under this Act. However, payments and other transfers of value they receive from manufacturers will be publicly reported. Therefore, it is important that these reports are accurate and complete. Inaccurate reports could have an adverse effect on a physician’s reputation. Each physician is the only person who can access and initiate procedures to correct errors in reports pertaining to them, before the reports are published. Penn State has no opportunity to review or petition for correction of any of these reports regarding individual faculty members.
Physicians are urged to register with the website to receive notice of reports. CMS will not initiate direct contact with physicians; registration is essential in order to receive notification. Physicians will have the opportunity to review and dispute information before it is published on the public website. It is important to make sure that CMS has received accurate information because incorrect information could potentially affect your professional reputation.
- Become familiar with the information that will be reported about you.
- Keep records of all payments and other transfers of value you receive from applicable manufacturers or applicable GPOs.
- Register with CMS and subscribe to their email list to receive updates regarding the program.
- Look at the information manufacturers and GPOs submitted on your behalf.
- If the information submitted about you is incorrect, follow the procedures outlined by CMS to dispute it. You must note the dispute directly in the Open Payments system, which will alert the manufacturer of the dispute. CMS strongly encourages individuals to include their own contact information in the comments with the disputes to facilitate rapid resolution of the dispute.
Pre-submission Review Process
- The manufacturer/GPO can, but is not required to, give the physician, teaching hospital, or physician owner/investor the chance to see their information before sending it to CMS. This process is voluntary. CMS will not oversee pre-submission reviews.
- If you ask for a pre-submission review, there is a better chance that the information sent to CMS about you is accurate and complete.
CMS Review Process
Once the manufacturer or GPO has submitted the data to CMS, the process is as follows:
- CMS will give physicians and physician owners/investors 45 days to review and work with the manufacturers or GPOs to correct the information. After those 45 days, manufacturers or GPOs will have an additional 15 days to submit corrections based on any disputes identified by physicians, and physician owners/investors. The review and correction period starts at least 60 days before the information is made public.
- During the review and correction period, physicians and physician owners/investors can dispute information about them that they do not think is correct.
- If data is disputed, CMS will notify the manufacturers or GPOs that some of their data has been disputed, but will not mediate the dispute directly. Manufacturers or GPOs should work with physician and physician owner/investor to correct the information.
- Once the dispute is resolved, the manufacturers or GPOs must send CMS a revised report for the correct data and re-attest that it is correct.
- If the manufacturer or GPO cannot resolve the dispute with the physician or physician owner/investor and correct the data in the initial 45 days or subsequent 15 days, they should continue trying to find a resolution. This review, dispute and correction process will impact publication as follows:
- While the review and correction system will be open year-round, only the data corrections noted during the 45-day review and correction period, and subsequent 15-day dispute resolution period, will be updated before publication.
- CMS will update data from the current and previous year at least once annually, in addition to the initial data publication that followed the data submission.
Who does the Sunshine Act impact?
- Manufacturers – Manufacturers of pharmaceutical/biologic products or medical devices that are reimbursed by the U.S. federal government, whether through Medicare, Medicaid, or state children’s health insurance.
- Group purchasing organizations
- Teaching hospitals
The Sunshine Act applies to payments made to:
- Doctors of Medicine
- Doctors of Osteopathy
- Doctors of Dentistry
- Doctors of Dental Surgery
- Doctors of Podiatry
- Doctors of Optometry
- Doctors of Chiropractic Medicine
… who have an active license to practice.
- Other healthcare professionals are not included.
- Employees of a manufacturer
- Medical students
What are manufacturers Required to Report to CMS?
- Any type of payments or transfers of value to physicians including:
- Consulting fees
- Compensation for services other than consulting, including serving as faculty or as a speaker at an event other than a continuing education program
- Food and beverage
- Travel and lodging
- Charitable contributions
- Royalty or license
- Current or prospective ownership or investment interest
- Compensation for serving as faculty or as a speaker for an unaccredited and non-certified continuing education program
- Compensation for serving as faculty or as a speaker for an accredited or certified continuing education program
- These payments include:
- Direct payments or transfers to the physician
- Third-party payments or transfers
- Indirect payments or transfers
- Ownership and investment interest (including immediate family members of physicians)
If I receive payment from a separate entity on behalf of a pharmaceutical manufacturer, is that reportable?
Yes, manufacturers will be required to report any indirect payments or transfers made at their “direction, instruction or requirement.”
The College of Medicine Conflict of Interest Program is happy to provide more information or try to answer any of your questions about this program. Contact COIProgram@pennstatehealth.psu.edu or 717-531-0003, ext. 283526.
The College of Medicine COI Program may not be able to assist you with CMS website issues. This is a government website, and the College’s program has no other information on the navigation of the website outside of what is posted. The helpline to the CMS website is 855-326-8366.
- Patient Protection and Affordable Care Act. 111 Congress HR 3590 2010:111-148.
- American Medical Association: Physician Financial Transparency Reports (Sunshine Act) – This site also provides a link for a free smartphone app that you may download to track reportable transfers.
- Association of American Medical Colleges: Physician Payments Sunshine Act
- Centers for Medicare and Medicaid Services: National Physician Payment Transparency Program – Open Payments (send questions to OpenPayments@cms.hhs.gov)