Conflict of Interest Questions Answered

At Penn State College of Medicine, all investigators (as defined by University Policy RP06), faculty and designated administrators are required to complete an annual disclosure.

Any University employee, regardless of title or position, who has the ability to make independent decisions related to the design, conduct or reporting of University research, but not including individuals who perform only incidental or isolated tasks related to a University research project. Since title and position are not indications of who is an “Investigator,” it is possible for students and postdocs to meet this definition.

If a postdoctoral fellow, graduate student, medical student and/or resident meet the definition of Investigator, then they must comply with policy RP06 (See Policy RP06 Disclosure and Management of Significant Financial Interests) and all related regulations.

If you conduct research at the University and have been identified as an “Investigator,” or if you have a faculty appointment or are a designated administrator/purchasing staff, you are required to submit a financial disclosure regardless of whether or not you have a Significant Financial Interest.

Yes. An investigator’s responsibility under RP06 is to identify Significant Financial Interests that are related to one’s Institutional Responsibilities. An SFI can be that of the investigator or those of the investigator’s spouse, partner or dependent child(ren). The COI Official, through the COI Program and COI Committee, then determines whether any potential conflicts exist.

No, if you are an affiliated unpaid faculty member or an occasional or PRN employee, you are not required to disclose (as long as you are not an Investigator on Penn State research). Only full-time and part-time paid faculty members are required to disclose.

Principal Investigators, Multiple (“Co”) Principal Investigators, Co-Investigators and any person listed as Senior or Key Personnel on a proposal or award are nearly always considered Investigators for purposes of Significant Financial Interest disclosure. It is possible that there will be situations where an individual in one of these roles could be excluded from the definition of Investigator, but in practice all persons named on a proposal or award should follow the requirements of Investigators under University policy and federal regulations.

Yes. If you are an investigator you must update your disclosure within 30 days of acquiring or discovering a new Significant Financial Interest, including sponsored or reimbursed travel, and you must also ensure that your disclosure is up-to-date at the time of submitting any new proposal for sponsored funding. Failure to meet these deadlines can result in additional administrative requirements and delays to receiving your funds.

If you are not an investigator you must update your disclosure within 30 days of:

• Beginning employment with the University or Penn State Health Milton S. Hershey Medical Center
• Submitting an application for research funding
• When a Significant Financial Interest is acquired with a new entity that has not previously been disclosed

All investigators, faculty and designated administrators are required to make a disclosure at least on an annual basis. For the College of Medicine, the annual disclosure period will typically be from Jan. 1 to April 30.

All disclosures are done electronically via COINS.

In addition to annual disclosure, all investigators are required to update their disclosures within 30 days of acquiring or discovering a new Significant Financial Interest. This includes reimbursed or sponsored travel.

For those that are not investigators, in addition to the annual disclosure, you are required to update your disclosure within 30 days of the following instances:

• Beginning employment with the University or Penn State Health Milton S. Hershey Medical Center
• Submitting an application for research funding
• When a Significant Financial Interest is acquired with a new entity that has not previously been disclosed

If you submit your annual disclosure past a deadline, you may be subject to suspension or termination. Additionally, research funding may be delayed, as the Office of Research Affairs will not release funds for a project until any COI review has been completed. In addition, noncompliance procedures may need to be followed at the University, and if you have PHS (NIH) funding, your project may be subject to a retrospective review to determine if any actual bias has occurred.

Although the COI Program makes every effort to expedite the review process, it is still important to submit your disclosure and any updates in a timely manner.

If your disclosure requires review by the Conflict of Interest Review Committee, it can take several weeks, depending on the complexity of information and any follow-up meetings or information-collection required.

In addition, if your research involves human participants, please note that the IRB will not complete its review of your application until the COI review has been completed.

Finally, the Office of Research Affairs will not release funds for a project until all compliance reviews have been completed.

Investigators must disclose those Significant Financial Interests that “reasonably appear to be related” to the Investigator’s Institutional Responsibilities. Each Investigator can make a reasonable, good-faith determination about whether or not any given Significant Finanical Interest is related to their Institutional Responsibilities, rather than simply disclosing everything. They need to ask whether, to the best of their knowledge, the Research or other Institutional Responsibilities that they have could affect the value of the financial interest, or could have a financial impact on the Entity in which they hold the financial interest (even if only in the future).

Generally, however, income received from consulting or speaking on behalf of an entity is always related because the Investigator has been retained as a consultant based on their overall expertise in their field.

In addition, if an Entity in which an SFI is held is involved in the same research project (e.g., as a sponsor or via a subcontract), then it is always related to the Investigator’s Institutional Responsibilities and the financial interest and research project should be disclosed in COINS.

No, every investigator, faculty member and designated administrator is required to disclose all financial interest that is related to their Institutional Responsibilities.

Common examples of institutional responsibilities could be the following:

• Research (regardless if funded or not);
• Research consultation;
• Teaching;
  • Example: You own stock in Merck and you lecture on a particular product manufactured by Merck.
• Outreach;
• Professional practice (e.g., clinical medical practice, veterinarian practice, practice of law, etc.);
  • Example: You are a speaker for Medtronic devices and receive income for speaking. You also use Medtronic devices in your professional practice and make purchasing decisions related to Medtronic devices.
• University committee memberships (e.g., Faculty Senate, Purchasing Committees);
  • Example: You own stock in a medical device company and you are also on the purchasing committee and make purchasing decisions related to this particular medical device.
• Service on University panels.

For purposes of determining which Research projects to list in your disclosure as “related” to your Significant Financial Interest (SFI), you should determine whether a given SFI could be affected by any specific Research project or is in an entity whose financial interest could be affected by a Research project. This means, for example, that the value of the SFI could be driven up or down, or a relationship extended or terminated, based on the results of the Research.

If the answer is yes, that project should be added to your disclosure as “related” to each SFI it could affect. It is important to understand that the disclosure of the Research as related is necessary if any of these effects could occur, even if none of these effects actually do occur.

Some common examples of Research projects that are related to SFI in this way include, but are not limited to:

• You are a paid consultant to ABC company, which also subcontracts a portion of a Research project to your Penn State laboratory or you subcontract a portion of the research to ABC company.
• You are a paid speaker for ABC company, and also the principal investigator of a Penn State Research projects funded by ABC company.
• You own stock in ABC company and also conduct Research to test the products of ABC company.
• ABC company has paid for travel for you and you also conduct research at Penn State that is likely to develop Intellectual Property that you know would be of interest to ABC company.
• You own stock in ABC company and ABC company provides cost-sharing on an award in your laboratory at Penn State.

Please note that the Institution, through the COI Official, COI Committee and COI Program, is charged with determining whether an actual, potential or perceived conflict of interest exists between any disclosed significant financial interests and the Investigator’s research. For this reason, the COI Program may ask you to modify your disclosure to add research projects as “related.”

No, any funds coming through the University’s Office of Sponsored Programs (i.e., the College of Medicine Office of Research Affairs) do not constitute SFI and do not need to be disclosed. Such funding supports your role at the University and is not an outside financial interest.

No. Income from American institutions of higher education, teaching hospitals or research centers affiliated with the above is not included in Significant Financial Interest and does not need to be disclosed. However, honoraria or payments from foreign institutions must be disclosed.

Income from service on a study section for a U.S. government funding agency does not need to be disclosed because it is a government source. Please note, however, that if you are an investigator and you serve on a proposal review board for a non-profit Entity, such as a foundation, any income over $5,000 is considered a Significant Financial Interest and must be disclosed. If you are not an investigator, you do not need to disclose income from service on a study section for a U.S. government funding agency or a non-profit Entity.

This depends on two things.

First, are you classified as an investigator? If so, then if the journal is published by a private organization, either for profit or non-profit, you need to disclose the income. However, if it is published by an American government agency or an American institution of higher education, you do not need to disclose the income.

If you are not an Investigator, and the journal is published by a non-profit entity, you do not need to disclose, but if it is published by a for-profit entity, you do need to disclose. Follow the same guidelines as for other income.

Investments such as mutual funds, in which an Investigator does not have control over the individual securities held, are excluded from Significant Financial Interest and do not need to be disclosed. If you own other investments, such as stock in an individual corporation, even if held in a retirement account, those investments can be bought or sold at your discretion, and you will need to evaluate each such investment in order to determine whether it is reasonably related to your Institutional Responsibilities.

The lunch would be considered a gift and could be disclosed if, in aggregate with other compensation or any equity in the company, you exceed the $5,000 threshold for the past 12 months. However, if the lunch (gift) is the only financial interest you have in the company, then it would not need to be disclosed. Please note that this is not a travel expense, as the lunch occurred locally. If you receive meals while traveling, it is not required to be disclosed specifically, either, but can be included in the total expense of the trip if you know the expense.

Yes, professional societies are non-profit organizations, and if you are an Investigator, travel and income from them is required to be disclosed.

If you are not an Investigator, income and travel from non-profits, not affiliated or controlled by for-profit entities, does not need to be disclosed.

For example: Dr. X is a speaker for Pfizer and has received $3,000 in the previous calendar year. Dr. X is also working on a study sponsored by Pfizer that involves human subjects.

Yes, for the College of Medicine, any financial interest that you have in any for-profit entity that is related to human subject research will require disclosure. The same is true for Intellectual Property rights and interest. Regardless of whether the Intellectual Property rights and interest have generated income, if it is related to human subject research, it is required to be disclosed.

Travel disclosure is incorporated into the electronic disclosure form (COINS).

You do not need to disclose travel that is sponsored or reimbursed by a U.S. federal, state or local government agency, a U.S. institution of higher education, a U.S. teaching hospital, a U.S. academic medical center or a research center affiliated with any of the above.

When making a disclosure for travel, the individual disclosing will only be required to disclose the following information:

• The entity that has reimbursed or sponsored the travel
• The number of trips taken that have been reimbursed or sponsored by that entity
• The purpose of the travel
• The destination
• The duration of the trip

If the individual knows the cost of the travel, it would be valuable to provide that information; however, if the value is not known, it is not required to be disclosed. (This question is asked in the disclosure form but is not required).

No, for the disclosure of travel, an investigator, faculty member and/or designated administrator will only be required to disclose travel that is reimbursed or sponsored to them directly, and not travel that is reimbursed or sponsored to their spouse and/or dependent children.

No. Travel paid with funds from a sponsored award does not need to be disclosed. In the case of travel, the federal regulations use the word sponsored to refer to situations where travel has been arranged and paid for by an Entity, such as where ABC Company directly pays an airline and/or hotel on an Investigator’s behalf.

Yes, if the individual that has received the reimbursed or sponsored travel is considered an investigator as defined by University Policy RP06, they are required to disclose any occurrence of reimbursed or sponsored travel by any for-profit and/or non-profit entity within 30 days of the travel.

However, if the individual is not an investigator as defined by Penn State RP06, they are not required to disclose travel that is reimbursed or sponsored by a non-profit entity. Rather, individuals not considered as an Investigator will only be required to disclose the occurrence of any reimbursed or sponsored travel by any for-profit entity at least on an annual basis.

No, this would not constitute a significant financial interest and would not require disclosure, as the travel is being handled through the University. Under the NIH 2011 regulations, income which includes sponsored or reimbursed travel by an institution of higher education is excluded, and especially if it is paid by Penn State as your employer, it would not require disclosure.

If you are an Investigator, either before or after the trip, but at the latest 30 days after the trip.

If you are not an investigator and have previously disclosed Significant Financial Interest with the same company, then with your next disclosure update..

That depends on whether the Entity sponsoring the trip is related to the student’s University Research. The student, together with their adviser, must determine whether the Entity sponsoring or reimbursing the travel is related to the student’s Institutional Responsibilities. Some examples include, but are not limited to, ABC Company gives a subcontract to the student’s adviser’s lab, and interviews the student for a job; ABC Company licenses Intellectual Property on which the student is an inventor, and interviews the student for a job.

Yes, all investigators are required to disclose income and travel received from any foreign institutions of higher education, teaching hospitals or governments that are related to their institutional responsibilities. However, those College of Medicine faculty who are not considered investigators would not be required to disclose financial interest from foreign non-profit entities just as they would not be required to disclose income from U.S. non-profit entities.

Yes, all investigators, faculty members and other designated administrators are required to disclose income and travel received from foreign entities that are related to their institutional responsibilities.

Yes. All College of Medicine Investigators and faculty who have Intellectual Property rights and interest related to human subjects research must disclose that IP regardless of whether the IP has generated income or meets the $5,000 threshold.

Yes, this should be disclosed according to the guidelines mentioned elsewhere in this guide.

Here you have two different financial interests related to the same Intellectual Property:

• A royalty stream through Penn State Research Foundation from the licensing revenue, and
• Income or other financial interests in your company from the commercialization activities.

You should disclose your equity or ownership interest in the company; you should disclose income which you receive from the company from its commercialization efforts or other activities; and you should disclose the income which you receive from PSRF for licensing revenues.

Use of University facilities, equipment and effort to develop a privately-owned invention, in the absence of a formal research agreement with the University, would be in violation of Penn State policy.

For further information, please see Penn State policies FN14 (Use of University Tangible Assets, Equipment, Supplies and Services), AC80 (Private Consulting Practice) and IP06 (Technology Transfer and Entrepreneurial Activity).

For Investigators who are not Senior or Key Personnel on a PHS-funded award with a Financial Conflict of Interest, none of the information disclosed to the University is publicly accessible. For Investigators who are Senior or Key Personnel on a PHS-funded award and for which a Financial Conflict of Interest has been identified in relation to one or more such awards, the following information will be available publicly, via a written response from the University to a requestor, within five business days of the Conflict of Interest Program receiving the request:

• The Investigator’s name;
• The title(s) of the affected project(s);
• The Investigator’s role on the affected project(s);
• The name of the Entity in which the Investigator has an SFI/FCOI;
• The nature of the SFI, e.g., income, equity, etc.;
• The approximate value of the SFI, in dollar ranges as set by the PHS.

An Entity is any domestic or foreign, public or private, for-profit or not for-profit, organization (excluding Federal, State and Local governmental agencies). Examples include, but are not limited to: small or large businesses, corporations, sole proprietorships, LLCs, Ltds., 501(c)s, and partnerships.

Institutional Responsibilities are your professional responsibilities on behalf of the University. Examples include, but are not limited to:

• research
• research consultation
• teaching
• outreach
• professional practice (e.g., clinical medical practice, veterinary practice, practice of law)
• committee membership (e.g., Faculty Senate, Purchasing Committees)
• service on panels, such as IRB or Data or Safety Monitoring Boards

SFI stands for “significant financial interest” and is defined as anything of monetary value held by you, your spouse or your dependent children, that reasonably appears to be related to your institutional responsibilities, including:

• Compensation or other payments (e.g., consulting fees or honoraria) exceeding $5,000 in a non-publicly traded entity or exceeding $5,000 when aggregated with the value of any equity interests held in a publicly-traded entity;
• Equity interests (e.g., stocks, stock options or other ownership interests) exceeding $5,000 when aggregated with any compensation received from a publicly-traded entity, or any equity interests in a non-publicly traded entity;
• Intellectual property rights and interests (e.g., patents, copyrights) upon receipt of income exceeding $5,000 related to such rights; and
• Sponsored or Reimbursed Travel of any value or amounts.

When you submit your disclosure in COINS, one of two things happens:

• If you disclose no SFI, your disclosure will transition directly to an “end state” within the system, requiring no further review.
• If you disclose one or more SFI, your disclosure is routed to your department chair for review and then to staff in the Conflict of Interest Program. Staff will review the disclosure to determine whether it can be processed administratively or if it will require full committee review.

COI Program staff are authorized by the Conflict of Interest Review Committee to review certain types of disclosures administratively, according to the Standard Operating Procedures Regarding Review and Management of Conflict of Interest (internal access only; login required). These types of disclosures either present a low potential for significant conflict of interest or they do not involve any research/purchasing responsibilities that are directly-related to the disclosed SFI. COI staff, as delegates of the COI Official/Conflict of Interest Review Committee, have regulatory responsibility for determining the relatedness of research to SFI; however, investigators are often involved in the analysis as well.

A disclosure requires full committee review when none of the conditions allowing administrative review apply. Typically, this occurs in situations where an investigator has disclosed one or more Significant Financial Interests that are directly related to the Investigator’s University research or purchasing responsibilities.

If your disclosure requires full committee review, you will be notified by COI Program staff that it is being scheduled for a meeting. You may choose to attend the meeting. In the meantime, staff may also contact you to gather as much information as possible in order to expedite the committee review process. If the committee determines that a potential or perceived conflict of interest exists, it will develop a management plan in order to allow you to maintain the financial interest and also perform the related research.

The committee is concerned with the potential for real or perceived conflict between one’s Significant Financial Interest and any related research. The committee wants to ensure there is a bright line distinguishing activities for an outside entity from activities performed at the University, and it seeks to protect researchers from criticism down the road for failing to have disclosed relevant financial interests. In addition, the committee is concerned with ensuring that students’/trainees’ primary focus is on academics and that their studies/theses are not at risk of being delayed or influenced by involvement with an outside entity.

Having a Financial Conflict of Interest is not a bad thing. Rather, it requires that measures be taken to promote transparency and objectivity, as well as to protect Investigators and the University from undue criticism. If it is determined that you have a FCOI, the committee will work to develop and approve a Management Plan to address the relationship between your Significant Financial Interest and your University research/responsibilities.

A Management Plan is a set of requirements outlined by the committee, and agreed to by the investigator, which are aimed at promoting transparency in financial relationships and objectivity in research. The management plan can include, but is not limited to, such things as:

• A requirement to disclose one’s Significant Financial Interests in related publications/presentations
• Disclosure in consent when human subjects are involved
• Appointment of a monitor to ensure that work that could be affected, or perceived to be affected, by the Significant Financial Interest is proceeding without any concerns
• Formal notification sent to the sponsor outlining the potential conflict and the Management Plan that addresses it
• Disclosure to students and colleagues working on related projects

Investigators have the opportunity to provide feedback and request changes to the plan before agreeing to abide by it.

Funds for sponsored research projects which are related to your disclosed Significant Financial Interest cannot be released until all compliance reviews, including the COI review, are complete. Note that if you are planning to use human participants in your research, the IRB will approve your application until after the COI review has been completed and a conflict of interest, if one is identified, is covered by a Management Plan.

The most important thing that an Investigator can do is submit their disclosure and any subsequent updates to their disclosure in a timely manner, in accordance with dates and timeframes prescribed in University Policy RP06.

Talk about your plans with COI Program staff and your Department Chair to identify potential concerns and to ensure that all checks and reviews are completed prior to submitting proposals. As a general recommendation, Company and Penn State research activities must be kept separate; it is not advisable to serve as the Penn State PI on awards originating with your company, nor should you serve as PI on both sides of any award. Appointing a family member to serve as PI at your company is not recommended. You should consider research facilities; a company should have its own research facilities. If you are considering the use of Penn State equipment or facilities, you should talk to the Controller’s Office as early as possible.

You are encouraged to review PSU policies RA06 (Small Business Innovation Research (SBIR) Collaboration) and RA07 (Small Business Technology Transfer (STTR) Collaboration).

No University personnel with an ownership interest, or whose immediate family has an ownership interest, in a small business entity may participate in research at the University related to an SBIR award involving that same small business. In order to participate in research at the University related to an STTR involving a small business in which you/your family have ownership interest, conflict of interest review and management is required.

Most importantly, protect your research, your business interests, and Penn State by being fully transparent.

Access to COINS is limited to as few people as are required to complete a review of the disclosure and, if necessary, develop of a COI Management Plan. When you submit your disclosure, it is routed to your department chair for review, and then on to the COI Program. If committee review is necessary, the disclosure is shared with the committee around the time of the meeting. Sometimes it is necessary to share certain information from a disclosure with individuals in other offices, including but not limited to General Counsel, Research Affairs, Purchasing, Medical Innovation or the Human Subjects Protection Office, and sometimes deans or associate deans, in order to facilitate a desired outcome for the Investigator/Discloser.

COI Program staff will only share those pieces of information which are relevant to a given inquiry, so for example, consulting income is likely not relevant to the Center for Medical Innovation when discussing a patent concern, while royalty income may be.

Yes, you would be a PHS-funded investigator in this situation. If asked, you can let the other institution know that PSU has a PHS-compliant FCOI Policy (University Policy RP06), and you will complete your disclosure requirements in COINS. The COI Program will handle reporting of required information to the prime awardee institution so that it can, in turn, meet its reporting requirements to the PHS Awarding Component.

The Office of Research Affairs together with the COI Program will take care of ensuring the compliance of Investigators on the subcontract at the other institution. Please ensure that the Office of Research Affairs is aware of all collaborating Investigators at other institutions.