Conflicts of Interest & Commitment

Conflicts of Interest and Commitment

Introduction

In this module, you will explore the following aspects of conflicts of interest and commitment related to research:

  1. The nature and types of conflicts of interest
  2. Disclosing and managing conflicts of interest
  3. University of New Hampshire (UNH) policies on financial conflict of interest in research
  4. Conflicts of commitment

Introduction (cont.)

The module consists of:

Case Study

Click on the image below to read the case study.

Conflicts of Interest

Trust is an integral feature of the scientific research enterprise:

Any situation or action creating suspicion that the design, conduct, and/or reporting of research activities are biased erodes trust at all levels and is damaging to scientific research.

Conflicts of Interest (cont.)

In the research setting, individuals often face competing obligations and conflicting interests. These may include, but are not limited to:

Where competing obligations exist, it is important that one obligation does not blind an individual to the other(s).

Conflicts of Interest (cont.)

In the research enterprise, a conflict of interest is defined as a situation where a researcher’s personal interests, such as career, reputation, or finances, inherently conflict with his/her professional obligations to honest, objective, and responsible conduct of research activities (Pritchard, 2002).

Where personal interests affect professional obligations in research activities, the integrity of the research may be compromised.

Conflicts of Interest (cont.)

Personal interests or professional obligations by themselves do not raise ethical issues. The relationship between the interests and the obligations, however, may raise ethical concerns that need to be addressed (Pritchard, 2002).

The concern presented by most conflicts of interest is that the personal interest may directly and significantly influence the professional obligation if acted upon. That is, researchers’ professional judgment is biased by their personal or non-professional interests. The concern is one directional; for conflict of interest purposes, there is no concern when professional obligations supersede self-interest.

Conflicts of Interest (cont.)

As research is a human endeavor, bias is almost impossible to eliminate. Researchers can bias research in many ways, many times unknowingly, including via research questions, study design, design of experiments, data analysis and/or interpretation, and presentation/reporting of results. All these types of bias are problematic, and are usually addressed through peer review of research studies, either when proposed to sponsors or submitted for publication.

Conflicts of Interest (cont.)

Conflicting interests are inevitable in the conduct of research as researchers balance personal interests, such as career, reputation, and finances, with professional obligations, such as objectivity, openness, honesty, and accuracy.

Conflicting interests provide an incentive to engage in unethical behavior but not all lead to unethical action (Barnbaum and Byron, 2001). In general, conflicting interests themselves are not unethical. It is the course of action taken upon recognition of a conflict of interest that determines whether the conflict raises ethical concerns (Pritchard, 2002).

Conflicts of Interest (cont.)

Unethical action occurs when researchers who have a motivating self-interested reason that competes with a professional obligation act upon it. Examples of unethical action include, but are not limited to:

Conflicts of Interest (cont.)

Conflicts of interest are cause for concern in other areas of research, including peer review and use of human subjects.

Many funding agencies and journals have conflict of interest policies for peer reviewers to help promote objectivity in the grant proposal or manuscript review process. Measures include requiring individuals remove themselves as a reviewer for:

Conflicts of Interest (cont.)

Conflicts of interest in human subjects research require heightened scrutiny due to their potential to affect the rights and welfare of human subjects. Such conflicts commonly arise when researchers conduct research sponsored by, or involving a product of, an entity with which they have a relationship. The UNH Institutional Review Board for the Protection of Human Subjects in Research (IRB) requires all applicants whose projects are externally funded acknowledge on the application form that they have read the UNH policy on financial conflict of interest in research pertinent to the funding source, and will comply with the requirements.

Conflicts of Interest (cont.)

Two high profile cases involving unethical treatment of human subjects also involved financial conflicts of interest.

Conflicts of Interest (cont.)

Two high profile cases involving unethical treatment of human subjects also involved financial conflicts of interest (cont.).

Types of Conflicts

Conflicts of interest can be categorized as to whether they are real, potential, or perceived.

Most conflicts of interest are real in that the conflict has the capacity to bias a researcher’s professional judgment regardless of the researcher’s actions (Friedman, 2002). An example of a real conflict of interest is a researcher who hires a student for whom he is the faculty advisor to work in his company.

Potential conflicts of interest are those that might generate real conflicts of interest if certain events happen. For example, if a researcher is nominated to a review panel that will review a proposal from the researcher’s institution, the conflict of interest is potential until the point when the researcher accepts the position, wherein the conflict of interest becomes real (Friedman, 1992).

Types of Conflicts (cont.)

Perceived conflicts of interest are those where a situation appears to present an opportunity for the researcher’s professional judgment to be biased when in fact it does not.

Perception or appearance of a conflict of interest resulting from a personal interest may be as damaging as a real conflict of interest and should be avoided. Similarly, perception or appearance of bias in judgment resulting from a conflict of interest may be as damaging as if bias in judgment actually occurred and should be avoided. For example, a researcher’s spouse works for a company that is funding the researcher’s work but who is not in a position where she can influence company business decisions.

Types of Conflicts (cont.)

The following are the possible outcomes of a situation where a conflict of interest in research exists:

Types of Conflicts (cont.)

Examples of activities that constitute a conflict of interest in research include, but are not limited to:

Types of Conflicts (cont.)

Examples of activities that constitute a conflict of interest (cont.):

Types of Conflicts (cont.)

Conflicts of interest in an academic setting may arise in areas other than research. For example, UNH employees must comply with the University System of New Hampshire (USNH) Purchasing Policy. Examples under B4, Ethical Practices and Conflict of Interest, include employees:

Another example is the USNH Nepotism Policy (section 6).

Types of Conflicts (cont.)

Conflicts of interest may also involve institutions and/or institutional officials. For examples, in an institutional conflict of interest, an institution or institutional official acting in his/her capacity on behalf of an institution may affect or appear to affect activities of the institution.

In the Jesse Gelsinger case, the University of Pennsylvania had a financial interest in the company that sponsored the trial in which Jesse died but which was not disclosed to Jesse.

Disclosure & Management

Disclosure of a conflict can be a key factor in protecting an individual’s reputation and career from potentially harmful allegations of unethical behavior. Although disclosure of a conflict of interest does not resolve the ethical issues presented by the conflict, it is an important first step.

Researchers should disclose to all colleagues and students with whom they work on a related project, and in all publications and public presentations any financial or personal interests that present a conflict of interest so that audiences are fully informed. Some journals require that authors disclose all sources of financial support of the reported research at the time of manuscript submission.

Before embarking on collaborative research, collaborators should disclose all conflicts of interest that might impact the design, conduct, or reporting of research activities.

Disclosure & Management (cont.)

Once disclosed, most conflicts of interest can be managed or reduced (so that they are acceptable to all parties involved) or eliminated. Methods for managing, reducing, or eliminating conflicts of interest include, but are not limited to:

UNH Policies on Financial Conflict of Interest in Research

Regulations (e.g., Public Health Service [PHS], National Science Foundation [NSF]) exist governing financial conflicts of interest of researchers who apply for federal funds.

In accordance with these regulations, UNH has adopted two policies on financial conflict of interest in research:

  1. A policy for research projects proposed for funding, or funded, by the PHS or any other organization that requires compliance with the PHS regulations, and
  2. A policy for research projects proposed for funding, or funded, by any other external organizations.

All researchers submitting proposals for external funding through the UNH Sponsored Programs Administration office must acknowledge on the Internal Approval Routing Form that they have read the UNH policy pertinent to the funding source, and will comply with its terms.

UNH Policies (cont.)

The UNH policy for PHS-funded projects applies to any individual who is responsible for the design, conduct, or reporting of research activities (investigator) funded, or proposed for funding, by PHS whether an UNH employee or otherwise (e.g., consultant).

The UNH policy requires that every investigator

The project director, principal investigator, key personnel, or any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding, which may include, for example, collaborators or consultants.

responsible disclose all his/her significant financial interests and those of his/her spouse or domestic partner and dependent children related to his/her institutional responsibilities no later than the time of application by UNH for PHS funds.

UNH Policies (cont.)

Significant financial interests (SFIs) are defined (click on link to read definitions) in the UNH policy for PHS-funded projects. They include:

In the policy for PHS-funded projects, significant financial interests do NOT include:

UNH Policies (cont.)

In the policy for PHS-funded projects, significant financial interests do NOT include (cont.):

UNH Policies (cont.)

Prior to UNH submitting a proposal to PHS for research funding, any investigator who has a significant financial interest that reasonably appears to be related to the investigator’s institutional responsibilities must complete and submit to the Office of the Senior Vice Provost for Research (OSVPR) a Disclosure Statement for Financial Conflict of Interest in Research for Projects funded by the Public Health Service, with all required supporting documentation.

UNH Policies (cont.)

Financial disclosure statements are reviewed by the UNH Disclosure Review Committee (DRC). The DRC determines whether an investigator’s SFI is related to the PHS-funded research and if so, whether the SFI represents a financial conflict of interest (FCOI).

A SFI is related to the PHS-funded research when the DRC reasonably determines that the SFI could be affected by the PHS-funded research, or is in an entity whose financial interest could be affected by the research.

An FCOI is a SFI that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

UNH Policies (cont.)

If the DRC determines that a FCOI exists, the DRC requests the investigator submit a proposed conflict management plan that details steps that will be taken to manage, reduce, or eliminate the FCOI. The DRC reviews the proposed conflict of interest management plan and approves it or adds conditions to ensure that the conflict is managed, reduced, or eliminated.

Management plan conditions to manage, reduce, or eliminate a conflict may include, but are not limited to:

UNH Policies (cont.)

Management plan conditions to manage, reduce, or eliminate the conflict may include, but are not limited to (cont.):

UNH Policies (cont.)

Management plan conditions to manage, reduce, or eliminate the conflict when human subjects are involved in research may include, but are not limited to:

UNH Policies (cont.)

Resolution of the conflict or approval of the management plan must take place prior to expenditure of any funds from a PHS award. All financial disclosures must be updated by the investigator during the period of the award as significant financial interests change. An investigator may appeal the DRC’s decision to the UNH President who will consult with the DRC and the investigator before making a final determination.

UNH Policies (cont.)

Investigators must disclose to UNH SFIs related to their institutional responsibilities before submitting new proposals for PHS funding and in the following situations:

During the award period, each investigator participating in PHS-funded research must submit to UNH an updated disclosure of SFI related to their institutional responsibilities at least annually (fiscal year July 1 – June 30).

UNH Policies (cont.)

Investigators receiving PHS funds must complete training regarding financial conflicts of interest, investigators’ responsibilities regarding disclosure of significant financial interests, and the PHS regulations prior to engaging in research related to any PHS-funded grant and at least every four years. Completion of this module fulfills this training requirement.

Further, investigators must complete training within 30 days in the following situations:

UNH Policies (cont.)

The second UNH financial conflict of interest in research policy applies to any individual who is responsible for the design, conduct, or reporting of research activities funded or proposed for funding by external sources other than the PHS.

This UNH policy requires that all participants in a project who are responsible for the design, conduct, or reporting of research activities disclose any significant financial interests that would reasonably appear to be affected by the research.

UNH Policies (cont.)

A significant financial interest (SFI) is defined in this UNH policy as:

Examples of SFIs might include, but are not limited to:

UNH Policies (cont.)

SFIs do NOT include:

UNH Policies (cont.)

Prior to submitting a proposal for external funding, a researcher who has a SFI that might be affected by the research must complete and submit to the OSVPR a Financial Conflict of Interest in Research Disclosure Statement and all required supporting documentation.

Financial Disclosure Statements are reviewed by the UNH DRC. The DRC determines whether the SFI could reasonably be expected to affect the design, conduct, or reporting of the activities funded or proposed for funding, and, if so related, whether the SFI represents a financial conflict of interest (FCOI).

A researcher’s SFI is related to the research when the DRC determines that the SFI could be affected by the research; or is in an entity whose financial interest could be affected by the research.

UNH Policies (cont.)

If the DRC determines that a FCOI exists, the DRC requests the researcher submit a proposed conflict management plan that details steps that could be taken to manage, reduce, or eliminate the FCOI. The DRC reviews the proposed conflict of interest management plan and approves it or adds conditions to ensure that the conflict is managed, reduced, or eliminated.

Researchers submitting management plans must complete training regarding financial conflicts of interest, investigators’ responsibilities regarding disclosure of significant financial interests, and the UNH policy before project funds may be release. Completion of this module fulfills this training requirement.

UNH Policies (cont.)

Under both policies, unless otherwise designated in a management plan, the researcher’s department chair or supervisor shall provide general oversight for implementation of the plan, and is responsible for monitoring implementation of, and the researcher’s compliance with, the management plan.

For any reports related to the administration of a management plan that are over 30 days late, the SVPR may freeze project funds until the reports are submitted to the DRC for review. At the end of the period for which the management plan is in effect, the researcher needs to certify that he/she has complied with its terms.

UNH Policies (cont.)

The UNH DRC investigates alleged violations of the two policies. Violations include, but are not limited to:

If alleged violations are substantiated, the DRC recommends action to the UNH President. Sanctions may include:

Conflicts of Commitment

A conflict of commitment (also known as a conflict of effort or obligation) exists in the research context when external demands impede a researcher’s ability to fulfill his/her obligations to the institution that employs him/her and/or the grant(s) through which he/she is funded.

External professional activities might include, but are not limited to, the following:

Conflicts of Commitment (cont.)

Due to their nature, conflicts of commitment rarely affect professional judgment. They may, however, impact professional and institutional responsibilities and obligations, and should be managed to avoid ethical concerns.

Before embarking on collaborative research projects, collaborators should disclose external demands that might impede their ability to fulfill their obligations to the project.

Where conflicts of commitment also involve conflicts of interest, researchers should fully disclose the conflicts and employ steps to manage, reduce, or eliminate both.

Conflicts of Commitment (cont.)

The UNH Conflict of Interest and Commitment policy (section 7 of UNH.V.D.7) addresses the pursuit of professional activities and interests by faculty and staff that may conflict with their primary employment responsibilities at the institution. The policy obliges employees to avoid ethical, legal, financial and other conflicts of interest to ensure that their outside activities and interests do not conflict with their primary employment responsibilities at the institution.

Conflicts of Commitment (cont.)

The UNH Conflict of Interest and Commitment policy covers the following issues:

Conflicts of Commitment (cont.)

The UNH Conflict of Interest and Commitment policy (section 7 of UNH.V.D.7) allows faculty, on average, time equivalent to one day during each five-day academic week during the appointment period for outside consulting or other professional activities. The academic administrator of the college, through the chairperson of the faculty member’s department, should be informed of the outside activities (disclosure). Agreement should be reached between the chairperson and faculty member that the activities satisfy the requirements of the UNH Conflict of Interest and Commitment policy.

If the activities are expected to require more time in a given situation, a faculty member needs to make arrangements with the department chairperson and/or dean of the school/college.

Review Scenario 1

Scenario: A UNH faculty member has formed a private company with other investors to further his research into commercial applications. He has 4% equity in the company (worth approximately $8,000) and is the chief scientific officer, for which he receives $9,000 a year in salary. To help support additional basic research in his UNH lab, the faculty member is submitting through UNH a grant proposal to the National Institutes of Health (NIH) (NIH is a Public Health Service [PHS] agency) and one to the Department of Defense (DoD) (DoD is not a PHS agency). Which of the following does the faculty need to do (check all that apply)?
Correct. However, another answer exists.
Incorrect.
Incorrect.
Incorrect.
Correct. However, another answer exists.
Correct. However, another answer exists.
You have selected all of the correct statements.

Review Scenario 2

Scenario: A staff member at UNH is a structural failure and computer modeling expert. He currently is working on an externally-funded research project studying methods for retro-fitting office buildings in areas at risk for major earthquakes. He recently agreed to be a paid expert witness for a city in such a locale, and will soon testify on the city’s behalf in a lawsuit filed by the family of a city worker injured in a recent earthquake. He has asked a graduate student in the modeling lab to “do him a favor” and pull together a list of scholarly articles that he should review in preparation for his testimony. He also plans to use the lab computer and modeling programs, after regular work hours, to review various scenarios for a report to the city’s attorney. Which of the following statements are true?

1. He must disclose to the graduate student that the literature review is for his consulting work.

Correct.
Incorrect.

2. It is not an issue for him to use the lab’s computer and software, because he is doing it after regular work hours.

Incorrect.
Correct.

Review Scenario 2 (cont.)

Scenario: A staff member at UNH is a structural failure and computer modeling expert. He currently is working on an externally-funded research project studying methods for retro-fitting office buildings in areas at risk for major earthquakes. He recently agreed to be a paid expert witness for a city in such a locale, and will soon testify on the city’s behalf in a lawsuit filed by the family of a city worker injured in a recent earthquake. He has asked a graduate student in the modeling lab to “do him a favor” and pull together a list of scholarly articles that he should review in preparation for his testimony. He also plans to use the lab computer and modeling programs, after regular work hours, to review various scenarios for a report to the city’s attorney. Which of the following statements are true?

3. In a future presentation about retro-fitting buildings in the same city, the UNH team must disclose that one member has done consulting work for the city.

Correct.
Incorrect.

4. He must submit a disclosure statement to the SVPR before agreeing to be an expert witness.

Incorrect.
Correct.

Review Scenario 3

Scenario: A faculty member at UNH forms a private company in order to further her research in the biomedical sciences. She is the sole owner of the company, and is the chief scientific officer as well as the chief executive officer, although she plans to look for outside investors in her company. Initially, she spends most of her spare time getting the company going. To help sustain her UNH lab and her basic research, she focuses on submitting grants to external sponsors. To have time to do this, she recruits students from her department, several of whom are her advisees, to conduct initial experiments in her UNH lab. Which of the following statements statements are true?

1. It is acceptable for the faculty member to hire as employees students who are her advisees.

Incorrect.
Correct.

2. It is acceptable for the faculty member to hire as employees students who are not her advisees.

Correct.
Incorrect.

Review Scenario 3 (cont.)

Scenario: A faculty member at UNH forms a private company in order to further her research in the biomedical sciences. She is the sole owner of the company, and is the chief scientific officer as well as the chief executive officer, although she plans to look for outside investors in her company. Initially, she spends most of her spare time getting the company going. To help sustain her UNH lab and her basic research, she focuses on submitting grants to external sponsors. To have time to do this, she recruits students from her department, several of whom are her advisees, to conduct initial experiments in her UNH lab. Which of the following statements are true?

3. The faculty member does not need to disclose her financial interest and/or her role in the company to students in her department if they are her employees.

Incorrect.
Correct.

4. It is acceptable for the faculty member to use UNH facilities for her company’s work as long as there is a formal written agreement in place with UNH.

Correct.
Incorrect.

Review Scenario 3 (cont.)

Scenario: A faculty member at UNH forms a private company in order to further her research in the biomedical sciences. She is the sole owner of the company, and is the chief scientific officer as well as the chief executive officer, although she plans to look for outside investors in her company. Initially, she spends most of her spare time getting the company going. To help sustain her UNH lab and her basic research, she focuses on submitting grants to external sponsors. To have time to do this, she recruits students from her department, several of whom are her advisees, to conduct initial experiments in her UNH lab. Is the following statement true?

5. The faculty member must disclose her financial interest in the company before submitting proposals for research funds through UNH to external sponsors.

Correct.
Incorrect.

Review Scenario 4

Scenario: A faculty member at UNH has been awarded a grant from a federal agency to conduct research. Part of the research project involves a very complicated and specialized data collection process, for which the UNH researcher does not have the expertise, nor do any of her collaborators. The researcher’s brother, however, owns a company which specializes in this type of data collection. In her funding application, the researcher proposed to hire out the data collection to a qualified company, but did not identify specifically her brother’s company. Now she has the funding, she is ready to hire the services of her brother’s company. What does the researcher need to do next (check all that apply)?
Incorrect.
Incorrect.
Correct. However, another answer exists.
Correct. However, another answer exists.
Incorrect.
Correct. However, another answer exists.
You have selected all of the correct statements.

Case Study Review

Click on the image below to see the case study that was presented at the beginning of this module.

Congratulations!

Once you have finished all of the review questions click ’Certify Completion’.

Certify Completion