Conflicts of Interest in Human Subjects Research (2022)

Introduction

Researchers, as experts in their fields, are often sought after to consult, serve on advisory boards, or participate in speakers’ bureaus for companies. These opportunities not only bring prestige to the individual researcher, but also to the organization by which they are employed. It is important for researchers to understand the federal regulations that govern disclosure and management of individual conflicts of interest (COIs), and when a financial COI may be considered significant. This module identifies federal regulations that govern disclosure of individual COIs and discusses when individual significant financial interests in research may be considered COIs.

Learning Objectives

By the end of this module, you should be able to:

  • Identify federal regulations that govern disclosure of individual COIs.
  • Discuss when individual significant financial interests in research may be considered COIs.

Disclosure of COIs

Federal regulations and policies governing disclosure of research-related individual COIs are broad, and in the case of the Public Health Service (PHS) regulation, somewhat complicated. The PHS, U.S. Food and Drug Administration (FDA), and National Science Foundation (NSF) regulations only address individual financial COIs. Organizational policy may require the disclosure of non-financial COIs, as well as institutional COIs (ICOIs). Organizational policy is often based on PHS and NSF disclosure thresholds for financial holdings or remuneration from non-governmental funding sources such as pharmaceutical sponsors of research studies.

When must COIs be disclosed?

The federal regulations also have different requirements for when individual financial COIs must be disclosed.

FDAWhen submitting marketing applications for drugs, biologics, or devices must certify the absence of certain financial interests or to disclose financial interests of researchers who conducted clinical studies covered by the regulation at 21 CFR 54.4(a).
NSFNo later than at the time of proposal submission for NSF-funded research.
PHSNo later than at the time of proposal submission for PHS-funded research.
Organizational PolicyVaries; many organizations require researchers to disclose COIs before they submit their studies for Institutional Review Board (IRB) review.

There are some federal COI policies that are broader and may apply to personal relationships and ICOIs (for example, procurement-related issues that may create ICOIs).

(Video) Understanding Conflicts of Interest: Ethical Issues and Problems

Note that to date, no federal regulations exist that govern disclosure or management of ICOIs. However, accrediting bodies (such as, the Association for the Accreditation of Human Research Protections Programs [AAHRPP]) require organizations seeking accreditation to have an ICOI policy governing human subjects research.

What must be disclosed?

  • PHS regulation at 42 CFR 50 (Policies of General Applicability 2011), requires each “investigator” named on a PHS proposal to disclose “significant financial interests” to a designated official at the applicant organization.
  • NSF policy requires researchers to disclose “significant financial interests,” but the NSF definition of “significant financial interests” differs somewhat from the PHS definition.
  • FDA regulation at 21 CFR 54.3(c) (Financial Disclosures by Clinical Investigators) specifies that the FDA may refuse to file any marketing application that does not contain a disclosure of researchers’ financial interests or a certification that the applicant acted with due diligence to obtain researchers’ disclosures, but was unable to do so. The FDA threshold is much higher than either of the PHS and NSF “significant financial interests” disclosure thresholds.
  • Organizational policies vary and may require COI disclosure for both financial and non-financial individual COIs. Organizations may also require disclosure beyond that required by any applicable federal regulations or policies

Defining Financial Interest

The definitions for financial interest vary. It is important for researchers to know the definition the agency or policy uses to know when and what to disclose. Not all financial interests meet the threshold for disclosure, nor are all financial interests considered conflicts.

  • Significant financial interest (SFI) is defined as “a financial interest consisting of one or more of the following interests” that “reasonably appears to be related to the researcher’s organizational responsibilities” (Policies of General Applicability 2011).
  • PHS at 42 CFR 50, Subpart F (Policies of General Applicability 2011) defines a financial conflict of interest (FCOI) as an SFI that could “directly and significantly affect the design, conduct or reporting of PHS-funded research” (Policies of General Applicability 2011).

When does a SFI become a FCOI?

An organization’s designated review mechanism in compliance with the definitions and procedures in its written policies will determine when a researcher’s SFI becomes a FCOI. In general, a SFI may become a FCOI when the SFI could directly and significantly affect the design, conduct or reporting of the funded research.

Conflicts of Interest in Human Subjects Research (1)

There are some federal COI policies that are broader and may apply to personal relationships and ICOIs (for example, procurement-related issues that may create ICOIs). It is important for researchers to be aware of COI policies at their own organization, which often require disclosure beyond that required by any applicable federal regulations or policies (that is, at a much lower threshold).

Summary

It is important for organizations to have strong compliance programs to ensure disclosure of COIs. Disclosure reduces the appearance of or the potential for bias in the research. Organizations must determine when a SFI may be a FCOI, and have adequate policies and procedures in place for management.

References

  • Financial Disclosure by Clinical Investigators, 21 CFR § 54 (2011).
  • Policies of General Applicability, 42 CFR § 50 (2011).

Quiz

Question 1

The Public Health Service (PHS), U.S. Food and Drug Administration (FDA), and National Science Foundation (NSF) regulations address:

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  • Institutional non-financial COIs
  • Individual financial COIs
  • Institutional financial COIs
  • Individual non-financial COIs

Comment:

The PHS, FDA, and NSF regulations only address individual financial COIs.

Question 2

The PHS regulations require:

  • Each “investigator” named on a proposal to disclose “significant financial interests” to the federal funding agency.
  • Each “investigator” named on a proposal to disclose “significant financial interests” to a designated official at the applicant organization.
  • Each “investigator” names on a proposal to disclose “significant financial interests” to the FDA for drug studies.
  • Each “investigator” named on a proposal to disclose “significant financial interests” to the Institutional Review Board (IRB).

Comment:

PHS regulation at 42 CFR 50 (Policies of General Applicability 2011), requires each “investigator” named on a PHS proposal to disclose “significant financial interests” to a designated official at the applicant organization. The sponsor reports COIs to the FDA when applying for marketing approval.

Question 3

Quiz - Case Study

(Video) Conflicts of Interest in Research: Identifying and Managing Investigators' Financial Conflicts

Dr. Jones works as a cardiologist at a Midwest University Medical Center and earns approximately $15,000 per year from Big Medicines Pharmaceuticals giving talks to other doctors about one of the company’s marketed drugs that is used to treat heart infections. Dr. Jones has a SFI with Big Medicines Pharmaceuticals because he receives non-salary compensation of over $5,000 from the company. Big Medicines has approached Dr. Jones about his organization participating as a site in a clinical trial. Dr. Jones would be the local principal investigator. The research is a large multi-site, randomized, double-blind, placebo-controlled trial to examine the efficacy of an investigational drug to prevent heart attacks with 3,000 subjects total. It is expected that three to four subjects would be enrolled at Dr. Jones’s site. Who determines if Dr. Jones has a FCOI with this proposed research?

  • Dr. Jones’ organization
  • Institutional Review Board (IRB)
  • Big Medicines Pharmaceuticals
  • Dr. Jones

Comment:

An assessment is usually made by a committee charged with reviewing investigator COIs at the organization. The committee will use the organization’s policy for disclosure of conflicts as the basis for its review. If the compensation meets the threshold for SFI, the committee then determines if the SFI is a FCOI for the investigator in the proposed research.

If the organization defines a FCOI as any financial interest that could directly and significantly impact the design, conduct, and/or reporting of the results of this research, the committee may find that Dr. Jones has a FCOI relative to the proposed research, because Big Medicines is funding the research, and also compensates Dr. Jones personally for his talks.

Question 4

Quiz - Case Study

Dr. Jones works as a cardiologist at a Midwest University Medical Center and earns approximately $15,000 per year from Big Medicines Pharmaceuticals giving talks to other doctors about one of the company’s marketed drugs that is used to treat heart infections. Dr. Jones has a SFI with Big Medicines Pharmaceuticals because he receives non-salary compensation of over $5,000 from the company. Big Medicines has approached Dr. Jones about his organization participating as a site in a clinical trial. Dr. Jones would be the local principal investigator. The research is a large multi-site, randomized, double-blind, placebo-controlled trial to examine the efficacy of an investigational drug to prevent heart attacks with 3,000 subjects total. It is expected that three to four subjects would be enrolled at Dr. Jones’s site. In the following scenario, some existing safeguards against bias are described.

(Video) Human Subject Research Conflict of Interest Recording

  • By the time Dr. Jones is approached by Big Medicine, the drug company has already designed the research plan and the study is ongoing.
  • The research design itself is randomized and double-blinded. This is one way to guard against manipulation of the study results.
  • Restricting recruitment and thus the contribution of three or four sets of subject data to the study, out of the 3,000 needed to meet research aims, would also guard against significant impact solely by Dr. Jones.
  • Finally, assuming there are no “subjective measurements” that Dr. Jones would be expected to obtain that would introduce bias (“How does the subject seem to be feeling at this visit?”); his role would be to collect the data and send it to the company for analysis. It is unlikely that the reporting of the results would be impacted by his FCOI.

How could the organization further add protection against bias in this scenario?

  • Remove Dr. Jones from the contract negotiation process with the company.
  • Refuse to allow the organization’s participation as a site in the research study.
  • Disclose Dr. Jones’ remuneration from the sponsor in the consent document and the consent process.
  • Require Dr. Jones to return the $5,000 compensation to the company.

Comment:

Given this potential impact on the research via recruitment and obtaining consent from subjects, it would be appropriate to manage this FCOI by not allowing Dr. Jones to directly recruit or consent subjects. The COI management plan also could require that Dr. Jones’ remuneration received from the company is disclosed to the research subjects in the consent document and during the consent process. Refusing to allow participation as a site would limit patient access to possible beneficial research. This is not the optimal response.

Question 5

Quiz - Case Study

Dr. Jones works as a cardiologist at a Midwest University Medical Center and earns approximately $15,000 per year from Big Medicines Pharmaceuticals giving talks to other doctors about one of the company’s marketed drugs that is used to treat heart infections. Dr. Jones has a SFI with Big Medicines Pharmaceuticals because he receives non-salary compensation of over $5,000 from the company. Big Medicines has approached Dr. Jones about his organization participating as a site in a clinical trial. Dr. Jones would be the local principal investigator. The research is a large multi-site, randomized, double-blind, placebo-controlled trial to examine the efficacy of an investigational drug to prevent heart attacks with 3,000 subjects total. It is expected that three to four subjects would be enrolled at Dr. Jones’s site. When does Dr. Jones’ significant financial interest (SFI) become a possible financial conflict of interest (FCOI)?

  • When the SFI is not disclosed
  • Only if the SFI is over 15 percent of Dr. Jones’ salary from the university
  • When the SFI could directly and significantly affect the design, conduct or reporting of the funded research
  • Up to 12 months (one year) after Dr. Jones receives payment

Comment:

(Video) Beware conflicts of interest | Dan Ariely

In general, a SFI may become a FCOI when the SFI could directly and significantly affect the design, conduct or reporting of the funded research.

FAQs

What would be considered a conflict of interest in research? ›

The term “conflict of interest (COI) in research” refers to situations in which financial or other personal considerations may compromise — or have the appearance of compromising — an investigator's professional judgment in conducting or reporting research.

Are researchers permitted to have conflict of interest? ›

Investigators are not permitted to begin any research activity when they have reported an actual or apparent conflict of interest before they receive a written determination from the Vice President of Research as to how to manage the conflict.

Why is conflict of interest problematic in research? ›

Conflicts of interest have the potential to inappropriately influence many aspects of research - from how a study is designed, how data is collected, analyzed and reported, to what individuals/suppliers are involved in the work.

How do you handle conflict of interest in research? ›

To assure that appropriate steps are taken in each case to minimize the likelihood of conflicts of interest, the following steps should be followed:
  1. Approval and execution of the transaction document. ...
  2. Employee Certification. ...
  3. Institutional Certification. ...
  4. Approval of Conflict Management Plan. ...
  5. Required Disclosure.

What is conflict of interest explain with example? ›

A conflict of interest arises when what is in a person's best interest is not in the best interest of another person or organization to which that individual owes loyalty. For example, an employee may simultaneously help himself but hurt his employer by taking a bribe to purchase inferior goods for his company's use.

Is conflict of interest an ethical issue? ›

Principle of Ethics III, Rule of Ethics B, of the Code specifically prohibits conflicts of professional interest. "Individuals shall avoid engaging in conflicts of interest whereby personal, financial, or other considerations have the potential to influence or compromise professional judgment and objectivity."

What is the risk of conflict of interest? ›

Conflicts of interest (COI) arise when an individual's personal interests could compromise their judgement, decisions, or actions in the workplace. Conflicts are caused by friends and family, financial or social factors, and can be detrimental to the business.

Who is required to report conflicts of interest? ›

To help identify potential conflicts of interest, the law requires public officials and employees in designated positions in a conflict of interest code to report their financial interests on a form called Statement of Economic Interests (Form 700).

Who determines whether an academic research conflict of interest can be managed? ›

The RCOI Officer is responsible for identifying and managing research conflicts of interest.

How do you write no conflict of interest in a research paper? ›

Please tick one of the following boxes: □ We have no conflict of interest to declare. We have a competing interest to declare (please fill in box below): This statement is to certify that all Authors have seen and approved the manuscript being submitted. We warrant that the article is the Authors' original work.

How does conflict of interest affect the outcome of a research? ›

Conflicts of interest may be actual, potential or perceived and involve financial and non-financial benefits. Conflicts of interest may affect, or be perceived to affect, a researcher's impartiality and judgement, which can erode confidence in the research.

When you read a research publication why it is important to check the conflict of interest section? ›

Authors are held to have collective responsibility for the contents of an article; if one author fails to declare a conflict of interest, the peer review process may be deemed compromised and the whole paper retracted.

Who is most responsible for managing potential conflict of interest in a piece of publication research misconduct? ›

Research supervisors: Research supervisors are responsible for looking out for any potential conflicts of interest between funders and researchers on a regular basis.

How do you explain conflict of interest? ›

What is a Conflict of Interest? A conflict of interest occurs when an individual's personal interests – family, friendships, financial, or social factors – could compromise his or her judgment, decisions, or actions in the workplace.

What is another term for conflict of interest? ›

A conflict of interest or a dispute. problem. dispute. clash. conflict.

What are 3 types of conflict of interest? ›

Three Common Types of Conflicts of Interest
  • Nepotism. Nepotism happens when an individual in charge of a hiring process chooses to award a job offer to someone in their own family or with whom they have a personal relationship. ...
  • Self-Dealing. ...
  • Business Relationships.

Why is it important to avoid conflict of interest? ›

Conflicts of interest can undermine a company's culture. If a company is not vigilant in identifying and conflicts of interest, especially at the senior management level, the company's culture can be threatened. CEOs and other senior executives have been at the center of some significant ethical lapses.

What is actual conflict of interest? ›

Actual conflicts of interest arise when there is a direct conflict between a staff member's duties and responsibilities and their personal interests which influence the performance of those duties.

Is conflict of interest illegal? ›

The federal conflict of interest rules are found at 18 U.S.C. § 208 with implementing regulations at 5 C.F.R. § 2635.402. Essentially, these rules prohibit you from taking official action in a particular matter involving any entity in which you, or someone whose interests are imputed to you, have a financial interest.

How do you address conflict of interest? ›

Managing conflict of interest requires a balance

Identifying risks. Prohibiting unacceptable forms of private interest. Raising awareness of the circumstances in which conflicts can arise. Building capacities to prevent conflict of interest through training.

What are the consequences of breaching conflict of interest? ›

It can result in reputational risk, a failure to act in the best interest of the entity, and poor governance. Additionally, not addressing a conflict of interest can create disharmony amongst management and directors, especially where individuals are dealing in an area that they are passionate about.

What is the punishment for conflict of interest? ›

If the conduct was not willful, then it is a misdemeanor punishable by not more than one year in prison. However, if the conduct was willful, then the maximum penalty is five years in prison.

When should you declare a conflict of interest? ›

If you find yourself in a position of an actual, potential or a perceived conflict of interest you must declare it so that action can be taken to assess the risk and, where required, to manage or mitigate it.

When should a conflict of interest be disclosed? ›

You are also required to disclose during the year if 1) you acquire a new financial interest or gift or 2) you wish to work or consult for an outside entity. If you acquire a new financial interest or gift that is covered under the policy, you must disclose within 30 days of acquiring the interest.

What is reportable conflict of interest? ›

A Conflict of Interest arises when a financial or other personal interest, activity, or relationship may reasonably be expected to compromise an Employee's judgment in carrying out University responsibilities. All employees have an ongoing duty to disclose any conflict when it arises.

Which of the following most accurately describes a conflict of interest? ›

Which of the following most accurately describes an institutional conflict of interest? It occurs when an institution's financial or non-financial interests could interfere with its research activities.

What is conflict of interest in qualitative research? ›

Qualitative researchers often use the term conflict of interest to describe role conflicts where their relationships with research participants involve multiple roles as researchers as well as (perhaps) teachers, clinicians, activists, colleagues, or friends.

What is conflict of interest in research PDF? ›

A conflict of interest, or “COI,” may exist when professional judgment or actions could be influenced by a private or personal interest, resulting in personal, financial, or professional gain. COI can affect the design, conduct, or reporting of research data and possibly impact research participants.

What are the 5 main causes for conflict? ›

There are five main causes of conflict: information conflicts, values conflicts, interest conflicts, relationship conflicts, and structural conflicts. Information conflicts arise when people have different or insufficient information, or disagree over what data is relevant.

How do conflicts of interest affect research integrity? ›

Conflicts of interest do not necessarily amount to research misconduct. If the potential gain is large, however, then principles that guide responsible conduct in research may be compromised. Conflicts of interest increase the risk of unintentional bias.

Why do authors have to disclose conflicts of interest? ›

Editors and peer-reviewers should have all the necessary information so that they can assess the quality of the research. Therefore, it is an ethical requirement to be transparent and reveal any potential conflicts of interest that could affect the reviewers' judgment.

Is conflict of interest a publication misconduct? ›

According to the U.S. Office of Research Integrity, having a conflict of interest is not in itself unethical, and there are some that are unavoidable. 1 Full transparency is always the best course of action, and, if in doubt, disclose. References 1.

Who can we avoid conflict of interest in research and publication? ›

It is the responsibility of everyone involved in research and publication, especially authors, to identify and declare potential conflicts to ensure the smooth processing of a manuscript.

Where do you put conflict of interest in a research paper? ›

If you are submitting your article for publishing in a journal that requires you to make a 'Declaration of Conflicting Interests', please include such a declaration at the end of your manuscript, following any acknowledgments and prior to the references, under the heading 'Conflict of Interest Statement'.

What kinds of measures or strategies can help prevent research misconduct? ›

Strategies to Support Research Integrity
  • Ensure policies governing academic research not only are in place, but are followed. ...
  • Set standards for supervision of all testing. ...
  • Enforce expectations for process rigor. ...
  • Communicate expectations for accurate accounting of time spent on research activities.
21 Aug 2018

What is primary interest in conflict of interest? ›

The primary interest that conflict of interest policies seek to protect varies according to the purpose of a professional activity. Primary interests include promoting and protecting the integrity of research, the welfare of patients, and the quality of medical education.

What are the 4 types of conflict of interest? ›

Part 3: Different types of conflicts of interest
  • financial conflict;
  • non-financial conflict;
  • conflict of roles; or.
  • predetermination.

What is conflict of interest in qualitative research? ›

Qualitative researchers often use the term conflict of interest to describe role conflicts where their relationships with research participants involve multiple roles as researchers as well as (perhaps) teachers, clinicians, activists, colleagues, or friends.

Which of the following is a type of conflict of interest? ›

Types of conflict of interest and duty

A conflict of interest is where an employee or director has private interests that could improperly influence, or be seen to influence, their decisions or actions in the performance of their public duties.

How do you write no conflict of interest in a research paper? ›

Please tick one of the following boxes: □ We have no conflict of interest to declare. We have a competing interest to declare (please fill in box below): This statement is to certify that all Authors have seen and approved the manuscript being submitted. We warrant that the article is the Authors' original work.

What are the 3 conflict of interest we should consider? ›

In accordance with the department's Standard of Practice: A COI can occur when an employee has, or is seen to have, a private interest, either financial (pecuniary) or non-financial (non-pecuniary), which conflicts or may conflict with the discharge of the employee's official duties.

What is another term for conflict of interest? ›

A conflict of interest or a dispute. problem. dispute. clash. conflict.

Is conflict of interest a risk? ›

While not all conflicts of interest are illegal, they can still be damaging. Common consequences of COIs include negative impacts to corporate culture and reputation, confidential information disclosure, steep fines, and legal recourse.

How does conflict of interest affect research output? ›

Conflicts of interest may be actual, potential or perceived and involve financial and non-financial benefits. Conflicts of interest may affect, or be perceived to affect, a researcher's impartiality and judgement, which can erode confidence in the research.

Why is interest important in research? ›

Studies have consistently shown that interest increases attention, recall and levels of effort. Meta-analysis of over 150 studies undertaken in 1992 found that individual interest was correlated with both academic and laboratory performance.

What could be the best possible way of handling conflicts of interest? ›

Prohibiting unacceptable forms of private interest. Raising awareness of the circumstances in which conflicts can arise. Building capacities to prevent conflict of interest through training. Ensuring effective procedures to resolve conflict-of-interest situations.

What is a real conflict of interest? ›

3 A real conflict of interest occurs where there is a conflict between the public duty and personal interests of an employee that improperly influences the employee in the performance of his or her duties.

What is actual conflict of interest? ›

Actual conflicts of interest arise when there is a direct conflict between a staff member's duties and responsibilities and their personal interests which influence the performance of those duties.

What are the elements of conflict of interest? ›

To avoid common misunderstandings of the concept that can lead to misplaced and ultimately ineffective or counterproductive policies, the committee stresses the importance of each of the three main elements of a conflict of interest: the primary interest, the secondary interest, and the conflict itself.

When should you declare a conflict of interest? ›

If you find yourself in a position of an actual, potential or a perceived conflict of interest you must declare it so that action can be taken to assess the risk and, where required, to manage or mitigate it.

What to write if there is no conflict of interest? ›

If no declaration is made, the following will be printed under this heading in your article: 'None Declared'. Alternatively, you may wish to state that 'The author(s) declare(s) that there is no conflict of interest'.

Why do authors have to disclose conflicts of interest? ›

Editors and peer-reviewers should have all the necessary information so that they can assess the quality of the research. Therefore, it is an ethical requirement to be transparent and reveal any potential conflicts of interest that could affect the reviewers' judgment.

Videos

1. "Research Compliance @ UNM: Human Subjects, Animals, Export Control, and Conflicts of Interest"
(AIRE at UNM)
2. Conflicts of Interest in Biomedical Research
(Penn Medical Ethics & Health Policy Online)
3. Responsible Conduct of Research Seminar Series: Conflict of Interest
(UC Berkeley Events)
4. Disclosures: Conflicts of Interest & Conflict of Commitments
(University of California (UC) Training & Education)
5. ETHICALLY SPEAKING: CASE STUDY ON CONFLICTS OF INTEREST
(DrexelCNHP)
6. How to fix a conflict of interest for your journal paper
(University English Hub)

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