Conflicts of Interest

To meet the needs of its clients and comply with the Department of Health and Human Services (HHS) guidance entitled “Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection,” WCG IRB has established a policy for reviewing financial conflicts of interest of investigators, research staff and institutions (WCG IRB defines research staff as people who are involved in the actual study conduct and the assessment of eligibility and outcomes, obtaining consent, and recruitment, or as otherwise defined by applicable institutional policy.)  Please complete the designated Financial Interest Disclosure Form available on the Forms page of wcgclinical.com.

WCG IRB considers that the most important step in managing potential conflicts of interest lies in appropriate disclosure, and this begins with the investigator’s disclosure to a sponsor and the IRB of financial holdings, relationships, and other interests that might constitute a conflict of interest for the researcher as an investigator. When the researcher is a member of an institution, disclosure of potential conflicts to the appropriate institutional committee or office is also required.

The investigator or study staff will be considered to have a financial conflict of interest if the investigator, investigator’s immediate family (spouse and dependent children), the study staff, or the study staff’s family:

• Has a financial interest in the research with value that cannot be readily determined (for example, stock that is not publicly traded);
• Has a financial interest in the research with value that exceeds $5,000 other than payments for conducting the trial as outlined in the clinical trials agreement;
• Has a financial interest in the research with value that exceeds 5% ownership;
• Has received or will receive compensation with value that may be affected by the outcome of the study;
• Has a proprietary interest in the research, such as a patent, trademark, copyright, or licensing agreement;
• Has received or will receive payments other than payment for the conduct of clinical research from the sponsor that exceed $5,000 in the last 365 days;
• Any governance or executive relationship with the sponsor (e.g., board of director, CEO);
• Has a financial interest that requires disclosure to the sponsor or funding source; 
• Has any other financial interest that the investigator believes may interfere with his or her ability to protect participants; or
• Is affiliated with an institution that has a lower conflict of interest threshold than the amounts referenced above.

Diversified mutual funds or similar instruments in which the shareholder has no control over the equities held by the fund are not considered to present a conflict of interest.

With respect to rules issued by NIH (NOT-OD-11-109) effective Aug. 24, 2012, our reporting threshold for study teams was changed to $5,000. [U.S. Department of Health and Human Services (HHS) issued a final rule] (https://grants.nih.gov/grants/policy/coi/index.htm) 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).]

A financial conflict of interest is not intrinsically wrong. Rather, the purpose of analyzing a financial conflict of interest is to determine when the interest offers incentive to the investigators or other party to breach a duty to participants or to society, and to determine how to address the conflict of interest. As individuals vary in their personal integrity, and as the WCG IRB Board generally does not know investigators and other parties intimately enough to judge their integrity, WCG IRB uses two reasonable-person standards for analysis:

• First, the Board considers whether the financial conflict of interest could challenge the integrity of a reasonable individual.
• Second, the Board considers whether the financial conflict of interest would appear to a reasonable member of the general public to be a conflict that could challenge the integrity of the conflicted party.

Using these reasonable person standards, the Board considers the following factors in its analysis of the reported conflict of interest:

Amount of Risk

The degree of risk and discomfort faced by participants in research varies greatly. In high-risk studies, such as those involving the use of a medical device in invasive surgery, a conflict of interest could greatly affect the risks faced by participants. In a study involving the analysis of human tissue, the risks to the participants are generally limited to confidentiality issues.

Effect of the Conflict of Interest on Subjective Decision-Making

The participation of the party with the conflict of interest could affect subjective decision making, both consciously and subconsciously, and thus influence the conflicted party’s judgment and behavior. Subjective decisions that could be influenced by a conflict include the design of the research, choosing which participants to enroll, clinical care provided to the participants, use of participants’ confidential medical information, data collection and analysis, adverse event reporting, and the presentation of research findings.

Amount of Interaction Between the Conflicted Party and the Participants

Many of the concerns about the conflicted party’s decisions will be lessened if the conflicted party does not interact directly with participants. For example, in many tissue studies the conflicted investigator simply receives waste samples from a surgery facility, and has no contact with the participants. On the other hand, in a similar study the investigator may also perform the surgery, in which case the concerns over the effect of the conflict are greater.

Other Parties Involved in Overseeing the Conflict of Interest

Often, there are other parties besides the IRB involved in the oversight of conflicts of research.

• For FDA-regulated studies, the FDA will provide a scientific review of the research results.
• NIH does detailed reviews of research proposals in advance, and inquiries about conflicts of interest at certain procedural steps.
• Some institutions have assigned participant advocates who sit in on the consent process.

The Board will consider the role and oversight of these and other such parties.

Training in Conflict of Interest

The investigator or other conflicted party may have participated in training on the ethical analysis of conflict of interest and, therefore, may be more aware of the ethical issues and in need of less oversight.

Nature of the Interest, and Relationship to the Research: The interest may be one in which large change is possible based on the outcomes of the study under review. An equity interest in a start-up company could be drastically affected by the research results, whereas stock in a large pharmaceutical company is not as likely to be affected. Is it a single site study or a multi-center study? The ability of the investigator or other conflicted party to affect the financial interest varies greatly in these different situations.

Unique Qualifications

Occasionally, the investigator or institution is uniquely qualified to conduct the research. For instance, the investigational article may be a surgical device that has been developed by a surgeon who specializes in a surgical technique that only he/she conducts.

Possible Board Actions

The following are actions the Board may take regarding conflicts of interest:

• A finding that the conflict of interest is not likely to jeopardize participant safety or influence the investigator’s decision-making and does not require further action. 
• A finding that disclosure of the conflict to participants or others is necessary. 
• A finding that controls on the conflict need to be put into place, such as limiting the role of the investigator with a conflict of interest. 
• A finding that the conflict is unacceptable and must be eliminated in order for the research to proceed. 
• Other.

Compensation to Investigators and Study Teams for the Conduct of Research

Financial compensation to investigators and to other members of the study team should be at fair market value for the time, procedures, and services provided.

Recruitment Bonuses: WCG IRB defines a recruitment bonus as an additional payment or incentive provided to the investigator, study staff, or site dependent solely on a number of participants being enrolled, dependent on the speed at which participants are enrolled, or payment or incentive that is offered only after a certain number of participants have been enrolled. Recruitment bonuses create a conflict of interests concern because the study team members stand to directly and financially benefit from enrolling more participants, or from enrolling participants faster, which may (intentionally or even unintentionally) encourage study team members to recruit less appropriate participants, or to pressure or persuade patients to enroll in research studies. WCG IRB does not allow recruitment bonuses (extra payments tied to the rate or timing of recruitment or enrollment). WCG IRB does allow payment for time spent screening for recruitment purposes on a fair market value basis to be built into the study budget.

The term “payment or incentive” includes any items of value, such as direct payment, gift certificates, travel vouchers, physical items such as watches, and so forth. Any recruitment plans that include recruitment incentives, whether planned at study start or added later during the study, must be reported to and approved by the IRB. The IRB will assess these proposals on a case-by-case basis, with the intention of preventing apparent or potential conflicts of interest that may impact the rights and welfare of research participants. These should be submitted in the form of administrative letters for consideration.

Referral fees/finder’s fees, which are payments made to people who are not members of the study team in return for referring potential participants to the study, are discussed in the section on Participant Recruitment Practices and Materials.