Several salient themes emerged in the interviews, including general attitudes toward conflicts of interest, circumstances in which financial interests should be disclosed, the rationale and benefits of disclosure, what information should be disclosed, negative effects of and barriers to disclosure, and the timing and presentation of disclosure. We discuss each in turn. shows the prevalence of the various themes separately for IRB chairs, COIC chairs, and investigators. All quotations in the following section remain anonymous to protect respondent’s identities.
Relative Frequency of Respondents Who Mentioned a Theme by Respondent Type
Some respondents suggested that concerns about conflicts of interest were unwarranted.
Respondents held one of three basic attitudes toward financial conflicts of interest and their management, which we categorized as believing that attention to conflicts of interests is either overblown or important or that conflicts of interest are unavoidable. Some respondents suggested that concerns about conflicts of interest were unwarranted. For example, an investigator dismissed the idea that an equity holding could bias the conduct of a study:
As far as I am concerned, the conflict of interest thing is blown way, way, way out of proportion. I honestly believe that with the ability to affect a stock you may own or a pharmaceutical company that you may be involved with in any manner by doing a simple drug study, the amount of money therein is so incontestably small. Let’s say...we do a dozen studies for [Company X]...and it is a $2 billion company. I mean, you know, how could I possibly...Let’s say that I owned a lot of stock in [Company X]. I mean, the application of a new drug to the company, let alone our ability to participate in that drug, would not affect that one iota. So, as far as I am concerned, conflict of interest is overblown.
In contrast, others felt that conflicts of interest are a serious problem. One COIC chair remarked, “The future of academic health centers depends on [COIC oversight] being done right.” Finally, others indicated that conflicts of interests were a necessary part of life that can not be avoided entirely. One IRB chair’s comments are representative:
Well, I think conflicts of interest are an important part of practically every human transaction. ... The only way we can remove conflict of interest is to all live in individual cages and not have any interactions with each other. The institutions obviously have to balance that with the incentives that they provide for their members, as well as their interactions with society as a whole.
Disclosure of Financial Interests
Most respondents suggested that disclosure should occur under all circumstances in which a financial interest exists. Close to half of the sample indicated that the disclosure itself depended on the type of financial relationship: I guess the most common [financial relationship] is everybody gets support from pharmaceutical companies to do the trial. But those are usually based on sort of a fee per patient going through....And in that sense I do not really see that as a financial disclosure that is necessary, because those budgets are, at least in my institution, very tightly regulated and very much fee-for-service type thing. So, I do not really think that there is a lot of need for saying Company XYZ is paying me $6,000 for every patient we enroll on this, and those costs are going to pay for extra lab and time of people who do extra exams and fill out paperwork and submit things to the IRB.
An IRB chair mentioned that risks to the research participants would also factor into decisions about disclosure:
I do not know if [disclosure] is a requirement, but probably obliquely, or explicitly, and it depends on how large the incentive is and how it might adverse or increase the risk, or induce the investigator to put the patient at greater risk.
No respondent indicated that disclosure of financial interests should never take place.
Rationale and Benefits of Disclosure
Despite their agreement about the need to disclose financial interests to potential research participants, the respondents offered a variety of justifications for doing so. These included better informed decision making regarding participation, trust and transparency, reducing the risk of liability, and others, such as the role of disclosure in managing public perceptions and the institution’s management of particular financial interests.
Informed Decision Making
The most frequently discussed justification for disclosing financial interests was to enable potential research participants to make better informed decisions. One respondent said, “If people are going to do this ethically and morally you should give them as much information as you can so that they can make reasonable decisions.” However, some respondents expressed strong negative views about the possibility of better informed decisions through the disclosure of financial benefits: “I do not think it adds any piece of information that would help them judge being in the study or the quality of the data that will come out of the study.” Others expressed ambivalence about the rationale for disclosure:
I do not think it is the kind of information that patients use to make decisions about which trial they will participate in. But when they are asked that bottom-line question - you know, “Will you participate?” - it is at that point that they really do require this type of full disclosure. In other words, I do not want to load up the consent form and consent process with even more forms that are just going to get in the way of the patients making decisions.
Trust and Transparency
Another prominent reason for disclosing financial interests in research involved engendering participants’ trust in investigators, the research institution, and the research enterprise in general. One COIC chair was particularly passionate:
The benefits of disclosure obviously is we develop a culture where people increasingly realize and trust academic health centers as working in their best interest, and partnering with, and that word is sort of en vogue, but I think it is a very important word, but that they are a part of our team. That benefit is tremendous.
Some respondents underscored the need for disclosure to prevent a later reaction of distrust if research participants learned about a previously undisclosed conflict of interest. Several respondents said that whether disclosure would build trust depended on the individual situation and that in some cases such disclosures could decrease trust in the researchers or research institution.
Closely related to trust was the notion that disclosure is important to maintain an environment of transparency. However, one IRB chair noted the difficulty in determining what aspects of the study should be transparent to potential research participants:
We make decisions all the time about what we are going to put in a consent form. You know, if 5,000 people have received a drug for 10,000 patient-years, and one person dropped dead of a cardiac arrhythmia, do we put that risk in the consent form? No, we do not. Because we have to make some decisions about what is material and germane to the decision. And I guess that we have decided that those are not material and germane to a decision.
Reducing the Risk of Liability
Several respondents in each group stated that disclosure of conflicts of interest was necessary to avoid legal liability if something went wrong with the trial or if a research participant later became upset about the presence of a financial interest. Among the IRB chairs, however, some disagreed that reducing liability should be a rationale for disclosure.
Less frequently cited reasons for disclosure included potential research participants’ basic right to know this information and the need for institutions to manage the public’s perceptions of conflicts of interest. Regarding the latter, several respondents noted that disclosure would be important to avoid a newspaper headline about their institution’s conflicts of interest.
While no respondent mentioned deterrence (i.e., discouraging investigators from holding questionable financial interests) as a rationale for disclosure, one COIC chair felt that disclosure could help investigators and institutions police themselves:
And also, by declaring it, I think the institution and the investigators appropriately keep under their nose[s] the issues that...may be influencing them, and it continually alerts them to the possibility of potential for hidden bias in their studies. And it is important because they are training the next level of investigators. So this is something that is important to have, I think, always in front of us, because we do this [research] as a privilege and not as a right.