Research ethics committees (RECs) have a crucial role in protecting children in research. However, studies on REC members’ perspectives on paediatric research are scarce. We conducted a qualitative study to explore Swedish scientific REC members’ perspectives on ethical aspects in applications involving children with severe health conditions. The REC members considered promoting participation, protecting children and regulatory adherence to be central aspects. The results underscored the importance of not neglecting ill children’s rights to adapted information and participation. REC members supported (...) a contextual and holistic approach to vulnerability and risk, which considers the child’s and parents’ psychological wellbeing and the child’s integrity, both short and long term. The ethical complexity of paediatric research requires continuous ethical competence development within RECs. (shrink)

Non-financial interests, and the conflicts of interest that may result from them, are frequently overlooked in biomedicine. This is partly due to the complex and varied nature of these interests, and the limited evidence available regarding their prevalence and impact on biomedical research and clinical practice. We suggest that there are no meaningful conceptual distinctions, and few practical differences, between financial and non-financial conflicts of interest, and accordingly, that both require careful consideration. Further, a better understanding of the complexities of (...) non-financial conflicts of interest, and their entanglement with financial conflicts of interest, may assist in the development of a more sophisticated approach to all forms of conflicts of interest. (shrink)

Starting from Miranda Fricker’s recent work on the concept of testimonial injustice, this paper considers what duties testimonial justice creates for speakers. I discuss this question in relation to disclosures of so-called personal conflicts of interest, which authors are sometimes required or encouraged to declare when submitting their work to journals. Personal characteristics that have been disclosed by authors include smoking status, class background and ethnicity. The purpose of this paper is two-fold. First, I argue that disclosures of personal characteristics (...) raise problems of testimonial injustice in two ways: they can unfairly undermine researchers’ credibility and prejudice readers against the results or arguments proposed; and such disclosures can contribute to epistemic injustice more broadly by strengthening the view that individuals who share the features disclosed should, at least in some contexts, be given less credibility than others. The second goal of the paper is to argue that, while Fricker’s account focuses on the epistemic virtues of hearers in responding in the right way to testimonial injustice, there are also important duties of testimonial injustice incumbent on speakers. I propose three such duties. (shrink)

The physician-researcher conflict of interest has thus far eluded satisfactory solution. Most attempts to deal with it focus on improving informed consent. But those attempts are not successful and may even make things worse. Research subjects are already voluntarily undertaking the risks of research — we should not ask them to go it alone — to undergo medical “treatment” without medical “care.” The only effective solution is that in much clinical research, each research subject should have a doctor independent from (...) the research study. (shrink)

The physician-researcher conflict of interest, a long-standing and widely recognized ethical challenge of clinical research, has thus far eluded satisfactory solution. The conflict is fairly straightforward. Medical research and medical therapy are distinct pursuits; the former is aimed at producing generalizable knowledge for the benefit of future patients, whereas the latter is aimed at addressing the individualized medical needs of a particular patient. When the physician-researcher combines these pursuits, he or she serves two masters and cannot — no matter how (...) well-intentioned — avoid the risk of compromising the duties owed in one of the professional roles assumed. Because of the necessary rigidity of a research protocol, the more demanding of the two masters is frequently the research.The problem of the physician-researcher conflict has been evident since the first attempts to regulate human research in the United States. Otto E. Guttentag, a physician at the University of California School of Medicine in San Francisco, addressed the conflict in a 1953Sciencemagazine article. (shrink)

In the last decade, there has been increased recognition of the importance of disclosing and managing non-financial conflicts of interests to safeguard the objectivity, integrity, and trustworthiness of scientific research. While funding agencies and academic institutions have had policies for addressing non-financial interests in grant peer review and research oversight since the 1990s, scientific journals have been only recently begun to develop such policies. An impediment to the formulation of effective journal policies is that non-financial interests can be difficult to (...) recognize and define. Journals can overcome this problem by providing guidance concerning the types of non-financial interests that should be disclosed, including direct research interests, direct professional interests, expert testimony, involvement in litigation, holding a leadership position in a non-governmental organization, providing technical or scientific advice to a non-governmental organization, and personal or professional relationships. The guidance should apply to authors, editors, and reviewers. (shrink)

Stricter policies regarding conflicts of interest policies will increase transparency but have limitations and unintended adverse consequences. Physicians and the medical profession should take the lead in developing policies, rather than responding to external regulations. The goal is to reduce significant risks of undue influence, while keeping the burdens and opportunity costs of policies acceptable.

Financial relationships between physicians and industry are widespread. Highly publicized financial relationships between physicians and industry raised disturbing questions about the trustworthiness of clinical research, practice guidelines, and clinical care decisions. Recent incidents spurred calls for stricter conflict of interest policies and led to new federal laws and NIH regulations. These stricter policies have evoked praise, concerns, and objections. Because these new federal requirements need to be interpreted and implemented, spirited discussions of conflicts of interest in medicine will continue.

We discuss the relationship between expertise, expert authority, and trust in the case of vaccine research and policy, with a particular focus on COVID-19 vaccines. We argue that expert authority is not merely an epistemic notion, but entails being trusted by the relevant public and is valuable if it is accompanied by expert trustworthiness. Trustworthiness requires, among other things, being transparent, acknowledging uncertainty and expert disagreement (e.g., around vaccines’ effectiveness and safety), being willing to revise views in response to new (...) evidence, and being clear about the values that underpin expert recommendations. We explore how failure to acknowledge expert disagreement and uncertainty can undermine trust in vaccination and public health experts, using expert recommendations around COVID-19 vaccines as a case study. (shrink)

Conflict of interests in medicine are typically taken to be financial in nature: it is often assumed that a COI occurs when a healthcare practitioner’s financial interest conflicts with patients’ interests, public health interests, or professional obligations more generally. Even when non-financial COIs are acknowledged, ethical concerns are almost exclusively reserved for financial COIs. However, the notion of “interests” cannot be reduced to its financial component. Individuals in general, and medical professionals in particular, have different types of interests, many of (...) which are non-financial in nature but can still conflict with professional obligations. The debate about healthcare delivery has largely overlooked this broader notion of interests. Here, we will focus on health practitioners’ moral or religious values as particular types of personal interests involved in healthcare delivery that can generate COIs and on conscientious objection in healthcare as the expression of a particular type of COI. We argue that, in the healthcare context, the COIs generated by interests of conscience can be as ethically problematic, and therefore should be treated in the same way, as financial COIs. (shrink)

A conflict of interest is a situation in which a person has competing loyalties or interests that make it difficult to fulfil his or her duties impartially. Conflict of interest is not categorically improper in itself but requires proper management. A SCOPUS literature search was performed for publications on the efficacy/safety of Phospho-Di-Esterase Inhibitors for treating erectile dysfunction. A categorization tool was used to review and classify the publications as supportive/not-supportive for the discussed active ingredient and reporting or not reporting (...) a COI for that specific drug or for the remaining PDEIs. Multivariable binary logistic regression was performed. In the 419 selected records the prevalence of supportive opinions was higher when a COI for the index label was declared. The CoOpCaT showed good internal consistency, discriminative validity and intra/inter-rater agreement. The strongest predictor for a supportive opinion was the total number of financial COIs for the index label. A mild protective effect of the total number of financial COIs for any competitor label was noted. Financial COIs have frequently been associated with bias, and the measures currently adopted to restrain it lack effectiveness. Some evidence for monitoring and/or compensating this bias is reported here, but the ultimate solution remains distant. (shrink)