A wide range of medical institutions have developed and implemented policies to mitigate the adverse consequences of conflicts of interest. These newly implemented policies, which include regulation of industry contact with physicians and hospitals, controls on gifts from industry, and greater transparency in industry sponsored activities, have generated considerable controversy.Formulating and evaluating policies in a neutral, unbiased fashion can be difficult for those personally affected. When people have a stake in an issue, they tend to process information in a selective (...) fashion that supports their personal interests, a phenomenon known as “motivated reasoning.” When decision makers with preexisting opinions are exposed to information, they are inclined to selectively use the information to arrive at conclusions that justify their prior beliefs. When confronted with information that contradicts existing views, people evaluate it with greater skepticism. Additionally, once decision makers have reached a decision, they are likely to evaluate subsequent evidence in a biased manner that supports their decision. (shrink)

A number of unique problems plague human research protection efforts at United States (U.S.) State and Territorial Departments of Health (DOHs) problems which might be ameliorated through a consolidated national or regional, independent, not-for-profit Institutional Review Board (IRB).

A number of unique problems plague human research protection efforts at United States State and Territorial Departments of Health. The first problem is related to the number of Institutional Review Boards operated by and Federalwide Assurances held by DOHs. The lack of these two essential regulatory human research protection program mechanisms points to a possible inadequacy of infrastructure at DOHs for protecting human subjects. The second and third problems are related to the use and interpretation of research protection laws and (...) regulations at DOHs. Parsing public health activities into research or practice can be vexing and likely produces variability in how individual DOHs make the determination between research and practice and the outcomes of such decisions for the same or similar projects. A related problem is that DOH or Institutional Review Board officials might misclassify public health practice activities as research, which can have costly, adverse consequences. (shrink)

Disclosure is a common response to conflicts of interest; it is intended to expose the conflict to scrutiny and enable it to be appropriately managed. For disclosure to be effective the receiver of the disclosure needs to be able to use the information to assess how the conflict may impact on their interests and then implement a suitable response. The act of disclosure also creates an expectation of self-regulation, as the person with the conflicting interests will be mindful of their (...) own potential biases and aware that their decisions may be monitored. This article discusses some of the problems of relying on disclosure as a solution to address conflicts of interest in research, including the added complexities around institutional conflicts of interest. The case of Dan Markingson illustrates these issues and highlights the vulnerable position relying on disclosure as a solution leaves research participants in. (shrink)