Practicing research ethics: Private-sector physicians & pharmaceutical clinical trials

Abstract

This paper focuses on constructions of research ethics by primary care physicians in the USA as they engage in contract research for the pharmaceutical industry. Drawing first upon historical studies of physicians as investigators and then upon 12 months of qualitative fieldwork in the South Western US, this paper analyzes the shifting, contextualized ethics that shape physicians' relationships with patients/subjects and pharmaceutical companies. Just as physicians followed professional codes of ethics prior to the codification of acceptable research conduct in the 1980s, physicians today continue to develop tacit systems of research ethics. This paper argues that private-sector physicians primarily conceptualize their ethical conduct in relation to the pharmaceutical companies hiring them, not to human subjects they enroll in clinical trials. This is not to say that these physicians do not follow the formal U.S. regulation to protect human subjects, but rather that their financial relationships with the pharmaceutical industry have a greater influence on their identities as researchers and on their constructions of their ethical responsibilities.

Ethical Issues in Outsourcing: The Case of Contract Medical Research and the Global Pharmaceutical Industry

“…Local review committees serve as watchdogs ensuring that researchers follow the protocols. In some cases, researchers can apply to the pharmaceutical companies to change the protocols when they deem them onerous and the client firms are free to grant that exemption if they deem it necessary (Fisher 2008). Violation of ethical rules occurs when contract researchers engage in behavior that violates basic universal ethical norms.…”

“…Those who participate in contract research are given clearly defined protocols by the pharmaceutical companies to follow. Studies indicate that researchers often discover that following the protocols is not always so clear-cut (Fisher 2008). Researchers often think that there is room for them to bend the rules and establish their own clinical guidelines especially when they determine that a protocol is unreasonable.…”

“…Researchers often think that there is room for them to bend the rules and establish their own clinical guidelines especially when they determine that a protocol is unreasonable. Fisher (2008) notes that deciding how much to bend those rules draws ethics into the equation. Although pharmaceutical companies are known to be flexible about their protocols and would grant exemptions to researchers when asked, most researchers believe that their professional judgments should trump study protocols (Fisher 2008).…”

“…Even more significant is the relationship between the parties is what contract researchers think about who bears responsibility for ethics in CMR. Fisher (2008) found that contract researchers often believe that third parties such as local IRBs, and governments, not they, are responsible for determining the ethics of the clinical trials they conduct. Their argument is that since pharmaceutical firms hand the protocols to them, the responsibility for ethics should rest with them.…”

“…The point here is not that contract researchers do not take their role to act with care seriously, most probably do. Rather, as Fisher (2008) notes, the issue is that rather than seeing that as their primary ethical obligation, they see it as merely part of the good conduct of study protocols.…”