Effects of disclosing financial interests on participation in medical research: A randomized vignette trial

Abstract

Background-Little is known about the effects of investigators' financial disclosures on potential research participants.

Moving Toward Evidence-Based Human Participant Protection

“…Here we would include, as exemplars, research such as Katz and Fox (2004) ethnographic study of informed consent procedures in two US health care settings and Felt et al (2009) interviewbased study of informed consent in the context of tissue donation in Austrian clinical research. Other significant traditional topics, increasingly populating this growing field of research, include studies on the impact of disclosing to human participants the financial interests of physicians and other investigators conducting the research (Weinfurt et al 2008), as well as the roles and relationships human participants and researchers must negotiate during the course of a research study. (Dyregrov 2004;Morris et al 2004;N.…”

Incentivizing Recruitment and Retention to Address Enrollment Challenges in Clinical Research

“…Interestingly, there is some evidence that patients generally do not find per capita investigator payments problematic, although they have greater concern when equity interests are present. 24 Adequately disclosing incentive arrangements and studying patients' reactions are a central element of assessing their ethical impact. 25…”

Void for Vagueness

“…On a scale of 1 to 5, where 3 indicates uncertainty about participating, 4 that they "probably" would participate, and 5 that they "definitely" would participate, patients who were given no disclosures about financial interests had a mean score of 3.5. 5 To have that as a mean score, there no doubt had to be a fair number of 4s, if not some 5s. (If they received a disclosure that the investigator had an equity interest at stake, the mean dropped to 3.2.)…”