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The federal research misconduct regulations finalized in 2005 did not incorporate important principles regarding human subjects protections articulated in The Belmont Report, yet research misconduct can involve harms to research subjects and to subsequent patients whose treatments are based on false research findings. Consistency with the Belmont principles would require assuring regular monitoring to detect research misconduct, tracing effects of research misconduct on trial participants and informing them of these effects, and assuring timely correction of published reports of research findings if research misconduct related to the study was subsequently discovered. Research misconduct has historically been viewed as a matter for the scientific community to manage; it is actually a threat to the welfare of human subjects and ethically ought to be treated as such. [ABSTRACT FROM AUTHOR]

Background: It has been more than two decades since the only interview study of whistleblowers in academic research. There remains a need to appreciate whistleblower experience, role in scientific integrity, and whether policies provide adequate protection.Methods: We contacted the institutional official for research, the institutional review board (IRB) director, and the Institutional Animal Care and Use Committee (IACUC) director from a random sample of 25 of the highest 200 NIH funded institutions. We assessed the willingness of respondents to send a hypothetical solicitation letter to whistleblowers who had lodged complaints related to research.Results: The response rate was 41%. Despite a willingness to distribute a solicitation letter (68% respondents), most wanted further institutional approval before sending it (76%).Conclusion: Data from this pilot study suggest substantial obstacles to obtaining access to whistleblowers by way of anonymous solicitation letters distributed by institutions. [ABSTRACT FROM PUBLISHER]

Background:In an earlier study, we described the impact of formal misconduct determinations on established scientists’ careers, showing that many retained scientific careers, and more than half (51%) continued to publish at least one paper per year after their cases were decided. Here, we extend our study to examine the ramifications of final misconduct findings by the Office of Research Integrity (ORI) on the careers of postdoctoral fellows.Methods:We tracked publication histories and attempted to track down all postdoctoral trainees found by ORI to have committed misconduct, and attempted to interview them about their experiences.Results:Trainees found to have committed misconduct between 1993 and 2007 whom we could trace were less likely to continue to publish than more established scientists, with only 11% publishing more than one paper per year after their misconduct determinations. Our assessment is constrained by our inability to reliably trace postdoctoral fellows, reflecting the fact that a majority of U.S. postdocs are from other countries.Conclusions:Because of concern about the fairness of severe punishment of trainees, the U.S. Office of Research Integrity appears to be shifting from funding debarments toward requiring education, mentorship, and oversight for trainees, which may enhance the likelihood of rehabilitation. Whether this policy succeeds remains to be seen. [ABSTRACT FROM AUTHOR]