scholarly journals Disclosing Conflicts of Interest in Clinical Research: Views of Institutional Review Boards, Conflict of Interest Committees, and Investigators

2006 ◽  
Vol 34 (3) ◽  
pp. 581-591 ◽  
Author(s):  
Kevin P. Weinfurt ◽  
Joëlle Y. Friedman ◽  
Michaela A. Dinan ◽  
Jennifer S. Allsbrook ◽  
Mark A. Hall ◽  
...  
Keyword(s):  
Clinical Research ◽  
Conflicts Of Interest ◽  
Informed Consent Process ◽  
Institutional Review Boards ◽  
Research Participants ◽  
Professional Groups ◽  
Institutional Review ◽  
Financial Interests ◽  
Basic Norm ◽  
Financial Conflicts Of Interest

Investigator and institutional financial conflicts of interest have raised concerns about both the integrity of clinical research and protecting the rights and welfare of research participants. In response, professional groups and governmental bodies have issued guidance for managing conflicts of interest to minimize their potential untoward effects. Although a variety of approaches have been offered, a common protection is to disclose financial interests in research to potential research participants as part of the recruitment and informed consent process. This approach reinforces a basic norm of candor, ideally allowing potential research participants to evaluate whether financial interests should affect their decision to participate in research. Disclosure to potential research participants is viewed as an alternative to having regulators or research institutions limit or prohibit all financial interests in research, assuming that not all such interests are unacceptable.

Ethical Conduct of Clinical Trials, Institutional Review Boards, Informed Consent, and Financial Conflicts of Interest

2019 ◽  
pp. 545-548
Author(s):  
Christian B. Ramers
Keyword(s):  
Informed Consent ◽  
Ethical Issues ◽  
Conflicts Of Interest ◽  
Ethical Conduct ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
Essential Components ◽  
Financial Conflicts Of Interest

Describe the essential components of the ethical conduct of research, the role of the institutional review board, the process of informed consent, the potential areas of conflict of interest for clinicians participating in research, and other ethical issues related to research in HIV medicine.

Differential payment to research participants in the same study: an ethical analysis

2019 ◽  
Vol 45 (5) ◽  
pp. 318-322 ◽  
Author(s):  
Govind Persad ◽  
Holly Fernandez Lynch ◽  
Emily Largent
Keyword(s):  
Clinical Research ◽  
Ethical Analysis ◽  
Institutional Review Boards ◽  
Research Participants ◽  
Institutional Review ◽  
Study Participants ◽  
Incentive Payments ◽  
Review Boards

Recognising that offers of payment to research participants can serve various purposes—reimbursement, compensation and incentive—helps uncover differences between participants, which can justify differential payment of participants within the same study. Participants with different study-related expenses will need different amounts of reimbursement to be restored to their preparticipation financial baseline. Differential compensation can be acceptable when some research participants commit more time or assume greater burdens than others, or if inter-site differences affect the value of compensation. Finally, it may be permissible to offer differential incentive payments if necessary to advance the goals of a study. We encourage investigators and Institutional Review Boards to think about whether to offer payment, in what amounts and for what purpose, and also to consider whether differential payment can help promote the scientific and ethical goals of clinical research.

Perspectives of clinical research coordinators on disclosing financial conflicts of interest to potential research participants

2007 ◽  
Vol 4 (3) ◽  
pp. 272-278 ◽  
Author(s):  
Joëlle Y Friedman ◽  
Jeremy Sugarman ◽  
Jatinder K Dhillon ◽  
Venita DePuy ◽  
Christine K Pierre ◽  
...  
Keyword(s):  
Clinical Research ◽  
Conflicts Of Interest ◽  
Research Participants ◽  
Clinical Research Coordinators ◽  
Financial Conflicts Of Interest

scholarly journals Ethical Guidelines for Publishing in the Journal of Cachexia, Sarcopenia and Muscle Clinical Reports

2016 ◽  
Vol 1 (1) ◽  
Author(s):  
Stephan Von Haehling ◽  
Nicole Ebner ◽  
John E Morley ◽  
Andrew JS Coats ◽  
Stefan D Anker
Keyword(s):  
Conflicts Of Interest ◽  
Research Work ◽  
Ethics Committees ◽  
Institutional Review Boards ◽  
Original Research ◽  
Ethical Guidelines ◽  
Abstract Form ◽  
Institutional Review ◽  
Ethical Authorship ◽  
Available Information

AbstractThis article details the principles of ethical authorship and publishing in the Journal of Cachexia, Sarcopenia and Muscle Clinical Reports (JCSM Clinical Reports). At the time of submission to JCSM Clinical Reports, the corresponding author, on behalf of all co-authors, needs to certify adherence to these principles. The principles are obtained below: All authors listed on a manuscript considered for publication have approved its submission and (if accepted) publication as provided to JCSM Clinical Reports;No person having a right to be recognized as author has been omitted from the list of authors on the submitted manuscript;The submitted work is original and is neither under consideration elsewhere nor has it been published previously in whole or in part other than in abstract form;All authors certify that the work is original and does not contain excessive overlap with prior or contemporaneous publication elsewhere, and where the publication reports on cohorts, trials, or data that have been reported on before these other publications must be referenced;All original research work are approved by the relevant bodies such as institutional review boards or ethics committees;All conflicts of interest, financial or otherwise, that may affect the authors' ability to present data objectively, and relevant sources of funding have been duly declared in the manuscript;The manuscript in its published form will be maintained on the servers of JCSM Clinical Reports as a valid publication only as long as all statements in the guidelines on ethical publishing remain true; andIf any of the aforementioned statements ceases to be true, the authors have a duty to notify the Editors of JCSM Clinical Reports as soon as possible so that the available information regarding the published article can be updated and/or the manuscript can be withdrawn.

scholarly journals The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network–initiated clinical trials

2018 ◽  
Vol 16 (1) ◽  
pp. 3-10 ◽  
Author(s):  
Michael P Diamond ◽  
Esther Eisenberg ◽  
Hao Huang ◽  
Christos Coutifaris ◽  
Richard S Legro ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Child Health ◽  
Clinical Research ◽  
Human Development ◽  
Reproductive Medicine ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
The Impact ◽  
Review Boards

Background/aims: Timely review of research protocols by institutional review boards leads to more rapid initiation of clinical trials, which is critical to expeditious translation from bench to bedside. This observational study examined the impact of a single institutional review board on time and efforts required to initiate clinical trials by the National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network. Methods: Collection of data from the same six main clinical sites for three current clinical trials and two past clinical trials, including time from institutional review board submission to approval, pages submitted, consent form length, number of required attachments, other regulatory requirements, order of review at central or local sites, and language in documents at individual participating sites. Results from two past clinical trials were also included. Results: While time required for actual institutional review board submission’s review and initial approval was reduced with use of a single institutional review board for multicenter trials (from a mean of 66.7–24.0 days), total time was increased (to a mean of 111.2 or 123.3 days). In addition to single institutional review board approval, all institutions required local approval of some components (commonly consent language and use of local language), which varied considerably. The single institutional review board relied on local institutions for adding or removing personnel, conflict of interest review, and auditing of activities. Conclusion: A single institutional review board reduced time for initial review and approval of protocols and informed consents, although time for the entire process was increased, as individual institutions retained oversight of components of required regulatory review. In order to best achieve the National Institute of Health’s goals for improved efficiency in initiation and conduct of multisite clinical research, greater coordination with local institutional review boards is key to streamlining and accelerating initiation of multisite clinical research.

Ethical Conduct of Clinical Trials, Institutional Review Boards, Informed Consent, and Financial Conflicts of Interest

2017 ◽  
Author(s):  
Christian B. Ramers
Keyword(s):  
Informed Consent ◽  
Conflicts Of Interest ◽  
Institutional Review Boards ◽  
Ethical Considerations ◽  
Governmental Organizations ◽  
Institutional Review ◽  
The Us ◽  
Guidelines And Recommendations ◽  
Study Designs

Ethics and conflicts of interest are important considerations when planning and carrying out research. It is the role of the institutional review board to weigh these against protection of the research subject when evaluating research proposals. The ethical considerations when performing research include basic ethical principles (e.g., autonomy, confidentiality, non-maleficence, informed consent, beneficence, justice, and utility), as well as nuances such as appropriate study designs, investigator conflict of interests, and bias in all its forms. To help guide clinicians, a number of professional and governmental organizations have published guidelines and recommendations on various aspects of clinical research (e.g., the American Medical Association, the National Institutes of Health, and the US Food and Drug Administration).

Protecting Research, Preserving Trust

2015 ◽  
Author(s):  
Josephine Johnston ◽  
Naomi Scheinerman
Keyword(s):  
Biomedical Research ◽  
Special Interest ◽  
Conflicts Of Interest ◽  
Research Integrity ◽  
Research Institutions ◽  
The Past ◽  
Financial Interests ◽  
Financial Conflicts Of Interest ◽  
The U.S ◽  
Financial Relationships

This chapter reviews the two main concerns about financial relationships with industry: that they could conflict with research-related obligations leading to biased or flawed research and an incomplete research record, and that they could undermine trust in biomedical research, researchers, and research institutions. We show that these concerns are valid, and that they persist in the U.S., despite a gradual tightening over the past decade of rules and regulations regarding financial conflicts of interest in biomedical research. The threat that financial interests can pose to research integrity should be of special interest to psychiatry for two reasons: they are prevalent in this field, and they pose heightened risks due to the nature of psychiatry itself. Finally, we recommend that psychiatry—and individual research psychiatrists—take more seriously the threat posed by financial relationships with industry, and work together to develop additional strategies for avoiding and managing financial conflicts of interest.

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