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).

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.

Qualitative research ethics on the spot

2015 ◽  
Vol 23 (4) ◽  
pp. 455-464 ◽  
Author(s):  
Christine Øye ◽  
Nelli Øvre Sørensen ◽  
Stinne Glasdam
Keyword(s):  
Qualitative Research ◽  
Informed Consent ◽  
Research Ethics ◽  
Ethical Issues ◽  
Ethical Dilemmas ◽  
Institutional Review Boards ◽  
Ethical Guidelines ◽  
Ethical Considerations ◽  
Institutional Review ◽  
Review Boards

Background: The increase in medical ethical regulations and bureaucracy handled by institutional review boards and healthcare institutions puts the researchers using qualitative methods in a challenging position. Method: Based on three different cases from three different research studies, the article explores and discusses research ethical dilemmas. Objectives and ethical considerations: First, and especially, the article addresses the challenges for gatekeepers who influence the informant’s decisions to participate in research. Second, the article addresses the challenges in following research ethical guidelines related to informed consent and doing no harm. Third, the article argues for the importance of having research ethical guidelines and review boards to question and discuss the possible ethical dilemmas that occur in qualitative research. Discussion and conclusion: Research ethics must be understood in qualitative research as relational, situational, and emerging. That is, that focus on ethical issues and dilemmas has to be paid attention on the spot and not only at the desktop.

scholarly journals A call for structured ethics appendices in social science papers

2021 ◽  
Vol 118 (29) ◽  
pp. e2024570118
Author(s):  
Edward Asiedu ◽  
Dean Karlan ◽  
Monica Lambon-Quayefio ◽  
Christopher Udry
Keyword(s):  
Data Collection ◽  
Social Science ◽  
Conflicts Of Interest ◽  
Human Subjects ◽  
Intellectual Freedom ◽  
Institutional Review Boards ◽  
Human Subjects Research ◽  
Research Results ◽  
Institutional Review

Ethics in social science experimentation and data collection are often discussed but rarely articulated in writing as part of research outputs. Although papers typically reference human subjects research approvals from relevant institutional review boards, most recognize that such boards do not carry out comprehensive ethical assessments. We propose a structured ethics appendix to provide details on the following: policy equipoise, role of the researcher, potential harms to participants and nonparticipants, conflicts of interest, intellectual freedom, feedback to participants, and foreseeable misuse of research results. We discuss each of these and some of the norms and challenging situations of each. We believe that discussing such issues explicitly in appendices of papers, even if briefly, will serve two purposes: more complete communication of ethics can improve discussions of papers and can clarify and improve the norms themselves.

Differences between research ethics committees

2007 ◽  
Vol 23 (1) ◽  
pp. 17-23 ◽  
Author(s):  
Sarah J. L. Edwards ◽  
Tracey Stone ◽  
Teresa Swift
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
Institutional Review Boards ◽  
Research Ethics Committees ◽  
Ethical Considerations ◽  
Local Conditions ◽  
Ethical Judgments ◽  
Risks And Benefits ◽  
The United Kingdom ◽  
Institutional Review

Objectives:To examine differences in the ethical judgments made by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs).Methods:We did a review of the literature and included any study that attempted to compare the ethical judgments made by different RECs or IRBs when reviewing one or more protocol.Results:There were twenty-six articles reporting such discrepancies across Europe, within the United Kingdom, Spain, and United States. Of these studies, there were only five reports of some RECs approving while others rejecting the same protocol. All studies, however, reported differences in the clarifications and revisions asked of researchers regarding consent, recruitment, risks and benefits, compensation arrangements, and scientific issues.Conclusions:The studies were generally anecdotal reports of researchers trying to do research. New rules requiring a single ethical opinion for multi-site research at least in European Member States may simply conceal problematic issues in REC decision making. In the last analysis, we should expect a certain degree of variation and differences if we are to keep a committee system of review, although there is a pressing need to investigate the way in which RECs make these judgments. In particular, we need to identify the source of any aberrations, distortions, or confusions that could arbitrarily affect these judgments. Furthermore, local conditions remain important ethical considerations and should not be sidelined in pursuit of greater “consistency.”

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 Researchers’ perspectives on the role of study partners in dementia research

2014 ◽  
Vol 26 (10) ◽  
pp. 1649-1657 ◽  
Author(s):  
Betty S. Black ◽  
Holly Taylor ◽  
Peter V. Rabins ◽  
Jason Karlawish
Keyword(s):  
Academic Research ◽  
Research Participation ◽  
Research Process ◽  
Institutional Review Boards ◽  
Enrollment Decisions ◽  
Caregiver Support ◽  
Institutional Review ◽  
Dementia Research ◽  
Role Responsibilities

ABSTRACTBackground:Study partners for dementia research participants are vital to the research process, but little is known about their role, responsibilities, and experiences. Study partners are usually family members or friends – often the patient's informal caregiver – who are knowledgeable about and usually accompany the participant to study visits. This study examines researchers’ perspectives on the role of study partners in dementia research.Methods:Qualitative data collection and analytic methods were used. Semi-structured individual interviews with principal investigators, study coordinators, and research nurses (i.e. researchers; n = 17) at two academic research sites were recorded, transcribed, and content analyzed to identify themes in the data.Results:According to researchers, study partners either make or help make research enrollment and post-enrollment decisions, serve as knowledgeable informants for the participants, manage the logistics that enable participants to comply with a study's protocol, and provide comfort and encouragement for the patient to engage in and complete a study. Researchers describe ideal qualities of study partners as being able to provide reliable information, being dependable and adherent to the protocol, and not expecting a benefit. They also report that study partners may face both practical and emotional challenges during research participation. However, researchers believe that study partners derive dementia-related education, caregiver support, and satisfaction from their involvement in research.Conclusions:Investigators, potential study partners, and institutional review boards should be aware of study partners’ research responsibilities, challenges, and their interests as caregivers.

Informed Consent

PEDIATRICS ◽  
1967 ◽  
Vol 39 (2) ◽  
pp. 309-309
Author(s):  
H. DAVID MOSIER
Keyword(s):  
Informed Consent ◽  
Clinical Investigation ◽  
Ethical Considerations

It is difficult to imagine a physician investigator who does not also at the same time play the role of "physician-friend" in the sense of Dr. Silverman's proposal (Pediatrics, 38:373, 1966). Any physician responsible for the subjects of clinical investigation must perform his role guided by the same ethical considerations that guide other physicians in the care of their patients. Were it otherwise, the subjects would be placed at some jeopardy as to their welfare and the preservation of their dignity.

Handbook on Using Administrative Data for Research and Evidence-based Policy

2020 ◽  
Keyword(s):  
Administrative Data ◽  
Data Security ◽  
Data Use ◽  
Decision Makers ◽  
Institutional Review Boards ◽  
Evidence Based ◽  
Evidence Based Policy ◽  
Institutional Review ◽  
Address Data ◽  
The Us

The Handbook on Using Administrative Data for Research and Evidence-based Policy offers guidance for researchers, data providers, and decision-makers who would like to use administrative data to inform policy. Administrative data has the potential to change the future of research, in particular when combined with experiments that can help test the effectiveness of planned programs and evaluate new hypotheses. This Handbook offers a roadmap to overcome potential challenges in using administrative data for research and evaluation purposes. The technical chapters address data use agreements, working with institutional review boards, physical data security, privacy, and more. Ten complementary case studies showcase diverse models of successful administrative data partnerships in the US, Canada, Europe, Africa, and Asia.

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