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.

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).

The Role of the Institutional Review Board in Research Involving Human Subjects

1983 ◽  
Vol 17 (11) ◽  
pp. 828-834 ◽  
Author(s):  
John A. Bosso
Keyword(s):  
Experimental Research ◽  
Human Subjects ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Federal Regulations ◽  
Research Subjects ◽  
Basic Composition ◽  
Institutional Review ◽  
Policies And Procedures

Concern with the rights and welfare of human experimental research subjects has given rise to the evolution of institutional review boards. This article describes the basic composition and purposes of these boards, as well as the federal regulations by which they are governed. Since many of these regulations are open to interpretation, the policies and procedures of one such board are included to represent an example of how these regulations are interpreted and applied.

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.

Ethics and Regulation in Organ Procurement Research

2002 ◽  
Vol 12 (4) ◽  
pp. 257-265 ◽  
Author(s):  
Terrence F. Ackerman ◽  
Rebecca P. Winsett
Keyword(s):  
Informed Consent ◽  
Organ Procurement ◽  
Institutional Review Board ◽  
Future Research ◽  
Ethical Practice ◽  
Human Research ◽  
Research Activities ◽  
Institutional Review ◽  
Waiver Of Consent

This article explores the role of ethics and regulation in human research conducted by organ procurement agencies; basic ethical principles for human research are outlined. Organ procurement agencies are not required to observe federal regulations; however, voluntary adherence will ensure that procurement research is conducted according to current standards of ethical practice. Although most organ procurement research will qualify for exempt status, this determination should be made by an institutional review board. Even if studies qualify for exempt status, there is a moral presumption that informed consent should be sought, unless certain narrow conditions for waiver of consent are satisfied. Finally, when future research utilizing organ procurement records is anticipated, procurement coordinators should provide sufficiently detailed information to families about such plans to permit their advance informed consent to research activities.

The Institutional Review Board and Protecting Human Subjects: 10 Frequently Asked Questions

2005 ◽  
Vol 15 (3) ◽  
pp. 291-295
Author(s):  
Sheldon Zink ◽  
Laura Kimberly ◽  
Stacey Wertlieb
Keyword(s):  
Human Subjects ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Research Subjects ◽  
Human Research ◽  
Institutional Review Board Approval ◽  
Institutional Review ◽  
Human Research Subjects ◽  
Review Boards

It is essential that anyone involved in research involving human subjects be familiar with the purpose and role of institutional review boards. Institutional review boards are designed, first and foremost, to protect human research subjects by overseeing the implementation of federal regulations regarding protection of human subjects. The federal government requires institutional review board approval for any human subject research that receives federal funding, and many scholarly journals require proof of institutional review board approval of the research before publication. In this article, the answers to 10 frequently asked questions about the role of institutional review boards highlight the important contributions made by institutional review boards to the conduct of ethically sound research. The aim is to generate a working knowledge of the institutional review board's function that can be used by every researcher contemplating working with human research subjects. This is the first in a series of 3 articles examining common issues in research ethics.

CONSENT: IN RESEARCH AND IN DAILY PRACTICE

PEDIATRICS ◽  
1989 ◽  
Vol 84 (5) ◽  
pp. A68-A68
Author(s):  
Student
Keyword(s):  
Informed Consent ◽  
Clinical Medicine ◽  
Daily Practice ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Utilization Review ◽  
Human Research ◽  
Consent Forms ◽  
Institutional Review ◽  
Board System

It is arguably the case that informed consent requirements have affected human research more deeply than they have the practice of clinical medicine, and that this is so at least in part because informed consent in research has been mandated and monitored by federal controls and regulations that link funding for research to consent procedures. However, it is doubtful that. . . adding review of consent forms to the tasks of utilization review committees would have the same level of impact on clinical medicine as the institutional review board system has had on human research. Institutional review boards are a system of prior, rather than after-the-fact, review they are concerned solely with questions of research ethics; and they are in a position to address questions of voluntariness and competency in a way utilization committees could not.

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.

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