Children as Research Subjects: A Dilemma

2000 ◽  
Vol 25 (6) ◽  
pp. 745-764 ◽  
Author(s):  
Loretta M. Kopelman
Keyword(s):  
Medical Science ◽  
Ethics Committees ◽  
Complex Problem ◽  
Best Interests ◽  
Institutional Review Boards ◽  
Minimal Risk ◽  
Research Subjects ◽  
Nuremberg Code ◽  
Research Guidelines ◽  
Institutional Review

ABSTRACT A complex problem exists about how to promote the best interests of children as a group through research while protecting the rights and welfare of individual research subjects. The Nuremberg Code forbids studies without consent, eliminating most children as subjects, and the Declaration of Helsinki disallows non-therapeutic research on non-consenting subjects. Both codes are unreasonably restrictive. Another approach is represented by the Council for the International Organizations of Medical Science, the U.S. Federal Research Guidelines, and many other national policies. They allow research ethics committees or institutional review boards to authorize studies with acceptable balances of likely benefits and harms, but neither clarify how to balance them nor explain the meaning of pivotal concepts, like “minimal risk.” Paths to the improvement of balancing or consequentialist approaches include (1) improving standardizing of risk assessment, (2) rejecting crude utilitarianism, (3) identifying and justifying normative or moral judg-ments, and (4) acknowledging extra-regulatory thresholds and deontological or non-negotiable duties to children.

Ethical Issues in Prehospital Research

1993 ◽  
Vol 8 (S1) ◽  
pp. S11-S14 ◽  
Author(s):  
Eric A. Davis ◽  
Ronald F. Maio
Keyword(s):  
World War Ii ◽  
Medical Research ◽  
Ethical Issues ◽  
Human Subjects ◽  
Medical Science ◽  
Institutional Review Boards ◽  
Research Subjects ◽  
Institutional Review ◽  
Protection Of Human Subjects ◽  
The Individual

The atrocities committed by Nazi physicians and scientists, in the name of furthering medical science, is an appalling page of the history of medical research. In the wake of World War II, the scientific community strived to develop regulations to guard against future abuses in medical research. However, a particularly sobering thought is that the atrocities in Germany were being carried out in a country that had specific regulations for protecting human research subjects: Nazi Germany was the only European country to have such regulations. A more in-depth look at these regulations reveals institutional or department heads were held accountable, but not the individual researcher. The lesson from this analysis is clear: individual investigators must bear the responsibility of conducting ethical research. Governmental regulations and Institutional Review Boards never can replace investigators who are advocates for the protection of human subjects.The purpose of this paper is to address issues broadly regarding ethics and prehospital research, with a focus on the topic of informed consent.

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.

IRB Creep: Federal Regulations Protecting Human Research Subjects and Increasing Instructors' Responsibilities

2009 ◽  
Vol 24 (1) ◽  
pp. 31-43 ◽  
Author(s):  
Diane A. Riordan ◽  
Michael P. Riordan
Keyword(s):  
Review Process ◽  
Human Subjects ◽  
Institutional Review Boards ◽  
Federal Regulations ◽  
Federally Funded ◽  
Research Subjects ◽  
Accounting Faculty ◽  
Institutional Review ◽  
Human Research Subjects ◽  
Review Boards

ABSTRACT: Federal regulations require oversight of federally sponsored research involving human subjects. Universities have responded by forming Institutional Review Boards (IRBs). Although these regulations only apply to federally funded projects, universities have extended the oversight to include all projects involving human subjects. From our own experience, we observe that not all accounting faculty are aware of their responsibilities to their local boards. The sanctions for failing to follow required procedures depend on the infraction, and range from an order to cease work on the project to termination of university service for the faculty member and expulsion for the student. This report helps accounting faculty understand how the review process may affect their role as instructors and serves as encouragement to them to become familiar with the requirements of local review boards.

scholarly journals Perinatal Outcomes of Subjects Enrolled in a Multicenter Trial with a Waiver of Antenatal Consent

2020 ◽  
Author(s):  
Anup C. Katheria ◽  
Phillip Allman ◽  
Jeff M. Szychowski ◽  
Jochen Essers ◽  
Waldemar A. Carlo ◽  
...  
Keyword(s):  
Perinatal Outcomes ◽  
Multicenter Trial ◽  
Institutional Review Boards ◽  
Positive Pressure ◽  
Minimal Risk ◽  
Delayed Cord Clamping ◽  
Clinical Trial Registration ◽  
Institutional Review ◽  
Cord Clamping ◽  
Waiver Of Consent

Objective This study aimed to determine whether outcomes differed between infants enrolled in the PREMOD2 trial and those otherwise eligible but not enrolled, and whether the use of waiver effected these differences. Study Design The multicenter PREMOD2 (PREmature infants receiving Milking Or Delayed cord clamping) trial was approved for waiver of antenatal consent by six of the nine sites institutional review boards, while three sites exclusively used antenatal consent. Every randomized subject delivered at a site with a waiver of consent was approached for postnatal consent to allow for data collection. Four of those six sites’ IRBs required the study team to attempt antenatal consent when possible. Three sites exclusively used antenatal consent. Results Enrolled subjects had higher Apgar scores, less use of positive pressure ventilation, a lower rate of bronchopulmonary dysplasia, and a less frequent occurrence of the combined outcome of severe intraventricular hemorrhage or death. A significantly greater number of infants were enrolled at sites with an option of waiver of consent (66 vs. 26%, risk ratio = 2.54, p < 0.001). At sites with an option of either approaching families before delivery or after delivery with a waiver of antenatal consent, those approached prior to delivery refused consent 40% (range 15–74% across six sites) of the time. Conclusion PREMOD2 trial demonstrated analytical validity limitations because of the variable mix of antenatal consent and waiver of consent. A waiver of antenatal consent for minimal risk interventional trials conducted during the intrapartum period will be more successful in enrolling a representative sample of low and high-risk infants if investigators are able to enroll all eligible subjects. Clinical Trial Registration ClinicalTrials.gov identifier: NCT03019367. Key Points

Experimentation on Human Subjects

2017 ◽  
Author(s):  
Robert M. Veatch ◽  
Amy Haddad ◽  
E. J. Last
Keyword(s):  
Ethical Issues ◽  
Human Subjects ◽  
Medical Science ◽  
Nuremberg Code ◽  
Subject Selection ◽  
Research Guidelines ◽  
Voluntary Consent ◽  
Nuremberg Trials ◽  
Privacy And Confidentiality ◽  
International Document

This chapter examines ethical issues in research involving human subjects. The Nuremberg trials, which exposed to all humankind the outrageous things that could be done in the name of medical science, led to the Nuremberg Code, the first international document from public sources setting out an ethic for research on human subjects. Basic differences are outlined between the goals of therapy for the good of a patient and those of research that focus on attainment of knowledge and the good of society. To protect the interests of human subjects who take part in research, guidelines such as the Declaration of Helsinki have been established for assessing risks and benefits, voluntary consent, protection of privacy and confidentiality, and equity in subject selection. The chapter focuses on the difficulty in calculating harms and benefits to subjects and challenges of obtaining informed consent for participation in research.

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.

Educational Research and the Protection of Human Subjects

1977 ◽  
Vol 2 (2) ◽  
pp. 477-519 ◽  
Author(s):  
Benjamin S. DuVal
Keyword(s):  
Educational Research ◽  
Human Subjects ◽  
Institutional Review Boards ◽  
Research Subjects ◽  
Institutional Review ◽  
Legal Restrictions ◽  
Research On Human Subjects ◽  
Protection Of Human Subjects ◽  
Judicial Recognition ◽  
Review Boards

Educational research is increasingly subject to legal restrictions designed for the protection of human subjects of research. In this article the author discusses legal restrictions–both in the courts and under HEW regulations–on educational research, comparing these restrictions with those on biomedical research. He finds that although educational research in particular instances may give rise to suits for damages for invasion of privacy or intentional infliction of psychological distress, the legal issues relating to educational research will most often be resolved in proceedings before institutional review boards charged by HEW with the responsibility for passing upon proposals to conduct research on human subjects. He argues that the interests protected in proceedings before institutional review boards are not limited to those that have received judicial recognition in suits for damages. The author finds that the requirement that the informed consent of subjects be obtained presents difficult issues for educational research. He notes in particular the problems presented by research proposals that as an element of the research design contemplate the observation of subjects without their knowledge and the use of children as research subjects.

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