Rethinking Risk in Pediatric Research

2008 ◽  
Vol 36 (3) ◽  
pp. 567-576 ◽  
Author(s):  
Kathleen Cranley Glass ◽  
Ariella Binik
Keyword(s):  
Institutional Review Boards ◽  
Personal Perspective ◽  
Decision Making Process ◽  
Phase I Trials ◽  
Autonomous Choice ◽  
Research Participants ◽  
Risks And Benefits ◽  
Institutional Review ◽  
Safety And Toxicity ◽  
Toxicity Of Drugs

Many activities concerning the unknown involve the potential for risk, and clinical research is no exception. Some research participants experience correlative benefit; others do not. When the participants are adults, as in Phase I trials with healthy volunteers, we rely on a highly individualistic decision-making process based on autonomous choice. This assumes that the ability to make voluntary, competent, informed choices, evaluating the risks and benefits from a personal perspective, offers the best protection for research participants. Rightly or wrongly, we depend heavily on informed consent for protection. We have further refined our post-Nuremberg ethical principles by requiring that safety and toxicity of drugs and devices be first assessed on the least vulnerable. In addition, we assume Institutional Review Boards (IRBs) will screen out protocols involving an inappropriate level of risk.

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.”

Making Risk-Benefit Assessments of Medical Research Protocols

2004 ◽  
Vol 32 (2) ◽  
pp. 338-348 ◽  
Author(s):  
Alex Rajczi
Keyword(s):  
Medical Research ◽  
Institutional Review Boards ◽  
Federal Regulations ◽  
Standard Account ◽  
Risks And Benefits ◽  
Research Protocols ◽  
Institutional Review ◽  
Medical Experiments ◽  
Expected Benefits ◽  
Medical Research Ethics

Most medical experiments are reviewed by groups known as Institutional Review Boards (IRBs); according to every standard account of medical research ethics, an IRB should not approve an experiment unless it has an acceptable combination of risks and benefits. This requirement is often stated in different terms. Some codes say that an experiments benefits to individuals and society must outweigh its risks. Others say that the experiment must have a favorable risk-benefit ratio. The Code of Federal Regulations says that risks must be reasonable in relation to the expected benefits.However, even though everyone agrees that an experiment must have an acceptable combination of risks and benefits, almost nothing has been said about what it would mean to weigh risks against benefits, compute risk-benefit ratios, or figure out if an experiments risks are reasonable.

“I Wouldn’t Trust the Parents To ‘Do No Harm’ To a Queer Kid”: Rethinking Parental Permission Requirements for Youth Participation in Social Science Research

2020 ◽  
pp. 155626462098313
Author(s):  
Jennifer Patrice Sims ◽  
Cassandra Nolen
Keyword(s):  
Social Science Research ◽  
Science Research ◽  
The United States ◽  
Institutional Review Boards ◽  
Parental Consent ◽  
Lgbtq Youth ◽  
Standard Requirement ◽  
Research Participants ◽  
Institutional Review ◽  
Youth Research

Obtaining parental consent for youth to participate in research is a standard requirement in the United States. However, the assumption that involving parents is the best way to protect youth research participants is untenable for some populations. This study draws on interviews with 19 LGBTQ+ mixed-race participants to examine lay views of parental consent requirements for LGBTQ+ youth research participants. Qualitative data analysis found concerns about potentially outing LGBTQ+ youth to intolerant parents. Interviewees also asserted that adolescents aged 16 and older are competent enough and should have the autonomy to consent themselves. Finally, interviewees raised several methodological concerns regarding the biased research that may result from parental consent requirements. We agree with others that U.S. Institutional Review Boards should end uncritical requirements for parental consent for older adolescents and should routinize the use and study of alternative protective measures.

scholarly journals What do you mean by ‘informed consent’? Ethics in economic development research

2020 ◽  
Author(s):  
Anna Josephson ◽  
Melinda Smale
Keyword(s):  
Developing Countries ◽  
Economic Development ◽  
Informed Consent ◽  
Low Income ◽  
Institutional Review Boards ◽  
Voluntary Participation ◽  
Ethical Standards ◽  
Development Research ◽  
Research Participants ◽  
Institutional Review

The ethical conduct of research requires the informed consent and voluntary participation of research participants. Institutional Review Boards (IRBs) work to ensure that these ethical standards are met. However, incongruities in perspective and practice exist across regions. In this paper, we focus on informed consent as practiced by agricultural and applied economists, with emphasis on research conducted in low income and/or developing countries. IRB regulations are clear but heterogeneous, emphasizing process, rather than outcome. The lack of IRBs and institutional reviews in some contexts and the particulars of the principles employed in others may fail to adequately protect research participants.

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.

scholarly journals A proposal and prototype for a Research Risk Repository to improve the protection of research participants

2011 ◽  
Vol 8 (6) ◽  
pp. 705-715 ◽  
Author(s):  
Annette Rid ◽  
David Wendler
Keyword(s):  
Empirical Data ◽  
Current Practice ◽  
Institutional Review Boards ◽  
Important Research ◽  
Limited Extent ◽  
Research Participants ◽  
Research Risks ◽  
Institutional Review ◽  
Vital Resource ◽  
Systematic Collection

Background Accurate and consistent risk assessment is vital for the protection of research participants. Yet, current evaluation of the risks of research interventions often does not take into account the relevant empirical data. This approach raises concern that current practice may not be protecting research participants adequately, or that it may be thwarting acceptable research. Purpose To propose and evaluate the possibility of creating and maintaining a Research Risk Repository which would make empirical data on the risks of research interventions available to institutional review boards, investigators, funders, and others. Methods Analysis of the usefulness of a Research Risk Repository and evaluation of whether currently available empirical data are sufficient to establish such a repository. Results Creation of a Research Risk Repository would provide a vital resource for systematically and accurately evaluating the risks of biomedical research. Realizing this goal requires data that have at least 4 characteristics: (1) trustworthy: to ensure credibility to all stakeholders; (2) robust: to support confident risk determinations; (3) inclusive: to cover all potential harms of the interventions under review; and (4) comprehensive: to determine which factors influence the risks of the interventions under review. Evaluation of existing data reveals that they satisfy these requirements for only a few research interventions and, even in those cases, only to a limited extent. Gaps in the currently available evidence highlight the need for systematic collection and maintenance of data on the risks posed by research interventions. Limitations Creation and maintenance of a Research Risk Repository would be costly and require regular updating as new data are collected, and new practices and interventions emerge. Conclusions A Research Risk Repository has the potential to significantly improve the consistency and accuracy of the evaluation of research risks. However, currently available data are generally insufficient for this purpose. Future collection and maintenance of data on the risks posed by research interventions will help to ensure that research participants receive appropriate protection and promote important research consistent with adequate subject protection.

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