Ethical Oversight, Consent, and Confidentiality

2014 ◽  
pp. 37-45
Author(s):  
Suzanne L. West ◽  
Wendy A. Visscher
Keyword(s):  
Ethical Oversight

scholarly journals Principles for the production and dissemination of recruitment material for three clinical trials of an online intervention

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Stefan Rennick-Egglestone
Keyword(s):  
Social Media ◽  
Clinical Trials ◽  
Health Research ◽  
Online Intervention ◽  
Ethics Committee ◽  
Promotional Material ◽  
Media Campaigns ◽  
Social Media Platforms ◽  
Ethical Oversight ◽  
Research Studies

AbstractSome health research studies recruit participants through electronic mechanisms such as the placement of messages on social media platforms. This raises questions for ethics committee oversight, since effective social media campaigns might involve the production and dissemination of hundreds of contemporaneous messages. For the Narrative Experiences Online (NEON) study, we have developed nine principles to control the production and dissemination of promotional material. These have been approved by an ethics committee and enable the audit of our recruitment work. We propose that the drafting for approval of recruitment principles by health research studies may, in many cases, strike an appropriate balance between enabling ethical oversight of online recruitment work and the potential burden of message review.

Ethical, Legal and Regulatory Issues of Paediatric Translational Research. Call for an Adequate Model of Governance

2020 ◽  
Vol 27 (3) ◽  
pp. 213-231
Author(s):  
Annagrazia Altavilla ◽  
Viviana Giannuzzi ◽  
Mariangela Lupo ◽  
Donato Bonifazi ◽  
Adriana Ceci
Keyword(s):  
Translational Research ◽  
Research Infrastructure ◽  
Paediatric Research ◽  
Adequate Model ◽  
Regulatory Issues ◽  
Societal Issues ◽  
Translational Approach ◽  
Legal Frameworks ◽  
Ethical Oversight ◽  
Paediatric Medicines

Abstract The lack of paediatric medicines, including innovative and advanced ones, is a long-lasting and well-known problem at European and international levels. Despite the existing legal frameworks and incentives, children remain deprived of many kinds of therapy because of challenges faced in appropriately study and tailoring medicinal and other products for them. In this context, the necessity to foster paediatric research addressing unsolved and uncovered issues within a ‘translational approach’ has appeared. This article, after having clarified the concept of translational research in the perspective of the establishment of a European paediatric research infrastructure (RI), will identify and point out ethical, legal and regulatory issues particularly relevant in a children’s rights perspective. It concludes asking for the setting up of an adequate model of governance within a future RI, including adequate and independent ethical oversight and a pluridisciplinary common service dealing with ethical, legal and societal issues relevant for children.

Responsible Science and Research Animal Use

ILAR Journal ◽  
2019 ◽  
Vol 60 (1) ◽  
pp. 1-4
Author(s):  
Patricia V Turner ◽  
R Wayne Barbee
Keyword(s):  
Animal Welfare ◽  
Animal Research ◽  
Animal Science ◽  
Scientific Excellence ◽  
Experimental Planning ◽  
Animal Use ◽  
Animal Care ◽  
Science And Research ◽  
Ethical Oversight ◽  
Animal Handlers

Abstract This issue of the ILAR Journal focuses on the topic of responsible science as it relates to animal research. We start with the concept of the scientist as a responsible citizen and then move through multiple phases of research including careful experimental planning, reporting, and incorporation of laboratory animal science. The work of the Institutional Animal Care and Use Committee (IACUC) or animal ethical/oversight body in reviewing both animal use and contributing to scientific excellence is explored. Additional topics include protection of animal handlers from multiple experimental hazards, use of agricultural animals and wildlife studies, regulatory ambiguities, and harmonization of animal research. Rounding out the issue is a discussion of how animal care and use programs can enhance animal welfare while mitigating regulatory burden, and our responsibility to clearly communicate the ethical use of animals in advancing biomedical research. A deeper understanding of these topics can assist scientists in simultaneously advancing their research and animal welfare.

Concepts of Risk in Nanomedicine Research

2012 ◽  
Vol 40 (4) ◽  
pp. 809-822 ◽  
Author(s):  
Linda F. Hogle
Keyword(s):  
New Technologies ◽  
Human Subjects ◽  
Medical Science ◽  
Ethical Concern ◽  
Mitigation Measures ◽  
Ethical Review ◽  
Benefit Analysis ◽  
The Common ◽  
Risk Benefit Analysis ◽  
Ethical Oversight

Risk is the most often cited reason for ethical concern about any medical science or technology, particularly those new technologies that are not yet well understood, or create unfamiliar conditions. In fact, while risk and risk-benefit analyses are but one aspect of ethical oversight, ethical review and risk assessment are sometimes taken to mean the same thing. This is not surprising, since both the Common Rule and Food and Drug Administration (FDA) foreground procedures for minimizing risk for human subjects and require local IRBs to engage in some sort of risk-benefit analysis in decisions to approve or deny proposed research. Existing ethical review and oversight practices are based on the presumption that risk can be clearly identified within the planned activities of the protocol, that metrics can reasonably accurately predict potential hazards, and that mitigation measures can be taken to deal with unintended, harmful, or catastrophic events.

Implications of the Revised Common Rule for Qualitative Health Research: Opportunities, Concerns, and Recommendations

2021 ◽  
pp. 104973232110611
Author(s):  
Jill Owczarzak ◽  
Katherine C. Smith
Keyword(s):  
Qualitative Research ◽  
Health Research ◽  
Behavioral Interventions ◽  
Behavioral Science ◽  
Human Subjects ◽  
Important Change ◽  
Research Subjects ◽  
Common Rule ◽  
Qualitative Health Research ◽  
Ethical Oversight

In January 2019, revisions to federal regulations that outline requirements for ethical oversight of human subjects research (The Revised Common Rule) went into effect. These revisions reflect major changes in thinking about risk and protection of research subjects. The Revised Common Rule (RCR) considerably curtails federal oversight of social and behavioral science, with most non-interventional research and “benign” behavioral interventions becoming exempt from mandated Institutional Review Board (IRB) approval, although determination of exemption remains with IRBs. As two qualitative health researchers serving on IRBs, we consider how this contraction of federal oversight dovetails with longstanding criticisms of IRB oversight of qualitative research. We explore the passage of the RCR as a point of potentially important change in procedure and principle in relation to ethical oversight of qualitative health research. We identify challenges and opportunities with these changes at the institutional, professional, and individual levels for ethical and impactful qualitative research.

The Research-Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight

2013 ◽  
Vol 43 (s1) ◽  
pp. S4-S15 ◽  
Author(s):  
Nancy E. Kass ◽  
Ruth R. Faden ◽  
Steven N. Goodman ◽  
Peter Pronovost ◽  
Sean Tunis ◽  
...  
Keyword(s):  
Ethical Oversight

scholarly journals Ethics: use and misuse of assisted reproductive techniques across species.

2021 ◽  
Author(s):  
Madeleine Campbell
Keyword(s):  
Veterinary Medicine ◽  
Scientific Evidence ◽  
Evidence Base ◽  
Fundamental Question ◽  
Current Evidence ◽  
Ethical Imperative ◽  
Personal Opinion ◽  
Reproductive Techniques ◽  
Lay Public ◽  
Ethical Oversight

The boundaries of what we are able to do using ARTs are fast moving. In both human and veterinary medicine this presents a fundamental question: ‘Just because we can, should we?’ Or, to rephrase the same question: ‘How can we distinguish between what is a use and a misuse of an ART, across species?’ This paper assesses the scientific evidence base for and against the use of ARTs, and offers a personal opinion on how we can use such evidence to inform an ethical distinction between justifiable and unjustifiable uses of the techniques. It is argued that the law provides a necessary but insufficient basis for such distinctions. Based in evidence about harms and benefits, ARTs may be classified into three groups: those which should be rarely used; those for which current evidence supports arguments both for and against their use; and those which there is an ethical imperative to use. Which category a particular ART falls into varies depending upon the species to which it is being applied and the reason we are using it. In order to ensure that our ethical oversight keeps up with our technical prowess, the medical and veterinary professions should keep discussing and debating the moral basis of the use of ARTs, not only with each other but also with the lay public.

Sign in / Sign up

Export Citation Format

Share Document