“A Cohort of Pirate Ships”: Biomedical Citizen Scientists’ Attitudes Toward Ethical Oversight

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.

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

European Journal of Health Law ◽

10.1163/15718093-bja10010 ◽

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.

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Responsible Science and Research Animal Use

ILAR Journal ◽

10.1093/ilar/ilz020 ◽

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.

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Concepts of Risk in Nanomedicine Research

The Journal of Law Medicine & Ethics ◽

10.1111/j.1748-720x.2012.00709.x ◽

2012 ◽

Vol 40 (4) ◽

pp. 809-822 ◽

Cited By ~ 5

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.

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

Qualitative Health Research ◽

10.1177/10497323211061101 ◽

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.

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