The Ethics of Innovation: Ethical Decision-Making and Review for Field Studies and Projects Targeting Dogs and Cats

To date, independent ethical oversight of many companion animal welfare initiatives has been limited and, in some instances, inadequate. Beyond a blurred line between “innovation” and “research,” the nature of the work conducted in animal welfare projects is often poorly aligned with established institutional ethical review structures, which are designed for research involving humans or research involving animals and are also focused on industry and academic institutions. This commentary details the struggle of one United States-based nonprofit organization to find ethical guidelines and support for conducting non-traditional field-based animal welfare studies, and subsequent experience establishing an Ethical Review Board to evaluate organizational initiatives. The commentary discusses member selection, materials and processes, and lessons and learnings from the creation and use of an Ethical Review Board. Sharing content of the ethical review process, as well as challenges and learnings from it, is intended to support other organizations and individuals seeking to ensure that innovation for animal welfare consistently meets high ethical standards.

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

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.

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

Some 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.

Perceptions of laboratory animal facility managers regarding institutional transparency

Institutions that conduct animal research are often obliged to release some information under various legal or regulatory frameworks. However, within an institution, perspectives on sharing information with the broader public are not well documented. Inside animal facilities, managers exist at the interface between the people who conduct animal research and those charged with providing care for those animals. Their perception of transparency may influence their interpretation of the institutional culture of transparency and may also influence others who use these facilities. The objective of our study was to describe perceptions of transparency among animal research facility managers (all working within the same ethical oversight program), and how these perceptions influenced their experiences. Semi-structured, open-ended interviews were used to describe perceptions and experiences of 12 facility managers relating to animal research transparency. Four themes emerged from the participant interviews: 1) communication strategies, 2) impact on participant, 3) expectations of transparency, and 4) institutional policies. Similarities and differences regarding perceptions of transparency existed among participants, with notable differences between participants working at university versus hospital campuses. These results illustrate differences in perceptions of transparency within one institutional animal care and use program. We conclude that institutions, regulators and the public should not assume a uniform interpretation of a culture of transparency among managers, and that sustained communication efforts are required to support managers and to allow them to develop shared perspectives.

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

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.

Ethics review of big data research: What should stay and what should be reformed?

Background Ethics review is the process of assessing the ethics of research involving humans. The Ethics Review Committee (ERC) is the key oversight mechanism designated to ensure ethics review. Whether or not this governance mechanism is still fit for purpose in the data-driven research context remains a debated issue among research ethics experts. Main text In this article, we seek to address this issue in a twofold manner. First, we review the strengths and weaknesses of ERCs in ensuring ethical oversight. Second, we map these strengths and weaknesses onto specific challenges raised by big data research. We distinguish two categories of potential weakness. The first category concerns persistent weaknesses, i.e., those which are not specific to big data research, but may be exacerbated by it. The second category concerns novel weaknesses, i.e., those which are created by and inherent to big data projects. Within this second category, we further distinguish between purview weaknesses related to the ERC’s scope (e.g., how big data projects may evade ERC review) and functional weaknesses, related to the ERC’s way of operating. Based on this analysis, we propose reforms aimed at improving the oversight capacity of ERCs in the era of big data science. Conclusions We believe the oversight mechanism could benefit from these reforms because they will help to overcome data-intensive research challenges and consequently benefit research at large.

ETHICAL ISSUES IN CLINICAL TRIALS: A REVIEW OF THE RECENT LITERATURE, AN ETHICAL ARGUMENTATION

Purpose: To identify ethical issues and risks involved in clinical trials and develop a conceptual model of identified issues in patient safety in clinical trials. Methodology: The review comprises of qualitative meta-analysis of available literature to identify potential ethical issues involved in the field of clinical trials. Findings: Our review identifies gaps in following core areas: 1) Research vs. Practice; 2) Inform Consent; 3) Ethical Oversight. Existing literature shows gaps in the true definition of research and does not clarify points of difference to clinical care. Existing guidelines are still confusing about the requirement of inform consent, in which cases it is mandatory and in which cases it should be waived off. There are indiscripencies, how much information should be provided in the inform consent disclosure. Is ethical oversight required in all research studies and if so at what level. We will build a streamline ethical argumentation to identify gaps in the existing literature, evaluate existing guidelines, analyze the contents to reach a conclusion and put forward recommendations for quality improvement. Conclusions: For the definition of research and its difference with clinical practice, decision should be taken in the best interest of the patient whether it is patient care or it is research.For ethical overview oversight, we suggest concept of proportionate review. Inform consent should be seeked in all researches but if becomes a barrier in patient care then waiver should be granted for the well-being of the patient. All information should be disclosed to the research participants so that they make an informed decision for their participation.