Uneasy Relations: Crime Ethnographies and Research Ethics

This chapter accentuates some of the reasons why crime ethnographies can face difficulties with the ethics review process, including prominent issues relating to informed consent, risk and harm, anonymity, and criminal behavior. Universities in most Western countries have established research ethics boards over the past twenty years responsible for assessing the ethical conduct of research. Qualitative research can fit poorly into the largely positivist ethics framework, resulting in an often-frustrating situation for ethnographers seeking to move ahead with their research. One paradox of this situation is that the ethics process itself seems poised to give rise to a subset of academic deviants in the form of crime ethnographers who may find that they are obliged to circumvent or disregard some formal ethical strictures in order to engage in ethnographic practices that otherwise seem uncontroversial or even innocuous.

Pragmatics of Crime Ethnographies

This chapter lays out some of the “how to” of crime ethnographies, from its early planning stages to securing funding and institutional approval, going through ethics review, and arriving at the field site. It also provides an overview of the difficulties establishing and maintaining a presence in different criminological field sites, the ethical dilemmas involved in carrying out a crime ethnography, and questions about positionality that researchers have to contemplate. It further provides an insight into how ethnographic knowledge is produced in practice, from writing field notes to questions about if, when, and how to record to analyzing data and discusses questions of staying safe and when to leave the field.

International Coordination of Research Ethics Review: An Adequacy Model

International direct-to-participant (DTP) genomics research involves the use of mobile technology to recruit, consent, and study participants remotely. This model can facilitate research across broad geographies and many countries, but must also comply with the norms of multiple recruitment jurisdictions, with each jurisdiction typically requiring at least one local research ethics review. Each additional research ethics review increases bureaucratic hurdles without necessarily strengthening the protection of participants’ rights and interests. For DTP genomic research, obtaining a review may in fact be impossible in the absence of a local research partner. This paper proposes an “adequacy” approach, inspired by data protection law, to coordinate the regulation and oversight of international DTP genomics research. This involves one country voluntarily assessing whether another country’s research ethics reviews are equivalent to its own, in terms of objectives and effectiveness. Ethics-approved projects led by researchers from countries recognized as adequate are deemed to comply with local norms, eliminating the need for a duplicative local review. Adequacy preserves the sovereignty of countries to determine their own regulatory aims and which other countries to trust. It therefore provides a voluntary, incremental path towards greater global coordination of health research oversight.

Governance frameworks for COVID-19 research ethics review and oversight in Latin America: an exploratory study

Background Research has been an essential part of the COVID-19 pandemic response, including in Latin American (LA) countries. However, implementing research in emergency settings poses the challenge of producing valuable knowledge rapidly while upholding research ethical standards. Research ethics committees (RECs) therefore must conduct timely and rigorous ethics reviews and oversight of COVID-19 research. In the LA region, there is limited knowledge on how countries have responded to this need. To address this gap, the objective of our project is to explore if LA countries developed policies to streamline ethics review and oversight of research in response to the pandemic while ensuring its adherence to ethical standards, and to analyze to what extent these governance frameworks are in accordance with international guidance. Methods We conducted a descriptive and exploratory study assessing the COVID-19 research ethics governance frameworks of 19 LA countries, considering 4 dimensions based on international COVID-19 ethics guidance documents: (i) ethics review organizational model adopted, (ii) measures to coordinate between RECs and other research stakeholders, (iii) operational guidance for RECs, and (iv) key ethical issues for review and oversight of COVID-19 research. Results 10 out of 19 LA countries have some policy to streamline ethics review of COVID-19 research. Of these countries only 6 issued comprehensive documents following international guidance that contemplate strategies with recommendations for concrete actions for a timely and rigorous review. Conclusion LA countries adopted partial strategies and operational guidance that may demonstrate a lack of a comprehensive view of research ethics for the review and oversight of COVID-19 research. Continuing efforts should be directed to strengthen LA countries' research capacity to respond timely and ethically to future health emergencies. Past lessons and the ones from this pandemic should be the basis to develop international standards and operational guidelines for ethics review and oversight of any research for public health emergencies.

“An Official Conscience and Warranting Agency”: Institutional Isomorphism and the Rise of Dutch Ethics Review in the 1970s and 1980s

Why did medical research involving human subjects, a practice that is arguably as old as medicine itself, come to be regulated by research ethics committees in the late twentieth century? In this essay, I answer this question for the Netherlands, by querying the rise of ethics review in the 1970s and 1980s through the lens of “institutional isomorphism”. Drawing on the classic work of Paul Dimaggio and Walter Powell, I argue that extra-national changes to funding and publishing requirements in this period were identifiably more important for the emergence of ethics review in the Netherlands than were ethical concerns for research misconduct – a process that was marked by definitive elements of internationally coercive, and perhaps also of mimetic isomorphism. In addition, I detail how, as a consequence of these developments, those involved in Dutch ethics review came to consider “variation and inconsistency” as one of the system’s biggest problems in the late 1980s. To remedy this, numerous normative isomorphic attempts were undertaken in the late twentieth century to make all Dutch research ethics committees act in the same way. This emphasis on institutional homogeneity has been borne out in the Netherlands, even though it has repeatedly been criticized for hampering democratic and ethical decision-making.

Use of home parenteral nutrition in severely neurologically impaired children

ObjectiveTo review the outcome of children with severe neurological impairment (NI) and intestinal failure (IF) referred to our specialist multidisciplinary IF rehabilitation service and to discuss implications.DesignCase report series, descriptive analysis.SettingIF rehabilitation programme at a tertiary children’s hospital in the UK.PatientsChildren with severe NI referred to our IF rehabilitation programme from 2009 to 2019.Main outcome measuresDemographic and social data, diagnosis, clinical condition, use of home parenteral nutrition (HPN), complications, ethics review outcome and advance care plans.ResultsSix patients with severe NI were referred to our IF rehabilitation service. Consent for publication was obtained from five families. After thorough medical review and clinical ethics committee assessment, three children started HPN, one had intravenous fluids in addition to enteral feed as tolerated and one intravenous fluids only. The HPN children survived 3–7.08 years (median 4.42 years) on treatment. Objective gastrointestinal signs, for example, bleeding improved without excessive HPN-related complications. Symptomatic improvement was less clear. Analgesia was reduced in three of the five children. All cases had detailed symptom management and advance care plans regularly updated.ConclusionsHPN can play a role in relieving gastrointestinal signs/symptoms in children with severe NI and IF. HPN can be conceptualised as part of good palliative care if judged to be in the child’s best interests. However, given its risks and that HPN has the potential to become inappropriately life-sustaining, a thorough ethics review and evaluation should be performed before it is initiated, withheld or withdrawn in children with severe NI.

Ethics issues identified by applicants and ethics experts in Horizon 2020 grant proposals

Background: We assessed the ethics review of proposals selected for funding under the Marie Skłodowska-Curie Actions (MSCA) and the European Research Council (ERC) in Horizon 2020, EU’s framework programme for research and innovation, 2014-2020. Methods: We analysed anonymized datasets for 3,054 MSCA individual fellowships (IF), 417 MSCA Innovative Training Networks (ITN), and 1,465 ERC main-listed proposals with ethics conditional clearance, over four years (2016 to 2019). The datasets included the information on ethics issues identified by applicants in their proposal and ethics issues and requirements identified by ethics experts during the ethics review. Results: 42% of proposals received ethical clearance. For proposals with conditional ethics clearance (n=3546), most of the identified ethics issues by both applicants and ethics experts were in the ethics categories related to humans; protection of personal data; environment, health and safety; and non-EU countries. Ethics experts identified twice as many ethics issues compared to applicants across funding schemes, years, and from high- and low-research performing countries. ERC grants had the highest number of ethics requirements per proposal (median (Md)=8, interquartile range (IQR=4-14), compared to ITN (Md=6, IQR=3-13) and IF grants (Md=3, IQR=2-6). The majority of requirements had to be fulfilled after grant agreement: 99.4% for IF, 99.5% for ITN, and 26.0% for ERC. For 9% of the proposals, the requirements included the appointment of an independent ethics advisor and 1% of the proposals had to appoint an ethics advisory board. Conclusions: Many applicants for highly competitive H2020 funding schemes lack awareness of ethics issues raised by their proposed research. There is a need for better training of researchers at all career stages about ethics issues in research, more support to researchers from research organizations to follow the funding agencies requirements, as well as further development and harmonization of the ethics appraisal process during grant assessment.

Guiding Ethics Review in Pharmacy Education Research and Scholarship at UBC: Clarifying the Unclear

While it goes without saying that ethically sound practices are imperative for high-quality educational scholarship, institutional ethics guidance is often unclear about how to treat educational scholarship generally, and quality improvement/assurance studies and the scholarship of teaching and learning, specifically. Amongst health profession education researchers, including those in pharmacy, this lack of clarity has led to confusion regarding existing ethics governance and ambivalence regarding ethics requirements. Drawing on the experiences of one pharmacy school in western Canada, this commentary describes an ethics vetting guide developed explicitly to address current uncertainty about ethics requirements for pharmacy education scholarship. Clarifying the problem, describing the guide, and exploring what was learned along the way provide a basis for re-centering ethics in the development of scholarly projects and decision-making regarding formal ethics review. The importance of instilling ethical intelligence, delineating research from quality improvement/assurance work, and addressing current gaps in ethics oversight and governance of educational scholarship are among key lessons learned during guide development along with suggestions for new institutional ethics guidance directly targeting educational scholarship to supplement current national guidelines.