Ethical Review Process Research Articles

Protocol for a mixed-methods evaluation of a massive open online course on real world evidence

IntroductionIncreasing number of Massive Open Online Courses (MOOCs) are being used to train learners at scale in various healthcare-related skills. However, many challenges in course delivery require further understanding, for...

The Changing Research Data Landscape and the Experiences of Ethics Review Board Chairs: Implications for Library Practice and Partnerships

Academic libraries have to a large extent taken the lead in facilitating new approaches to research data management, but changes to the research data landscape have had an impact on numerous areas of academic work, including ethics review. Using interpretive phenomenological analysis of interviews with chairs of Canadian research ethics boards, this study explores how ethics review boards have experienced changes to data policy and related technologies in order to describe the ethical implications of new approaches to data management and to explore ways in which the library, ethics review boards, and other campus partners might harmonize efforts to support emerging data practices. While ethics review boards in Canada are keenly aware of open data policies, data publishing in practice is still nascent. There is uncertainty about the adoption of changing technologies for research and their impacts on privacy protection. Where responsibility lies for addressing these uncertainties is often unclear. Academic libraries and research ethics boards are well-suited to engage in mutual knowledge transfer and to integrate data management planning and ethics review processes. Institutional-level oversight that includes all campus departments impacted by changes to the research data landscape may facilitate improved communication and reduce role ambiguity.

Abstract 5554: Preclinical characterization of GSK532, a novel STING agonist with potent anti-tumor activity

Abstract The cGAS-STING pathway is the major cytosolic DNA sensing pathway to induce downstream innate immune responses against viral infection as well as tumorigenesis. Recently it has been demonstrated that cGAS-STING pathway takes central stage in the immune sensing of tumor. STING activation induces the production of type I interferons (IFNα and β) and pro-inflammatory cytokines that collectively stimulate tumor antigen cross presentation to CD8 T cells and primes the adaptive immune response against tumor. In order to evaluate the potential of STING agonism to activate the anti-tumor immune response, we developed GSK532, a novel cyclic dinucleotide (CDN). Unlike cGAMP, the endogenous CDN ligand for STING, GSK532 potently activates STING both in vitro and in vivo. In vitro functional assays demonstrated the ability of GSK532 to induce cytokine responses in a panel of human PBMC samples with various STING haplotypes. Furthermore, GSK532 was shown to activate STING orthologs from preclinical species including cyno, minipig, dog, rat and mice. GSK532 demonstrated high stability in human whole blood with minimal degradation observed over 52 hrs. When dosed intratumorally, GSK532 induced a strong anti-tumor effect in the CT26 murine syngeneic model in both the injected (primary) and uninjected (distal) tumors. The cured mice were resistant to rechallenge with same tumor cell line indicating the involvement of an adaptive immune response. Further evidence of the development of anti-tumor adaptive immune response comes from the observation that the efficacy of GSK532 was significantly attenuated when CD8+ T cells were depleted in the murine model. Consistent with the anti-tumor efficacy, pharmacokinetic analysis demonstrated high exposure and long retention of GSK532 in both injected and distal tumors and pharmacodynamic studies showed induction of IFNβ and several inflammatory cytokines (TNFα, IL-6, etc) in both tumors. Currently, GSK532 is being progressed towards clinical investigation. All studies were conducted in accordance with the GSK Policy on the Care, Welfare and Treatment of Laboratory Animals and were reviewed the Institutional Animal Care and Use Committee either at GSK or by the ethical review process at the institution where the work was performed. Citation Format: Jingsong Yang, Michael Adam, Jim Clemens, Katrina Creech, Jess Schneck, Kishore Pasikanti, Jean-Luc Tran, Devika Joglekar, Chris Hopson, Scott Pesiridis, Joshi Ramanjulu, Yiqian Lian, Jerry L. Adams, James Smothers, Axel Hoos. Preclinical characterization of GSK532, a novel STING agonist with potent anti-tumor activity [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 5554.

Research ethics review at University Eduardo Mondlane (UEM)/Maputo Central Hospital, Mozambique (2013\u20132016): a descriptive analysis of the start-up of a new research ethics committee (REC)

BackgroundMozambique has seen remarkable growth in biomedical research over the last decade. To meet a growing need, the National Committee for Bioethics in Health of Mozambique (CNBS) encouraged the development of ethical review processes at institutions that regularly conduct medical and social science research. In 2012, the Faculty of Medicine (FM) of University Eduardo Mondlane (UEM) and the Maputo Central Hospital (MCH) established a joint Institutional Committee on Bioethics for Health (CIBS FM & MCH). This study examines the experience of the first 4 years of the CIBS FM & MCH.MethodsThis study provides a descriptive, retrospective analysis of research protocols submitted to and approved by the CIBS FM & MCH between March 1, 2013 and December 31, 2016, together with an analysis of the Committee’s respective reviews and actions.ResultsA total of 356 protocols were submitted for review during the period under analysis, with 309 protocols approved. Sixty-four percent were submitted by students, faculty, and researchers from UEM, mainly related to Master’s degree research (42%). Descriptive cross-sectional studies were the most frequently reviewed research (61%). The majority were prospective (71%) and used quantitative methodologies (51%). The Departments of Internal Medicine at MCH and Community Health at the FM submitted the most protocols from their respective institutions, with 38 and 53% respectively. The CIBS’s average time to final approval for all protocols was 56 days, rising to 161 for the 40 protocols that required subsequent national-level review by the CNBS.ConclusionsOur results show that over its first 4 years, the CIBS FM & MCH has been successful in managing a constant demand for protocol review and that several broad quality improvement initiatives, such as investigator mentoring and an electronic protocol submission platform have improved efficiency in the review process and the overall quality of the protocols submitted. Beyond Maputo, long-term investments in training and ethical capacity building for CIBS across the country continue to be needed, as Mozambique develops greater capacity for research and makes progress toward improving the health of all its citizens.

Ethics of care in participatory health research: mutual responsibility in collaboration with co-researchers

In the field of participatory health research (PHR) and related action research paradigms, limitations of standard ethical codes and institutional review processes have been identified. PHR is highly situational and relational, part of a hierarchical health care context and therefore ethics of care has been suggested as a helpful theoretical approach that emphasises responsibilities and relationships. The purpose of this article is to explore the value of Tronto’s second-generation ethics of care for reflection on ethical challenges experienced by academic researchers. Using the design of a collaborative auto-ethnography, this article starts from a story of a researcher who deals with dilemmas in responsibility to care for co-researchers with lived experiences during a PHR study in the field of acute psychiatric care. By analysing the challenges together with all co-researchers, using a framework of ethics of care, we discovered the importance of self-care and existential safety for an ethical PHR practice. The reflexive meta-narrative shows that the ethics of care lens is useful to untangle moral dilemmas in all participatory research-related paradigms for all engaged.

Exploring the Gaps in Practical Ethical Guidance for Animal Welfare Considerations of Field Interventions and Innovations Targeting Dogs and Cats.

Simple SummaryLarge populations of domestic dogs and cats are found living, or in close association with humans. They are often targeted by field interventions or innovations to enhance their welfare or to reduce conflict with communities or wildlife. Ethical review is a cornerstone of responsible engagement that aims to promote animal and human wellbeing. For the review process to be robust, identifying and understanding the ethical dilemmas that may be encountered when working with dogs and cats in field contexts, together with their human communities and in multi-stakeholder partnerships would be advantageous. We explored existing guidance from other disciplines (regulated animal research, veterinary and human clinical trials, and research conducted on wildlife) and identified gaps in ethical frameworks that do not adequately address the specific and practical needs of nongovernmental or intergovernmental organizations, government agencies or independent researchers working with dogs and cats in field contexts. Navigating practical ethical concerns in complex, highly variable field contexts necessitates the development of additional resources that can better inform reliable ethical review processes, and subsequently enhance the humaneness and effectiveness of future interventions and innovations.Domestic dogs (Canis lupus familiaris) and cats (Felis silvestris catus) are common species targeted by nongovernmental or intergovernmental organizations, veterinarians and government agencies worldwide, for field interventions (e.g., population management, rabies vaccination programs) or innovations (e.g., development of technologies or pharmaceuticals to improve animal welfare). We have a moral responsibility to ensure that the conduct of this work is humane for dogs or cats, and to consider the human communities in which the animals live. Ethical review is widely accepted as being integral to responsible practice, and it is fundamental to good science that underpins innovation. Despite the necessity of field interventions or innovations to advance the welfare of individuals or populations of animals, we found a lack of specific guidance and review processes to help navigate ethical dilemmas surrounding the conduct of such work. This can be detrimental to the wellbeing of animals and their human communities. Here we identify the gaps in existing ethical frameworks (specifically application of Reduction and Refinement principles, challenges of obtaining meaningful informed consent with variations in the quality of human-animal relationships, and limited resources regarding considerations of local stakeholders), and outline the need for additional tools to promote ethical conduct in the field.

The Ethics of Student Participation in Economic Experiments: Arguments and Evidence

Ethics review boards scrutinise the recruitment of students as “over-researched” study participants. This challenges economists conducting standard university lab experiments. We discuss the potential ethical risks of economic experiments for student participants and identify potential design countermeasures to alleviate such concerns. We test these experimentally and find support for some (debriefings, informed consent procedures, educational relevance, non-teacher experimenters) but not others (opt-in, recruitment databases, private payment delivery, experiments outside class time and flat rewards). Moreover, there are gender differences in participants’ perceptions of the countermeasures. The paper is intended to inform experimental economists who want to (1) design experiments and protocols to reduce ethical risks without sacrificing scientific integrityand (2) develop arguments for their design choices in ethical review processes. We call for and inform an experimental economics ethics code to address the growing awareness and governance of experimental ethics issues.

Ethics, Epistemology and Ethnography: The Need for an Anthropological Debate on Ethical Review Processes in Germany

Abstract Over the last years, debates on research ethics – and the way the ethicality of ethnographic research is assessed by institutional boards and committees – have flourished in national and international anthropology. This article discusses the state of the debate in Germany where ethical review boards have remained so far largely absent in regard to anthropological research and where the commitment to ‘act ethically’ during fieldwork (and beyond) remains largely voluntary. By drawing on ethnographic fieldwork on HIV / AIDS and social relations in Tanzania, I highlight that medical anthropologists may face particular ethical challenges in their work, due to the often close relationship of their research with human suffering. Furthermore, however, I argue that the sub-discipline can raise important questions concerning the potential institutionalization of ethical review processes in anthropology in Germany and the pitfalls that should be avoided with regard to the ‘fetishization’ of certain ethical ...

Conducting research through cross national collaboration.

To explore the collaborative nature of an international research project with other advanced practice nurse researchers and critically analyse the process. Research within the nursing community is recognized internationally as important to ensure that nurses participate in cutting-edge health care and promote evidence-based practices, yet there is little detail found in literature on how a successful collaborative relationship is initiated and conducted in advanced practice research. Discussion paper: The purpose of this paper is to discuss the process of collaboration on a research study among advanced practice nurses from four countries who are members of an international organization. The collaborative process in international nursing research can be challenging and rewarding. It is important to remember that there is a relationship between the complexity of the study and the time required to complete it. Keys to success include following established guidelines. This project was a valuable experience in developing collaborative relationships as well as creating partnerships for future research to build on the knowledge gained. The authors' linkages to universities facilitated their participation in the research and completion of the ethical review processes. The use of social media and university resources was indispensable.

Expanding Ethics Review Processes to Include Community-Level Protections: A Case Study from Flint, Michigan.

As the Flint community endeavors to recover and move forward in the aftermath of the Flint water crisis, distrust of scientific and governmental authorities must be overcome. Future community engagement in research will require community-level protections ensuring that no further harm is done to the community. A community ethics review explores risks and benefits and complements institutional review board (IRB) review. Using the case of Flint, I describe how community-level ethical protections can reestablish a community's trust. All IRBs reviewing protocols that include risk to communities and not merely individual participants should consider how community members are engaged in the proposed research and identify and respond to questions and domains of concern from community members.

The new Health Research Authority framework: still work to do to facilitate high-quality public health research in English local authorities.

Will the new Health Research Authority (HRA) framework go far enough? Dr Emily Phipps, Professor Sian Griffiths of The Chinese University of Hong Kong, and Dr Mark Sheehan of the Nuffield Department of Population Health, Oxford University, consider the challenges facing the new HRA framework in addressing research into public health interventions on both an individual and a population level.IntroductionIn 2013, the public health functions of the National Health Service (NHS) in England moved to local government as part of reforms under the Health and Social Care Act 2012.[1] In this setting, the public health team commissions and manages a broad portfolio of programmes that aim to positively influence the local population's health and wellbeing, reduce inequalities and promote a healthy lifestyle.[2] The very nature of this work requires public health interventions to span the functions of health and politics, bringing together expertise from clinical, nursing, social care and local government backgrounds.Developing a robust evidence base for the delivery of public health interventions is key to ensuring that public health teams can provide the most effective and efficient service possible. Research governance processes regulate the design, implementation and dissemination of studies into public health interventions and are a legal requirement of health research conducted in England. However, there is currently significant variation in the quality and accessibility of research governance processes in local authorities in England to support the study of public health interventions.[1] In a recent nationwide study by Rainey et al.,[3] 35% of research governance leads listed on a national local authority database were no longer in post, and 25% of respondents from local authority public health and social care teams reported not having or not being aware of research governance arrangements in their local authority.Where such processes are available, a lack of familiarity with the relatively recently introduced public health functions to local authority can make it difficult for research projects to be assessed in a robust and appropriate manner. Research governance leads unfamiliar with governance issues pertinent to the study of public health interventions may be reluctant to pass review and approval. This risk may mean that projects are altered at the point of design to 'fit' the model most familiar to the research governance lead, rather than being of a methodology best suited to the hypothesis in question, in order to increase the likelihood of approval.Ethical review processes are a fundamental part of research governance, protecting the safety, dignity, rights and wellbeing of study participants. Researchers wishing to study public health interventions in local authorities rely on there being robust and appropriate ethical review services available in that organisation. As the nature of this research is unlikely to involve conventional methodology or typically medical interventions, local NHS research governance teams will likely not feel appropriately equipped to provide approval. In addition, academic research ethics committees often will not review the ethics of applications for research that is being conducted without university involvement, and vary widely in their approval processes and remit.[4] National guidance on the provision of research governance services, such as ethical review processes within local authority settings in England, may be one way to ensure standardised and appropriate services are available.In January 2015, the Health Research Authority (HRA) took over the responsibilities of the National Research Ethics Service and National Social Care Research Ethics Committee, so that all research involving health and social care in England is now governed by the same authority. The HRA are currently developing a high-level framework to guide the revision of local research governance policy which should recognise the changes to health and social care functions introduced in 2012. …

Improving the process of research ethics review

BackgroundResearch Ethics Boards, or Institutional Review Boards, protect the safety and welfare of human research participants. These bodies are responsible for providing an independent evaluation of proposed research studies, ultimately ensuring that the research does not proceed unless standards and regulations are met.Main bodyConcurrent with the growing volume of human participant research, the workload and responsibilities of Research Ethics Boards (REBs) have continued to increase. Dissatisfaction with the review process, particularly the time interval from submission to decision, is common within the research community, but there has been little systematic effort to examine REB processes that may contribute to inefficiencies. We offer a model illustrating REB workflow, stakeholders, and accountabilities.ConclusionBetter understanding of the components of the research ethics review will allow performance targets to be set, problems identified, and solutions developed, ultimately improving the process.

The Governance of Animal Care and Use for Scientific Purposes in Africa and the Middle East.

Animals are commonly used for scientific purposes in Africa and the Middle East. However, this field is often inadequately regulated, with many countries lacking national legislation, policies, or guidelines for the care and use of animals used for research, testing, or education. This results in an essentially uncontrolled system where scientific quality and animal wellbeing cannot robustly be guaranteed, which may hinder acceptance (i.e., publication) of results by the scientific community and limit public confidence. Though accepted international guidelines and best practice recommendations exist that could be adopted or adapted to meet local needs, the responsible conduct of research and animal welfare may not be prioritized in regions that are affected by instability, poverty, disease, or malnutrition. Some notable exceptions do, however, exist in individual countries or institutions where ethical review processes, oversight of animal health and welfare, the competence of personnel, and other scientific standards are appropriately regulated and implemented. These countries and institutions represent nodes of expertise that could act as platforms of support for surrounding regions in terms of the provision of education, training, and sharing of experience and resources. To make such regional capacity-strengthening efforts sustainable will require regional cooperation, the establishment of regional networks, harmonization of policies, pooled resources, and long-term investment in education, training, and infrastructure. An overarching system is needed to oversee the efficient promotion of scientific and ethical standards and the dissemination of information on laboratory animal science in Africa and the Middle East, while each country should remain able to maintain a system of oversight that reflects its own cultures, traditions, religions, laws, and regulations. This article provides an overview of the governance of the care and use of animals for scientific purposes in different regions of Africa and the Middle East as a foundation for coordinated future advancement.

Research Ethics in the Assessment of PhD Theses: Footprint or Footnote?

There is an expectation that all researchers will act ethically and responsibly in the conduct of research involving humans and animals. While research ethics is mentioned in quality indicators and codes of responsible researcher conduct, it appears to have little profile in doctoral assessment. There seems to be an implicit assumption that ethical competence has been achieved by the end of doctoral candidacy and that there is no need for candidates to report on the ethical dimensions of their study nor for examiners to assess this integral aspect of researcher development. In the context of ensuring that institutions are fulfilling their responsibility of producing ethically sensitive and competent researchers, it is salient to investigate whether doctoral thesis examiners make comment about ethical issues in their reports. This study analysed an archive of examiner reports to identify the frequency, magnitude and nature of examiner comment about ethics. Although comment was rare (5% of reports) examiners provided: prescriptive instruction on ethical review processes; formative instruction on the design, conduct, and reporting of research projects; and positive or negative judgments about a candidate's ethical competence, the latter often aligned with meeting, or not meeting, 'doctoral standards'. The scarcity of ethics in examination criteria and examiner reports implies a silence that needs to be addressed to ensure graduating candidates are prepared to conduct ethical and responsible research.

A framework for public involvement at the design stage of NHS health and social care research: time to develop ethically conscious standards

Plain English summaryResearchers who conduct studies in health and social care are encouraged to involve the public as early as possible in the process of designing their studies. Before their studies are allowed to start researchers must seek approval from a Research Ethics Committee, which will assess whether the study is going to be safe and ethical for patients or healthy volunteers to take part in. The process of ethical review does not consider how researchers work with patients and the public early on to design their studies. Furthermore, there is no requirement for researchers to seek ethical approval for public involvement. However, in our work advising researchers about public involvement we have found that the ways in which researchers involve the public in the design of their studies are sometimes unintentionally unethical, and this is the focus of our paper. We have observed ten areas where ethical issues may arise because of the actions researchers may or may not take and which might consequently have a negative impact. Therefore, we have used these observations to develop a “framework” to help researchers and the public work together at the early design stage in ways that are ethical. Our intention for the framework is to help researchers be mindful of these ten areas and how easily ethical issues can arise. The framework suggests some ways to overcome the potential issues in each of the ten areas. The ten areas are: 1) Allocating sufficient time for public involvement; 2) Avoiding tokenism; 3) Registering research design stage public involvement work with NHS Research & Development Trust Office at earliest opportunity; 4) Communicating clearly from the outset; 5) Entitling public contributors to stop their involvement for any unstated reasons; 6) Operating fairness of opportunity; 7) Differentiating qualitative research methods and public involvement activities; 8) Working sensitively; 9) Being conscious of confidentiality and 10) Valuing, acknowledging and rewarding public involvement.We looked to see whether any other similar approaches to helping researchers address potential ethical issues when working with the public on designing studies have been published and to our knowledge none exist. Our framework is presented as a draft and believe that it would now benefit from input from researchers and the public to gauge how useful it is and whether there are any other possible situations that it might need to cover.The current paper highlights real life examples of how ethical issues can arise during public involvement activities at the research design stage. We refer to “the research design stage” as the time between the generation of the research ideas and when formal permissions to start the work including ethical approval are granted. We argue that although most researchers work ethically at this early stage, some may still benefit from being informed about ethically conscious approaches to involving the public.The paper highlights 10 ethical issues that we have observed with involving the public at the research design stage. We provide examples of these observed scenarios to illustrate the issues and make suggestions for how they can be avoided to help researchers become more ethically conscious when involving the public at the research design stage. Currently the draft framework comprises: 1) Allocating sufficient time for public involvement; 2) Avoiding tokenism; 3) Registering research design stage public involvement work with NHS Research & Development Trust Office at earliest opportunity; 4) Communicating clearly from the outset; 5) Entitling public contributors to stop their involvement for any unstated reasons; 6) Operating fairness of opportunity; 7) Differentiating qualitative research methods and public involvement activities; 8) Working sensitively; 9) Being conscious of confidentiality and 10) Valuing, acknowledging and rewarding public involvement.The draft framework will help researchers to recognise the ethical issues when involving the public and is intended to be used voluntarily in a self-regulatory way. We believe that the draft framework requires further consultation and input from the wider research community and the public before endorsement by national UK bodies such as INVOLVE and the Health Research Authority (HRA).

Safe and Inclusive Research Practices for Qualitative Research Involving People with Dementia: A Review of Key Issues and Strategies.

Developing strategies to ensure the safe participation of people with dementia in research is critical to support their wider inclusion in research and to advance knowledge in the areas of dementia policy and practice. This literature review synthesizes and critically appraises different approaches to promote the safe participation of people with dementia in qualitative research. Two databases were searched for articles that discuss the methodological or ethical aspects of qualitative research involving people with dementia. We did not focus on informed consent or ethical review processes as these have been reviewed elsewhere. Key issues that impact participant safety include: language, gatekeepers, the research relationship, communication, dealing with distress, knowledge dissemination, and researcher skills. By synthesizing different approaches to safety and highlighting areas of debate, we hope to advance discussion and to contribute to the development of inclusive research methods.

Capacity for ethical and regulatory review of herbal trials in developing countries: a case study of Moringa oleifera research in HIV-infected patients

BackgroundLack of regulatory capacity limits the conduct of ethical and rigorous trials of herbal medicines in developing countries. Sharing ethical and regulatory experiences of successful herbal trials may accelerate the field while assuring human subjects protection. The methods and timelines for the ethical and regulatory review processes for the first drug regulatory authority approved herbal trial in Zimbabwe are described in this report.MethodsThe national drug regulatory authority and ethics committee were engaged for pre-submission discussions. Six applications were submitted. Application procedures and communications with the various regulatory and ethics review boards were reviewed. Key issues raised and timelines for communications were summarized.ResultsThere was no special framework for the approval of herbal trials. One local institutional review committee granted an exemption. Key issues raised for revision were around pre-clinical efficacy and safety data, standardization and quality assurance of the intervention as well as consenting procedures. Approval timelines ranged between eight and 72 weeks.ConclusionsIn the absence of a defined framework for review of herbal trials, approval processes can be delayed. Dialogue between researchers and regulators is important for successful and efficient protocol approval for herbal trials in developing countries.Trial registrationThe study was registered prospectively on August 3, 2011 with clinicaltrials.gov (NCT01410058).

IMPROVING THE EFFICIENCY OF AFRICAN RESEARCH ETHICS COMMITTEES AND STANDARDISING ETHICS REVIEW PROCESSES THROUGH AN AUTOMATED REVIEW PLATFORM

BackgroundThe sheer amount of research being conducted in Africa, the under-resourced research ethics committees (RECs), and the lack of modern review technologies has resulted in unprecedented review timelines – with...

Enhancing the Efficiency and Quality of African Research Ethics Review Processes – Through an Automated Review Platform

Background: The sheer amount of research being conducted in Africa, the under-resourced research ethics committees (RECs), and the lack of modern review technologies have resulted in unprecedented ethics review timelines. Method: The Research for Health Innovation Organiser (RHInnO Ethics), an automated review platform, facilitates and manages the entire ethics review process. In 2015, RHInnO Ethics was used by 25 RECs in 8 African countries. We evaluated its impact on efficiency, data security and cost using an online questionnaire administered to REC administrators in user countries. Results: The RECs interviewed were diverse with membership of 9-46 members; reviewing between 50–2000 protocols annually including observational, investigational new drugs and diagnostics. Reported areas of high impact (81%-100% of respondents) included improved: protocol submission and distribution process, quality of communication between RECs and researchers, standardized review process and data security. Reported areas of medium impact (60%-80% of respondents) included reduced; REC administrator’s workload and RECs’ administrative costs. Improved reviews of multicenter trials were reported by 2 years reported 57% reduction in review time while those who used RHInnO Ethics for ± 1 year, (80%) reported it is too early to tell. Conclusion: RHInnO Ethics has achieved high-impact on data security, submission process, communication, standardization and cost reduction. However, a long-term evaluation approach is needed to determine impact on review timelines. Integration of new M&E indicators on efficiency into the platform would improve RECs capacity to conduct long-term impact.

Participatory Research and the Medicalization of Research Ethics Processes

This article illustrates how medicalized epistemologies and methodologies significantly influence the institutional ethical review processes applied to sociolegal research in law schools. It argues this development has elevated particular renderings of mental distress and objectivity to universal definitions, potentially placing a straitjacket on methodological innovation. The authors use two case studies from their experiences as researchers in a UK Law School, alongside a small-scale survey of sociolegal researchers in other UK law schools, to illustrate the problems that can arise in securing ethical approval for sociolegal research, in particular with participatory research designs that mobilize ideas of mental distress and objectivity not premised on conventional medical understandings. The article develops key proposals that the authors feel merit further inquiry. First, there should be a comprehensive evaluation of how the jurisdiction of ethical review for sociolegal research is established. Second, sociolegal scholarship can contribute to debates concerning the discursive, material and procedural constitution of institutional ethics approval processes. Finally, we might rethink the nature of, and relationship between, university-based research ethics committees and National Health Service research ethics committees, by placing both within wider ecologies of capacities for ethical decision-making.