Research Ethics Regulations Research Articles

Ethics Governance Outside the Box: Reimagining Blockchain as a Policy Tool to Facilitate Single Ethics Review and Data Sharing for the 'omics' Sciences

Clinical research and health information data sharing are but ripples in a growing wave of reimagined applications of distributed ledger technologies beyond the digital marketplace for which they were originally created. This paper explores the use of distributed ledger technologies to facilitate single institutional ethics review of multi-site, collaborative studies in the dataintensive sciences such as genetics and genomics. Immutable record-keeping, automatable protocol amendments and direct connectivity between stakeholders in the research enterprise (e.g., researchers, research ethics committees, institutions, funders and regulators) comprise several of the conceptual and technological advantages of distributed ledger technologies to research ethics review. This novel-use proposal dovetails recent policy reforms to research ethics review across North America that mandate a single ethics review for any study that takes place across more than one research site. Such reforms in the United States, Canada and Australia replace prior institution-by-institution approval mechanisms that contributed to significant research delays and duplicative procedures for collaborative research worldwide. While this paper centers on the Common Rule revision in the United States, the single ethics review mandate is a noteworthy example of regulation evolving in parallel with advances in the dataintensive sciences it governs. The informational exchange capacities of distributed ledger technologies align well with the procedural goals of streamlining the ethics review system under the new Common Rule ahead of its official implementation on January 19, 2020. The ethical, legal and social implications of applying such technologies to ethics review will be explored in this concept paper. Namely, the paper proposes how administrative data from research ethics committees (REC) could be protected and shared responsibly, as well as interinstitutional cooperation negotiated within a centralized network of research ethics committees using the blockchain.
 Keywords: Blockchain, Data Sharing, Ethics Review, Governance, IRB, Research, Single Mutual Recognition

Research misconduct is common among Middle East scientists, new study shows

Research misconduct is a serious problem in the Middle East, a survey of academic scientists there shows. Nearly 60% of respondents reported committing at least one breach of research ethics, and almost 75% said they knew of similar problems among their colleagues. “Scientific misconduct represents a significant issue in several universities in the Middle East,” the paper says. Previous studies have found that misconduct is common in the U.S., Europe, and beyond. However, this is the first examination of the problem in the Middle East, the authors say. They analyzed anonymous responses from 278 investigators at universities in three countries: Egypt, Lebanon, and Bahrain (J. Acad. Ethics 2017, DOI: 10.1007/s10805-017-9295-9). The most common type of misconduct was circumventing research ethics regulations, followed by fabrication and falsification of data. Faculty were less likely to have committed misconduct than students and postdocs. Lack of ethics training was a significant predictor of misconduct.

A Cross-Sectional Survey Study to Assess Prevalence and Attitudes Regarding Research Misconduct among Investigators in the Middle East.

Recent studies from Western countries indicate significant levels of questionable research practices, but similar data from low and middle-income countries are limited. Our aims were to assess the prevalence of and attitudes regarding research misconduct among researchers in several universities in the Middle East and to identify factors that might account for our findings. We distributed an anonymous questionnaire to a convenience sample of investigators at several universities in Egypt, Lebanon, and Bahrain. Participants were asked to a) self-report their extent of research misconducts, as well as their knowledge of colleagues engaging in similar research misconducts and b) provide their extent of agreement with certain attitudes about research misconduct. We used descriptive, bivariate, and multivariate logistic regression statistics to analyze the data. Data from 278 participants showed a high prevalence of misconduct, as 59.4% of our respondents self-reported to committing at least one misbehaviors and 74.5% reported having knowledge of any misbehaviors among any of their colleagues. The most common type of self-report misconduct was "circumventing research ethics regulations" (50.5%) followed by "fabrication and falsification" (28.6%). A significant predictor of misconduct included a lack of "prior ethics training". Scientific misconduct represents a significant issue in several universities in the Middle East. The demonstration that a lack of "prior ethics training" was a significant predictor of misconduct should lead to educational initiatives in research integrity. Further studies are needed to confirm whether our results can be generalized to other universities in the Middle East.

Ética e pesquisa em educação: entre a regulação e a potencialidade reflexiva da formação

Este artigo apresenta uma pesquisa exploratória que busca contribuir com os debates sobre ética e pesquisa no contexto atual da recente aprovação da Resolução CNS Nº 510/2016, normativa regulatória para as Ciências Humanas e Sociais (CHS). Para isso, construímos um argumento que aborda a questão da regulação e destaca também aspectos da reflexão ética no ofício de pesquisar e na formação de pesquisadores. A metodologia combinou a análise documental e o levantamento de opiniões de pesquisadores líderes e vice-líderes de grupos de pesquisa em educação da Região Sul através do uso de um questionário web. Os resultados da pesquisa mostram que no grupo dos 53 respondentes predomina o inconformismo com a situação atual da regulação da ética em pesquisa e prevalece a ideia de que esse tema corresponde tanto à regulação como à formação. Em relação aos riscos da pesquisa em educação as opiniões divergem e é escasso o reconhecimento de dilemas éticos nessa atividade.

A qualitative study on acceptable levels of risk for pregnant women in clinical research

BackgroundThere is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. The aim of our paper was to explore what stakeholders who are actively involved in the conduct of clinical research in pregnant women deem an acceptable level of risk for pregnant women in clinical research. Accordingly, we used the APOSTEL VI study, a low-risk obstetrical randomised controlled trial, as a case-study.MethodsWe conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed healthcare professionals, Research Ethics Committee members (RECs) and regulators who are actively involved in the conduct of clinical research in pregnant women, in addition to pregnant women recruited for the APOSTEL VI case-study in the Netherlands.ResultsThree themes characterise the way stakeholders view risks in clinical research in pregnant women in general. Additionally, one theme characterises the way healthcare professionals and pregnant women view risks with respect to the case-study specifically. First, ideas on what constitutes an acceptable level of risk in general ranged from a preference for zero risk for the foetus up to minimal risk. Second, the desirability of clinical research in pregnant women in general was questioned altogether. Third, stakeholders proposed to establish an upper limit of risk in potentially beneficial clinical research in pregnant women in order to protect the foetus and the pregnant woman from harm. Fourth and finally, the case-study illustrates that healthcare professionals’ individual perception of risk may influence recruitment.ConclusionsHealthcare professionals, RECs, regulators and pregnant women are all risk adverse in practice, possibly explaining the continuing underrepresentation of pregnant women in clinical research. Determining the acceptable levels of risk on a universal level alone is insufficient, because the individual perception of risk also influences behaviour towards pregnant women in clinical research. Therefore, bioethicists and researchers might be interested in changing the perception of risk, which could be achieved by education and awareness about the actual benefits and harms of inclusion and exclusion of pregnant women.

ETHICAL CONSIDERATIONS IN THE HANDLING OF A COMPLAINT REPORT AGAINST A STUDY TEAM: CASE OF A CLINICAL TRIAL (EARNEST) PARTICIPANT

BackgroundThe major role of an ethics committee is to protect participants from harm through participating in a health research study. This includes investigating participant complaints to ensure that their wellbeing...

A framework for analysis of research risks and benefits to participants in standard of care pragmatic clinical trials.

Standard of care pragmatic clinical trials that compare treatments already in use could improve care and reduce costs, but there is considerable debate about the research risks of standard of care pragmatic clinical trials and how to apply informed consent regulations to such trials. We sought to develop a framework integrating the insights from opposing sides of the debate. We developed a formal risk-benefit analysis framework for standard of care pragmatic clinical trials and then applied it to key provisions of the US federal regulations. Our formal framework for standard of care pragmatic clinical trial risk-benefit analysis takes into account three key considerations: the ex ante estimates of risks and benefits of the treatments to be compared in a standard of care pragmatic clinical trial, the allocation ratios of treatments inside and outside such a trial, and the significance of some participants receiving a different treatment inside a trial than outside the trial. The framework provides practical guidance on how the research ethics regulations on informed consent should be applied to standard of care pragmatic clinical trials. Our proposed formal model makes explicit the relationship between the concepts used by opposing sides of the debate about the research risks of standard of care pragmatic clinical trials and can be used to clarify the implications for informed consent.

Where are human subjects in Big Data research? The emerging ethics divide

There are growing discontinuities between the research practices of data science and established tools of research ethics regulation. Some of the core commitments of existing research ethics regulations, such as the distinction between research and practice, cannot be cleanly exported from biomedical research to data science research. Such discontinuities have led some data science practitioners and researchers to move toward rejecting ethics regulations outright. These shifts occur at the same time as a proposal for major revisions to the Common Rule—the primary regulation governing human-subjects research in the USA—is under consideration for the first time in decades. We contextualize these revisions in long-running complaints about regulation of social science research and argue data science should be understood as continuous with social sciences in this regard. The proposed regulations are more flexible and scalable to the methods of non-biomedical research, yet problematically largely exclude data science methods from human-subjects regulation, particularly uses of public datasets. The ethical frameworks for Big Data research are highly contested and in flux, and the potential harms of data science research are unpredictable. We examine several contentious cases of research harms in data science, including the 2014 Facebook emotional contagion study and the 2016 use of geographical data techniques to identify the pseudonymous artist Banksy. To address disputes about application of human-subjects research ethics in data science, critical data studies should offer a historically nuanced theory of “data subjectivity” responsive to the epistemic methods, harms and benefits of data science and commerce.

Applying “Place” to Research Ethics and Cultural Competence/Humility Training

Research ethics principles and regulations typically have been applied to the protection of individual human subjects. Yet, new paradigms of research that include the place-based community and cultural groups as partners or participants of environmental research interventions, in particular, require attention to place-based identities and geographical contexts. This paper argues the importance of respecting “place” within human subjects protections applied to communities and cultural groups as part of a critical need for research ethics and cultural competence training for graduate research students. These protections and benefits are extensions of the Belmont Principles and have been included in recent recommendations from research regulatory committees.

Is it ethical to prevent secondary use of stored biological samples and data derived from consenting research participants? The case of Malawi.

BackgroundThis paper discusses the contentious issue of reuse of stored biological samples and data obtained from research participants in past clinical research to answer future ethical and scientifically valid research questions. Many countries have regulations and guidelines that guide the use and exportation of stored biological samples and data. However, there are variations in regulations and guidelines governing the reuse of stored biological samples and data in Sub-Saharan Africa including Malawi.DiscussionThe current research ethics regulations and guidelines in Malawi do not allow indefinite storage and reuse of biological samples and data for future unspecified research. This comes even though the country has managed to answer pertinent research questions using stored biological samples and data. We acknowledge the limited technical expertise and equipment unavailable in Malawi that necessitates exportation of biological samples and data and the genuine concern raised by the regulatory authorities about the possible exploitation of biological samples and data by researchers. We also acknowledge that Malawi does not have bio-banks for storing biological samples and data for future research purposes. This creates room for possible exploitation of biological samples and data collected from research participants in primary research projects in Malawi. However, research ethics committees require completion and approval of material transfer agreements and data transfer agreements for biological samples and data collected for research purposes respectively and this requirement may partly address the concern raised by the regulatory authorities. Our concern though is that there is no such requirement for biological samples and data collected from patients for clinical or diagnostic purposes.SummaryIn conclusion, we propose developing a medical data and material transfer agreement for biological samples and data collected from patients for clinical or diagnostic purposes in both public and private health facilities that may end up in research centers outside Malawi. We also propose revision of the current research ethics regulations and guidelines in Malawi in order to allow secondary use of biological samples and data collected from primary research projects as a way of maximizing the use of collected samples and data. Finally, we call for consultation of all stakeholders within the Malawi research community when regulatory authorities are developing policies that govern research in Malawi.

Ethical responsibilities toward indirect and collateral participants in pragmatic clinical trials.

Pragmatic clinical trials are designed to inform decision makers about the benefits, burdens, and risks of health interventions in real-world settings. Pragmatic clinical trials often use for research purposes data collected in the course of clinical practice. The distinctive features of pragmatic clinical trials demand fresh thinking about what is required to act properly toward people affected by their conduct, in ways that go beyond ensuring the protection of rights and welfare for "human research subjects" under conventional research ethics regulations. To stimulate such work, we propose to distinguish among categories of research participants in pragmatic clinical trials as follows: Direct participants: (1) individuals being directly intervened upon and/or (2) individuals from whom personal identifiable data are being collected for the purposes of the pragmatic clinical trial. Indirect participants: individuals who are (1) not identified as direct participants and (2) whose rights and welfare may be affected by the intervention through their routine exposure to the environment in which the intervention is being deployed. Collateral participants: patient groups and other stakeholder communities who may be otherwise affected by the occurrence and findings of the pragmatic clinical trial. We illustrate these distinctions with case examples and discuss the distinctive responsibilities of researchers and pragmatic clinical trial leadership toward each type of participant. We suggest that pragmatic clinical trial investigators, institutional review boards, health systems leaders, and others engaged in the research enterprise work together to identify these participants. For indirect participants, risks and benefits to which they are exposed should be weighed to ensure that their rights and welfare are protected accordingly, and communication strategies should be considered to help them make well-informed decisions. Collateral participants could provide input on the design, planning, and conduct of a pragmatic clinical trial and offer insights regarding the best way to communicate the trial's results to their constituencies.

Is research ethics regulation really killing people?

It has been argued that research ethics regulation is leading to loss of life by delaying life-saving research. For example, Whitney and Schneider argue that the delays to the ISIS-2 trial cost 6538 lives. This suggests that there are grounds for rejecting research ethics regulation. However, the methods adopted by critics are flawed because: they conflate regulatory delays with those due to genuine normative requirements that would be present even if the regulatory framework was not; and looking at the impact of regulation on a per-project basis is the wrong metric, because it neglects all the unsuccessful research and because delaying specific projects does not reduce the overall research done by researchers. Research ethics regulation does not lead to substantial losses of life, but we have strong obligations to make it as efficient as possible.

Beyond the ‘therapeutic misconception’: Research, care and moral friction

In research ethics regulation, health care and research are depicted as serving distinct goals, and policies are in place to prevent what is seen as patients’ misconceived understanding of research as health care. On the basis of ethnographic research in four Danish hospitals in conjunction with a cardiovascular drug trial in patients with chronic disease, we argue that the objectives of health care and research often merge in mutually constitutive practices. We build on observations of trial activities, interviews with physician-investigators, research nurses, patient-participants and trial sponsors and a survey of the patient-participants. We found an organization of clinical drug trials allowing extraordinary care relationships to form, which makes trial participation attractive for patients and allows information to flow more freely. However, the research-care intermingling generates moral concerns for those involved. We conceptualize these concerns as a productive moral friction resulting from research staff caring too much for patients. We identify four situations in which friction arises: when care-giving comes to replace specialist contact, when caring for individuals appears unfair for the collective, when care motives may be doubted and when patients invent their own ways of helping staff in order to reciprocate their care. We conclude that the presentation of the research-care tension as an ethical dilemma is misleading and even part of the problem that must be dealt with by those involved.

Corrigendum: Ethical issue related to "Blood glucose levels, insulin concentrations, and insulin resistance in healthy women and women with premenstrual syndrome: A comparative study"

Clin Exp Reprod Med. 2013;40(2):76-82. http://dx.doi.org/10.5653/cerm.2013.40.2.76 This article was published with an incorrect ethical issue. In the text (p.77, line 18) This study complied with all of the principles of research ethics regulations which have been adopted by the Iranian Ministry of Health. Likewise, the study protocol was approved by the Institutional Review Board of Jahrom University of Medical Sciences. Although the IRB approved this study, the medical students of our own institution might be vulnerable subjects. However, ethical approval was obtained from the Ethics Committee and all of the participants gave their written informed consent. The corrected form is as follows: This study complied with all of the principles of research ethics regulations which are adopted by the Iranian Ministry of Health. Ethical approval for this study (references number: D/A/3755) was provided by the institutional review board (IRB) of Jahrom University of Medical Sciences, Jahrom, Iran (Chairperson M. Poorahmad; MD) on April 2010. Therefore, after obtaining the IRB approval and after getting participants informed consents, 60 female medical students were included in the study.

New take-off to an international journal.

The Journal of Korean Brain Tumor Society was first published on March 30, 2002, and 22 issues have been published until 2012 without delay or interruption. The journal was published twice a year and was a mix of Korean and English languages. When we consider the reality in the field of brain tumor research, it was possible because of a lot of effort and sacrifice of many members of the previous editor-in chiefs. I would like to express our deepest gratitude to the members of the former editor-in chiefs. Through these efforts of the past 10 years, the Journal of Korean Brain Tumor Society was approved as a regular member by Korean Association of Medical Journal Editors (KAMJE) in 2013, and was able to establish a foundation to develop into an international journal in the future. The Korean Society for Neuro-Oncology which was founded in 2011 decided to publish a journal in collaboration with The Korean Brain Tumor Society. Through many discussions, the Journal of Korean Brain Tumor Society was re-launched as an English journal with a new name Brain Tumor Research and Treatment (BTRT). BTRT is the official journal of The Korean Brain Tumor Society and The Korean Society for Neuro-Oncology. BTRT aims to enter the SCI (E) class within five years. To develop into an international journal, we appointed international editors who are very famous in the field of brain tumor research, such as Susan M. Chang (UCSF), Frederick F. Lang (MDACC), Hideyuki Saya (Keio University), Koichi Ichimura (National Cancer Center Japan), Patrick Y. Wen (Harvard Medical School), Michael Lim (Johns Hopkins Hospital), and Isaac Yang (UCLA). We reinforced the review committee as a comprehensive multi-disciplinary team consisting of prestige experts of neurosurgery, radiation oncology, hemato-oncology, pediatric hemato-oncology, radiology, pathology, and basic scientists. The journal homepage and on-line submission system will be completed in the near future with wholehearted help from The Korean Brain Tumor Society and The Korean Society for Neuro-Oncology. The BTRT covers all basic and clinical researches related to brain and spinal cord tumors, and papers from all over the world are welcome. Currently, the representative journals in the field of Neuro-oncology are Neuro-Oncology and the Journal of Neuro-Oncology, which are very high quality journals and which are hard to be accepted for publication. Therefore, BTRT welcomes submissions especially from Asian countries. We hope that BTRT serves as a venue of the academic communication and sharing of information among brain tumor researchers from around the world, as well as from Asia. We had planned to publish twice a year, but within a short period, we aim to publish 4 times a year. So, submissions from many researchers are needed. BTRT just began to prepare to be listed as SCI (E) class. Therefore, all papers that are submitted should comply with all the international research ethics regulations, and peer review will be more stringent than before. We will switch to open access and will try to be listed in KoreaMed, Synapse, Pubmed Central, SCOPUS, etc to be able to be read by many readers from all over the world. Lastly, I want to express my sincere gratitude to Professor Oh-Ryong Kim, the president of Korean Brain Tumor Society, and Doctor Seung-Hoon Lee, the president of Korean Society for Neuro-Oncology for the wholehearted help. And I want to offer words of thanks to the members of editorial board, reviewers that have been participated enthusiastically.

Developing a guideline for clinical trial protocol content: Delphi consensus survey

BackgroundRecent evidence has highlighted deficiencies in clinical trial protocols, having implications for many groups. Existing guidelines for randomized clinical trial (RCT) protocol content vary substantially and most do not describe systematic methodology for their development. As one of three prespecified steps for the systematic development of a guideline for trial protocol content, the objective of this study was to conduct a three-round Delphi consensus survey to develop and refine minimum content for RCT protocols.MethodsPanellists were identified using a multistep iterative approach, met prespecified minimum criteria and represented key stakeholders who develop or use clinical trial protocols. They were asked to rate concepts for importance in a minimum set of items for RCT protocols. The main outcome measures were degree of importance (scale of 1 to 10; higher scores indicating higher importance) and level of consensus for items. Results were presented as medians, interquartile ranges, counts and percentages.ResultsNinety-six expert panellists participated in the Delphi consensus survey including trial investigators, methodologists, research ethics board members, funders, industry, regulators and journal editors. Response rates were between 88 and 93% per round. Overall, panellists rated 63 of 88 concepts of high importance (of which 50 had a 25th percentile rating of 8 or greater), 13 of moderate importance (median 6 or 7) and 12 of low importance (median less than or equal to 5) for minimum trial protocol content. General and item-specific comments and subgroup results provided valuable insight for further discussions.ConclusionsThis Delphi process achieved consensus from a large panel of experts from diverse stakeholder groups on essential content for RCT protocols. It also highlights areas of divergence. These results, complemented by other empirical research and consensus meetings, are helping guide the development of a guideline for protocol content.

The Irrationality of Research Ethics Regulation in the UK: Is Medical Research Really the Only Risky Research?

Research ethics regulation in the UK wrongly equates medical research and only medical research with risky research, allowing some highly risky research to avoid appropriate regulation. If we want to ensure ethical research in the UK, then we ought to regulate all research, albeit with a lighter touch than is presently the case in the NRES system.

Ethical issues posed by cluster randomized trials in health research

The cluster randomized trial (CRT) is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to fulfill responsibly their respective roles. Our project will provide a systematic analysis of the ethics of cluster trials. Here we have outlined a series of six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation:1. Who is a research subject?2. From whom, how, and when must informed consent be obtained?3. Does clinical equipoise apply to CRTs?4. How do we determine if the benefits outweigh the risks of CRTs?5. How ought vulnerable groups be protected in CRTs?6. Who are gatekeepers and what are their responsibilities?Subsequent papers in this series will address each of these areas, clarifying the ethical issues at stake and, where possible, arguing for a preferred solution. Our hope is that these papers will serve as the basis for the creation of international ethical guidelines for the design and conduct of cluster randomized trials.

Commentary: Systems, rules and the costs of being ethical - a response to D. Chalmers and to S. Whitney and C. Schneider

Commentary: Systems, rules and the costs of being ethical - a response to D. Chalmers and to S. Whitney and C. Schneider

Embryos, ethics and expertise: the emerging model of the research ethics regulator

Embryonic stem cell research poses challenges for traditionally secular governing structures. An increasingly popular response has been to create research ethics regulators, bureaucratic agencies assigned to generate or enforce normative regulations surrounding the use of embryos in research. This paper examines three examples: Japan's Bioethics and Biosafety Office, the UK's Human Fertilisation and Embryology Authority and the California Institute of Regenerative Medicine. It explores the structure and mandate of each agency, its definition and employment of ethico-technical expertise and the extent to which the relocation of normative decision-making from the political sphere and into the voluntary sphere has democratized decision-making about the use of emerging technologies. We conclude that the model of the research ethics regulator appears successful at ameliorating public conflict and channeling dissent but there is little evidence to suggest that a reliance on ethico-technical, lay expertise has resulted in the relief of traditional critiques of regulatory culture. Copyright , Beech Tree Publishing.