Canada’s Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans mandates that all research involving human subjects be reviewed and approved by a research ethics board . We have little evidence on how researchers are dealing with this requirement in multisite studies, which involve more than one REB. We retrospectively examined 22 REB submissions for two minimal-risk, multisite studies in leading Canadian institutions. Most REBs granted expedited review to the studies, while one declared the application to (...) be exempt from review. Time between submission and approval ranged greatly, from four to 546 days. We received a total of 155 REB queries for changes and clarifications, most of which asked for further information, clarification, or additional documents. Less than a third of the REB queries were requests for specific changes, and a vast majority had a very limited impact on the research projects. Institutions also varied broadly in their description of what was required of local principal investigators. We conclude that the organizational and practical challenges these results imply could deter researchers from embarking on multisite research projects, and that recently proposed changes to the TCPS will not solve these problems. (shrink)

In Canada, all research conducted by individuals associated with universities must be subjected to review by research ethics boards (REB). Unfortunately, decisions reached by REBs may seriously compromise the integrity of university-based research. In this paper attention will focus on how requirements of REBs and a legal department in four Canadian universities affected response rates to a survey of domestic and international students. It will be shown that in universities in which students were sent a (...) legalistic cover letter to a mail survey, or were required to sign a consent form, lower response rates were achieved than in universities in which students were sent a relatively friendly letter. In turn, lower response rates resulted in: sample characteristics that deviated from population characteristics; a reduction in the possibility of testing research hypotheses; and increased survey costs. As a consequence, it is argued that the unreasonable demands of REBs are seriously compromising the quality of research that can be carried out on Canadian university students. (shrink)

Genomic research may uncover results that have direct actionable benefit to the individual. An emerging debate is the degree to which researchers may have responsibility to offer results to the biological relatives of the research participant. In a companion study to one carried out in the United States, we describe the attitudes of Canadian Research Ethics Board chairs to this issue and their opinions as to the role of the REB in developing related policy.

BackgroundWhile ethicists have for many years called for human subject trial participants and, in some cases, local community members to benefit from participation in pharmaceutical and other intervention-based therapies, little is known about how these discussions are impacting the practice of research ethics boards that grant ethical approval to many of these studies.MethodsTelephone interviews were conducted with 23 REB members from across Canada, a major funder country for human subject research internationally. All interviews were digitally recorded (...) and transcribed verbatim. After coding, the data was analyzed to identify central themes and topics. Themes were identified, application of the themes was confirmed, and these themes were then used to populate the findings of this manuscript.ResultsOur analysis of the interviews identified two primary themes when considering what benefits are owed to research participants and their communities. 1) Most study participants felt that given that these studies are led by persons in the role of researcher rather than health care provider, they had a limited obligation to provide benefits to study participants. 2) These REB members were all working in Canada, a high income country where most residents enjoy high levels of access to health care. As a result of this context, the study participants tended to focus on ethical concerns including obtaining informed consent and avoiding undue inducement to participate in research rather than ensuring that study participants directly benefit from successful trials.ConclusionsResearch on REB members’ attitudes toward what benefits are owed to study participants and community members is needed in other countries in order to determine how context affects these attitudes. (shrink)

The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans was first developed to establish a standard of practice in research ethics by the three federal agencies responsible for funding institutional research in Canada: Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council, and Social Sciences and Humanities Research Council. In 2010, a second edition of the policy, known as the TCPS 2, was released with updated information and expanded coverage of (...) research ethics issues. According to the TCPS 2, the Agencies’ mandate is “to promote research that is conducted according to the highest ethical standards,” and the TCPS 2 serves as a benchmark for this with respect for human dignity as its underlying value. Research institutions receiving Agency funding are to comply with this policy statement by forming Research Ethics Boards to review all research involving human participants. The intention behind this review requirement is to provide a proportionate assessment of the benefit-to-risk ratio of the research, and in that process, to safeguard “respect for persons”, express a “concern for welfare”, and uphold “justice”. Research may not proceed until ethics approval is granted by an institution’s REB. The current study evaluates REB members’ perspectives on their knowledge of research ethics, and juxtaposes these perceptions with those of researchers. Specifically, we are interested in the extent to which REB members with less experience read the TCPS 2, and whether those with less experience have decreased confidence in their ethics knowledge. (shrink)

In order to illuminate the potential harms of MRI research, we present data obtained by examining MRI research proposal files that had been submitted for review to several Canadian Research Ethics Boards. The data reveal that REB review of the studies contained omissions, considerable variability, and sometimes confusion regarding MRI research risks and risk classification. If our findings reflect the general state of REB review of MRI research in Canada and elsewhere, there is (...) a pressing need for REBs to be educated about MRI risks in order to responsibly facilitate the disclosure of these research risks in consent forms and during the consent process. Developing a standard template consent form that discloses MRI research risks might be a way to ensure attention to and disclosure of risks. (shrink)

Research Ethics Boards (REBs) at universities are chaired and staffed by researchers who serve to enforce codes of ethics by scrutinizing research proposals. Yet there is widespread dissatisfaction with the REB approval process. This article examines the sources of that dissatisfaction, the place for codes of ethics in the conducting of research, the evidence for risk to research participants as the basis for those codes, and the effectiveness of REBs in protecting (...) class='Hi'>research participants. We offer suggestions for how REB chairs, members, and researchers can improve the REB approval process so that it is fair and responsive. (shrink)

Research Ethics Boards (REBs) provide oversight for Canadians that research projects will comply with standards of ethics if the studies are carried out as described in the documents that have been approved. While REBs have traditionally been affiliated with institutions such as universities and hospitals, a number of factors - including the increased volume of research being conducted outside academic centres - have resulted in the establishment of some private or independent REBs. This, in (...) turn, has raised concerns about the credibility of REBs in the private sector and their capacity to handle issues around conflict of interest. This Breakout Session was an opportunity to hear the perspectives of people associated with institutional and private REBs and examine perceived problems with boards in the private sector, scrutinize theoretical and structural differences between types of REBs, and look at whether or not there is room for both institutional and private boards in the Canadian research review landscape. (shrink)

Background: The offer of aggregate study results to research participants following study completion is increasingly accepted as a means of demonstrating greater respect for participants. The attitudes of research ethics board chairs towards this practice, although integral to policy development, are unknown.Objectives: To determine the attitudes of REB chairs and the practices of REBs with respect to disclosure of results to research participants.Design: A postal questionnaire was distributed to the chairs of English-language university-based REBs in Canada. (...) In total, 88 REB chairs were eligible. The questionnaire examined respondents’ attitudes towards offering participants completed study results, methods for delivering this information, and barriers to disclosing results.Findings: The response rate was 89.8%. Chairs were highly supportive of offering results to research participants. Only 19.5% of chairs responded that a policy or guideline that governed the return of research results to participants existed at their institution. Most chairs supported the idea of their REB instituting a set of guidelines recommending that researchers offer results to participants in a lay format. Chairs identified the major impediments to the implementation of programmes offering to return results to participants as being financial cost and retaining contact with research participants .Conclusions: University-based REB chairs overwhelmingly support the offer of research results to participants. This is incongruent with the frequent lack of existing REB guidelines recommending this practice. REBs should support guidelines that diminish identified barriers and promote consistency in offering to return results. (shrink)

This paper explores issues of professional ethics that are relevant to those who engage in the ethical review of research with human subjects. Codes of ethics of a number of professional groups are examined for guidance offered to research ethics board members. The thought of the philosopher, Mike Martin, is introduced as a way to highlight some of the ethical issues that reviewers encounter in their work. Martin believes that ideals contribute to the coherence of (...) an individual’s life by shaping character. His discussion of caring, justice, trust, and professional distance offer a resource for reviewers to refl ect on the ethicaldimensions of their work. (shrink)

Research Ethics Boards (REBs) provide oversight for Canadians that research projects will comply with standards of ethics if the studies are carried out as described in the documents that have been approved. While REBs have traditionally been affiliated with institutions such as universities and hospitals, a number of factors - including the increased volume of research being conducted outside academic centres - have resulted in the establishment of some private or independent REBs. This, in (...) turn, has raised concerns about the credibility of REBs in the private sector and their capacity to handle issues around conflict of interest. This Breakout Session was an opportunity to hear the perspectives of people associated with institutional and private REBs and examine perceived problems with boards in the private sector, scrutinize theoretical and structural differences between types of REBs, and look at whether or not there is room for both institutional and private boards in the Canadian research review landscape. (shrink)

University based academic Research Ethics Boards (REB) face the particularly difficult challenge of trying to achieve representation from a variety of disciplines, methodologies and research interests. Additionally, many are currently facing another decision – whether to have students as REB members or not. At Ryerson University, we are uniquely situated. Without a medical school in which an awareness of the research ethics review process might be grounded, our mainly social science and humanities REB must (...) also educate and foster awareness of the ethics review process throughout the academic community. Our Board has had and continues to have students as active members. While there are challenges to having students as Board members, these are clearly outweighed by the advantages, for both the academic community and the future of ethically sound research in the social sciences and humanities. Moreover, the challenges are often based on misconceptions and can be easily overcome through increased education and understanding of the research ethics review process by the academic community at large. The purpose of this paper is to describe and discuss the experiences, advantages and challenges of having students as REB members. The advantages of having students as REB members include the following: (1) Students are the proposed participants in many of our reviewed protocols and student members may illuminate unique issues of participation. (2) Students are active and highly engaged members of the REB. (3) Having students on the REB enhances awareness of research ethics within the University. (4) Student REB members have an opportunity to mentor other students and provide leadership for both undergraduate and graduate students. (5) Students are more vigorously recruited than faculty members and often apply for student positions with enthusiasm and preparation. (6) In creating an atmosphere of excellence in research, engaging students at the beginning of their research career will help in creating tomorrow’s leaders in research and research ethics. The challenges of having students as REB members include the following: (1) Faculty members may be uneasy regarding the prospect of students reviewing protocols. (2) Faculty members may be concerned about confidentiality and respect with students reviewing faculty research protocols. (3) There may be an increased burden for students who serve as members on an REB. (4) There is concern that students will offer less continuous service to the REB. (5) There is a common misconception that students do not have the experience to carry out ethical reviews. While there are challenges from faculty members and others regarding having students as REB members, these challenges are often based on misconceptions about the nature of the REB work and the ethics review process in general. These challenges are also often based on the misconception of the ethics review process as one of peer review and evaluation, instead of a community-based and inclusive process. Having student members is a long-term strategy for both overcoming the misconceptions of the REB as a “necessary evil” and for fostering an awareness of the imperative for ethically sound research in the social sciences and humanities. (shrink)

The Internet has been used as a place for and site of an array of research activities. From online ethnographies to public data sets and online surveys, researchers and research regulators have struggled with an array of ethical issues around the conduct of online research. This paper presents a discussion and findings from Buchanan and Ess's study on US-based institutional review boards and the state of internet research ethics.

Introduction: Variation across research ethics boards in conditions placed on access to medical records for research purposes raises concerns around negative impacts on research quality and on human subject protection, including privacy.Aim: To study variation in REB consent requirements for retrospective chart review and who may have access to the medical record for data abstraction.Methods: Thirty 90-min face-to-face interviews were conducted with REB chairs and administrators affiliated with faculties of medicine in Canadian universities, using structured (...) questions around a case study with open-ended responses. Interviews were recorded, transcribed and coded manually.Results: Fourteen sites required individual patient consent for the study to proceed as proposed. Three indicated that their response would depend on how potentially identifying variables would be managed. Eleven sites did not require consent. Two suggested a notification and opt-out process. Most stated that consent would be required if identifiable information was being abstracted from the record. Among those not requiring consent, there was substantial variation in recognising that the abstracted information could potentially indirectly re-identify individuals. Concern over access to medical records by an outside individual was also associated with requirement for consent. Eighteen sites required full committee review. Sixteen allowed an external research assistant to abstract information from the health record.Conclusions: Large variation was found across sites in the requirement for consent for research involving access to medical records. REBs need training in best practices for protecting privacy and confidentiality in health research. A forum for REB chairs to confidentially share concerns and decisions about specific studies could also reduce variation in decisions. (shrink)

In the context of academic research, a diversity of ethical issues, conditioned by the different roles of members within these institutions, arise. Previous studies on this topic addressed mainly the perceptions of researchers. However, to our knowledge, no studies have explored the transversal ethical issues from a wider spectrum, including other members of academic institutions as the research ethics board (REB) members, and the research ethics experts. The present study used a descriptive phenomenological approach to (...) document the ethical issues experienced by a heterogeneous group of Canadian researchers, REB members, and research ethics experts. Data collection involved socio-demographic questionnaires and individual semi-structured interviews. Following the triangulation of different perspectives (researchers, REB members and ethics experts), emerging ethical issues were synthesized in ten units of meaning: (1) research integrity, (2) conflicts of interest, (3) respect for research participants, (4) lack of supervision and power imbalances, (5) individualism and performance, (6) inadequate ethical guidance, (7) social injustices, (8) distributive injustices, (9) epistemic injustices, and (10) ethical distress. This study highlighted several problematic elements that can support the identification of future solutions to resolve transversal ethical issues in research that affect the heterogeneous members of the academic community. (shrink)

Background: The Declaration of Helsinki prohibits the publication of articles that do not meet defined ethical standards for reporting of research ethics board approval and informed consent. Despite this prohibition and a call to highlight the deficiency for the reader, articles with potential ethical shortcomings continue to be published.Objective: To determine what proportion of articles in major medical journals lack statements confirming REB approval and informed consent, and whether accompanying commentary alerts readers to this deficiency.Design: Retrospective, observational study.Setting: (...) Online review of five major medical journals.Population: All clinical research articles published online between 1 January 2005 and 31 December 2006 in the BMJ, Lancet, Annals of Internal Medicine, JAMA and the New England Journal of Medicine.Measurements: Statement of REB approval and informed consent.Results: Of 1780 articles reviewed, 1133 met inclusion criteria , 36 articles lacked a statement of REB approval, 62 lacked disclosure of informed consent and 15 articles lacked both. Articles that did not state REB approval were associated with not stating informed consent . There were no editorial comments to alert readers to the lack of either REB approval or informed consent statements associated with any of the deficient articles.Conclusions: Articles that lack explicit statements of REB approval and informed consent are infrequent but continue to be published in major medical journals without editorial statements to alert the reader to this deficiency. (shrink)

Researchers seeking to engage in projects related to Tribal communities and their citizens, lands, and non-human relatives are responsible for understanding and abiding by each Tribal nation’s research laws and review processes. Few studies, however, have described the many diverse forms of Tribal research review systems across the United States (US). This study provides one of the most comprehensive examinations of research review processes administered by Tribal Research Review Boards (TRRBs) in the US. Through a (...) systematic analysis, we consider TRRBs’ online presence, online documentation, and themes across documents, for five entity types: Tribal nations and Tribal consortiums, Tribal colleges and universities, Tribal health organizations, Indian Health Services, and other Tribal organizations. Results include an assessment of online presence for 98 potential TRRBs, identification of 118 publicly available online documents, and analysis of 41 themes across four document types: Tribal research codes and TRRBs’ guidelines, applications, and post-approval documents. Altogether, this research provides a macro-level analysis of the most common types of TRRBs in the US in an effort to increase researchers’ understanding of these important processes as they prepare to ethically engage Tribal communities in research. These results aim to empower Tribal decision makers as they align their TRRBs’ online visibility and documentation with community priorities and strengthen their protections for the rights and wellbeing of their citizens and community. Ultimately, by expanding our knowledge of TRRBs across the US, this contribution seeks to uphold Tribal sovereignty in research and promote ethical approaches to research with Indigenous communities. (shrink)

Background: Despite potential benefits of the return of research results to research participants, the TriCouncil Policy Statement , which reflects Canadian regulatory ethical requirements, does not require this. The policies of Canadian research ethics boards are unknown.Objectives: To examine the policies of Canadian university based REBs regarding returning results to research participants, and to ascertain if the presence/absence of a policy may be influenced by REB member composition.Design: Email survey of the coordinators of Canadian (...) university based REBs to determine the presence/absence of a policy on return of research results to research participants both during an ongoing study and at conclusion. REB coordinators were asked to return a copy of the policy or guidelines and to describe the member composition of their REB.Findings: Of 50 REBs that were contacted 34 responded and 22 met the inclusion criteria. Two had a policy that governed the return of research results while on a study, and seven following the completion of a study. Presence of an ethicist or a lawyer on the REB did not influence the presence/absence of such policies. No REBs had specific guidelines describing how participants should be informed of results.Conclusions: Most REBs did not require researchers to disclose study results to research participants either during or following a study. Thus this study identifies an ethical shortcoming in the conduct of human research in Canada. It has also demonstrated that there are no clear recommendations by REBs to facilitate the return of results to participants following research projects. (shrink)

This research focuses on how research ethics committee and integrity board members discuss and decide on solutions to case scenarios that involve a dimension of research ethics or integrity in collaborative settings. The cases involved issues around authorship, conflict of interest, disregard of good scientific practice and ethics review, and research with vulnerable populations (children and neonates). The cases were set in a university, a hospital, or a research institute. In the (...) class='Hi'>research, we used a deductive qualitative approach with thematic analysis. Twenty-seven research ethics committee and research integrity board members from 16 European countries and one country outside Europe participated. Participants represented natural and life sciences, social sciences, and humanities. They worked on cases involving ethical/integrity issues in six different constellations. Results show that experts apply key elements of ethical decision making, namely identification of ethical issues, stakeholders, guidelines, solutions, and own positionality, in dealing collaboratively with ethics/ integrity problems, and the nature of the application depends on the complexity of the case. Understanding how individuals knowledgeable in research ethics and integrity, in this case, individuals serving on research ethics committees and integrity boards, approach ethical/ moral issues can help to identify strategies that may be useful in the development of research ethics and integrity training for junior researchers who may benefit from learning professional strategies. (shrink)

Ethics review committees have become a common institution in English-speaking research communities, and are now increasingly being adopted in a variety of research environments. In light of existing debates on the aptness of ethics review boards for assessing research work in the social sciences, this article investigates the ways in which researchers navigate issues of research ethics in the absence of a formal review procedure or of an ethics review board. Through (...) the analysis of qualitative and quantitative data, the article questions the overall utility of ethics review boards. Highlighting the importance of space for sharing, the authors argue for the development of a new type of structure that takes into account researchers’ ‘ethos of responsibility’ as an adequate ethical compass for research in the social sciences. (shrink)

This study examined Canadian Research Ethics Board practices concerning continuing ethics review of approved studies. A mail-out questionnaire was used to elicit information from Canadian REB representatives about whether their board engaged in continuing ethics review, and, if so, what their methods were. The study found that a majority of REBs conduct continuing ethics review. REBs conduct continuing ethics review of clinical trial research significantly more often than of academic research. The study (...) also found little difference in the frequency of continuing ethics review between academic and other types of REBs. The most commonly reported method for conducting continuing ethics review was a review of ongoing research reports. (shrink)

BackgroundThe amount of research utilizing health information has increased dramatically over the last ten years. Many institutions have extensive biobank holdings collected over a number of years for clinical and teaching purposes, but are uncertain as to the proper circumstances in which to permit research uses of these samples. Research Ethics Boards (REBs) in Canada and elsewhere in the world are grappling with these issues, but lack clear guidance regarding their role in the creation of (...) and access to registries and biobanks.MethodsChairs of 34 REBS and/or REB Administrators affiliated with Faculties of Medicine in Canadian universities were interviewed. Interviews consisted of structured questions dealing with diabetes-related scenarios, with open-ended responses and probing for rationales. The two scenarios involved the development of a diabetes registry using clinical encounter data across several physicians' practices, and the addition of biological samples to the registry to create a biobank.ResultsThere was a wide range of responses given for the questions raised in the scenarios, indicating a lack of clarity about the role of REBs in registries and biobanks. With respect to the creation of a registry, a minority of sites felt that consent was not required for the information to be entered into the registry. Whether patient consent was required for information to be entered into the registry and the duration for which the consent would be operative differed across sites. With respect to the creation of a biobank linked to the registry, a majority of sites viewed biobank information as qualitatively different from other types of personal health information. All respondents agreed that patient consent was needed for blood samples to be placed in the biobank but the duration of consent again varied.ConclusionParticipants were more attuned to issues surrounding biobanks as compared to registries and demonstrated a higher level of concern regarding biobanks. As registries and biobanks expand, there is a need for critical analysis of suitable roles for REBs and subsequent guidance on these topics. The authors conclude by recommending REB participation in the creation of registries and biobanks and the eventual drafting of comprehensive legislation. (shrink)

Objective: To examine how research ethics boards review research projects in emerging disciplines such as functional neuroimaging.Design: To compare the criteria applied and the decisions reached by REBs that reviewed the same mock research protocol in functional neuroimaging.Participants: 44 Canadian biomedical REBs, mostly working in public university or hospital settings.Main measurements: The mock research protocol “The Neurobiology of Social Behavior” included several ethical issues operating at all three levels: personal, institutional and social. Data consisting (...) of responses to closed questions were analysed quantitatively. Qualitative analysis of open-question responses used mixed classification.Results: Similar criteria were used by most participating REBs. Yet the project was unconditionally approved by 3 REBs, approved conditionally by 10 and rejected by 30.Conclusions: The results point to the difficulty for REBs of reviewing all kinds of research projects, regardless of field, by relying on international and national norms framed in general terms and a possible variation between REBs in the interpretation of their mandate for the protection of research subjects. (shrink)

The question of clinical science in public health emergencies (e.g., natural disasters, environmental releases, infectious diseases, and especially pandemics) raised by Edwards (2013) is a typical...

The process of research is often lengthy and can be extremely arduous. It may take many years to proceed from the initial development of an idea through to the comparison of the new modalities against a current gold-standard practice. Each step along the way involves rigorous scientific review, where protocols are scrutinized by multiple scientists not only in the specific field at hand but related fields as well. In addition to scientific review, most countries require a further review by (...) a panel that will specifically address the ethics of the proposed research. In Canada, those panels are referred to as Research Ethics Boards (REB), with the United States counterparts known as Institutional Review Boards (IRB). (shrink)

ABSTRACTGiven the ethical controversies concerning HIV vaccine trials , we aimed to understand through an exploratory study how members of institutional review boards in the United States and research ethics committees in South Africa view issues concerning the process and content of reviews of these studies. We mailed packets of 20 questionnaires to 12 US IRB chairs and administrators and seven REC chairs to distribute to their members. We received 113 questionnaires . In both countries, members tended (...) to be white males with advanced academic degrees. Compared to the US, SA members called for ‘major changes’ in HVT protocols more frequently , and were less likely to think that HVT participants understood risks and benefits or informed consent forms . In both countries, members were divided on several critical issues , but agreed that they needed more training. Of the SA respondents, 40% reported that they were ‘self‐taught’ in ethics. This study, the first we know of to offer quantitative data comparing US vs. non‐US IRBs/RECs, thus suggests key similarities and differences , along with needs for education. These initial exploratory data in this area have important implications for IRBs, RECs, policy‐makers and scholars concerning future practice, training, policy, and investigations in research ethics, and prevention and treatment of HIV and other diseases in the developing world and elsewhere. (shrink)

The Johns Hopkins‐Fogarty African Bioethics Training Program (FABTP) has offered a fully‐funded, one‐year, non‐degree training opportunity in research ethics to health professionals, ethics committee members, scholars, journalists and scientists from countries across sub‐Saharan Africa. In the first 9 years of operation, 28 trainees from 13 African countries have trained with FABTP. Any capacity building investment requires periodic critical evaluation of the impact that training dollars produce. In this paper we describe and evaluate FABTP and the efforts of (...) its trainees.Our data show that since 2001, the 28 former FABTP trainees have authored or co‐authored 105 new bioethics‐related publications; were awarded 33 bioethics‐related grants; played key roles on 78 bioethics‐related research studies; and participated in 198 bioethics workshops or conferences. Over the past nine years, trainees have collectively taught 48 separate courses related to bioethics and have given 170 presentations on various topics in the field. Many former trainees have pursued and completed doctoral degrees in bioethics; some have become editorial board members for bioethics journals. Female trainees were, on average, less experienced at matriculation and produced fewer post‐training outputs than their male counterparts. More comprehensive studies are needed to determine the relationships between age, sex, previous experience and training program outputs. (shrink)

In both law and ethics, precedent shapes the deliberation of novel issues. Despite the interconnection between new and old decisions, few research ethics boards have an explicit mechanism for archiving issue-based research ethics decisions to inform future decisions. With the intent of promoting expediency, consistency, and accountability in REB decision-making, Sunnybrook Health Sciences Centre implemented a “decision bank”: a formal mechanism for systematically capturing institutional REB decisions. We describe the development of the decision bank, (...) its implementation, and the lessons we have learned from both. The decision bank, which is categorized by general issue themes such as consent, study design, and privacy, is still in the early implementation phase, but it provides a much-needed method to address the paucity of formal mechanisms and literature in a biomedical field otherwise inundated with evidence-based information. (shrink)

Ethical conduct is a maxim in scholarly research as well as scholarly endeavour generally. In the case of research involving humans, few if any question the necessity for ethics approval of procedures by ethics boards or committees. However, concerns have been raised about the appropriateness of ethics approval processes for social science research arguing that the orientation of ethics boards and committees to biomedical and experimental scientific research, institutional risk aversion, (...) and other factors lead to over-protection of research participants and overly restrictive processes that delay and sometimes prevent important social science research. This is particularly significant when social science research is required to respond to social, environmental, or health emergencies and in contract research projects for the reasons explained. This analysis of an ethics approval case study adds to increasing concerns that ethics approval processes can have perverse effects in the social sciences. While a single case study does not provide generalizable findings, in-depth analysis of a significant case can identify issues that need to be further explored. Recommendations offer pathways for facilitating social science research including in emergency situations in which timeliness is important and in collaborative approaches such as participatory action research, while maintaining high ethical standards. (shrink)

Advanced Cell Technology's Ethics Advisory Board has been called window dressing for a corporate marketing plan. But the scientists and managers have paid attention, and the lawyers have gone along.

The application of artificial intelligence and machine learning technologies in healthcare have immense potential to improve the care of patients. While there are some emerging practices surro...

Guidelines for Institutional Review Boards (IRBs) or research ethics committees exist at national and international levels. These guidelines are based on ethical principles and establish an internationally acceptable standard for the review and conduct of medical research. Having attained a multinational consensus about what these fundamental guidelines should be, IRBs are left to interpret the guidelines and devise their own means of implementing them. Individual and community values bear on the interpretation of the guidelines so different (...) IRBs attain different levels of effectiveness. In the Caribbean and Pan American regions there are few IRBs. Obstacles to the establishment and function of IRBs are exacerbated in developing regions like these by differences in language, literacy, and local value systems; education, administrative expertise, facilities, and access to information are also limited. A regional IRB network might facilitate more uniform ethical review in developing countries, and simplify IRB procedures. (shrink)

Research ethics committees (RECs) have a crucial role in protecting children in research. However, studies on REC members’ perspectives on paediatric research are scarce. We conducted a qualitative study to explore Swedish scientific REC members’ perspectives on ethical aspects in applications involving children with severe health conditions. The REC members considered promoting participation, protecting children and regulatory adherence to be central aspects. The results underscored the importance of not neglecting ill children’s rights to adapted information and (...) participation. REC members supported a contextual and holistic approach to vulnerability and risk, which considers the child’s and parents’ psychological wellbeing and the child’s integrity, both short and long term. The ethical complexity of paediatric research requires continuous ethical competence development within RECs. (shrink)

The increasing use of information and communication technologies (ICT) to help facilitate neuroscience adds a new level of complexity to the question of how ethical issues of such research can be identified and addressed. Current research ethics practice, based on ethics reviews by institutional review boards (IRB) and underpinned by ethical principalism, has been widely criticised and even called ‘imperialist’. In this paper, we develop an alternative way of approaching ethics in neuro-ICT research, (...) based on discourse ethics, which implements responsible research and innovation through dialogues. We draw on our work in Ethics Support, using the Human Brain Project as empirical evidence of the viability of this approach. (shrink)

Recently, Indigenous commentators have begun to analyse the way in which institutional Research Ethics Boards engage with Indigenous researchers and participants, respond to Indigenous peoples’ concerns with academic research activities, and scrutinise the ethics proposals of Indigenous scholars. Of particular concern for Indigenous commentators is that the work of REBs often results in the marginalisation of Indigenous approaches to knowledge construction and dissemination, especially in relation to the vexed issue of informed consent. Based on analysis (...) of the results of research with Indigenous researchers and research participants, this paper argues that institutionalised REBs’ preference for ‘universal’ and ‘individualised’ approaches for determining ethical research conduct marginalises Indigenous approaches to ethical research conduct. The paper concludes by calling for a decolonisation of REB processes through recognition of the validity of communal processes for attaining the informed conse... (shrink)

The Johns Hopkins-Fogarty African Bioethics Training Program (FABTP) has offered a fully-funded, one-year, non-degree training opportunity in research ethics to health professionals, ethics committee members, scholars, journalists and scientists from countries across sub-Saharan Africa. In the first 9 years of operation, 28 trainees from 13 African countries have trained with FABTP. Any capacity building investment requires periodic critical evaluation of the impact that training dollars produce. In this paper we describe and evaluate FABTP and the efforts of (...) its trainees.Our data show that since 2001, the 28 former FABTP trainees have authored or co-authored 105 new bioethics-related publications; were awarded 33 bioethics-related grants; played key roles on 78 bioethics-related research studies; and participated in 198 bioethics workshops or conferences. Over the past nine years, trainees have collectively taught 48 separate courses related to bioethics and have given 170 presentations on various topics in the field. Many former trainees have pursued and completed doctoral degrees in bioethics; some have become editorial board members for bioethics journals. Female trainees were, on average, less experienced at matriculation and produced fewer post-training outputs than their male counterparts. More comprehensive studies are needed to determine the relationships between age, sex, previous experience and training program outputs. (shrink)