Recruiting minorities into research studies requires special attention, particularly when studies involve “extra-vulnerable” participants with multiple vulnerabilities, e.g., pregnant women, the fetuses/neonates of ethnic minorities, children in refugee camps, or cross-border migrants. This study retrospectively analyzed submissions to the Ethics Committee of the Faculty of Tropical Medicine (FTM-EC) in Thailand. Issues related to the process and outcomes of proposal review, and the main issues for which clarification/revision were requested on studies, are discussed extensively.

Ethical approval must be obtained before medical research can start. We describe the differences in EA for an pseudonymous, non-interventional, observational European study. Sixteen European national coordinators of the international study on very old intensive care patients answered an online questionnaire concerning their experience getting EA. N = 8/16 of the NCs could apply at one single national ethical committee, while the others had to apply to various regional ECs and/or individual hospital institutional research boards. The time between applying for (...) EA and the first decision varied between 7 days and 300 days. In 9/16 informed consent from the patient was not deemed necessary; in 7/16 informed consent was required from the patient or relatives. The upload of coded data to a central database required additional information in 14/16. In 4/16 the NCs had to ask separate approval to keep a subject identification code list to de-pseudonymize the patients if questions would occur. Only 2/16 of the NCs agreed that informed consent was necessary for this observational study. Overall, 6/16 of the NCs were satisfied with the entire process and 8/16 were unsatisfied. 11/16 would welcome a European central EC that would judge observational studies for all European countries. Variations in the process and prolonged time needed to get EA for observational studies hampers inclusion of patients in some European countries. This might have a negative influence on the external validity. Further harmonization of ethical approval process across Europe is welcomed for low-risk observational studies. Getting ethical approval for low-risk, non-interventional, observational studies varies enormously across European countries. (shrink)

The ethical parameters of business research, especially that undertaken by doctoral candidates, are an under researched area. This exploratory research analyses research ethics in the business and management contexts as espoused in perceived low risk ethics applications from business doctoral candidates in light of the principles of Australian research ethics guidelines. Applications are also analysed in terms of power relationships, methods of access and informed consent, pressure to complete research expeditiously, conflict of interest and cross-cultural understandings. Findings suggest that research (...) design, personal relationships with participants and nuanced understandings of the contextual dimensions of risk may be of concern in the proposed research. However, a reflexive process also questions the cultural and other assumptions of both researchers and ethics administrators underlying these concerns. (shrink)

Research Ethics Committees (RECs) are frequently a focus of complaints from researchers, but evidence about the operation and decisions of RECs tends to be anecdotal. We conducted a systematic study to identify and compare the ethical issues raised in 54 letters to researchers about the same 18 applications submitted to three RECs over one year. The most common type of ethical trouble identified in REC letters related to informed consent, followed by scientific design and conduct, care and protection of research (...) participants, confidentiality, recruitment and documentation. Community considerations were least frequently raised. There was evidence of variability in the ethical troubles identified and the remedies recommended. This analysis suggests that some principles may be more institutionalized than others, and offers some evidence of inconsistency between RECs. Inconsistency is often treated as evidence of incompetence and caprice, but a more sophisticated understanding of the role of RECs and their functioning is required. (shrink)

Despite significant scholarly debate about knowledge production in the management discipline through the peer-review journal processes, there is minimal discussion about the ethical treatment of the research subject in these publication processes. In contrast, the ethical scrutiny of management research processes within research institutions is often highly formalized and very focused on the protection of research participants. Hence, the question arises of how management publication processes should best account for the interests of the research subject, both in the narrow sense (...) of specific research participants and in the broader understanding of the subject of the research. This question is particularly pertinent in light of significant codification of research ethics within academic institutions, and increasing self-reflection within the management discipline about the “good” of management research and education. Findings from a survey and interviews with management journal editors reveal a complex scenario; many editors believe that a formalized requirement within the journal publication process may have detrimental outcomes and, in fact, diminish the ethical integrity of management scholarship. Building on these findings, this paper argues that ethical concern for the research subject merely in terms of institutional rule compliance and avoidance of harm to individual participants is insufficient, and calls for explicitly positive engagement with both the individual and the collective subject of management research should receive due ethical consideration. An alternative model involving reflexive ethical consideration of research subjects across the publication process—with implications for role of authors, reviewers, editors, and research subjects—is outlined. (shrink)

The American Journal of Bioethics, Volume 11, Issue 6, Page 27-29, June 2011.

Background A topic of great concern in bioethics is the medical research conducted in poor countries sponsored by wealthy nations. Western drug companies increasingly view Latin America as a proper place for clinical research trials. The region combines a large population, modern medical facilities, and low per capita incomes. Participants from developing countries may have little or non alternative means of treatment other than that offered through clinical trials. Therefore, the provision of a valid informed consent is important. Methods To (...) gain insight about some aspects of the informed consent procedure in a major cancer centre in Mexico, we conducted a three-step evaluation process: 1) a ten point multiple choice survey questionnaires, was used to explore some aspects of the patients' experiences during the informed consent process, 2) researchers' knowledge about specific aspects of the informed consent was evaluated in this study using survey questionnaires; and 3) the comprehensibility, readability and number of pages of the consent forms were analysed. The socioeconomic and educational level of the patients, were also considered. Results were reported using a numerical scale. Results Thirty five patients, 20 doctors, and 10 individuals working at the hospital agreed to participate in the study. Eighty three percent of the patients in the study were classified as living in poverty; education level was poor or non existent, and 31% of the patients were illiterate. The consent forms were difficult to understand according to 49% of the patients, most doctors agreed that the forms were not comprehensible to the patients. The average length of the IC documents analysed was 14 pages, and the readability average score was equivalent to 8TH Grade. Conclusion The results presented in this work describe some relevant characteristics of the population seen at public health care institutions in Mexico. Poverty, limited or no education, and the complexity of the information provided to the patients may question the validity of the informed consent procedure in this group of patients. (shrink)

Small-scale research projects involving human subjects have been identified as being effective in developing critical appraisal skills in undergraduate students. In deciding whether to grant ethical approval to such projects, university research ethics committees must weigh the benefits of the research against the risk of harm or discomfort to the participants. As the learning objectives associated with student research can be met without the need for human subjects, the benefit associated with training new healthcare professionals cannot, in itself, justify such (...) risks. The outputs of research must be shared with the wider scientific community if it is to influence future practice. Our survey of 19 UK universities indicates that undergraduate dissertations associated with the disciplines of medicine, dentistry and pharmacy are not routinely retained in their library catalogues, thus closing a major avenue to the dissemination of their findings. If such research is unlikely to be published in a peer-reviewed journal, presented at a conference, or otherwise made available to other researchers, then the risks of harm, discomfort or inconvenience to participants are unlikely to be offset by societal benefits. Ethics committees should be satisfied that undergraduate research will be funnelled into further research that is likely to inform clinical practice before granting ethical approval. (shrink)

BackgroundInformed consent is an ethical and legal requirement for research involving human participants. However, few studies have evaluated the process, particularly in Africa.Participants in a case control study designed to identify correlates of immune protection against tuberculosis (TB) in South Africa. This study was in turn nested in a large TB vaccine efficacy trial.The aim of the study was to evaluate the quality of consent in the case control study, and to identify factors that may influence the quality of consent.Cross-sectional (...) study conducted over a 4 month period.MethodsConsent was obtained from parents of trial participants. These parents were asked to complete a questionnaire that contained questions about the key elements of informed consent (voluntary participation, confidentiality, the main risks and benefits, etc.). The recall (success in selecting the correct answers) and understanding (correctness of interpretation of statements presented) were measured.ResultsThe majority of the 192 subjects interviewed obtained scores greater than 75% for both the recall and understanding sections. The median score for recall was 66%; interquartile range (IQR) = 55%–77% and for understanding 75% (IQR = 50%–87%). Most (79%) were aware of the risks and 64% knew that they participated voluntarily. Participants who had completed Grade 7 at school and higher were more likely (OR = 4.94; 95% CI = 1.57 – 15.55) to obtain scores greater than 75% for recall than those who did not. Participants who were consented by professional nurses who had worked for more than two years in research were also more likely (OR = 2.62; 95% CI = 1.35–5.07) to obtain such scores for recall than those who were not.ConclusionNotwithstanding the constraints in a developing country, in a population with low levels of literacy and education, the quality of informed consent found in this study could be considered as building blocks for establishing acceptable standards for public health research. Education level of respondents and experience of research staff taking the consent were associated with good quality informed consent. (shrink)

The American Journal of Bioethics, Volume 11, Issue 6, Page 29-31, June 2011.

The increasing need for innovative research driven by rapid global changes gives doctoral supervisors of early-stage researchers a significant role in facilitating the ethical conduct of qualitative research. In the context of European Commission funding, the demands of research ethics and integrity place a tremendous responsibility on the supervisors of early-stage researchers involved in cross-national projects. This document study seeks to illuminate the role of the supervisors in facilitating research ethics in these projects. Specifically, we describe and discuss the supervisor (...) role associated with five approaches to doctoral supervision of qualitative research, namely those described as ‘Functional’, ‘Enculturation’, ‘Critical thinking’, ‘Emancipation’ and ‘Developing a quality relationship’. The main challenges for supervisors of cross-national research projects are the cultural and linguistic mobilisation of ethical principles in qualitative research processes and the management of the future use of open data. The results from this study have implications for planning and conducting cross-national studies within research involving human participants. These results can guide supervisors in the codification and mobilisation of ethical qualitative research in practice. (shrink)

Compared to institutional and area-based ethics committees, little is known about the structure and activities performed by ethics committees at national medical organizations and societies. This five year follow-up study aimed to determine (1) the creation and function of ethics committees at medical organizations in Japan, and (2) their general strategies to deal with ethical problems. The study sample included the member societies of the Japanese Association of Medical Sciences (n=92 in 1998, n=96 in 2003). Instruments consisted of two sections: (...) (1) the structure, function and activities of ethics committees, and (2) the strategies for dealing with ethical problems. Response rates were 84.4% in 1998 and 64.4% in 2003. Findings showed a significant increase of ethics committees at medical organizations between 1998 (25.6%) and 2003 (50.0%). Members were mostly male, medical doctors in clinical or basic medicine, and members of the organization. The major functions of ethics committees were ethical reviews of research protocols, policy making and ethical reviews of manuscripts submitted for journal publication. Among organizations that did not have an ethics committee, a significant decrease was found in organizations that replied that they had never experienced an ethical problem which needed further investigation (p<0.01). Findings suggested an overall rise in awareness of the importance of ethical issues and also highlighted an increase in recognition of responsibility regarding ethical problems. (shrink)

Submission of study protocols to research ethics committees constitutes one of the earliest stages at which planned trials are documented in detail. Previous studies have investigated the amendments requested from researchers by RECs, but the type of issues raised during REC review have not been compared by sponsor type. The objective of this study was to identify recurring shortcomings in protocols of drug trials based on REC comments and to assess whether these were more common among industry-sponsored or non-industry trials.

Gaining ethical clearance to conduct a study is an important aspect of all research involving humans but can be time-consuming and daunting for novice researchers. This article stems from a larger ethnographic study that examined research capacity building in Irish nursing and midwifery. Data were collected over a 28-month time frame from a purposive sample of 16 nurse or midwife research fellows who were funded to undertake full-time PhDs. Gaining ethical clearance for their studies was reported as an early ‘rite (...) of passage’ in the category of ‘labouring the doctorate’. This article penetrates the complexities in Irish clinical research ethics by describing the practices these nurse and midwife researchers encountered and the experiences they had. The key issue of representation that occurred in the context of ‘medicalized’ research ethics is further explored including its meaning for nursing or midwifery research. (shrink)