One of the key criticisms of the ethical review process is the time taken to decision, and associated resource use. A key source of delay is that most submissions are required to respond to at leas...

Background Conducting ethically sound research is a fundamental principle of scientific inquiry. Recent research has indicated that ethical concerns are insufficiently dealt with in dissertations. Purpose To examine which research ethical topics were addressed and how these were presented in terms of complexity of reasoning in Swedish nurses' dissertations. Methods Analyses of ethical content and complexity of ethical reasoning were performed on 64 Swedish nurses' PhD dissertations dated 2007. Results A total of seven ethical topics were identified: ethical approval (94% (...) of the dissertations), information and informed consent (86%), confidentiality (67%), ethical aspects of methods (61%), use of ethical principles and regulations (39%), rationale for the study (20%) and fair participant selection (14%). Four of those of topics were most frequently addressed: the majority of dissertations (72%) included 3–5 issues. While many ethical concerns, by their nature, involve systematic concepts or metasystematic principles, ethical reasoning scored predominantly at lesser levels of complexity: abstract (6% of the dissertations), formal (84%) and systematic (10%). Conclusions Research ethics are inadequately covered in most dissertations by nurses in Sweden. Important ethical concerns are missing, and the complexity of reasoning on ethical principles, motives and implications is insufficient. This is partly due to traditions and norms that discount ethical concerns but is probably also a reflection of the ability of PhD students and supervisors to handle complexity in general. It is suggested that the importance of ethical considerations should be emphasised in graduate and post-graduate studies and that individuals with capacity to deal with systematic and metasystematic concepts are recruited to senior research positions. (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.

There is considerable controversy about the mandatory ethics review of research. This paper engages with the arguments offered by Murray Dyck and Gary Allen against mandatory review, namely, that this regulation fails to reach the standards that research ethics committees apply to research since it is harmful to the ethics of researchers, has little positive evidence base, leads to significant harms (through delaying valuable research) and distorts the nature of research. As these are commonplace arguments offered by researchers against regulation (...) it is useful to assess their strength and the conclusion that they are taken to support, namely, that we ought to move back to a system of trust in researchers without compulsory regulation. Unfortunately, these arguments are at best weak and to some degree come into conflict in terms of supporting the desired conclusion. (shrink)

Human Research Ethics Committee (HREC) reviewers often provide similar feedback across applications, which suggests that the problem lies in researcher awareness of key issues rather than novel, unsolvable challenges. If common problems can be addressed before lodgement by applicants referencing clear evidence-based supports (e.g., FAQs on common application shortcomings), it would improve efficiency for HREC members and expedite approvals. We aim to inform such supports by analysing the patterns in the most frequent feedback made by HREC members during review processes. (...) We collected every instance (_N_ = 4,195) of feedback made on _N_ = 197 ‘low-risk’ protocols by all HREC staff (_N_ = 16) at one institution over the course of a full year (2019). Reflexive thematic analysis to identify themes (and content analysis to determine relative frequency) revealed that the top three themes are consistent with existing literature: Consent, Administrative, and Methodological concerns. However, we identified important new themes that are not captured in previous research, including ‘Risk to Researchers’, ‘Commercial benefit, scope and scale’, ‘Diversity’ (covering issues of cultural sensitivity, language and accessibility), as well as fair right to a complaints process. Our thorough exploration of information-rich primary data marks an important methodological improvement over previous studies and offers a theoretical contribution to understanding themes that have heretofore been overlooked in the ethics review process. By identifying the common challenges experienced in HREC review we can better inform tailored supports to applicants (by extension reducing workload burdens on HREC systems) and reduce their perceived barriers to engaging in challenging but meaningful research. (shrink)

Mozambique 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 encouraged the development of ethical review processes at institutions that regularly conduct medical and social science research. In 2012, the Faculty of Medicine of University Eduardo Mondlane and the Maputo Central Hospital established a joint Institutional Committee on Bioethics for Health. This study examines the experience of the first 4 years of the CIBS FM (...) & MCH. This 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. A 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. Descriptive cross-sectional studies were the most frequently reviewed research. The majority were prospective and used quantitative methodologies. 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. Our 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. (shrink)

Disquiet about the research ethics review process has, historically, been anecdotal and often takes the form of ‘atrocity stories’ from researchers about the bureaucratic nature of the application process or inconsistency and capriciousness in decision-making. However, systematic evidence has often been lacking. We analysed 100 decision letters written by NHS research ethics committees (RECs). We found evidence of poor communication in the way in which REC decisions were conveyed to applicants. Typos and grammatical mistakes were found in almost 30% of (...) letters; sometimes wording was impolite and demonstrated a lack of respect towards applicants; and there was often lack of clarity about the nature of a revision and whether the revision was compulsory or optional. The analysis provides messages for RECs about how they can improve their practices to establish a more cooperative relationship between researcher and committee through the careful use of language and attention to detail in decision letters. (shrink)

BackgroundMany studies have been published about ethics committees and the clarifications requested about the submitted applications. In Finland, ethics committees require a separate statement on ethical aspects of the research in applications to the ethics committee. However, little is known about how researchers consider the ethical aspects of their own studies.MethodsThe data were collected from all the applications received by the official regional ethics committee in the Hospital District of Northern Savo during 2004–2009 (n = 688). These included a total (...) of 56 studies involving research on tissue other than blood. The statements by the researchers about the ethics about their own research in these applications were analyzed by thematic content analysis under the following themes: recruitment, informed consent, risks and benefits, confidentiality and societal meaning.ResultsThe researchers tended to describe recruitment and informed consent process very briefly. Usually these descriptions simply stated who the recruiter was and that written consent would be required. There was little information provided on the recruitment situation and on how the study recruiters would be informed. Although most of the studies were clinical, the possibility was hardly ever discussed that patients could fail to distinguish between care and research.ConclusionThe written guidelines, available on the webpages of the ethics committee, do not seem to be enough to help researchers achieve this goal. In addition to detailed guidelines for researchers, investigators need to be taught to appreciate the ethical aspects in their own studies. (shrink)

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.

Background: Due to the important role of depression in major illnesses, screening measures for depression are commonly used in medical research. The protocol for managing participants with positive screens is unclear and raises ethical concerns. The aim of this article is to identify and critically discuss the ethical issues that arise when a positive screen for depression is detected, and offer some guidance on managing these issues.DiscussionDeciding on whether to report positive screens to healthcare practitioners is both an ethical and (...) a pragmatic dilemma. Evidence suggests that reporting positive depression screens should only be considered in the context of collaborative care. Possible adverse effects, such as the impact of false-positive results, potentially inappropriate labelling, and potentially inappropriate treatment also need to be considered. If possible, the psychometric properties of the selected screening measure should be determined in the target population, and a threshold for depression that minimises the rate of false-positive results should be chosen. It should be clearly communicated to practitioners that screening scores are not diagnostic for depression, and they should be informed about the diagnostic accuracy of the measure. Research participants need to be made aware of the consequences of the detection of high scores on screening measures, and to be fully informed about the implications of the research protocol.SummaryFurther research is needed and the experiences of researchers, participants, and practitioners need to be collated before the value of reporting positive screens for depression can be ascertained. In developing research protocols, the ethical challenges highlighted should be considered. Participants must be agreeable to the agreed protocol and efforts should be made to minimise potentially adverse effects. (shrink)

Objective. A retrospective examination of numbers of applications, decision rates, and process errors in 2015 was done for comparison with earlier studies to understand current ethics secretariat workload. Methods. In December 2015 information from committee minutes of all the meetings in 2015 was collected to quantify change in application numbers and process errors. Statistical analysis used SAS for Windows. Statistical significance was set at p<0.05. Results. There were 809 new general research applications considered in 2015. Monthly approvals at first evaluation (...) ranged from 4 to 30% with an overall approval rate of 16%. Minor revision was required in 72%, major revision in 11% and 1% of applications were not approved. The χ2 test for trend for initial approval showed a statistically significant decrease across the study periods. However, the χ2 test for trend for pending responses from applicants was also statistically significant. Informed consent and missing information process errors were the most frequent. There were statistically significant increases in lapses of confidentiality methods and discrepancies on application forms. Conclusion. Applications to the Wits Human Research Ethics Committee ) for ethics clearance almost doubled between 2003 and 2015 while approvals at first evaluation approximately halved. This has increased the workload on the HREC secretariat. Process error rates are similar to those in an earlier study except that confidentiality and discrepancies have shown a statistically significant increase. Given limitation on the number of secretariat staff in the current stringent financial circumstances of South African universities, applicants need to improve the quality of their applications to increase approval at first review and reduce secretariat workload. (shrink)