[Differentiated review of biomedical research projects by ethics committees].
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ABSTRACT:
SUBMITTER: Portales MB
PROVIDER: S-EPMC8083817 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Despite a growing consensus on the importance of integrating sex and gender in health research, research across disciplines continues to be conducted and reported without a gender focus. Research ethics committees (RECs) can play a particularly powerful role in identifying the gender gaps at an early stage of the development of research protocols. Their role is missing in the dialogue related to improving gender awareness and analysis in health research. A scoping review was conducted to examine the extent to which RECs discuss and consider the inclusion and analysis of sex and gender in health research and to examine the literature regarding the gender balance of RECs. The limited literature around gender and research ethics reveals the power and potential of RECs to ensure that gender dimensions are thoughtfully included in health research, and sheds light on the gaps that exist. These include an under-representation of women on RECs, a lack of awareness of the importance of gender-related aspects in health research and a paucity of gender-related training to RECs. Guidelines such as the Sex and Gender Equity in Research guidelines are required for RECs to strengthen the ways in which health research is gendered from conception of a research protocol to its publication.
| S-EPMC9623496 | biostudies-literature
Project description:ObjectiveHealth-related research in sub-Saharan Africa (SSA) has grown over the years. However, concerns have been raised about the state of research ethics committees (RECs). This scoping review examines the literature on RECs for health-related research in SSA and identifies strategies that have been applied to strengthen the RECs. It focuses on three aspects of RECs: regulatory governance and leadership, administrative and financial capacity and technical capacity of members.DesignA scoping review of published literature, including grey literature, was conducted using the Joanna Briggs Institute approach.Data sourcesBioOne, CINAHL, Embase (via Ovid), Education Abstracts, Global Health, Google Scholar, Jstor, OpenEdition (French), Philosopher's Index, PsycINFO, PubMed, Science Citation and Expanded Index (Web of Science), reference lists of included studies and specific grey literature sources.Eligibility criteriaWe included empirical studies on RECs for health-related research in SSA, covering topics on REC leadership and governance, administrative and financial capacity and the technical capacity of REC members. We included studies published between 01 January 2000 and 18 February 2022 and written in English, French, Portuguese or Swahili.Data extraction and synthesisTwo independent reviewers screened the records. Data were extracted by one reviewer and cross-checked by another. Owing to the heterogeneity of included studies, thematic analysis was used.ResultsWe included 54 studies. The findings show that most RECs in SSA work under significant administrative and financial constraints, with few opportunities for capacity building for committee members. This has an impact on the quality of reviews and the overall performance of RECs. Although most countries have national governance systems for RECs, they lack regulations on accountability, transparency and monitoring of RECs.ConclusionsThis review provides a comprehensive overview of the literature on RECs for health-related research in SSA and contributes to our understanding of how RECs can be strengthened.
| S-EPMC9680187 | biostudies-literature
Project description:In the last decade, Paraguay has made progress in the development of health-related research involving human subjects. This entails the obligation of the State to ensure that research is conducted ethically: protecting the dignity, rights and welfare of the participants, scientific integrity and adherence to international ethical guidelines. Research Ethics Committees are the main instance or resource to guarantee the aforementioned obligation. In view of the above and the context lacking adequate regulation in which research is currently carried out in the country, this article will defend the ethical imperative of establishing an accreditation system for research ethics committees. To this end, its necessity will be presented and justified and some objections related to the ethical imperative defended will be answered, such as the per se value of the accreditation of research ethics committees in the protection of participants, the investment of time and bureaucracy involved in the accreditation processes and the incipient regulatory framework for research on human beings in Paraguay. Finally, it will be proposed to strengthen the governance of research ethics in the country, as the main means to establish, implement and supervise an accreditation system for research ethics committees.
| S-EPMC11349314 | biostudies-literature
Project description:IntroductionHealth research in low-income and middle-income countries, which face the greatest burden of disease, is a vital component of efforts to combat global health inequality. With increased research, there has also been concern about ethical and regulatory issues and the state of research ethics committees, with various attempts to strengthen them. This scoping review examines the literature on ethics committees for health-related research in sub-Saharan Africa, with a focus on regulatory governance and leadership, administrative and financial capacity, and conduct of ethical reviews.Methods and analysisWe will use the methodological approach proposed by Arksey and O'Malley and adapted by Levac et al and the Joanna Briggs Institute. Inclusion and exclusion criteria are based on the 'Population-Concept-Context' framework. Literature (from January 2000 to December 2020) will be searched in multiple databases including Embase and PubMed and websites of relevant organisations. All records will be screened by applying the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Review flowchart: two reviewers will independently screen titles and abstracts, and full text of included records. Using an inductive approach, we will synthesise the literature, identify best practice and gaps in evidence on strengthening research ethics committees.Ethics and disseminationEthical approval is not required as the review will include only published literature. The findings will be published in a peer-reviewed journal and presented at stakeholder meetings and conferences.
| S-EPMC8362705 | biostudies-literature
Project description:The increased use of big data in the medical field has shifted the way in which biomedical research is designed and carried out. The novelty of techniques and methods brought by big data research brings new challenges to institutional review boards (IRBs). Yet it is unclear if IRBs should be the responsible oversight bodies for big data research and, if so, which criteria they should use. A large but heterogenous set of ethics guidelines and normative responses have emerged to address these issues. In this study, we conducted a scoping review of soft-law documents and guidelines with the aim of assessing ongoing normative efforts that are proliferating in this domain. We also synthesize a set of recurrent guidelines that could work as a baseline to create a harmonized process for big data research ethics.
| S-EPMC7814666 | biostudies-literature
Project description:ObjectivesTo assess the completeness of reporting of sample size determinations in unpublished research protocols and to develop guidance for research ethics committees and for statisticians advising these committees.DesignReview of original research protocols.Study selectionUnpublished research protocols for phase IIb, III, and IV randomised clinical trials of investigational medicinal products submitted to research ethics committees in the United Kingdom during 1 January to 31 December 2009.Main outcome measuresCompleteness of reporting of the sample size determination, including the justification of design assumptions, and disagreement between reported and recalculated sample size.Results446 study protocols were reviewed. Of these, 190 (43%) justified the treatment effect and 213 (48%) justified the population variability or survival experience. Only 55 (12%) discussed the clinical importance of the treatment effect sought. Few protocols provided a reasoned explanation as to why the design assumptions were plausible for the planned study. Sensitivity analyses investigating how the sample size changed under different design assumptions were lacking; six (1%) protocols included a re-estimation of the sample size in the study design. Overall, 188 (42%) protocols reported all of the information to accurately recalculate the sample size; the assumed withdrawal or dropout rate was not given in 177 (40%) studies. Only 134 of the 446 (30%) sample size calculations could be accurately reproduced. Study size tended to be over-estimated rather than under-estimated. Studies with non-commercial sponsors justified the design assumptions used in the calculation more often than studies with commercial sponsors but less often reported all the components needed to reproduce the sample size calculation. Sample sizes for studies with non-commercial sponsors were less often reproduced.ConclusionsMost research protocols did not contain sufficient information to allow the sample size to be reproduced or the plausibility of the design assumptions to be assessed. Greater transparency in the reporting of the determination of the sample size and more focus on study design during the ethical review process would allow deficiencies to be resolved early, before the trial begins. Guidance for research ethics committees and statisticians advising these committees is needed.
| S-EPMC3604970 | biostudies-literature
Project description:BACKGROUND:Screening for Down's syndrome forms part of routine obstetric practice. Ethical considerations relating to genetic screening form a major part of the workload of research ethics committees. This study investigated the attitudes of research ethics committee members to several conditions varying in clinical severity and prognosis, including Down's syndrome. METHODS:The members of 40 randomly chosen research ethics committees were surveyed. A simple questionnaire comprising 19 clinical scenarios based around four "clinical" conditions was designed to review conditions that were potentially embarrassing, affecting life span but not mental ability, premature death, and intellectual impairment with a risk of neonatal cardiac defects (Down's syndrome). Screening tests with different degrees of effectiveness were described and the diagnostic test descriptions ranged from having no risk to an unaffected fetus to causing spontaneous abortion of two normal fetuses for each affected fetus identified. Replies were graded on a scale of 1 to 5. RESULTS:Seventy seven replies were received from 28 different research ethics committees. Screening was supported for treatment of a life threatening condition (95% in favour) but screening for conditions of a slight increase in premature death (14% in favour) or cosmetic features (10% in favour) were considered unethical. Views were ambiguous (49% in favour) about conditions involving significant shortening of lifespan. Down's syndrome screening was considered more ethical when described as a serious condition (56% in favour) than when the clinical features were described (44% in favour). Once increased rates of spontaneous abortion on confirmatory testing were added, 79% (21% in favour) and 86% (14% in favour) stated that screening was unethical (for "serious" and "clinical features" descriptions, respectively). CONCLUSIONS:Down's syndrome screening raises ethical concerns about genetic testing in general that need to be dealt with before the introduction of any prenatal screening test.
| S-EPMC1769927 | biostudies-literature
Project description:BackgroundDuring the beginning of the COVID-19 pandemic there was an urgent need for accelerated review of COVID-19 research by Medical Research Ethics Committees (MRECs). In the Netherlands this led to the implementation of so-called 'fast-track-review-procedures' (FTRPs) to enable a swift start of urgent and relevant research. The objective of this study is to evaluate FTRPs of MRECs in the Netherlands during the COVID-19 pandemic and to compare them with the regular review procedures (RRPs).Methods and findingsAn explanatory sequential mixed method study was conducted. Online questionnaires and four group interviews were conducted among MREC representatives and investigators of COVID-19 research. In addition, data from a national research registration system was requested. Main outcome measures are differences in timelines, quality of the review and satisfaction between FTRPs and RRPs. The total number of review days was shorter in FTRP (median 10.5) compared to RRPs (median 98.0). Review days attributable to the MRECs also declined in FTRPs (median 8.0 versus 50.0). This shortening can be explained by installing ad hoc (sub)committees, full priority given to COVID-19 research, regular research put on hold, online review meetings and administrative leniency. The shorter timelines did not affect the perceived quality of the review and ethical and legal aspects were not weighted differently. Both MREC representatives and investigators were generally satisfied with the review of COVID-19 research. Weaknesses identified were the lack of overview of COVID-19 research and central collaboration and coordination, the delay of review of regular research, and limited reachability of secretariats.ConclusionsThis study shows that accelerated review is feasible during emergency situations. We did not find evidence that review quality was compromised and both investigators and MRECs were content with the FTRP. To improve future medical ethical review during pandemic situations and beyond, distinguishing main and side issues, working digitally, and (inter)national collaboration and coordination are important.
| S-EPMC8301608 | biostudies-literature
Project description:BACKGROUND AND METHODS:Psychiatric research can occasionally present particular ethical dilemmas, but it is not clear what kind of problems local research ethics committees (LRECs) actually experience in this field. We aimed to assess the type of problems that committees encounter with psychiatric research, using a postal survey of 211 LRECs. RESULTS:One hundred and seven (51%) of those written to replied within the time limit. Twenty eight (26%) experienced few problems with psychiatric applications. Twenty six (24%) emphasised the value of a psychiatric expert on the committee. The most common issues raised were informed consent (n=64, 60%) and confidentiality (n=17, 16%). The use of placebos (and washout periods) (n=18, 17%), the validity of psychiatric questionnaires (n=16, 15%) and overuse of psychiatric "jargon" (n=14, 13%) in psychiatric applications also raised concern. CONCLUSIONS:Our results suggest that LRECs have specific concerns regarding methodology, consent, and confidentiality in psychiatric research, and that they find psychiatric input invaluable.
| S-EPMC1733685 | biostudies-literature
Project description: Not available
| S-EPMC1779815 | biostudies-literature