Dataset Information

Determining the level of data sharing, and number of publications, from research databases that have been given a favourable opinion by UK research ethics committees.

ABSTRACT: OBJECTIVE:To determine data sharing and number of publications coming from research databases that have been given a favourable opinion by UK National Health Service (NHS) Research Ethics Committees (RECs). DESIGN:Cohort study. INCLUSION CRITERIA & SETTING:All research databases listed on the UK Health Research Authority's Assessment Review Portal (HARP) that had received a favourable ethics opinion as of January 2018. MAIN OUTCOME MEASURES:Publications and data access requests are either listed on HARP or notified through subsequent email correspondence. RESULTS:Out of 354 eligible databases, 34% had granted access requests and 40% had produced at least one peer-reviewed paper or conference abstract/talk. We could not establish contact with 9% of databases, and 19% reported no access requests or publications. Only 9% of databases were up to date with all annual reports. Email responses from database owners showed a range of attitudes towards data sharing. CONCLUSION:Less than half of research databases that have received a favourable opinion from NHS research ethics committees share their data and produce publications. There is also considerable variability in the operation of research databases and understanding of the purpose of research databases. This work was hampered by incomplete records due mainly to researchers not submitting annual reports.

SUBMITTER: Trace S

PROVIDER: S-EPMC7528358 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Publications

Determining the level of data sharing, and number of publications, from research databases that have been given a favourable opinion by UK research ethics committees.

Trace Samantha S Bracher Mike M Kolstoe Simon E SE

BMJ open 20200930 9

<h4>Objective</h4>To determine data sharing and number of publications coming from research databases that have been given a favourable opinion by UK National Health Service (NHS) Research Ethics Committees (RECs).<h4>Design</h4>Cohort study.<h4>Inclusion criteria & setting</h4>All research databases listed on the UK Health Research Authority's Assessment Review Portal (HARP) that had received a favourable ethics opinion as of January 2018.<h4>Main outcome measures</h4>Publications and data acce ...[more]

PMID: 32998929

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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.

Project description:The review of requests for a positive opinion of the ethics committees (application procedure) as a requirement to start a clinical trial in Germany has been completely redesigned with the transposition of EU Directive 2001/20/EC in the 12(th) Amendment of the German Medicines Act in August 2004. The experience of applicants (sponsors, legal representatives of sponsors in the EU and persons or organizations authorized by the sponsors to make the application, respectively) in terms of interactions with the ethics committees in Germany has been positive overall, especially with respect to ethics committee adherence to the statutory timelines applicable for review of requests. However, inconsistencies between ethics committees exist in terms of the form and content of the requirements for application documents and their evaluation. With the objective of further improving both the quality of applications and the evaluation of those applications by ethics committees, a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA) was conducted from January to April 2008. Based on reasoned opinions issued by the respective ethics committee in charge of the coordinating principal investigator (coordinating ethics committee), the type and frequency of formal and content-related objections to applications according to section sign 7 of the German Good Clinical Practice (GCP) Regulation were systematically documented, and qualitative and quantitative analyses performed. 21 out of 44 members of the VFA participated in the survey. 288 applications for Phase I-IV studies submitted between January and December 2007 to 40 ethics committees were evaluated. This survey shows that about one in six applications is incomplete and has formal and/or content objections, respectively, especially those that pertain to documents demonstrating the qualification of the investigator and/or suitability of the facilities. These objections are attributable to some extent to the differing and/or unclear requirements of the individual ethics committees on the content and comprehension of the submission documents. However, applicants also need to pay more attention to the completeness and validity of the submission documents. The majority of content-related objections apply to the patient information and consent documents and study protocols submitted. Applicants on average acted upon only 3 out of 4 objections, for various reasons: the relevant information was already given in the submitted documents, but had not been taken into consideration by the ethics committees; objections were not applicable; objections lacked a legal basis. In such cases the applicants made reference to the specific information already submitted or gave reasons for not acting on the objection. This course of action was accepted by the ethics committees, with few exceptions. The survey sheds light on the existing inconsistencies in the evaluations of applications by the various ethics committees and suggests ways in which the existing constructive dialogue between applicants and ethics committees may provide a basis to further harmonize both the requirements regarding form and content of application documents, and the criteria for evaluation of applications by ethics committees within the legal framework.

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Dataset Information

Determining the level of data sharing, and number of publications, from research databases that have been given a favourable opinion by UK research ethics committees.

Publications

Determining the level of data sharing, and number of publications, from research databases that have been given a favourable opinion by UK research ethics committees.

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