Evaluation of clinical trials by Ethics Committees in Germany – results and a comparison of two surveys performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa)

Russ, Hagen; Busta, Susanne; Jost, Bertfried; Bethke, Thomas D.

doi:10.3205/000206

Cited by 1 publication

(8 citation statements)

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“…However, the findings confirm an association between deficiencies in sensitive aspects of the research application, such as documentation submitted, informed consent, research objectives and hypotheses, methods and procedures, legal, and economic reports, and a non-favorable opinion in the first ethical review process. On one hand, these findings indicating deficiencies in the applications are in consonance with previous studies in which similar outcomes have been reported, such as: incomplete documentation ( 24 ), legal and ethical aspects inappropriately addressed ( 2 , 25 ), informed consents not properly written ( 2 , 19 , 26 ), and an insufficient description of sensitive aspects related to the objectives, methods or procedures ( 2 , 19 ). In addition, some of the aforementioned aspects have been associated either with a non-favorable opinion or with delays in the ethical review process ( 25 ).…”

Section: Discussionsupporting

confidence: 90%

“… a Nursing ( 18 ), biology ( 5 ), biochemistry ( 2 ), chemistry ( 6 ), biotechnology ( 4 ), and pharmacy ( 2 ) . b Master ( 21 ), Medical specialty (33), and Bachelor ( 23 ) .…”

Section: Resultsmentioning

confidence: 99%

“… a Nursing ( 18 ), biology ( 5 ), biochemistry ( 2 ), chemistry ( 6 ), biotechnology ( 4 ), and pharmacy ( 2 ) . …”

Section: Resultsmentioning

confidence: 99%

“…The main responsibility of a Research Ethics Committee (REC) is to guarantee that a biomedical research application meets the standards of scientific, ethical and legal rigor prior to its experimental execution ( 2 ). This obligation, in Spain, has been regulated within the framework of the Organic Law ( Ley Orgánica , LO) LO 3/2018 ( 3 ), both on the protection of personal data; the LO 41/2002, on patient autonomy and obligations regarding information and clinical documentation ( 4 ); the SCO/362/2008, on good clinical practice ( 5 ); and the Royal Decree ( Real Decreto , RD) RD 1090/2015, on clinical trials with drugs ( 6 ).…”

Section: Introductionmentioning

confidence: 99%

“…For example, McNeill ( 8 ), Beshir ( 9 ), and Wagner and colleagues ( 10 ) agree that the REC's administrative work involves a slow bureaucratic process, which has been sometimes criticized as costly or at least making the review process laborious. Others have criticized that inflexible requirements for adherence to narrow literal interpretations of certain normative can lead to a system that is more concerned with “legalism” than the protection of human research participants ( 2 , 11 ). Furthermore, some authors ( 12 , 13 ) have highlighted the inconsistencies across different committees, even though they were following the same national normative.…”

Section: Introductionmentioning

confidence: 99%

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Characterization of Factors Predicting a Favorable Opinion of Research Applications Submitted for an Ethical Review Process

Mirpuri¹,

García‐Álvarez²,

Acín-Gericó³

et al. 2022

Front. Med.

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IntroductionIn Spain, biomedical research applications must receive a positive ethical opinion from Research Ethics Committees (RECs) before being executed. There is limited information on how to optimize the ethical review process to reduce delays. This study was performed to characterize variables predicting favorable opinions at the first ethical review performed by a REC.Material and MethodsThe study assessed all research applications revised by a REC in 2019–2020. Data was extracted from REC's database of La Rioja, Spain. Variables collected covered three areas: (i) principal investigator's profile; (ii) study design; and (iii) ethical review process. A model based on multiple logistic regression analysis was created to identify variables explaining favorable opinions in first rounds of ethical review processes.ResultsThe sample included 125 applications (41 submitted in 2019, and 84 in 2020). At the first review, nine (7%) applications were rejected, 56 (45%) were approved, and the remaining 60 (48%) required at least two reviews prior to approval. When comparing both years, a 2-fold increase in the number of applications submitted, and a difference in the ratio of applications with a favorable vs. non-favorable opinion were observed. Furthermore, a model predicted 71% of probability of obtaining a favorable opinion in the first ethical review. Three variables appeared as being explanatory: if the principal investigator is either the group leader or the department's head (OR = 17.39; p < 0.001), and if the informed consent (OR = 11.79; p = 0.01), and methods and procedures (OR = 34.15; p < 0.001) are well done.ConclusionsThese findings confirm an increase in the number of submissions and a difference in the ratio of applications approved by year. Findings observed also confirm deficiencies in “informed consent” and in “methods and procedures” are the two main causes of delay for favorable ethical opinions. Additionally, findings highlight the need that group leaders and heads of departments should be more involved in guiding and supervising their research teams, especially when research applications are led by less experienced researchers. Based on these findings, it is suggested that an adequate mentoring and targeted training in research could derive in more robust research applications and in smoother ethical review processes.

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Section: Discussionsupporting

confidence: 90%

“… a Nursing ( 18 ), biology ( 5 ), biochemistry ( 2 ), chemistry ( 6 ), biotechnology ( 4 ), and pharmacy ( 2 ) . b Master ( 21 ), Medical specialty (33), and Bachelor ( 23 ) .…”

Section: Resultsmentioning

confidence: 99%

“… a Nursing ( 18 ), biology ( 5 ), biochemistry ( 2 ), chemistry ( 6 ), biotechnology ( 4 ), and pharmacy ( 2 ) . …”

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%