scholarly journals Consent to research participation: understanding and motivation among German pupils

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jana Reetz ◽  
Gesine Richter ◽  
Christoph Borzikowsky ◽  
Christine Glinicke ◽  
Stephanie Darabaneanu ◽  
...  
Keyword(s):  
Research Ethics ◽  
Research Participation ◽  
Ethics Committees ◽  
Consent Form ◽  
Questionnaire Study ◽  
Therapeutic Misconception ◽  
Research Education ◽  
Foundational Research ◽  
Staged Approach

Abstract Background The EU’s 2006 Paediatric Regulation aims to support authorisation of medicine for children, thus effectively increasing paediatric research. It is ethically imperative to simultaneously establish procedures that protect children’s rights. Method This study endeavours (a) to evaluate whether a template consent form designed by the Standing Working Group of the German-Research-Ethics-Committees (AKEK) adequately informs adolescents about research participation, and (b) to investigate associated phenomena like therapeutic misconception and motives for research participation. In March 2016 a questionnaire study was conducted among 279 pupils (mean age 13.1 years) of a secondary school in northern Germany. Results A majority of participants showed a general good understanding of foundational research ethics concepts as understood from the AKEK consent form. Nevertheless, our data also suggests possible susceptibility to therapeutic misconception. Own health concerns and pro-social considerations were found to be significant motivational factors for participating in research, while anticipation of pain lessens likelihood of participation. Advice from trusted others is an important decisional influence, too. Furthermore, data security was found to be a relevant aspect of adolescents’ decision-making process. Conclusion Bearing in mind adolescents’ generally good understanding, we infer the lack of knowledge about medical research in general to be one source of therapeutic misconception. To further improve the quality of consent we propose a multi-staged approach whereby general research education is completed before an individual becomes a patient or potential participant. To the best of our knowledge this is the first German questionnaire-study addressing issues of informed consent in a large under-age sample.

scholarly journals Ethical review of COVID-19 research in the Netherlands; a mixed-method evaluation among medical research ethics committees and investigators

PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0255040
Author(s):  
R. IJkema ◽  
M. J. P. A. Janssens ◽  
J. A. M. van der Post ◽  
C. M. Licht
Keyword(s):  
The Netherlands ◽  
Medical Research ◽  
Research Ethics ◽  
Mixed Method ◽  
Ethics Committees ◽  
Ethical Review ◽  
Research Ethics Committees ◽  
Registration System ◽  
Medical Research Ethics

Background During 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 findings An 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. Conclusions This 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.

scholarly journals Ethical Concerns in Suicide Research: Results of an International Researcher Survey

2019 ◽  
Vol 14 (4) ◽  
pp. 383-394 ◽  
Author(s):  
Karl Andriessen ◽  
Lennart Reifels ◽  
Karolina Krysinska ◽  
Jo Robinson ◽  
Georgia Dempster ◽  
...  
Keyword(s):  
Research Ethics ◽  
Suicide Prevention ◽  
Online Survey ◽  
International Association ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Potential Harm ◽  
Ethical Concerns ◽  
International Researcher

Researchers and research ethics committees share a common goal of conducting ethically sound research. However, little is known of researchers’ experiences in obtaining ethics approval for suicide-related studies. This study aimed to investigate what concerns researchers have received on suicide-related ethics applications and how they dealt with it. Thirty-four respondents, recruited through the International Association for Suicide Prevention, filled out an online survey. The study found that researchers have received important concerns regarding potential harm and researchers’ responsibilities to participants. Researchers modified their application and/or consulted their research ethics committee in response to the concerns, which had a positive/neutral impact on their given study. Anticipating concerns and improved collaboration between researchers and research ethics committees should protect the quality of suicide prevention research.

Research Ethics and Misguided Moral Intuition

2004 ◽  
Vol 32 (1) ◽  
pp. 111-116 ◽  
Author(s):  
Franklin G. Miller
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Clinical Care ◽  
Research Participation ◽  
Ethical Standards ◽  
Therapeutic Misconception ◽  
Physician Patient Relationship ◽  
Research Designs ◽  
Ethical Thinking ◽  
Physician Patient

The term therapeutic misconception was coined by Paul Appelbaum and his colleagues to describe the tendency of patients enrolled in clinical trials to confuse research participation with the personal clinical attention characteristic of medical care. It has not been recognized that an analogous therapeutic misconception pervades ethical thinking about clinical research with patient-subjects. Investigators and bioethicists often judge the ethics of clinical research based on ethical standards appropriate to the physician-patient relationship in therapeutic medicine. This ethical approach to clinical research constitutes a misconception because it fails to appreciate the ethically significant differences between clinical research and clinical care.In this article I argue that the assumption that the ethical principles governing the practice of therapeutic medicine should also apply to clinical research with patient- subjects produces incoherence in research ethics and erroneous guidance concerning certain controversial research designs.

scholarly journals Comprehensive survey among statistical members of medical ethics committees in Germany on their personal impression of completeness and correctness of biostatistical aspects of submitted study protocols

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e032864
Author(s):  
Geraldine Rauch ◽  
Lorena Hafermann ◽  
Ulrich Mansmann ◽  
Iris Pigeot
Keyword(s):  
Medical Ethics ◽  
Missing Values ◽  
Sample Size Calculation ◽  
Ethics Committees ◽  
Secondary Outcome ◽  
Study Protocols ◽  
Individual Assessment ◽  
Statistical Problems ◽  
Multiple Comparison Procedures

ObjectivesTo assess biostatistical quality of study protocols submitted to German medical ethics committees according to personal appraisal of their statistical members.DesignWe conducted a web-based survey among biostatisticians who have been active as members in German medical ethics committees during the past 3 years.SettingThe study population was identified by a comprehensive web search on websites of German medical ethics committees.ParticipantsThe final list comprised 86 eligible persons. In total, 57 (66%) completed the survey.QuestionnaireThe first item checked whether the inclusion criterion was met. The last item assessed satisfaction with the survey. Four items aimed to characterise the medical ethics committee in terms of type and location, one item asked for the urgency of biostatistical training addressed to the medical investigators. The main 2×12 items reported an individual assessment of the quality of biostatistical aspects in the submitted study protocols, while distinguishing studies according to the German Medicines Act (AMG)/German Act on Medical Devices (MPG) and studies non-regulated by these laws.Primary and secondary outcome measuresThe individual assessment of the quality of biostatistical aspects corresponds to the primary objective. Thus, participants were asked to complete the sentence ‘In x% of the submitted study protocols, the following problem occurs’, where 12 different statistical problems were formulated. All other items assess secondary endpoints.ResultsFor all biostatistical aspects, 45 of 49 (91.8%) participants judged the quality of AMG/MPG study protocols much better than that of ‘non-regulated’ studies. The latter are in median affected 20%–60% more often by statistical problems. The highest need for training was reported for sample size calculation, missing values and multiple comparison procedures.ConclusionsBiostatisticians being active in German medical ethics committees classify the biostatistical quality of study protocols as low for ‘non-regulated’ studies, whereas quality is much better for AMG/MPG studies.

scholarly journals Philosophers in research ethics committees—what do they think they’re doing? An empirical-ethical analysis

2021 ◽  
Author(s):  
Charlotte Gauckler
Keyword(s):  
Research Ethics ◽  
Applied Ethics ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Structured Interviews ◽  
Discussion Section ◽  
Philosophical Perspective ◽  
Level 3 ◽  
Practical Level

AbstractResearch ethics committees in Germany usually don’t have philosophers as members and if so, only contingently, not provided for by statute. This is interesting from a philosophical perspective, assuming that ethics is a discipline of philosophy. It prompts the question what role philosophers play in those committees they can be found in. Eight qualitative semi-structured interviews were conducted to explore the self-perception of philosophers regarding their contribution to research ethics committees. The results show that the participants generally don’t view themselves as ethics experts. They are rather unanimous on the competencies they think they contribute to the committee but not as to whether those are philosophical competencies or applied ethical ones. In some cases they don’t see a big difference between their role and the role of the jurist member. In the discussion section of this paper I bring up three topics, prompted by the interviews, that need to be addressed: (1) I argue that the interviewees’ unwillingness to call themselves ethics experts might have to do with a too narrow understanding of ethics expertise. (2) I argue that the disagreement among the interviewees concerning the relationship between moral philosophy and applied ethics might be explained on a theoretical or on a practical level. (3) I argue that there is some lack of clarity concerning the relationship between ethics and law in research ethics committees and that further work needs to be done here. All three topics, I conclude, need further investigation.

scholarly journals Preventing ethics dumping: the challenges for Kenyan research ethics committees

2020 ◽  
pp. 174701612092506
Author(s):  
Kate Chatfield ◽  
Doris Schroeder ◽  
Anastasia Guantai ◽  
Kirana Bhatt ◽  
Elizabeth Bukusi ◽  
...  
Keyword(s):  
Research Ethics ◽  
Resource Constraints ◽  
Ethics Committees ◽  
Shared Responsibility ◽  
Standards Of Care ◽  
Primary Data ◽  
Research Ethics Committees ◽  
Governance System ◽  
Middle Income ◽  
System Resource

Ethics dumping is the practice of undertaking research in a low- or middle-income setting which would not be permitted, or would be severely restricted, in a high-income setting. Whilst Kenya operates a sophisticated research governance system, resource constraints and the relatively low number of accredited research ethics committees limit the capacity for ensuring ethical compliance. As a result, Kenya has been experiencing cases of ethics dumping. This article presents 11 challenges in the context of preventing ethics dumping in Kenya, namely variations in governance standards, resistance to double ethics review, resource constraints, unresolved issues in the management of biological samples, unresolved issues in the management of primary data, unsuitable informed consent procedures, cultural insensitivity, differing standards of care, reluctance to provide feedback to research communities, power differentials which facilitate the exploitation of local researchers and lack of local relevance and/or affordability of the resultant products. A reflective approach for researchers, built around the values of fairness, respect, care and honesty, is presented as a means of taking shared responsibility for preventing ethics dumping.

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