Quality of consent forms in pharmacogenetic studies: a survey of research ethics committees in Spain

2006 ◽  
Vol 3 (3) ◽  
pp. 231-237 ◽  
Author(s):  
Miguel Ruiz-Canela ◽  
Ma Jesus Baena-Molina
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Consent Forms

scholarly journals Insights into the perception that research ethics committees are a barrier to research with seriously ill children: A study of committee minutes and correspondence with researchers studying seriously ill children

2019 ◽  
Vol 34 (3) ◽  
pp. 413-423 ◽  
Author(s):  
Ashleigh E Butler ◽  
Katherine Vincent ◽  
Myra Bluebond-Langner
Keyword(s):  
Content Analysis ◽  
Research Ethics ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Review Committee ◽  
Committee Meeting ◽  
Consent Forms ◽  
The United Kingdom ◽  
Seriously Ill ◽  
Participant Information

Background: Research ethics committees are commonly perceived as a ‘barrier’ to research involving seriously ill children. Researchers studying seriously ill children often feel that committees view their applications more harshly compared to applications for research with other populations. Whether or not this is the case in practice is unknown. Aim: The aim of this study was to explore committees’ concerns, expectations and decisions for research applications involving seriously ill children submitted for review in the United Kingdom. Design: Content analysis of committee meeting minutes, decision letters and researcher response letters. Setting/participants: Chief investigators for National Institute of Health Research portfolio studies involving seriously ill children were contacted for permission to review their study documents. Results: Of the 77 applications included in this study, 57 received requests for revisions at first review. Committee expectations and concerns commonly related to participant information sheets, methodology, consent, recruitment or formatting. Changes were made to 53 of these studies, all of which were subsequently approved. Conclusion: Our findings suggest that committees review applications for research involving seriously ill children with the same scrutiny as applications for research with other populations. Yet, the perception that committees act as a barrier to this type of research persists. We suggest that this perception remains due to other factors including, but not limited to, the high levels of formatting or administrative revisions requested by committees or additional study requirements needed for research involving children, such as multiple versions of consent forms or participant information sheets.

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.

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.

Research ethics committees

BMJ ◽  
1990 ◽  
Vol 300 (6724) ◽  
pp. 608-608
Author(s):  
M. Drury
Keyword(s):  
Research Ethics ◽  
Ethics Committees ◽  
Research Ethics Committees
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