Clinical Research and Ethics Committees

2003 ◽  
pp. 7-12
Keyword(s):  
Clinical Research ◽  
Ethics Committees

Should Research Ethics Committees Be Observing the Law or Working by Ethical Principles?

2005 ◽  
Vol 1 (1) ◽  
pp. 23-26 ◽  
Author(s):  
Charles Warlow
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Public Interest ◽  
Ethics Committees ◽  
Unintended Consequences ◽  
Research Ethics Committees ◽  
Individual Interest ◽  
The Public ◽  
The Law ◽  
The Individual

Recent laws, and their interpretation, have made clinical research more difficult to do, and sometimes impossible. Furthermore the results of that research which can be done may even be unreliable. This is certainly against the public interest, and indeed the individual patient interest as well. But ethics committees have to abide by the law and so even though it is surely unethical to work against the public and individual interest that is exactly what ethics committees now have to endorse. The unintended consequences of the new regulations must be reduced by amending the law.

scholarly journals Regulatory developments in the conduct of clinical trials in India

2016 ◽  
Vol 1 ◽  
Author(s):  
R. Roy Chaudhury ◽  
D. Mehta
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Clinical Research ◽  
Supreme Court ◽  
Large Scale ◽  
Ethics Committees ◽  
Informed Consent Process ◽  
Consent Process ◽  
Regulatory Institutions ◽  
Indian Supreme Court

There has been a drop in clinical research in India following stringent conditions put in place by the Indian Supreme Court in 2013. The Court's orders came in the wake of irregularities highlighted in the conduct of clinical trials in the country. This paper highlights the steps taken by the Indian regulator, the Central Drugs Standard Control Organisation to comply with these directions. These are of three kinds: strengthening regulatory institutions, protecting participant safety and creating regulatory certainty for sponsors and investigators. Examples include the large-scale training of Ethics Committees, framing detailed guidelines on compensation and audiovisual recording of the informed consent process, as well as reducing the time taken to process applications. It is expected that these measures will inspire confidence for the much-needed resumption of clinical research.

scholarly journals Challenges and proposed solutions in making clinical research on COVID-19 ethical. A status quo analysis across German research ethics committees

2020 ◽  
Author(s):  
Alice Faust ◽  
Anna Sierawska ◽  
Katharina Krueger ◽  
Anne Wisgalla ◽  
Joerg Hasford ◽  
...  
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Broad Spectrum ◽  
Clinical Studies ◽  
Ethics Committees ◽  
Vulnerable Groups ◽  
Research Ethics Committees ◽  
Scientific Validity ◽  
Study Planning ◽  
Independent Review

Background: In the course of the COVID-19 pandemic, the biomedical research community′s attempt to focus the attention on fighting COVID-19, led to several challenges within the field of research ethics. However, we know little about the practical relevance of these challenges for Research Ethics Committees (RECs). Methods: We conducted a qualitative survey across all 52 German RECs on the challenges and potential solutions with reviewing proposals for COVID-19 studies. We de-identified the answers and applied thematic text analysis for the extraction and synthesis of challenges and potential solutions that we grouped under established principles for clinical research ethics. Results: We received an overall response rate of 42%. The 22 responding RECs reported that they had assessed a total of 441 study proposals on COVID-19 until 21 April 2020. For the review of these proposals the RECs indicated a broad spectrum of challenges regarding i) social value (e.g. lack of coordination), ii) scientific validity (e.g. provisional study planning), iii) favourable risk-benefit ratio (e.g. difficult benefit assessment), iv) informed consent (e.g. strict isolation measures), v) independent review (e.g. lack of time), vi) fair selection of trial participants (e.g. inclusion of vulnerable groups), and vii) respect for study participants (e.g. data security). Mentioned solutions ranged from improved local/national coordination, over guidance on modified consent procedures, to priority setting across clinical studies. Conclusions: RECs are facing a broad spectrum of pressing challenges in reviewing COVID-19 studies. Some challenges for consent procedures are well known from research in intensive care settings but are further aggravated by infection measures. Other challenges such as reviewing several clinical studies at the same time that potentially compete for the recruitment of in-house COVID-19 patients are unique to the current situation. For some of the challenges the proposed solutions in our survey could relatively easy be translated into practice. Others need further conceptual and empirical research. Our findings together with the increasing body of literature on COVID-19 research ethics, and further stakeholder engagement should inform the development of hands-on guidance for researchers, funders, RECs, and further oversight bodies.

scholarly journals Research approvals iceberg: helping it melt away

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Simon E. Kolstoe ◽  
David Carpenter
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Health Research ◽  
Ethics Committees ◽  
Research Network ◽  
Regulatory Environment ◽  
Research Ethics Committees ◽  
The Uk ◽  
Governance Processes ◽  
Local Research

Abstract Background In their paper “Research approvals iceberg: how a ‘low-key’ study in England needed 89 professionals to approve it and how we can do better” Petrova and Barclay highlight concerns with the health research regulatory environment in the UK. Discussion As long-standing chairs of NHS research ethics committees, researchers, and also academics in research ethics, we are also often frustrated with the regulatory process in the UK. However, we think that Petrova and Barclay’s analysis is misleading because it conflates research ethics with governance and funding processes, thus failing to adequately distinguish between the national coordinating function of the Health Research Authority, local research governance processes, and interactions with research sponsors and/or the Clinical Research Network.

scholarly journals Understanding and attitudes of the Jordanian public about clinical research ethics

2020 ◽  
pp. 174701612096677
Author(s):  
Mera A Ababneh ◽  
Sayer I Al-Azzam ◽  
Karem Alzoubi ◽  
Abeer Rababa’h ◽  
Saddam Al Demour
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Ethics Committees ◽  
Public Understanding ◽  
Face To Face ◽  
Knowledge And Attitudes ◽  
Positive Attitudes ◽  
Negative Perceptions ◽  
Knowledge Deficits ◽  
Public Views

In Jordan, research ethics committees exist in most health settings. However, little is known about Jordanian public views regarding the ethics of clinical research. This study aimed to evaluate Jordanian public understanding and attitudes about ethics in clinical research. A questionnaire was used to collect information that included demographics, public knowledge, and attitudes towards ethics in clinical research. It was administered via face-to-face interviews in two major cities in Jordan from 1st June to 15th August 2017. Of the 2315 respondents, 2.33% were found to have poor knowledge, 22.16% had fair knowledge, and 75.51% had good knowledge of ethics in clinical research. Furthermore, 75.81% of respondents had positive attitudes towards ethics in research. However, only 45.23% reported that they trust clinical researchers in Jordan. Even though a large majority of respondents were aware of key features of research ethics, efforts are needed to address negative perceptions and knowledge deficits.

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