Paying Clinical Research Participants: One Institution's Research Ethics Committees' Perspective

2006 ◽  
Vol 1 (4) ◽  
pp. 37-44 ◽  
Author(s):  
Elizabeth B. D. Ripley ◽  
Frank L. Macrina ◽  
Monika Markowitz
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Research Participants

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.

Protecting vulnerable research participants: A Foucault-inspired analysis of ethics committees

2011 ◽  
Vol 18 (5) ◽  
pp. 640-650 ◽  
Author(s):  
Truls I Juritzen ◽  
Harald Grimen ◽  
Kristin Heggen
Keyword(s):  
Research Ethics ◽  
Academic Freedom ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Research Practices ◽  
Research Participants

History has demonstrated the necessity of protecting research participants. Research ethics are based on a concept of asymmetry of power, viewing the researcher as powerful and potentially dangerous and establishing ethics committees as external agencies in the field of research. We argue in favour of expanding this perspective on relationships of power to encompass the ethics committees as one among several actors that exert power and that act in a relational interplay with researchers and participants. We employ Michel Foucault’s ideas of power as an omnipresent force which is dynamic and unstable, as well as the notion that knowledge and power are inextricably intertwined. The article discusses how research ethics committees may affect academic freedom. In addition it is pointed out that research participants could be harmed — not only by unfortunate research practices, but also by being subjected to the protective efforts of ethics monitoring bodies.

Payment of research participants: current practice and policies of Irish research ethics committees

2012 ◽  
Vol 39 (9) ◽  
pp. 591-593 ◽  
Author(s):  
Eric Roche ◽  
Romaine King ◽  
Helen M Mohan ◽  
Blanaid Gavin ◽  
Fiona McNicholas
Keyword(s):  
Research Ethics ◽  
Current Practice ◽  
Ethics Committees ◽  
Research Ethics Committees ◽  
Research Participants

scholarly journals Informed consent in cluster randomised trials: a guide for the perplexed

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e054213
Author(s):  
Hayden P Nix ◽  
Charles Weijer ◽  
Jamie C Brehaut ◽  
David Forster ◽  
Cory E Goldstein ◽  
...  
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Randomised Trial ◽  
Ethics Committees ◽  
Cluster Randomised Trial ◽  
Research Ethics Committees ◽  
Randomised Trials ◽  
Research Participants ◽  
Inappropriate Use ◽  
Cluster Randomised

In a cluster randomised trial (CRT), intact groups—such as communities, clinics or schools—are randomised to the study intervention or control conditions. The issue of informed consent in CRTs has been particularly challenging for researchers and research ethics committees. Some argue that cluster randomisation is a reason not to seek informed consent from research participants. In fact, systematic reviews have found that, relative to individually randomised trials, CRTs are associated with an increased likelihood of inadequate reporting of consent procedures and inappropriate use of waivers of consent. The objective of this paper is to clarify this confusion by providing a practical and useful framework to guide researchers and research ethics committees through consent issues in CRTs. In CRTs, it is the unit of intervention—not the unit of randomisation—that drives informed consent issues. We explicate a three-step framework for thinking through informed consent in CRTs: (1) identify research participants, (2) identify the study element(s) to which research participants are exposed, and (3) determine if a waiver of consent is appropriate for each study element. We then apply our framework to examples of CRTs of cluster-level, professional-level and individual-level interventions, and provide key lessons on informed consent for each type of CRT.

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 Challenges and proposed solutions in making clinical research on COVID-19 ethical: a status quo analysis across German research ethics committees

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Alice Faust ◽  
Anna Sierawska ◽  
Katharina Krüger ◽  
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

Abstract 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 (1) social value (e.g. lack of coordination), (2) scientific validity (e.g. provisional study planning), (3) favourable risk–benefit ratio (e.g. difficult benefit assessment), (4) informed consent (e.g. strict isolation measures), (5) independent review (e.g. lack of time), (6) fair selection of trial participants (e.g. inclusion of vulnerable groups), and (7) 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 Perspectives of non-specialists on the potential to serve as ethics committee members

2019 ◽  
Vol 47 (5) ◽  
pp. 1868-1876
Author(s):  
Chikako Kane ◽  
Kenshi Takechi ◽  
Masayuki Chuma ◽  
Hiroshi Nokihara ◽  
Tomoko Takagai ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Research Ethics ◽  
Ethics Committees ◽  
Research Review ◽  
Research Ethics Committees ◽  
Review Committee ◽  
Future Studies ◽  
Detailed Explanation ◽  
Key Issues

Objective In Japan, under the new Clinical Trials Act pertaining to investigator-initiated clinical trials that came into effect on 1 April 2018, review boards should review proposed clinical trials while considering written opinions from specialists. Additionally, involvement of non-specialists is mandatory, and attention is being placed on their effective contributions. This study was performed to determine representative key issues with which to promote these contributions. Methods This qualitative study was conducted in 2018 using a focus group interview of six non-specialists regarding perspectives on clinical research itself and research ethics committees. Results For perspectives on clinical research itself, 33 codes were established and sorted into 2 categories and 6 subcategories relating to ambivalence toward clinical research. For perspectives on research ethics committees, 54 codes were established and sorted into 3 categories and 10 subcategories relating to the theme “knowledge and an environment that promotes non-specialist members’ participation.” One notable result was the willingness of participants to obtain details about a study should they be selected. Conclusions The results suggest that detailed explanation of a particular study would encourage non-specialist members to participate in a clinical research review committee. Education aimed at non-specialist participation should therefore be considered in future studies.

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