Ethical Issues in Emergency Research

2009 ◽  
Vol 5 (3) ◽  
pp. 125-126
Author(s):  
David Hunter
Keyword(s):  
Research Ethics ◽  
Ethical Issues ◽  
Emergency Research ◽  
Next Of Kin ◽  
Research Participants ◽  
Ethics Review ◽  
Research Ethics Review ◽  
Lung Injuries ◽  
Car Crashes

This study appeared in full in the last issue of Research Ethics Review (2009; 5(2): 83). Based on prior research that has indicated it may be beneficial, a researcher wants to administer a heart medication to patients who have suffered lung injuries in car crashes. Due to the emergency nature of the research, seeking consent either from the research participants or, at least initially, their next of kin is difficult.

Ethical Issues in Data Collection: A Commentary

2007 ◽  
Vol 3 (3) ◽  
pp. 89-90
Author(s):  
Paula McGee
Keyword(s):  
Rheumatoid Arthritis ◽  
Data Collection ◽  
Research Ethics ◽  
Ethical Issues ◽  
Ethics Review ◽  
Research Ethics Review

This study appeared in full in the last issue of Research Ethics Review (2007; 3 (2): 53). John Harris is investigating the effectiveness of a new regime for the treatment rheumatoid arthritis. His role involves asking patients to fill out a questionnaire that normally takes about 35 minutes to complete. The case study outlines three events: a patient whose eyesight is poor, another who cannot read and a receptionist who is discovered reading some of the completed questionnaires.

Inadequacy of ethical conduct and reporting of stepped wedge cluster randomized trials: Results from a systematic review

2017 ◽  
Vol 14 (4) ◽  
pp. 333-341 ◽  
Author(s):  
Monica Taljaard ◽  
Karla Hemming ◽  
Lena Shah ◽  
Bruno Giraudeau ◽  
Jeremy M Grimshaw ◽  
...  
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Randomized Trials ◽  
Cluster Randomized Trials ◽  
Stepped Wedge ◽  
Research Participants ◽  
Ethics Review ◽  
Research Ethics Review ◽  
Stepped Wedge Trials ◽  
Cluster Randomized

Background/aims The use of the stepped wedge cluster randomized design is rapidly increasing. This design is commonly used to evaluate health policy and service delivery interventions. Stepped wedge cluster randomized trials have unique characteristics that complicate their ethical interpretation. The 2012 Ottawa Statement provides comprehensive guidance on the ethical design and conduct of cluster randomized trials, and the 2010 CONSORT extension for cluster randomized trials provides guidelines for reporting. Our aims were to assess the adequacy of the ethical conduct and reporting of stepped wedge trials to date, focusing on research ethics review and informed consent. Methods We conducted a systematic review of stepped wedge cluster randomized trials in health research published up to 2014 in English language journals. We extracted details of study intervention and data collection procedures, as well as reporting of research ethics review and informed consent. Two reviewers independently extracted data from each trial; discrepancies were resolved through discussion. We identified the presence of any research participants at the cluster level and the individual level. We assessed ethical conduct by tabulating reporting of research ethics review and informed consent against the presence of research participants. Results Of 32 identified stepped wedge trials, only 24 (75%) reported review by a research ethics committee, and only 16 (50%) reported informed consent from any research participants—yet, all trials included research participants at some level. In the subgroup of 20 trials with research participants at cluster level, only 4 (20%) reported informed consent from such participants; in 26 trials with individual-level research participants, only 15 (58%) reported their informed consent. Interventions (regardless of whether targeting cluster- or individual-level participants) were delivered at the group level in more than two-thirds of trials; nine trials (28%) had no identifiable data collected from any research participants. Overall, only three trials (9%) indicated that a waiver of consent had been granted by a research ethics committee. When considering the combined requirement of research ethics review and informed consent (or a waiver), only one in three studies were compliant. Conclusion The ethical conduct and reporting of key ethical protections in stepped wedge trials, namely, research ethics review and informed consent, are inadequate. We recommend that stepped wedge trials be classified as research and reviewed and approved by a research ethics committee. We also recommend that researchers appropriately identify research participants (which may include health professionals), seek informed consent or appeal to an ethics committee for a waiver of consent, and include explicit details of research ethics approval and informed consent in the trial report.

Randomised evaluation of government health programmes does present a challenge to standard research ethics frameworks

2019 ◽  
Vol 46 (1) ◽  
pp. 34-35
Author(s):  
Samuel I Watson ◽  
Mary Dixon-Woods ◽  
Richard J Lilford
Keyword(s):  
Research Ethics ◽  
Ethical Review ◽  
Recent Issue ◽  
Human Welfare ◽  
Research Participants ◽  
Ethics Review ◽  
Research Ethics Review ◽  
Unethical Research ◽  
Health Programmes ◽  
Roll Out

AbstractIn a recent issue of Journal of Medical Ethics (JME), we discussed the ethical review of evaluations of interventions that would occur whether or not the evaluation was taking place. We concluded that standard research ethics frameworks including the Ottawa Statement, which requires justification for all aspects of an intervention and its roll-out, were a poor guide in this area. We proposed that a consideration of researcher responsibility, based on the consequences of the research taking place, would be a more appropriate way delineate the scope of research ethics review. Weijer and Taljaard present a counterargument to our proposal, which we address in this reply. They claim that a focus on researcher responsibility will weaken the protection of research participants and link it to ‘unethical research’ and a ‘government experimenting on its own people’. However, the moral responsibility of researchers is defined in terms of the consequences of the research on human welfare and harm, not in opposition to it. Weijer and Taljaard argue that researchers must justify what they are studying whether or not they have any control over it and that governments must justify their programmes, including by demonstrating equipoise, to a research ethics committee if they implement them in a randomised way. We strongly disagree that this is a defensible way to define the scope of research ethics review and argue that this provides no further protections to research participants beyond what we propose, but places a potential barrier to learning from government programmes.

Ethical Issues in Researching Pregnant Women: A Commentary

2007 ◽  
Vol 3 (2) ◽  
pp. 51-52 ◽  
Author(s):  
Shirley Jones ◽  
Paula McGee
Keyword(s):  
Magnetic Resonance Imaging ◽  
Magnetic Resonance ◽  
Pregnant Women ◽  
Research Ethics ◽  
Ethical Issues ◽  
Resonance Imaging ◽  
Healthy Women ◽  
Ethics Review ◽  
Research Ethics Review ◽  
Singleton Pregnancies

This study appeared in full in the last issue of Research Ethics Review (2007; 3(1): 18). Rowena Jones is an obstetrician working in a busy hospital for women. Her research focuses on changes in women's brains during pregnancy1. Rowena plans to use magnetic resonance imaging to record images of the brains of women in the second and third trimesters and after birth at 6 and 24 weeks. Her sample consists of two groups of healthy women with uncomplicated and singleton pregnancies, the first primigravid and the second multiparous. There will be a minimum of five and a maximum of ten women in each group.

A Novel Framework for Reflecting on the Functioning of Research Ethics Review Panels

2007 ◽  
Vol 14 (1) ◽  
pp. 99-116 ◽  
Author(s):  
Colin Macduff ◽  
Andrew McKie ◽  
Sheelagh Martindale ◽  
Anne Marie Rennie ◽  
Bernice West ◽  
...  
Keyword(s):  
Health Care ◽  
Nursing Education ◽  
Research Ethics ◽  
Health Care Professionals ◽  
Rapid Change ◽  
Health Care Research ◽  
Ethical Review ◽  
Review Panel ◽  
Ethics Review ◽  
Research Ethics Review

In the past decade structures and processes for the ethical review of UK health care research have undergone rapid change. Although this has focused users' attention on the functioning of review committees, it remains rare to read a substantive view from the inside. This article presents details of processes and findings resulting from a novel structured reflective exercise undertaken by a newly formed research ethics review panel in a university school of nursing and midwifery. By adopting and adapting some of the knowledge to be found in the art and science of malt whisky tasting, a framework for critical reflection is presented and applied. This enables analysis of the main contemporary issues for a review panel that is primarily concerned with research into nursing education and practice. In addition to structuring the panel's own literary narrative, the framework also generates useful visual representation for further reflection. Both the analysis of issues and the framework itself are presented as of potential value to all nurses, health care professionals and educationalists with an interest in ethical review.

scholarly journals Bringing Ethics Review Home to Cowichan: Indigenizing Ethics Review in British Columbia, Canada

2021 ◽  
Vol 16 (2) ◽  
Author(s):  
Cowichan Tribes
Keyword(s):  
British Columbia ◽  
Research Ethics ◽  
First Nations ◽  
Indigenous Peoples ◽  
Preterm Births ◽  
High Rate ◽  
Community Members ◽  
Ethics Review ◽  
Research Ethics Review ◽  
United Nations Declaration

Cowichan Tribes’ territory, located in the Cowichan Valley on Vancouver Island, British Columbia, Canada, is experiencing an alarmingly high rate of preterm births compared to the national average of Indigenous Peoples in Canada. In response, and in partnership with the First Nations Health Authority (FNHA), Cowichan Tribes is in the first year of a 3-year study to investigate causes. Cowichan Tribes’ Elders and community members are guiding the study to ensure it follows Cowichan Tribes’ research processes and to support self- determination in research. Furthermore, as a way to enhance reconciliation, Elders and community members guided an on-site ethics review on Cowichan Tribes territory. This article outlines the collaborative, in-person research ethics review process that Cowichan Tribes, Island Health, and FNHA completed on August 21, 2019. The purpose of this article is to provide suggestions other First Nations could use when conducting a research ethics review, and to explain how this process aligns with the principles of ownership, control, access, and possession (OCAP®), the United Nations Declaration on the Rights of Indigenous Peoples, the Truth and Reconciliation Commission of Canada, and above all, the Cowichan snuw’uy’ulh (teachings from Elders).

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