scholarly journals Adherence with reporting of ethical standards in COVID-19 human studies: a rapid review

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lydia O’Sullivan ◽  
Ronan P. Killeen ◽  
Peter Doran ◽  
Rachel K. Crowley
Keyword(s):  
Informed Consent ◽  
Case Studies ◽  
Observational Studies ◽  
Case Series ◽  
Rapid Review ◽  
Ethical Standards ◽  
Ethical Guidelines ◽  
Editorial Policies ◽  
Research Participants ◽  
Declaration Of Helsinki

Abstract Background Patients with COVID-19 may feel under pressure to participate in research during the pandemic. Safeguards to protect research participants include ethical guidelines [e.g. Declaration of Helsinki and good clinical practice (GCP)], legislation to protect participants’ privacy, research ethics committees (RECs) and informed consent. The International Committee of Medical Journal Editors (ICMJE) advises researchers to document compliance with these safeguards. Adherence to publication guidelines has been suboptimal in other specialty fields. The aim of this rapid review was to determine whether COVID-19 human research publications report compliance with these ethical safeguards. Methods A rapid systematic literature review was conducted in MEDLINE using the search term ‘COVID-19’. The search was performed in April 2020 with no start date and repeated to include articles published in November 2020. Filters were ‘Full free text available’ and ‘English Language’. Two reviewers assessed article title, abstracts and full texts. Non-COVID-19 articles and non-clinical studies were excluded. Independent reviewers conducted a second assessment of a random 20% of articles. The outcomes included reporting of compliance with the Declaration of Helsinki and GCP, REC approval, informed consent and participant privacy. Results The searches yielded 1275 and 1942 articles of which 247 and 717 were deemed eligible, from the April  search and November respectively. The majority of journals had editorial policies which purported to comply with ICMJE ethical standards. Reporting of compliance with ethical guidelines was low across all study types but was higher in the November search for case series and observational studies. Reporting of informed consent for case studies and observational studies was higher in the November search, but similar for case series. Overall, participant confidentiality was maintained but some case studies included a combination of details which would have enabled participant identification. Reporting of REC approval was higher in the November search for observational studies. Conclusions While the majority of journal’s editorial policies purported to support the ethical safeguards, many COVID-19 clinical research publications identified in this rapid review lacked documentation of these important safeguards for research participants. In order to promote public trust, ethical declarations should be included consistently.

Editorial

2006 ◽  
Vol 3 (5) ◽  
Author(s):  
Tade M Spranger
Keyword(s):  
Informed Consent ◽  
Case Studies ◽  
Biomedical Research ◽  
Genetic Research ◽  
Research Participants ◽  
Legal Questions

AbstractBiomedical research raises manifold ethical and legal questions. Matthew Rimmer's article considers whether the granting of patents in respect of biomedical genetic research should be conditional upon the informed consent of research participants. He focuses upon several case studies like

scholarly journals What do you mean by ‘informed consent’? Ethics in economic development research

2020 ◽  
Author(s):  
Anna Josephson ◽  
Melinda Smale
Keyword(s):  
Developing Countries ◽  
Economic Development ◽  
Informed Consent ◽  
Low Income ◽  
Institutional Review Boards ◽  
Voluntary Participation ◽  
Ethical Standards ◽  
Development Research ◽  
Research Participants ◽  
Institutional Review

The ethical conduct of research requires the informed consent and voluntary participation of research participants. Institutional Review Boards (IRBs) work to ensure that these ethical standards are met. However, incongruities in perspective and practice exist across regions. In this paper, we focus on informed consent as practiced by agricultural and applied economists, with emphasis on research conducted in low income and/or developing countries. IRB regulations are clear but heterogeneous, emphasizing process, rather than outcome. The lack of IRBs and institutional reviews in some contexts and the particulars of the principles employed in others may fail to adequately protect research participants.

scholarly journals Being a good spy: Legitimizing access to web-based observation

2015 ◽  
Vol 9 (2) ◽  
pp. 19 ◽  
Author(s):  
Ingeborg Grønning
Keyword(s):  
Informed Consent ◽  
Methodological Approach ◽  
Ethical Standards ◽  
Online Forums ◽  
Ethical Guidelines ◽  
High Quality ◽  
High Quality Research ◽  
Web Based ◽  
Complex Issue ◽  
The Public

<p>Observation of online forums is a relevant methodological approach for researchers in several disciplines. However, ethical guidelines on such observations challenge the ethically concerned researcher. In this paper, I reflect on how I carried out my observation of an online weight-loss forum, and how I could have conducted it differently to meet ethical standards and the demands of high-quality research. After receiving approval from the forum administrators to observe the forum, information about my project on obesity was posted online. Some of the participants reacted negatively to my presence in the forum. This paper draws on the evolving discussion between researcher and participants on the complex issue of research ethics, particularly informed consent, in studying closed forums on the Internet. It is suggested that evaluating whether participants are harmed is more important than the public/private divide when considering whether informed consent is necessary.</p>

Miami Heat: Patent Law, Informed Consent and Benefit-Sharing

2006 ◽  
Vol 3 (5) ◽  
Author(s):  
Matthew Rimmer
Keyword(s):  
Informed Consent ◽  
Case Studies ◽  
Genetic Research ◽  
Patent Law ◽  
Benefit Sharing ◽  
Research Participants

AbstractThis article considers whether the granting of patents in respect of biomedical genetic research should be conditional upon the informed consent of research participants. It focuses upon several case studies.

Informed consent: Towards improved lay-friendliness of patient information sheets

2014 ◽  
Vol 10 (3) ◽  
pp. 201-211
Author(s):  
Morten Pilegaard ◽  
Hanne Berg Ravn
Keyword(s):  
Informed Consent ◽  
Information Structure ◽  
Language Use ◽  
Ethical Standards ◽  
Structured Interviews ◽  
Explorative Study ◽  
Microsoft Word ◽  
Text Production ◽  
Linguistic Intervention ◽  
Set Up

Regional research ethics committee (REC) members have voiced a need for the linguistic improvement of informed consent documents to ensure duly informed consent and to ease committee deliberation. We have little knowledge of what elements of language use hamper comprehension, or of the extent of medical researchers’ appreciation of this problem and their willingness to accept intervention. This qualitative, explorative study proposes an intervention design and tests its feasibility and acceptability. Semi-structured interviews with potential REC applicants informed a linguistic intervention benchmarked against existing guidelines, mandated locally and nationally, and then evaluated quantitatively in a semi-controlled set-up and qualitatively via questionnaires. Potential applicants professed the psychological acceptability of linguistic intervention. The intervention comprised a downloadable Microsoft Word template outlining information structure, a detailed guideline offering advice for each move and self-selected linguistic screening. It was used by 14 applicants and had a measurable effect on REC deliberation time and approval rates. The intervention instruments overall made it easier for applicants to produce informed consent documents meeting prescribed ethical standards concerning lay-friendliness. In conclusion, it was found that linguistic intervention is relevant, feasible and psychologically acceptable to REC applicants; it aids their text production process and seems to enhance the lay-friendliness of these texts.

Commentary 1: Research with Persons Under Involuntary Commitment—Ethical Issues Surrounding Competence and Voluntariness

2019 ◽  
Vol 14 (5) ◽  
pp. 475-478
Author(s):  
Matthé Scholten ◽  
Jochen Vollmann
Keyword(s):  
Informed Consent ◽  
Ethical Issues ◽  
Research Participation ◽  
Research Participant ◽  
Involuntary Commitment ◽  
Proxy Consent ◽  
Undue Influence ◽  
Research Participants ◽  
Manic Symptoms ◽  
Prospective Research

In this case commentary, we analyze ethical concerns that were raised in response to an interview with a woman with bipolar disorder who was under involuntary commitment. We focus on competence and voluntariness as two prerequisites for valid informed consent. We recommend that judgments of competence be based on whether prospective research participants sufficiently possess certain decision-making abilities. Based on this functional approach, we argue that manic symptoms need not undermine competence and that, even if we were to assume that the research participant became incompetent during the interview, this would not invalidate her consent retroactively. It would, however, compromise her ability to revoke her consent. We furthermore show that obtaining additional proxy consent for research participation may compromise the autonomy of service users who are competent to consent. Then we turn to the issue of voluntariness. Arguing that neither the great strength nor the external etiology of a desire compromises voluntariness, we propose that the voluntariness of a decision instead depends on whether the decision-maker endorses it on reflection. The researchers disclosed that prospective research participants’ decision about study participation would have no influence on the duration of the commitment or the quality of care. We contend that because of this neither coercion nor undue influence was exerted in the informed consent process. Nevertheless, there is an increased likelihood of perceived coercion and undue influence under conditions of involuntary commitment, and we close by suggesting some safeguards to prevent this.

scholarly journals Informed Consent and the Disclosure of Clinical Results to Research Participants

2017 ◽  
Vol 17 (7) ◽  
pp. 58-60 ◽  
Author(s):  
Alessandro Blasimme ◽  
Celine Moret ◽  
Samia A. Hurst ◽  
Effy Vayena
Keyword(s):  
Informed Consent ◽  
Clinical Results ◽  
Research Participants

scholarly journals Use of androgenic anabolic steroids by patients under treatment for substance use disorder: case series

2017 ◽  
Vol 66 (2) ◽  
pp. 120-123 ◽  
Author(s):  
Julio Mario Xerfan do Amaral ◽  
Marcelo Santos Cruz
Keyword(s):  
Mental Health ◽  
Substance Use ◽  
Case Studies ◽  
Substance Use Disorder ◽  
Mental Health Professionals ◽  
Health Professionals ◽  
Anabolic Steroids ◽  
Case Series ◽  
Structured Interview ◽  
Androgenic Anabolic Steroids

ABSTRACT The present study reports several case studies about the use of androgenic-anabolic steroids (AAS) by patients under treatment for substance use disorder (SUD). Ten subjects were interviewed, two women and eight men, ranging from 25 to 43 years old. Regarding treatment regime, eight subjects were inpatients and two, outpatients. ASSIST-WHO and MINI-SUD scales and a semi-structured interview were used as research instruments. Seven subjects reported the use of AAS within fewer than twelve months from the interview date. Mental health professionals did not previously question none of the subjects were about the use of AAS. We discuss the efficacy of the chosen instruments to assess AAS use.

scholarly journals Assessment of the Appropriateness of the i-CONSENT Guideline Recommendations for Improving Understanding of the Informed Consent Process in Clinical Studies

2021 ◽  
Author(s):  
Jaime Fons-Martínez ◽  
Cristina Ferrer-Albero ◽  
Javier Diez-Domingo
Keyword(s):  
Informed Consent ◽  
Clinical Studies ◽  
Informed Consent Process ◽  
Consent Process ◽  
Ethical Guidelines ◽  
Potential Participant ◽  
Virtual Meeting ◽  
Continuous Interaction ◽  
And Gender ◽  
First Contact

Abstract Background: The H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders.Methods: An adaptation of the RAND/UCLA Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, regulators, investigators, ethics experts, and the pharmaceutical industry. The process included two rounds of rating and a virtual meeting.Results: Fifty-three recommendations were evaluated. After the first round, 34 recommendations were judged appropriate; 19 were judged uncertain; and none was judged inappropriate. After the second round, 9 uncertains changed to appropriate. All recommendations rated medians of 6.5-9 on a 1-9 scale (1 = extremely inappropriate, 5 = uncertain, 9 = extremely appropriate).The sections “General recommendations” and “Gender perspective during the consent process for clinical studies” showed the highest uncertainty rating. The four keys to improving the understanding of the ICP in clinical studies are to: (1) consider consent a two-way continuous interaction that begins at the first contact with the potential participant and continues until the end of the study; (2) improve investigators’ communication skills; (3) co-create the information; and (4) use a layered approach, including information to compensate for the potential participant’s possible lack of health literacy and a glossary of terms.Conclusions: The RAND/UCLA method has demonstrated validity for assessing the appropriateness of recommendations in ethical guidelines. The recommendations of the i-CONSENT guidelines were mostly judged appropriate by all stakeholders involved in the informed consent process.

Sign in / Sign up

Export Citation Format

Share Document