Informed Consent Documents Used in Critical Care Trials Often Do Not Implement Recommendations*

Atwere, Pearl; McIntyre, Lauralyn; Carroll, Kelly; Hayes, Tavis; Brehaut, Jamie

doi:10.1097/ccm.0000000000002815

Cited by 8 publications

(7 citation statements)

References 33 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…This study examined study documents provided to consultees and legal representatives who are involved in decisions about research participation on behalf of an adult who lacks capacity to consent. Although there are important conceptual differences between providing consent for ourselves and on behalf of another, the results from this study supported previous research that found that many study documents lack items deemed to be important for promoting high-quality decisions [12, 24]. A lack of information about the proxy’s role and the legal basis for his/her decision risks failing to meet the requirements for decisions about research participation to be fully informed, and may therefore threaten the ethical conduct of such research [25].…”

Section: Discussionsupporting

confidence: 86%

Research involving adults lacking capacity to consent: a content analysis of participant information sheets for consultees and legal representatives in England and Wales

Shepherd

Wood

Griffith

et al. 2019

Trials

View full text Add to dashboard Cite

Background Research involving adults who lack the capacity to provide informed consent can be challenging. In England and Wales there are legal provisions for consulting with others who know the person with impaired capacity. The role of the ‘proxy’ (or ‘surrogate’) is to advise researchers about the person’s wishes and feelings or to provide consent on the person’s behalf for a clinical trial of a medicine. Information about the study is usually provided to the proxy; however, little information is available to proxies about their role, or the appropriate legal and ethical basis for their decision, to help inform their decision-making. The aim of this study was to analyse the written information that is provided to consultees and legal representatives. Methods Studies including adults lacking capacity to consent which utilised consultees or legal representatives were identified using the UK Clinical Trials Gateway database. A representative sample ( n = 30) were randomly selected. Information sheets and other study documents provided to proxies were obtained, and relevant content was extracted. Content analysis was conducted through four stages: decontextualisation of the unit of analysis, recontextualisation, categorisation, and compilation. The data were summarised narratively according to each theme and category. Results Considerable variation was found in the written information sheets provided to proxies. Most directed proxies to consider the wishes and feelings of the person who lacked capacity and to consult with others during the decision-making process. However, a small number of studies extended the scope of the proxy’s role to consider the person’s suitability or eligibility for the study. Particular discrepancies were found in information provided to those acting as consultees or legal representatives in a professional, as opposed to a personal, capacity. Incorrect uses of terminology were frequently found, and a small number of studies inaccurately interpreted the law. Conclusions Despite undergoing ethical review, study documents lacked essential information, incorrectly used terminology, and conflated professionals’ clinical and representation roles. Future recommendations include ensuring proxies are provided with adequate and accurate information which complies with the legal frameworks. Further research is needed to explore the information and decision-making needs of those acting as consultees and legal representatives. Electronic supplementary material The online version of this article (10.1186/s13063-019-3340-5) contains supplementary material, which is available to authorized users.

show abstract

Section: Discussionsupporting

confidence: 86%

Research involving adults lacking capacity to consent: a content analysis of participant information sheets for consultees and legal representatives in England and Wales

Shepherd

Wood

Griffith

et al. 2019

Trials

View full text Add to dashboard Cite

show abstract

“…The representations of the IC by trial participants and physicians are quite varied, but they converge in considering it as a bureaucratic/legal act, difficult to understand and written in "technical" language. These aspects have already emerged in previous studies [6][7][8]. This issue continues to be critical, since the physician's duty to inform the trial participants cannot be reduced to a bureaucratic burden considered fulfilled with the mere acquisition of a "written informed consent form."…”

Section: Discussionmentioning

confidence: 99%

“…However, research has documented that ICs are often written using technical language and thus may confuse participants rather than enlighten them [5,6]. Many participants have a limited understanding of the research or treatment they agree to undergo [1,[6][7][8][9][10][11]. Furthermore, in the literature, there is neither agreement on what the threshold is to be able to consider the understanding of the IC as "sufficient" [11] nor what is the "best practice" available to obtain it [12].…”

Section: Introductionmentioning

confidence: 99%

“…RCTs in oncology follow specific protocols compounded in multistage randomized trials which involve high levels of risks. Evidence-based clinical practice show that morbidity and fatal side effects, as well as aspects dealing with life-prolongation or cure, intensify ethical issues surrounding IC given that severely ill patients have more difficulty understanding than less unable patients [7].…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Expectations, experiences and preferences of patients and physicians in the informed consent process for clinical trials in oncology

Gangeri

Alfieri

Greco

et al. 2021

Support Care Cancer

View full text Add to dashboard Cite

PurposeThe aim of the present study was to explore (1) informed consent (IC) representations, level of understanding, needs, and factors that influence the willingness of cancer patients to participate in randomized controlled trials (RCTs) (phase I) and (2) representations, experiences, and critical issues of physicians involved in the same process (phase II). Methods Semi-structured interviews were conducted with 20 cancer patients who had been asked to enroll in a phase II/III RCT (phase I). Two focus groups were conducted with 13 physicians enrolled in the same process (phase II). The content produced was analyzed through a thematic analysis. ResultsThe themes that emerged in the first phase I were grouped into six categories: IC representation, randomization, experimentation, meeting with the physician, factors that influence the willingness to participate, and trial participants' needs. The themes emerged in the phase II were grouped into four: IC representation, critical issues of the IC, relationship, and recruitment of trial participants. Each theme is articulated into sub-themes and deeply discussed. Conclusion This study highlights (1) the gap between what is ethically demanded in a RCT consultation and the reality of the situation and (2) the difference in perceptions between patients and physicians with reference to the meaning, objectives, and level of understanding of IC.

show abstract

“…The accurate substituted judgments should be morally valid, reflecting the beliefs of the patients and respecting the autonomy of the patients [ 3 , 6 ]. Therefore, obtaining informed consent from the patients in the ICU is a challenge and could pose an ethical dilemma for the researchers [ 7 , 13 ].…”

Section: Introductionmentioning

confidence: 99%

The Attitudes of Relatives of ICU Patients toward Informed Consent for Clinical Research

Mahafzah

Alzoubi

Khabour

2020

Critical Care Research and Practice

View full text Add to dashboard Cite

Background. Informed consent is a key ethical requirement for biomedical research that is implemented to ensure autonomy and voluntary participation. However, patients in the intensive care unit (ICU) may be unconscious or severely ill and thus lack the capacity for decisions about research participation. Thus, relatives or guardians are usually asked to provide informed consent prior to the inclusion of ICU patients in research. Aims. This study aimed to assess the attitudes and preferences of relatives of ICU patients toward informed consent in biomedical research in Jordan. Subjects and Methods. A sample of 184 relatives with a critically ill next of kin in the ICU was anonymously surveyed regarding their attitudes and preferences toward giving informed consent for biomedical research on behalf of their patients. Results. The study showed that the majority of relatives had a positive attitude toward the informed consent process on behalf of their patients in the ICU (72.3%). The perception that participation in research would be directly beneficial to their patient was the most significant reason to provide informed consent among relatives. The degree of relatedness to the patient was significantly associated with the decision to provide informed consent on behalf of the patients in the ICU. Additionally, more than 70% of the relatives strongly agreed to take part in clinical research if they were to be unconscious patients in the ICU. Moreover, the majority of the respondents agreed that their first-degree relatives would give consent on their behalf. Conclusion. Relatives with a critically ill next of kin in the ICU had positive attitudes toward providing informed consent on behalf of their patients. This was motivated by the direct benefit from the research to their patient.

show abstract

Informed Consent Documents Used in Critical Care Trials Often Do Not Implement Recommendations*

Cited by 8 publications

References 33 publications

Research involving adults lacking capacity to consent: a content analysis of participant information sheets for consultees and legal representatives in England and Wales

Research involving adults lacking capacity to consent: a content analysis of participant information sheets for consultees and legal representatives in England and Wales

Expectations, experiences and preferences of patients and physicians in the informed consent process for clinical trials in oncology

The Attitudes of Relatives of ICU Patients toward Informed Consent for Clinical Research

Contact Info

Product

Resources

About