Novel consent process for research in dying patients unable to give consent.
Ontology highlight
ABSTRACT: Objectives
To develop a process of advance consent to enable research to be undertaken in patients in the terminal phase.Design
Feasibility study of an advance consent process to support a randomised controlled trial of two antimuscarinic drugs (hyoscine hydrobromide and glycopyrronium bromide) in the management of noisy respirations associated with retained secretions ("death rattle").Setting
Palliative care wards in a major cancer centre.Participants
Patients admitted to a palliative care ward who may develop "death rattle" and thus be eligible for randomisation.Main outcome measures
Patient accrual; acceptability of the consent process.Results
Of the 107 patients approached, 58 patients gave advance consent to participate in the study. Of these, 15 patients developed death rattle and were randomised to receive either hyoscine or glycopyrronium; 16 patients died elsewhere; 15 patients died on the palliative care wards but were not randomised; 12 patients are still alive.Conclusions
Initial assessment suggests that this is a workable consent process allowing research to be undertaken in patients who are unable to give consent at the time of randomisation. Patient accrual rates to date are lower than needed to recruit adequate numbers in the time allotted to answer the research question.
SUBMITTER: Rees E
PROVIDER: S-EPMC166125 | biostudies-literature | 2003 Jul
REPOSITORIES: biostudies-literature
Publications
Novel consent process for research in dying patients unable to give consent.
Rees Elizabeth E Hardy Janet J
BMJ (Clinical research ed.) 20030701 7408
<h4>Objectives</h4>To develop a process of advance consent to enable research to be undertaken in patients in the terminal phase.<h4>Design</h4>Feasibility study of an advance consent process to support a randomised controlled trial of two antimuscarinic drugs (hyoscine hydrobromide and glycopyrronium bromide) in the management of noisy respirations associated with retained secretions ("death rattle").<h4>Setting</h4>Palliative care wards in a major cancer centre.<h4>Participants</h4>Patients ad ...[more]
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Project description:BackgroundUnder the Canadian Criminal Code, medical assistance in dying (MAiD) requires that patients give informed consent and that their ability to consent is assessed by 2 clinicians. In this study, we intended to understand how Canadian clinicians assessed capacity in people requesting MAiD.MethodsThis qualitative study used interviews conducted between August 2019 and February 2020, by phone, video and email, to explore how clinicians assessed capacity in people requesting MAiD, what challenges they had encountered and what tools they used. The participants were recruited from provider mailing listserves of the Canadian Association of MAiD Assessors and Providers and Aide médicale à mourir. Interviews were audio-recorded and transcribed verbatim. The research team met to review transcripts and explore themes as they emerged in an iterative manner. We used abductive reasoning for thematic analysis and coding, and continued to discuss until we reached consensus.ResultsThe 20 participants worked in 5 of 10 provinces across Canada, represented different specialties and had experience assessing a total of 2410 patients requesting MAiD. The main theme was that, for most assessments, the participants used the conversation about how the patient had come to choose MAiD to get the information they needed. When the participants used formal capacity assessment tools, this was mostly for meticulous documentation, and they rarely asked for psychiatric consults. The participants described how they approached assessing cases of nonverbal patients and other challenging cases, using techniques such as ensuring a quiet environment and adequate hearing aids, and using questions requiring only "yes" or "no" as an answer.InterpretationThe participants were comfortable doing MAiD assessments and used their clinical judgment and experience to assess capacity in ways similar to other clinical practices. The findings of this study suggest that experienced MAiD assessors do not routinely require formal capacity assessments or tools to assess capacity in patients requesting MAiD.
| S-EPMC8084565 | biostudies-literature
Project description:The increased international sharing of data in research consortia and the introduction of new technologies for sequencing challenge the informed consent (IC) process, adding complexities that require coordination between research centres worldwide. Rare disease consortia present special challenges since available data and samples may be very limited. Thus, it is especially relevant to ensure the best use of available resources but at the same time protect patients' right to integrity. To achieve this aim, there is an ethical duty to plan in advance the best possible consent procedure in order to address possible ethical and legal hurdles that could hamper research in the future. Therefore, it is especially important to identify key core elements (CEs) to be addressed in the IC documents for international collaborative research in two different situations: (1) new research collections (biobanks and registries) for which information documents can be created according to current guidelines and (2) established collections obtained without IC or with a previous consent that does not cover all CEs. We propose here a strategy to deal with consent in these situations. The principles have been applied and are in current practice within the RD-Connect consortia - a global research infrastructure funded by the European Commission Seventh Framework program but forward looking in terms of issues addressed. However, the principles established, the lessons learned and the implications for future research are of direct relevance to all internationally collaborative rare-disease projects.
| S-EPMC4989211 | biostudies-literature
Project description:ObjectivesSeeking consent for minimal risk research in the ICU poses challenges, especially when the research is time-sensitive. Our aim was to determine the extent to which ICU patients or surrogates support a deferred consent process for a minimal risk study without the potential for direct benefit.DesignProspective cohort study.SettingFive ICUs within a tertiary care hospital.PatientsNewly admitted ICU patients 18 years old or older.InterventionsWe administered an eight-item verbal survey to patients or surrogates approached for consent to participate in a minimal risk, ICU-based study. The parent study involved noninvasive collection of biosamples and clinical data at the time of ICU admission and again 3 days later. If patients had capacity at the time of ICU admission, or if a surrogate was readily available, consent was sought prior to initial sample collection; otherwise, a waiver of consent was granted, and deferred consent was sought 3 days later. Quantitative and qualitative data were analyzed.Measurements and main resultsOne hundred fifty-seven individuals were approached for consent to participate in the parent study; none objected to the consent process. One hundred thirty-five of 157 (86%) competed the survey, including 94 who consented to the parent study and 41 who declined. Forty-four of 60 individuals (73%) approached for deferred consent responded positively to the question "Did we make the right choice in waiting until now to ask your consent?" three of 60 (5%) responded negatively, and 13 of 60 (22%) made a neutral or unrelated response. The most common reason given for endorsing the deferred consent process was the stress of the early ICU experience 25 of 44 (61%).ConclusionsMost patients and surrogates accept a deferred consent process for minimal risk research in the ICU. For appropriate ICU-based research, investigators and Institutional Review Boards should consider a deferred consent process if the subject lacks capacity and an appropriate surrogate is not readily available.
| S-EPMC5661876 | biostudies-literature
Project description:Background: Currently, many initiatives are devoted to optimizing informed consent for participation in clinical research. Due to the digital transformation in health care, a shift toward electronic informed consent (eIC) has been fostered. However, empirical evidence on how to implement eIC in clinical research involving neonates is lacking. Methods: Semi-structured interviews were conducted with 31 health care professionals active in Belgium or the Netherlands. All health care professionals had experience in conducting clinical research involving neonates. Interviews were audio-recorded, transcribed and analyzed using the framework method. Results: Interviewees generally supported the use of eIC in clinical research involving neonates. For example, eIC could enable parents to receive study feedback via the eIC system. Requirements were expressed for parental involvement to decide on which feedback would be appropriate to return. Moreover, experts specialized in presenting information and designing electronic systems should be involved. Broad consensus among health care professionals indicates that the face-to-face-interaction between parents and the research team is vital to establish a relationship of trust. Therefore, it is necessary that the use of eIC runs alongside personal interactions with the parents. Concerns were raised about the accessibility of eIC to parents. For this reason, it was suggested that parents should always be given the possibility to read and sign a paper-based informed consent form or to use eIC. Conclusions: Health care professionals' views indicate that the use of eIC in clinical research with neonates may offer various opportunities. Further development and implementation will require a multi-stakeholder approach.
| S-EPMC8441012 | biostudies-literature
Project description:UNLABELLED: Consent for a clinical anesthesia research trial is frequently sought in hospital on the day of surgery. This time is often associated with increased anxiety, diminished privacy, and limited opportunity for reflection. Our objective was to determine whether a preadmission telephone call on the day before surgery resulted in greater satisfaction compared to the traditional practice of initiating the consent process on the day of surgery. We randomized 124 patients eligible for participation in a minimal-risk clinical anesthesia trial to receive either a preadmission telephone call on the day before surgery to initiate consent (Telephone group; n = 62), or no telephone call (Control group; n = 62). In the Telephone group, 21 patients (33.9%) were successfully contacted by telephone, whereas 41 patients (66.1%) were not contacted. Both the Telephone and Control groups reported similar understanding regarding the purpose of the trial. Both groups similarly agreed that the time and setting of recruitment and consent were appropriate. Patients in both groups reported having enough time to consider their participation in the trial. Few patients in either group reported feeling anxious at the time of consent or pressured to participate in the trial. Finally, patients in both groups were equally satisfied with the consent process. IMPLICATIONS: A preadmission telephone call on the day before surgery to initiate the consent process for a minimal-risk clinical anesthesia research trial does not improve satisfaction among consenting patients compared to initiating consent in hospital on the day of surgery, and can be an impractical method to initiate the consent process.
| S-EPMC2504112 | biostudies-other
Project description:BACKGROUND:A challenge of conducting research in critically ill children is that the therapeutic window for the intervention may be too short to seek informed consent prior to enrolment. In specific circumstances, most international ethical guidelines allow for children to be enrolled in research with informed consent obtained later, termed deferred consent (DC) or retrospective consent. There is a paucity of data on the attitudes of parents to this method of enrolment in paediatric emergency research. OBJECTIVES:To explore the attitudes of parents to the concept of DC and to expand the knowledge of the limitations to informed consent and DC in these situations. METHOD:Children presenting with uncomplicated febrile seizures or bronchiolitis were identified from three separate hospital emergency department databases. Parents were invited to participate in a semistructured telephone interview exploring themes of limitations of prospective informed consent, acceptability of the DC process and the most appropriate time to seek DC. Transcripts underwent inductive thematic analysis with intercoder agreement, using Nvivo 11 software. RESULTS:A total of 39 interviews were conducted. Participants comprehended the limitations of informed consent under emergency circumstances and were generally supportive of DC. However, they frequently confused concepts of clinical care and research, and support for participation was commonly linked to their belief of personal benefit. CONCLUSION:Participants acknowledged the requirement for alternatives to prospective informed consent in emergency research, and were supportive of the concept of DC. Our results suggest that current research practice seems to align with community expectations.
| S-EPMC5695338 | biostudies-literature
Project description:BackgroundThe process of informed consent for enrolment to a clinical research study can be complex for both participants and research staff. Challenges include respecting the potential participant's autonomy and information needs while simultaneously providing adequate information to enable an informed decision. Qualitative research with small sample sizes has added to our understanding of these challenges. However, there is value in garnering the perspectives of research participants and staff across larger samples to explore the impact of contextual factors (time spent, the timing of the discussion and the setting), on the informed consent process.MethodsResearch staff and research participants from Ireland and the UK were invited to complete an anonymous survey by post or online (research participants) and online (research staff). The surveys aimed to quantify the perceptions of research participants and staff regarding some contextual factors about the process of informed consent. The survey, which contained 14 and 16 multiple choice questions for research participants and staff respectively, was analysed using descriptive statistics. Both surveys included one optional, open-ended question, which were analysed thematically.ResultsResearch participants (169) and research staff (115) completed the survey. Research participants were predominantly positive about the informed consent process but highlighted the importance of having sufficient time and the value of providing follow-up once the study concludes, e.g. providing results to participants. Most staff (74.4%) staff reported that they felt very confident or confident facilitating informed consent discussions, but 63% felt information leaflets were too long and/or complicated, 56% were concerned about whether participants had understood complex information and 40% felt that time constraints were a barrier. A dominant theme from the open-ended responses to the staff survey was the importance of adequate time and resources.ConclusionsResearch participants in this study were overwhelmingly positive about their experience of the informed consent process. However, research staff expressed concern about how much participants have understood and studies of patient comprehension of research study information would seem to confirm these fears. This study highlights the importance of allocating adequate time to informed consent discussions, and research staff could consider using Teach Back techniques.Trial registrationNot applicable.
| S-EPMC8371296 | biostudies-literature
Project description:BackgroundThe informed consent process aims to provide potential participants with information about health research that enables them to make an informed decision as to whether they choose to participate, or not. However, it remains unclear as to whether the process is effective for those who are under-served in health research. It is a pivotal issue within health research that the diversity of people who participate is broadened. The National Institute for Health Research (NIHR) pledges to support equality, diversity and inclusion, actively creating opportunities for all citizens whom are eligible, to take part in health research.MethodsIn order to understand how the informed consent process for under-served populations in health research works, under what circumstances and in what respects, a realist review approach will be undertaken. Searches will be carried out using electronic databases (EMBASE, MEDLINE, Web of Science and PsycINFO), along with selected websites and grey literature. Development of initial rough programme theory(ies) will lead to a more refined programme theory that will provide an explanation of context, mechanism and outcomes. Stakeholder involvement by NIHR (Public) Research Champions, health professionals and clinical academics will provide expert opinion about concepts and programme theory.DiscussionFindings of this realist review will highlight how the informed consent process in health research affects the experience and decision-making process of potential participants from under-served populations. They will be written up in accordance with RAMESES guidelines and disseminated to patients and the public, health researchers, health professionals and policymakers through peer-reviewed publication, presentations and discussions. The review will contribute to our understanding of the mechanisms that cause both positive and negative outcomes in the informed consent process for those whom are often under-represented in health research to inform policy, study design and delivery.
| S-EPMC8034278 | biostudies-literature
Project description:Background/aimsMany investigators have tested interventions to improve research participant understanding of information shared during the informed consent process, using a variety of methods and with mixed results. A valid criticism of most consent research is that studies are often conducted in simulated research settings rather than ongoing clinical studies. The present study rigorously tested two simple and easily adoptable strategies for presenting key consent information to participants eligible to enroll in six actual clinical trials (i.e. six parent studies).MethodsIn collaboration with the study team from each parent study, we developed two consent interventions: a fact sheet and an interview-style video. The content of each of the intervention was based on the information shared in the consent form approved for each parent study. Participants were randomized to the standard consent process, or to one of the two interventions. Once exposed to the assigned consent mode, participants were asked to complete an assessment of understanding. The study was powered to determine whether those exposed to the fact sheet or video performed better on the consent assessment compared to those exposed to the standard consent. We also assessed participant satisfaction with the consent process.ResultsA total of 284 participants were randomized to one of the three consent arms. Assessments of understanding were completed with a total of 273 participants from July 2017 to April 2019. Participants exposed to the video had better understanding scores compared to those exposed to the standard consent form process (p value = 0.020). Participants were more satisfied with the video when compared to the standard consent. Participants who received the fact sheet did not achieve higher overall understanding or satisfaction scores when compared to the standard consent process.ConclusionThis randomized study of two novel consent interventions across six different clinical trials demonstrated a statistically significant difference in participant understanding based on overall scores among those exposed to the video intervention compared to those exposed to the standard consent.
| S-EPMC10173028 | biostudies-literature
Project description:There is increasing evidence that clinical trial participants are uninformed about the trials in which they participate, raising ethical concerns regarding informed consent. The aim of this pilot study was to explore clinical trial participants' use of consent discussions and information sheets when considering participating in clinical trials research. A qualitative, interview-based pilot study was designed in order to elicit, through dialogue, details of the reasons for participants' use of, and preferences regarding, different modes of information provision. Semi-structured interviews were undertaken with two different groups of patients who were participants in the Reinforcement of Closure of Stoma Site trial. The first group comprised newly-consented trial participants, who had been recruited up to 72 hours before our interview; the second group comprised patients attending a follow-up clinic 12 months after joining the trial. Thirteen participants were recruited in total: three newly-consented patients, and ten follow-up patients. The study found that participants' use of consent discussions to gain information about clinical trials was varied, and that they only minimally used information sheets after providing initial consent for the trial. Participants demonstrated varying degrees of knowledge about the trial, with some having forgotten that they were still involved in the trial. Participants reported a high level of trust in medical staff as a reason for not seeking more information about the trial. Some participants reported dissatisfaction with the timing of information provision. Some were amenable to novel ways of receiving trial information, such as web-based methods. The pilot study demonstrated the feasibility of a larger study into the provision of information to prospective clinical trial participants. The results suggest that considering alternative ways of providing information and the appropriateness of existing information provision may be acceptable to and useful for potential trial participants.
| S-EPMC7302495 | biostudies-literature