Participants’ informed consent in adaptive, platform drug trials in hospitalized COVID-19 patients: Not all approaches are ethically acceptable
Commentary
Rafael Dal-Ré, Arthur L Caplan, Teck Chuan Voo
European Journal of Internal Medicine, 27 June 2022
Open Access
Excerpt
…Obtaining participants’ informed consent is one of the basic safeguards for ensuring ethically conducted clinical research. Investigators must provide potential participants all reasonable relevant trial information so that they can make an informed decision. How investigators seek participants’ informed consent should be consistent with international ethical standards. First, informed consent must be obtained from patients with capacity. If a patient is incapable of consenting (e.g., intubated patient), the investigator must seek informed consent from their legal representative. During the pandemic, at the trial design stage, investigators of the four aforementioned ad-RCTs (Table 1) decided that deferred consent was an acceptable approach as they realized that many potential trial participants would be incapable of providing consent and having access to the patient’s legal representative could be extremely difficult to obtain. Their decisions were backed by the research ethics committees involved in the review and approval of the ad-RCTs’ protocols. Patients unable to consent were included in the trial and informed consent obtained once they were able to provide it (or when the legally authorized representative became available), rendering the consent deferred. However, deferred consent must fulfil several conditions to be ethically acceptable. Second, trial investigators should seek the informed consent of potential participants before randomization, which ensures that all participants receive the same information on the trial procedures and available treatments in all study arms. This is applicable to any RCT, but it is even more relevant when it is likely that the legal representative of many participants will be involved. The participant’s legal representative should decide considering to what extent study participation promotes the individual’s clinical interests, and to this end should know all the therapies under assessment…
Year: 2022
Consent for orthopaedic trauma surgery during the COVID-19 pandemic
Consent for orthopaedic trauma surgery during the COVID-19 pandemic
Selmi H, Davies A, Walker J, Heaton T, Sabharwal S, Dani M, Fertleman M, Reilly P
BMJ Open Quality, 1 June 2022, 11(2)
Abstract
Introduction
The COVID-19 pandemic has brought a series of new challenges to the management of surgical patients. The consent process relies on a foundation of open and non-coerced discussion between clinician and patient, which includes all the potential risks of surgery. This must be updated to incorporate the additional risks of surgery during the pandemic including infection with the SARS-CoV-2 and increased risks of complications with the potential requirement for intensive care support.
Aim
The aim of this multi-cycle quality improvement project was to ensure all patients were fully informed of the risks of developing COVID-19 and the possible need for intensive care unit (ICU) support.
Methods
We investigated the quality of the consent process for patients undergoing surgery for trauma at our major trauma centre. Our baseline data collection included a review of all orthopaedic trauma consent forms over a 4-week period in March 2020. We subsequently undertook three further Plan-Do-Study-Act (PDSA) cycles over separate 4-week periods. First, in June 2020, after education measures and presentation of baseline data, second in July 2020 after further education and regular digital reminders were sent to staff, and third in September 2021 after the implementation of an electronic consent form.
Results
At baseline, only 2.6% of consent forms mentioned the risk of COVID-19 and none mentioned the risk of requiring ITU support. Through three PDSA cycles this increased to 97% of cases where consent forms displayed the additional risks of COVID-19 and the potential need for ITU admission.
Conclusion
Our quality improvement project improved the informed consent procedure at our trust. By incorporating these additional risks into the template of an electronic consent form, we hope to achieve sustained improvement in practice.
Keys to improving the informed consent process in research: Highlights of the i-CONSENT project
Keys to improving the informed consent process in research: Highlights of the i-CONSENT project
Editorial
Jaime Fons-Martinez, Cristina Ferrer-Albero, Javier Diez-Domingo
Health Expectations, 27 July 2022
Open Access
Excerpt
The ethical and legal governance of all aspects of informed consent in research is becoming increasingly extensive and complex. Instead of a single directive, informed consent is governed by a series of international rules applied to biomedical research, clinical trials and biobanks, while various ethical guidelines for research have been published by different international bodies.
Informed consent is an essential part of any research involving humans, but the array of available guidelines can complicate the informed consent process for sponsors, researchers and participants. Sponsors, in particular, find it difficult to adapt the informed consent process to the characteristics of the participants. Moreover, because of the length and complexity of informed consents, some participants may misconstrue key points and agree to participate in a trial that they do not fully understand. In these cases, the decision on their participation is mainly based on discussions with the researcher, which lacks traceability…
Success rate of acquiring informed consent and barriers to participation in a randomized controlled trial of laparoscopic versus open surgery for non-curative stage IV colon cancer in Japan
Success rate of acquiring informed consent and barriers to participation in a randomized controlled trial of laparoscopic versus open surgery for non-curative stage IV colon cancer in Japan
Journal Article
Tomonori Akagi, Kosuke Suzuki, Yohei Kono, Shigeo Ninomiya, Tomotaka Shibata, Yoshitake Ueda, Hidefumi Shiroshita, Tsuyoshi Etoh, Akio Shiomi, Masaaki Ito, Jun Watanabe, Kohei Murata, Yasumitsu Hirano, Manabu Shimomura, Shunsuke Tsukamoto, Yukihide Kanemitsu, Masafumi Inomata
Japanese Journal of Clinical Oncology, 22 July 2022
Abstract
Background
Successful achievement of randomized controlled trials (RCTs) is dependent on the acquisition of informed consent (IC) from patients. The aim of this study was to prospectively calculate the proportion of participation in a surgical RCT and to identify the reasons for failed acquisition of IC.
Methods
A 50-insitution RCT was conducted to evaluate oncological outcomes of open and laparoscopic surgery for stage IV colon cancer (JCOG1107: UMIN-CTR 000000105). The success rate of obtaining IC was evaluated in eight periods between January 2013 and January 2021. In addition, reasons for failed acquisition of IC were identified from questionnaires.
Results
In total, 391 patients were informed of their eligibility for the trial, and 168 (42%) were randomly assigned to either the laparoscopic surgery group (n = 84) or open surgery group (n = 84). The success rate of IC acquisition ranged from 33 to 58% in three periods. The most common reasons for failed IC acquisition were the patients’ preference for one approach of surgery based on recommendations from referring doctors and family members, and anxiety/unhappiness about randomization.
Conclusions
The success rate of acquiring IC from patients for an RCT of laparoscopic versus open surgery for stage IV colon cancer was lower than the expected rate planned in the protocol. To obtain the planned rate, investigators should make efforts to inform patients and their families about the medical contributions a surgical RCT can make and recognize that the period in equipoise may be limited.
Future informed consent research – a step in the wrong direction!
Future informed consent research – a step in the wrong direction!
JM Clements, LJ Convie, SJ Kirk, M Clarke
British Journal of Surgery, 22 July 2022; 109(Suppl 4)
Open Access
Abstract
Introduction
Over 300 million invasive procedures occur globally every year, each requiring patient informed consent. No single outcome measure exists for measurement of the informed consent process. A core outcome set (COS) for informed consent for therapy consisting of 9 outcomes has been developed to define what outcomes matter to key stakeholders in the informed consent process. We aimed to identify the frequency of uptake of the COS consent outcomes in future randomised control trials.
Methods
A systematic review of prospectively registered randomised control trial protocols was performed. The online trial registries World Health Organisation (WHO) International Clinical Trials Registry Platform (ICTRP) and the US National Library of Medicine ClinicalTrials.gov were searched. All studies assessing interventions designed to improve the informed consent process were considered.
Results
627 registered protocols were identified of which 22 met the inclusion criteria. Only two core outcomes were reported in any prospective interventional consent trial protocols. Patient satisfaction with the consent process and patient satisfaction with the amount of information were observed which employed unvalidated tools. Patient knowledge was the predominant primary outcome measure (n=20). Unvalidated measurement tools were used in all cases. Patient anxiety, decisional regret and decisional conflict were the only outcomes consistently measured using validated measurement tools.
Conclusion
The use of unvalidated outcome measurement tools in future consent trials are widespread. This review has highlighted the clear disconnect between chosen outcomes in future consent trial protocols and an established informed consent COS, limiting the potential value of outputs in future consent trials.
Take-home message
A clear disconnect exists between the outcome measures used in prospective consent randomised trials and an established core outcome set for informed consent for therapy.
When is it impractical to ask informed consent? A systematic review
When is it impractical to ask informed consent? A systematic review
Review Article
Sara JM Laurijssen, Rieke van der Graaf, Wouter B van Dijk, Ewoud Schuit, Rolf HH Groenwold, Diederick E Grobbee, Martine C de Vries
Clinical Trials, 1 July 2022
Abstract
Background
Informed consent is one of the cornerstones of biomedical research with human subjects. Research ethics committees may allow for a modification or a waiver of consent when the research has social value, involves minimal risk, and if consent is impractical to obtain. While the conditions of social value and minimal risk have received ample attention in research ethics literature, the impractical condition remains unclear. There seem to be different interpretations of the meaning of impractical within academic literature. To address this lack of clarity, we performed a systematic review on the interpretation of impractical.
Methods
First, we examined international research ethics guidelines on their usage and interpretation of impractical. Next, we used international ethical guidelines to identify synonyms of the term “impractical.” Accordingly, PubMed, Embase, and Web of Science were searched for articles that included “informed consent” and “impractical” or one of its synonyms.
Results
We found that there were only a few international ethics guidelines that described what could be considered impractical. Out of 2329 identified academic articles, 42 were included. Impractical was used to describe four different conditions: (1) obtaining informed consent becomes too demanding for researchers, (2) obtaining informed consent leads to invalid study outcomes, (3) obtaining informed consent harms the participant, and (4) obtaining informed consent is meaningless for the participant.
Conclusion
There are conditions that render conventional informed consent truly impractical, such as untraceable participants or harm for participants. At the same time, researchers have a moral responsibility to design an infrastructure in which consent can be obtained, even if they face hardship in obtaining consent. In addition, researchers should seek to minimize harm inflicted upon participants when harm may occur as a result of the consent procedure. Invalidity of research due to consent issues should not be regarded as impractical but as a condition that limits the social value of research. Further research is essential for when a waiver of informed consent based on impractical is also reasonable.
Toward Meeting the Obligation of Respect for Persons in Pragmatic Clinical Trials
Toward Meeting the Obligation of Respect for Persons in Pragmatic Clinical Trials
Morain SR, Kraft SA, Wilfond BS, Mcguire A, Dickert NW, Garland A, Sugarman J
The Hastings Center Report, 1 May 2022; 52(3) pp 9-17
Abstract
Research ethics oversight systems have traditionally emphasized the informed consent process as the primary means by which to demonstrate respect for prospective subjects. Yet how researchers can best fulfill the ethical obligations of respect for persons in pragmatic clinical trials (PCTs)-particularly those that may alter or waive informed consent-remains unknown. We propose eight dimensions of demonstrating respect in PCTs: (1) engaging patients and communities in research design and execution, (2) promoting transparency and open communication, (3) maximizing agency, (4) minimizing burdens and promoting accessibility, (5) protecting privacy and confidentiality, (6) valuing interpersonal interactions with clinicians and study team members, (7) providing compensation, and (8) maximizing social value. While what respect requires in the context of PCTs will vary based on the nature of the PCT in question, the breadth of these dimensions demonstrates that respect obligations extend beyond informed consent processes.
When is public private? Tweets, privacy and consent in health research
When is public private? Tweets, privacy and consent in health research
Sabitra Kaphle, Rachel Kornhaber, Susan Hunt, Roger Watson, Michelle Cleary
Nurse Education in Practice, August 2022; 63
Introduction
Online social media platforms provide opportunities for the global community to share and express their views, opinions, reactions, and feelings openly. The use of social media for the purpose of information sharing surged during the COVID-19 pandemic due to mandated physical distancing requirements. This is a seemingly consensual catharsis at a time of heightened need for alternative social activity and critical information sharing. Communication on open social media platforms has created opportunities for researchers to access and analyse rich, publicly available data to study a range of topics and issues. The creation of this abundant public data has also led to fundamental methodological and ethical challenges for social science researchers. Namely, is the use of this public data for research a breach of privacy and confidentiality? Are social media users becoming involuntary research participants as their communications and personal information are mined and published on without participant insight and informed consent? In this discussion, we aim to highlight some of the critical methodological and ethical issues that researchers must consider while using Twitter as a data source to publish from.
Assessment of Social Trust in Relatives of Discharged Patients With Personal Consent and Other Relatives of Patients
Assessment of Social Trust in Relatives of Discharged Patients With Personal Consent and Other Relatives of Patients
Research Article
Hamid Reza Moretza Bagi, Zhila Khamnian, Forough Hatami, Samad Shams Vahdati, Reza Yazdani, Sama Rahnemayan
Journal of Patient Experience, 6 July 2022
Abstract
Lack of social trust in the physician–patient relationship will disrupt health. Since social trust has not been sufficiently studied in patients’ companions, this study investigates and compares social trust and its dimensions in companions of patients discharged against medical advice with total patients’ companions in the emergency room. In this cross-sectional descriptive-comparative study, 385 patients’ companions were enrolled. This study was done by a questionnaire with five subscales: honesty, frankness, cooperative tendency, confidence, and trust. Data were analyzed using descriptive statistics and analytical statistics methods. In this study, there was no significant difference between the mean score of social trust between companions of patients discharged against medical advice (61.11 ± 9.01) and patients discharged after treatment (62.27 ± 6.97). There was a significant relationship between the mean score of the 2 groups only in the frankness domain (P-value = .001). The level of social trust in the patients’ companions was moderate in both groups. Companions of discharged patients after completing the treatment process are more explicit than the companions of patients discharged against medical advice.
Co-creation with research participants to inform the design of electronic informed consent
Co-creation with research participants to inform the design of electronic informed consent
Evelien De Sutter, David Geerts, Pascal Borry, Kristien Coteur, Dorien Bamps, Heleen Marynissen, Els Ampe, Els Geenens, Marleen Depré, Isabelle Huys
Digital Health, 6 June 2022; 8 pp 1–11
Open Access
Abstract
Objective
This study aimed to provide recommendations for a personalized electronic informed consent interface that is adapted to research participants’ needs and could enable a longitudinal interaction between the participants and the research team.
Methods
The co-creation process consisted of three co-creation workshops, one focus group discussion, and four semi-structured interviews. In total, 24 participants, who had taken part in four disparate clinical studies in Belgium, were involved. Descriptive statistics and qualitative content analysis were applied to analyze the survey data and audio recordings.
Results
Varying perceptions on the type and amount of information described in an informed consent form were reported. Other findings were related to the structure and presentation of information, setting preferences for data sharing, and electronically signing new informed consent versions. Regarding the long-term interaction, most of the participants wanted to receive progress updates, including the results, of the study in which they had taken part. They proposed to receive a notification, preferably via email, in case new information is made available on the electronic informed consent interface.
Conclusions
To optimally support the design of an electronic informed consent interface, it is key to understand the research participants’ needs. Study findings suggest that an electronic informed consent interface may be a promising technological application to interactively provide study-related information and to keep participants informed during and after the clinical study.
Center for Informed Consent Integrity 