The Timing of Research Consent
Benjamin Sachs
Ethical Theory and Moral Practice, 28 September 2021
Open Access
Abstract
This essay is about the timing of research consent, a process that involves (potential) participants being given information about, among other things, upcoming research interventions and then being invited to waive their claims against those interventions being undertaken. The standard practice, as regards timing, is as follows: (potential) participants are invited to waive all their claims at a single moment in time, and that point in time immediately follows the information-provision. I argue that there we’re not justified in keeping to this practice. What we ought to do is disaggregate the claim-waiving part of the process and move it later, such that the (potential) participant is invited to waive her claim against the undertaking of any given intervention only the immediate moment before that intervention is to be undertaken.
Month: November 2021
Multicenter Social Media Community Consultation for an Exception From Informed Consent Trial of the XStat device (PhoXstat Trial)
Multicenter Social Media Community Consultation for an Exception From Informed Consent Trial of the XStat device (PhoXstat Trial)
Original Article
Shannon W. Stephens, Paige Farley, Sean P. Collins, Monica D. Wong, Ashley B. Panas, Bradley M. Dennis, Neal Richmond, Kenji Inaba, Karen N.Brown, John B. Holcomb, Jan O. Jansen
Journal of Trauma and Acute Care Surgery, 5 October 2021
Abstract
Introduction
Community Consultation (CC) is a key step for Exception from Informed Consent (EFIC) research. Using social media to conduct CC is becoming more widely accepted, but has largely been conducted by single sites. We describe our experience of a social media-based CC for a multicenter clinical trial, coordinated by the lead clinical site.
Methods
Multicenter CC administered by the lead site and conducted in preparation for a three-site prehospital randomized clinical trial. We utilized Facebook and Instagram advertisements targeted to the population of interest. When “clicked” the advertisements directed individuals to study-specific websites, providing additional information and the opportunity to opt out. The lead institution and one other hospital relied on a single website, whereas the third center set up their own website. Site views were evaluated using Google analytics.
Results
The CC took 8 weeks to complete for each site. The advertisements were displayed 9.8 million times, reaching 332,081 individuals, of whom 1,576 viewed one of the study-specific websites. There were no opt-outs. The total cost was $3,000. The costs per person reached were $1.88, $2.00 and $1.85 for each of the three sites. A number of site-specific issues (multiple languages, hosting of study-specific websites) were easily resolved.
Conclusion
This study suggests it is possible for one institution to conduct multiple, simultaneous, social media-based CC campaigns, on behalf of participating trial sites. Our results suggest this social media CC model reaches many more potential subjects and is economical and more efficient than traditional methods.
The ethics of quality improvement studies: do the needs of the many outweigh the needs of the few?
The ethics of quality improvement studies: do the needs of the many outweigh the needs of the few?
Editorial
Peter A. Goldstein
British Journal of Anaesthesia, 4 October 2021
Summary
Clinical research involving human subjects and quality improvement (QI) projects share a common goal of seeking to improve human health, whether by directly changing the standard of care (research) or by improving the process(es) by which that care is delivered (QI). Whether a QI project requires informed consent (written or oral) is a function of the risk–benefit analysis of the study; such a determination should not be at the sole discretion of the investigators, but should come from an appropriately constituted review board with expertise in the ethics of biomedical research.
Improving patient informed consent for haemophilia gene therapy: the case for change
Improving patient informed consent for haemophilia gene therapy: the case for change
Laurence Woollard, Richard Gorman, Dakota J. Rosenfelt
Therapeutic Advances in Rare Disease, 31 August 2021; 2 pp 1-16
Open Access
Abstract
Adeno-associated virus-based gene therapy points to a coming transformation in the treatment of people living with haemophilia, promising sustained bleed control and potential improvement in quality of life. Nevertheless, the consequences of introducing new genetic material are not trivial. The perceived benefits should not minimise the challenges facing patients in understanding the long-term risks and providing a valid and meaningful informed consent, whether in a research or clinical setting. Informed consent is a fundamentally important doctrine in both medical ethics and health law, upholding an individual’s right to define their personal goals and make their own autonomous choices. Patients should be enabled to recognise their clinical situation, understand the implications of treatment and integrate every facet of their life into their decision. This review describes informed consent processes for haemophilia gene therapy clinical trials, factors affecting patients’ decision making and the availability of patient-centred decision support interventions, to ensure that patients’ interests are being protected. Regulatory guidance has been published for physicians and manufacturers in haemophilia on informed consent, including for gene therapy, while best practice recommendations for patient–physician discussions are available. In all settings, however, communicating and presenting highly technical and complex therapeutic information is challenging, especially where multiple barriers to scientific knowledge and health literacy exist. We propose several evidence-informed strategies to enhance the consent procedure, such as utilising validated literacy and knowledge assessment tools as well as participatory learning environments over an extended period, to ensure that patients are fully cognisant of the consent they give or deny. Further research is needed to define new, creative approaches for patient education and the upholding of ethical values in the informed consent process for gene therapy. The lessons learnt and approaches developed within haemophilia could set the gold standard for good practice in ensuring ethical preparedness amidst advances in genetic therapies.
Data protection-compliant broad consent for secondary use of health care data and human biosamples for (bio)medical research: towards a new German national standard
Data protection-compliant broad consent for secondary use of health care data and human biosamples for (bio)medical research: towards a new German national standard
Sven Zenker, Daniel Strech, Kristina Ihrig, Jahns, Roland, Gabriele Müller, Christoph Schickhardt, Georg Schmidt, Ronald Speer, Eva Winkler, Sebastian Graf von Kielmansegg, Johannes Drepper
OSF Preprints, 7 October 2021
Open Access
Abstract
Background
The secondary use of deidentified but not anonymized patient data is a promising approach for enabling precision medicine and learning health care systems. In most national jurisdictions (e.g., in Europe and North America), this type of secondary use requires patient consent. While various ethical, legal, and technical analyses have stressed the opportunities and challenges for different types of consent over the past decade, no country has yet established a national consent standard accepted by the relevant authorities.
Methods
A working group of the national Medical Informatics Initiative in Germany conducted a requirements analysis and developed a GDPR-compliant broad consent standard involving all relevant stakeholder groups and authorities.
Results
This paper presents the broad consent text together with a guidance document on mandatory safeguards for broad consent implementation. The mandatory safeguards comprise i) independent review of individual research projects, ii) organizational measures to protect patients from involuntary disclosure of protected information, and iii) comprehensive information for patients and public transparency. This paper further describes the key issues discussed with the relevant authorities, especially the position on additional or alternative consent approaches such as dynamic consent.
Discussion
Both the resulting broad consent text and the national consensus process are relevant for similar activities internationally. A key challenge of aligning consent documents with the various stakeholders was explaining and justifying the decision to use broad consent and the decision against using alternative models such as dynamic consent. Public transparency for all secondary use projects and their results emerged as a key factor in this justification. While currently largely limited to academic medicine in Germany, the first steps for extending this broad consent approach to wider areas of application, including smaller institutions and medical practices, are currently under consideration.
Reliability of self-report versus the capacity to consent to treatment instrument to make medical decisions in brain metastasis and other metastatic cancers
Reliability of self-report versus the capacity to consent to treatment instrument to make medical decisions in brain metastasis and other metastatic cancers
Original Research
Mackenzie E. Fowler, Dario A. Marotta, Richard E. Kennedy, Adam Gerstenecker, Meredith Gammon, Kristen Triebel
Brain and Behaviour, 2 October 2021
Open Access
Abstract
Objective
To evaluate the ability of persons with metastatic cancer to self-assess their medical decision-making capacity (MDC). To investigate this, we compared an objective measure of MDC with self-ratings and evaluated predictors of agreement.
Methods
Data were obtained from a cross-sectional study of metastatic cancer patients at a large academic medical center. Across all standards of MDC, sensitivity, specificity, and reliability using Gwet’s AC1 statistic were calculated using the objective measure as the gold standard. Logistic regression was used to evaluate predictors of agreement between the measures across all MDC standards.
Results
In those with brain metastases, high sensitivity (greater than 0.7), but low specificity was observed for all standards. Poor reliability was observed across all standards. Higher age resulted in higher odds of disagreement for Standard 3 (appreciation) (OR: 1.07, 95% CI: 1.00, 1.15) and Standard 4 (reasoning) (OR: 1.05, 95% CI: 1.00, 1.10). For Standard 3, chemotherapy use and brain metastases compared to other metastases resulted in higher odds of disagreement (Chemotherapy: OR: 5.62, 95% CI: 1.37, 23.09, Brain Metastases: OR: 5.93, 95% CI: 1.28, 27.55). For Standard 5 (understanding), no predictors were associated with disagreement.
Conclusions
For less cognitively complex standards (e.g., appreciation), self-report may be more valid and reliable than more cognitively complex standards (e.g., reasoning or understanding). However, overall, MDC self-report in the current sample is suboptimal. Thus, the need for detailed assessment of MDC, especially when patients are older or used chemotherapy, is indicated. Other studies should be conducted to assess MDC agreement longitudinally.
Awareness and Perception of Healthcare Providers about Proxy Consent in Critical Care Research
Awareness and Perception of Healthcare Providers about Proxy Consent in Critical Care Research
Research Article
Rania Mahafzah, Karem H. Alzoubi, Omar F. Khabour, Rana Abu-Farha
Critical Care Research and Practice, 30 September 2021
Open Access
Abstract
Objective
Proxy consent respects patients’ autonomy when they are incapable of providing consent for research participation. Healthcare providers need to understand the ethical regulations and practices relevant to the proxy consent process. Thus, this study aimed to assess the knowledge and attitudes of healthcare providers about research proxy consent in the ICU setting.
Methods
A cross-sectional survey-based design was used in the study. Study participants were resident and specialist physicians, registered nurses, and registered pharmacists from ICU units in Jordan. Participants were asked to fill out a questionnaire developed to assess their knowledge and attitudes towards informed proxy consent for research studies conducted at the ICU.
Results
In this study, 145 healthcare providers completed the study questionnaire. The healthcare providers agreed that the purpose of the proxy consent is to inform the participants about the potential benefits (66.9%) and risks (66.9%) related to the research to study and respect patient’s autonomy (44%), to discuss alternative options (62.1%), and to protect the researchers from any litigation (84.1%). Regarding the assessment of proxy consent, 65.5% of respondents believed that relatives are considered as an authorized legal representative for an informed consent decision on behalf of their ICU patients (65.5%) as they are knowledgeable about patients’ values and preferences and have the desire to provide the necessary help. Respondents also agreed that the informed consent process should explain research protocols and procedures (76.6%), therapeutic alternatives (84.1%), potential benefits (41.4%), and potential risks (44.1%) and that participation in the research is voluntary (66.9%). No significant differences in the responses were found among different groups of healthcare providers.
Conclusion
The majority of healthcare providers had inadequate awareness about the ethical aspects regarding the informed proxy consent process. Providing training regarding the informed consent process can improve the quality of the proxy consent process in clinical research studies in the ICU setting.
Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial
Comparing a Multimedia Digital Informed Consent Tool With Traditional Paper-Based Methods: Randomized Controlled Trial
Fuad Abujarad, Peter Peduzzi, Sophia Mun, Kristina Carlson, Chelsea Edwards, James Dziura, Cynthia Brandt, Sandra Alfano, Geoffrey Chupp
JMIR Formative Research, 19 October 2021; 5(10)
Abstract
Background
The traditional informed consent (IC) process rarely emphasizes research participants’ comprehension of medical information, leaving them vulnerable to unknown risks and consequences associated with procedures or studies.
Objective
This paper explores how we evaluated the feasibility of a digital health tool called Virtual Multimedia Interactive Informed Consent (VIC) for advancing the IC process and compared the results with traditional paper-based methods of IC.
Methods
Using digital health and web-based coaching, we developed the VIC tool that uses multimedia and other digital features to improve the current IC process. The tool was developed on the basis of the user-centered design process and Mayer’s cognitive theory of multimedia learning. This study is a randomized controlled trial that compares the feasibility of VIC with standard paper consent to understand the impact of interactive digital consent. Participants were recruited from the Winchester Chest Clinic at Yale New Haven Hospital in New Haven, Connecticut, and healthy individuals were recruited from the community using fliers. In this coordinator-assisted trial, participants were randomized to complete the IC process using VIC on the iPad or with traditional paper consent. The study was conducted at the Winchester Chest Clinic, and the outcomes were self-assessed through coordinator-administered questionnaires.
Results
A total of 50 participants were recruited in the study (VIC, n=25; paper, n=25). The participants in both groups had high comprehension. VIC participants reported higher satisfaction, higher perceived ease of use, higher ability to complete the consent independently, and shorter perceived time to complete the consent process.
Conclusions
The use of dynamic, interactive audiovisual elements in VIC may improve participants’ satisfaction and facilitate the IC process. We believe that using VIC in an ongoing, real-world study rather than a hypothetical study improved the reliability of our findings, which demonstrates VIC’s potential to improve research participants’ comprehension and the overall process of IC.
The application and promotion of electronic informed consent
The application and promotion of electronic informed consent
Dong, L. Qin, W. Wu, C. Tang, W. Long, Z. Yang, L. Ling, L. Lu
Chinese Journal of Evidence-Based Medicine, 2021; 21(7) pp 851-857
Abstract
Under the background of the global COVID-19 pandemic, electronic informed consent (eConsent) utilizes technology to provide a new method and idea for clinical trials. It has the advantages of convenience and efficiency, which greatly improves the efficiency of clinical trials. At present, this concept has not been put forward in China while it has been clarified clearly abroad, and some countries have launched a variety of trials and formulated various regulations to further standardize the eConsent. Based on the current situation of eConsent in China, this study analyzed the design and implementation of eConsent, summarized relevant domestic and foreign laws and regulations, and proposed opportunities and challenges for electronic informed consent as well as the relevant preparations for the implementation of this technology in China.
Beyond Agree or Disagree: A Consent Story and Storytelling for Indonesian Children
Beyond Agree or Disagree: A Consent Story and Storytelling for Indonesian Children
Fitri Arlinkasari, Debra Flanders Cushing, Evonne Miller
Ethics and Integrity in Research with Children and Young People, 4 November 2021
Abstract
Researchers face many ethical challenges when conducting research with children. Ethical issues can be even more significant when researchers work with children from low-income urban settings in the Global South. This chapter presents reflections on research conducted with children aged 6–12 years old who live in Jakarta, Indonesia. Underpinned by the new sociology of childhood, the study was designed to gather these children’s perspectives on child-friendly public spaces in their neighbourhoods. A range of qualitative methods were used including child-led tours, drawings, observations and interviews. As part of the study, the authors developed and reflected on the use of story and storytelling to deliver the research information and obtain the children’s consent to participate. The authors’ experience demonstrates that story and storytelling supported children’s competence and engaged them in a meaningful informed consent process. This approach is especially relevant for children with low literacy skills and whose parents or caregivers may not be available to help children decide on their participation in research. The chapter concludes with recommendations for effectively approaching this ethical challenge in future social research with children from similar backgrounds.
Center for Informed Consent Integrity 