Legal authorized representative experience with smartphone-based electronic informed consent in an acute stroke trial
Diogo C Haussen, Leah Craft, Shannon Doppelheuer, Gabriel Martins Rodrigues, Alhamza R Al-Bayati, Krishnan Ravindran, Meagan Schultz, Loretta Sutherly, Kiva M Schindler, Michael R Frankel, Raul G Nogueira
BMJ Journal of Neurointerventional Surgery, 17 September 2019
The pilot use of a smartphone platform for electronic informed consent (e-Consent) in large vessel occlusion acute stroke (LVOS) trials has recently been reported. The degree of satisfaction from Legal Authorized Representatives (LARs) with regard to this process remains to be established.
A single-center study evaluating the experience of LARs with the use of e-Consent in a LVOS randomized trial of an investigational drug administered within 12 hours of last known normal was carried out. A structured survey was used to evaluate the experience of the LARs with the e-consenting process.
From February to November 2018, 60 consecutive patients were e-Consented. Of these, 53 LARs completed the survey. The median (IQR) age of the patients was 63 (53–70) years, baseline/discharge National Institutes of Health Stroke Scale score was 17 (12–20)/3(1–12), and 45% were independent at discharge. The survey was applied in person in 43% of cases and via telephone in 57%. Median LAR age was 48 (39–59) years, 64% were female, and a multi-ethnic composition was observed. Forty percent of LARs had less than tertiary level of education (high-school or less). Regarding the e-Consent, 98% of LARs reported to be ‘clear’ and 83% felt ‘very comfortable’ in signing. The overall experience was ‘excellent/good’ in 91%. Despite the positive general impression regarding the use of e-Consent, 12 LARs (22%) would have preferred paper consent. Multivariable regression indicated that lower educational status (tertiary education or less: OR 5.09, 95% CI 1.02 to 25.48; p=0.04) and lower baseline ASPECTS score (OR 0.63, 95% CI 0.41 to 0.96; p=0.03) were independently associated with preference for paper consent.
e-Consent was overall very well perceived by LARs in a randomized clinical trial of LVOS. A minority of proxies, who were more commonly less formally educated, would have preferred paper consenting.
Informed consent and ethical reporting of research in clinical trials involving participants with psychotic disorders
Guy M.Weissinger, Connie M.Ulrich
Contemporary Clinical Trials, September 2019; 84
Informed consent is critical for protecting vulnerable individuals interested in research participation, like those with psychotic disorders (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder, etc.). Individuals with psychotic disorders may have fluctuating capacity to consent and capacity assessment prior to research participation can help determine decisional status. However, there is little research on how, or if, these assessments are conducted in clinical research. A systematic review of randomized medication or device trials that specifically recruited individuals with psychotic disorders to understand the use and reporting of capacity assessment to consent was conducted. A total of 646 articles were reviewed using a developed questionnaire on ethical reporting of consent practices and capacity assessment. Less than 10% (n = 34; 5.3%) of the studies reported an assessment of capacity to provide informed consent and less than half of those used a standardized assessment. Sixty-four (9.9%) of the articles reported capacity to provide informed consent in the study’s inclusion and exclusion criteria. Additionally, 66 (10.2%) of the articles did not provide a statement about institutional review board (IRB) approval; and given the large number of medication and device trials, one out of five articles (n = 134; 20.7%) reported no statement about potential conflicts of interest. Future research should continue to examine these issues and to better understand the benefits and challenges of research participation with psychotic individuals and their decisional capacity in this context.
Improving Translation and Cultural Appropriateness of Spanish-Language Consent Materials for Biobanks
Kathleen M. Brelsford, Ernesto Ruiz, Catherine M. Hammack, and Laura M. Beskow
Ethics & Human Research, September-October 2019; 41(5) pp 16-27
A growing proportion of prospective research participants in the United States speak limited or no English. We conducted cognitive interviews with native Spanish speakers to test Spanish-language translations of simplified and traditional biobank consent forms. Comprehension was generally high and did not differ by form. Most of those who received the simplified form felt it contained the right amount of information, compared with fewer than half of those who received the traditional form. Qualitative results allowed us to identify overarching issues related to tone, formality, and voice that may affect prospective participants’ trust and willingness to participate. Certain characteristics of written Spanish are seemingly at odds with recommended actions to simplify consent forms; thus, even when significant empirical effort has been expended to develop simplified consent materials in English, additional work is needed to ensure the accuracy, comprehensibility, and cultural-congruence of Spanish-language translations.
Informed Consent in Thailand: What Standard Is It? Which One Should It Be?
Asia Pacific Journal of Health Law & Ethics, July 2019; (12)3 pp 1-32
The concept of informed consent has long been observed in the Thai medical community. However, an appropriate standard prescribing a physician’s duty to disclose medical information has never been comprehensively discussed in Thailand. Moreover, to the best of my knowledge, the Supreme Court of Thailand has never decided any case where a party claims informed consent as a cause of action either. This paper seeks to fill that gap. I also anticipate that this kind of cause of action will definitely be the disputed issue for the Supreme Court to decide in the foreseeable future.
In this paper, I provide the analysis of the current statute governing informed consent in Thailand. More importantly, I argue that the appropriate standard of disclosure for Thailand should be the professional or physician-based standard. The physician has a duty to disclose only the information other reasonable physicians would reveal to their patients in similar circumstances. For Thailand, this standard is more suitable than the patient-centered standard in terms of both cultural and legal contexts. The standard can effectively safeguard the patient autonomy as well as work to his/her advantage in litigation. The U.S. doctrine of informed consent is comparatively discussed throughout the paper.
Informed Consent Process in the New Millennium
Ranabir Pal, Swapan K Paul
Bengal Physician Journal, May-August 2018; 5(2) pp 22-24
In this new millennium, the clinical trial is inseparably linked with an upgrade of health care by generating invaluable data in preventive, promotive and curative health. Globally research experts have concerns regarding ensuring financial and other compensations along with optimum health benefits for research participants in clinical trials in the emerging market economy. A significant number of human healthy volunteers (participants) take part in researches in both developed and developing countries. Participants are frequently unaware that the informed consent process is mandatory for investigators, funders and participants and their free will must be documented. There are sparse published medical works of literature that attempted to assess the extent to which all the norms of the informed consent process are followed in Indian settings in this area to the best of our knowledge. We need to conduct researches on the preparedness of the clinical trials participants towards their awareness of the criticality of the informed consent process and their motives for participation. This narrative review enlightened the facts that very patient, extensive and careful transparent narration and dissemination of the information can only ensure truly informed and autonomous decision improving the validity of the study.
Contested Organ Harvesting from the Newly Deceased: First Person Assent, Presumed Consent, and Familial Authority
Mark J Cherry
The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine, 16 September 2019; 44(5) pp 603–620
Organ procurement policy from the recently deceased recasts families into gatekeepers of a scarce medical resource. To the frustration of organ procurement teams, families do not always authorize organ donation. As a result, efforts to increase the number of organs available for transplantation often seek to limit the authority of families to refuse organ retrieval. For example, in some locales if a deceased family member has satisfied the legal conditions for first-person prior assent, a much looser and easier standard to satisfy than informed consent, organ retrieval may proceed despite the family’s objections. Some countries have replaced voluntary consent to organ donation with forms of organ conscription. Often referred to under the misnomer “presumed consent,” such policies legalize the harvesting of organs at death, unless individuals exercise official options to opt out. As this article explores, however, there are good grounds for affirming the authority of the family to consent to or to deny organ donation on behalf of recently deceased family members, as well as to reject first-person assent and “presumed consent” policies of organ procurement. Insofar as individuals have failed clearly and competently to provide informed consent to organ donation, moral authorization for the use of the person and his body ought to be grounded on the foundational authority of the family, rather than the state’s supposed interests in obtaining organs for transplantation.
Public knowledge and attitudes towards consent policies for organ donation in Europe. A systematic review
Alberto Molina Pérez, David Rodríguez-Arias, Janet Delgado-Rodríguez, Myfanwy Morgan, Mihaela Frunza, Gurch Randhawa, Jeantine Reiger-Van de Wijdeven, Eline Schiks, Sabine Wöhlke, Silke Schicktanz
Transplantation Reviews, 2019; 33(1) pp 1-8
Background: Several countries have recently changed their model of consent for organ donation from opt-in to opt-out. We undertook a systematic review to determine public knowledge and attitudes towards these models in Europe. Methods: Six databases were explored between 1 January 2008 and 15 December 2017. We selected empirical studies addressing either knowledge or attitudes towards the systems of consent for deceased organ donation by lay people in Europe, including students. Study selection, data extraction, and quality assessment were conducted by two or more reviewers independently. Findings: Awareness of the consent model was lower in opt-out countries than in opt-in countries. A majority of the public agrees with opt-in, regardless of the law in their own country. There are ambivalent attitudes regarding the opt-out system. The public tend to prefer opt-in and mandatory choice over opt-out when several options are offered. Interpretation: The assumption that people in opt-out countries are aware of the legal requirements to be excluded from the pool of potential donors is not supported by the results of this review. This is a concern, since ignorance hinders people’s autonomy regarding organ donation decision-making. Higher awareness of consent model in opt-in countries may reflect greater efforts to inform the public through campaigns to motivate donation. Legal moves towards opt-out are at odds with people’s expressed preferences. Main limitations of this review are the lack of data from some countries, study population heterogeneity, and methodological shortcomings.
Vaccine Controversies: the Case for Freedom and Informed Consent
Jane M. Orient
Journal of American Physicians and Surgeons, September 2019; 24(3)
…There is increasing pressure to add HPV vaccine to the long list of vaccines already mandated for school attendance, and to reduce exemptions for all vaccines. In California, which already eliminated all exemptions except medical ones, proposed legislation would severely constrain permitted contraindications and subject physicians who write for exemptions to intense scrutiny. AAPS has written letters to several state legislatures concerning the need for informed consent for all medical interventions, including vaccines, and a statement to congressional committees opposing federal vaccine mandates.5 Other than AAPS and a new organization, Physicians for Informed Consent (https://physiciansforinformedconsent.org/), medical organizations generally do not oppose mandates…
(Un)informed Consent: Studying GDPR Consent Notices in the Field
Christine Utz, Martin Degeling, Sascha Fahl, Florian Schaub, and Thorsten Holz. 2019
2019 ACM SIGSAC Conference on Computer and Communications Security (CCS ’19), November 11–15, 5 September 2019
Since the adoption of the General Data Protection Regulation (GDPR) in May 2018 more than 60 % of popular websites in Europe display cookie consent notices to their visitors. This has quickly led to users becoming fatigued with privacy notifications and contributed to the rise of both browser extensions that block these banners and demands for a solution that bundles consent across multiple websites or in the browser. In this work, we identify common properties of the graphical user interface of consent notices and conduct three experiments with more than 80,000 unique users on a German website to investigate the influence of notice position, type of choice, and content framing on consent. We find that users are more likely to interact with a notice shown in the lower (left) part of the screen. Given a binary choice, more users are willing to accept tracking compared to mechanisms that require them to allow cookie use for each category or company individually. We also show that the widespread practice of nudging has a large effect on the choices users make. Our experiments show that seemingly small implementation decisions can substantially impact whether and how people interact with consent notices. Our findings demonstrate the importance for regulation to not just require consent, but also provide clear requirements or guidance for how this consent has to be obtained in order to ensure that users can make free and informed choices.
Concise Consent Forms Appreciated—Still Not Comprehended: Applying Revised Common Rule Guidelines in Online Studies
Evan K. Perrault, Seth P. McCullock
Journal of Empirical Research on Human Research Ethics, 6 June 2019; 14(4)
As informed consent documents have historically gotten lengthier, recent revisions to federal Common Rule guidelines now require consent forms that are “concise” and presented in ways that “facilitate comprehension.” The current research sought to apply these guidelines by developing a consent process for an online study that was only 71 words and also allowed participants a choice to either continue directly to the study or learn more about the study to which they were consenting. All participants (100%, N = 429) decided to continue directly to the study, choosing to forgo additional information about the study and the institutional review board (IRB) approval process. Participants indicated they liked this streamlined consent process, even though on average they only comprehended about half of the information this streamlined process contained. A plurality of participants indicated they would like to see this style of streamlined consent continued in future online studies. However, if we want to continue referring to informed consent as informed, future research should be welcomed and supported by IRBs to seek ways to apply the newest Common Rule guidelines while increasing comprehension; otherwise, informed consent will likely always remain an oxymoron.