What information and the extent of information to be provided in an informed assent/consent form of pediatric drug trials
Research article
Nut Koonrungsesomboon, Pimlak Charoenkwan, Rungrote Natesirinilkul, Kanda Fanhchaksai, Wannachai Sakuludomkan, Nimit Morakote
BMC Medical Ethics, 16 November 2022; 23(113)
Open Access
Abstract
Background
This study aimed to determine the elements and the extent of information that child participants and their parents would like to read in an informed assent form (IAF)/informed consent form (ICF) of a pediatric drug trial.
Methods
A descriptive survey was conducted to determine the perceived importance of each element of the ICF content from child participants and their parents who underwent informed assent/consent of a multi-center pediatric drug trial. The respondents were asked to indicate the level of importance of each item in a questionnaire, by giving a rating scale from 1 (not important) to 5 (very important).
Results
A total of 22 families, 17 child participants with the diagnosis of hematology or oncology diseases and 27 parents, were enrolled. Among 30 items, risk–benefit aspects (i.e., direct health benefit [mean: 4.71 for child respondents, 4.89 for parent respondents], indirect/societal benefit [mean: 4.65, 4.85], major foreseeable risk [mean: 4.47, 4.78], post-trial benefit/provision [mean: 4.59, 4.74], and all adverse effects of the drug including uncommon adverse effects [mean: 4.53, 4.74]) were perceived to be of most concerning items from both child participants’ and parents’ viewpoint. None of the items were considered ‘slightly important’ or lower by more than 20% of the respondents.
Conclusions
For pediatric drug trials, risk–benefit information (including direct health benefit, indirect/societal benefit, and post-trial benefit/provision, as well as major foreseeable risk and adverse effects of the drug) should be made a salient feature of an IAF/ICF. This empirical data could help related stakeholders arrange essential information in order of importance and tailor an IAF/ICF to better suit child participants’ and parents’ needs, particularly for pediatric drug trials involving children with the diagnosis of hematology or oncology diseases.
Operationalization of assent for research participation in pre-adolescent children: a scoping review
Operationalization of assent for research participation in pre-adolescent children: a scoping review
Research
Florence Cayouette, Katie O’Hearn, Shira Gertsman, Kusum Menon
BMC Medical Ethics, 3 November 2022; 23(106)
Open Access
Abstract
Background
Seeking assent from children for participation in medical research is an ethical imperative of numerous institutions globally. However, none of these organizations provide specific guidance on the criteria or process to be used when obtaining assent. The primary objective of this scoping review was to determine the descriptions of assent discussed in the literature and the reported criteria used for seeking assent for research participation in pre-adolescent children.
Methods
Medline and Embase databases were searched until November 2020 using the term “assent” in the title or abstract. Inclusion criteria were (1) studies enrolling children which specifically described operationalization of the assent process and (2) studies of the assent process which provided a description of assent. Data collected included participant information, patient criteria for seeking assent, guidelines referenced, description of assent reported, how assent was obtained and assent information presented, and reported assent rate. For qualitative articles focusing on the assent process, important themes were identified.
Results
A total of 116 articles were included of which 79 (68.9%) operationalized assent and 57 studies (%) described the assent process. The most commonly reported criterion used to determine the ability of a child to assent was age (35.4%, 28/79). The reported minimal age for obtaining pediatric assent varied considerably across and within jurisdictions (5–13 years; median 7.5 years, IQR 7.0, 9.75). Cognitive ability was reported as a criterion for obtaining assent in 5.1% (4/79) of studies. Assent rates were only reported in 17.7% (14/79) of citations and ranged from 32.0 to 100%. Analysis of the 57 studies describing the assent process identified several themes, including age thresholds, assessment of capacity, variable knowledge of pediatric assent and parental roles.
Conclusion
We found significant variation in criteria used for assessment of patient capacity, delivery of information used to obtain assent and documentation of the assent process. While we acknowledge that individual children, settings and jurisdictions may require different approaches to obtaining assent, there should be agreement on important principles to be followed with resulting common guidance on assessing capacity, delivering information and documentation of the assent process for publication.
A Video-Based Consent Tool: Development and Effect of Risk–Benefit Framing on Intention to Randomize
A Video-Based Consent Tool: Development and Effect of Risk–Benefit Framing on Intention to Randomize
Alex Lois, Jonathan E. Kohler, Sarah E. Monsell, Kelsey M. Pullar, Jesse Victory, Stephen R. Odom, Katherine Fischkoff, Amy H. Kaji, Heather L. Evans, Vance Sohn, Lillian S. Kao, Shah-Jahan Dodwad, Anne P. Ehlers, Hasan B. Alam, Pauline K. Park, Anusha Krishnadasan, David A. Talan, Nicole Siparsky, Thea P. Price, Patricia Ayoung-Chee, William Chiang, Matthew Salzberg, Alan Jones, Matthew E. Kutcher, Mike K. Liang, Callie M. Thompson, Wesley H. Self, Bonnie Bizzell, Bryan A. Comstock, Danielle C. Lavallee, David R. Flum, Erin Fannon, Larry G. Kessler, Patrick J. Heagerty, Sarah O. Lawrence, Tam N. Pham, Giana H. Davidson
Journal of Surgical Research, March 2023; 283 pp 357-367
Abstract
Introduction
Nearly 75% of clinical trials fail to enroll enough participants, and cohorts often fail to reflect the clinical and demographic diversity of at-risk populations. Effective recruitment strategies are critically important for successful clinical trials. Framing treatment risks are known to affect medical decision-making for both physicians and patients but has not been rigorously studied in surgical trials. We sought to examine the impact of a high-quality video-based consent tool and the effect of risk–benefit framing on patient willingness to participate in a surgical clinical trial.
Methods
A standardized video consent was shown to all potential participants in the Comparison of Outcomes of antibiotic Drugs and Appendectomy (CODA) trial, a randomized controlled trial comparing antibiotics and surgery for acute appendicitis. We report (1) differences in recruitment between two versions of a video-based tool that differed in production quality and (2) the impact of risk–benefit framing on participant randomization rates. The reasons for declining randomization were also assessed.
Results
Of 4697 eligible patients approached to participate in the CODA trial, 1535 (33% [95% confidence interval (CI): 31%-34%]) agreed to randomization; this did not change from video version 1 to version 2. There was no difference in participation between positively framed videos (32% [95% CI: 30%-34%]) versus negatively framed videos (33.0% [95% CI: 30.8-35.2]). The most common reason for declining participation was treatment preference (72% for surgery and 18% for antibiotics).
Conclusions
Neither the change from video 1 to video 2 nor the positive versus negative framing affected participant willingness to randomize. The stakeholder-informed video-based consenting tool used in CODA was an effective strategy for the recruitment of a heterogeneous patient population within the proposed study period.
Electronic informed consent criteria for research ethics review: a scoping review
Electronic informed consent criteria for research ethics review: a scoping review
Research
Mohd Yusmiaidil Putera Mohd Yusof, Chin Hai Teo, Chirk Jenn Ng
BMC Medical Ethics, 21 November 2022; 23 (117)
Open Access
Abstract
Background
The research shows a growing trend in using an electronic platform to supplement or replace traditional paper-based informed consent processes. Instead of the traditionally written informed consent document, electronic informed consent (eConsent) may be used to assess the research subject’s comprehension of the information presented. By doing so, respect for persons as one of the research ethical principles can be upheld. Furthermore, these electronic methods may reduce potential airborne infection exposures, particularly during the pandemic, thereby adhering to the beneficence and nonmaleficence principle. This scoping review aims to identify the ethics related criteria that have been included in electronic informed consent processes and to synthesize and map these criteria to research ethics principles, in order to identify the gaps, if any, in current electronic informed consent processes.
Methods
The search was performed based on internet search and three main databases: PubMed, SCOPUS and EBSCO. PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation guideline was used to report this work.
Results
Of 34 studies that met the inclusion criteria, 242 essential original constructs were collated, and 7 concepts were derived. Digital content showed the highest percentage of collated original constructs (27%, n = 65) followed by accessibility (24%, n = 56), comprehension engagement (18%, n = 43), autonomy (14%, n = 34), confidentiality (11%, n = 25), language (5%, n = 13), and parental consent (1%, n = 2). Twenty-five new items were synthesized for eConsent criteria which may provide guidance for ethical review of research involving eConsent.
Conclusion
The current study adds significant value to the corpus of knowledge in research ethics by providing ethical criteria on electronic informed consent based on evidence-based data. The new synthesized items in the criteria can be readily used as an initial guide by the IRB/REC members during a review process on electronic informed consent and useful to the future preparation of a checklist.
Learning to listen: A complementary approach to informed consent for patients with visual impairments
Learning to listen: A complementary approach to informed consent for patients with visual impairments
Forum
Kayo Takashima, Takeshi Soma, Kaori Muto, Kohji Nishida, Jusaku Minari
Stem Cell Reports, 10 November 2022
Open Access
Excerpt
This forum describes an exploratory approach for assisting individuals with visual impairment during the informed consent (IC) process to participate in a cutting-edge trial. Our approach has been developed to focus on potential participants’ preparedness to give IC, along with the creation of supporting audio material…
Body donation in Italy and the issue of consent: Operational suggestions
Body donation in Italy and the issue of consent: Operational suggestions
Gianluca Montanari Vergallo, Vittoria Masotti, EnricoMarinelli
Legal Medicine, February 2023; 60
Abstract
The authors aimed to analyze the Italian law of 10 February 2020, n. 10, which governs the post mortem donation of one’s body and tissues for training, educational and scientific research purposes. The different models of consent set forth in this set of norms are discussed, reaching the conclusion that the most suitable option for balancing the interests at stake is the one that authorizes all uses of the body for the sole purposes expressly permitted by the donor. After briefly laying out the current legislation on the subject, particularly regarding the ways of expressing consent, the authors highlight how the legislation enacted by Italian lawmakers is meant to codify the absolute preeminence to the donor’s right to self-determination.
Italian law n. 219/2017 on consent and advance directives: survey among Ethics Committees on their involvement and possible role
Italian law n. 219/2017 on consent and advance directives: survey among Ethics Committees on their involvement and possible role
Research
Corinna Porteri, Giulia Ienco, Edda Mariaelisa Turla, Carlo Petrini, Patrizio Pasqualetti
BMC Medical Ethics, 16 November 2022; 23(114)
Open Access
Abstract
Background
On December 2017 the Italian Parliament approved law n. 219/2017 “Provisions for informed consent and advance directives” regarding challenging legal and bioethical issues related to healthcare decisions and end-of-life choices. The law does not contain an explicit reference to Ethics Committees (ECs), but they could still play a role in implementing the law.
Methods
A questionnaire-based survey was performed among the ECs of the Italian Institute for Research and Care belonging to the Network of neuroscience and neurorehabilitation, with the aim of (1) knowing whether the ECs participated and, if so, how in the process of implementation of law n. 219/2017 in the referring institutes; (2) investigating the point of view of the ECs regarding their possible involvement in the process; (3) exploring the contribution ECs can provide to give effective implementation to the law principles and provisions.
Results
Seventeen ECs out of thirty took part in the survey; the characteristics of the responding and non-responding committees are similar, so the responding ECs can be regarded as representative of all ECs in the Network. Nine ECs did not discuss the law in anyway: the main reason for this is that the referring institutions (6) and the health care professionals (3) did not ask for an EC intervention. Nevertheless, the large majority of the ECs believe that their involvement in the implementation of the law as a whole is appropriate (8) or absolutely appropriate (6), while 3 of them are neutral. No EC believes that the involvement is inappropriate. The aspect of the law on which the 14 ECs converge in considering the EC involvement appropriate/absolutely appropriate is the one related to the health facilities obligation to guarantee the full and proper implementation of the principles of the law.
Conclusions
Our survey confirms that ECs believe they can play a role in the implementation of law n. 219/2017, although this does not entirely correspond to what the committees have actually done in reality. This role could be better exercised by ECs specifically established for clinical practice, which would have a composition, functioning and a mandate better suited to the purpose. This supports the call for a national regulation of ECs for clinical practice.
Attitudes of European students towards family decision-making and the harmonisation of consent systems in deceased organ donation: a cross-national survey
Attitudes of European students towards family decision-making and the harmonisation of consent systems in deceased organ donation: a cross-national survey
Research
Alberto Molina-Pérez, Gabriele Werner-Felmayer, Kristof Van Assche, Anja M. B. Jensen, Janet Delgado, Magdalena Flatscher-Thöni, Ivar R. Hannikainen, David Rodriguez-Arias, Silke Schicktanz, Sabine Wöhlke
BMC Public Health, 15 November 2022; 22(2080)
Open Access
Abstract
Background
European countries are increasingly harmonising their organ donation and transplantation policies. Although a growing number of nations are moving to presumed consent to deceased organ donation, no attempts have been made to harmonise policies on individual consent and the role of the family in the decision-making process. Little is known about public awareness of and attitudes towards the role of the family in their own country and European harmonisation on these health policy dimensions. To improve understanding of these issues, we examined what university students think about the role of the family in decision-making in deceased organ donation and about harmonising consent policies within Europe.
Methods
Using LimeSurvey© software, we conducted a comparative cross-sectional international survey of 2193 university students of health sciences and humanities/social sciences from Austria (339), Belgium (439), Denmark (230), Germany (424), Greece (159), Romania (190), Slovenia (190), and Spain (222).
Results
Participants from opt-in countries may have a better awareness of the family’s legal role than those from opt-out countries. Most respondents opposed the family veto, but they were more ambivalent towards the role of the family as a surrogate decision-maker. The majority of participants were satisfied with the family’s legal role. However, those who were unsatisfied preferred to limit family involvement. Overall, participants were opposed to the idea of national sovereignty over consent policies. They favoured an opt-out policy harmonisation and were divided over opt-in. Their views on harmonisation of family involvement were consistent with their personal preferences.
Conclusions
There is overall division on whether families should have a surrogate role, and substantial opposition to granting them sole authority over decision-making. If European countries were to harmonise their policies on consent for organ donation, an opt-out system that grants families a surrogate decision-making role may enjoy the widest public support.
The Completeness of Informed Consent Form Filling and Protection of Consumer Rights in Hospital Healthcare Services
The Completeness of Informed Consent Form Filling and Protection of Consumer Rights in Hospital Healthcare Services
Anggra Yudha, Ramadianto Barkah, Rosadi Hindun, Nafiah Sindy, Risa Nandiesty, Rulli Saqinah, Nur Windah Fadillah, Frisca Mahrunissa
HIV Nursing, 30 October 2022
Open Access
Abstract
Fulfillment the completeness of filling out the informed consent form is one of the minimum service standards in hospitals, but until now there are some hospitals that have not complied this obligation. This study aims to understand the legal protection of patients’ rights as consumers related to the completeness of filling out an informed consent form in medical record services in hospitals. This research uses a normative legal approach through descriptive analysis. The secondary data used in this study were obtained through a study of the literature. The results of the analysis in this study show that the fulfillment of the completeness of filling out the informed consent form is a form of obligation of business actors to fulfill consumer rights which include the right to be treated or served correctly and honestly and not discriminatory and the right to obtain advocacy, protection, and consumer protection dispute resolution efforts properly. The violation of the patient’s right to obtain a minimum standard of health services in the form of incomplete filling of the informed consent form is a violation of consumer rights in health services. According to the provisions of the Consumer Protection Law, the settlement of disputes regarding violations of these rights can be carried out through providing compensation to patients by business actors, filing lawsuits by patients, and even criminal charges against business actors. The conclusion obtained in this study is that the completeness of filling out the informed consent form in the medical record service at the hospital contains protection of consumer rights in the form of the right to obtain health services in accordance with the standards in legislation and legal rights. As a protection for the rights of these patients, consumer protection legal instruments in Indonesia require business actors to provide compensation to patients. Consumers are also given the authority to file claims and lawsuits. Based on these conclusions, it can be said that this study provides a new formulation regarding the protection of patient rights as consumers regarding the completeness of filling out an informed consent form in medical record services in hospitals.
Information Privacy in Healthcare — The Vital Role of Informed Consent
Information Privacy in Healthcare — The Vital Role of Informed Consent
Roy McClelland, Colin M. Harper
European Journal of Health Law, 27 October 2022
Abstract
The use and disclosure of patient information is subject to multiple legal and ethical obligations. Within European human rights law the differences relating to consent are reflected in the separate requirements of data protection law, the common law, and professional ethics. The GDPR requires explicit consent. This contrasts with the ethical and common law availability of reliance on implied consent for the use of patient information for that patient’s care and treatment. For any proposed use of patient information for healthcare purposes other than direct care, even where GDPR may be satisfied if the patient refuses to consent to disclosure, the information should not normally be disclosed. For any proposed use or disclosure outside healthcare the justification should normally be consent. However, consent is often not possible or appropriate and an overriding public interest can be relied upon to justify the use or disclosure, both legally and ethically.
Center for Informed Consent Integrity 