Equitable and Informed Consent in Genetic Studies
Editor’s Note
Ann Marie Navar, Sadiya S. Khan
JAMA Cardiology, 16 November 2022
Excerpt
…Importantly, these participants comprised an already highly selected population in whom higher levels of both genetic knowledge and researcher trust would be expected. Participants were recruited largely from tertiary care academic centers, were cared for by a heart failure program, and had consented to undergo whole-exome sequencing. Despite this, several knowledge gaps were identified. For example, 1 in 5 patients believed that once a genetic variant is found, disease can always be prevented or cured. Genetic knowledge was also lower in Hispanic participants and non-Hispanic Black participants compared with non-Hispanic White participants. Reasons for this are unknown, likely multifactorial, and may include differences in exposure to prior education about genetics, disparities in prior referrals for genetic counseling, and differences in the effectiveness of the informed consent process in addressing gaps in knowledge about genetic testing…
Month: December 2022
Core elements of participant consent documents for Canadian human genomics research and the National Human Genome Library: guidance for policy
Core elements of participant consent documents for Canadian human genomics research and the National Human Genome Library: guidance for policy
Holly Longstaff, Jaime Flamenbaum, Etienne Richer, Jeanne Egar, Christopher R. McMaster, Ma’n H. Zawati
Canadian Medical Association Journal, 15 November 2022; 194(44)
Open Access
Excerpt
…The purpose of this guidance for policy is to present a core set of elements for participant consent documents to be used in local human genome–based research projects across Canada and to support the development of the national CHGL. These core elements can be also used as a research ethics tool when evaluating human genome–based research projects…
Sharing genomic data for health research: institutional trust and trustworthiness, and informed consent
Sharing genomic data for health research: institutional trust and trustworthiness, and informed consent
Mackenzie Graham
Canadian Medical Association Journal, 15 November 2022; 194(44)
Open Access
Excerpt
Recent years have seen a dramatic increase in the collection, storage and curation of human genomic data for biomedical research. These data sets hold great promise for research into the genetic basis of disease, and represent more diverse populations than have traditionally been accessible in research. Large-scale federated data networks like the proposed Canadian Human Genome Library (CHGL) represent a potential way of providing secure access to these data to researchers beyond select institutions. However, the promise of human genomics research has been encumbered by ethical concerns about data sharing. One particular concern is whether it is possible to obtain informed consent to the population-level research that genomic databases like the CHGL are intended to facilitate.
Participants in genome-based research or patients who receive genome or exome sequencing as part of their clinical care may be asked to consent to allow their data — not only genomic data but associated clinical or administrative data stored by an institution — to be made available to future researchers. Because the future uses of these data are unknown at the time of data collection, concern has been raised about whether consent for this future data use is, or can be, informed…
Importance of decisional capacity tools in obtaining informed consent in clinical settings
Importance of decisional capacity tools in obtaining informed consent in clinical settings
Original Article
Miroslav Radenković
Bioethics, 24 November 2022
Open Access
Abstract
Informed consent represents a specific protocol for obtaining consent from a fully informed human subject to take part in clinical research. Still, informed consent is not only required for clinical trials but it also represents a critical precondition before enrolment in standard everyday medical procedures. Relevant fundamental criteria for obtaining informed consent must be followed, and that is that patient must have the decisional capacity to reach autonomous decision. The patient must be adequately informed and not coerced. Evaluating decisional capacity is crucial to providing the required level of care. The decision of which decisional capacity tool to use can be challenging because of various dissimilarities among the instruments. In this paper, four widely documented instruments have been evaluated, namely, the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), the Hopkins Competency Assessment Test (HCAT), the Structured Interview for Competency/Incompetency Assessment Testing, Ranking Inventory (SICIATRI), and the Capacity Assessment Tool (CAT). Some of them include a fully structured interview; semi-structured forms characterise others. Most of them are adaptable for different scenarios, and yet, some are tailored for specific treatment decisions. Some evaluate all four components of decisional capacity, while others do not. Although a broad range of capacity assessment tools is available, it has been shown that they notably improve the accuracy of capacity evaluations. Given that many pathological conditions could result in impaired decisional capacity, physicians must be able to correctly and consistently assess the capacity for which education and previous experience are pivotal.
Working in a gray area—Healthcare staff experiences of receiving consent when caring for persons with dementia
Working in a gray area—Healthcare staff experiences of receiving consent when caring for persons with dementia
Dementia, 15 November 2022
Research Article
Lena Östlund, Marie Ernsth Bravell, Linda Johansson
Abstract
Background
Every person has the right to autonomy, and to be involved in decisions about their care. When persons with dementia have difficulties in expressing what they want, their autonomy is challenged. Staff should strive to involve the person in care decisions, to obtain consent and to avoid the use of coercion and restraints. However, care without consent exists and coercion and restraints are being used. In order to improve care, further knowledge is warranted.
Aims
The purpose of this study was to explore staff’s experiences of obtaining consent when caring for persons with dementia.
Methods
In total 14 focus group interviews were conducted with staff with experience of dementia care who work in either home care or residential care in Sweden. An inductive qualitative content analysis was used to analyze the collected data.
Results
Three categories were generated describing staff experiences of consent in dementia care: the person as the decision-maker, the staff as the decision-makers, and the viability of the consent. Overall, staff found it difficult to know if they really had consent from the individual. Even if the person verbally gave consent, it was challenging to know if the person really understood what they had consented to. Common to all three categories was the significance of the relationship between the person with dementia and staff: getting to know the person, recognizing the person’s response in terms of their facial expressions and body language as well as being able to explain and justify specific actions to the person.
Conclusion
Staff need better conditions in dementia care, including training and time to reflect on how to obtain consent. A person-centered approach can be one way to develop care and ensure that persons with dementia are allowed autonomy and to share in making decisions.
A Bioethics Framework for At-risk Child/Adolescent Access to Key Reproductive Health Services Without Parental Consent
A Bioethics Framework for At-risk Child/Adolescent Access to Key Reproductive Health Services Without Parental Consent
Forouzan Akrami, Alireza Zali, Mahmoud Abbasi
Iranian Journal of Pediatrics, December 2022; 32(6)
Open Access
Abstract
Context
Access of adolescents to key reproductive health services (KRHS) has been emphasized; however, how to provide it has not been addressed. This study aimed to propose a bioethics framework to justify at-risk child/adolescent access to KRHS without parental consent.
Evidence Acquisition
First, articles and documents were searched using the age of consent laws, reproductive health, and ethical/legal standards phrases with AND/OR separators in PubMed and Web of Science using the Google Scholar search engine in English. After a concise review of the age of consent in child/adolescent-related laws, at-risk child/adolescent access to KRHS without parental consent was justified using major ethical and legal principles and standards.
Results
Given the different purposes and nature of harm preventive services, in the first part, the authors argue that considering the age of consent for at-risk adolescents’ access to KRHS is a limiting and inefficient factor, and KRHS could be provided for the at-risk adolescent with his/her own assent. In the second part, the authors argue that in decision-making for at-risk adolescents’ access to KRHS, the best interest standard is applicable on the ground of harm standard. Regarding the sociocultural context of the community, after assessing the seriousness of the harm and the threshold of intervention, practical steps are taken toward reducing or removing harm and choosing the option that best promotes adolescents’ interests.
Conclusions
Regarding the existence of restrictive laws, the suggested framework can be applied in different communities as a bioethics policy guide for legislation and appropriate actions of adolescents’ healthcare professionals.
What information and the extent of information to be provided in an informed assent/consent form of pediatric drug trials
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.
Center for Informed Consent Integrity 