Informed Consent: A Monthly Review

August 2019

This digest aggregates and distills key content around informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the GE2P2 Global Foundation’s Center for Informed Consent Integrity, which is solely responsible for its content. Comments and suggestions should be directed to:

Paige Fitzsimmons, MA
Associate Fellow
GE2P2 Global Foundation

David R. Curry
President & CEO
GE2P2 Global Foundation

PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_August 2019

Consent for clinical genome sequencing: considerations from the Clinical Sequencing Exploratory Research Consortium

Consent for clinical genome sequencing: considerations from the Clinical Sequencing Exploratory Research Consortium
Yu JH, Appelbaum PS, Brothers KB, Joffe S, Kauffman TL, Koenig BA, Prince AE, Scollon S, Wolf SM, Bernhardt BA, Wilfond BS
Personalized Medicine, 17 Jul 2019
Implementing genome and exome sequencing in clinical practice presents challenges, including obtaining meaningful informed consent. Consent may be challenging due to test limitations such as uncertainties associated with test results and interpretation, complexity created by the potential for additional findings and high patient expectations. We drew on the experiences of research teams within the Clinical Sequencing Exploratory Research (CSER1) Consortium on informed consent for clinical genome and exome sequencing (CGES) to negotiate consensus considerations. We present six considerations for clinicians and 12 key points to communicate as they support patients in deciding whether to undergo CGES. These considerations and key points provide a helpful starting point for informed consent to CGES, grounded in the Clinical Sequencing Exploratory Research (CSER1) experience.

Informed consent and community engagement in open field research: lessons for gene drive science

Informed consent and community engagement in open field research: lessons for gene drive science
Jerome Amir Singh
BMC Medical Ethics, 27 July 2019; 20(54) 
Open Access
The development of the CRISPR/Cas9 gene editing system has generated new possibilities for the use of gene drive constructs to reduce or suppress mosquito populations to levels that do not support disease transmission. Despite this prospect, social resistance to genetically modified organisms remains high. Gene drive open field research thus raises important questions regarding what is owed to those who may not consent to such research, or those could be affected by the proposed research, but whose consent is not solicited. The precise circumstances under which informed consent must be obtained, and from whom, requires careful consideration. Furthermore, appropriate engagement processes should be central to any introduction of genetically modified mosquitos in proposed target settings.
In this work, international guidance documents on informed consent and engagement are reviewed and applied to the genetically modified mosquito research context. Five analogous research endeavours that involve area-wide / open field experiments are reviewed. The approach of each in respect to the solicitation of individual informed consent and community engagement are highlighted.
While the solicitation of individual informed consent in host settings of gene drive field trials may not be possible or feasible in some instances, local community and stakeholder engagement will be key to building trust towards the proposed conduct of such research. In this regard, the approaches taken by investigators and sponsors of political science field research and weather modification field research should be avoided. Rather, proponents of gene drive field research should look to the Eliminate Dengue field trials, cluster randomised trials, and pragmatic clinical trials for guidance regarding how the solicitation of individual informed consent of host communities ought to be managed, and how these communities ought to be engaged.

Optimising informed consent in school-based adolescent vaccination programmes in England: A multiple methods analysis

Optimising informed consent in school-based adolescent vaccination programmes in England: A multiple methods analysis
Tracey Chantler, Louise Letley, Pauline Paterson, Joanne Yarwood, Vanessa Saliba, Sandra Mounier-Jack
Vaccine, 24 July 2019
Open Access
The process of obtaining informed consent for school-based adolescent immunisation provides an opportunity to engage families. However, the fact that parental consent needs to be obtained remotely adds complexity to the process and can have a detrimental effect on vaccine uptake. We conducted a multiple methods analysis to examine the practice of obtaining informed consent in adolescent immunisation programmes. This involved a thematic analysis of consent related data from 39 interviews with immunisation managers and providers collected as part of a 2017 service evaluation of the English adolescent girls’ HPV vaccine programme and a descriptive statistical analysis of data from questions related to consent included in a 2017 survey of parents’ and adolescents’ attitudes to adolescent vaccination. The findings indicated that the non-return of consent forms was a significant logistical challenge for immunisation teams, and some were piloting opt-out consent mechanisms, increasing the proportion of adolescents consenting for their own immunisations, and introducing electronic consent. Communicating vaccine related information to parents and schools and managing uncertainties about obtaining adolescent self-consent for vaccination were the main practical challenges encountered. Survey data showed that parents and adolescents generally agreed on vaccine decisions although only 32% of parents discussed vaccination with their teenager. Parental awareness about the option for adolescents to self-consent for vaccination was limited and adolescents favoured leaving the decision-making to parents. From the interviews and variability of consent forms it was evident that health professionals were not always clear about the best way to manage the consent process. Some were also unfamiliar with self-consent processes and lacked confidence in assessing for ‘Gillick competency’. Developing pathways and related interventions to improve the logistics and practice of consent in school-based adolescent immunisation programmes could help improve uptake.

Vaccination over Parental Objection — Should Adolescents Be Allowed to Consent to Receiving Vaccines?

Vaccination over Parental Objection — Should Adolescents Be Allowed to Consent to Receiving Vaccines?
Ross D. Silverman, Douglas J. Opel, Saad B. Omer
New England Journal of Medicine, 11 July 2019; 381(2)
…Such cases raise the question of whether adolescent minors should be able to consent to vaccinations without parental permission. For minors to be able to choose to be vaccinated over parental objections, most states would need to make substantive changes to laws governing medical consent. Since children are generally considered nonautonomous under U.S. law, treatment of a child in a medical setting requires parental permission, typically until a child reaches 18 years of age. Parents are generally given broad discretion in making decisions on behalf of their children, in part because they know their child best, are positioned to weigh competing family interests, and are permitted to raise their child as they choose. Such discretion doesn’t mean that adolescents have no role in decisions that affect them, however. Out of respect for adolescents’ developing autonomy, clinicians routinely explore their understanding of health-related issues, solicit their agreement on care plans, navigate discordance between parental and adolescent preferences, and protect adolescents’ confidentiality interests.

Both ethical principles and state laws also support independent decision making by adolescents in cases in which failing to grant adolescents autonomy could foreseeably result in substantial risk to the minor or to public health. For instance, all states have laws permitting minors to make independent, confidential clinical decisions regarding certain sensitive or stigmatized health care services, such as those related to sexual health, reproduction, mental health, and substance use disorders. Roughly 20% of jurisdictions require adolescents to be at least 12 or 14 years of age to make such decisions; others don’t designate a minimum age of consent.3 A court may also grant an older adolescent (typically 16 years or older) legal emancipation or deem the adolescent to be a “mature minor” who is able to make certain decisions independently.

Most states, however, don’t authorize adolescents to independently consent to vaccination…

Facilitating Informed Permission/Assent/Consent in Pediatric Clinical Trials

Facilitating Informed Permission/Assent/Consent in Pediatric Clinical Trials
Susan M. Abdel-Rahman
Pediatric Drugs, 17 July 2019; pp 1-10
Individuals approached to participate in human subjects research, irrespective of age, must be completely apprised of the study, and researchers must ensure that the information is understood to the fullest extent possible, prior to decision making. However, evolving regulatory and institutional requirements have led to permission/assent/consent (PAC) forms that are unnecessarily complex, serving only to exacerbate the challenges associated with communicating this important information to prospective participants. At greatest risk are children and other individuals with low literacy, limited English proficiency, and diminished mental capacity, populations all too often neglected in clinical research. This paper examines various strategies that have been evaluated to facilitate informed PAC, drawing on experiences across a broad array of populations whose needs overlap with those of children. These strategies range from simplifying PAC forms for readability and creating multimedia PAC delivery tools to actively engaging participants on their understanding of PAC elements by leveraging testing, rewards, and third-party communications. Notably, the findings from strategies that have been explored in more than one setting are uniformly mixed with respect to their ability to improve comprehension, underscoring the challenges that persist in designing, implementing, and objectively examining strategies intended to facilitate informed PAC. However, these studies do serve to highlight efforts that may reduce anxiety around, and increase the satisfaction of participants with, the PAC process. Ultimately, accommodating a diverse participant pool will require the consideration, and continual refinement, of various PAC strategies along with the engagement of team members who are intimately familiar with these populations.

Consent in paediatric neurosurgery: adequacy of documentation and parental perspectives

Consent in paediatric neurosurgery: adequacy of documentation and parental perspectives
Adikarige H. D. Silva, Haren Wijesinghe, Nilesh Mundil, William Lo, A. Richard Walsh, Guirish A. Solanki, Desiderio Rodrigues
Child’s Nervous System, 9 July 2019; pp 1–7
Original Article
Consenting paediatric patients for surgical procedures remains inherently unique in that it is underpinned by principles such as parental responsibility, assessment of the child’s capacity to consent, and adherence to national/legal guidelines. Quality record keeping is an important objective evidence to demonstrate the highest standards of medical care provided to our patients. The consent form is a crucial medical record encapsulating the attainment of informed consent from a parent/guardian for performing a procedure on their child. We aimed to prospectively evaluate the consenting process in our department to assess adequacy of documentation and parental perspectives.
A prospective study using qualitative descriptive design was conducted with parents of 50 children requiring neurosurgical procedures over a 3-month period.
All patients understood the primary diagnosis and type of surgery. Procedure-specific risks were understood by 98% and 84% could remember the mentioning of general risks of surgery. Only a minority of parents (24%) could recollect that alternative options of management including no treatment were discussed. In cases where relevant, laterality was only documented in 56% of consent forms. All patients felt that an informed decision regarding consent to surgery was made. However, 12% suggested areas where further improvement could be made in the timing of consent and the way information could be better provided.
Consent is more than a signature on a form. It provides objective evidence of a shared decision-making process between the surgeon, patient, and their parent/guardian. Our initial study highlights multiple areas for improvement.

Informed consent and ethical reporting of research in clinical trials recruiting participants with psychotic disorders

Informed consent and ethical reporting of research in clinical trials recruiting participants with psychotic disorders
Guy M. Weissinger, Connie M. Ulrich
Contemporary Clinical Trials, 24 June 2019
Informed consent is the foundation of modern biomedical research and it is vital for assuring the safety of vulnerable individuals, like those with psychotic disorders (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder, etc.). All individuals who are involved in clinical research must have consented to participate or had surrogate consent from a representative. As individuals with psychotic disorders may not always have capacity to consent, assessment of capacity before research participation is vital but there is little research on how these assessments are conducted in clinical research. The authors conducted a systematic review of high-risk trials, defined as randomized medication or device trials that specifically recruited individuals with psychotic disorders, to understand the use of capacity to consent assessment and their reporting. A total of 646 articles, which mostly recruited participants with schizophrenia and were medication trials, were coded using a standardized questionnaire on consent practices and ethical reporting of research. Only 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 had capacity to provide informed consent in the study inclusion/exclusion criteria. Additionally, 66 (10.2%) of the articles did not have a statement about IRB approval and 134 (20.7%) had no statements about potential conflicts of interest. Though limitations to the review exist, it is clear that both in conducting high-risk research with individuals with psychotic disorders and when reporting research findings, there are ethical issues that must be addressed.

Use of multimedia during informed consent: novelty or necessity

Use of multimedia during informed consent: novelty or necessity
Henry H. Chill, Uri Dior, David Shveiky
International Urogynecology Journal, 13 July 2019; pp 1–3 
The process of informed consent is an integral part of the preoperative encounter. In theory, it has the potential to educate patients, enabling them to reach a true autonomous decision regarding the treatment offered. Unfortunately, in recent years informed consent has become overly complicated for the average patient. Questions have been raised regarding the ability of the process, as practiced nowadays, to actually increase knowledge and achieve its goals. In search of new ways to increase patient comprehension, researchers have suggested use of multimedia during the process of informed consent. Visualization of complex ideas, interactive learning and tailoring the procedure to fit patient needs are all advantages presented by use of multimedia during the process. Several randomized prospective trials have looked into this topic and have presented promising data in favor of multimedia use. Informed consent is a process with unfulfilled potential, and use of multimedia may be part of the solution. In our opinion, it is time to change the way we educate patients.

Electronic informed consent: the need to redesign the consent process for the digital age

Electronic informed consent: the need to redesign the consent process for the digital age
Personal Viewpoint
Helen Lunt, Saxon Connor, Helen Skinner, Greg Brogden
International Medicine Journal, 11 July 2019
The delivery of healthcare, which includes the informed consent process, is moving to a digital environment. This change in informed consent delivery will be associated with opportunities, risks and also unintentional consequences. Physicians are well placed to contribute to the ongoing dialogue about what is needed to make the informed consent process fit for purpose, in the digital age.