Consent Forms and Procedures [BOOK CHAPTER]

Consent Forms and Procedures [BOOK CHAPTER]
Ann-Margret Ervin, Joan B. Cobb Pettit
Principles and Practice of Clinical Trials
Springer Nature, 11 November 2019
Open Access
Obtaining the informed consent of a participant is a prerequisite for enrollment in a clinical trial. In the United States, federal regulations provide the framework for establishing informed consent with additional protections for persons considered vulnerable due to incarceration, illiteracy, or other condition. Investigators are tasked with providing sufficient information about the research to satisfy the ethical and regulatory requirements while communicating it in a manner that maximizes the participant’s ability to make an informed decision regarding study enrollment. There are clinical trial design features that are essential to include in the consent form with care to describe topics such as randomization, allocation ratio, and masking in a manner understood by the lay public. The informed consent discussion should continue throughout the course of the trial as informally reaffirming the participant’s willingness to continue participation and reconsenting them when there are significant changes to the study protocol are important considerations for providing truly informed consent.

Loopholes in the Research Ethics System? Informed Consent Waivers in Cluster Randomized Trials with Individual‐Level Intervention

Loopholes in the Research Ethics System? Informed Consent Waivers in Cluster Randomized Trials with Individual‐Level Intervention
Alex John London, Monica Taljaard, Charles Weijer
Ethics & Human Research, 2 November 2020
Individual‐cluster trials randomize groups of individuals but deliver study interventions directly to individual participants. We examine three arguments that might justify the perception that the bar for a waiver of consent should be lower in such trials than for individually randomized trials. We contend that if these arguments are treated as sufficient to grant a waiver of consent, then a loophole emerges in research oversight. Such loopholes are morally hazardous for study participants, the integrity of science, and public trust in the research enterprise. We conclude by articulating the standards that research ethics committees should use to evaluate requests for waivers of consent in individual‐cluster trials.

Informed Consent for Genetic and Genomic Research

Informed Consent for Genetic and Genomic Research
Jeffrey R. Botkin
Current Protocols in Human Genetics, 17 November 2020
Genetic research often utilizes or generates information that is potentially sensitive to individuals, families, or communities. For these reasons, genetic research may warrant additional scrutiny from investigators and governmental regulators, compared to other types of biomedical research. The informed consent process should address the range of social and psychological issues that may arise in genetic research. This article addresses a number of these issues, including recruitment of participants, disclosure of results, psychological impact of results, insurance and employment discrimination, community engagement, consent for tissue banking, and intellectual property issues. Points of consideration are offered to assist in the development of protocols and consent processes in light of contemporary debates on a number of these issues. © 2020 Wiley Periodicals LLC.

Audiovisual Modules to Enhance Informed Consent in the ICU: A Pilot Study

Audiovisual Modules to Enhance Informed Consent in the ICU: A Pilot Study
Original Clinical Report
Tyler J. Loftus, Maria E. Alfaro, Tiffany N. Anderson, Travis W. Murphy, Olga Zayko, John P. Davis, Zachary A. Hothem, Dijoia B. Darden, Rohit P. Patel, Wanda Whittet, Edward K. McGough, Azra Bihorac, Chasen A. Croft, Martin D. Rosenthal, R. Stephen Smith, Erin L. Vanzant, Fredrick A. Moore, Scott C. Brakenridge, Gabriela L. Ghita, Babette A. Brumback, Alicia M. Mohr, Philip A. Efron
Critical Care Explorations, 23 November 2020; 2(12)
Obtaining informed consent for commonly performed ICU procedures is often compromised by variability in communication styles and inadequate verbal descriptions of anatomic concepts. The objective of this study was to evaluate the efficacy of an audiovisual module in improving the baseline knowledge of ICU procedures among patients and their caregivers.
Prospective, observational study.
Forty-eight–bed adult surgical ICU at a tertiary care center.
Critically ill surgical patients and their legally authorized representatives. .
An audiovisual module describing eight commonly performed ICU procedures.
Measurements and Main Results
Fifty-nine subjects were enrolled and completed an 11-question pre- and postvideo test of knowledge regarding commonly performed ICU procedures and a brief satisfaction survey. Twenty-nine percent had a healthcare background. High school was the highest level of education for 37% percent of all subjects. Out of 11 questions on the ICU procedure knowledge test, subjects scored an average 8.0 ± 1.9 correct on the pretest and 8.4 ± 2.0 correct on the posttest (p = 0.055). On univariate logistic regression, having a healthcare background was a negative predictor of improved knowledge (odds ratio, 0.185; 95% CI, 0.045–0.765), indicating that those with a health background had a lower probability of improving their score on the posttest. Among subjects who did not have a healthcare background, scores increased from 7.7 ± 1.9 to 8.3 ± 2.1 (p = 0.019). Seventy-five percent of all subjects indicated that the video was easy to understand, and 70% believed that the video improved their understanding of ICU procedures.
Audiovisual modules may improve knowledge and comprehension of commonly performed ICU procedures among critically ill patients and caregivers who have no healthcare background.

Using a cartoon questionnaire to improve consent process in children: a randomized controlled survey

Using a cartoon questionnaire to improve consent process in children: a randomized controlled survey
Clinical Research Article
Shanshan Qiu, Yang Xia, Feng Tian, Yanfang Yang, Jijun Song, Liqin Chen, Hao Mei, Fan Jiang, Nan Bao, Shijian Liu
Pediatric Research, 17 November 2020
The aim of the study was to evaluate the effectiveness of an audio and animated cartoon questionnaire (AACQ) at improving consent process in child for biospecimen donation.
A multi-center randomized and controlled survey was performed at two pediatric hospitals in China from 2019 to 2020. Children aged from 7 to 18 years in the pediatric surgery wards were invited to investigate the participants’ willingness and attitudes for donating biospecimens. A total of 264 children, including 119 in the AACQ group and 145 in the TQ group, and 67 parents of children were analyzed. A separate knowledge test was acquired in the questionnaires.
Our findings showed that the response rate of the AACQ group (89.85%) was significantly higher than that of the TQ group (68.44%; p < 0.001). AACQ can improve the child’s understanding, increase children’s engagement in biospecimen donation, reduced the differences in selected characteristics affecting children understanding, and enhanced their risk awareness of donating biospecimens. We also found that increasing pain and privacy disclosure were the most popular concern among children for the refusal to donate biospecimens.
AACQ is an effective and standardized tool of content delivery to children from the surgical wards. Children who fully understood of biospecimen donation are suggested to participate in the consent signing.

Moral structuring of children during the process of obtaining informed consent in clinical and research settings

Moral structuring of children during the process of obtaining informed consent in clinical and research settings
Research Article
Anderson Díaz-Pérez, Elkin Navarro Quiroz, Dilia Esther Aparicio Marenco
BMC Medical Ethics, 25 November 2020; 21(122)
Open Access
Informed consent is an important factor in a child’s moral structure from which different types of doctor–patient relationships arise. Children’s autonomy is currently under discussion in terms of their decent treatment, beyond what doctors and researchers perceive. To describe the influential practices that exist among clinicians and researchers toward children with chronic diseases during the process of obtaining informed consent.
This was a cross-sectional, qualitative study via a subjective and interpretivist approach. The study was performed by conducting semi-structured interviews of 21 clinicians and researchers. Data analysis was performed using the SPSS version 21® and Atlas Ti version 7.0® programs.
The deliberative and paternalistic models were influential practices in the physician–patient relationship. In the deliberative model, the child is expected to have a moral awareness of their care. The paternalistic model determined that submission was a way of structuring the child because he or she is considered to be a subject of extreme care.
The differentiated objectification [educational] process recognizes the internal and external elements of the child. Informed consent proved to be an appropriate means for strengthening moral and structuring the child.

Young women’s autonomy and information needs in the schools-based HPV vaccination programme: a qualitative study

Young women’s autonomy and information needs in the schools-based HPV vaccination programme: a qualitative study
Research Article
Harriet Fisher, Karen Evans, Jo Ferrie, Julie Yates, Marion Roderick & Suzanne Audrey
BMC Public Health, 10 November 2020; 20(1680)
Open Access
Until 2019, the English schools-based human papillomavirus (HPV) vaccination programme was offered to young women (but not young men) aged 12 to 13 years to reduce HPV-related morbidity and mortality. The aim of this study is to explore the extent to which young women were able to exercise autonomy within the HPV vaccination programme. We consider the perspectives of young women, parents and professionals and how this was influenced by the content and form of information provided.
Recruitment was facilitated through a healthcare organisation, schools and community organisations in a local authority in the south-west of England. Researcher observations of HPV vaccination sessions were carried out in three schools. Semi-structured interviews took place with 53 participants (young women, parents of adolescent children, school staff and immunisation nurses) during the 2017/18 and 2018/19 programme years. Interviews were recorded digitally and transcribed verbatim. Thematic analysis was undertaken, assisted by NVivo software.
Young women’s active participation and independence within the HPV vaccination programme was constrained by the setting of vaccination and the primacy of parental consent procedures. The authoritarian school structure influenced the degree to which young women were able to actively participate in decisions about the HPV vaccination programme. Young women exercised some power, either to avoid or receive the vaccine, by intercepting parental consent forms and procedures. Reliance on leaflets to communicate information led to unmet information needs for young women and their families. Communication may be improved by healthcare professional advocacy, accessible formats of information, and delivery of educational sessions.
Strategies to improve communication about the HPV vaccine may increase young people’s autonomy in consent procedures, clarify young people’s rights and responsibilities in relation to their health care services, and result in higher uptake of the HPV vaccination programme.

Be legally wise: When is parental consent required for adolescents’ access to pre-exposure prophylaxis (PrEP)?

Be legally wise: When is parental consent required for adolescents’ access to pre-exposure prophylaxis (PrEP)?
Ann Strode, Catherine M. Slack, Zaynab Essack, Jacintha D. Toohey, Linda-Gail Bekker
Southern African Journal of HIV Medicine, 10 November 2020
Open Access
South African adolescents (12–17 years) need an array of prevention tools to address their risk of acquiring the life-long, stigmatized condition that is HIV. Prevention tools include pre-exposure prophylaxis (PrEP). However, service providers may not be clear on the instances where self-consent is permissible or when parental consent should be secured.
To consider the legal norms for minor consent to PrEP using the rules of statutory interpretation.
Legal and policy framework.
We find that PrEP should be interpreted as a form of ‘medical treatment’; understood broadly so that it falls within the ambit of one of consent norms in the Children’s Act. When PrEP is interpreted as ‘medical treatment’, then self-consent to PrEP is permissible for persons over 12 years, if they have the mental capacity and maturity to understand the benefits, risks, social and other implications of the proposed treatment. Currently, PrEP is only licensed for persons over 35 kg. Reaching the age of 12 years is a necessary but not sufficient criteria for self-consent and service-providers must ensure capacity requirements are met before implementing a self-consent approach. Decisional support and adherence support are critical.
We recommend that service-providers should take steps to ensure that those persons who meet an age requirement for self-consent, also meet the capacity requirement, and that best practices in this regard be shared. We also recommend that policy makers should ensure that PrEP guidelines are updated to reflect the adolescent consent approach articulated above. It is envisaged that these efforts will enable at-risk adolescents to access much needed interventions to reduce their HIV risk.

Consent and refusal of treatment by older children in emergency settings

Consent and refusal of treatment by older children in emergency settings
Dominique Moritz, Phillip Ebbs
Emergency Medicine Australasia, 9 November 2020
The law recognises that children can exert an increasing level of autonomy and decision‐making about their healthcare as they mature, and that intelligence and maturity levels will vary from one child to the next. Therefore, the parameters for when older children can consent to healthcare can be a complex area for clinicians to navigate. Refusal of treatment provides additional challenges for clinicians because the law is less clear about when older children can be involved in refusing treatment which is in their best interests. This article outlines relevant legislation concerning child consent to treatment across Australian jurisdictions and examines refusal of treatment by children using the 2018 case of Mercy Hospitals Victoria v D1 & Anor.

Problematizing consent: searching genetic genealogy databases for law enforcement purposes

Problematizing consent: searching genetic genealogy databases for law enforcement purposes
Samuel, D. Kennett
New Genetics and Society, 18 November 2020
Genetic genealogy databases have become particularly attractive to law enforcement agencies, especially in the United States (US), which have started to employ genealogists to search them with unknown origin DNA from unidentified human remains (suicides, missing persons) or from a serious crime scene, to help identify the victim, or a potential suspected perpetrator, respectively. While this investigative genetic genealogy (IGG) technique holds much promise, its use – particularly during serious criminal investigations – has sparked a range of social and ethical concerns. Receiving consent for IGG from genetic genealogy database users has been argued as a way to address such concerns. While critiques of the importance of consent are well documented in the biomedical and forensic biobanking literature, this has not been explored for IGG. We sought to address this gap by exploring the views of UK stakeholders. Our research question was: what are UK public and professional stakeholders’ views about the importance of the consent process for IGG when used for serious criminal cases? The methodological approach was interview-based and exploratory. Our analysis identified that all interviewees stressed the importance of consent, though interviewees’ narratives pointed to inadequacies of individual-based consent as an ethical panacea for IGG.