Informed Consent: A Monthly Review

February 2023 :: Issue 50

This digest aggregates and distills key content addressing 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 Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:

Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_February 2023

Investigating demographic differences in patients’ decisions to consent to COVID-19 research

Investigating demographic differences in patients’ decisions to consent to COVID-19 research
Research Article
Kelly Robertson, Kimberly Reimold, Ann M. Moormann, Raquel Binder, Kristen A. Matteson, Heidi K. Leftwich
The Journal of Maternal-Fetal & Neonatal Medicine, 7 November 2022; 36
Open Access
COVID-19 disease severely impacted pregnant persons, resulting in a significant increase in poor maternal health outcomes, with a disproportionate impact on minority populations and individuals with low socioeconomic status. We sought to determine demographic differences between birthing parents with SARS-CoV-2 infections who consented to research study participation versus those who declined. By analyzing demographic differences, we are able to ensure the generalizability of study outcomes and to aid in future prospective research design, with the ultimate goal of recognizing and ameliorating research disparities.
We conducted a secondary analysis to investigate demographic differences in patients who consented to versus declined study participation, in an effort to confirm the external validity of the study results and ensure minority populations most affected by SARS-CoV-2 infection were accurately represented. An IRB waiver was obtained to conduct retrospective chart review for demographic data collection of all patients approached for the COVID-19 Analysis on Perinatal Specimens Related to ExpoSure (CARES) research study. Pregnant patients with SARS-CoV-2 infection were identified at a single hospital center and approached either in person or via phone, with a translator if primary language listed as non-English. Demographic variables including race, ethnicity, primary language, and insurance type were obtained from the electronic medical record and analyzed via Chi-square to determine significant differences between individuals who consented to participation and those who declined participation.
One hundred and fifty-eight pregnant patients with SARS-CoV-2 infection were approached for CARES study participation. Eighty-nine patients consented to study participation, while 69 declined study participation. A retrospective chart review was conducted on all 158 patients. Patients who identified as Black race or non-White race were more likely to decline participation (23.2%, p = .031, 68.1%, p = .026), compared to patients who identified as White (31.9%) (Table 1). Patients with public insurance were also more likely to decline study participation (72.5%, p = .049) compared to those with private insurance (27.5%). There was no significant difference between primary language spoken or ethnicity in patients who participated or declined. There was no difference in study participation between patients who identified as Asian race or Other race, compared to patients who identified as White race.
We found significant differences in race and insurance type between pregnant patients with SARS-CoV-2 infection who consented versus declined research study participation. Our study showed that patients who identify as Black race or have public insurance are less likely to consent to research study participation. However, when demographics of consented patients are compared to county, state, and national demographics of female patients age 18–49 with confirmed SARS-CoV-2 infection obtained from a dataset collected by the Center for Disease Control and Prevention (CDC), there was no significant difference between race representation of patients who consented to study participation. This suggests that though the external validity of the CARES study is confirmed, more efforts need to be made to address racial and socioeconomic disparities in research participation.

Incentivization and the moral problem of involuntary consent in medical research

Incentivization and the moral problem of involuntary consent in medical research
Victor Chidi Wolemonwu
History and Philosophy of Medicine, 18 January 2023
Open Access
The legal and moral permissibility of clinical research entails that researchers must secure the voluntary, informed consent of prospective research participants before enrolling them in studies. In seeking the consent of potential participants, researchers are also allowed to incentivise the recruitment process because many studies would fail to meet enrollment goals without a financial incentive for participation. Some philosophers and bioethicists contend that the use of incentives to secure consent from research subjects is problematic because it constitutes undue inducement and a coercive offer. Some proponents of this view are Ruth Macklin (1981, 1989) and Joan McGregor (2005). Macklin claims that it is ethically inappropriate to pay research subjects. The payment is likely to coerce the research subject, thereby violating the ethical requirement on the voluntariness of research participation. Also, such offers can prompt subjects to lie, deceive or conceal information that, if known, would disqualify them as participants. For McGregor, incentives could be undue and coercive because they make offerees better off relative to their baseline as well as constrain them to accept the offer of incentives as the only eligible choice or option. I argue that coercive offers are distinct from undue inducement. Coercive offers are essentially morally objectionable because by making people accept an offer through threats for the sake of some interests or ends, the offeror vitiates the offeree’s capacity to make informed, voluntary, and rational decisions and choices. I further claim that the quantity of an incentive does not render an inducement undue. I contend that the only condition under which incentives are regarded as an undue inducement and as such vitiates an agent’s voluntary consent is if they are offered through deceptive or manipulative means.

Using the consolidated framework for implementation research to guide a pilot of implementing an institution level patient informed consent process for clinical research at an outpatient setting

Using the consolidated framework for implementation research to guide a pilot of implementing an institution level patient informed consent process for clinical research at an outpatient setting
Xuling Lin, Joanne Yong Ern Yuen, Wei Quan Jeremy Chan, Tushar Gosavi Divakar, Nicole Chwee Har Keong, Lester Chee How Lee, Sumeet Kumar, Chew Seah Tan, Kim Chin Pauline Soon, Yee Pheng Amy Chew, Heriati Mohd Yazid, Farah Julieanna Mohd Saleh, Fenglong Cai, Fui Chih Chai, Nur Fakhirah Mohamed Azwan, Nurhidayah Mohamad Faizal, Siew Choo Lou, Siew Sin Priscilla Tan, Cut Marini Jarimin, Gowri Michael Stanley, Khadijah Hussien, Nurhazah Sanmwan, Nur Hidayah Amran, Nurliana Ramli, Shermyn Xiu Min Neo, Louis Chew Seng Tan, Eng King Tan, Elaine Lum
Pilot and Feasibility Studies, 12 January 2023; 9(6)
Open Access
In Singapore, research teams seek informed patient consent on an ad hoc basis for specific clinical studies and there is typically a role separation between operational and research staff. With the enactment of the Human Biomedical Research Act, there is increased emphasis on compliance with consent-taking processes and research documentation. To optimize resource use and facilitate long-term research sustainability at our institution, this study aimed to design and pilot an institution level informed consent workflow (the “intervention”) that is integrated with clinic operations.
We used the Consolidated Framework for Implementation Research (CFIR) as the underpinning theoretical framework and conducted the study in three stages: Stage 1, CFIR constructs were used to systematically identify barriers and facilitators of intervention implementation, and a simple time-and-motion study of the patient journey was used to inform the design of the intervention; Stage 2, implementation strategies were selected and mapped to the Expert Recommendations for Implementing Change (ERIC) taxonomy; Stage 3, we piloted and adapted the implementation process at two outpatient clinics and evaluated implementation effectiveness through patient participation rates.
We identified 15 relevant CFIR constructs. Implementation strategies selected to address these constructs were targeted at three groups of stakeholders: institution leadership (develop relationships, involve executive boards, identify and prepare champions), clinic management team (develop relationships, identify and prepare champions, obtain support and commitment, educate stakeholders), and clinic operations staff (develop relationships, assess readiness, conduct training, cyclical tests of change, model and simulate change, capture and share local knowledge, obtain and use feedback). Time-and-motion study in clinics identified the pre-consultation timepoint as the most appropriate for the intervention. The implementation process was adapted according to clinic operations staff and service needs. At the conclusion of the pilot, 78.3% of eligible patients provided institution level informed consent via the integrated workflow implemented.
Our findings support the feasibility of implementing an institution level informed consent workflow that integrates with service operations at the outpatient setting to optimize healthcare resources for research. The CFIR provided a useful framework to identify barriers and facilitators in the design of the intervention and its implementation process.

Is the informed consent form only a symbolic document in clinical trials?

Is the informed consent form only a symbolic document in clinical trials?
Mini Review
Buket Gungor
Archives of Pharmacy and Pharmaceutical Sciences, 19 December 2022
Open Access
Being one of the basic principles of clinical research, informed consent is definitely a legal responsibility and ethical duty for health professionals. The purpose of obtaining informed consent is to enable the subjects to make an autonomous decision by providing them with accurate and clear information about the research at the stage of participation. Due to medical advancements and the increasing complexity of diagnostic and experimental methods in clinical research, the prepared Informed Consent Forms (ICFs) have become difficult to understand. Viewing ICFs as just a necessary legal and symbolic document of participation in research often results in an insufficiently informed consent process for subjects. Research shows that the rate of understanding the basic information in the consent forms prepared for the subjects participating in the clinical trials ranged from 52.1% to 75.8%…

A Comparative Data Protection Analysis of Healthcare Robots: On Informed Consent in Human-Robot Interaction

A Comparative Data Protection Analysis of Healthcare Robots: On Informed Consent in Human-Robot Interaction
Research Article
Yueh-Hsuan Weng
Frontiers in Artificial Intelligence and Applications, 1 January 2023
As societies across the developed world are dealing with problems associated with aging populations, a promising solution in the form robotics technologies that support elderly people in their daily healthcare has emerged. However, emerging technology are like a double-edge sword. Although healthcare robots can be used for elderly and disabled people with different levels of assistive supports, ie by monitoring their real time health for prompt interaction or by communicating with people to reduce their anxiety, they also bring with them many concerns from an ethical, legal and societal perspective. Among them, one serious issue is privacy and data protection. When healthcare robots are powered by machine learning and distributed databases, “data-driven” networked healthcare robots will be able to gather a huge amount of personal data in physical environments through their interactions with humans. There are several alternative approaches of data protection for “data-driven” networked healthcare robots, including privacy by design, de-identification of data and informed consent. In this article our focus is on the issue of informed consent in human-robot interaction. My argument is that specific conditions of intelligent robots (i.e., embodiment) will mean that the principle of informed consent cannot just be copied and applied to “data-driven” networked healthcare robots. I will make the comparison of the two types of informed consent to clarify our targeted “informed consent in human-robot interaction”. Furthermore, there is a need to discuss potential legal conflicts of this new type of informed consent when it is applied to different countries and their respective legal regimes. Hence, in this article I will conduct a comparative legal analysis of European, American and Japanese data protection law to investigate how such differences might influence the implementation of informed consent to data-driven healthcare robots.

Exploring the challenges of and solutions to sharing personal genomic data for use in healthcare

Exploring the challenges of and solutions to sharing personal genomic data for use in healthcare
Lasse Parvinen, Ari Alamäki, Heli Hallikainen, Marko Mäki
Health Informatics Journal, January-March 2023; 29(1)
Boosted by the COVID-19 pandemic, as well as the tightened General Data Protection Regulation (GDPR) legislation within the European Union (EU), individuals have become increasingly concerned about privacy. This is also reflected in how willing individuals are to consent to sharing personal data, including their health data. To understand this behaviour better, this study focuses on willingness to consent in relation to genomic data. The study explores how the provision of educational information relates to willingness to consent, as well as differences in privacy concerns, information sensitivity and the perceived trade-off value between individuals willing versus unwilling to consent to sharing their genomic data. Of the respondents, 65% were initially willing to consent, but after educational information 89% were willing to consent and only 11% remained unwilling to consent. Educating individuals about potential health benefits can thus help to correct the beliefs that originally led to the unwillingness to share genomic data.

Revisiting informed consent in forensic genomics in light of current technologies and the times

Revisiting informed consent in forensic genomics in light of current technologies and the times
Original Article
Bruce Budowle, Antti Sajantila
International Journal of Legal Medicine, 16 January 2023
Open Access
Informed consent is based on basic ethical principles that should be considered when conducting biomedical and behavioral research involving human subjects. These principles—respect, beneficence, and justice—form the foundations of informed consent which in itself is grounded on three fundamental elements: information, comprehension, and voluntary participation. While informed consent has focused on human subjects and research, the practice has been adopted willingly in the forensic science arena primarily to acquire reference samples from family members to assist in identifying missing persons. With advances in molecular biology technologies, data mining, and access to metadata, it is important to assess whether the past informed consent process and in particular associated risks are concomitant with these increased capabilities. Given the state-of-the-art, areas in which informed consent may need to be modified and augmented are as follows: reference samples from family members in missing persons or unidentified human remains cases; targeted analysis of an individual(s) during forensic genetic genealogy cases to reduce an investigative burden; donors who provide their samples for validation studies (to include population studies and entry into databases that would be applied to forensic statistical calculations) to support implementation of procedures and operations of the forensic laboratory; family members that may contribute samples or obtain genetic information from a molecular autopsy; and use of medical and other acquired samples that could be informative for identification purposes. The informed consent process should cover (1) purpose for collection of samples; (2) process to analyze the samples (to include type of data); (3) benefits (to donor, target, family, community, etc. as applicable); (4) risks (to donor, target, family, community, etc. as applicable); (5) access to data/reports by the donor; (6) sample disposition; (7) removal of data process (i.e., expungement); (8) process to ask questions/assessment of comprehension; (9) follow-up processes; and (10) voluntary, signed, and dated consent. Issues surrounding these topics are discussed with an emphasis on addressing risk factors. Addressing informed consent will allow human subjects to make decisions voluntarily and with autonomy as well as secure the use of samples for intended use.

Informed consent for expanded carrier screening: Past, present, and future

Informed consent for expanded carrier screening: Past, present, and future
Britton D. Rink
Prenatal Diagnosis, 13 January 2023
History, law, bioethics, and geocultural influences all have impacted the modern application of informed consent. It is a complex, multilayered process to communicate information and obtain voluntary patient permission before a health care intervention. Lack of provider education about genetic disorders, complexities of advanced genomic technologies, limited time during patient encounters, and low health literacy within a population all represent challenges to effective communication. There is no consensus on how informed consent in reproductive genetics is optimally obtained. Expanded carrier screening (ECS) is purposed to simultaneously test for a large list of diseases in a pan-ethnic manner. The increased use of ECS is driven by advances in genomic technologies, decreased cost, an improved understanding of single gene disorders, and in support of reproductive autonomy. Academic organizations recommend pretest counseling when patients consider ECS, yet best practice is not established. Ongoing research is needed to determine how optimally implement informed consent given the increased complexity of ECS.

Community Genetics screening in a pandemic: solutions for pre-test education, informed consent, and specimen collection

Community Genetics screening in a pandemic: solutions for pre-test education, informed consent, and specimen collection
Bronwyn Terrill, Lauren McKnight, Angela Pearce, Heather Gordon, William Lo, I-Chieh Jennifer Lee, Monica Runiewicz, Alex Palmer, Lesley Andrews, Edwin Kirk, Daniel Goldberg, John Tucker, David Murray, Warren Kaplan, Sarah Kummerfeld, Leslie Burnett
European Journal of Human Genetics, 11 January 2023
Open Access
A Community Genetics carrier screening program for the Jewish community has operated on-site in high schools in Sydney (Australia) for 25 years. During 2020, in response to the COVID-19 pandemic, government-mandated social-distancing, ‘lock-down’ public health orders, and laboratory supply-chain shortages prevented the usual operation and delivery of the annual testing program. We describe development of three responses to overcome these challenges: (1) pivoting to online education sufficient to ensure informed consent for both genetic and genomic testing; (2) development of contactless telehealth with remote training and supervision for collecting genetic samples using buccal swabs; and (3) a novel patient and specimen identification ‘GeneTrustee’ protocol enabling fully identified clinical-grade specimens to be collected and DNA extracted by a research laboratory while maintaining full participant confidentiality and privacy. These telehealth strategies for education, consent, specimen collection and sample processing enabled uninterrupted delivery and operation of complex genetic testing and screening programs even amid pandemic restrictions. These tools remain available for future operation and can be adapted to other programs.