Informed Consent: A Monthly Review

February 2021

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 2021

Editor’s Note:
The latest webinar in the Center’s continuing series was held on January 20th 2021 and included a presentation from Pat Furlong and Ryan Fischer, both of Parent Project Muscular Dystrophy, titled PPMD Gene Therapy Preference Study: Eliciting patient and caregiver preference for emerging gene therapies. The presentation focused on their work on the quantification of patient and caregiver preferences in gene therapy studies to help inform research and researchers and how this impacts the understanding of informed consent in rare disease, specifically Duchenne Muscular Dystrophy. The presentation was followed by a discussion with call participants. Full information and the webinar recording can be found here on the Center for Informed Consent Integrity website.

Clinical Research without Consent: Challenges for COVID-19 Research

Clinical Research without Consent: Challenges for COVID-19 Research
Ian Freckelton
Journal of Law and Medicine, 28 December 2020; 28(1) pp 90-106
The imperatives generated by the need for research into efficacious forms of treatment for COVID-19 have shone a fresh light upon the criteria for inclusion in clinical trials of persons unable to provide informed consent by reason of a number of factors including the seriousness of their illness symptomatology. This column identifies diversity in European, United States and Australian legislative and other guidance on the ethical issues that arise in respect of clinical research to which participants are not able to consent. It reviews the decision-making by the New South Wales Civil and Administrative Tribunal in a 2020 case in which permission was sought to conduct a clinical trial into a drug, STC 3141, designed by researchers as a potential treatment for patients with Adult Respiratory Distress Syndrome arising from COVID-19. It outlines the reasoning of the Tribunal in the context of debates about the balance to be struck between clinically useful medication trials and the need to avoid exploitation of vulnerable persons not able to provide their own consent, be that by virtue of disabilities such as acuteness of illness or dementia symptomatology. It contends that the decision illustrates the potential for research to be undertaken safely and ethically, utilising subjects in an intensive care unit who are unable to provide consent.

Electronic informed consent information for residual newborn specimen research: findings from focus groups with diverse populations

Electronic informed consent information for residual newborn specimen research: findings from focus groups with diverse populations
Original Article
Caren J. Frost, Erin P. Johnson, Brieanne Witte, Louisa Stark, Jeff Botkin, Erin Rothwell
Journal of Community Genetics, 22 January 2021
We developed a video and an app for obtaining consent about allowing newborn blood spots (NBS) to be used as biospecimen resources for biobanking. Newborn screening programs test for treatable diseases and leave residual biospecimens that can be used in future research activities. We conducted focus groups and interviews with three diverse communities to determine (a) how well the consent tools worked and (b) participant familiarity with NBS. Participants preferred the video and noted that they were unaware that NBS could be used for future research. Providing information about how biospecimens could be used was a key issue.

Informed Consent: What Must Be Disclosed and What Must Be Understood?

Informed Consent: What Must Be Disclosed and What Must Be Understood?
Joseph Millum, Danielle Bromwich
American Journal of Bioethics, 18 January 2021
Over the last few decades, multiple studies have examined the understanding of participants in clinical research. They show variable and often poor understanding of key elements of disclosure, such as expected risks and the experimental nature of treatments. Did the participants in these studies give valid consent? According to the standard view of informed consent they did not. The standard view holds that the recipient of consent has a duty to disclose certain information to the profferer of consent because valid consent requires that information to be understood. The contents of the understanding and disclosure requirements are therefore conceptually linked. In this paper, we argue that the standard view is mistaken. The disclosure and understanding requirements have distinct grounds tied to two different ways in which a token of consent can be rendered invalid. Analysis of these grounds allows us to derive the contents of the two requirements. It also implies that it is sometimes permissible to enroll willing participants who have not understood everything that they ought to be told about their clinical trials.

Caregivers’ Understanding of Informed Consent in a Randomized Control Trial

Caregivers’ Understanding of Informed Consent in a Randomized Control Trial
Original Research
Dorothy Helen Boyd, Yinan Zhang, Lee Smith, Lee Adam, L. Foster Page & W. M. Thomson
Journal of Bioethical Inquiry, 15 January 2021
There are differences in caregivers’ literacy and health literacy levels that may affect their ability to consent to children participating in clinical research trials. This study aimed to explore the effectiveness, and caregivers’ understandings, of the process of informed consent that accompanied their child’s participation in a dental randomized control trial (RCT). Telephone interviews were conducted with a convenience sample of ten caregivers who each had a child participating in the RCT. Pre-tested closed and open-ended questions were used, and the findings were produced from an inductive analysis of the latter and a descriptive analysis of the former. Participants had limited understanding of the purpose of the RCT and rated the readability of the consent form more highly than they rated their understanding of the research. All felt that informed consent was vital, but some caregivers had not read the consent documents. Some caregivers enrolled their child in the RCT because they trusted the researchers, and the majority wanted to improve dental care for children. The informed consent process was not always effective despite high readability of the informed consent documents. Researchers must consider the health literacy of the study group, and actively engaging with caregivers to achieve meaningful informed consent may be challenging. Future research could explore participants’ perspectives of informed consent in populations with low health literacy and assess whether an underlying expectation not to comprehend health-related information may be a barrier to informed consent.

The reality of informed consent: empirical studies on patient comprehension—systematic review

The reality of informed consent: empirical studies on patient comprehension—systematic review
Tomasz Pietrzykowski, Katarzyna Smilowska
BMC Trials, 14 January 202; 22(57)
Open Access
Informed consent is a basic concept of contemporary, autonomy-based medical practice and facilitates a shared decision-making model for relations between physicians and patients. Thus, the extent to which patients can comprehend the consent they grant is essential to the ethical viability of medicine as it is pursued today. However, research on patients’ comprehension of an informed consent’s basic components shows that their level of understanding is limited.
Systemic searches of the PubMed and Web of Science databases were performed to identify the literature on informed consent, specifically patients’ comprehension of specific informed consent components.
In total, 14 relevant articles were retrieved. In most studies, few clinical trial participants correctly responded to items that examined their awareness of what they consented to. Participants demonstrated the highest level of understanding (over 50%) regarding voluntary participation, blinding (excluding knowledge about investigators’ blinding), and freedom to withdraw at any time. Only a small minority of patients demonstrated comprehension of placebo concepts, randomisation, safety issues, risks, and side effects.
We found that participants’ comprehension of fundamental informed consent components was low, which is worrisome because this lack of understanding undermines an ethical pillar of contemporary clinical trial practice and questions the viability of patients’ full and genuine involvement in a shared medical decision-making process.

Selfie consents, remote rapport, and Zoom debriefings: collecting qualitative data amid a pandemic in four resource-constrained settings

Selfie consents, remote rapport, and Zoom debriefings: collecting qualitative data amid a pandemic in four resource-constrained settings
Mark Donald C Reñosa, Chanda Mwamba, Ankita Meghani, Nora S West, Shreya Hariyani, William Ddaaki, Anjali Sharma, Laura K Beres
BMJ Global Health, 8 January 2021; 6(1)
Open Access
In-person interactions have traditionally been the gold standard for qualitative data collection. The COVID-19 pandemic required researchers to consider if remote data collection can meet research objectives, while retaining the same level of data quality and participant protections. We use four case studies from the Philippines, Zambia, India and Uganda to assess the challenges and opportunities of remote data collection during COVID-19. We present lessons learned that may inform practice in similar settings, as well as reflections for the field of qualitative inquiry in the post-COVID-19 era. Key challenges and strategies to overcome them included the need for adapted researcher training in the use of technologies and consent procedures, preparation for abbreviated interviews due to connectivity concerns, and the adoption of regular researcher debriefings. Participant outreach to allay suspicions ranged from communicating study information through multiple channels to highlighting associations with local institutions to boost credibility. Interviews were largely successful, and contained a meaningful level of depth, nuance and conviction that allowed teams to meet study objectives. Rapport still benefitted from conventional interviewer skills, including attentiveness and fluency with interview guides. While differently abled populations may encounter different barriers, the included case studies, which varied in geography and aims, all experienced more rapid recruitment and robust enrollment. Reduced in-person travel lowered interview costs and increased participation among groups who may not have otherwise attended. In our view, remote data collection is not a replacement for in-person endeavours, but a highly beneficial complement. It may increase accessibility and equity in participant contributions and lower costs, while maintaining rich data collection in multiple study target populations and settings.

Informed Consent Procedure in Clinical Trials Promoted by the Hospital: Knowledge and Perceptions of Primary Care Physicians

Informed Consent Procedure in Clinical Trials Promoted by the Hospital: Knowledge and Perceptions of Primary Care Physicians
Gómez-Arbonés J, Salazar-Alarcon E, Solanilla-Puertolas M, Ortega-Bravo M, , Vallez-Valero L, Schoenenberger-Arnaiz JA
Journal of Clinical Trials & Research, 24 April 2020; 3(3) pp 197-202
Open Access
To evaluate Primary Care Physician’s (PCP) awareness degree concerning their patient’s participation in Clinical Trials (CT) analyze the communication methods used and obtain physicians personal views.
Authors performed a cross-sectional observational study that included CTs approved by the Institutional Review Board at a Regional University Hospital (n=78). Among these 37 CTs were selected. PCPs involved in these trials received a questionnaire regarding aspects of the CTs in which their patients participated. The communication systems established in the study protocols were analyzed.
Out of 89 PCPs contacted, 82.1% were aware of their patient’s participation in CTs. The information reached them through verbal communication from the participant (56.3%). PCPs also accessed it through electronic medical records (EMR) (34.0%). A majority (97.4%) considered being informed about the participation of their patients in CTs should be compulsory.
Communication of patients’ participation in CTs fundamentally takes place through a verbal interaction between patients and their doctor. PCPs consider that the preferred method of communication would be an alarm system in the patient’s EMR.

Ethical review and informed consent guidelines of high impact anthropology, business, and education research journals

Ethical review and informed consent guidelines of high impact anthropology, business, and education research journals
Original Article
Antti Mikael Rousi
Learned Publishing, 11 January 2021
Whereas participant protection protocols are norms in medical research, they are only recently being adopted in social and behavioural sciences. This study examined human subject guidelines in the top 40 high‐impact anthropology, business, and education research journals according to their impact factor as released in 2019. For these 120 journals, a unified classification framework was developed to capture the central elements of their ethical review and informed consent requirements. The findings suggest that the investigated journals do not view ethical review as an established norm for interview and survey studies. Only 10 (8%) journals required ethical review from all studies involving human participants. Informed consent was more frequently addressed, but none of the fields exhibited widely established guidelines similar to medical research journals. A total of 31 (26%) journals required informed consent from all studies involving human participants. There was little difference between the three disciplines investigated. Although the investigated journals represented social and behavioural sciences, their guidelines often concerned medical or intervention research with few requirements for interaction (e.g. survey) research. There is an opportunity for high‐impact journals to establish norms for adoption by researchers and other journals.

Old Challenges or New Issues? Genetic Health Professionals’ Experiences Obtaining Informed Consent in Diagnostic Genomic Sequencing

Old Challenges or New Issues? Genetic Health Professionals’ Experiences Obtaining Informed Consent in Diagnostic Genomic Sequencing
Research Article
Danya F. Vears, Pascal Borry, Julian Savulescu, Julian J. Koplin
American Journal of Bioethics, 5 October 2020; pp 12-23
While integrating genomic sequencing into clinical care carries clear medical benefits, it also raises difficult ethical questions. Compared to traditional sequencing technologies, genomic sequencing and analysis is more likely to identify unsolicited findings (UF) and variants that cannot be classified as benign or disease-causing (variants of uncertain significance; VUS). UF and VUS pose new challenges for genetic health professionals (GHPs) who are obtaining informed consent for genomic sequencing from patients.
We conducted semi-structured interviews with 31 GHPs across Europe, Australia and Canada to identify some of these challenges.
Our results show that GHPs find it difficult to prepare patients to receive results because a vast amount of information is required to fully inform patients about VUS and UF. GHPs also struggle to engage patients – many of whom may be focused on ending their ‘diagnostic odyssey’ – in the informed consent process in a meaningful way. Thus, some questioned how ‘informed’ patients actually are when they agree to undergo clinical genomic sequencing.
These findings suggest a tension remains between sufficient information provision at the risk of overwhelming the patient and imparting less information at the risk of uninformed decision-making. We suggest that a shift away from ‘fully informed consent’ toward an approach aimed at realizing, as far as possible, the underlying goals that informed consent is meant to promote.