Informed Consent: A Monthly Review
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_April 2022
Evaluating models of consent in changing health research environments
Svenja Wiertz, Joachim Boldt
Medicine, Health Care and Philosophy, 14 March 2022
While Specific Informed Consent has been the established standard for obtaining consent for medical research for many years, it does not appear suitable for large-scale biobank and health data research. Thus, alternative forms of consent have been suggested, based on a variety of ethical background assumptions. This article identifies five main ethical perspectives at stake. Even though Tiered Consent, Dynamic Consent and Meta Consent are designed to the demands of the self-determination perspective as well as the perspective of research as a public good, they are still also criticized from both perspectives. In addition, criticisms based on concerns of justice, participation and democratic deliberation, and relational concerns have been levelled at each of the models. As all of these perspectives have valid points to make, the task at hand lies in balancing these ethical perspectives. What constitutes an adequate balancing depends on contextual factors. These factors include digital infrastructure and digital literacy, data safety regulation, good scientific and clinical practice, transparent debates on ethically relevant features of research, social inequalities, anti-discrimination laws and practices, trust in health care institutions and recognition of patient preferences, and consensus on unethical research. We argue that the role of context in determining acceptable models of consent puts the ethical importance of models of consent into perspective. Since altering contextual factors can help to live up to the ethical concerns at stake in debates about models of consent, opting for such a shift of focus comes without ethical loss.
Four reasons why too many informed consents to clinical research are invalid: a critical analysis of current practices
Anne Wisgalla, Joerg Hasford
BMJ Open – Ethics, 4 March 2022
Informed consent (IC) is a central ethical and legal requirement for clinical research that aims to protect the autonomy of participants. To enable an autonomous decision and valid consent, adequate understanding must be ensured. However, a considerable proportion of participants do not understand the relevant aspects about participation in research, for example, approximately 45% could not name at least one risk. As such, the inadequate understanding of IC has been known for several decades, and it still constitutes a severe problem for the ethical conduct of research. Through delineating the most pressing deficits of current IC procedures that lead to insufficient understanding, we aim to encourage the discussion among stakeholders, for example, clinical researchers, and to provide the grounds for practical solutions.
(1) IC documents are too long to be read completely, thus, make it very difficult for potential participants to identify the material facts about the trial. (2) The low readability of the IC documents disadvantages persons with limited literacy. (3) The therapeutic misconception frequently prevents participants to realise that the primary purpose of clinical research is to benefit future patients. (4) Excessive risk disclosures, insufficient information about expected benefits and framing effects compromise a rational risk/benefit assessment.
Due to these deficits, practices of IC in clinical research too often preclude adequate understanding of prospective participants, thus, invalidating IC. The gap between the well-specified ethical norm to enable IC and its insufficient translation into practice can no longer be accepted, as participant rights and the public trust in responsible research are at stake. Hence, immediate action is needed to address the prevailing deficits.
Streamlined versus traditional consent for low-risk comparative effectiveness trials: a randomized experimental study to measure patients’ and public attitudes
Nancy E Kass, Ruth R Faden, Stephanie R Morain, Kristina Hallez, Rebecca A Stametz, Amanda R Milo, Deserae Clarke
Journal of Comparative Effectiveness Research, 3 March 2022
Streamlining consent for low-risk comparative effectiveness research (CER) could facilitate research, while safeguarding patients’ rights.
Materials & methods
2618 adults were randomized to one of seven consent approaches (six streamlined and one traditional) for a hypothetical, low-risk CER study. A survey measured understanding, voluntariness, and feelings of respect.
Participants in all arms had a high understanding of the trial and positive attitudes toward the consent interaction. Highest satisfaction was with a streamlined approach showing a video before the medical appointment. Participants in streamlined were more likely to mistakenly think a signature was required.
Streamlined consent was no less acceptable than traditional, signed consent. Streamlined and traditional approaches achieved similar levels of understanding, voluntariness and a feeling that the doctor–patient interaction was respectful.
Getting the Most out of Consent: Patient-Centered Consent for an Acute Stroke Trial
Neal W. Dickert, Kathleen Metz ,S. Iris Deeds, Michael J. Linke, Andrea R. Mitchell, Candace D. Speight, Opeolu M. Adeoye
Ethics & Human Research, 26 February 2022
Informed consent for clinical trials in acute stroke is characterized by challenges related to urgency, cognitive impairment, and geographical separation. Context-appropriate approaches are needed for this setting. We conducted a mixed-methods project involving focus groups and interviews as well as collaboration with a patient advisory panel and a central institutional review board (CIRB) to design and implement a patient-driven consent process for a multicenter trial incorporating adaptive randomization. Remote consent was recognized as challenging but acceptable. Adaptive randomization was viewed positively, but significant potential for misunderstanding was appreciated. Collaboration between the patient advisory panel and the CIRB resulted in a shortened, more patient-centered consent form that was approved at all sites with few modifications. An information sheet was developed as a resource for patients and surrogates after enrollment. Collaboration between investigators, patient partners, and a CIRB can facilitate innovation and implementation of patient-centered, context-appropriate consent strategies.
Reshaping the review of consent so we might improve participant choice
Research Ethics, 15 September 2021
Consent is one necessary foundation for ethical research and it’s one of the research ethics committee’s major roles to ensure that the consent process meets acceptable standards. Although on Oxford ‘A’ REC (an NHS Research Ethics Committee based in the UK) we’ve been impressed by the thought and work put into this aspect of research ethics, we’ve continued to have concerns about the suitability and effectiveness of consent processes in supporting decision making, particularly for clinical trials. There’s poor understanding of what people want to help them decide; current processes don’t provide the best grounding for informed consent and there’s inadequate public involvement. We’ve also found a lack of proportionality with researchers failing to adapt consent procedures in proportion to the burdens and consequences of the study. As a result, people are often not best helped to make an informed choice when asked to join a research study. To address these concerns, we considered how we might improve this aspect of research ethics review. Recognising the central importance of the dialogue between the volunteer and researcher, we’ve drawn up a model or flowchart of what we deem good consent practice, proposing consent should be built around four simple steps:
Step 1: Introducing the study and the choices: helping the potential participants get an overview of the proposal and introducing the key issues.
Step 2: Explaining all the details of the study using the detailed Participant Information Sheet.
Step 3: After a gap, if necessary, reviewing and checking understanding.
Step 4: Reaching agreement and recording consent.
These steps, we believe, could help all involved and this article lays out ways we might improve participant choice while complying with accepted principles and current regulations.
The Effect of Digital Literacy on Participation in Social Media Clinical Trials in Cancer: Tailoring an Informed Consent Process
Debra Parker Oliver, George Demiris, Karla T. Washington, Kyle Pitzer, Connie Ulrich
Telemedicine and e-Health, 21 Mar 2022
This study asked: (1) How does digital literacy influence one’s decision to consent to a social media intervention study? (2) What is a brief way to assess individual digital literacy before an individual’s decision to participate in a trial? and (3) How can a consent process be tailored around an individual’s digital literacy level?
We used an assessment tool to investigate digital literacy of those who chose to consent to a clinical trial and those who did not consent to the clinical trial but agreed to participate in a digital literacy study.
A total of 161 hospice caregivers completed the digital literacy assessment. Older individuals and those who rated themselves as more proficient in the use of technology and social media were more likely to consent to the social media clinical trial.
We found that asking participants to rate their technology skills and social media skills allows researchers to tailor a consent process. For those who are comfortable with technology and social media the traditional process is appropriate. For individuals that rate themselves with weaker technology and social media skills it is important that the consent process includes assurance they will receive adequate support in the use of the technology and the media. The next step is to test the assessment and tailoring of consent processes for a social media clinical trial. Clinical Trial # NCT02929108.
Trust and digital privacy in healthcare: a cross-sectional descriptive study of trust and attitudes towards uses of electronic health data among the general public in Sweden
Sara Belfrage, Gert Helgesson, Niels Lynøe
BMC Medical Ethics, 4 March 2022; 23(19)
The ability of healthcare to protect sensitive personal data in medical records and registers might influence public trust, which in turn might influence willingness to allow healthcare to use such data. The aim of this study was to examine how the general public’s trust relates to their attitudes towards uses of health data.
A stratified sample from the general Swedish population received a questionnaire about their willingness to share health data. Respondents were also asked about their trust in the management and protection of electronic health data.
A large majority (81.9%) of respondents revealed high levels of trust in the ability of healthcare to protect electronic patient data. Good health was associated with significantly higher levels of trust compared to bad health. Respondents with low levels of trust were significantly less willing to allow personal data to be used for different purposes and were more inclined to insist on being asked for permission beforehand. Those with low levels of trust also perceived risks of unauthorized access to personal data to be higher and the likely damage of such unauthorized access worse, compared to those with high levels of trust.
Trust in the ability of healthcare to protect electronic health is generally high in Sweden. Those with higher levels of trust are more willing to let their data be used, including without informed consent. It thus seems crucial to promote trust in order to be able to reap the benefits that digitalization makes possible through increased access and use of data in healthcare.
Informed consent and algorithmic discrimination – is giving away your data the new vulnerable?
Hauke Behrendt, Wulf Loh
Review of Social Economy, 1 March 2022
This paper discusses various forms and sources of algorithmic discrimination. In particular, we explore the connection between – at first glance – ‘voluntary’ sharing or selling of one’s data on the one hand and potential risks of automated decision-making based on big data and artificial intelligence on the other. We argue that the implementation of algorithm-driven profiling or decision-making mechanisms will, in many cases, disproportionately disadvantage certain vulnerable groups that are already disadvantaged by many existing datafication practices. We call into question the voluntariness of these mechanisms, especially for certain vulnerable groups, and claim that members of such groups are oftentimes more likely to give away their data. If these existing datafication practices exacerbate prior disadvantages, they ‘compound historical injustices’ (Hellman, 2018) and thereby constitute forms of morally wrong discrimination. To make matters worse, they are even more prone to further algorithmic discriminations based on the additional data collected from them.
A Blockchain-Based Consent Mechanism for Access to Fitness Data in the Healthcare Context
May Alhajri, Carsten Rudolph, Ahmad Salehi Shahraki
IEEE Access, 24 February 2022; 10 pp 22960 – 22979
Wearable fitness devices are widely used to track an individual’s health and physical activities to improve the quality of health services. These devices sense a considerable amount of sensitive data processed by a centralized third party. While many researchers have thoroughly evaluated privacy issues surrounding wearable fitness trackers, no study has addressed privacy issues in trackers by giving control of the data to the user. Blockchain is an emerging technology with outstanding advantages in resolving consent management privacy concerns. As there are no fully transparent, legally compliant solutions for sharing personal fitness data, this study introduces an architecture for a human-centric, legally compliant, decentralized and dynamic consent system based on blockchain and smart contracts. Algorithms and sequence diagrams of the proposed system’s activities show consent-related data flow among various agents, which are used later to prove the system’s trustworthiness by formalizing the security requirements. The security properties of the proposed system were evaluated using the formal security modeling framework SeMF, which demonstrates the feasibility of the solution at an abstract level based on formal language theory. As a result, we have shown that blockchain technology is suitable for mitigating the privacy issues of fitness providers by recording individuals’ consent using blockchain and smart contracts.