Informed Consent: A Monthly Review
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June 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:

Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_June 2021

Influence of Social and Cultural Factors on the Decision to Consent for Monoclonal Antibody Treatment among High-Risk Patients with Mild-Moderate COVID-19

Influence of Social and Cultural Factors on the Decision to Consent for Monoclonal Antibody Treatment among High-Risk Patients with Mild-Moderate COVID-19
Research Article
Dennis M. Bierle, Ravindra Ganesh, Caroline G. Wilker, Sara N. Hanson, Darcie E. Moehnke, Tammy A. Jackson, Priya Ramar, Jordan K. Rosedahl, Lindsey M. Philpot, Raymund R. Razonable
Journal of Primary Care & Community Health, 25 May 2021
Open Access
Abstract
Background
The clinical outcomes of patients who decline anti-spike monoclonal antibody therapies for coronavirus disease-2019 (COVID-19) is not known. Factors associated with the decision to accept or decline the offer for anti-spike monoclonal antibody therapies are not established. This study aimed to identify factors impacting the decision to consent for monoclonal antibody therapies and assess the differences in clinical outcomes of patients who accepted compared to those who declined these therapies.
Methods
This retrospective cohort study enrolled 2820 adult patients who were offered monoclonal antibody therapies, bamlanivimab and casirivimab-imdevimab, for COVID-19 at Mayo Clinic in the Midwest between 11/19/2020 and 12/31/2020. The primary endpoint is the decision to accept or decline monoclonal antibody treatment. Secondary endpoints were patient-level factors that could have impacted the decision to accept treatment (age, gender, race, ethnicity, primary language spoken, and medical comorbidities). The main clinical endpoint was hospitalization within 28 days of COVID-19 diagnosis.
Results
59.1% (n = 1669) chose to accept monoclonal antibody therapy, and 40.9% (n = 1151) chose to decline the offer for treatment. Patients were more likely to accept treatment if they were non-Hispanic White, English speaking, identified a spouse or life partner, had a religious affiliation, and possessed more medical comorbidities. Overall, 28-day hospitalization rate was 2.6% (n = 72/2820) and was higher among those who declined (3.3%) than those who accepted monoclonal antibody therapy (2.0%; Rate Ratio = 0.62, 95% Confidence Interval, 0.39-0.98).
Conclusions
Despite having more comorbidities, patients who accepted monoclonal antibody treatments had a lower rate of hospitalization compared to patients who declined treatment. Several social and cultural factors were associated with the decision to decline therapy, including race, language, ethnicity, and lack of social support. These findings can inform public health efforts to reduce social disparities in the treatment of COVID-19 and increase utilization of monoclonal antibody therapies in high risk populations.

COVID-19 vaccination: your guide to consent

COVID-19 vaccination: your guide to consent
Erin Dean
Nursing Standard (2014+), 3 March 2021; 36(3)pp 42-43
Excerpt
The COVID-19 vaccination campaign is the biggest in the history of the NHS, with millions of people being offered the vaccine. Consent must be obtained before starting any treatment or investigation or providing personal care. This includes the administration of all vaccines.

For many, the idea of consent is inextricably linked to signing a form, and the government has introduced a number of consent forms specifically for the COVID-19 vaccine programme, including forms for adults and care home residents.

Yet RCN and government guidance is clear: consent should be a process rather than a single event and a signature alone does not demonstrate that the consent process has been followed.

Here, we look at the key issues surrounding consent, and the implications for nursing staff who are involved in the COVID-19 vaccine programme…

Improving consent forms for first-in-human trials through participant feedback

Improving consent forms for first-in-human trials through participant feedback
Hannah Claire Sibold, Gavin Paul Campbell, John Bourgeois, Margie D. Dixon, R Donald Harvey, Rebecca D. Pentz
Journal of Clinical Oncology, 28 May 2021; 39(15)
Abstract
Background
Risks and benefits of investigational agents that have not been tested in humans are, at best, incompletely characterized in nonclinical investigations. Despite the growing emphasis to include patient voices in clinical trial design, no published research has explored patient preferences on how best to convey the information that the agent has not been tested in humans. This study established that First in Human (FIH) consent forms present this information in different locations and queried participants for their input on the preferable FIH consent form structure.
Methods
Consent forms for FIH oncology trials open to accrual at Winship Cancer Institute in 2019-2020 were analyzed for (1) the location of the mention that the study drug has not been used in humans before (FIH information), (2) the location of animal and other nonclinical data, and (3) placement of the risks section. Patients offered enrollment in a FIH trial were eligible for this study. Participants were interviewed during a clinic visit after consent was obtained. An ethics researcher asked questions about the participant’s opinions on the wording and placement of the FIH, nonclinical, and risk information in the specific trial consent form. All interviews were audio-recorded and double coded by two independent coders. The location of FIH and nonclinical data in the consent forms was compared to the patient’s suggested location for this information.
Results
Saturation of themes was reached after interviewing 17 (17/19, 89% accrual) participants who were enrolled in 9 different FIH trials. Twenty FIH consents were qualitatively analyzed. Preferred placement compared to actual consent placement is listed in the table. 82% (14/17) of participants thought that nonclinical data on risks and efficacy was important to mention. 95% (19/20) of consents listed nonclinical data and most participants thought the placement in the consent was appropriate but 18% (3/17) of participants wanted the information earlier in the consent. No consent forms that were analyzed had the risks section before the study schedule; however, 47% (8/17) of participants wanted to move the risks sections before the study schedule.
Conclusions
There is considerable variation in the layout of FIH consent forms that does not align with patient preferences. Standardization of FIH consent forms to better reflect patient input is essential in order to promote understandability of these important yet sometimes misunderstood clinical trials and to ensure ethical informed consent.

Preparing accessible and understandable clinical research participant information leaflets and consent forms: a set of guidelines from an expert consensus conference

Preparing accessible and understandable clinical research participant information leaflets and consent forms: a set of guidelines from an expert consensus conference
Research Article
Eleanor Coleman, Lydia O’Sullivan, Rachel Crowley, Moira Hanbidge, Seán Driver, Thilo Kroll, Aoife Kelly, Alistair Nichol, Orlaith McCarthy, Prasanth Sukumar, Peter Doran
Research Involvement and Engagement, 18 May 2021; 7(31)
Open Access
Abstract
Background
In line with Good Clinical Practice and the Declaration of Helsinki, it is the investigator’s responsibility to ensure that research participants are sufficiently informed, to enable the provision of informed consent. The Participant Information Leaflet/Informed Consent Form is key to facilitating this communication process. Although studies have indicated that clinical research Participant Information Leaflets/Informed Consent Forms are not optimal in terms of accessibility, there is little or no specific guidance available. The aim of this research was to propose and agree a set of guidelines for academic researchers and sponsors for preparing accessible and understandable Participant Information Leaflets/Informed Consent Forms.
Methods
A literature review identified guidance for the preparation of patient-facing documents. Following critical appraisal, key recommendations were extracted and a set of recommendations which can be applied to clinical research Participant Information Leaflets/Informed Consent Forms were prepared. These recommendations were evaluated and amended by an Expert Consensus Conference consisting of a group of key stakeholders. The stakeholders included members of a Research Ethics Committee (both lay and expert), a patient advocate, experienced clinical researchers, a plain English editor and a Data Protection Officer. Consensus was reached regarding a final set of recommendations.
Results
44 recommendations were agreed upon and grouped into five categories: Layout, Formatting, Content, Language and Confirming Readability. These recommendations aimed to maximize accessibility for lay participants, including readers with dyslexia, literacy or numeracy challenges, thereby improving the quality of the consent process.
Conclusions
More empirical research is needed to further improve the informed consent process for research participants. However, these recommendations are informed by the current literature and have been ratified by expert stakeholders. It is hoped that these recommendations will help investigators and sponsors to consistently and efficiently produce more accessible clinical research Participant Information Leaflets/Informed Consent Forms.

Cross-sectional study on patients’ understanding and views on the informed consent procedure of a secondary stroke prevention trial

Cross-sectional study on patients’ understanding and views on the informed consent procedure of a secondary stroke prevention trial
Original Article
Felizitas A Eichner, Joschua M Reis, Joaquim Dores, Vladimir Pavlovic, Luisa Kreß, Naeimeh Daneshkhah, Renate Weinhardt, Armin Grau, Johannes Mühler, Hassan Soda, Christopher J Schwarzbach, Michael Schuler, Karl Georg Haeusler, Peter U Heuschmann
European Journal of Neurology, 14 May 2021
Open Access
Abstract
Background
Improving understanding of study contents and procedures might enhance recruitment into studies and retention during follow-up. However, data in stroke patients on understanding of the informed consent (IC) procedure are sparse.
Methods
We conducted a cross-sectional study among ischemic stroke patients taking part in the IC procedure of an ongoing cluster-randomized secondary prevention trial. All aspects of the IC procedure were assessed in an interview using a standardized 20-item questionnaire. Responses were collected within 72 hours after the IC procedure and analyzed quantitatively and qualitatively. Participants were also asked regarding main reasons for participation.
Results
146 stroke patients (65±12 years, 38% female) were enrolled. On average, patients recalled 66.4% (95% CI 65.2%-67.5%) of the content of the IC procedure. Most patients understood that participation was voluntary (99.3%) and that they had the right to withdraw consent (97.1%). 79.1% of the patients recalled the study duration, 56.1% the goal. Only 40.3% could clearly state a benefit of participation and 28.8% knew their group allocation. Younger age, higher graduation and allocation to the intervention group were associated with better understanding. Of all patients, 53% exclusively stated a personal, 22% an altruistic reason for participation.
Conclusions
While understanding of patient rights was high, many patients were unable to recall other important aspects of study content and procedures. Increased attention to older and less educated patients may help to enhance understanding in this patient population. Actual recruitment and retention benefit of an improved IC procedure remains to be tested in a randomized trial.

Leveraging Technology Solutions to Automate Informed Consent in a Clinical Research Hospital

Leveraging Technology Solutions to Automate Informed Consent in a Clinical Research Hospital
Claribel L. Sawyerr
University of Maryland Baltimore, Doctor of Nursing Practice Projects, May 2021
Open Access
Abstract
Problem: Paper informed consent (PIC) forms are associated with incomplete and or inaccurate information such as missing signatures and incorrect patient identification. The Food and Drug Administration’s Bioresearch Monitoring Program audit for the 2019 fiscal year lists failure to obtain informed consent (IC) requirements as one of the most common violations (2%) by clinical investigators in clinical trials. In a selected practice site, approximately 440 (2%) out of 25,000 PICs were returned by the medical records department to clinicians in 2019 due to incomplete and or inaccurate information. This resulted in significant delays in the start of clinical trials, incurring additional time and effort for participants and clinicians to correct and or re-consent. Purpose: The purpose of this quality improvement project was to implement electronic informed consent (EIC) for research participants in the adult oncology, infectious disease, and digestive diseases outpatient clinics in a clinica­­l research hospital. Methods: Pre and post implementation surveys were administered to clinicians (n = 43) to obtain baseline perceptions, and compare preferences and satisfaction with using PIC versus EIC. The clinicians were trained on using EIC for signatures, then EIC was implemented and tracked for eight specific protocol studies. Results: The average confirmed IC available in the electronic health record (EHR) within one day of signing by clinicians for all three clinics increased from 52.5% (pre) to 61.3% (post). EIC use increased by 20%, and returned consents decreased from an average of 2.2% to 0.6%. Clinician preference to use EIC over PIC increased from 44.8% to 57.1%, Fisher’s Exact Test = 0.5256, 2-sided, p > .05. Conclusions: Replacing PIC with EIC was preferred by clinicians, improved documentation of consent, and decreased the time for consent availability in the EHR. The implications for practice are that automating informed consent is associated with improved consenting processes and supports remote workflows.

Symptoms of Medication Withdrawal in Parkinson’s Disease: Considerations for Informed Consent in Patient-Oriented Research

Symptoms of Medication Withdrawal in Parkinson’s Disease: Considerations for Informed Consent in Patient-Oriented Research
Short Communication
Kaitlyn R. Hay, Neevi Kukreti, Paula Trujillo, Ya-Chen Lin, Hakmook Kang, Daniel O. Claassen
Pharmaceutical Medicine, 29 April 2021
Abstract
Introduction
Dopamine medication withdrawal in Parkinson’s disease (PD) is commonly employed in clinical practice and can be required for participation in research studies. When asked to withdraw from medications, participants often enquire as to what symptoms they should expect.
Objectives
This study sought to improve the informed consent process by identifying patient-reported symptoms when dopamine treatment is withheld. We also sought to provide clinical guidance regarding the extent of these symptoms and consider participant willingness to undergo these assessments.
Methods
Participants were recruited from community-based PD programs and support groups in Nashville, Tennessee, USA. A patient-based questionnaire determined the frequency and severity of motor and nonmotor symptoms. The questionnaire also assessed whether patients would be willing to abstain from medication at a future date and under what circumstances.
Results
A total of 31/90 participants reported willingness to withdraw from dopaminergic medications for clinical or research purposes. Tremor, walking, and balance were the most common motor symptoms that worsened during this time. Sleep dysfunction, constipation, and tremor were noted as the most severe symptoms. Of note, 10% of participants indicated that they would not be willing to go off medications again, suggesting that a minority of patients find this to be most discomforting. When prompted for a reason why participants would be willing to come off of their medications again, “for clinical purposes” was selected the most.
Conclusions
Study teams should list these symptoms in the applications to their institutional review board and in the informed consent to provide guidance for participants.

Ethical Considerations in Social Sciences: The Dilemmas of Informed Consent

Ethical Considerations in Social Sciences: The Dilemmas of Informed Consent
Haji Karim Khan, Hussain, Mir Alam
Research Journal of Social Sciences & Economics Review, April-June 2021; 2(2)
Open Access
Abstract
Informed consent is an integral component of research ethics in Social Sciences. It has been observed that in Pakistan, most of the research ethics have been borrowed from the Western context. Therefore, it is vital to see how research ethics are being construed and practiced in Pakistan having different socio-cultural values and norms. In the case of informed consent, the bigger question is ‘how informed the informed consent is?’ Thus, in this paper, through a qualitative exploratory approach, we have explored how active Social Science researchers in our universities, see the notion of informed consent. We interviewed eighteen university teachers for the study. Transcribed the interviews verbatim and analyzed those using robust qualitative approaches. Findings show that ‘informed consent’ becomes a dilemma for the researchers given the variations in the socio-cultural and linguistic contexts of the settings. Findings have pertinent implications for policymakers, university management, and researchers in the context of Social Sciences.

Implementing continuous consent in qualitative research

Implementing continuous consent in qualitative research
Research Article
Fride Haram Klykken
Qualitative Research, 9 May 2021
Abstract
This article examines ways of approaching informed consent as a relationally constituted process in qualitative research practices. It argues that a researcher’s operationalization of informed consent should be coherent with the overall epistemological framework of the project. Based on empirical examples from an ethnographic inquiry in an educational setting, the principle of informed consent is discussed as a reflexive and ethical tool throughout the inquiry, including its pre-fieldwork, fieldwork and post-fieldwork phases. Strategies of explicitly and implicitly (re)negotiated consent and dissent are discussed and illustrated by drawing on some of the recent discussions of continuous consent practices. The article’s conceptualization of a continuous, situated and relational approach to informed consent is also supported by the concepts of response-ability and thinking with care in research ethics.