Researchers’ views on, and experiences with, the requirement to obtain informed consent in research involving human participants: a qualitative study
Research Article
Antonia Xu, Melissa Therese Baysari, Sophie Lena Stocker, Liang Joo Leow, Richard Osborne Day & Jane Ellen Carland
BMC Medical Ethics, 2 October 2020; 21(93)
Open Access
Abstract
Background
Informed consent is often cited as the “cornerstone” of research ethics. Its intent is that participants enter research voluntarily, with an understanding of what their participation entails. Despite agreement on the necessity to obtain informed consent in research, opinions vary on the threshold of disclosure necessary and the best method to obtain consent. We aimed to investigate Australian researchers’ views on, and their experiences with, obtaining informed consent.
Methods
Semi-structured interviews were conducted with 23 researchers from NSW institutions, working in various fields of research. Interviews were analysed and coded to identify themes.
Results
Researchers reported that consent involved information disclosure, understanding and a voluntary decision. They emphasised the variability of consent interactions, which were dependent on potential participants’ abilities and interests, study complexity and context. All researchers reported providing written information to potential participants, yet questioned the readability and utility of this information. The majority reported using signed consent forms to ‘operationalise’ consent and reported little awareness of, and lack of support in implementing more dynamic informed consent procedures, such as verbal informed consent, that was fit for the purposes of their studies. Views on Human Research Ethics Committees (HRECs) varied. Some reported inconsistent, arduous inputs on the information form and consent process. Others expressed reliance on HRECs for guidance, viewing them as institutional safeguards.
Conclusions
This study highlights the importance of transparent relationships, both between researchers and participants, and between researchers and HRECs. Where the relationship with study participants was reported as more robust, researchers felt that they were better able to ensure participants made better, more informed decisions. Where the relationship with HRECs was reported as more robust, researchers were more likely to view them as institutional safeguards, rather than as bureaucratic hindrances. Conscientious and mindful researchers are paramount to ensuring the procedure accommodates individual requirements. This study advocates that when designing ethical informed consent practices, researchers should be integrated as autonomous players with a positive input on the process, rather than, in the worst case, predatory recruiters to be curtailed by information forms and oversight.
Year: 2020
High-impact RCTs without prospective informed consent: a systematic review
High-impact RCTs without prospective informed consent: a systematic review
Review
Roma Dhamanaskar, Jon F Merz
Journal of Investigative Medicine, 1 October 2020
Abstract
The prevalence of randomized controlled trials (RCTs) performed without fully informed prospective consent from subjects is unknown. We performed this study to estimate the prevalence of high-impact RCTs performed without informed consent from all subjects and examine whether such trials are becoming more prevalent. We performed a systematic review of English-language RCTs published from 2014 through 2018 identified in Scopus and sorted to identify the top 100 most highly cited RCTs each year. Text search of title and abstract included terms randomized controlled or clinical trial and spelling variants thereof, and excluded metaanalyses and systematic reviews. We independently identified the most highly cited RCTs based on predefined criteria and negotiated to agreement, then independently performed keyword searches, read, abstracted and coded information regarding informed consent from each paper and again negotiated to agreement. No quality indicators were assessed. We planned descriptive qualitative analysis and appropriate quantitative analysis to examine the prevalence and characteristics of trials enrolling subjects with other than fully informed prospective consent. We find that 44 (8.8%, binomial exact 95% CI 6.5% to 11.6%) of 500 high-impact RCTs did not secure informed consent from at least some subjects. The prevalence of such trials did not change over the 5 years (OR=1.09, z=0.78, p=0.44). A majority (66%) of the trials involved emergency situations, and 40 of 44 (90.9%) of the trials involved emergency interventions, pragmatic designs, were cluster randomized, or a combination of these factors. A qualitative analysis explores the methods of and justifications for waiving informed consent in our sample of RCTs.
Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review
Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review
Review
Evelien De Sutter, Drieda Zaçe, Stefania Boccia, Maria Luisa Di Pietro, David Geerts, Pascal Borry, Isabelle Huys
Journal of Medical Research, October 2020; 22(10)
Open Access
Abstract
Background
Informed consent is one of the key elements in biomedical research. The introduction of electronic informed consent can be a way to overcome many challenges related to paper-based informed consent; however, its novel opportunities remain largely unfulfilled due to several barriers.
Objective
We aimed to provide an overview of the ethical, legal, regulatory, and user interface perspectives of multiple stakeholder groups in order to assist responsible implementation of electronic informed consent in biomedical research.
Methods
We conducted a systematic literature search using Web of Science (Core collection), PubMed, EMBASE, ACM Digital Library, and PsycARTICLES. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were used for reporting this work. We included empirical full-text studies focusing on the concept of electronic informed consent in biomedical research covering the ethical, legal, regulatory, and user interface domains. Studies written in English and published from January 2010 onward were selected. We explored perspectives of different stakeholder groups, in particular researchers, research participants, health authorities, and ethics committees. We critically appraised literature included in the systematic review using the Newcastle-Ottawa scale for cohort and cross-sectional studies, Critical Appraisal Skills Programme for qualitative studies, Mixed Methods Appraisal Tool for mixed methods studies, and Jadad tool for randomized controlled trials.
Results
A total of 40 studies met our inclusion criteria. Overall, the studies were heterogeneous in the type of study design, population, intervention, research context, and the tools used. Most of the studies’ populations were research participants (ie, patients and healthy volunteers). The majority of studies addressed barriers to achieving adequate understanding when using electronic informed consent. Concerns shared by multiple stakeholder groups were related to the security and legal validity of an electronic informed consent platform and usability for specific groups of research participants.
Conclusions
Electronic informed consent has the potential to improve the informed consent process in biomedical research compared to the current paper-based consent. The ethical, legal, regulatory, and user interface perspectives outlined in this review might serve to enhance the future implementation of electronic informed consent.
Exception From Informed Consent: How IRB Reviewers Assess Community Consultation and Public Disclosure
Exception From Informed Consent: How IRB Reviewers Assess Community Consultation and Public Disclosure
Research Article
Makini Chisolm-Straker, Denise Nassisi, Mohamud R. Daya, Jennifer N.B. Cook, Ilene F. Wilets, Cindy Clesca, Lynne D. Richardson
AJOB Empirical Bioethics, 29 September 2020
Abstract
Exception from Informed Consent (EFIC) regulations detail specific circumstances in which Institutional Review Boards (IRB) can approve studies where obtaining informed consent is not possible prior to subject enrollment.
To better understand how IRB members evaluate community consultation (CC) and public disclosure (PD) processes and results, semi-structured interviews of EFIC-experienced IRB members were conducted and analyzed using thematic analysis.
Interviews with 11 IRB members revealed similar approaches to reviewing EFIC studies. Most use summaries of CC activities to determine community members’ attitudes; none reported using specific criteria nor recalled any CC reviews that resulted in modifications to or denials of EFIC studies. Most interviewees thought metrics based on Community VOICES’s domains (feasibility, participant selection, quality of communication, community perceptions, investigator/IRB perceptions) would be helpful.
IRB members had similar experiences and concerns about reviewing EFIC studies. Development of metrics to assess CC processes may be useful to IRBs reviewing EFIC studies.
The Meaning of Informed Consent: Genome Editing Clinical Trials for Sickle Cell Disease
The Meaning of Informed Consent: Genome Editing Clinical Trials for Sickle Cell Disease
Stacy Desine, Brittany M. Hollister, Khadijah E. Abdallah, Anitra Persaud, Sara Chandros Hull, Vence L. Bonham
AJOB Empirical Bioethics, 12 October 2020; 11(4) pp 195-207
Open Access
Abstract
Background
A first therapeutic target of somatic genome editing (SGE) is sickle cell disease (SCD), the most commonly inherited blood disorders, affecting more than 100,000 individuals in the United States. Advancement of SGE is contingent on patient participation in first in human clinical trials. However, seriously ill patients may be vulnerable to overestimating the benefits of early phase studies while underestimating the risks. Therefore, ensuring potential clinical trial participants are fully informed prior to participating in a SGE clinical trial is critical.
Methods
We conducted a mixed-methods study of adults with SCD as well as parents and physicians of individuals with SCD. Participants were asked to complete a genetic literacy survey, watch an educational video about genome editing, complete a twopart survey, and take part in focus group discussions. Focus groups addressed topics on clinical trials, ethics of gene editing, and what is not understood regarding gene editing. All focus groups were audio-recorded, transcribed, and analyzed using conventional content analysis techniques to identify major themes.
Results
Our study examined the views of SCD stakeholders regarding what they want and need to know about genome editing to make an informed decision to participate in a SGE clinical trial. Prominent themes included stakeholders’ desire to understand treatment side effects, mechanism of action of SGE, trial qualification criteria, and the impact of SGE on quality of life. In addition, some physicians expressed concerns about the extent to which their patients would understand concepts related to SGE; however, individuals with SCD demonstrated higher levels of genetic literacy than estimated by physicians.
Conclusions
Designing ethically robust genome editing clinical trials for the SCD population will require, at a minimum, addressing the expressed information needs of the community through culturally sensitive engagement, so that they can make informed decisions to consider participation in clinical trials.
Context-Relative Norms Determine the Appropriate Type of Consent in Clinical Biobanks: Towards a Potential Solution for the Discrepancy between the General Data Protection Regulation and the European Data Protection Board on Requirements for Consent
Context-Relative Norms Determine the Appropriate Type of Consent in Clinical Biobanks: Towards a Potential Solution for the Discrepancy between the General Data Protection Regulation and the European Data Protection Board on Requirements for Consent
Original Research/Scholarship
Indrakusuma, S. Kalkman, M. J. W. Koelemay, R. Balm & D. L. Willems
Science and Engineering Ethics, 13 October 2020
Open Access
Abstract
Clinical biobanks processing data of participants in the European Union (EU) fall under the scope of the General Data Protection Regulation (GDPR), which among others includes requirements for consent. These requirements are further specified by the Article 29 Working Party (WP29)—an EU advisory body currently known as the European Data Protection Board (EDPB). Unfortunately, their guidance is cause for some confusion. While the GDPR allows participants to give broad consent for research when specific research purposes are still unknown, the WP29 guidelines suggest that additional consent for specific uses should be obtained in addition to broad consent when this becomes applicable. This discrepancy elicits the question whether clinical biobanks can fail the requirement of consent if they obtain broad consent, but not a specific consent for each biomedical study. We analysed this discrepancy within the framework of contextual integrity, in order to describe the context-relative informational norms that govern information flows in clinical biobanks. However, our analysis demonstrates that there is no uniform set of norms that can be applied to all clinical biobanks. As such, neither the GDPR nor the WP29 guidance can act as a “one size fits all” approach to all clinical biobanks. Rather, differences between clinical biobanks—especially regarding the scientific aims and patient populations—make the case for context-relative norms that determine the appropriate type of consent.
Informed consent procedures for emergency interventional research in patients with traumatic brain injury and ischaemic stroke
Informed consent procedures for emergency interventional research in patients with traumatic brain injury and ischaemic stroke
Personal View
Erwin J O Kompanje, Jeroen T J M van Dijck, Vicky Chalos, Sophie A van den Berg, Paula M Janssen, Paul J Nederkoorn, Mathie uvan der Jagt, Giuseppe Citerio, Nino Stocchetti, Diederik W J Dippel, Wilco C Peul
The Lancet Neurology, 21 October 2020
Summary
Health-care professionals and researchers have a legal and ethical responsibility to inform patients before carrying out diagnostic tests or treatment interventions as part of a clinical study. Interventional research in emergency situations can involve patients with some degree of acute cognitive impairment, as is regularly the case in traumatic brain injury and ischaemic stroke. These patients or their proxies are often unable to provide informed consent within narrow therapeutic time windows. International regulations and national laws are criticised for being inconclusive or restrictive in providing solutions. Currently accepted consent alternatives are deferred consent, exception from consent, or waiver of consent. However, these alternatives appear under-utilised despite being ethically permissible, socially acceptable, and regulatorily compliant. We anticipate that, when the requirements for medical urgency are properly balanced with legal and ethical conduct, the increased use of these alternatives has the potential to improve the efficiency and quality of future emergency interventional studies in patients with an inability to provide informed consent.
The Attitudes of Relatives of ICU Patients toward Informed Consent for Clinical Research
The Attitudes of Relatives of ICU Patients toward Informed Consent for Clinical Research
Research Article
Rania Mahafzah, Karem H. Alzoubi, Omar F. Khabour
Critical Care Research and Practice, 9 October 2020
Open Access
Abstract
Background
Informed consent is a key ethical requirement for biomedical research that is implemented to ensure autonomy and voluntary participation. However, patients in the intensive care unit (ICU) may be unconscious or severely ill and thus lack the capacity for decisions about research participation. Thus, relatives or guardians are usually asked to provide informed consent prior to the inclusion of ICU patients in research.
Aims
This study aimed to assess the attitudes and preferences of relatives of ICU patients toward informed consent in biomedical research in Jordan.
Subjects and Methods
A sample of 184 relatives with a critically ill next of kin in the ICU was anonymously surveyed regarding their attitudes and preferences toward giving informed consent for biomedical research on behalf of their patients.
Results
The study showed that the majority of relatives had a positive attitude toward the informed consent process on behalf of their patients in the ICU (72.3%). The perception that participation in research would be directly beneficial to their patient was the most significant reason to provide informed consent among relatives. The degree of relatedness to the patient was significantly associated with the decision to provide informed consent on behalf of the patients in the ICU. Additionally, more than 70% of the relatives strongly agreed to take part in clinical research if they were to be unconscious patients in the ICU. Moreover, the majority of the respondents agreed that their first-degree relatives would give consent on their behalf.
Conclusion
Relatives with a critically ill next of kin in the ICU had positive attitudes toward providing informed consent on behalf of their patients. This was motivated by the direct benefit from the research to their patient.
Family perceptions of clinical research and the informed consent process in the ICU
Family perceptions of clinical research and the informed consent process in the ICU
Short Communication
Marie Labruyère, Nicolas Meunier-Beillard, Fiona Ecarnot, Audrey Large, François Aptel, Jean-Baptiste Roudaut, Pascal Andreu, Auguste Dargent, Jean-Philippe Rigaud, Jean-Pierre Quenot
Journal of Critical Care, 28 September 2020
Abstract
Purpose
We investigated experiences of families who provide consent for research on behalf of a loved-one hospitalized in intensive care (ICU).
Methods
Multicentre, qualitative, descriptive study using semi-directive interviews in 3 ICUs. Eligible relatives were aged >18 years, and had provided informed consent for a clinical trial on behalf of a patient hospitalized in ICU. Interviews were conducted from 06/2018 to 06/2019 by a qualified sociologist, recorded and transcribed.
Results
Fifteen relatives were interviewed; average age 50.3 ± 15 years. All emphasized their interest in clinical research, seeing it as a duty. Involving their loved-one in research allowed them to find meaning in the events. Participants underlined that trust in caregivers and communication are determinant. The strict regulation of research was perceived as a guarantee of safety. Participants felt they lacked the intellectual capacity and knowledge to question explanations. The greatest fear was not that they might incur a risk for the patient, but rather, that they might deprive the patient of a chance at a cure.
Conclusion
Acceptance of research opportunities by relatives on behalf of decisionally-incapacitated patients is underpinned by trust in the physicians and the legislative framework. Communication and the quality of information provided by the caregivers are key.
Caregiver Perspectives on Informed Consent for a Pediatric Learning Healthcare System Model of Care
Caregiver Perspectives on Informed Consent for a Pediatric Learning Healthcare System Model of Care
Research Article
E. Pritchard, T. A. Zabel, L. A. Jacobson, E. Jones, C. Holingue, L. G. Kalb
AJOB Empirical Bioethics, 26 October 2020
Abstract
Background
Data is needed to provide insight into the issue of preference around consent for use of pediatric clinical data for research. This study evaluated caregivers’ preferences concerning use of their child’s clinical information.
Methods
Caregivers of children (n = 101; response rate 81.5% of n = 124) presenting for psychological evaluation at an urban medical center viewed a video regarding how the information contained in their child’s medical record could be used for research.
Results
An anonymous survey following the video indicated that: 1) >90% of caregivers felt comfortable with their child’s information being used; 2) >90% of caregivers felt their child’s privacy would be adequately protected; 3) 98% of caregivers reported themselves to be as or more likely to return to the institution after viewing the video; 4) 60% of caregivers felt no additional consent procedures beyond viewing the video were needed, while 20% preferred an opt-out and 20% preferred a traditional consent procedure. Caregiver demographic variables were largely unrelated to consent preferences.
Discussion
Overall, caregivers reported strong support for use of their child’s clinical data for research purposes.
Center for Informed Consent Integrity 