Research recruitment and consent methods in a pandemic: a qualitative study of COVID-19 patients’ perspectives
Serena S Small, Erica Lau, Kassandra McFarlane, Patrick M Archambault, Holly Longstaff, Corinne M Hohl
BMC Medical Research Methodology, 11 May 2023
Virtual data collection methods and consent procedures adopted in response to the COVID-19 pandemic enabled continued research activities, but also introduced concerns about equity, inclusivity, representation, and privacy. Recent studies have explored these issues from institutional and researcher perspectives, but there is a need to explore patient perspectives and preferences. This study aims to explore COVID-19 patients’ perspectives about research recruitment and consent for research studies about COVID-19.
We conducted an exploratory qualitative focus group and interview study among British Columbian adults who self-identified as having had COVID-19. We recruited participants through personal contacts, social media, and REACH BC, an online platform that connects researchers and patients in British Columbia. We analyzed transcripts inductively and developed thematic summaries of each coding element.
Of the 22 individuals recruited, 16 attended a focus group or interview. We found that autonomy and the feasibility of participation, attitudes toward research about COVID-19, and privacy concerns are key factors that influence participants’ willingness to participate in research. We also found that participants preferred remote and virtual approaches for contact, consent, and delivery of research on COVID-19.
Individuals who had COVID-19 are motivated to participate in research studies and value autonomy in their decision to participate, but researchers must be sensitive and considerate toward patient preferences and concerns, particularly as researchers adopt virtual recruitment and data collection methods. Such awareness may increase research participation and engagement.
For all (Hu)mankind? The intersection of mental capacity, informed consent and contract law with U.K. space law
Alexander Ian Simmonds
International Journal of Discrimination and the Law, May 2023
The UK Space Industry Act 2018 has now been supplemented with the new Space Industry Regulations. While examples of Space Tourism grace our screens and newsfeeds on an increasingly regular basis such as William Shatner’s recent voyage (Luscombe, 2021) the UK Regulations also pave the way for ‘human occupants’ (UK Space Industry Regulations, Regulation 2) to experience such a flight (UK Space Agency, 2020). A key part of the regulations pertaining to human occupants is that they must provide ‘informed consent’ before embarking on such a flight. If, as is likely to be the case, future courts are to draw analogies with the current state of medical law in this area, spaceflight operators will have to tread carefully if they are to avoid vitiating any informed consent by ‘bombarding’ any willing human occupant with technical detail prior to their flight (Simmonds, 2020). Whilst this could prove legally problematic for ‘capacitous’ individuals within the meaning of the Mental Capacity Act 2005, it is likely to be even more so for those who could be deemed, in some aspects of their cognitive ability, to lack capacity. UK Space Legislation as it presently stands faces three problems: 1) There is presently no legal mechanism under UK Space Law to determine capacity. 2) As examples from the Court of Protection indicate, ‘capacity’ is a very nuanced legal concept and individuals who, on the fact of things, may appear to lack capacity as regards potentially risky activities, have been regarded by the Courts as, at least, partially capacitous in respect of certain decisions. Operators may find themselves having to tread a fine line to avoid claims of discrimination. 3) because of point 1) and the state of the Law of Contract as regards contractual relationships entered into by potentially incapacitous individuals, further significant legal problems may present themselves. This paper will focus primarily on the Law in England and Wales but some of the overarching conclusions will be of relevance to all UK jurisdictions.
Capacity to consent to research in older adults with normal cognitive functioning, mild and major neurocognitive disorder: an Italian study
Federica Del Signore, Alessia Rosi, Rocco Palumbo, Nicola Allegri, Alfredo Costa, Stefano Govoni, Elena Cavallini
Mediterranean Journal of Clinical Psychology, January 2023
A specific evaluation of the capacity to consent to research in older adults with cognitive decline is often not included routinely in research practice. However, there is a need to evaluate this competence adopting brief standardized instruments to guarantee their ethical rights. The present study evaluated in older adults with normal cognitive functioning, and major and mild neurocognitive disorders whether the Mini-Mental State Examination (MMSE) and a brief battery of neuropsychological tests are sensitive and specific to discriminate subjects able to provide consent to research.
54 participants with Major Neurocognitive Disorder (MajorNCD), 22 with Mild Neurocognitive Disorder (MildNCD), and 37 Normal Cognitive Functioning individuals (NCF). The capacity to provide consent was assessed using the MacArthur Competence Assessment Tool for Clinical Research. Cognitive functioning was assessed using the MMSE, Verbal Fluency Tests, Trail Making Test (TMT-A), Immediate and Delayed Recall Test.
In the MildNCD and NCF groups, the aggregate score of neuropsychological tests showed high sensitivity and specificity in classifying subjects able to provide consent to research. In the MajorNCD group, MMSE, Recall test, and TMT-A performed better than the aggregate score in classifying subjects as able of consenting to the hypothetical research.
The choice of the best tool to assess the ability to provide consent to research may depend on the degree of cognitive impairment. MMSE is a good tool for subjects with MajorNCD. A more comprehensive battery of neuropsychological tests would represent a better tool in NCF and MildNCD individuals.
The psychoanalytic frame and the consent situation: the child patient’s position in the publication dilemma
Journal of Child Psychotherapy, 12 May 2023
The author explores the current dilemma regarding consent standards for the publication of child patient clinical material, and the psychic impact on the child when seeking permission to publish. It is proposed that a psychoanalytic view creates an additional dimension to the more universal ethic of ‘do no harm’, requiring clinicians to consider the unconscious experience of the patient as the core of the matter. The term consent situation is introduced to describe the way in which providing a draft of the clinician’s writing about the patient’s experience in treatment, and then asking the patient and family for permission to publish it, subjects them to external realities of an oedipal nature, compromising the frame around the treatment, and the vital cycle of the containing function in the treatment. The frame could potentially be compromised from the beginning in the form of a leaky container, during the treatment as a betrayal of the frame, or after the treatment has ended as an intrusion into the containing object. The author shows how this is a burden to all young patients that could be collectively carried by the professional community, by using creative modifications to systems of professional development and publishing.
Medical staff’s sense of awareness of informed consent for adolescent cancer patients and the need for decision-making support practiced from the perspective of trauma-informed approach
Kyoko Tanaka, Maoko Hayakawa, Makiko Mori, Naoko Maeda, Masako Nagata, Keizo Horibe
BMC Medical Ethics, 6 May 2023; 24(28)
It has not been established how to assess children’s and adolescents’ decision-making capacity (DMC) and there has been little discussion on the way their decision-making (DM). The purpose of this study was to examine actual situation and factors related to difficulties in explaining their disease to adolescent cancer patients or obtaining informed consent (IC). The cross-sectional questionnaire survey was conducted. Physicians who have been treating adolescent cancer patients for at least five years answered a self-administered questionnaire uniquely developed about clinical difficulties in explaining, IC and factors related patient’s refusal of medical treatment (RMT). Descriptive statistics for each item and a polychoric correlation analysis of the problems and factors related to the explanation were conducted. As a result, fifty-six physicians were participated (rate of return: 39%). Explaining the disease and treatment to patients (83.9%), IC to patients (80.4%), and explaining the disease and treatment to parents (78.6%) was particularly problematic. Difficulties to provide support related with patient’s refusal of medical treatment and to explain disease and treatment for patient and parents were related to difficulties obtaining IC for the patient. Conclusion: There are clinically difficult to explain for the patient or parents and to obtain IC for the patient. It is necessary to establish a disease acceptance assessment tool for the adolescent generation so that it can be applied in the field.
Editor’s note: We acknowledge the grammatical inconsistencies in this abstract.
Parental Engagement in Consent Processes for Enrollment in Biomedical HIV Prevention Trials: Implications for Minor Adolescents’ Willingness to Participate
Amelia Knopf, Claire Burke Draucker, J. Dennis Fortenberry, Mary A. Ott, Renata Arrington-Sanders, Daniel Reirden, John Schneider, Diane Straub, Susan Ofner, Giorgos Bakoyannis, Gregory Zimet
Journal of Adolescent Health, May 2023; 72(5) pp 703-711
Minor adolescents are often excluded from HIV prevention clinical trials due to unresolved ethical issues. Their under-representation in research leads to delayed access to new HIV prevention approaches. We examine the relationship between consent procedures, trial features, demographic and social characteristics, and minor adolescents’ willingness to participate (WTP) in biomedical HIV prevention research.
We recruited 14–17-year-olds at risk of HIV for this quasi-experimental study. Adolescents were randomly assigned to (1) self-consent, (2) adult permission required, or (3) parental permission required and underwent simulated consent procedures for two types of HIV prevention trials. They rated likelihood of participating in each study if offered the opportunity and completed a survey with demographic, social, and behavioral measures.
One hundred and twenty nine adolescents with diverse identities and socioeconomic status enrolled. Among the 58% of participants who identified as lesbian, gay, bisexual, transgender, or queer (LGBTQ), 76% were out to at least one parent/guardian (outness). Mean WTP was 3.6 (of 5; 5 = definitely would participate) across all participants and both trial types. We found no evidence of an association between WTP and consent condition, LGBTQ identity, or outness. However, medical mistrust, communication with parents, and concern about HIV were associated with WTP.
Our results suggest adolescents are willing to participate in HIV prevention trials and parental involvement in the consent process may not be the most important deciding factor. However, variation in WTP within consent groups, and variation in other significant variables, underscores the need for individualized approaches to recruitment and consent for these trials.
Editor’s note: This is a US based publication.
Children must co-design digital health research
The Lancet Digital Health, 7 April 2023
… A multipronged approach is needed to change prevalent risk behaviours in adolescents. Yet few eHealth studies have assessed whether multiple health behaviour change (MHBC) interventions work, even though risk behaviours commonly co-occur, with more than 80% of adolescents engaging in two or more risk behaviours and more than 33% engaging in three or more. In this issue, Katrina Champion and colleagues describe a cluster randomised trial in Australia of more than 6000 11–13-year-olds enrolled in a 6-week school-based MHBC web-based and app-based intervention (Health4Life) designed to modify six chronic disease risk behaviours. The trial showed that the intervention was not effective in modifying adolescent risk behaviours despite improving knowledge about chronic disease risk factors over 24 months. These results are consistent with a previous meta-analysis by the authors, showing that eHealth MHBC interventions were not effective in reducing alcohol use, smoking, or sugar-sweetened beverage intake among school students. But, why do so many of these digital interventions fail?…
Educate Before You Operate: Improving the Informed Consent Process
Brian Piatkowski, Jeanne Lee, Eli Strait
Journal of Burn Care & Research, 15 May 2023
The informed consent process is a daily task for providers with a surgical patient population. In the burn population, informed consent is often presented by an intern or resident physician. Consent is comprised of surgical debridement with a multitude of options for coverage of their wounds. The current state of practice is a verbal overview of all the possible procedures that may be done to the patient’s wound(s). Patients often verbalize feeling overwhelmed with the amount of information on the consent and often have questions related to their procedure just before the brief of the operative case.
An educational video was developed that detailed the surgical procedure and the potential burn wound coverings. A 3-question survey was given to patients who have already been through the informed consent process. Survey metrics examined knowledge of consent when signed, the satisfaction of verbal explanation, and if a video would increase understanding. The video was given to the same patients to watch. After the video was viewed, those patients were then again surveyed. Providers were also given a 3-question survey before viewing the video. Survey metrics examined comfort of consent, knowledge of procedures, and if the video would increase patient understanding of consent topics. The providers were then surveyed after watching the video.
Initial post-implementation data shows that patients and providers have increased comfort and knowledge in the informed consent process. Patients show an 80% increase in understanding of consent, a 72% increase in satisfaction with video vs verbal overview, and a 97% increase in satisfaction with material viewed. Provider data shows a 65% increase in the comfort of consent, a 64% increase in knowledge of procedures, and a 97% increase that the video will help patients understand their consent. This shows that this evidence-based project is an improvement from the current standard of practice.
The informed consent process is an opportunity for providers and patients to have a moment of discussion. It is a pivotal point in which a patient and a provider determine the next step of their care. The patient must have clear communication and education regarding the procedures to which they are consenting. It is also a discussion where a provider can provide education and support at what is an overwhelming time for patients in their hospital stay.
Applicability of Research to Practice
Implementation of a standardized audio/video teaching method for burn surgical patients is an effective way to increase patient and provider satisfaction regarding the informed consent process. Implementing this educational tool is a cost-effective and simple way to educate burn patients before their surgical procedures. There is an overall improvement in patient satisfaction and increased satisfaction in the providers who obtain the consent.
Alternative Means of Informed Consent in Cardiology: Strategies and Effectiveness in a Group of Italian Patients
Ines Testoni, Lucia Ronconi, Francesca Lampis, Erika Iacona, Josephine Zammarrelli, Sara Pompele, Roberto Valle, Gabriele Boscolo, Diego De Leo
Behavioral Sciences, 19 May 2023
Informed consent practices in healthcare represent a fundamental element of patient-centred care; however, the traditional use of a written, paper-based description of the medical procedure to obtain informed consent presents many limitations. This research aimed to evaluate the effects of an alternative modality of obtaining informed consent using a brief informative video for patients waiting to undergo a coronary angiography procedure in Italy. The study involved 40 participants—28 males and 12 females (mean age: 68.55, SD = 13.03)—divided equally into two groups: one group received the video-based informed consent and the other received a traditional paper-based form. Each group was asked to fill in two questionnaires; one was created by the researchers to measure the patient’s level of understanding of the given information and the perception of usefulness of the informed consent, and the other was the Depression Anxiety Stress Scales-21 (DASS-21), which evaluates levels of anxiety, depression and stress. A comparison of the results of the two groups showed that videobased informed consent allowed participants to better understand the given information, to feel more confident concerning their subjective comprehension of it and to perceive the video-based informed consent as more useful than the traditional one. The video-based informed consent did not lead to higher levels of anxiety, depression or stress among the participants. It can be hypothesized that video-based formats may represent a more useful, understandable and safe alternative to traditional paper-based informed consent in healthcare.
Editor’s note: The editors recognize the need for further research in this area before conclusions can be drawn.
Implementation in Midwifery Services: A Description Study
Nina Zuhana, Eka Budiarto, Lia Dwi Prafitri, Rini Kristiyanti
Advances in Social Science, Education and Humanities Research, May 2023
Midwifery services must be provided by midwives by implementing legal ethics in midwifery. This ethics can be fulfilled by giving informed consent before performing midwifery services. Informed consent is obtained by giving information about the midwifery services that will be provided to the patient and asking the patient to sign the midwifery service agreement sheet indicating that the patient is willing to receive the provided midwifery information and services as well as all the possible consequences. Informed consent is required when midwives provide care for pregnancy, childbirth, postpartum, and newborns. The objective of this study was to identify the implementation of informed consent by midwives in providing midwifery services in health care facilities such as hospitals, health centers, and autonomous midwifery practices. This research was a descriptive study with a cross-sectional approach involving 71 midwives in Pekalongan Regency. It was carried out in March 2021 by distributing questionnaires to the participating midwives who were selected through a quota sampling method. The collected data were analyzed by using central tendency and frequency distribution. The results of data analysis showed that the average age of the participants was 36.5 years old, the average length of work was 12.8 years, and the education level of the majority of them was diploma three (69%). A total of 70.4% of the midwives obtained informed consent before providing midwifery services. This number indicates that there were midwifery services that had not implemented ethical and legal aspects. The ethical and legal noncompliance cases in midwifery services might increase if no effort to achieve 100% informed consent implementation was taken. Therefore, regulation that manage and bind midwives in carrying out informed consent to achieve 100% implementation of it in midwifery services is needed.
Editor’s note: The midwives in this article are practicing in Indonesia.