Use of pre-enrollment randomization and delayed consent to maximize participation in a clinical trial of opt-in versus opt-out tobacco treatment

Use of pre-enrollment randomization and delayed consent to maximize participation in a clinical trial of opt-in versus opt-out tobacco treatment
Original Research
Babalola Faseru, Laura M. Mussulman, Niaman Nazir, Edward F. Ellerbeck, Elena Shergina, Taneisha S. Scheuermann, Byron J. Gajewski, Delwyn Catley, Kimber P. Richter
Substance Abuse, 18 April 2022; 43(1)
Abstract
Background
Enrollment in smoking cessation trials remain sub-optimal. The aim of this analysis was to determine the effectiveness of a modified Zelen’s design in engaging hospitalized patients who smoke in a pragmatic OPT-IN versus OPT-OUT tobacco treatment trial.
Methods
At bedside, clinical staff screened smokers for eligibility, randomized eligible into study arms, and delivered the appropriate treatment approach. Study staff called randomized patients at one-month post-discharge, debriefed patients on the study design, and collected consent to participate. We used frequencies and percentages for categorical variables and means and standard deviations for quantitative variables to describe the characteristics of those who consented and were enrolled versus those who did not enroll. We also compared the characteristics of participants who consented and those who were reached and explicitly refused consent at one-month follow-up. We used the Cohen’s d measure of effect size to evaluate differences.
Results
Of the 1,000 randomized, 741 (74.1%) consented to continue in the study at one-month follow-up. One hundred and twenty-seven (12.7%) refused consent and 132 (13.2%) were unreachable. Cohen’s d effect size differences between those who consented/enrolled (n = 741) and those who were not enrolled (n = 259) were negligible (<0.2) for age, gender, race/ethnicity, and most forms of insurance. The effect size was small for Medicaid (0.36), and other public insurance (0.48). After excluding those unreached at 1 month (12.7%), there were medium Cohen’s d effect size differences between those who consented to participate (n = 741) and those who explicitly refused (n = 127) with respect to age (0.55) and self-pay or no insurance (0.51). There were small to negligible effect size differences with respect to sex, race/ethnicity, and other forms of health insurance.
Conclusions
The modified Zelen’s design resulted in successful enrollment of most participants who were initially randomized into the trial, including those not motivated to quit.

The ethical performance of access and consent in ethnographic research on social work encounters with migrant-background service users

The ethical performance of access and consent in ethnographic research on social work encounters with migrant-background service users
Hanna Kara, Maija Jappinen, Camilla Nordberg, Anna-Leena Riitaoja
Qualitative Social Work, 2022; pp 1-16
Open Access
Abstract
In this article, we contribute to an emerging body of literature concerning the often overlooked topics of access and consent in research. We posit our understanding of access and consent as continuous ethical reflection and negotiation, conceptualised here as ethical performance, which is particularly valuable in research in institutional contexts defined by numerous power asymmetries. We draw empirically from research on street level institutional encounters between social work practitioners and migrant-background service users in the Helsinki capital region. Access in this research was a multi-stage process including various stage-related negotiations, and the previous stages always influenced the stages that followed. Nevertheless, access and consent were always erratic and subject to revision. We describe how the need for ethical reflexivity arises in various concrete, often unpredictable, situations, and argue for the importance of paying explicit analytical attention to negotiations regarding access and consent.

The Effect of Digital Literacy on Participation in Social Media Clinical Trials in Cancer: Tailoring an Informed Consent Process

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
Abstract
Introduction
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?
Methods
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.
Results
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.
Conclusions
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.

Patient-centred consent in women’s health: does it really work in antenatal and intra-partum care?

Patient-centred consent in women’s health: does it really work in antenatal and intra-partum care?
Research
Jacqueline Nicholls, Anna L David, Joseph Iskaros, Anne Lanceley
BMC Pregnancy and Childbirth, 25 February 2022; 22(156)
Open Access
Abstract
Background
Legal and social changes mean that information sharing and consent in antenatal and intrapartum settings is contentious, poorly understood and uncertain for healthcare professionals. This study aimed to investigate healthcare professionals’ views and experiences of the consent process in antenatal and intrapartum care.
Methods
Qualitative research performed in a large urban teaching hospital in London. Fifteen healthcare professionals (obstetricians and midwives) participated in semi-structured in-depth interviews. Data were collectively analysed to identify themes in the experiences of the consent process.
Results
Three themes were identified: (1) Shared decision-making and shared responsibility –engaging women in dialogue is often difficult and, even when achieved, women are not always able or do not wish to share responsibility for decisions (2) Second-guessing women – assessing what is important to a woman is inherently difficult so healthcare professionals sometimes feel forced to anticipate a woman’s views (3) Challenging professional contexts – healthcare professionals are disquieted by consent practice in the Labour ward setting which is often at odds with legal and professional guidance.
Conclusions
Results suggest that there is a mismatch between what is required of healthcare professionals to effect an antenatal or intrapartum consent process concordant with current legal and professional guidance and what can be achieved in practice. If consent, as currently articulated, is to remain the barometer for current practice, healthcare professionals need more support in ways of enabling women to make decisions which healthcare professionals feel confident are autonomous whatever the circumstances of the consultation.

Consent Requirements for Testing Health Policies: An Intercontinental Comparison of Expert Opinions

Consent Requirements for Testing Health Policies: An Intercontinental Comparison of Expert Opinions
Original Research Article
Astrid Berner-Rodoreda, Shannon McMahon, Nir Eyal, Puspita Hossain, Atonu Rabbani, Mrittika Barua, Malabika Sarker, Emmy Metta, Elia Mmbaga, Melkizedeck Leshabari, Daniel Wikler, Till Bärnighausen
Journal of Empirical Research on Human Research Ethics, 10 February 2022
Abstract
Individual informed consent is a central requirement for clinical research on human subjects, yet whether and how consent requirements should apply to health policy experiments (HPEs) remains unclear. HPEs test and evaluate public health policies prior to implementation. We interviewed 58 health experts in Tanzania, Bangladesh and Germany on informed consent requirements for HPEs. Health experts across all countries favored a strong evidence base, prior information to the affected populations, and individual consent for ‘risky’ HPEs. Differences pertained to individual risk perception, how and when consent by group representatives should be obtained and whether HPEs could be treated as health policies. The study adds to representative consent options for HPEs, yet shows that more research is needed in this field – particularly in the present Covid-19 pandemic which has highlighted the need for HPEs nationally and globally.

Experiences and practices of key research team members in obtaining informed consent for pharmacogenetic research among people living with HIV: a qualitative study

Experiences and practices of key research team members in obtaining informed consent for pharmacogenetic research among people living with HIV: a qualitative study
Research Article
Nabukenya Sylvia, Ochieng Joseph, Kaawa-Mafigiri David, Munabi Ian, Nakigudde Janet, Nakwagala Frederick Nelson, Barugahare John, Kwagala Betty, Ibingira Charles, Twimwijukye Adelline, Sewankambo Nelson, Mwaka Erisa Sabakaki
Research Ethics, 7 February 2022
Abstract
This study aimed to explore experiences and practices of key research team members in obtaining informed consent for pharmacogenetics research and to identify the approaches used for enhancing understanding during the consenting process. Data collection involved 15 qualitative, in-depth interviews with key researchers who were involved in obtaining informed consent from HIV infected individuals in Uganda for participation in pharmacogenetic clinical trials. The study explored two prominent themes: approaches used to convey information and enhance research participants’ understanding and challenges faced during the consenting process. Several barriers and facilitators for obtaining consent were identified. Innovative and potentially effective consenting strategies were identified in this study that should be studied and independently verified.

“Informed Consent in the Refugees and Immigrants Mental Health Researches – A Qualitative Systematic Review and Recommendations”

“Informed Consent in the Refugees and Immigrants Mental Health Researches – A Qualitative Systematic Review and Recommendations”
Fatemah Samir Alghamdi
Arab Journal for Scientific Publishing, January 2022
Open Access
Abstract
The refugee and migration crisis is at its most critical consideration in history. Millions of people fled their countries to save their lives from armed conflicts or natural disasters that impacted their mental and physical health. This article aimed to map out the body of published articles in the refugees’ and immigrants’ researches to highlight the method of informed consent process that is crucial for the Institutional Review Boards. This research systematically reviewed published literature between 2010 and 2020 on acquiring informed consent among refugees and immigrants. This systematic review was conducted in the Association of Computing Machinery (ACM), PschInfo, EBSCO, and PubMed using Preferred Reporting Items of Systematic Review and Meta-Analyses (PRISMA) framework to identify the process of informed consent in researches that addressed mental health and related issues among refugees and immigrants. A total of 32 qualitative and quantitative research genres were reviewed to highlight the informed consent procedure in refugees and immigrants researches between 2010 to 2020. The current research found out three themes: a third party involvement, participants’ educational level, and ethical violation in the informed consent process. Also, this research suggested the multifaceted informed consent to maximize their search outcomes and elude ethical violations.

Informed Consent as a Component of Online Research Ethics — The Perspective of the Participants

Informed Consent as a Component of Online Research Ethics — The Perspective of the Participants
Online Research
Nataša B. Matović, Kristinka Č. Ovesni
Globethics.net, 1 November 2021
Abstract
The paper discusses informed consent as a component of online research ethics. It begins from the analysis of understanding, from the preconditions on which the realization depends, and from the difficulties that accompany the application of the informed consent in practice. The aim of the empirical part of the research is to determine the characteristics of the process of obtaining the informed consent in online research and to examine the factors on which they depend. The sample included 153 teachers. Data were collected with the survey-type questionnaires and with the descriptive assessment scales. For data processing, besides the frequencies and percentages, the χ2 test and Kramer ‘s V correlation coefficient were performed. The results indicate that most of the respondents have had experience of giving informed consent in online surveys in which they have participated so far; that the text often contained information about the purpose and the goal of the research, apart from the tasks of the respondents in the research; that the majority of the teachers evaluate the content of the text as understandable and useful; and also that most of the characteristics depend on the environment of the school in which the teachers are employed. The results are discussed in the context of the possibility of improvement of the process of obtaining informed consent from the respondents in the online survey.

Editor’s note: Globethics.net is a global network of teachers and institutions with the vision to embed ethics in higher education. It hosts a publishing house open to all the authors interested in applied ethics.

Informed consent in psychotherapy: a survey on attitudes among psychotherapists in Switzerland

Informed consent in psychotherapy: a survey on attitudes among psychotherapists in Switzerland
Research
Klara Eberle, Martin grosse Holtforth, Marc Inderbinen, Jens Gaab, Yvonne Nestoriuc, Manuel Trachsel
BMC Medical Ethics, 12 November 2021; 22(150)
Open Access
Abstract
Background
The legal and ethical guidelines of psychological professional associations stipulate that informed consent by patients is an essential prerequisite for psychotherapy. Despite this awareness of the importance of informed consent, there is little empirical evidence on what psychotherapists’ attitudes towards informed consent are and how informed consent is implemented in psychotherapeutic practice.
Methods
155 psychotherapists in Switzerland completed an online survey assessing their attitudes regarding informed consent.
Results
Among the surveyed psychotherapists, there was a high consensus on important information that should be communicated to patients in the context of informed consent. Almost all psychotherapists rated confidentiality and its exemptions (95%) and self-determined decision-making (97%) as important. The importance to disclose information regarding fees and the empirical effectiveness of the provided treatment, were both seen as important by more than 80% of participants. The disclosure of personal information about the therapist was rated as important by 60%. Other aspects, which are not direct components of informed consent but rather overarching goals, were also evaluated rather homogeneously: self-determined decision making of the patient was rated as important by almost all of the surveyed psychotherapists (97%). The following components were also judged as important by a majority of the participants: promotion of hope (80%) and discussion of treatment goals (93%). Most psychotherapists described the implementation of informed consent as an ongoing process, rather than a one-time event during the first session of therapy. Therapists’ age, postgraduate training, treated patient group, and setting influenced attitudes towards informed consent.
Conclusions
The present study shows that informed consent is perceived by psychotherapists as both a challenge and a resource. The implementation of informed consent in psychotherapy requires further research from a clinical and ethical perspective.

From Shadow Profiles to Contact Tracing: Qualitative Research into Consent and Privacy

From Shadow Profiles to Contact Tracing: Qualitative Research into Consent and Privacy
Sacha Molitorisz, James Meese, Jennifer Hagedorn
Law, Technology and Humans, 8 November 2021; 3(2)
Abstract
For many privacy scholars, consent is on life support, if not dead. In July 2020, we held six focus groups in Australia to test this claim by gauging attitudes to consent and privacy, with a spotlight on smartphones. These focus groups included discussion of four case studies: ‘shadow profiles’, eavesdropping by companies on smartphone users, non-consensual government surveillance of its citizens and contact tracing apps developed to combat COVID-19. Our participants expressed concerns about these practices and said they valued individual consent and saw it as a key element of privacy protection. However, they saw the limits of individual consent, saying that the law and the design of digital services also have key roles to play. Building on these findings, we argue for a blend of good law, good design and an appreciation that individual consent is still valued and must be fixed rather than discarded – ideally in ways that are also collective. In other words, consent is dead; long live consent.