Assessing for Quality Informed Consent With Subjects Enrolling in Clinical Research
Case
Laura R. Holtz
SAGE Research Methods Cases: Medicine and Health, 2020
Abstract
Research subjects are asked to participate in the informed consent process before participating in research. The elements and regulatory requirements of informed consent are well documented. However, there is less known about the quality of informed consent discussions that are occurring with potential subjects. There is evidence that these discussions may be lacking in quality to effectively meet the intended goals. Research professionals may need additional training, skills, and tools to help increase subject’s understanding of informed consent. It is necessary to identify the characteristics of quality informed consent. In addition, tools and strategies, such as Teach Back and Documentation of Informed Consent process, can be utilized to operationalize the assessment of understanding when conducting informed consent. Quality may lead to increased engagement and compliance with study protocols and reductions in subject withdrawals. Both research staff and participants will benefit with increased confidence by addressing quality in informed consent.
Assessing readability and comprehension of informed consent materials for medical device research: A survey of informed consents from FDA’s Center for Devices and Radiological Health
Assessing readability and comprehension of informed consent materials for medical device research: A survey of informed consents from FDA’s Center for Devices and Radiological Health
Fabienne Santel, Isatu Bah, Katherine Kim, Ja-An Lin, Jack McCracken, Adaeze Teme
Contemporary Clinical Trials, October 2019; 85
Abstract
Legally effective informed consent has been a long-standing requirement for FDA-regulated clinical studies. However, informed consent forms (ICFs) are often thought to be too long, too complex, and too difficult for participants to understand. In this article, investigators from the FDAs Center for Devices and Radiological Health (CDRH) surveyed 399 ICFs from approved investigational device exemption (IDE) applications for fiscal years 2015 and 2016 to evaluate the readability of ICFs.
The investigators collected data from the ICFs, using variables related to structure, readability, and comprehension.
The investigators found that the mean grade-reading levels of the ICFs ranged from 10th grade to college level (Table 2), higher than the recommended 6th to 8th grade level, when measured by major readability evaluation tools (the SMOG readability grade level formula, the Flesch-Kincaid Index Grade Level Readability Formula, the Flesch Reading Ease test, and the Dale-Chall readability formula).
Overall, the ICFs and informed consent (IC) processes, as described in the IDE application, lacked components that enhanced participants’ comprehension, such as short sentences (e.g., no more than 8 to 10 to words) and the use of pictures, tables, and diagrams.
CDRH investigators believe that information about ICFs’ readability, comprehension, and structure will help support current and future efforts to improve the IC process. The intent of the article is to demonstrate that improvements are needed in the IC process and to encourage clinical trial stakeholders to consider implementing those approaches that optimize patient comprehension in the development of their IC processes.
Electronic Informed Consent in Clinical Research
Electronic Informed Consent in Clinical Research
White Paper
Medidata, 2019
Open Access
Executive Summary
Medidata is conducting a study to understand the regulatory positions, adoption and the variability regarding electronic informed consent (eConsent) around the world. This exercise has come about due to the extensive number of regulatory relevant inquiries Medidata gets from sponsors and organizations managing trials in research. The life science industry is keen to have the option to leverage electronic means for consenting trial participants but are uncertain of the regulatory positions on the topic. The only way to seek clarity on this topic was to directly engage with relevant authorities.
The study initially focused on the countries in the European geographic region but has evolved to other regions including Asia Pacific and the Americas. The study prioritized countries where there was an aspiration to utilize electronic informed consent by organizations running clinical trials…
Ethics and access when consent must come first [BOOK CHAPTER]
Ethics and access when consent must come first [BOOK CHAPTER]
Hugh Busher, Alison Fox
Implementing Ethics in Educational Ethnography
Taylor & Francis, 2019; Chapter 4
Open Access
Abstract
Formalised procedures to obtain and document informed consent from research participants are at the heart of the shift from informal to formalised research ethics. Critiques claim that the requirements to obtain consent from all potential participants before the onset of a study will make it impossible to do ethnographic research and participant observation in institutional settings such as schools. Drawing on experiences from an ethnographic research project in secondary schools in Norway, the aim of this chapter is to discuss the ethical considerations and, embedded in these, the methodological and analytical challenges involved in doing participant observation in schools where not all pupils and parents have consented to participation in the research. The chapter suggests possible ways forward for tackling these challenges for ethnographic researchers working in schools.
A ResearchKit app to deliver paediatric electronic consent: Protocol of an observational study in adolescents with arthritis
A ResearchKit app to deliver paediatric electronic consent: Protocol of an observational study in adolescents with arthritis
Research Paper
Chitra Lalloo, Quynh Pham, Joseph Cafazzo, Elizabeth Stephenson, Jennifer Stinson
Contemporary Clinical Trials Communications, 14 January 2020
Open Access
Abstract
ResearchKit is an open-source software framework designed to streamline the process of screening and consenting participants into research studies. By digitizing traditionally analog processes, ResearchKit has potential to increase the reach, efficiency, and scalability of mobile health (mHealth) research. The model has been successfully applied in adult settings. However, to our knowledge, no group has sought to adapt ResearchKit for a pediatric research environment in Canada. The potential benefits for building paediatric mHealth apps compatible with remote eConsent are numerous: (1) access to studies can be broadened from small groups of children and families who live in close proximity to research sites to whole populations across geographical boundaries, (2) increased convenience for study participants because they can complete consent on their smartphone from their home, rather than in person or on paper, and (3) large-scale study enrollment can be conducted with fewer resources than traditional face-to-face methods. We describe the rationale and design of a proof-of-concept observational study focused on implementing remote eConsent in a Canadian pediatric population. A community-based sample of adolescents with arthritis will be remotely onboarded to use the iCanCope pain self-management app for 8-weeks. Outcomes will focus on: (1) fidelity and acceptability of the eConsent process, (2) fidelity of the iCanCope app in terms of engagement and acceptability, (3) participant study experience including level of perceived support and acceptability of study tasks, and (4) clinical outcomes related to use of the iCanCope app over an 8-week period.
Modeling Clinical Processes to Consent Research Donors of Remnant Biospecimens in an Outpatient Cardiology Clinic
Modeling Clinical Processes to Consent Research Donors of Remnant Biospecimens in an Outpatient Cardiology Clinic
Stephanie E. Soares, Nicholas R. Anderson, Leslie J. Solis, Javier E. López
Biopreservation and Biobanking, 26 December 2019
Abstract
Introduction
Informed consent for research biospecimen donations is traditionally obtained through a face-to-face interaction with research staff and by signing an Institutional Review Board (IRB)-approved printed form. Electronic signatures (eSign) are routinely used in the electronic medical record (EMR) for the consenting of clinical services after patients review printed documentation. Our goal was to develop an electronic self-consenting workflow that mimicked clinical services. Specifically, we tested a research consent process for the biobanking of remnant clinical samples that relies solely on clinical resources in a busy outpatient practice.
Materials and Methods
The Biorepositories Core Resource (BCR) unit initiated a new enterprise-wide biobanking infrastructure for consenting patients, termed Biospecimen Use for Research-Related Investigations and Translational Objectives (BURRITO). BURRITO is modeled after an established clinical process called Terms and Conditions of Service (TACOS). The TACOS requires patients to annually review printed documentation and self-consent electronically for clinical services. BURRITO also requires patients to review printed documentation and self-consent with eSign to opt-in for remnant biospecimen banking, but patients must complete this process only once. We captured eSign for consents directly into the EMR without research staff.
Results
Patients reviewed the IRB-approved documents and self-consented during their cardiology clinic visit. At checkout, their participation preferences were electronically documented by clinic staff. During a 6-month period, 123 patients agreed to donate. After a review of process, a second 3-month period identified 202 patients agreeing to donate. BURRITO did not require face-to-face interactions with research staff, used a “no-paper” eSign for consent, and created discrete fields in the clinical EMR of the patient’s preference.
Conclusions
BURRITO electronically documents informed consent using an EMR functionality and the least amount of clinical and research resources. Our results show promise for developing institutionally adopted processes, which could leverage existing clinical workflows for universal research consenting and scalability.
An end to coercion: rights and decision-making in mental health care
An end to coercion: rights and decision-making in mental health care
Policy & Practice
Kanna Sugiura, Faraaz Mahomed, Shekhar Saxena, Vikram Patel
Bulletin of the World Health Organization, January 2020; 98(1)
Article
The United Nations Convention on the Rights of Persons with Disabilities requires a paradigm shift from a medical model of disability to a social model that emphasizes overcoming the barriers to equality created by attitudes, laws, government policies and the social, economic and political environment. The approach adopted by the social model recognizes that people with psychosocial disabilities have the same right to take decisions and make choices as other people, particularly regarding treatment, and have the right to equal recognition before the law. Consequently, direct or supported decision-making should be the norm and there should be no substitute decision-making. Although recent mental health laws in some countries have attempted to realize a rights-based approach to decision-making by reducing coercion, implementing the Convention on the Rights of Persons with Disabilities can be challenging because it requires continuous refinement and the development of alternatives to coercion. This article reviews the impact historical trends and current mental health frameworks have had on the rights affected by the practice of involuntary treatment and describes some legal and organizational initiatives that have been undertaken to promote noncoercive services and supported decision-making. The evidence and examples presented could provide the foundation for developing a context-appropriate approach to implementing supported decision-making in mental health care.
Conducting a Randomized Controlled Trial in Care Homes: The Challenges of Recruiting Residents Who Lack Capacity to Consent
Conducting a Randomized Controlled Trial in Care Homes: The Challenges of Recruiting Residents Who Lack Capacity to Consent
Case
Victoria Shepherd, Jane Davies
SAGE Research Methods Cases: Medicine and Health, 2020
Abstract
Older people living in care homes (long-term care facilities) are at high risk of developing infections due to weakened immunity, close proximity living, and other multiple illnesses. As a result, care home residents are prescribed far more antibiotics than the general population. Probiotics are friendly live bacteria that may give health benefits by improving the immune system of care home residents and reducing the spread of harmful bacteria. We conducted a randomized controlled trial to investigate whether a probiotic supplement could reduce the number of infections in care home residents, reduce antibiotic use in this vulnerable group, and so help curb antibiotic resistance. Conducting clinical trials in care homes can be challenging, in part because a high proportion of residents have conditions such as dementia that may affect their ability to provide informed consent to take part. When someone lacks capacity to provide consent for themselves, alternative processes are followed to ensure that the research is conducted ethically. This case study provides an account of the challenges of conducting a randomized controlled trial in care homes, focusing on the recruitment of residents who lack capacity to consent, and strategies we employed to ensure their appropriate inclusion in the trial.
Informed Consent for the Human Research Subject with a Neurologic Disorder
Informed Consent for the Human Research Subject with a Neurologic Disorder
Neil H. Vaishnav, Winston Chiong
Seminars in Neurology, 2018; 38 pp. 539-547
Open Access
Abstract
The doctrine of informed consent sits at the intersection of law, ethics, and neuroscience, posing unique challenges for human subject research involving neurological patients. These challenges are compounded by the variegated nature of both neurological injury and the law governing research consent. This article provides a framework for investigators likely to encounter subjects with some degree of neurological impairment, whose capacity to consent requires scrupulous assessment prior to enrollment in research trials. We consider several researches and disease contexts— from emergency epilepsy research to long-term dementia research—and clarify the ethical and legal principles governing consent for participation in each. We additionally explore empirical research on consent capacity and survey several areas of emerging ethical import that will require the attention of investigators in decades to come.
The challenges of making informed decisions about treatment and trial participation following a cancer diagnosis: a qualitative study involving adolescents and young adults with cancer and their caregivers
The challenges of making informed decisions about treatment and trial participation following a cancer diagnosis: a qualitative study involving adolescents and young adults with cancer and their caregivers
Research Article
Ruth I. Hart, David A. Cameron, Fiona J. Cowie, Jeni Harden, Nicholas B. Heaney, David Rankin, Angela B. Jesudason, Julia Lawton
BMC Health Services Research, 8 January 2020; 20(25)
Open Access
Abstract
Background
Limited attention has been paid to adolescents and young adults’ (AYA’s) experiences in the aftermath of a cancer diagnosis, despite this being a time when potentially life-changing decisions are made. We explored AYA’s and caregivers’ experiences of, and views about, making treatment and trial participation decisions following a cancer diagnosis, in order to understand, and help facilitate, informed treatment decision-making in this age group.
Methods
Interviews were undertaken with 18 AYA diagnosed, or re-diagnosed, with cancer when aged 16–24 years, and 15 parents/caregivers. Analysis focused on the identification and description of explanatory themes.
Results
Most AYA described being extremely unwell by the time of diagnosis and, consequently, experiencing difficulties processing the news. Distress and acceleration in clinical activity following diagnosis could further impede the absorption of treatment-relevant information. After referral to a specialist cancer unit, many AYA described quickly transitioning to a calm and pragmatic mind-set, and wanting to commence treatment at the earliest opportunity. Most reported seeing information about short-term side-effects of treatment as having limited relevance to their recovery-focused outlook at that time. AYA seldom indicated wanting to make choices about front-line treatment, with most preferring to defer decisions to health professionals. Even when charged with decisions about trial participation, AYA reported welcoming a strong health professional steer. Parents/caregivers attempted to compensate for AYA’s limited engagement with treatment-relevant information. However, in seeking to ensure AYA received the best treatment, these individuals had conflicting priorities and information needs.
Conclusion
Our study highlights the challenging context in which AYA are confronted with decisions about front-line treatment, and reveals how their responses make it hard to ensure their decisions are fully informed. It raises questions about the direct value, to AYA, of approaches that aim to promote decision-making by improving understanding and recall of information, though such approaches may be of value to caregivers. In seeking to improve information-giving and involvement in treatment-related decision-making at diagnosis, care should be taken not to delegitimize the preference of many AYA for a directive approach from trusted clinicians.
Center for Informed Consent Integrity 