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
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.
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.
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
Policy & Practice
Kanna Sugiura, Faraaz Mahomed, Shekhar Saxena, Vikram Patel
Bulletin of the World Health Organization, January 2020; 98(1)
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
Victoria Shepherd, Jane Davies
SAGE Research Methods Cases: Medicine and Health, 2020
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
Neil H. Vaishnav, Winston Chiong
Seminars in Neurology, 2018; 38 pp. 539-547
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
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)
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.
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.
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.
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.
Consent for babies born following surrogate pregnancies
Heather Sharon Hodgson, Abigail Nye, Fiona Finlay
Diseases in Childhood, 14 January 2020
Surrogate pregnancies are becoming more common, but the law governing who can give consent following surrogate births is complex. Parental responsibility (PR) may be held by a variety of individuals, depending on the specific circumstances.
We conducted a survey of paediatric medical staff within Health Education South West to establish knowledge regarding consent for a baby before a parental or adoption order is obtained. Our results showed that 19% of the 47 respondents answered all scenarios correctly. 43% of respondents knew that the surrogate mother had PR in all scenarios; however, 13% incorrectly assumed that either intended parent always had PR. Knowledge of other individuals who could provide consent in the scenarios was variable.
Our survey revealed poor understanding regarding medicolegal aspects of consent in these complex situations, emphasising the need for more specific published guidance for primary and secondary healthcare professionals encountering these babies in the early postnatal period.
Broad consent under the GDPR: an optimistic perspective on a bright future
Life Sciences, Society and Policy, 6 January 2020; 16(1)
Broad consent – the act of gaining one consent for multiple potential future research projects – sits at the core of much current genomic research practice. Since the 25th May 2018, the General Data Protection Regulation (GDPR) has applied as valid law concerning genomic research in the EU and now occupies a dominant position in the legal landscape. Yet, the position of the GDPR concerning broad consent has recently been cause for concern in the genomic research community. Whilst the text of the GDPR apparently supports the practice, recent jurisprudence contains language which is decidedly less positive. This article takes an in-depth look at the situation concerning broad consent under the GDPR and – despite the understandable concern flowing from recent jurisprudence – offers a positive outlook. This positive outlook is argued from three perspectives, each of which is significant in defining the current, and ongoing, legitimacy and utility of broad consent under the GDPR: the principled, the legal technical, and the practical.
Opt-in consent policies: potential barriers to hospital health information exchange
Apathy NC, Holmgren AJ
The American Journal of Managed Care, 1 January 2020; 26(1) e14-e20
To (1) assess whether hospitals in states requiring explicit patient consent (“opt-in”) for health information exchange (HIE) are more likely to report regulatory barriers to HIE and (2) analyze whether these policies correlate with hospital volume of HIE.
Cross-sectional analysis of US nonfederal acute care hospitals in 2016.
We combined legal scholarship surveying HIE-relevant state laws with the American Hospital Association Annual Information Technology Supplement for regulatory barriers and hospital characteristics. Data from CMS reports for hospitals attesting to Meaningful Use stage 2 (MU2; renamed “Promoting Interoperability” in 2018) in 2016 captured hospital HIE volume. We used multivariate logistic regression and linear regression to estimate the association of opt-in state consent policies with reported regulatory barriers and HIE volume, respectively.
Hospitals in states with opt-in consent policies were 7.8 percentage points more likely than hospitals in opt-out states to report regulatory barriers to HIE (P = .03). In subgroup analyses, this finding held among hospitals that did not attest to MU2 (7.7 percentage points; P = .02). Among hospitals attesting, we did not find a relationship between opt-in policies and regulatory barriers (8.0 percentage points; P = .13) or evidence of a relationship between opt-in policies and HIE volume (β = 0.56; P = .76).
Our findings suggest that opt-in consent laws may carry greater administrative burdens compared with opt-out policies. However, less technologically advanced hospitals may bear more of this burden. Furthermore, opt-in policies may not affect HIE volume for hospitals that have already achieved a degree of technological sophistication. Policy makers should carefully consider the incidence of administrative burdens when crafting laws pertaining to HIE.
Autonomy in organ donations v family consent: a South African legislative context
Magda Slabbert, Bonnie Venter
De Jure Law Journal, 2019
The lack of availability of transplantable donor organs remains the main obstacle to improving organ donation rates on a global level. The purpose of this article is to investigate the role of family consent in the donation process from a legal perspective. The question is posed whether family members should be approached to provide consent for deceased organ donation or whether the right to self-determination of the deceased should be honoured. The article analyses Chapter 8 of the National Health Act 61 of 2003 to determine the current legal position with regard to consent in the organ donation process. It is concluded that due to the continued stagnant state of the availability of donor organs in South Africa, at the very least appropriate, valid consent should not be nullified by a relative’s objection.
Informed Consent to Vaccination: Theoretical, Legal, and Empirical Insights
Dorit Rubinstein Reiss, Nili Karako-Eyal
American Journal of Law and Medicine, 23 January 2020
Informed consent matters — so does protecting people from infectious diseases. This paper examines what the appropriate informed consent process for vaccines should look like and how the process is conceptualized by law and health authorities. Drawing on the extensive theoretical and empirical literature on informed consent and vaccination, this article sets out what an ideal informed consent process for vaccination would consist of, highlighting the need for autonomous decisions. To be autonomous, decisions need to be based on full, accessible information and reached without coercion. We suggest that the information provided must address the nature of the procedure — including benefits to the child, benefits to society, and risks. Parents should have their concerns and misconceptions addressed. The information needs to be accessible and include an opportunity to ask questions. Based on this ideal model we examined in detail the legal framework surrounding informed consent to vaccination and the process as conceptualized by health authorities in two countries, Israel and the United States, to assess whether they meet the requirements. These two countries are similar in some of their values, for example, the importance of individual autonomy, and face similar problems related to vaccine hesitancy. At the same time, there are meaningful differences in their vaccine policies and the current structures of their informed consent processes, allowing for a meaningful comparison. We found neither country met our ideal informed consent process, and suggested improvements both to the materials and to the processes used to obtain informed consent.