From the Lab Bench to the Battlefield: Novel Vaccine Technologies and Informed Consent [BOOK CHAPTER]
Paul Eagan, Sheena M. Eagan
Ethics of Medical Innovation, Experimentation, and Enhancement in Military and Humanitarian Contexts
Springer, 18 March 2020; pp 69-85
Abstract
Vaccines are a commonly used medical countermeasure against many infectious diseases and represent one of the tools used by militaries to maintain a healthy fighting force. Vaccines also constitute an essential intervention during humanitarian missions where contagious disease outbreaks can be the primary cause of the crisis or a by-product of social upheaval and natural disaster. Though many infectious diseases are recurrent problems and vaccines exist to address the threat, recent outbreaks of H1N1, Ebola, and Zika have brought to the forefront the inherent inadequacies of traditional vaccine development. New technologies such as nucleic acid-based therapies provide some hope for a more rapid and robust response capability. The potential acceleration of the vaccine development pipeline carries both opportunities and potential pitfalls. The use of immune enhancement technologies, experimental immunization protocols or unproven vaccines in military personnel or vulnerable populations during times of crisis brings to the forefront ethical issues concerning the adequacy of informed consent, human experimentation, and free choice. An overview of novel vaccine technologies is followed by an analysis of the ethical issues surrounding informed consent and human experimentation in vulnerable military and civilian populations.
The role of institutional review boards, and hospital pharmacists as members, in the informed consent process in clinical research: a retrospective observational study
The role of institutional review boards, and hospital pharmacists as members, in the informed consent process in clinical research: a retrospective observational study
E Villamañán, C Sobrino, M Freire, JN Inmaculada, SR Luis, L Patricia, C Lara, E Fernández De Uzquiano, A Herrero, M Moreno
European Journal of Hospital Pharmacy, 24 March 2020; 27(suppl 1:6ER-023)
Open Access
Abstract
Background and importance
It is the responsibility of institutional review boards (IRBs) and hospital pharmacists, as members of these boards, to review a research proposal and ensure that adequate informed consent procedures are implemented in an ethical way, promoting participant autonomy and protecting them from potential harm. In this context, informed consent forms (ICFs) have become increasingly complex and difficult for patients to understand.
Aim and objectives
To analyse non-approval of clinical research by IRBs, related to deficiencies found in the ICFs. Secondary outcomes were type of objections in terms of readability, length, description of study purpose, design, expected benefits and foreseeable risks. Other ethical and legal aspects, such as voluntary agreement to participate, right to withdraw, biological sample management and access to personal data were also analysed
Material and methods
This was a retrospective observational study of the clinical studies evaluated by the IRB in a tertiary hospital. We evaluated the IRB resolutions of all clinical studies over 4 years, including interventional studies (clinical trials) and non-interventional research assessed by the IRB where a hospital pharmacist was a member of the board. The committee’s decisions on approval were registered in the minutes of the meetings. The pharmacists reviewed the minutes, evaluating the final opinion of the committee (approval/non-approval of the study) in the first review.
Results
A total of 91 sets of minutes, corresponding to the IRB meetings over 4 years, were analysed. In these meetings, 1858 clinical trials were evaluated (1057 clinical trials and 801 non-interventional studies). Of these, 1558 required informed consent for participation (83.9%, 95% CI 82.1–85.5) and 987 were not approved at first review due to deficiencies detected in the ICF (63.3%, 95% CI 60.9–65.7). The main reasons for non-approval were unreadability (11.7%), inadequate information given about access to personal data rights (9.2%), biological sample management (7.8%) and expected benefits (7.6%).
Conclusion and relevance
There was a high proportion of deficiencies in the ICFs for clinical research. They were an important reason for non-approval of protocols evaluated by IRBs. Taken together, there are three fundamental weaknesses in ICFs where IRBs in hospitals play a key role: improving their readability, adapting them to regulations concerning data protection or biological sample management, and avoiding misleading information concerning enrolment.
Ethics (Informed Consent and Conflicts of Interest) [BOOK CHAPTER]
Ethics (Informed Consent and Conflicts of Interest) [BOOK CHAPTER]
Kara K. Rossfeld, Jordan M. Cloyd, Elizabeth Palmer, Timothy M. Pawlik
Clinical Trials
Springer, 11 March 2020; pp 17-31
Abstract
The aim of clinical trials is to obtain generalizable knowledge that can be used to advance healthcare. The ethical issues in clinical trials arise when human subjects, who may not directly benefit from the research, are faced with the risk of being exploited or harmed. Additional ethical challenges pertain to informed consent of subjects and conflicts of interest of physician-investigators. The current ethical standards for research are based on guidelines and laws which were a necessary response to historical abuses of participants in the name of science. In this chapter, a framework for evaluating clinical research for ethical deficits is discussed, as are challenges in upholding ethical principles, including in obtaining informed consent from research participants as well as in navigating conflicts of interest.
Animation-supported consent for urgent angiography and angioplasty: a service improvement initiative
Animation-supported consent for urgent angiography and angioplasty: a service improvement initiative
Original Research
David S Wald, Oliver Casey-Gillman, Katrina Comer, Josephine Sarah Mansell, Howie Teo, Kyriacos Mouyis, Matthew Kelham, Fiona Chan, Selda Ahmet, Max Sayers, Vincent McCaughan, Nito Polenio
Heart, 10 March 2020
Open Access
Abstract
Objective
Patient understanding of angiography and angioplasty is often incomplete at the time of consent. Language barriers and time constraints are significant obstacles, particularly in the urgent setting. We introduced digital animations to support consent and assessed the effect on patient understanding.
Methods
Multi-language animations explaining angiography and angioplasty (www.explainmyprocedure.com/heart) were introduced at nine district hospitals for patients with acute coronary syndrome before urgent transfer to a cardiac centre for their procedure. Reported understanding of the reason for transfer, the procedure, its benefits and risks in 100 consecutive patients were recorded before introduction of the animations into practice (no animation group) and in 100 consecutive patients after their introduction (animation group). Patient understanding in the two groups was compared.
Results
Following introduction, 83/100 patients reported they had watched the animation before inter-hospital transfer (3 declined and 14 were overlooked). The proportions of patients who understood the reason for transfer, the procedure, its benefits and risks in the no animation group were 58%, 38%, 25% and 7% and in the animation group, 85%, 81%, 73% and 61%, respectively. The relative improvement (ratio of proportions) was 1.5 (95% CI 1.2 to 1.8), 2.1 (1.6 to 2.8), 2.9 (2.0 to 4.2) and 8.7 (4.2 to 18.1), respectively (p<0.001 for all comparisons).
Conclusion
Use of animations explaining angiography and angioplasty is feasible before urgent inter-hospital transfer and was associated with substantial improvement in reported understanding of the procedure, its risks and its benefits. The approach is not limited to cardiology and has the potential to be applied to all specialties in medicine.
From Subjective To Objective Informed Consent In Healthcare : Biobanks In Focus [CONFERENCE PAPER]
From Subjective To Objective Informed Consent In Healthcare : Biobanks In Focus [CONFERENCE PAPER]
Syeda Amna Sohail, Faiza Allah Bukhsh
Alice & Eve 2020: Celebration of Women in Computer Science – University of Twente, 24 January 2020 – 24 January 2020; Enschede, Netherlands
Abstract
Healthcare data has long been handled as per the national\local legislative and organizational prerequisites of the healthcare providers across the EU. This inculcates that the healthcare providers goals/objectives substantially dictated the data handling paths of the patients. Where the former could be starkly different from that of the patients/data subjects. Recently, healthcare stakeholders, for patients optimal value care, embedded the idea of Informed Consent (IC) at the onset of data collection. To transform the former, subjective way of data handling by healthcare providers into an objective pan European data handling procedure, the EU introduced General Data Protection Regulation, GDPR. Post GDPR, the EU legitimized patients IC as an integral part at the onset of patients information value care. Now IC, entails patients explicit, well informed , specific, free choice for his/her healthcare data collection and processing, demonstrated in an easily accessible and understandable manner with patients having the right of erasure at any point of data processing (GDPR, article 7). This poses limitations, specifically against scientific research, when applied in biobanks and bio-repositories. Limitations range from Biobanks data collection to data anonymization or/and pseudonymization to the data storage and sharing. In each phase of data handling, the issues and their respective solutions are discussed. Solution lies in defining the public/vital and legitimate interests and in incorporating the broad-open ended informed consent. This is vital for better health outcomes of the patients and the society at large. Regulatory and legislative authorities at the EU and national level must unite to resolve these issues.
Capacity to Consent to Research Participation in Adults with Metastatic Cancer: Comparisons of Brain Metastasis, Non-CNS Metastasis, and Healthy Controls
Capacity to Consent to Research Participation in Adults with Metastatic Cancer: Comparisons of Brain Metastasis, Non-CNS Metastasis, and Healthy Controls
Kyler Mulhauser, Dario A Marotta, Adam Gerstenecker, Gabrielle Wilhelm, Terina Myers, Meredith Gammon, David E Vance, Burt Nabors, John Fiveash, Kristen Triebel
Neuro-Oncology Practice, 9 March 2020
Abstract
Background
To evaluate the ability of persons with metastatic cancer to provide informed consent to research participation, we used a structured vignette-based interview to measure four consenting standards across three participant groups.
Methods
Participants included 61 persons diagnosed with brain metastasis, 41 persons diagnosed with non-CNS metastasis, and 17 cognitively intact healthy controls. All groups were evaluated using the Capacity to Consent to Research Instrument (CCRI), a performance-based measure of research consent capacity. The ability to provide informed consent to participate in research was evaluated across four consent standards: expressing choice, appreciation, reasoning, and understanding. Capacity performance ratings (intact, mild/moderate impairment, severe impairment) were identified based on control group performance.
Results
Results revealed that the brain metastasis group performed significantly lower than healthy controls on the consent standard of understanding, while both metastatic cancer groups performed below controls on the consent standard of reasoning. Both metastatic cancer groups performed similar to controls on the standards of appreciation and expressing choice. Approximately 60% of the brain metastasis group, 54% of the non-CNS metastasis group, and 18% of healthy controls showed impaired research consent capacity.
Conclusions
Our findings, using a performance-based assessment, are consistent with other research indicating that the research consent process may be overly cumbersome and confusing. This, in turn, may lead to research consent impairment not only in patient groups but also in some healthy adults with intact cognitive ability.
The Patients Have a Story to Tell: Informed Consent for People who use Illicit Opiates
The Patients Have a Story to Tell: Informed Consent for People who use Illicit Opiates
Research Article
Jane McCall, J Craig Phillips, Andrew Estafan, Vera Caine
Nursing Ethics, 26 February 2020
Abstract
Background
There is a significant discourse in the literature that opines that people who use illicit opiates are unable to provide informed consent due to withdrawal symptoms and cognitive impairment as a result of opiate use.
Aims
This paper discusses the issues related to informed consent for this population.
Ethical considerations
Ethical approval was obtained from both the local REB and the university. Written informed consent was obtained from all participants.
Method
This was a qualitative interpretive descriptive study. 22 participants were interviewed, including 18 nurses, 2 social workers and 2 clinic support workers. The findings were analyzed using thematic analysis, which is a way of systematically reducing the complexity of the information to arrive at generalized explanations.
Results
The staff at the clinic were overwhelming clear in their judgment that people who use opiates can and should be able to participate in research and that their drug use is not a barrier to informed consent.
Conclusions
It is important to involve people who use opiates in research. Protectionist concerns about this population may be overstated. Such concerns do not promote the interests of research participants. People who use heroin need to be able to tell their story.
Perspectives on Informed Consent Practices for Minimal-Risk Research Involving Foster Youth
Perspectives on Informed Consent Practices for Minimal-Risk Research Involving Foster Youth
Pediatrics Perspective
Mary V. Greiner, Sarah J. Beal and Armand H. Matheny Antommaria
American Academy of Pediatrics, March 2020
Excerpt
There are >430 000 children in protective custody (ie, foster care) in the United States. Despite known health disparities, there continues to be limited research to develop an evidence base for diagnosing and intervening to improve health conditions for children in foster care.6 One identified obstacle to recruitment is obtaining informed consent, the legal requirement for understanding and voluntary agreement to participate in research. Foster youth do not have a traditional parent or guardian and instead have many adults playing different roles in their lives, including their children’s services caseworker, their foster caregiver, their biological parent, their court-appointed special advocate or guardian ad litem (GAL), and their judge or magistrate. Each plays a role in decision-making for the child and could participate in the informed consent process…
Parental Understanding of Research Consent Forms in the PICU: A Pilot Study
Parental Understanding of Research Consent Forms in the PICU: A Pilot Study
Shira Gertsman, Katharine O’Hearn, Jess Gibson, Kusum Menon
Pediatric Critical Care Medicine, 28 February 2020
Abstract
Objectives
To describe legal guardians’ understanding of key concepts in a research consent form presented within 24 hours of their child’s admission to the [Paediatric Intensive Care Unit] PICU and to explore legal guardians’ opinions of the format (language, length) of the consent form and the overall consent process.
Design
Single-center, exploratory pilot study.
Setting
PICU at a tertiary-care hospital in Canada.
Subjects
Forty-one English- and French-speaking legal guardians of children less than 18 years old, who had been admitted to the PICU within the past 24 hours and were expected to stay at least 48 hours, between October 2018 and February 2019.
Interventions
The consent form from a previous PICU trial was given and explained to legal guardians within 24 hours of their child’s admission to the PICU.
Measurements and main results
Legal guardians’ understanding of key concepts in the consent form was evaluated using a questionnaire the day after the form was explained, and opinions were collected verbally and using an additional survey. The median number of questions answered incorrectly was three of seven (interquartile range = 2-4). Participants best understood the topic of the study (5% incorrect), but 80% of participants were unable to recall a single risk. The median rating of the language in the form was five of five (very easy to understand; interquartile range = 4-5), and 88% of participants said it was a reasonable length.
Conclusions
Despite positive opinions of the consent form, most legal guardians did not understand all key components of the consent information provided to them orally and in writing within 24 hours of their child’s PICU admission. Future studies are required to determine barriers to understanding and explore alternative approaches to obtaining consent in this setting.
EU Coordination of Serious Cross-Border Threats to Health: The Implications for Protection of Informed Consent in National Pandemic Policies
EU Coordination of Serious Cross-Border Threats to Health: The Implications for Protection of Informed Consent in National Pandemic Policies
Hannah Van Kolfschooten
European Journal of Risk Regulation, October 2019; 10(4) pp 635-651
Open Access
Abstract
This article discusses the development of a more supranational EU approach to regulate risks of “serious cross-border threats to health” such as pandemic disease outbreaks. It argues that the EU’s public health measures to prevent and tackle pandemics could affect individual patients’ rights, because the rights of individual European citizens are balanced against the importance of protecting the European community as a whole. This results in a tension between public health and individual rights in the EU, especially with regard to the right to informed consent, a central right in health law. In response to the 2013–2016 Ebola outbreak in West Africa, the EU introduced several preventive and responsive measures in the Member States to prevent the pandemic from spreading to the EU. The case study analysis of Dutch pandemic policies established in reaction to this outbreak shows that national pandemic policies are substantially shaped by EU actions, which has implications for the protection of the individual right to informed consent in the Member States.
Center for Informed Consent Integrity 