16:30 pm
Ethical perspectives of the involvement of vulnerable populations in health research
Elin Lampa | Uppsala University | Sweden
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Authors:
Elin Lampa | Uppsala University | Sweden
Dr. Ulrik Kihlbom | Uppsala University
Public involvement in research can lead to a richer understanding of the research topic, improve data quality and analysis, and increase trust in and dissemination of research findings. In addition, it can generate valuable knowledge and contribute to collaborations between sectors and actors, in order to benefit sustainable solutions to global problems. However, this all relies on public involvement being conducted in a meaningful, respectful and inclusive way, especially when involving representatives from vulnerable populations such as children and refugees. We are conducting a research project where we aim to identify the most pertinent ethical challenges and problems to the use of public involvement in vulnerable populations. Within the context of a public involvement evaluation project, we are currently collecting observational and qualitative data from research projects involving public representatives from vulnerable groups. The data collection is still ongoing, but preliminary findings include ethical challenges surrounding researchers’ responsibilities when inviting public representatives to a research project: What can researchers ask public representatives to contribute with in research? How do researchers protect public representatives from harm, and should it be their responsibility? Who should be responsible in taking these decisions? Based on the observational and qualitative data, we will conduct an empirically informed theoretical reflection on ethical aspects on involvement of vulnerable populations in health research. By July 2022, we will be ready to present findings from this project. Our long-term aim is contributing with support and guidance on ethical decision-making for researchers involving vulnerable populations in research.
16:45 pm
Children in Early-Phase Cancer Trials: Risk, Benefit and Social Value
Prof. Dr. Marcin Waligóra | Jagiellonian University Medical College | Poland
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Author:
Prof. Dr. Marcin Waligóra | Jagiellonian University Medical College | Poland
Background: Death rates in pediatric cancers dropped by more than 50% from 1970’ placing pediatric oncology among the most successful medical branches. Still about 1800 children die of cancer annually in the US and more than 6000 in Europe. Cancer in children often differs biologically from cancer in adults and many types of cancers exist only in pediatric populations, thus research with pediatric participants are necessary. Early-phase trials in clinical oncology are an essential first step to provide cancer therapies for children and yet they are posing a significant risk for participants. At the same time children in research are considered a vulnerable population and are protected in a stricter manner than adults.
Aim: In this presentation I will summarise extended studies performed by my group on the early-phase pediatric cancer trials in oncology. I will present the results of systematic risk/benefit and social value assessment for these trials in the light of regulatory and ethics framework of research with children. I argue that early-phase pediatric cancer trials are hard to classify, evaluate and approve within the current ethics framework and will offer an alternative approach.
17:00 pm
An ethical assessment of reaching hard-to-reach populations for clinical studies via social media
Theresa Willem | TUM | Germany
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Authors:
Theresa Willem | TUM | Germany
Dr. Bettina Zimmermann
Prof. Alena Buyx | Technical University Munich, Institute for History and Ethics in Medicine | Germany
Introduction: Researchers are increasingly using social media to recruit for clinical studies, hoping to improve recruitment accrual and to reach patient populations they would not reach through traditional recruitment channels. However, social media is not suitable as a recruitment tool across all study designs. We, thus, investigate the particularities of social media as recruitment tools for clinical studies and their suitability for recruiting hard-to-reach populations. Our focus lays on potential ethical implications.
Methods: We conducted qualitative interviews with interdisciplinary experts in bioethics, law, public relations, and clinical researchers as well as patients. Qualitative data is interpreted by standard content analysis methods and in terms of established biomedical and research ethics principles, particularly focusing on equality of access and vulnerability.
Outcome and conclusions: The suitability of social media recruitment for clinical studies is highly context-sensitive. Especially regarding hard-to-reach populations, careful assessment to legitimize such a procedure seems necessary. Accordingly, risk-benefit assessments need to weigh different strategic options of social media recruitment in light of the specific study design, target population, study-related factors as well as social and ethical circumstances. Risks of harm must be considered as well as potential efficiency and informed consent procedures. If high risks are possible, other recruitment methods should be prioritized. However, as social media recruitment can increase the quality of access to clinical studies especially for the hard-to-reach they should be considered for populations that cannot be reached otherwise.
17:15 pm
African Traditional healers perspectives on application of the informed consent doctrine during traditional medicine practice in South Africa: A qualitative study
Prof. Sylvester Chima | University of KwaZulu-Natal | South Africa
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Authors:
Francis Akpa-Inyang | University of KwaZulu-Natal | South Africa
Prof. Sylvester Chima | University of KwaZulu-Natal | South Africa
Abstract
Introduction: African traditional medicine practitioners offer treatment for different forms of illness to most people in Africa since it is readily available and affordable. However, individual’s rights to autonomy and bodily integrity maybe considered basic human rights, which could conflict with informed consent practice especially in cross-cultural settings.
Methods: This qualitative study used data from in-depth interviews with eight traditional practitioners to explore understanding and practice of informed consent during traditional medicine practice in South Africa. Interviews were carried out with four Nyanga and four Sangoma, with 2-30years experience as traditional healers, representative of the diverse group of traditional practitioners covered in this study. Thematic content analysis was used analyze transcribed and translated data.
Outcomes: Major themes that emerged from data analysis included: (a) the importance and amount of information disclosed by traditional healers, (b) methods used to obtain consent/agreement from patients and voluntariness of the process, (c) benefits and barriers of applying informed consent in traditional medicine practice. These themes and subthemes were explored, and results showed that African traditional practitioners disclose information such as diagnosis, risks, benefits, and treatment options to their patients, consistent with the informed consent doctrine.
Conclusions: Respondents acknowledged that it would be beneficial to apply a form of informed consent to African traditional medicine, that does not undermine African values of Ubuntu, which denotes humanity, dignity, and respect for others. This would bring honour and trust to African traditional medicine, while protecting patients’ rights, and helping to distinguish bona fide practitioners from impostors.