Article
Ethics
Tsaone Tamuhla, Nicki Tiffin, Taryn Allie
Summary: The use of electronic consent can address issues related to storing and retrieving paper consent forms. A tiered framework for electronic consent was designed and implemented with features such as branching logic, wet signature, and auto-archiver. Emphasis was placed on optimizing participant understanding by merging consent and participant information into one document. Example text and a REDCap template were provided to assist researchers in building informed consent protocols and forms.
BMC MEDICAL ETHICS
(2022)
Review
Ethics
Nina Kilkku, Arja Halkoaho
Summary: Background research on genomics and biobank activities is increasing internationally. In mental health research, concerns about participants' vulnerability and capacity for informed consent can impact recruitment. This study focuses on nurses' perspectives on informed consent practices in genomic research on mental health, highlighting themes such as consent capacity, emotional responses to participation, and factors influencing decisions to participate.
Article
Computer Science, Information Systems
Sarah K. Savage, Jonathan LoTempio, Erica D. Smith, E. Hallie Andrew, Gloria Mas, Amanda H. Kahn-Kirby, Emmanuele Delot, Andrea J. Cohen, Georgia Pitsava, Robert Nussbaum, Vincent A. Fusaro, Seth Berger, Eric Vilain
Summary: We implemented a chatbot consent tool to shift the time burden from study staff in support of a national genomics research study. We compared data from prospective participants who used the tool or had traditional consent conversations with study staff.
JOURNAL OF THE AMERICAN MEDICAL INFORMATICS ASSOCIATION
(2023)
Article
Oncology
Eline M. Bunnik, Wybo J. Dondorp, Annelien L. Bredenoord, Guido de Wert, Martina C. Cornel
Summary: The wider availability of genomic sequencing in cancer care allows for personalized medicine based on genetic characteristics. Genomic testing may yield various results beyond therapy-focused answers, such as germline mutations and variants of uncertain significance. Consent practices for genomic sequencing in mainstream cancer care should focus on preparing patients for unsolicited outcomes and may not require opt-out options when the chance of such findings is low. International guidelines for mainstreaming informed consent for genomic sequencing are necessary.
EUROPEAN JOURNAL OF CANCER
(2021)
Article
Psychiatry
Abhijit Nadkarni, Sheena Wood, Ankur Garg, Danielle Fernandes, Ethel D'Souza, Urvita Bhatia
Summary: The study found that the video-supplemented informed consent process was not superior to the traditional paper-based informed consent process in any domain. Further research is needed to identify contextually relevant best practices for the informed consent process, especially in settings with participants having limited education and in research involving people with mental health or substance use problems.
ASIAN JOURNAL OF PSYCHIATRY
(2021)
Article
Health Care Sciences & Services
Atsushi Kogetsu, Kazuto Kato
Summary: Online communication in medical research, including recruitment, informed consent, and data communication, provides numerous benefits, particularly for genome research and rare disease research. However, ethical challenges arising from or exacerbated by online communication must be addressed. This article presents an overview of these ethical issues and offers practical guidance for the ethical implementation of ICT in medical research.
JOURNAL OF MEDICAL INTERNET RESEARCH
(2022)
Article
Infectious Diseases
Seth C. Inzaule, Sofonias K. Tessema, Yenew Kebede, Ahmed E. Ogwell Ouma, John N. Nkengasong
Summary: The article highlights the importance of enhancing disease surveillance and management in Africa, discusses the opportunities and challenges of integrating pathogen genomics into public health surveillance systems, and provides recommendations such as establishing networks, training experts, and developing policies.
LANCET INFECTIOUS DISEASES
(2021)
Article
Genetics & Heredity
Amanda Pichini, Michelle Bishop
Summary: The study aimed to develop a nationally agreed, cross-professional competency framework for facilitating genomic tests. The evaluation indicated that the framework addresses the needs of healthcare professionals and provides ways to improve awareness and accessibility.
GENETICS IN MEDICINE
(2022)
Review
Medicine, General & Internal
Eleanor Hoverd, Sophie Staniszewska, Jeremy Dale
Summary: This realist review aims to investigate how the informed consent process in health research impacts potential participants from under-served populations. Findings will be disseminated to various stakeholders and contribute to understanding the mechanisms that cause positive and negative outcomes in order to inform policy, study design, and delivery in health research.
SYSTEMATIC REVIEWS
(2021)
Article
Clinical Neurology
Ally Peabody Smith, Nader Pouratian, Ashley Feinsinger
Summary: As neurologically implanted devices become more widely used in clinical applications, there are increasing opportunities for intracranial investigations in human patients. In some cases, patients participate in research during their awake brain surgery, without potential therapeutic benefits. Ethical challenges arise in such intraoperative studies, conducted during a clinical intervention, in a clinical setting, and often by the treating clinician. The need for innovative informed consent methods in intraoperative research is a pressing concern, but current practices are insufficient in addressing participant understanding and trust between patient-participants and surgeon-researchers.
Editorial Material
Multidisciplinary Sciences
Zane Lombard, Guida Landoure
Summary: Funding for a major genomics programme in Africa will run out this year, highlighting the importance of seizing the opportunity to address global health-related genomics inequality by leveraging the success of this initiative.
Article
Remote Sensing
Vyshnave Jeyabalan, Lorie Donelle, Patrick Meier, Elysee Nouvet
Summary: Drones are being introduced in healthcare delivery worldwide, particularly in remote areas with inadequate healthcare services. However, there is limited guidance on engaging communities in decision-making about drone use. This paper focuses on obtaining consent for implementing Drones for Health projects, highlighting ethical and practical challenges.
Article
Genetics & Heredity
Faith Kabata, Donrich Thaldar
Summary: This article revisits the debate on regulation of human genomic research in Africa and examines the concept of genomic sovereignty. The article argues that genomic sovereignty violates the rights of individuals and researchers and proposes a human rights approach as a more promising regulatory framework. By analyzing Mexico's regulatory approach based on genomic sovereignty and Finland's human genomic research framework, it demonstrates the alignment of a human rights approach with international human rights law.
FRONTIERS IN GENETICS
(2023)
Article
Multidisciplinary Sciences
Joseph Ochieng, Betty Kwagala, John Barugahare, Erisa Mwaka, Deborah Ekusai-Sebatta, Joseph Ali, Nelson K. Sewankambo
Summary: This study explores researchers' perspectives and experiences regarding feedback of incidental genomics findings to participants in genetics and genomics research. The study finds that researchers generally find it acceptable to share incidental research findings with participants, but face challenges such as lack of ethical guidelines and uncertainty about the findings.
Article
Multidisciplinary Sciences
Samah F. Al-Shatnawi, Karem H. Alzoubi, Rawand A. Khasawneh, Omar F. Khabour, Basima A. Almomani
Summary: Healthcare providers in Jordan show overall positive support towards emergency research, despite disagreement with the exception from informed consent (EFIC) policy. There is little support for enrolling family members or the public in emergency research, but more acceptance for self-enrollment. Attitudes towards EFIC and willingness to participate in emergency research do not significantly differ among participants from different disciplines.
Article
Public, Environmental & Occupational Health
Alice Matimba, Stuart Ali, Katherine Littler, Ebony Madden, Patricia Marshall, Sheryl McCurdy, Victoria Nembaware, Laura Rodriguez, Janet Seeley, Paulina Tindana, Aminu Yakubu, Jantina de Vries
Summary: As human genomics research in Africa generates large amounts of data, ethical issues arise regarding how to share actionable genetic information with participants. The H3Africa Ethics and Community Engagement Working group has developed a decision flowchart to guide decision-making and planning for genomics research projects in Africa.
Article
Public, Environmental & Occupational Health
Anja Bedeker, Michelle Nichols, Taryn Allie, Tsaone Tamuhla, Peter van Heusden, Olorunyomi Olorunsogbon, Nicki Tiffin
Summary: There is increasing recognition of the importance of benefit sharing in research programmes, but it can be challenging to implement. This paper presents a framework to assist research stakeholders in identifying opportunities for benefit sharing and intentionally including it in their research programmes.
Article
Endocrinology & Metabolism
Oppah Kuguyo, Joconiah Chirenda, Vasco Chikwasha, Doreen Macherera Mukona, Akimu Mageza, Lovemore Gwanzura, Alice Matimba
Summary: This study aimed to determine the status of diabetic foot services and management awareness among registered general nurses in Zimbabwe. The study found a lack of podiatrists and inadequate screening and education programs for diabetic foot at primary care level.
DIABETES RESEARCH AND CLINICAL PRACTICE
(2022)
Review
Biochemistry & Molecular Biology
Fatima Barmania, Juanita Mellet, Megan A. Ryder, Graeme Ford, Candice L. Herd, Tsaone Tamuhla, Candice Hendricks, Rachel Giles, Thumbiko Kalua, Fourie Joubert, Nicki Tiffin, Michael S. Pepper
Summary: The SARS-CoV-2 virus responsible for COVID-19 has a highly variable clinical presentation. Clinical phenotypes differ in terms of symptoms and response to treatment. Numerous studies have examined the genetic epidemiology associated with COVID-19. Our research group created a web-based database using Django framework to compile and provide searchable research on host genetic factors related to COVID-19 disease outcome.
EUROPEAN JOURNAL OF HUMAN GENETICS
(2022)
Article
Genetics & Heredity
C. Victor Jongeneel, Maritha J. Kotze, Archana Bhaw-Luximon, Faisal M. Fadlelmola, Yasmina J. Fakim, Yosr Hamdi, Samar Kamal Kassim, Judit Kumuthini, Victoria Nembaware, Fouzia Radouani, Nicki Tiffin, Nicola Mulder
Summary: This study conducted a survey among African scientists and stakeholders to evaluate their knowledge, institutional environment, and perception of genomic medicine. The findings provide guidance for African institutions to implement precision medicine approaches in their healthcare systems, including prioritization of infrastructures, translational research, information dissemination, training programs, and engagement with political stakeholders and the public.
FRONTIERS IN GENETICS
(2022)
Review
Surgery
Connor M. Bunch, Ernest E. Moore, Hunter B. Moore, Matthew D. Neal, Anthony V. Thomas, Nuha Zackariya, Jonathan Zhao, Sufyan Zackariya, Toby J. Brenner, Margaret Berquist, Hallie Buckner, Grant Wiarda, Daniel Fulkerson, Wei Huff, Hau C. Kwaan, Genevieve Lankowicz, Gert J. Laubscher, Petrus J. Lourens, Etheresia Pretorius, Maritha J. Kotze, Muhammad S. Moolla, Sithembiso Sithole, Tongai G. Maponga, Douglas B. Kell, Mark D. Fox, Laura Gillespie, Rashid Z. Khan, Christiaan N. Mamczak, Robert March, Rachel Macias, Brian S. Bull, Mark M. Walsh
Summary: The postoperative morbidity and mortality of convalescent COVID-19 patients has been found to be higher, highlighting the need for individual risk assessment and delayed elective surgeries to improve postoperative outcomes.
FRONTIERS IN SURGERY
(2022)
Article
Cardiac & Cardiovascular Systems
Etheresia Pretorius, Chantelle Venter, Gert Jacobus Laubscher, Maritha J. Kotze, Sunday O. Oladejo, Liam R. Watson, Kanshu Rajaratnam, Bruce W. Watson, Douglas B. Kell
Summary: Fibrin amyloid microclots and platelet hyperactivation in South African patients with Long COVID/PASC may be responsible for the persistent symptoms. Hypertension, high cholesterol levels, cardiovascular disease, and type 2 diabetes mellitus were found to be the most important comorbidities. The study highlights the need for further research on the pathophysiology and treatment of Long COVID/PASC.
CARDIOVASCULAR DIABETOLOGY
(2022)
Article
Hematology
Lize M. Grobbelaar, Arneaux Kruger, Chantelle Venter, Este M. Burger, Gert J. Laubscher, Tongai G. Maponga, Maritha J. Kotze, Hau C. Kwaan, Joseph B. Miller, Daniel Fulkerson, Wei Huff, Eric Chang, Grant Wiarda, Connor M. Bunch, Mark M. Walsh, Syed Raza, Mahmud Zamlut, Hunter B. Moore, Ernest E. Moore, Matthew D. Neal, Douglas B. Kell, Etheresia Pretorius
Summary: The newer Omicron variants of SARS-CoV-2 are more transmissible but less virulent compared to earlier variants. Clotting parameters associated with Omicron variants are significantly raised but still lower than more severe variants like beta and delta.
SEMINARS IN THROMBOSIS AND HEMOSTASIS
(2022)
Article
Oncology
Oppah Kuguyo, Nyasha Chambwe, Charles F. B. Nhachi, Nomsa Tsikai, Collet Dandara, Alice Matimba
Summary: This study describes the establishment of a biorepository using a cervical cancer cohort in Africa, recruiting 410 women with cervical cancer and collecting biospecimens and phenotype data. A workflow pipeline was developed for the collection, storage, and analysis of data and biospecimens, ensuring compliance with local and international biospecimen and data protection laws and policies.
Article
Ethics
Tsaone Tamuhla, Nicki Tiffin, Taryn Allie
Summary: The use of electronic consent can address issues related to storing and retrieving paper consent forms. A tiered framework for electronic consent was designed and implemented with features such as branching logic, wet signature, and auto-archiver. Emphasis was placed on optimizing participant understanding by merging consent and participant information into one document. Example text and a REDCap template were provided to assist researchers in building informed consent protocols and forms.
BMC MEDICAL ETHICS
(2022)
Article
Pharmacology & Pharmacy
Clint Johannes, Kelebogile E. Moremi, Merlisa C. Kemp, Lindiwe Whati, Penelope Engel-Hills, Martin Kidd, Ronald van Toorn, Mariaan Jaftha, Susan J. van Rensburg, Maritha J. Kotze
Summary: This study examined the impact of lipid metabolism on disability in people with multiple sclerosis (MS). It was found that a genetic variant in the FABP2 gene was associated with disability in MS patients, but this association was not observed in patients who followed a pathology-supported genetic testing program. Therefore, genetic testing can provide guidance for lifestyle interventions to improve disability in MS patients.
PERSONALIZED MEDICINE
(2023)
Article
Health Care Sciences & Services
Themba Mutemaringa, Alexa Heekes, Mariette Smith, Andrew Boulle, Nicki Tiffin
Summary: This paper describes the record linkage system implemented at the Provincial Health Data Centre (PHDC) in the Western Cape, South Africa, and evaluates its output. A stepwise deterministic record linkage approach is used to link patient data collected from health information systems in the province. The results show that the percentage of duplicates in the provincial patient database ranges from 10% to 20%.
INTERNATIONAL JOURNAL OF POPULATION DATA SCIENCE (IJPDS)
(2023)
Article
Multidisciplinary Sciences
Sunday O. Oladejo, Liam R. Watson, Bruce W. Watson, Kanshukan Rajaratnam, Maritha J. Kotze, Douglas B. Kell, Etheresia Pretorius
Summary: 'Long COVID' refers to the continued experience of SARS-CoV-2 symptoms in patients who have survived a COVID-19 infection. Millions of people worldwide are affected by Long COVID. Solving this conundrum requires lessons learned from the COVID-19 pandemic, where experts from various disciplines collaborated and shared data to tackle the problem. However, there is currently no global consensus on the definition, diagnosis, and treatment of Long COVID. This study examines data sharing and data science applications in understanding Long COVID and expediting relief for those affected.
SOUTH AFRICAN JOURNAL OF SCIENCE
(2023)
Article
Public, Environmental & Occupational Health
Oppah Kuguyo, Nomsa Tsikai, Senelisiwe Chipo Muradzikwa, Kudakwashe Mhandire, Charles Nhachi, Thulani Magwali, Mugove G. Madziyire, Alice Matimba, Collet Dandara
Summary: Cervical cancer is the leading cause of cancer deaths in women in Africa, mainly due to late diagnosis. This study in Zimbabwe found that more than half of the patients were diagnosed at stage 3 or later, with a low history of cervical cancer screening. The data highlights the need to improve screening education and uptake in Zimbabwe.
AFRICAN JOURNAL OF REPRODUCTIVE HEALTH
(2021)
