Table 1 - uploaded by Joses Muthuri Kirigia
Content may be subject to copyright.
Sample questions on survey questionnaire Theme 1: Existence of national framework for governing ethical review @BULLET Is there a law/policy establishing a national ethics committee? @BULLET What are the main functions of the national ethics committee?
Source publication
Background:
The increasing emphasis on research, development and innovation for health in providing solutions to the high burden of diseases in the African Region has warranted a proliferation of studies including clinical trials. This changing public health landscape requires that countries develop adequate ethics review capacities to protect and...
Similar publications
Involvement of patients in the research and development process (R&D) of new medicines—in all areas of indications—today is a widely accepted strategy in pharmaceutical industry to ensure relevance and suitability of the treatment under development. This may consist in, but is not limited to, patient input to achieve more patient-friendly protocol...
Citations
... evaluation 22,23 ; weak regulatory systems, resulting in slow review of clinical trial protocols and new drug applications; lack of supportive research environments; and competing demands on time and resources. [24][25][26][27] Guiding principles for expanding access to clinical trials for patients in Africa, 28 as well as clinical trial design and implementation considerations in the region, 15,27 have been outlined, including funding and technical support for local investigator-initiated clinical trials, on the basis of existing needs and resources that have the greatest potential to improve patient care. ...
Patients of African ancestry are not well-represented in cancer clinical trials despite bearing a disproportionate share of mortality both in United States and Africa. We describe key stakeholder perspectives and priorities related to bringing early-stage cancer clinical trials to Africa and outline essential action steps. Increasing Diversity, Market Access, and Capacity in Oncology Registration Trials—Is Africa the Answer? satellite session was organized at 2021 Accelerating Anti-Cancer Agent Development and Validation Workshop. Panelists included representatives of African Organization for Research and Training in Cancer, Uganda Cancer Institute, Uganda Women's Cancer Support Organization, BIO Ventures for Global Health, Bill & Melinda Gates Foundation, the US Food and Drug Administration, Nigeria's National Agency for Food and Drug Administration and Control, Bayer, and Genentech, with moderators from ASCO and American Cancer Society. Key discussion themes and resulting action steps were agreed upon by all participants. Panelists agreed that increasing diversity in cancer clinical trials by including African patients is key to ensuring novel drugs are safe and effective across populations. They underscored the importance of equity in clinical trial access for patients in Africa. Panelists discussed their values related to access and barriers to opening clinical trials in Africa and described innovative solutions from their work aimed at overcoming these obstacles. Multisectoral collaboration efforts that allow leveraging of limited resources and result in sustainable capacity building and mutually beneficial long-term partnerships were discussed as key to outlined action steps. The panel discussion resulted in valuable insights about key stakeholder values and priorities related to bringing early-stage clinical trials to Africa, as well as specific actions for each stakeholder group.
... Benatar and Singer (15) proposed that research ethics must ensure reducing the global health gaps and promoting fairness in medical and health studies. Also harmonization of health ethics regarding policies, practices, and procedures in the countries of the area of health, particularly, countries under similar conditions like geographical distribution (16)(17)(18). This is more pronounced during pandemics as any country must be ready with its public health, healthcare, and animal programs for good pandemic planning even though the country is not considered to be at risk. ...
During pandemics, the ethicists, public health professionals, and human rights advocates raise a red flag about different public health actions that should, at best, be addressed through integrated, global policies. How to rationalize the healthcare resources and prioritize the cases is not a recent challenge but the serious concern about that is how to achieve this while not increasing the vulnerability of the disadvantaged population. Healthcare professionals use different scoring systems as a part of their decision-making so the medical teams and triage committees can allocate resources for predictable health outcomes and prognosis as well as to appropriately triage the patients accordingly. However, the value of the existing scoring systems to manage COVID-19 cases is not well-established yet. Part of this problem includes managing non-COVID patients with chronic medical conditions like non-communicable diseases and addressing their medical needs during the pandemic complex context in a way to avoid worsening their conditions and, on the other hand, avoid hindering the establishment of comprehensive standards for dealing with COVID-19. In this article, we discuss this dilemma as well as how preexisting ethical standards were challenged by COVID-19. We also discuss how monitoring the consistent application of ethical standards during the medical trials of new medications, vaccines, or unproven medical interventions is also a critical issue.
... An assessment of research ethics committees in 33 African countries revealed that more than half of these were formed after the year 2000. 7 The study also highlighted that only a third of the ethics committees included individuals who had knowledge or training in medical ethics, and the study also found that most of those committees did not provide continued training for serving committee members. 7 In a different case study that looked at the composition of 12 African ethics committees, deep-seated problems with regularly timed meetings, committee member training, incompetent administration and financial transparency were highlighted. ...
... 7 The study also highlighted that only a third of the ethics committees included individuals who had knowledge or training in medical ethics, and the study also found that most of those committees did not provide continued training for serving committee members. 7 In a different case study that looked at the composition of 12 African ethics committees, deep-seated problems with regularly timed meetings, committee member training, incompetent administration and financial transparency were highlighted. 8 Solutions that address current Global North exclusion of many African research centers in RCT participation require an ethical system that is relevant to African countries, but equal to those of the developed world. ...
Disproportionately few clinical trials are undertaken on the African continent, in part due to lingering neocolonial attitudes in the Global North which keep research activity primarily in developing countries, while being skeptical of the abilities of those in the Global South to undertake organized clinical studies. In the era of the COVID-19 pandemic, applicable research and clinical trials should be undertaken in relevant populations in order to extrapolate to a population level. This is all the more important in Africa, which has a rich genetic diversity. We suggest that a lack of organized research ethics committees across the continent and a deficiency of appropriate training are responsible in part for the reluctance of clinical trial organizers in the developed countries of the Global North to engage with medical leadership in Africa. We consider ways of alleviating this problem, including suggesting a pan-continental surveillance of ethics committee agendas and of training, either through the auspices of the African Union or the World Health Organization. In addition, medical leadership in African nations must be encouraged to take ownership of their medical ethics agendas to facilitate decent international clinical trial participation for the good of the continent as a whole.
... Previous reviews written about the regulatory processes in Africa have shown that the region has several of shortcomings in the conduct of these. Specifically, issues include prolonged timelines for reviews, disparities in procedures for reviews and authorizations, and duplication of roles within different authorities [16,17]. The AVAREF network was formed as an informal capacity-building platform aimed at improving the regulatory oversight of interventional clinical trials being conducted in Africa [18]. ...
Background
The 2013–2016 Ebola epidemic in West Africa is the worst ever caused by Ebolaviruses with over 28,000 human cases and 11,325 deaths. The World Health Organisation (WHO) declared the epidemic a public health crisis that required accelerated development of novel interventions including vaccines. The Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit (MRC/UVRI & LSHTM Uganda Research Unit) was among the African research sites that implemented the VAC52150EBL1004 Ebola vaccine trial.
Objective
We report on the strategies utilised by the Unit and sponsor in ensuring expedited clinical trial approval and accelerated conduct.
Methods
Janssen Vaccines and Prevention B.V. conducted a phase 1 trial to evaluate the safety, tolerability, and immunogenicity of heterologous two-dose vaccination regimens using Ad26.ZEBOV and MVA-BN-Filo, in healthy adults in Africa. Accelerated implementation strategies are hereby presented.
Results
Strategies included: holding the African Vaccine Regulatory Forum (AVAREF) joint review meeting; expedited review by institutional ethics and country-specific regulatory bodies; competitive recruitment between sites; electronic data capture (EDC); frequent study monitoring schedule; involvement of a community advisory board (CAB); and utilization of a ‘phased’ study information-sharing approach in community engagement and participant recruitment. These strategies enabled the site to acquire approvals within 2 months and enrol 47 participants within a spurn of five. The same milestone is usually acquired in at least 1 year without accelerated implementation.
Conclusion
The use of well-thought strategies by sponsors and research sites can enable the implementation of accelerated research. We recommend the use of similar strategies in other settings.
... Previous reviews written about the regulatory processes in Africa have shown that the region has several of shortcomings in the conduct of these. Specifically, issues include prolonged timelines for reviews, disparities in procedures for reviews and authorizations, and duplication of roles within different authorities [16,17]. The AVAREF network was formed as an informal capacity-building platform aimed at improving the regulatory oversight of interventional clinical trials being conducted in Africa [18]. ...
ABSTRACT
Background: The 2013–2016 Ebola epidemic in West Africa is the worst ever caused by
Ebolaviruses with over 28,000 human cases and 11,325 deaths. The World Health Organisation
(WHO) declared the epidemic a public health crisis that required accelerated development of
novel interventions including vaccines. The Medical Research Council/Uganda Virus Research
Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit (MRC/
UVRI & LSHTM Uganda Research Unit) was among the African research sites that implemented
the VAC52150EBL1004 Ebola vaccine trial.
Objective: We report on the strategies utilised by the Unit and sponsor in ensuring expedited
clinical trial approval and accelerated conduct.
Methods: Janssen Vaccines and Prevention B.V. conducted a phase 1 trial to evaluate the
safety, tolerability, and immunogenicity of heterologous two-dose vaccination regimens
using Ad26.ZEBOV and MVA-BN-Filo, in healthy adults in Africa. Accelerated implementation
strategies are hereby presented.
Results: Strategies included: holding the African Vaccine Regulatory Forum (AVAREF) joint
review meeting; expedited review by institutional ethics and country-specific regulatory
bodies; competitive recruitment between sites; electronic data capture (EDC); frequent
study monitoring schedule; involvement of a community advisory board (CAB); and utilization
of a ‘phased’ study information-sharing approach in community engagement and participant
recruitment. These strategies enabled the site to acquire approvals within 2 months and enrol
47 participants within a spurn of five. The same milestone is usually acquired in at least 1 year
without accelerated implementation.
Conclusion: The use of well-thought strategies by sponsors and research sites can enable the
implementation of accelerated research. We recommend the use of similar strategies in other
settings
... African educational institutions are also increasingly demanding the conduct of research by students as part of the fulfillment of their diploma and degree programs, and much of this research involves interactions with human participants or their data. However, although there are a number of long-standing and wellfunctioning African research ethics committees (RECs) (Cleaton-Jones, 2010, 2012Cleaton-Jones and Vorster, 2008), studies have shown that many African research institutions do not have RECs and those that have the committees have inadequate capacity in terms of infrastructural and financial resources, membership diversity, and training of members to effectively and efficiently review proposed research, monitor ongoing studies, and optimally run REC activities (IJsselmuiden et al., 2012;Mokgatla et al., 2017;Motari et al., 2015;Nyika et al., 2009a;Silaigwana and Wassenaar, 2015). In addition, studies have also indicated that many African RECs lack national ethics guidelines, standard operating procedures (SOPs), as well as accreditation processes to evaluate the review of biomedical and social/behavioral studies (Nyika et al., 2009b;Silaigwana and Wassenaar, 2015). ...
Background
Africa is increasingly becoming an important region for health research, mainly due to its heavy burden of disease, socioeconomic challenges, and inadequate health facilities. Regulatory capacities, in terms of ethical review processes, are also generally weak. The ethical assessment of social and behavioral research is relatively neglected compared to the review of biomedical and clinical studies, which led us to develop an ethics review assessment tool for use in the review of social and behavioral research in Ethiopia, which could potentially be of value in low- and middle-income settings.
Methods
Initially, we did a comprehensive literature review on principles, guidelines, and practices of research ethics, on social and behavioral studies, from which we extracted query terms to explore the opinions of selected key informants and focus groups in Ethiopia. The discussants and informants were selected using a convenience sampling method to evaluate an ethics review template, which integrated issues that commonly arise in social and behavioral studies. Finally, we directly solicited opinions from the discussants about the desirability, feasibility, acceptability, and relevance of the ethics review assessment tool and used the resulting data to refine our initial draft.
Results and conclusion
Although the same basic ethics principles govern all research studies, social and behavioral research have some disciplinary particularities that may require reviewers to exercise a different orientation of ethical attention in some cases. Using a qualitative approach, we developed a review assessment tool that could potentially be useful to raise awareness, focus attention, and strengthen the review of social and behavioral studies by ethics review committees, particularly in settings without a long-standing tradition of reviewing such research. This process also exposed some areas where further capacity building and discussion of ethical issues may be necessary among stakeholders in the review of social and behavioral research.
... Some recent trends in the literature can also be identified. There is a fast growing global dimension to it (see, for instance, [46][47][48][49]; about a fifth of the 100 most recent publications retrieved by "ethics research committees" as a major heading in PubMed, Jan 2018, were from developing world countries or countries with smaller research communities). There is also attention to ethics approvals challenges and solutions for newer or newly popular study types, such as participatory research or co-design studies, [50][51][52][53] biospecimens and biobanking studies, [54][55][56] digital health research [57][58][59] and research in disaster and developing world contexts [60][61][62][63][64][65]. ...
Background
The red tape and delays around research ethics and governance approvals frequently frustrate researchers yet, as the lesser of two evils, are largely accepted as unavoidable. Here we quantify aspects of the research ethics and governance approvals for one interview- and questionnaire-based study conducted in England which used the National Health Service (NHS) procedures and the electronic Integrated Research Application System (IRAS). We demonstrate the enormous impact of existing approvals processes on costs of studies, including opportunity costs to focus on the substantive research, and suggest directions for radical system change.
Main text
We have recorded 491 exchanges with 89 individuals involved in research ethics and governance approvals, generating 193 pages of email text excluding attachments. These are conservative estimates (e.g. only records of the research associate were used). The exchanges were conducted outside IRAS, expected to be the platform where all necessary documents are provided and questions addressed. Importantly, the figures exclude the actual work of preparing the ethics documentation (such as the ethics application, information sheets and consent forms). We propose six areas of work to enable system change: 1. Support the development of a broad range of customised research ethics and governance templates to complement generic, typically clinical trials orientated, ones; 2. Develop more sophisticated and flexible frameworks for study classification; 3. Link with associated processes for assessment, feedback, monitoring and reporting, such as ones involving funders and patient and public involvement groups; 4. Invest in a new generation IT infrastructure; 5. Enhance system capacity through increasing online reviewer participation and training; and 6. Encourage researchers to quantify the approvals processes for their studies.
Conclusion
Ethics and governance approvals are burdensome for historical reasons and not because of the nature of the task. There are many opportunities to improve their efficiency and analytic depth in an age of innovation, increased connectivity and distributed working. If we continue to work under current systems, we are perpetuating, paradoxically, an unethical system of research approvals by virtue of its wastefulness and impoverished ethical debate.
... Several reviews have been published on research ethics in Africa 7,8 . All of these conclude that ethics and regulatory oversight for clinical trials in Africa are weak. ...
... The reviews also revealed that only 34% of the committees included individuals who had knowledge or training in medical ethics, and not all the committees provided continued training or adequate remuneration for those board members. 18 With little training and lack of financial recompense for the hours worked, the quality of many of these committees may at best be considered contentious, which again emphasizes the potential for exploitation by a global pharma incentive. ...
Jin Un Kim,1 Obinna Oleribe,2 Ramou Njie,3 Simon D Taylor-Robinson1 1Division of Digestive Health, Department of Surgery and Cancer, Imperial College London, London, UK; 2Excellence and Friends Management Care Centre, Abuja, Nigeria; 3MRC, Serekunda, The Gambia Abstract: The modern concept of globalization in health care and clinical research often carries a positive message for the “Global South” nations of Africa, South America and Southeast Asia. However, bioethical abuse of participants in clinical trials still exists in the Global South. Unethical studies directed by the “Global North”, formed by the medically advanced nations in North America, Western Europe and Japan, have been hugely concerning. The issue between the Global North and South is a well-recognized socioeconomic phenomenon of globalization. Medical exploitation has its roots in the socioeconomic interactions of a postcolonial world, and solutions to reducing exploitation require a deeper understanding of these societal models of globalization. We explore the fundamental causes of imbalance and suggest solutions. Reflecting on the globalization model, there must be an effort to empower the Global South nations to direct and govern their own health care systems efficiently on the basis of equality. Keywords: global health, bioethics, clinical trials, Africa, exploitation, imperialism
... While a survey from 2005 revealed that 36% of the respondent countries did not have ECs and 15% indicated that ethical approval of research proposals was not required, 19 a subsequent survey reported 90.9% of respondent countries had a national ethics committee (NEC); 79% of which were established by law and noted that more than half of the NECs (54.5%) were formed after the year 2000. 20 The continued evolution, growing complexity and globalization of clinical trials has led to recent evaluations of the existing clinical guidelines to ensure these guidelines are still current with the clinical trial landscape. As a result, an addendum to the ICH GCP guideline was issued in November 2016, 21 and an update to the 2001 WHO vaccine clinical trial guideline has been adopted to address such issues as the potential role of human challenge studies, adaptive clinical designs, extrapolation of efficacy between geographic/genetically diverse populations, and pharmacovigilance activities. ...
Over the past ten years there has been an increase in the number of vaccine clinical studies conducted in resource limited countries. These include vaccine trials for diseases such as malaria and dengue fever which are endemic to many low and lower-middle income countries. Concurrent with the increase in the number of trials, has been the increase and improvement in local infrastructure to enable the appropriate conduct and oversight of these trials in these settings, including strengthening of local scientific capabilities, ethical and regulatory oversight. While significant advances have been made, there remain gaps to be addressed including strengthening pharmacovigilance in these regions. There are also opportunities to establish novel collaborations to address diseases specific to these populations including strengthening local manufacturers, new ways to engage established large pharmaceutical companies and leveraging established global infrastructure and pathways to develop innovative products beyond vaccines.
