Small is beautiful: demystifying and simplifying standard operating procedures: a model from the ethics review and consultancy committee of the Cameroon Bioethics Initiative

Abstract Background Research ethics review is a critical aspect of the research governance framework for human subjects research. This usually requires that research protocols be submitted to a research ethics committee (REC) for review and approval. This has led to very rapid developments in the domain of research ethics, as RECs proliferate all over the globe in rhyme with the explosion in human subjects research. The work of RECs has increasingly become elaborate, complex, and in many cases urgent, necessitating supporting rules and procedures of operation. Guidelines for elaborating standard operating procedures (SOPs) for the functioning of RECs have also been proposed. The SOPs of well-placed and well-resourced RECs have tended to pay much attention to details, resulting, as a consequence, in generally long, elaborate, intricate and complex SOPs; a model that can hardly be replicated by other committees, equally under ethics review pressures, but working under much more constraining conditions in resource-destitute environments. Methods In this paper, we looked at the content and length of SOPs from African RECs and compared them to the World Health Organization (WHO)’s guidelines as the gold standard. We also looked at the SOPs from the Ethics Review and Consultancy Committee (ERCC) of the Cameroon Bioethics Initiative that we elaborated in a simplified way in 2013, and compared them to the WHO’s guidelines and to the other SOPs. Results Sixteen SOPs from 14 African countries were collected from various sources. Their average length was of 30 pages. By comparison to the guidance of the WHO, only six of them were found acceptable with more than 70 % of the criteria from the gold standard that were fully described. Among those six, two of them were very long and detailed (65 and 102 pages), while the four remaining SOPs ranged from 16 to 24 pages. The ERCC SOPs are seven pages long but maintain all that is of essence for the rigorous, efficient and timely review of protocols. Conclusions We are convinced that, because of their brevity, simplicity, clarity and user-friendliness, the ERCC SOPs recommend themselves as a model template to, at least, committees similarly situated and/or circumstanced as the ERCC of the Cameroon Bioethics Initiative is. In fact, brevity, clarity, simplicity and user-friendliness are recognized values. Whatever is brief and clear is better than what is not and saves time. What is simple and user-friendly is better than what is not even though the two have the same aims because it saves both time and mental energy. And if this be true in general, it is even truer of the context and its peculiar constraints that we are addressing

A perpetual source of DNA or something really different: ethical issues in the creation of cell lines for African genomics research

Background: The rise of genomic studies in Africa – not least due to projects funded under H3Africa – is associated with the development of a small number of biorepositories across Africa. For the ultimate success of these biorepositories, the creation of cell lines including those from selected H3Africa samples would be beneficial. In this paper, we map ethical challenges in the creation of cell lines. Discussion: The first challenge we identified relates to the moral status of cells living in culture. There is no doubt that cells in culture are alive, and the question is how this characteristic is relevant to ethical decision-making. The second challenge relates to the fact that cells in culture are a source of cell products and mitochondrial DNA. In combination with other technologies, cells in culture could also be used to grow human tissue. Whilst on the one hand, this feature increases the potential utility of the sample and promotes science, on the other it also enables further scientific work that may not have been specifically consented to or approved. The third challenge relates to ownership over samples, particularly in cases where cell lines are created by a biobank, and in a different country than where samples were collected. Relevant questions here concern the export of samples, approval of secondary use and the acceptability of commercialisation. A fourth challenge relates to perceptions of blood and bodily integrity, which may be particularly relevant for African research participants from certain cultures or backgrounds. Finally, we discuss challenges around informed consent and ethical review. Summary: In this paper, we sought to map the myriad of ethical challenges that need to be considered prior to making cell line creation a reality in the H3Africa project. Considering the relative novelty of this practice in Africa, such challenges will need to be considered, discussed and potentially be resolved before cell line creation in Africa becomes financially feasible and sustainable. We suggest that discussions need to be undertaken between stakeholders internationally, considering the international character of the H3Africa project. We also map out avenues for empirical research

Obtaining informed consent for genomics research in Africa: analysis of H3Africa consent documents.

BACKGROUND: The rise in genomic and biobanking research worldwide has led to the development of different informed consent models for use in such research. This study analyses consent documents used by investigators in the H3Africa (Human Heredity and Health in Africa) Consortium. METHODS: A qualitative method for text analysis was used to analyse consent documents used in the collection of samples and data in H3Africa projects. Thematic domains included type of consent model, explanations of genetics/genomics, data sharing and feedback of test results. RESULTS: Informed consent documents for 13 of the 19 H3Africa projects were analysed. Seven projects used broad consent, five projects used tiered consent and one used specific consent. Genetics was mostly explained in terms of inherited characteristics, heredity and health, genes and disease causation, or disease susceptibility. Only one project made provisions for the feedback of individual genetic results. CONCLUSION: H3Africa research makes use of three consent models-specific, tiered and broad consent. We outlined different strategies used by H3Africa investigators to explain concepts in genomics to potential research participants. To further ensure that the decision to participate in genomic research is informed and meaningful, we recommend that innovative approaches to the informed consent process be developed, preferably in consultation with research participants, research ethics committees and researchers in Africa

Responding to the COVID-19 Pandemic in Cameroon: A statement from the Cameroon Bioethics Initiative

The ongoing COVID-19 pandemic has caused devastating consequences across economies in the world, with substantial effects on lives and livelihoods. Cameroon has been one of the countries in sub-Saharan Africa with an increasing number of cases and fatalities from the disease. In an effort to support the government’s response to the epidemic, the Cameroon Bioethics Initiative (CAMBIN); a not-for-profit, non-governmental, non-political, non-discriminatory, multidisciplinary association issued a statement on COVID-19, primarily targeting the government and the general public. In this article, we situate the context within which the statement was issued and present the statement in its entirety

Addressing ethical issues in H3Africa research – the views of research ethics committee members

In June 2014, the H3Africa Working Group on Ethics organised a workshop with members of over 40 research ethics committees from across Africa to discuss the ethical challenges raised in H3Africa research, and to receive input on the proposed H3Africa governance framework. Prominent amongst a myriad of ethical issues raised by meeting participants were concerns over consent for future use of samples and data, the role of community engagement in large international collaborative projects, and particular features of the governance of sample sharing. This report describes these concerns in detail and will be informative to researchers wishing to conduct genomic research on diseases pertinent to the African research context

EDCTP regional networks of excellence: Initial merits for planned clinical trials in Africa

Abstract Background: Achieving the Millennium Development Goals (MDGs) and combating hotspots with escalating but preventable communicable diseases remain major challenges in Africa. The European and Developing Countries Clinical Trials Partnership (EDCTP) intervened to combat poverty-related diseases including malaria, tuberculosis and HIV/AIDS, and to conduct multi-centre clinical trials and multi-disciplinary health research through an innovative model of regional Networks of Excellence (NoEs)

Regulation of genomic and biobanking research in Africa: a content analysis of ethics guidelines, policies and procedures from 22 African countries

Background: The introduction of genomics and biobanking methodologies to the African research context has also introduced novel ways of doing science, based on values of sharing and reuse of data and samples. This shift raises ethical challenges that need to be considered when research is reviewed by ethics committees, relating for instance to broad consent, the feedback of individual genetic findings, and regulation of secondary sample access and use. Yet existing ethics guidelines and regulations in Africa do not successfully regulate research based on sharing, causing confusion about what is allowed, where and when. Methods: In order to understand better the ethics regulatory landscape around genomic research and biobanking, we conducted a comprehensive analysis of existing ethics guidelines, policies and other similar sources. We sourced 30 ethics regulatory documents from 22 African countries. We used software that assists with qualitative data analysis to conduct a thematic analysis of these documents. Results: Surprisingly considering how contentious broad consent is in Africa, we found that most countries allow the use of this consent model, with its use banned in only three of the countries we investigated. In a likely response to fears about exploitation, the export of samples outside of the continent is strictly regulated, sometimes in conjunction with regulations around international collaboration. We also found that whilst an essential and critical component of ensuring ethical best practice in genomics research relates to the governance framework that accompanies sample and data sharing, this was most sparingly covered in the guidelines. Conclusions: There is a need for ethics guidelines in African countries to be adapted to the changing science policy landscape, which increasingly supports principles of openness, storage, sharing and secondary use. Current guidelines are not pertinent to the ethical challenges that such a new orientation raises, and therefore fail to provide accurate guidance to ethics committees and researchers

Hepatitis C Virus Infection May Lead to Slower Emergence of P. falciparum in Blood

International audienceBACKGROUND: Areas endemic for Plasmodium falciparum, hepatitis B virus (HBV) and hepatitis C virus (HCV) overlap in many parts of sub-Saharan Africa. HBV and HCV infections develop in the liver, where takes place the first development stage of P. falciparum before its further spread in blood. The complex mechanisms involved in the development of hepatitis may potentially influence the development of the liver stage of malaria parasites. Understanding the molecular mechanisms of these interactions could provide new pathophysiological insights for treatment strategies in Malaria. METHODOLOGY: We studied a cohort of 319 individuals living in a village where the three infections are prevalent. The patients were initially given a curative antimalarial treatment and were then monitored for the emergence of asexual P. falciparum forms in blood, fortnightly for one year, by microscopy and polymerase chain reaction. PRINCIPAL FINDINGS: At inclusion, 65 (20.4%) subjects had detectable malaria parasites in blood, 36 (11.3%) were HBV chronic carriers, and 61 (18.9%) were HCV chronic carriers. During follow-up, asexual P. falciparum forms were detected in the blood of 203 patients. The median time to P. falciparum emergence in blood was respectively 140 and 120 days in HBV- and HBV+ individuals, and 135 and 224 days in HCV- and HCV+ individuals. HCV carriage was associated with delayed emergence of asexual P. falciparum forms in blood relative to patients without HCV infection. CONCLUSIONS: This pilot study represents first tentative evidence of a potential epidemiological interaction between HBV, HCV and P. falciparum infections. Age is an important confounding factor in this setting however multivariate analysis points to an interaction between P. falciparum and HCV at the hepatic level with a slower emergence of P. falciparum in HCV chronic carriers. More in depth analysis are necessary to unravel the basis of hepatic interactions between these two pathogens, which could help in identifying new therapeutic approaches against malaria