Model framework for governance of genomic research and biobanking in Africa – a content description

Genomic research and biobanking are expanding globally, with a promise to fast-track the research needed to improve approaches to disease treatment and prevention through scientific collaborations such as the Human Heredity and Health in Africa (H3Africa) initiative. Integral to this type of research is the availability of samples and data for research. The need for broad access brings along a host of ethical concerns, including those related to privacy and confidentiality, as well as fairness and equity in access and capacity to utilise these samples between scientists from the high income and low income countries. Addressing these concerns while promoting genomic research, especially in Africa, requires the implementation of a sound governance framework. In this paper, we describe the contents of a Framework for Best Practice for Genomics Research and biobanking in Africa that was developed, under the auspices of the H3Africa initiative. This framework is broad enough to be used and adapted by African countries to facilitate the development of country-specific guidelines and to help improve the conduct and governance of genomics research.


Introduction
The complete mapping of the human genome 1 brought along with it possibilities to better understand human health and its determinants which would help improve the way diseases and health conditions are managed. Since then, the number of genomic research studies and the need for biobanking has been growing globally 2-4 , with a steady increase in the number of such studies being conducted on the African continent 5 . Further scaling up genomics research with samples and data from diverse African populations 6 has great value considering that only a small portion of human diversity is found outside Africa 7 . Towards addressing this gap, a $76 million initiative referred to as the Human Heredity and Health in Africa Initiative (H3Africa) was funded jointly by the National Institutes of Health in the US and Wellcome Trust in the UK 3 . In order to fast-track realization of the benefits inherent in genomics research, the global community agreed to principles of 'open science', which promotes the value of sharing and reuse of data and samples as a critical component of the contemporary scientific landscape [8][9][10] . Although this has the strong potential to facilitate scientific discovery, it also raises a number of ethical concerns which includes appropriate model of consent that will allow for such sharing of data and samples while upholding participant autonomy 11-14 ; issues of withdrawal of consent 15,16 ; ownership of samples and data 17-20 ; privacy and confidentiality 15,21-23 ; and benefit sharing 24-26 . Such issues are not peculiar to African countries, but require a different lens in further elucidating the contextual concerns in African settings. Furthermore, there are concerns about trust 27 and fairness in research collaborations 10,28 , increased vulnerability of research participants due to lower socio-economic levels, a history of exploitation of local populations and researchers 29 , and cultural issues that all must be considered in the governance of genomics research and biobanking in Africa.
In addition to these ethical concerns, regulatory frameworks for health research in Africa are either non-existent, or where they exist, do not respond to the specific concerns raised by genomics research and biobanking 10,23,30 . Towards addressing this gap, the H3Africa Initiative considered it expedient to develop an ethics framework describing best practice for genomics research and biobanking. Described in terms of core principles and elements, the Framework considered African political history of exploitations from the West and accounts of ethical concerns in conducting genomics research and biobanking [30][31][32][33] to inform the choice of these core principles and elements. The phenomenon of "parachute research" -where fully equipped research teams from other countries arrive at the site where research is needed, conduct their research independently of others, and then leave, has been long cited as a challenge for genuine collaborative research in Africa as well as other developing countries in the world. That such practices are not part of the past was highlighted during the recent Ebola epidemic in some West African countries where international researchers are said to have carted specimens away from the affected countries without any form of oversight or recourse to local regulations or regulators 29 . A permutation of these practices is where African researchers are reduced to the role of data and sample collectors, without genuine attempts to ensure their involvement beyond such functions. One way to remedy such practices is by fostering sustainable capacity building for African intellectual leadership in the conceptualization, design, implementation and reporting of locally appropriate studies 30,34,35 -this is one of the core elements of the framework described here. It is also one of the main goals of the H3Africa initiative including support for equipment and infrastructure to enable researchers to develop biobanks and conduct large-scale genomics studies.
The aim of this framework is to guide governance, address sample and data sharing concerns, as well as to serve as a resource for countries to develop their local regulations. The process of engagement that led to the development of this framework is reported in another manuscript. 36 . This paper highlights the key contents of this framework and plans for its implementation across the African continent.

An overarching philosophical basis
In developing this ethics framework, it was important for key stakeholders to identify the overarching philosophical basis that should guide the development of ethical best practice for genomic research and biobanking. The issues of unfair research collaboration, lack of trust in research collaborations with scientists from the "West" and the related skepticisms among experts and community representatives 30,37-39 were key considerations. These remain genuine concerns that need to be addressed to promote inclusion of Africans in genomics research as the field progresses and the world benefits from its outcomes 6 . To ensure that African patients and researchers partake in genomic research to optimal benefit, we thought it important to adopt a normative basis from African cultural philosophy. "Ubuntu" is a largely South African worldview that focuses on the interrelatedness of humans in their quest for mutual co-existence and is one such African philosophy that was initially selected as a foundation for the framework 40,41 . There is strong ground to suggest the importance of principles of solidarity as articulated in the Ubuntu philosophy as a universal moral theory for sub Saharan Africa 42,43 . However, given its strong historical links to an era of struggle in apartheid South Africa and several accounts limiting it as a southern African philosophy 44,45 , its acceptance during

Amendments from Version 1
In this second version of our paper, we have added a bit more text to reflect some more recent discourse on the "Ubuntu" philosophy, being a key underlying philosophy initially considered for the framework -instead a Communitarian World View was adopted. In the first version, we inadvertently mentioned that there were 'five core principles', whereas they are four, which has now been corrected. We have now included some more discussion on the "African Intellectual Leadership". We have linked this issue with the 10/90 gap and the issues raised about poor diversity and inclusion in genomics research. Some more text to further put community engagement in better context including description of what we mean by 'genuine' (vs tokenistic) community engagement has been added. We have also added a bit more text on our future engagement plans on the framework.

REVISED
our consultations as a philosophical basis for the framework met with some resistance from stakeholders in other parts of Africa. Instead, upon consultation we agreed that the framework should adopt a more generic communal or solidarity-based worldview. Such a worldview recognises that individuals are shaped by their relations to people around them and emphasizes respectful and harmonious relationships between them. In the African research context, we agreed that a communitarian perspective would place central importance on reciprocity, consultation and accountability as key ethical values.

Core Principles and Elements
The framework proposes a set of four core principles that ought to underpin guidance for genomic research and biobanking initiatives in Africa. Whilst these principles are not new, they need to keep being emphasized to address particular concerns of African communities and scientists regarding trust and unfairness in research collaborations. A number of these principles have been echoed in a parallel initiative, the San Code of Ethics, which seeks to define how researchers ought to conduct their work when dealing with the San population in South Africa 46,47 , The four core principles of our framework emphasize the need for research to: a) be sensitive and respectful of African values and cultures; b) be designed primarily to benefit the African people, while acknowledged it may equally benefit the global population; c) ensure genuine and active intellectual participation of African investigators and other stakeholders in research and in dissemination of findings; and d) promote relationships characterised by respect, fairness, equity and reciprocity. As core principles, these aspects are non-negotiable and should be incorporated in the design and conduct of genomics research and biobanking initiatives in Africa.

Key elements of the Framework for Best Practice
In addition to these core principles, the Framework also describes ten key areas that need to be addressed in order to ensure that the core principles elucidated in the framework are realised. They include: African intellectual leadership; Consent; Community engagement; Ethics review; Avoidance of group harm and stigma; Benefit sharing; Capacity building; International collaboration and export of samples; Feedback of individual genetic findings; and Good governance. These core elements are not mutually exclusive. For instance, high-level capacity building is key to ensuring African intellectual leadership. These elements were informed by a review of guidelines documents and other similar texts from institutions in the global North such as the Global Alliance for Genomics and Health 48 and the Organization for Economic Cooperation and Development 49 among others, and adapted to African experiences and context, thus ensuring alignment with global best practices.

Highlights of the key elements of the framework
The gap in research investments between the north and south has been reported previously and considered unacceptable 50 . The persistence of this gap, more than two decades after it was initially described could strongly mitigate the potential of genomics research to provide novel insights into health disparities, foster better understanding of human biology, support improvement in individual clinical care and informing genetic diagnosis among others 6 . The underrepresentation of scientists from low and middle income countries (LMICs) 51 and African countries in particular 52 at all levels of research is one key area of intervention, which when addressed could significantly reduce this gap. Thus, central to this framework is the requirement for all genomics research collaborations in Africa to ensure African intellectual leadership -that scientists who are Africans and/ or based in African institutions should be engaged and supported to assume leadership roles in the design and implementation of both primary and secondary studies emergent therefrom with the H3Africa project being a good example 10 . This would further promote an earlier call that "developing countries must have the capacity to investigate their own health priorities" 53 , as well as the needed diversity to fully harness the potentials of genomics research in improving global health 10 . We do however recognise that for sustainability, this should be supported by more deliberate efforts by country governments to strengthen their health research systems.
Because sample and data sharing are essential to genomics research and biobanking, it is important that the consent process allows sharing and re-use whilst still respecting participant choice. While there are several models of informed consent that may support genomics research 54 , our framework promotes the use of broad consent. It is important to differentiate this from blanket consent, which is consent for sharing and use of data and specimen without any restrictions. Broad consent as understood in the framework allows for "use of samples and/or data for unspecified future studies, but with conditions. These conditions can involve, for instance a restriction on the types of studies or diseases that samples/data can be used for; a specified oversight and approval process for future use; ongoing consultation with sample donors about future use, if possible; and a process allowing participants to withdraw samples or data from the storage facility that holds them". Although debates about appropriate consent models for genomics and biobanking continue, there is growing consensus that broad consent may be the 'best compromise' consent model 55 . In their critical presentation of the outcomes of a workshop which aimed to identify the appropriate consent model for collection of biospecimen for use in future research, Grady et al. (2015) submitted that broad consent was considered "ethically appropriate, and preferable to lack of consent for the majority of biospecimen collection for future research uses" 54 . Furthermore, Tindana and De Vries (2016) in their paper on the perspectives of broad consent for genomics research in LMICs concluded that there are no a priori reasons against the use of broad consent for genomics research in Africa 56 . Empirical research conducted since then suggests that participants may also be supportive of broad consent if done sensitively and respectfully 57-59 . The proposed framework for acceptable broad consent includes initial consent, oversight of future research projects, and, when feasible, mechanisms for maintaining contact and communication with specimen donors. There is, however, an agreement among most proponents of broad consent that for optimal participant protection, whenever broad consent is used in genomics research to allow for future research use, it needs to be accompanied with a mechanism that promotes accountability and equity 60 in sharing specimen and/or data with other researchers while also ensuring that participants' choice are respected 54,56 .
The Framework considers that genuine community engagement (CE) is a key component of ensuring best practice in genomics research and biobanking in Africa, not in the least because it promotes respect for community values and perspectives and maximizes the social value of research 61 . Community engagement is one way to ensure that research conduct is aligned with a communitarian worldview. Furthermore, genuine community engagement is proposed as a condition for the use of broad consent 54,56 . To be clear, community engagement as put forward in the framework goes beyond tokenistic engagement which would involve a once-off meeting with some community members and rather denotes substantive engagement with various members of communities over time. The research team should seek to engage relevant communities at whom a particular project is targeted along the entire spectrum of research activities, from initial planning phases and data collection, to include the return of general study findings when projects end and policy translations where applicable. While there are several accounts of what it means to have a genuine community engagement 62,63 , to be considered meaningful, researchers should demonstrate that proposed CE initiatives are built on some of the known guiding principles or values of CE; adapting some of the related strategies as applicable 64,65 .
The framework recommends that all primary genomic research and biobanking studies must be reviewed by a competent research ethics review committee based in the country where samples are collected or stored. Research ethics review fulfils an important role in promoting ethical best practice and is key to the protection of research participants Such a role is very important in the African research that takes place in the context of a high burden of disease, poor access to basic necessities and healthcare, low average income and literacy levels as well as unfamiliarity of most of the people with biomedical research generally and genomic research specifically. A particular challenge is the limited capacity of research ethics committees in Africa to review genomics research and biobanking projects 66,67 . Using a matrix that maps the various elements of this framework against important issues that ethics committees are recommended to consider, Table 1 is proposed as a practical tool for ethics committees to provide oversight for good governance in genomics research and biobanking.
The avoidance of group harm or stigma is considered important particularly in the African research context where researchers may work with members of many different population groups, each characterised by their own language, culture and belief systems, some of which may be marginalised or discriminated against. Research may also involve groups of people suffering from stigmatised conditions or outlawed or stigmatising behaviours, phenotypes or lifestyles. In such a context, the reporting of genomic research results could aggravate existing stigma or marginalisation. An example is the way in which genomic research on the San included findings that were considered potentially stigmatising 46,47 .
In this example, Namibian San leaders were approached for participation in genomics research 68 without involvement of San political leadership or individuals with experience in science who could have properly explained the research project and who could have helped the research team in designing more appropriate consent processes. Whilst presented internationally as an example of 'best practice' for the involvement of 'indigenous' African populations 69 , this project, as well as its inconsiderate presentation of research results, was perceived as deeply offensive by the Namibian and South African San Councils and led to the development of the San Code for Ethics referenced earlier.
Because of this and other experiences, the framework requires researchers to be mindful of whether and how groups are identified in genomics research, and how research results are reported. Importantly, the framework suggests that community engagement may be one way to alleviate the potential for stigma. Genuine intellectual leadership by senior African researchers and their meaningful involvement in the preparation of manuscripts is equally important to ensure the respectful engagement with African populations and the responsible reporting of study findings.
In terms of benefit sharing, the framework proposes that genomics research and biobanking may bring intangible benefits in the form of general study results, social recognition, knowledge production and translation of relevant knowledge to healthcare practice. Whilst there may be some tangible benefits emanating from genomics research and biobanking in the form of (patentable) innovations or technologies, these are rare and should not be the focus of benefit sharing discussions. The framework describes, first, that it is imperative that researchers ensure that intangible benefits accrue to researchers and communities and they should be aware of this. It also describes that researchers should be mindful not to raise unrealistic expectations, and to clearly describe to communities and individuals the nature of potential benefits they can expect and those that they cannot.
Capacity building for African scientists is one of the central elements of the framework, and has been identified as one of the primary benefits emanating out of ongoing research endeavours such as H3Africa 25,70 . Building a critical mass of scholars in genomics and biobanking is essential to ensure the sustainability of these research approaches in Africa. Similarly, such a critical mass is needed to ensure that this research can be conducted by African research teams and under African intellectual leadership in the future, provided that capacity is built along the entire academic hierarchy and includes junior scientists as well as more senior ones. Importantly, capacity building would need to focus not just on training in genomics science and bioinformatics, but also in grants administration, contract negotiation, ethics and in transferable skills such as grant writing which enables sustainability of the genomics research. The expectation is that broad capacity building would ensure that research is responsive to the health needs of Africans, is sensitive to African ethical, legal and social issues, and that there is a strong avenue for the implementation of relevant research findings into national health policy and clinical practice. Good governance Good governance helps build and maintain public trust and ensure transparency of genomic and biobanking research Governance framework must include oversight on the use and reuse of samples There must be compliance with local, national and international guidelines and regulations Entities controlling access to samples must be comprised of members primarily residing on the African continent With regard to the export of samples to other countries, the framework acknowledges that this is often viewed as problematic by research ethics committees and other regulators, not in the least because it is viewed as perpetuating inequality. For this reason, the framework proposes that export should only be permitted where researchers can outline how their work will contribute to reducing global health inequality and what measures they have put in place to strengthen the research system in the country where the samples were collected. One example would be where junior and senior African students and researchers are meaningfully involved in all aspects of the research process, including aspects that happen in non-African laboratories and universities. Material Transfer Agreements (MTAs) are fundamental to underpin the fair export of samples. While the challenges around implementing MTAs remain, guidance offered for instance by the US Veterans Health Administration 71 and some model MTA templates such as the Uniform Biological Materials Transfer Agreement and its related templates 72 , could be useful in supporting institutions to navigate these challenges, arriving at MTAs that are more agreeable to collaborators in genomics research.
Whilst the framework offers some guidance on the feedback of individual genetic research results, it mainly proposes a range of questions that need to be considered in determining whether and under which conditions the return of research results may be appropriate in the African research context. Given the complexity of the issues, the H3Africa Consortium is developing a policy guiding researchers in how to decide which results to feedback, which expands on the summary guidance given in the framework.
Lastly, implementing a good governance regime is recommended in order to tie all these elements together towards optimal protection of participant in genomics research and biobanking. This should be a mechanism that provides oversight for re-use of samples and data sharing in line with the principles and elements set out in the framework. Such oversight is expected to among other things, ensure that decisions to provide access to sample and data for secondary use are sensitive to the need to promote genomics scholarship from African scientists and facilitate preferential use of data and access to samples for such scientists for a reasonable period of time. Such a preferential use provision is expected to further support African scientists, who may have challenges in engaging with the data and specimen available as fast as their counterparts due to systemic challenges such as poor power supply, poor access to academic databases for research, poor access to fast and reliable internet and so forth; or infrastructural challenges such as the availability of databases with comparable security protections that will allow for sharing data across countries and continents. In making these decisions however, it is important to find an appropriate balance between over-protection, which may hinder good science with potential benefit to humanity derivable from it. Typically, such a governance regime is achieved through the establishment of Sample Access Committees and Data Access Committee 73 . However, each country that seeks to use the framework, as a guide may have to develop a structure that works best considering local peculiarities.

Implementation mechanisms and amendments
The next step in our quest to consolidate and harmonize standards for African genomics research and biobanking is to engage broadly around the framework, and to develop template guidelines for adaptation.
Firstly, the framework provides the basis for further discussions and engagement with professional organisations, regulators and ethics committees across Africa. Through our consultation processes, we have built up a rich network of contacts with regulators and ethics committees at local, regional and national levels across the continent, and we are liaising with all of these to create awareness of the minimal standards described in the Framework. We are also liaising with professional science organisations including for instance the African Academy of Sciences (AAS), to explore how that organisation can take a leadership role in advancing ethical standards of genomics research and biobanking on the continent.
In terms of ensuring the incorporation of the standards outlined in the Framework into research practice, we are preparing more detailed guidelines that expand on the items in the Framework. This resource will be publicly available for use by ethics committees across the continent, and the hope is that ethics committees and national ethics councils will adapt and adopt the guidelines so that they become the gold standard for national regulation of genomics and biobanking. In order to ensure that they do, we will continue our engagement activities with committees and national councils, which are usually in the form of side meetings at the annual meetings of the H3Africa Consortium. In addition, we are increasingly involved in offering training to national and local ethics committees, which are invaluable in ensuring awareness of the Framework and guidelines emanating from them. Although there are no plans to commission formal evaluations on the uptake of the Framework, the H3Africa Working Group on Ethics and Community Engagement shall continue to collect information on references to the framework in publications as well as its use in country guidelines.

Disclaimer
The views expressed in this article are those of the authors. Publication in AAS Open Research does not imply endorsement by the AAS.

Data availability
No data are associated with this article. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Acknowledgements
The discussion with the leadership of the Consortium on this regard. Here is a summary of our responses to your specific comments on the paper:

I have some suggestions for the authors
The brief mention of the principle of "ubuntu" is interesting and is there any more recent discussion since the footnote 35 2007 reference? Thank you. Though our aim was not to dwell much on describing Ubuntu, we have however added a little more text and references in response to this comment. We feel that provides the additional information suggested without going too deep.
In the section on "Core Principles and elements', the authors mention 'five core principles" but only list four (a to d). They need to add the fifth This was one oversight; we actually have only four principles. Error corrected, thank you. The authors highlight the elements of their proposed framework (see 3 above) but do not include any discussion on the principle of "African intellectual leadership".
We have now included some more discussion on this as suggested. We have linked this issue with the 10/90 gap and the issues raised about poor diversity and inclusion in genomics research. Thank you. There has been a working connection between the H3Africa and the GA4GH and a reference could be included.
Thank you for this observation. We believe the acknowledgement and the new citation (in response to comment 5 below) is sufficient to demonstrate the connection between the two for the purposes of this paper.
In These global collaborations and interactions are worthy of reference and comment in the text at the section "Key elements of the Framework for Best Practice'. This records that the authors are striking out on a path for Africa but one informed by international developments and collaborations.
Thank you. We have included some reference while introducing the "Key Elements" section.
We declare no competing interests Competing Interests: On line 9 under consent process, I assume that "it" refers to broad consent. If so, that should be stated explicitly.
Under avoidance of group harm, there should not be a comma after note 52.

Does the article adequately reference differing views and opinions? Yes
Are all factual statements correct, and are statements and arguments made adequately supported by citations? Yes

Is the Open Letter written in accessible language? Yes
Where applicable, are recommendations and next steps explained clearly for others to follow? Yes No competing interests were disclosed.

Competing Interests:
I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.
Author Response 12 Nov 2018 , Federal Ministry of Health, Abuja, Nigeria aminu yakubu

Dear Prof Clayton
Thank you for reviewing our paper. We are pleased to learn that you consider it an important contribution to genomics research governance. We carefully reviewed your comments and taken the necessary actions and/or made the necessary modifications. Please find a summary below: This is an important paper setting forth guiding principles for genomics research in Africa. The document is clear and well written and will be quite helpful for the work of putting concrete mechanisms in place that protect the interests of individuals and communities while building local capacity and advancing research to improve health.
I have only one substantive comment, which is that it would be helpful to say more about what the authors mean by community engagement, specifying to what extent and on what topics the community should have input. This is often a contested issue.
Thank you for this comment. Indeed we share in your perspective but wanted to strike a balance between presenting CE within the scope of this descriptive paper and going in-depth to educate our readers more on the topic. However, because of this observation, we have added a bit more context.

My other comments are minor:
Under core principles, there is an extra "of" on the second line. Line removed, thank you. I saw only four principles, not five. This was an oversight; there are actually four. This has been corrected. On line 9 under consent process, I assume that "it" refers to broad consent. If so, that should be stated explicitly.
Yes, it does. We have added that specificity. Thank you. Under avoidance of group harm, there should not be a comma after note 52.
Addressed, thank you.
We declare no competing interests.

Competing Interests:
This article describes an ethics framework for genomics research and biobanking in Africa, which is valuable in the African public health context and to address global health inequality. The article is well-written and concise in its summary of the core principles and key elements of the framework. We see the contribution of the framework in the context of ELS implications of genomics and biobanks in its emphasis on the need for research to be sensitive and respectful of diverse cultures, values and belief systems of African populations. Also of significance is the goal to enhance capacity building and genuine intellectual participation of African researchers and stakeholders in genomics research. The authors of this article are to be commended for this important work.
Overall, the manuscript will make an important contribution. We have only minor suggestions for improvement. Although the key elements of the framework are well-presented, the authors do not address potential challenges that may be encountered while applying those key elements. We realise that the purpose of the article is to lay out the framework, and so does not address implementation issues. However, some additional detail may be good to add, in particular in the context of community engagement, which the authors emphasize as a key component for ensuring best practice in genomics research and biobanking in Africa. However, it is not clear from the framework what the authors mean by "genuine community engagement". There is a rich literature on engaging community members in research and the values and challenges of doing so. Community engagement goes beyond the meaningful involvement of African researchers to include individuals from the broader population and specific groups, and will need to address issues such as power dynamics between researchers who are considered experts and community members.
Other issues: On p. 3. The authors mention that "The process of engagement that led to the development of this framework is reported in another manuscript." A reference to this manuscript should be provided.
The paragraph on export of samples to other countries is incomplete (p. 6).
The "implementation mechanisms and amendments" section (p. 7) describes the next steps for raising awareness and engaging health organisations and national councils with the framework. It would be great to have more detail regarding future evaluation of the framework and the Working Group's engagement activities.

Does the article adequately reference differing views and opinions? Partly
Are all factual statements correct, and are statements and arguments made adequately supported by citations? Yes

Is the Open Letter written in accessible language? Yes
Where applicable, are recommendations and next steps explained clearly for others to follow? Yes No competing interests were disclosed.

Competing Interests:
We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.
Author Response 20 Nov 2018 , Federal Ministry of Health, Abuja, Nigeria aminu yakubu Dear Drs O'Doherty and Chuong, On behalf of my co-authors, I wish to thank you for taking the time to review our paper. We thought your comments were insightful and have made some changes to the paper in response. Please find below a summary of our responses to your comments. We shall submit the revised version of the paper shortly.
Overall, the manuscript will make an important contribution. We have only minor suggestions for improvement. Although the key elements of the framework are well-presented, the authors do not address potential challenges that may be encountered while applying those key elements. We realise that the purpose of the article is to lay out the framework, and so does not address implementation issues. However, some additional detail may be good to add, in particular in the context of community engagement, which the authors emphasize as a key component for ensuring best practice in genomics research and biobanking in Africa. However, it is not clear from the framework what the authors mean by "genuine community engagement". There is a rich literature on engaging community members in research and the values and challenges of doing so. Community engagement goes beyond the meaningful involvement of African researchers to include individuals from the broader population and specific groups, and will need to address issues such as power dynamics between researchers who are considered experts and community members.
Thank you for this comment. Indeed we share in your perspective but wanted to strike a balance between presenting CE within the scope of this descriptive paper and going in-depth to educate our readers more on the topic. However, because of this observation, we have added a bit more context and specify what we mean by genuine (vs tokenistic) engagement.
Other issues: On p. 3. The authors mention that "The process of engagement that led to the development of this framework is reported in another manuscript." A reference to this manuscript should be provided. Thank you. We have cited the paper, which is now "in press" with the BMC Medical Ethics journal The paragraph on export of samples to other countries is incomplete (p. 6). This omission is regretted. We wanted to make reference to the UBMTA and the VA guideline on MTAs. We have now done so. Thank you.
The "implementation mechanisms and amendments" section (p. 7) describes the next steps for raising awareness and engaging health organisations and national councils with the framework. It