High-Level Principles on Ethics, Governance and Resource Sharing


This joint NIH and Wellcome Trust policy document sets out a series of high-level best practice principles on ethics, governance and resource sharing with which all research networks and programs funded through the H3 Africa initiative will be expected to comply.

The core goal of the H3 Africa program is to enhance the capacity of African researchers to undertake cutting edge research to advance understanding of the genetic and environment determinants of common diseases and use this knowledge to improve the health of African populations. These principles aim to strike an appropriate balance in ensuring that adequate safeguards are in place to protect participants, while maximizing the ability of investigators to advance research in line with this goal.

Appropriate governance systems that are underpinned by shared values will be essential to achieve this balance and build trust in the initiative.

Oversight Mechanisms

  • The partner funders are committed to ensuring that their governance and program management mechanisms are transparent, proportionate and, to the extent allowed by individual agency policies and practices, underpinned by shared values.
  • Research programs and networks should establish appropriate systems for scientific and ethical oversight, with engagement of experts who are independent of the research team.
  • Research networks and programs must ensure compliance with national legislation and ethical review processes in the countries in which the initiatives operate.

Informed Consent

  • It is essential that all research participants give full informed consent for the research uses for which access to their samples and data is sought. The consent needs to be broad enough to allow for future and secondary uses of data, in line with the opportunities to use such data in advancing knowledge to improve health.
    • The consent needs to be broad enough to allow for future and secondary uses of data, in line with the opportunities to use such data in advancing knowledge to improve health.
    • The consent processes need to be appropriate for the cultural contexts in which the research takes place, and tailored accordingly.
  • Research networks and programs should develop a clear policy on the circumstances under which re-consent from research participants would be sought. Individual members of networks and programs may need to modify the policy to account for specific local or national needs.

H3Africa Guidelines for Informed Consent, August 2013


  • Research networks and programs have a fundamental obligation to research participants to make every effort to ensure that their privacy and confidentiality are maintained in the management, sharing and reporting of samples and data.
  • Adequate safeguards must be established to anticipate and manage possible risks to individuals and communities appropriately.

Sharing Research Samples, Data and Protocols

  • The Wellcome Trust and the National Institutes of Health expect researchers in receipt of their funds to manage and share research resources and research outputs in a way that maximizes the public benefit.
  • Detailed mechanisms for sharing data, samples and protocols between the research teams within the H3 Africa initiative, and with the wider research community, will be developed in partnership with the constituent research programs and networks, once funding decisions have been made.
  • Research networks and programs should establish clear and transparent policies based on these agreed mechanisms, which should be readily discoverable by potential users.
  • A key element of the H3 Africa initiative is the establishment of biorepositories to maintain and make available research samples and data. Once operational, and subject to a pilot phase, all H3Africa research programs and networks will be expected to use biorepositories to make their materials and data widely available, in a manner consistent with national legislation and ethical approvals.
  • Particular considerations in relation to samples, data and research protocols are outlined in more detail in Box 1 below.

Box 1 – particular considerations for sharing samples, data and research protocols


  • Given the limited and depletable nature of samples, careful consideration should be given as to when and how these samples are used and shared. Samples should be used in a manner that ensures the greatest benefit to the public.
  • The transfer of samples must be in accordance with all relevant local laws, and appropriate research ethics approval for all research projects must be in place in line with relevant local regulations and best practice.
  • When sharing samples, research networks and programs should consider whether they will require users to return the related research data and information to the network or program. Instructions on whether samples should be returned or destroyed at the end of the research project must also be included in associated material transfer agreements.

Research Data

  • Wellcome Trust and NIH policy requires that researchers maximise the availability of research data in a timely and responsible manner, and with as few restrictions as possible. As part of their applications, research networks and programmes are required to provide a data management and sharing plan which specifies how data outputs will be made available to potential users , and the timeframe over which this will occur. These plans will be considered as an integral part of the funding decision. The timings and mechanisms for sharing data will vary depending on the nature of the research proposed and associated ethical considerations. Data management and sharing plans will be considered on a case-by-case basis. Nonetheless, we would expect all research networks and programmes to address the following key considerations:
    • Security: Data must be held and shared in a safe and secure manner that provides adequate protections for research participants, and in a way that is fully consistent with the consent obtained from research participants.
    • Quality: Any data that are shared must be of an appropriate quality and in a format that enables them to be used by others, with sufficient metadata provided. Recognised data standards and metadata formats should be used wherever possible.
    • Repositories: Genomic data should be deposited in existing community data repositories wherever possible.
    • Access: The processes through which users can obtain access to the data should be proportionate, transparent and not unduly delay requests from legitimate users. It may be appropriate to apply different access processes for different data types.
    • Preservation: Consideration should be given as to how datasets of value will be preserved beyond the funding period in a way that maximizes their long-term value.
    • Resources: The resources required – in terms of personnel, infrastructure, tools and cost – should be considered and addressed in the proposed data-sharing plan.

Research Protocols

  • Research networks and consortia should ensure their research protocols are carefully documented and made freely available to others, in manner that allows their ready adoption by other researchers.

Feedback of Results to Research Participants

  • Research networks and programs should seek to ensure that summary aggregated research findings, including results with potential health implications for communities participating in the research are communicated to participants in a timely manner, as part of an ongoing process of engagement in the research.
  • The issues surrounding the communication of incidental findings of potential clinical significance to individual participants are highly complex, and an area in which best practice is still evolving. The funders are working on guidance for the research community on these issues.

Community Engagement

  • Research networks and programs should incorporate appropriate engagement with the communities participating in the research as an integral element – this should be an ongoing activity throughout the program which extends beyond the original consent and, as noted above, includes communication of results and their healthcare implications.

Capacity Building

  • A key goal of the H3 Africa initiative is to contribute to the building of sustainable research capacity in Africa. Research networks and programs should therefore seek to incorporate efforts to enhance capacity in the countries involved and enhance skills in research, data analysis and ethical review.
  • Research networks and programs should actively develop opportunities to collaborate with one another, and share materials and best practice, in taking forward training activities in a way that maximizes their impact, reach and sustainability.

Intellectual Property

  • In line with Wellcome Trust and NIH policies, intellectual property should be developed and used in a way that maximizes global health benefit.
  • Research Networks and programs should seek to manage intellectual property, and develop appropriate licensing terms, in ways that help to ensure equitable access to resulting health products and technologies for low and middle-income countries.

Benefit Sharing

  • Where appropriate, Research Networks and programs should establish mechanisms to ensure the equitable sharing of benefits with the communities participating in the research – this might take the form of contributions to capacity and skills development, or the specification of appropriate licensing terms that ensure access to healthcare benefits derived from the research.