Ethical Review

In order for the MalariaGEN research to be conducted, MalariaGEN partner institutions needed to obtain ethics approval for 29 sub-projects from 26 different research ethics committees in 15 countries, as well as obtain over-arching ethics approval for the MalariaGEN project from a research ethics committee in the UK. Each partner institution took a leading role in obtaining ethics approval locally, writing the ethics proposals and liaising with the ethics committees where this was necessary. The MalariaGEN Ethics team based in Oxford had a full-time staff member devoted to facilitating this process over eighteen months.

MalariaGEN Ethics meetings in Accra in 2005 and in Bamako in February 2006 served as a basis to identify and discuss the most important ethical challenges to MalariaGEN research. Insights from these meetings informed the development of proposals for review by the various ethics committees. The MalariaGEN Ethics Team acted as a resource for the PIs developing these proposals, and reviewed proposals prior to submission, provided text and support in writing the proposals, and ensured that the information provided in the proposals was an accurate reflection of the work proposed by the MalariaGEN Consortium. In addition, the MalariaGEN Ethics Team also compiled ethics documentation for the archived samples to assess the original consent given for sample collection, and to ensure that all samples used in MalariaGEN were collected with ethics approval.

Review for the majority of the sub-projects was completed relatively smoothly by Summer 2007 - about a year after the project started but in time for the bulk of the work to be done before the scheduled completion of the project. Among the points raised by ethics committees were issues relating to consent, the export of samples, ensuring the appropriate recognition of local investigators' contributions, and ways of assigning benefits to the country or community that donated the samples. In addition, some concerns were raised regarding confidentiality arrangements, most notably between researchers.

In a few sites the projects met with delays in the review process. A mix of anxiety about the scale of the proposed genomic research together with concerns about ethics committees abilities for to monitor sample use once samples were sent and stored abroad appeared to underlie most of these delays.

One of the main challenges in ethics review for a project like MalariaGEN lies in the means available to research ethics committees to identify the ethical issues associated with whole-genome association studies. Having access to an expert in genomic research that can assess the study protocol and inform the ethics review may be very difficult. Research projects like MalariaGEN may in the future need to take a more pro-active role in providing background information on the study methodology and the ethical issues it could raise, when and if this is appropriate.