Addressing challenges for research participant informed consent by using a tiered consent framework
29 Oct 2019 - 08:30
The diversity of African genomes can provide important new insights into biological processes and disease mechanisms. In order for researchers to ethically pursue this knowledge, people who donate their genetic material for study first provide informed consent for use of their specimens and data.
In many cases, researchers request “broad consent” for all current and future use, a practice which elides subtlety in participant choice. In their commentary published in Nature Genetics on the 28th of October, Victoria Nembaware and colleagues (with CIDRI-Africa Biomedical Data Integration Platform Academic Nicki Tiffin as Senior Author) propose a framework for obtaining and recording ethically sound, nuanced, tiered informed consent for participants’ data and sample use.
“A tiered consent model can protect against the future misuse of data and samples that might arise from stretching the boundaries of broad consent beyond the original intentions of participants. In order to respect participants’ choices, we also need to develop a culture of accurately digitalising informed consent participant choices.”—Associate Prof. Nicki Tiffin.
Their tiered approach addresses challenges associated with the “broad consent” model by providing detailed information about degrees of specimen/data use, and enabling participants to record a customised sharing profile through responses to specific questions.
The authors’ framework includes guidance on informed consent document content, questions to be asked for each component of tiered consent, and storage of responses.
Nembaware V, Johnston K, Diallo AA, Kotze MJ, Matimba A, Moodley K, Tangwa GB, Torrorey-Sawe R, Tiffin N. A framework for tiered informed consent for health genomic research in Africa. Nature Genetics. (2019).