Translational Science, DNA Commercialization, and Informed Consent: The Need for Specific Terminology, Insights from a Review of H3Africa Projects.
Commercialization Typology
DNA commercialization
Ethics of genetic research
H3Africa
Informed consent
Journal
Public health genomics
ISSN: 1662-8063
Titre abrégé: Public Health Genomics
Pays: Switzerland
ID NLM: 101474167
Informations de publication
Date de publication:
25 Jan 2022
25 Jan 2022
Historique:
received:
17
06
2021
accepted:
24
11
2021
entrez:
25
1
2022
pubmed:
26
1
2022
medline:
26
1
2022
Statut:
aheadofprint
Résumé
In the past decade, there has been an acceleration in genomic research, its applications, and its translation into healthcare products and services for the benefit of public health. These advances are critical to realizing the potential of genomic research for facilitating improved health and disease prevention, diagnosis, and treatment. Despite its tremendous opportunities, the dynamic and increasingly global landscape of genomic research commercialization has been accompanied by a variety of ethical challenges and concerns. The potential for unauthorized use of DNA samples from African people to develop a DNA chip amplifies discussion on the meanings, implications, and impacts of commercialization, benefit sharing, and appropriate consent in genomic research. Leadership of the Human Heredity and Health in Africa (H3Africa) Consortium convened a panel of experts to review research ethics practices employed in H3Africa Consortium projects and make recommendations regarding commercialization. Eighteen investigators submitted documents for projects involving data sharing and use of genetic information. A total of 39 informed consent documents associated with the 18 projects were reviewed. All 18 projects specified that samples would be used in future research. Less than half of the projects included language noting that samples could be used in drug or product development, that DNA samples would not be sold, and that profits would not be shared with participants. Four projects referred to commercialization. Analysis of information included in consent documents contributed to the development of a Commercialization Typology. The Typology identifies factors to consider regarding acceptability of particular instances of commercialization. DNA samples for translational research in product development require a transparent commercialization framework to inform the consent process.
Identifiants
pubmed: 35078200
pii: 000521371
doi: 10.1159/000521371
pmc: PMC9216313
doi:
Types de publication
News
Langues
eng
Sous-ensembles de citation
IM
Pagination
1-8Informations de copyright
© 2022 The Author(s) Published by S. Karger AG, Basel.
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