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Genetic material should be routinely collected in clinical vaccine trials--high consent rates can be achieved across all age groups


Trück, Johannes; O'Connor, Daniel; Darton, Tom C; John, Tessa M; Snape, Matthew D; Pollard, Andrew J (2013). Genetic material should be routinely collected in clinical vaccine trials--high consent rates can be achieved across all age groups. Vaccine, 31(25):2744-2748.

Abstract

BACKGROUND Genomic and transcriptomic studies underpin much investigation in biology and should be included routinely in clinical trials such as vaccine studies to provide new insight into the development of immunity and the genetic basis for adverse reactions. Interest in collecting and storing genetic material for subsequent high-throughput meta-analyses has increased substantially in recent years. Participants in clinical trials represent an important and invaluable source of clinical material and data.
METHODS Here, the experience of a single center in obtaining informed consent for the collection and long-term storage of genetic material from children, adolescents and adults, involved in clinical vaccine trials is presented and discussed.
RESULTS In 11 completed vaccine studies involving almost 3000 individuals, high rates of consent (in excess of 96%) for biobanking and future genetic testing were obtained. Rates were high for participants from all age groups; however, there was a significant increase toward greater uptake by older study participants.
CONCLUSIONS These high acceptance rates demonstrate that participants (and parents of young children) in vaccine studies are willing to consent and engage in genetic research, which provides support for routinely collecting genetic material in research involving healthy participants such as clinical vaccine trials.

Abstract

BACKGROUND Genomic and transcriptomic studies underpin much investigation in biology and should be included routinely in clinical trials such as vaccine studies to provide new insight into the development of immunity and the genetic basis for adverse reactions. Interest in collecting and storing genetic material for subsequent high-throughput meta-analyses has increased substantially in recent years. Participants in clinical trials represent an important and invaluable source of clinical material and data.
METHODS Here, the experience of a single center in obtaining informed consent for the collection and long-term storage of genetic material from children, adolescents and adults, involved in clinical vaccine trials is presented and discussed.
RESULTS In 11 completed vaccine studies involving almost 3000 individuals, high rates of consent (in excess of 96%) for biobanking and future genetic testing were obtained. Rates were high for participants from all age groups; however, there was a significant increase toward greater uptake by older study participants.
CONCLUSIONS These high acceptance rates demonstrate that participants (and parents of young children) in vaccine studies are willing to consent and engage in genetic research, which provides support for routinely collecting genetic material in research involving healthy participants such as clinical vaccine trials.

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Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Children's Hospital Zurich > Medical Clinic
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:7 June 2013
Deposited On:04 Apr 2019 09:18
Last Modified:04 Apr 2019 09:26
Publisher:Elsevier
ISSN:0264-410X
OA Status:Closed
Publisher DOI:https://doi.org/10.1016/j.vaccine.2013.03.070
PubMed ID:23623856

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