Attitudes of healthy volunteers to genetic testing in phase 1 clinical trials.

Sebastian Levesque,Eric Haan,Thomas M Polasek,Sepehr Shakib

doi:10.12688/f1000research.26828.1

Abstract

Background: Genetic testing in clinical trials introduces several ethical and logistical issues to discuss with potential participants when taking informed consent. The aim of this study was to explore the attitudes of healthy volunteers in phase 1 studies to the topics of genetic security, genetic privacy and incidental genetic findings. Methods: Healthy volunteers presenting for screening appointments at a phase 1 clinical trial unit (CMAX Clinical Research, Adelaide, Australia) took an anonymous paper survey about genetic testing. Results: There were 275 respondents to the survey. The mean age was 27 years (range 18-73); 54% were male and 53% were of North/Western European ethnicity. Just over half the healthy volunteers thought genetic security (56%) and genetic privacy (57%) were "important" or "very important". However, the security of their genetic information was ranked less important than other personal information, including mobile phone number, internet browser search history and email address. Two-thirds of respondents would trade genetic privacy for re-identifiability if information relevant to their health were discovered by genetic testing. Healthy volunteers favoured the return of incidental genetic findings (90% indicated this was "important" or "very important"). A level of risk (10 to 90%) for developing a serious medical condition that would "trigger" the return of incidental genetic findings to participants was not identified. Conclusions: Healthy volunteers screening for phase 1 clinical trials have mixed views about the importance of genetic security and genetic privacy, but they strongly favour the return of incidental genetic findings that could affect their health. These issues should be discussed with potential participants during informed consent for phase 1 clinical trials with genetic testing.

Highlights

Genetic testing during clinical drug trials can determine whether genetics influences how patients respond to drug therapy.[1,2] Increasingly, genetic information is collected from healthy volunteers during phase 1 clinical studies to identify factors that inform later stages of drug development, including dosing strategies, patient selection, and the potential role of biomarkers to monitor drug responses.[1]Genetic testing in clinical trials introduces several ethical and logistical issues for participation, including concerns about genetic security and genetic privacy and how investigators should proceed with incidental genetic findings
When participants were asked to rank the security of their genetic information against other personal identifying information, genetics had a similar mean rank to medical history, and was ranked less important than the other personal information such as mobile phone number, internet browser search history and email address (Figure 1B)
Number of previous studies at CMAX Clinical Research ns ns ns ns ns p = 0.006 p = 0.010 p = 0.015 ns ns ns Ethnicity ns ns ns ns na ns ns ns ns ns ns Discussion This is the first study to report the attitudes of healthy volunteers to genetic testing in phase 1 clinical trials

Summary

Introduction

Genetic testing during clinical drug trials can determine whether genetics influences how patients respond to drug therapy.[1,2] Increasingly, genetic information is collected from healthy volunteers during phase 1 clinical studies to identify factors that inform later stages of drug development, including dosing strategies, patient selection, and the potential role of biomarkers to monitor drug responses.[1]Genetic testing in clinical trials introduces several ethical and logistical issues for participation, including concerns about genetic security and genetic privacy and how investigators should proceed with incidental genetic findings. Genetic privacy is the protection of a person’s genetic information so they cannot be identified without knowledge and consent.[4] Incidental genetic findings are results unrelated to the initial reason for genetic testing. Genetic testing in clinical trials introduces several ethical and logistical issues to discuss with potential participants when taking informed consent. Conclusions: Healthy volunteers screening for phase 1 clinical trials have mixed views about the importance of genetic security and genetic privacy, but they strongly favour the return of incidental genetic findings that could affect their health. These issues should be discussed with potential participants during informed consent for phase 1 clinical trials with genetic testing

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