Clinical Development and Clinical Trials (AM_1180)
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Group report Clinical Development and Clinical Trials (AM_1180)
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Clinical Development and Clinical Trials (AM_1180)
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Vrije Universiteit Amsterdam (VU)
This is the group report for Clinical Development and Clinical Trials, about access to trial data in case of emergencies, such as pandemics. It was a mandatory, graded assignment.
Management, Policy-Analysis and Entrepreneurship in Health and Life Science
Clinical Development and Clinical Trials (AM_1180)
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RFI - Access to Trial Data for Emergencies
January 29th 2024 - Word count: 498
Dear Ms. E.M. Janse and Mr. E. Klaver,
Collecting informed consent (IC) from participants is important for clinical trials, IC should
be freely given and should consist of information about the aim of the study and processing
of personal data (GDPR, 2021). However, in emergency settings, such as pandemics, trial
data might contain important information for research outside of the initial intended use. To
enable the use of trial data for future objectives, we propose three strategies.
Additional informed consent with de-identified data
When IC is obtained from trial participants for the current trial, additional IC can be acquired
for the future reuse of data. The participant must be informed that data might be used in a
de-identified form, for future research purposes. De-identifying data includes removing all
information deemed as “first identifier data”, such as names, social security numbers and
addresses (Stanford University, n.d.). The revised common rule, known as “the federal policy
for the protection of human subjects”, from 2018 states the possibility of including IC for
de-identified data to be used in future research in informed consent forms (ICFs) (Cip, 2023).
In ICFs, it must either be stated that de-identified data can be used by other researchers for
other research purposes, or that it cannot be used for any future research purposes (Cip,
2023).
Approval from an Ethics Committee
If additional IC from trial participants cannot be obtained in emergency cases, approval from
an Ethics Committee (EC) should be sought (WMA, 2022). In addition, the use of the trial
data should be specified in the protocol of the new research, as included in the Declaration of
Helsinki for research involving human data. This is applicable to medical research using
human data, where obtaining IC is impossible or impractical (WMA, 2022). In such cases,
data can be collected, stored and reused with approval from an EC. For instance, this may
occur during pandemics, when such data must be accessed quickly to enhance the
development of a suitable treatment and diminish the spread and impact of a disease, and
obtaining informed consent can cause delays (Voit et al., 2023).
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