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Consent to
research in
pharmacogenomi
cs studies
An Ethical Analysis
Viviane Caya-Vandenbroek
Table of Content
Introduction……………………………………………………………………………………………….……... 2
Analysis…………………………………………………………………………………………………………….3
1.The scope of the consent………………………………………………………….…….…….……...3
2. Privacy and encryption of research samples…………..…….……..….…....…..…..…....…4
3. Access to research results……………………………………………………………………..……..4
4. Consent to additional studies during clinical trials………………………………………….….5
Ethical reflection………………………………………………………………………………………………...5
1. Role of the ERC……………………………………………………………….….…….…….……...6
2. Role of the legislative authorities………………………………………………………….……..9
Conclusion………………………………………………………………………………………….…….……. 10
References……………………………………………………………………………………………………… 13
Annex 1…………………………………………………………………………………………………………..14
Storage of biological samples guidelines (EMA)…..……..……..……..….…....…..…....…..…14
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Introduction
The principles of autonomy and integrity have been the basis for the concept of
enlightened consent for a long time. These principles support the importance of
obtaining a free and enlightened consent in the context of medical research. However, in
the era of genetics and genomics, various authors emphasize the importance of
updating the conditions to obtain an enlightened consent, in order to take into
consideration the new stakes that researchers and participants will face.1
This main update to the process of gaining an enlightened consent comes from the fact
that the research, made possible by the sequencing of the human genome, now often
involves more than just the participant himself or herself. In reality, they involve the
patients’ family, community and even the entire society. According to some ethicists, a
process to obtain consent that would take into account both social and individual stakes2
would allow acceleration in the progress in the treatment of diseases.
Pharmacogenomics, which is the study of the relation between genetics and
pharmacological response, is an example of a field of research that shows a high
potential to benefit the whole society. Therefore, it has to be articulated around a
definition of an enlightened consent based on community-shared values.
With regard to clinical trials involving pharmacogenomics data, questions about privacy
and patient consent remain unanswered. Pharmaceutical companies and researchers
collect, handle, and store genetic samples from the research participants. However, even
with universal guidelines providing information about raw genetic data handling, nothing
1 Knoppers BM, Chadwick R, “Human Genetic Research: Emerging Trends in Ethics” (2005) 6 Nature
Reviews: Genetics 75.
2 Chadwick R, Berg K, “Solidarity and equity: new ethical frameworks for genetic databases” (2001) 2
Nature Reviews: Genetics 318; Beskow LM, Burke W, Merz JF, et al., “Information Based Research for
Population-Based Research Involving Pharmacogenomics” (2001) JAMA 286:18 2316
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is mentioned about the fact that these samples might be used for further testing. This
situation feeds the fear that the sample could be used for other purposes than the initial
research objective, which brings up the following questions on an ethical point of view:
how is the storage of genetic information in pharmacogenomics studies different from
standard samples? How does it affect the validity of the enlightened consent form given
by the patient in this context? Incontestably, research in Pharmacogenomics raises
ethical, social, and legal issues that are extremely important to inquire and reflect on.
Analysis
The purpose of this text is to determine if the conditions inherent to an individual’s
consent tend to decrease in favor of the research or increase because of the threat for
privacy Pharmacogenomics studies involve. I will attempt to decipher the importance
given by the ethicists and the stakeholders to the community values such as reciprocity,
solidarity and universality in their supervision of the research in pharmacogenomics.
With this in mind, I have analyzed the emerging ethical tendencies from four notions
linked to consent in the context of Pharmacogenomics: 1. the scope of the consent, 2.
