[Ethical, Economic, Legal & Social] EELS Paper

The Pharmacogenomics Journal (2011) 11, 155–161; doi:10.1038/tpj.2011.11; published online 29 March 2011

Informed consent in the context of pharmacogenomic research: ethical considerations

H C Howard1,4, Y Joly2,4, D Avard2, N Laplante3, M Phillips3 and J C Tardif3

  1. 1Centre for Biomedical Ethics and Law, KULeuven, Leuven, Belgium
  2. 2Centre of Genomics and Policy, Faculty of Medicine, Department of Human Genetics, McGill University, Montréal, Québec, Canada
  3. 3Beaulieu-Saucier Université de Montréal Pharmacogenomics Centre and Montréal Heart Institute, Montréal, Quebéc, Canada

Correspondence: Dr HC Howard, Centre for Biomedical Ethics and Law, Katholieke Universiteit Leuven, Kapucijnenvoer 35, BOX 7001, Leuven 3000, Belgium. E-mail: heidi.howard@med.kuleuven.be

4These authors contributed equally to this work.

Received 15 September 2010; Revised 2 February 2011; Accepted 7 February 2011; Published online 29 March 2011.

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Abstract

Although the scientific research surrounding pharmacogenomics (PGx) has been relatively plentiful, the ethical research concerning this discipline has developed rather conservatively. Following investigation of the ethical, legal and social issues (ELSI) of PGx research, as well as consulting with key stakeholders, we identified six outstanding ethical issues raised by the informed consent process in PGx research: (1) scope of consent; (2) consent to ‘add-on’ studies; (3) protection of personal information; (4) commercialization; (5) data sharing; and (6) potential risks stemming from population-based research. In discussing these six areas as well as offering specific considerations, this article offers a solid base from which future practical guidelines for informed consent in PGx research can be constructed. As such, this effort works toward filling the ELSI gap and provides ethical support to the numerous PGx projects undertaken by researchers every year.

Keywords:

pharmacogenomics research; informed consent; ethical considerations

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Introduction

In the wake of the Human Genome Project, pharmacogenomics (PGx), the study of variations of DNA and RNA characteristics as related to drug response,1 was predicted to quickly transform the practice of medicine.2, 3, 4 However, with the growing realization of the many hurdles involved along the path to clinical outcomes, this initial wave of optimism has been gradually replaced by a more nuanced perspective. Nevertheless, PGx remains a promising discipline that has the potential to improve clinical outcomes and reduce the incidence of adverse reactions; as such, it is relevant for broader health-care considerations.5, 6

Although the scientific research surrounding PGx has been relatively plentiful, the ethical research concerning this discipline has developed rather conservatively. Following a comprehensive international policy review, there was found to be a surprising paucity of policy work in this area when compared with other disciplines in biomedical science.7, 8 The limited number of specific ethical guidelines in PGx research is particularly concerning as it implies that PGx researchers must often resort to more general ethical policies and speculate on whether they are applicable or not to their research projects. As a relatively new research field, PGx can be seen as a merging of clinical drug trials with genomic research. As such, it also brings together the ethical issues from each area of research, resulting in a list of concerns that are similar to, but more challenging at times than the sum of each set. For example, the concerns surrounding informed consent become amplified as the amount of information necessary to ensure participant understanding increases. Can all the information simply be ‘stuffed’ into one (already lengthy) consent form or should two consent forms be offered? Completely new ethical dilemmas may not be created per se, but the relevant ethical concerns must be analyzed and discussed specifically with PGx research in mind in order to ensure a proper ethical consideration of this research field.

Following an extensive review of the ethical, legal and social issues (ELSI) of PGx research, and after consulting with key stakeholders (see the elaboration of methods in Figure 1), we identified six outstanding ethical issues raised by the informed consent process in PGx research: (1) scope of consent; (2) consent to ‘add-on’ studies; (3) protection of personal information; (4) commercialization; (5) data sharing; and (6) potential risks stemming from population-based research. The study of these six areas along with the considerations made should serve as a stimulus to reflect on and discuss the ethical issues surrounding this field. This article also offers a solid base, from which future practical guidelines for informed consent in PGx research can be constructed. For example, we are conscious that informed consent documents for genetic research in North America are already lengthy, and we aim for the information in this article to be used to improve the quality of the information conveyed to research participants without adding complexity or length. As such, this effort works toward filling the ELSI gap and provides an ethical framework to the numerous PGx projects undertaken by researchers every year.

Figure 1.
Figure 1 - Unfortunately we are unable to provide accessible alternative text for this. If you require assistance to access this image, please contact help@nature.com or the author

Schematic representation of the consultation process with stakeholders regarding the issue of consent in pharmacogenomic research. This process resulted in the identification of the six ethical issues addressed in this paper.

Full figure and legend (87K)Download PowerPoint slide (190 KB)

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Ethical issues in PGx research

Scope of informed consent

In PGx, the breadth of permissible research for a given study, also known as the scope of consent, remains controversial.9, 10 The root of the controversy is whether it is necessary to disclose to participants all the specific research objectives for which their samples will be used. Traditionally, both legal and ethical norms relating to consent in biomedical research require that, as part of the consent process, researchers disclose to participants the specific objectives for which their samples will be used.10 However, this process of ‘specific consent’ might be antiquated in the modern era of large-scale biobanks and longitudinal studies. PGx research could proceed more efficiently and the value of samples will be maximized if there are no restrictions on the use of collected samples for future, as of yet, unspecified projects.11 Moreover, the high costs of creating and maintaining a biobank12 should also be taken into consideration. The challenge, therefore, lies in striking a balance between respecting a research participant's autonomy by disclosing how his or her samples will be used in the research and maximizing scientific progress. Many policy documents and recommendations on PGx advocate a compromise between both interests.7 For example, regarding genetic studies, some authors suggest obtaining consent for a range of related studies over a defined period of time with specific consent for research projects that could pose particularly problematic issues to the research participant.13

Related to the issue of consent is the phenomenon of data anonymization. Some are of the opinion that the more ‘protected’ the data are, the less specific the consent needs to be.14, 15 Undermining this logic, however, is the fact that there are intrinsic limits to the degree of sample and data protection that can reasonably and functionally be achieved.16, 17 This argument for data anonymization, therefore, might no longer be adequate to support the practice of obtaining blanket consent from research participants, or even very permissive broad consent. Anonymization of data is also problematic because it does not allow for the addition of new information, or for the withdrawal by participants.

In light of the fragmentation of the many different criteria proposed in PGx and genomic policies relating to scope of consent, the harmonization of these positions is proposed.7 This will be particularly important for collaborative research projects that involve samples collected by different researchers in different countries.

Recommendations

  1. When relevant, informed consent forms for PGx research should clearly outline the possibility that samples could be used for future research. The scope of future testing should be described to the greatest extent possible.
  2. The implications of agreeing to broad consent should be clearly discussed with research participants. Ideally, they should be given the choice of participating only in the present research or in future research as well.
  3. Initiatives to promote a greater harmonization of policies on this topic should be undertaken by stakeholders.

Consent to PGx ‘add-on’ studies

Inherently linked to the issue of the scope of consent is the phenomenon of PGx ‘add-on’ studies. These studies are conducted in conjunction with clinical trials, but research subjects do not necessarily have to participate in these in order to be part of the clinical trial.7, 18 There are two general types of add-on studies: (1) a request is made to study specific genetic variants that are thought to be associated with the performance of the drug being investigated in the clinical trial; (2) a request is made to store participants’ DNA samples for a certain period of time following the completion of the clinical trial for future, as of yet undefined research. In and of themselves add-on studies are not troublesome per se; in fact, their addition to the main clinical trial could be a potential source of individual benefit for some participants (for example, by finding the genetic cause of certain adverse effects). This being said, for obvious reasons, research should still be clearly distinguished from clinical care. Thus, the question that arises is whether a single consent form can address both the clinical trial and the PGx add-on studies? The concern lies in the possibility that subjects may misunderstand the nature of the PGx research, believing that participating in the add-on study is necessary in order to complete the main clinical trial.

Some policy documents on PGx advocate using a second, separate consent form specific to the PGx add-on study.18 This makes it obvious that the research participant is free to choose whether to participate in the PGx study and that this decision will not bear upon his or her participation in the main clinical trial. An added reason to use a separate consent form is because of the sheer amount of information that needs to be included regarding both the ‘pharmaco’ and genomic sections. For example, in the ‘pharmaco’ portion of the study, information about the drug being used, and the way in which the drug will be assigned and administered in the treatment arm vs the placebo arm needs to be given adequate space in order to be properly explained. However, the Council for International Organizations of Medical Sciences states that as PGx research becomes more common in pharmaceutical studies, there will likely be a shift toward using a single consent form for both the clinical trial and the PGx inquiries.19 For example, some researchers claim that because of the likelihood that many drug responses have a genetic basis, it would be a waste of resources to perform a phase IV clinical trial without genetic testing and then conduct an entirely new trial to study the PGx aspects separately.11 Although PGx add-on studies might become commonplace in the future, until this occurs, research participants may be unfamiliar with this type of study and their option of opting out. Thus, researchers must ensure that participants are aware that they are free to abstain from the sub-study, without affecting their participation in the main clinical trial.

Recommendations

  1. It should be made explicit in the consent document that participants can opt-out of the PGx study, and that this choice will not impact their participation in the main clinical trial. This is particularly important for studies using a single consent form for both the clinical trial and PGx add-on.
  2. If only one consent form is provided, the sections describing each type of study (the clinical trial and the PGx research) and the respective signature sections should be clearly distinguished from one another physically in spatial and visual terms in the consent form.

Protection of personal information

Another important feature of the consent process is the issue of protecting personal information. This issue has come to the forefront of the ethical and legal debate in recent years in genetic and genomic research; this is a particularly important issue for PGx as there will not only be genomic information included, but also clinical/medical information. PGx researchers require access to a large number of samples in order to validate new biomarkers and translate interesting preliminary findings into concrete clinical applications.20 This entails data and sample sharing and, as such, this could raise issues concerning the protection of personal information.

Some industry researchers have argued that PGx information is not particularly sensitive health information.21, 22 However, other scholars have pointed out that PGx research, like other types of genetic research, could produce incidental findings (some of those related to susceptibility to disease, paternity, etc.) and that databases used in PGx are also vulnerable to third-party misuse (that is, governmental law enforcement agencies, insurers, employers and drug companies).23, 24 Moreover, in PGx, sample collections are often controlled by private pharmaceutical companies.25 This raises additional concerns regarding the long-term governance of the samples (for example, What will happen to the samples if a company becomes bankrupt or is sold?).

The issue of sample anonymization is also pertinent here. Studies by Lin26 and Homer17 demonstrate the limits of sample anonymization to fully protect the identity of research participants and the possibility of re-identifying individuals participating in genetics research. This being said, the risk of identifying an individual should not be overestimated. Very few people have the combination of skills, interest, information, equipment and disregard for ethics to actually re-identify participants from their genetic data.27 Thus, confidentiality breaches resulting in adverse consequences for research participants remain rare in the field to this day. For example, results from research on genetic discrimination in insurance have yet to demonstrate any misappropriation or substantial use of genetic research data by insurers.28 Moreover, cryptography and anonymization techniques are constantly improving. The adoption of sample coding terminology by the International Conference on Harmonisation (ICH)1 will make it easier for PGx researchers to convey information concerning the confidentiality of personal information to research participants.

Recommendations

  1. PGx researchers should be transparent and precise in their consent forms regarding the mechanisms they use to protect the personal identity and the data of research participants, including their strengths and limitations.
  2. Given the recent advances in bioinformatics and information technology, it should be recognized that sample anonymization no longer provides absolute confidentiality and privacy protection for research participants. The limits of anonymization should be explained simply and truthfully in consent forms to research participants.
  3. For greater clarity and harmonization, PGx researchers should adopt the established coding terminology of the ICH in their consent forms.

Commercialization

The pharmaceutical industry, initially reluctant to support PGx research, has progressively taken a keen interest in this emerging discipline.29 Several predicaments, including the end of the blockbuster drug era, and the need to compensate for recent losses of patent protection, along with growing legal and regulatory pressure, have all contributed to the industry's increasing commitment to PGx research.29, 30 Although there could be major benefits to having growing ties between academia and industry, it should be recognized that the commercialization of PGx also raises challenging issues that will need to be addressed by policymakers in order to preserve public trust in academic research. Within the context of the consent process these issues generally relate to conflicts of interest, commercial research and ownership of material/potential innovations.

Clinical research with PGx add-on studies seem to be particularly conducive to conflicts of interest30 because of the potentially close ties developed between industry and academia and the large sums of money involved in clinical trials and PGx biobanks. These conflicts could be prevented by a process of systematic disclosure to both ethics committees and research participants. Important conflicts could necessitate changes to the protocol or to the research team.

Questions relating to the commercial potential of PGx research projects and the ownership of material/potential innovations are usually addressed in a quasi-contractual manner by stipulating on the consent form the sponsor’s right to participants’ material, as well as to any innovation or financial benefit emanating from the project. Ethical guidelines, mostly originating from the private sector, suggest that this transparency is ethically sufficient.31 However, it is unclear how using a consent form as a contract to protect the researcher against any future claim by the research participant to their own material or to the financial outcome of the research can be beneficial for the latter. Although transparency in the research process is usually a positive element, it may not, in this particular context, always be sufficient to ensure the complete fairness of the process and to respect the dignity of research participants. The concept of benefit sharing, as introduced to the field of genetics by UNESCO32 and HUGO,33 provides an avenue worth exploring to reestablish a more equitable relationship between research participants, researchers and research sponsors in PGx research.

Recommendations

  1. A declaration of conflicts of interest should automatically be reported and regularly updated by principal investigators and co-principal investigators of all PGx research projects (including add-on studies). Any conflict reported should be communicated to the ethics committee.
  2. The participants should be informed of the commercial potential of any PGx research project and that their participation will not entitle them to receive financial compensation or future intellectual property rights.
  3. PGx researchers expecting to commercialize their research findings should consider including a benefit-sharing plan within research protocols.

Data sharing

As mentioned earlier, large numbers of samples and data are needed to validate PGx research findings.20 Sharing can be done by depositing the samples and data in a public or controlled access repository (for example, the NIH dbGaP, the Wellcome Trust Case Control Consortium) or through bilateral or multilateral agreements between researchers. Such sharing of data in PGx research raises challenges because the ethical guidelines are often not written with data sharing in mind.20 Moreover, research is governed at the local level, with ethical committees sometimes being a source of conflicting obligations for researchers.

However important for the progress of PGx research, data sharing should not be done without first obtaining informed consent from the research participants. Disregarding consent-related limitations in the sharing of data is unethical as it violates both the right to confidentiality and the right to integrity of research participants.16 The need to share data should be considered by researchers and research sponsors from the very onset of a research project. The information shown in Table 1 concerning data sharing should be present in the informed consent form.


Finally, researchers should ensure that their plan for data sharing does not come into conflict with their intellectual property policy (including those of their institutions and/or research sponsors).

Recommendations

  1. The possibility of sharing samples and data with other researchers or depositing them in a public repository should be considered from the onset of any research project and disclosed in the informed consent form.
  2. A minimum amount of information regarding the sharing and its repercussions should be disclosed to the research participants in the informed consent form (see Table 1).
  3. Applicable intellectual property and commercialization policies should be reviewed at the beginning of projects to ensure that they do not impede the sharing or deposit of the data and samples.

Possible risks stemming from group or population-based research

Owing to an interest in population-specific genetic variation, geneticists have often relied on population definitions such as race, ethnicity, religion, language, nationality, culture, and so on in order to categorize groups of individuals belonging to different populations.34 Whereas the problems relating to the specific use of racial and ethnic labels are important, they have previously been extensively reviewed and therefore will not be explored here.35, 36 Instead, we focus on the notion of harm to groups owing to PGx studies that may specifically label such groups in research protocols, publications/presentations and press releases regardless of the labels used as identifiers.

As opposed to individual risks to participants, collective risks posed by research studies (including PGx) to all members of a specific ethnic, racial, geographic or religious community have not been regularly addressed in the evaluation of a human subject's protection.37 This is disconcerting because, although it is claimed that PGx strives for ‘personalized medicine’, the truth is that it is the population differences that currently serve as the foundation for most PGx research.38 The crux of the matter is that PGx research can pose risks not only to persons who have chosen to participate in a research project, but also to other individuals who have not participated but share social associations or other commonalities with the research subjects.38, 39 Such group targeting in public health ‘may cause the group to be stigmatized or increase already existing stigma.’38 Furthermore, genetic results also have the possibility of undermining ‘established cultural or religious traditions or legal or political status.’40

Foster and Sharp37 discuss different types of collective culturally specific risks presented by genetic research involving population-based research (Table 2) that are directly relevant for PGx. The authors go on to suggest that in order to diminish such group risks, researchers should establish a dialogue with members of a study population in order to insure that they fully understand the study. They also propose that researchers should learn how members of diverse groups might perceive risk (especially intra-community risks, as these are particularly difficult to perceive by those who are outside of the target population).37


A concrete example of high-profile international research that specifically studied identifiable groups is the HapMap Project.41 The care and attention attributed by theAdministrative Committee of the HapMap Project to appropriately refer to HapMap populations, avoiding overgeneralizations and the singling out of specific groups, is illustrative of the considerable challenge raised by population-based research.40

Recommendations

  1. Researchers should establish a dialogue with representatives of population groups targeted in the study so that they understand the work being performed and its possible consequences. Their opinions and social dynamics should be considered in the study design (including consent forms) in order to reduce the risk of collective harm to the group.
  2. In the process of informed consent, publications/conferences and press releases, it is imperative to avoid vague or overly broad labels for the groups under study, so as to avoid misguided over-generalization. Furthermore, such groups should not be singled out specifically in such a way that would obscure the fact that other groups may also have the trait and/or be carriers of the gene under study.
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Conclusion

This document aims to fill the ELSI gap that exists within the field of PGx research, and more particularly within the specific area of consent in research. We have identified and discussed six key areas that are particularly relevant to the ELSI in this field. This discussion along with the proposed considerations should contribute to an active multidisciplinary reflection by all stakeholders (for example, ethics committees, researchers, funding bodies, policymakers, etc.) in order to eventually result in the development of much needed PGx consent guidelines. Ideally, these guidelines should be accompanied by concrete examples that would facilitate their implementation by researchers. We are aware that in some countries, such as the United States, there are no requirements for explicit consent under specific research protocols (that is, a sample from a deceased donor, or when samples are anonymous or anonymized). However, given the large number of research projects that do require consent (that is, considering human subject research in the United States), it is important that the consent process in PGx research supports and maintains respect for participants and offers them a clear and fair view of the implications of contributing their sample and time to participate in the development of a promising research field.

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Conflict of interest

The authors declare no conflict of interest.

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Acknowledgements

This work was made possible by a grant from Genome Canada and Genome Quebec held by Drs Tardif and Phillips. Dr Howard is funded by the European Commission FP7 Marie Curie initiative.