Ethical Issues of Informed Consent with Data Sharing in Biobanks and Databases

Course: BTEC 502

Instructor: Professor Ma’n H. Zawati

Author: Esteban Levesque

McGill ID: 260955869

Research Essay

Ethical Issues of Informed Consent with Data Sharing in Biobanks and Databases

Introduction

Over the last decades, the development of healthcare and technology brought forward new innovations in order to make data more accessible to scientists that want to conduct different types of research. This evolution was in part possible due to the apparition of what is called data sharing. There is still no clear definition of what data sharing is, but professionals agree to say that it includes the deposition and preservation of data but that it is mostly related to the access of used and reused data. Another way to define data sharing is that it is the action of sending data, receiving data or both. Data sharing can be considered as beneficial in a lot of fields. For example, with a good utilisation of the data, data sharing permits a great evolution in science but also health. This can be explained by the utilisation of the same data in different kind of research. However, data sharing also have its defaults and problems. If, for example, the data used for the research is of poor quality or is eroded, the impact on the science and health will be even worse than normal. This can be explained that, if the data is of poor quality, then the results of all the different research where it will be used will be false or not accurate. Another default of data sharing is that there are a lot of ethical concerns with it which we will see right after with biobanks and databases. Since its creation, a lot of types of databases have been created. We can define those as a collection of information that is collected in computer systems and can be accessed easily through a computer. One of those databases emerged in the late 1990’s and is called a biobank. Biobanks can be defined as a biorepository that receives, exercises, distributes and stocks biospecimens and data associated with it for the use of research. To be clearer, we can state that biobanks correspond to a bank that stores biological samples for the use of research. We can say that data sharing and biobanks are closely related because, all the data used in research that imply data sharing is stocked in biobanks. Therefore, different ethical issues related to both appear. The first one is informed consent. We can define informed consent in research as the procedure in which a patient is informed of the risks, benefits and the different options of a given procedure or intervention. It is the process in which the patient can make a voluntary decision regarding the utilisation of its data with an understanding of how it will be used. Informed consent can be identified as an ethical issue for both biobanks and data sharing regarding the utilisation of the data and how it is transmitted from one research to another. Another ethical issue that can be associated with biobanks and data sharing is public trust. Public trust can be defined as the level at which the public believes that professionals and their profession will act in the public interest. In the case of data sharing and biobanks, we can say that public trust is related to the utilisation and the pertinence of the data. If, for example the data collected is of poor quality or if the data is used in a way to harm people, then the public trust will be lost. As data sharing consists of the utilisation of data stocked in biobanks for different purpose, public trust might not be acquired that easily. The third ethical issue that we will be talking about is privacy and confidentiality. Privacy and confidentiality can be defined by the article nine of the UNESCO Universal declaration of bioethics adopted in 2005: “The privacy of the persons concerned, and the confidentiality of their personal information should be respected. To the greatest extent possible, such information should not be used or disclosed for purposes other than those for which it was collected or consented to, consistent with international law, particular international human rights law.” Privacy and confidentiality can be identified as an ethical issue for data sharing and biobanking because of the big circulation of the data after the patient has given its consent.

The Importance of Informed Consent

        What we will see now is that informed consent can be considered as a more important ethical issue than public trust or privacy and confidentiality. First, we can agree to say that if there are problems regarding informed consent with data sharing and biobanks, the people that would have less trust in the system to share their data. This would impact greatly public trust and we can say that public trust is in part related to the respect of informed consent and the clear understanding of the situation from the patients. If, for example, the data would come to be used in another way the sharer thought, their trust in the professionals would decline. Therefore, we can say that public trust is in partly acquired with the respect of informed consent. We can say that informed is more important than public trust for biobanks and data sharing. If we now look at the third ethical issue stated in the introduction, privacy and confidentiality, we can also say that it is closely related to informed consent. To begin with, informed consent consists of informing the patient on how its data will be used in the future. When we talk about privacy and confidentiality, we will be looking at how the data will be preserved and stocked in order to keep the patient information stocked and private. Therefore, if informed consent is not respected correctly, the data might lose its privacy but also its confidentiality if, for example, the results of some research that used it was made public and non-anonymous. We can say that privacy and confidentiality is acquired only if informed consent is respected. The importance of informed consent with data sharing and biobanks is more consequent than both public trust and privacy and confidentiality because if we look at the two of them, we see that they are both dependant of informed consent. Therefore, we will be looking at informed consent in data sharing with biobanks and database in this essay.

Bioethical principles at stake

Data Sharing, biobanks and informed consent

        When we look at biobanks, we see that there are only two types of informed consent that are being applied with them. The first one is specific consent. Specific consent can be defined as a consent where the patient giving its data has the obligation to know the research objective but also the relevance of its data. It is also required to have a clear explanation on the data will be used for the research. The other form of consent used with biobanks and the one that is the most utilised is broad consent. Broad consent is a lot less restrictive than specific consent. It permits a better accessibility of the data from other researchers. We can define this kind of consent by the citation: “Broad consent, as understood here, is consent obtained at the time of enrolment in the biobank against a background of assurances about the overall scope and aims of the biobank as well as its governance” [1]. As broad consent is the most used for biobanks, we will look at the different bioethical issues associated with it and see in what way it can be resolved. When we look at the definition of broad consent, it is possible to identify two types of bioethical principles that are at stake here. The first one is principle of respect for autonomy and the second one is the principle of nonmaleficence. We will see in what way there are both related to broad consent and the potential issues associated with them. We will then look at different solution to solve these problems and what would be the best option to follow in the end.

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