Evaluation of biobank constitution and use: multicentre analysis in France and propositions for formalising the activities of research ethics committees

Abstract

Biobanks are collections of biological material and related files gathered and stored for clinical or research purposes. Here, we investigated the questions raised during the evaluation of biobanks by biomedical Research Ethics Committees (RECs), particularly in the context of genetic research. We sent a questionnaire to all RECs in France to survey their concerns and the ethical criteria used when evaluating research involving the storage of biological samples. Most of the RECs think that they should be consulted to evaluate the constitution of biobanks. The proportion of RECs of this opinion depended on whether the biobank is being constituted in the absence of an associated research project (initially created for clinical purposes or for undefined research) (14/28), whether the biobank is being constituted for research use (21/28) or whether an existing research biobank is being re-used (19/28). Views diverged concerning the way ethics principles are applied, showing that REC evaluations of biobanks might be formalised at each of the following steps: constitution, use and re-use. In this paper, we suggest concrete elements that could be integrated into the application of the new French law concerning the protection of the human beings participating in research as well as into international recommendations.

Introduction

Historical grounds, together with the development of biomedical research involving humans, led to the institution of Ethics Committees. These committees were officially created in 1975 in the Helsinki Declaration [29].

In France, a law passed in 1988 [13] led to the constitution of research ethics committees (RECs) for the protection of persons participating in biomedical research. There are now 48 such committees, each serving a defined geographical area. These committees are independent in their selection of members and in their finances. Members are drawn from groups representative of medical research, medical practitioners, universities, various major disciplines, and law. The recommendations formulated by the committees are transmitted to the Ministry of Health, which can independently review an opinion when judged necessary [13], [14]. The role of the committees, as defined by law, is to evaluate the validity of research, particularly as concerns: the protection of participants, informed consent of participants, methods of obtaining consent, financial compensation, general relevance of the project and whether the available means and the qualifications of the investigators involved are appropriate to meet the aims.

All biomedical research must be approved by an REC. It is not clear whether the evaluation of biobanks is part of the mission of the RECs and if so, in what way. A biobank can be defined as a group of biological samples (or biological by-products) that may consist of solid tissues, blood, saliva, or any other tissue or fluid containing nucleated cells. The biological samples are associated with files, often computerised, that may include the origin of the donors, clinical data and biological data [4], [6], [11]. These data may be identified, identifiable, directly anonymous or anonymised [18]. The way in which the files are handled differs according to the type of research. The term “biobank” covers all of the activities concerning the management of human biological samples and files including their transfer and access.

Following the development of biobanks, French official reports suggested that RECs should evaluate the constitution and storage of biological samples. In 1994, the Louisot Report [22] stated that “...the constitution of the collection…requires the opinion of the REC” and in 1998, the report of the French National Consultative Ethics Committee (CCNE) stated that “…this agreement will take into account measures involved in the collection, storage and abusive use (such as use in the context of employment, insurance…) of samples and any information concerning them” [5].

A number of studies have highlighted the ethical and legal issues raised by the constitution of biobanks, including the organisational and medical responsibilities [3], [8], [9], [10], [23], [24]. We have previously evaluated [4], [27] how the French RECs feel they are and should be involved in the constitution and use of biobanks, which ethical rules they believe are essential for the protection of persons and to what extent this is integrated into current practice. The aim of the present study was to identify current difficulties in the functioning of the committees. We used a questionnaire to examine whether the RECs consider that the constitution of a biobank requires their approval. Twenty-five of the 28 RECs that answered think that they should be consulted for the constitution of biobanks, but in practice, only 18 conduct such evaluations. The RECs believe that they should, and do, consider the content of the consent form, the information given to participants and confidentiality. Interestingly, elements such as uses of a biobank, its fate at the end of the study and the ways in which research results are communicated to participants are not evaluated although RECs think that they should be.

The goal of the present study is to define the roles and means of the RECs in the evaluation of biobanks. Our results focus first on the way RECs evaluate different types of biobank in the context of human genetics research, and second, on proposals that can be made to formalise these evaluations.