Abstract
BackgroundThe work of Research Ethics Boards (REBs), especially when involving genetics research and biobanks, has become more challenging with the growth of biotechnology and biomedical research. Some REBs have even rejected research projects where the use of a biobank with coded samples was an integral part of the study, the greatest fear being the lack of participant protection and uncontrolled use of biological samples or related genetic data. The risks of discrimination and stigmatization are a recurrent issue. In light of the increasing interest in biomedical research and the resulting benefits to the health of participants, it is imperative that practical solutions be found to the problems associated with the management of biobanks: namely, protecting the integrity of the research participants, as well as guaranteeing the security and confidentiality of the participant's information.MethodsWe aimed to devise a practical and efficient model for the management of biobanks in biomedical research where a medical archivist plays the pivotal role as a data-protection officer. The model had to reduce the burden placed on REBs responsible for the evaluation of genetics projects and, at the same time, maximize the protection of research participants.ResultsThe proposed model includes the following: 1) a means of protecting the information in biobanks, 2) offers ways to provide follow-up information requested about the participants, 3) protects the participant's confidentiality and 4) adequately deals with the ethical issues at stake in biobanking.ConclusionUntil a governmental governance body is established in Quebec to guarantee the protection of research participants and establish harmonized guidelines for the management of biobanks in medical research, it is definitely up to REBs to find solutions that the present lack of guidelines poses. The model presented in this article offers a practical solution on a day-to-day basis for REBs, as well as researchers by promoting an archivist to a pivotal role in the process. It assures protection of all participants who altruistically donate their samples to generate and improve knowledge for better diagnosis and medical treatment.
Highlights
The work of Research Ethics Boards (REBs), especially when involving genetics research and biobanks, has become more challenging with the growth of biotechnology and biomedical research
We present a practical model for the management of biobanks in biomedical research, which could alleviate the burden placed on REBs who are trying to evaluate genetics projects and at the same time, maximize the protection of research participants
A few years ago, the American Society of Human Genetics described four types of identification of samples for research purposes: a) anonymous: biological materials that were originally collected without identifiers and are impossible to link to their sources; b) anonymised: biological materials that were originally identified, but have been irreversibly stripped of all identifiers and are impossible to link to their sources; c) identifiable or coded or traceable: biological materials that are unidentified for research purposes, but can be linked to their sources through the use of a code
Summary
The work of Research Ethics Boards (REBs), especially when involving genetics research and biobanks, has become more challenging with the growth of biotechnology and biomedical research. BMC Medical Ethics 2006, 7:4 http://www.biomedcentral.com/1472-6939/7/4 the mandate to approve, reject, propose modifications to, or terminate any proposed or ongoing research involving human subjects which is conducted within, or by members of, the institution, using the considerations set forth according to the Tri-Council Policy as the minimum standard. It was accurately stated that "Institutional Review Boards have considerable experience in dealing with issues of recruitment, informed consent, confidentiality, and balancing risks and benefits. With the advancement of biotechnology and the growth in biomedical research, the role of REBs has become more complex, especially regarding research in genetics and related biobanks. The competence of REBs has been extended "to protocols potentially affecting the physical integrity, and the identity (social and familial) of an individual, bringing psychological and spiritual aspects to the forefront" [4]
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