A template for broad consent in biobank research. Results and explanation of an evidence and consensus-based development process.

BACKGROUND: Biobanks increasingly presume long-term storage of biomaterials and data that shall be used for future research projects which are today unspecified. Appropriate consent documents for sample donors must therefore explain the breadth of consent and other elements of the biobank governance framework. Recent reviews demonstrated high variability in what issues these documents mention or not and how the issues are explained. This might undermine the protection of sample donors, complicate networked biobank research, create research waste and impact on public trust. METHODS: A systematic analysis of international research guidelines and existing broad consent templates was performed. Based on this information an interdisciplinary expert group from the AKMEK (Permanent Working Party of German RECs) developed a draft template and organized a comprehensive stakeholder consultation. After revision the final template was consented by all 53 German RECs. RESULTS: This paper briefly explores the spectrum of potentially relevant issues for broad consent forms. It then elaborates the template and how it was designed to be applicable in different types of biobanks. DISCUSSION: To further improve the validity and applicability of broad consent forms in biobank and other big data research, practice evaluations are needed. We hope that in this regard the presented template supports the development of new consent forms as well as the evaluation and revision of existing ones.

The necessity of broad consent and complementary regulations for the protection of personal data in biobanks: what can we learn from the German case?

In order to follow population-based approaches for certain causes and risks of illnesses, more and more biobanks have been set up during the last years. Here, samples and personal data of the donors are collected and saved, whereby concrete research aims, at the time of storage of the bio-probes and the related data, are mostly undetermined. Biobanks, therefore, have the character of a collection of material and data that can be used for initially undetermined research projects. Under legal aspects the question arises whether the data subjects can consent only to an already determined use of their samples and data or can consent to a general use for research. In this article, we discuss the validity of broad consent and in how far the arising deficits in data protection need to be and can be compensated. Broad consent is, in our opinion, generally legally valid. It leads, however, to an encroachment of the ruling basic principles of data protection law. The 5-pillar concept of the German Ethics Council therefore suggests additional regulations to compensate the lacks of broad consent. While other recommendations and opinions - as far as can be seen - do only describe in vague terms the conditions for statutory regulations, the opinion of the German Ethics Council comprises very concrete statements. It, therefore, might serve as a model in the international debate on privacy and biobanks. As a result of the current debate, we identify this as a paradigm shift in data protection in biobanks.

[Ethical and legal aspects of including patients unable to consent in acute therapy studies. Example of a medication study for the treatment of intracerebral hemorrhage--the Heidelberg procedure]. / Ethische und juristische Aspekte beim Einschluss nicht einwilligungsfähiger Patienten in Akuttherapie-Studien. Beispiel einer Arzneimittelstudie zur Behandlung intrazerebraler Blutungen--das Heidelberger Verfahren.

Clinical trials in patients who cannot sign an informed consent are only possible under certain circumstances. The present paper explains the legal prerequisites and ethic rationales, which may allow including patients in such a trial without having signed informed consent. Translation of these prerequisites into practice needs the implementation of special inclusion procedures. These procedures will be explained using the example of the recombinant factor VIIa (rFVIIa) trials for intracerebral hemorrhage.

The conflict of understanding the genetic make-up of man and his knowledge of it.

The rapid development within the research of the human genome offers a great potential with regard to the diagnosis of genetic diseases but it also bears dangers of misuse. The starting point for avoiding these dangers is the autonomy of the individual, i.e. that the information about his genetic constitution should only be ascertained with his explicit consent. It is the duty of law to protect the individual and his relatives - who might also be concerned - without undermining the right to self-determination. Furthermore, it is discussed whether genetic tests should be limited to "health purposes" only. The problem of this limitation, however, is to define the term "health purposes" particularly when the criterion of "quality of life" is also taken into consideration. In order to assure a responsible handling of the genetic data, genetic analysis and especially the counselling of the subject should be reserved to the medical profession, since only a real understanding of the individual's genetic constitution with all risks and chances will enable him to make an informed and self-determined decision.

[The right not to know, in the German legislation (Part I)]. / El derecho a no saber en la legislación alemana (parte I).

The right not to know entails being aware of a reality which corresponds to the mental representation one makes of a circumstance through external sensory perceptions or through intellectual actions from which one derives conclusions. The author discusses the different manifestations of this right not to know, from the right not to be informed to a general right of waiver.