A primer for managing international collaboration and legal compliance in biobank based genomics
- Published
- Accepted
- Subject Areas
- Genomics, Ethical Issues, Legal Issues, Science and Medical Education, Medical Genetics
- Keywords
- Ethics, genomics, biobank, law, training, biospecimen, personal data, consent, incidental findings
- Copyright
- © 2016 Klingström et al.
- Licence
- This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, reproduction and adaptation in any medium and for any purpose provided that it is properly attributed. For attribution, the original author(s), title, publication source (PeerJ Preprints) and either DOI or URL of the article must be cited.
- Cite this article
- 2016. A primer for managing international collaboration and legal compliance in biobank based genomics. PeerJ Preprints 4:e2091v1 https://doi.org/10.7287/peerj.preprints.2091v1
Abstract
Legal & ethical compliance when sharing biospecimen across borders is a complex topic where few researchers can claim a high degree of competence. Therefore most major research projects now contain a component with dedicated experts on research ethics. But in most jurisdictions researchers still have a legal, as well as moral, duty to ensure that their research adhere to national standards and regulations. This review aim to strengthen the position of researchers by helping them to better understand the complex relationship between national law, the soft law mechanisms whereby these laws are enforced and the critical issue of how international research currently rely diffuse soft law mechanisms to enable collaborative research and the transfer of potentially sensitive information across national borders. By having an at least basic understanding of these topics researchers are better positioned to make autonomous decisions and communicate with experts who possess an in-depth knowledge of the issues described in the article. In such a context it is important for a researcher to understand how laws and ethics interact to enforce the basic concepts such as informed consent and the reporting of planned or incidental findings. But it must also be realized that even if such issues are important, they are not the core topic of interest to most researchers and this review should be seen as a basic primer to collaborating with experts rather than as a replacement for experts.
Author Comment
This is primer on how to maintain ethical & legal compliance in research where biospecimen are shared across national borders. For many researchers this is a frustrating and unnecessarily complex challenge as they lack the knowledge to communicate efficiently with experts in the field and lack access to written sources targeting people with significant experience in natural science but little exposure to social science or law. The aim is to provide researchers with an introduction to the subject and help them manage issues commonly faced by researchers who handle samples that contain personal data in form of metadata or genomic information. Researchers and ethicists related to the B3Africa project have been invited to contribute to the final development of the primer but all people interested in the topic are welcome to contribute with feedback.
Supplemental Information
Table 1: Forms of consent described in literature
Terms used in literature are not always univocal and may also be used with different levels of specificity. In the table, the specific definitions described by the authors have been clustered into more general of consent described in accordance with this article. The more specific definitions are listed in the column “Definition”, the terms used to name them are outlined in “Type of consent” and “Disagreement”.
Figure 1: Reciprocity of findings
a breakdown of potential situations encountered when conducting genetic analysis on collected samples and practical examples of cases clearly belonging to each quarter.
