What Are Some of the ELSI Challenges of International Collaborations Involving Biobanks,Global Sample Collection,and Genomic Data Sharing and How Should They Be Addressed?

Abstract

Many medical research studies require the transfer of human biological material and associated data between biobanks across the world. Ensuring compliance with various national ethical and legal frameworks may be a challenging task.¹ Organizations such as the European Commission,² the European Research Infrastructure Consortium (ERIC),³ the United Nations Organization for Education, Science and Culture (UNESCO),⁴ and the United States Department of Health & Human Services⁵ have therefore established online resources for providing researchers with information on various national ethics and legal documents and organizations. Knowledge about and access to such resources is useful for planning an international biobank collaboration, but not sufficient. As in most complex issues, the devil is in the details—and these details may be difficult to obtain and understand.

Data Acquisition Modes

To obtain details on how a particular ethical and legal issue (such as the management of incidental findings) is to be managed in various countries, four methods for data acquisition can be considered in the planning stage:

• Searching relevant national public websites

• Contacting national public bodies

• Contacting (national) ethics committees

• Contacting individuals with particular knowledge on the issue in question

In 2013, we conducted a pan-European survey on how the duty-of-care principle for return of research results introduced by the Council of Europe in the Additional Protocol to the Convention on Human Rights and Biomedicine in 2005⁶ had been implemented into national legislation. Embassies and National Ethics Committees from 29 European countries were formally approached and information requested. In addition, information was sought from public websites. Relevant information for a comparative legal analysis was obtained from just three of the 29 countries. Despite using this multi-faceted approach, we failed to obtain sufficient data for a comparative legal analysis. A very low response rate from national public bodies and a multitude of different languages (>20) made searching for in-depth information a daunting task. Our experience was that searching relevant national public websites has two major drawbacks: most such websites only offer information in the native language, and this information tends to be on a general level. Even if one masters 20 or more languages, the search may not provide the details needed for an appropriate research protocol. With respect to national public bodies and ethics committees, those few that actually responded to the survey rarely provided the details needed.

We, therefore, recommend that anyone planning an international study using human biological material and associated data engage with individuals having sufficient linguistic skills and in-depth knowledge on the ethical and legal issues in question in each participating country to ensure that all relevant ethical and legal issues are thoroughly investigated before a formal application is submitted to the various national approval boards.

Conclusion

Ensuring knowledge about and compliance with various national ethical and legal frameworks in multi-national biobank projects requires engagement with national experts. In addition, efforts are needed to provide more detailed information about the various requirements globally for the collection, storage, distribution, and use in each country to facilitate multi-national research and global specimen and data sharing.

References

Goebel

, Pickardt

, Bedau

, et al. Legal and ethical consequences of international biobanking from a national perspective: the German BMB-EUCoop project. Eur J Hum Genet, 2010; 18:522–525.

Ethic Links. European Commission. http://ec.europa.eu/archives/bepa/european-group-ethics/ethics-links/index_en.htm. Last accessed 12 June 2014 .

Biobanking and Biomolecular Resources Research Infrastructure - European Research Infrastructure Consortium. http://bbmri-eric.eu/. Last accessed 12 June 2014 .

Global Ethics Observatory. Paris: The United Nations Organization for Education, Science and Culture (UNESCO). http://www.unesco.org/new/en/social-and-human-sciences/themes/global-ethics-observatory/access-geobs/. Last accessed 12 June 2014 .

2014 Edition of the International Compilation of Human Research Standards. Washington, DC: U.S. Department of Health & Human Services. http://www.hhs.gov/ohrp/international/index.html. Last accessed 12 June 2014 .

Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research. Strasbourg: Council of Europe; 2005. http://conventions.coe.int/treaty/en/treaties/html/195.htm. Last accessed 12 June 2014 .