Legal and Ethical Challenges of International Direct-to-Participant Genomic Research: Conclusions and Recommendations

Abstract

Direct recruitment of participants using the internet has proven to be an effective strategy for increasing the number and diversity of participants in genomic research, especially research on rare diseases. Institutional review boards and research ethics committees (RECs) have approved this strategy for domestic research, but they have been reluctant to approve it for international research because they do not know whether it is legal to use direct recruitment in other countries without obtaining approval from an REC in each country from which participants may be enrolled. To inform this question, we obtained legal and ethics opinions from experts in 31 diverse countries, and their responses to our standard questions are separately published in this symposium. Although none of the countries has a law specifically addressing this emerging issue, it appears that local ethics approval would be required in many countries. This article presents the argument that single-site ethics review in the researcher’s country will facilitate this valuable research while still protecting the welfare and interests of participants and their countries.

Keywords: direct-to-participant research, Genomic research, international law, international research, IRBs, Research ethics

JEL Classification: K31, K32