Regulatory Landscape of International Direct-to-Participant (DTP) Genomic Research: Time to Untie the Gordian Knot?
J. Law Med.&Ethics, 47(2):2019
14 Pages Posted: 25 Apr 2019 Last revised: 10 Sep 2019
Date Written: April 1, 2019
Genomic research, especially on rare disorders, has been facilitated by the online recruitment of potential participants. Through cooperative arrangements with disease-specific patient organizations and internet postings, it has become a more efficient way to attract interested patients and their caregivers than traditional recruitment through physicians and hospitals. Eligible participants from remote locations can participate in genomic research by supplying a sample for genome sequencing along with their electronic health records. International direct-to-participant research promises to greatly increase the number and diversity of participants for research on rare diseases, but recruitment across borders is often thwarted by laws prohibiting research participation without ethics review in each country. Such a process, an essential part of traditional research, becomes burdensome and infeasible to enroll only a few participants in many countries. Thus, although global recruitment is a promising strategy, much work remains to be done on devising methods that are legally compliant and ethically acceptable for this novel research.
Keywords: Direct-to-participant, Genomic research, Informed consent, International law, Online recruitment, Privacy, Rare disorders
JEL Classification: K31, K32
Suggested Citation: Suggested Citation