Kinetiq Attends NIH-Supported Summit on International Genomic Research
Times and technology change rapidly, and ethical regulation of next-generation research methods must adapt as well. With a simple cheek swab, participants can self-collect genomic data and ship it to almost anywhere in the world. Recently, the National Institutes of Health (NIH) approved a grant to the University of Louisville to identify and prioritize the ethical issues involved in the international collection of genomic data. Key among their concerns is the ability of researchers to contact participants directly, and collect data without the use of hospitals, physicians, or biobanks; thereby eliminating typical sources of oversight. Kinetiq expert Dominic Chiarelli attended this meeting to discuss the implications for research.
Three Major Goals as Stated by the Grant
- Convene three expert working groups of researchers and IRB leaders to identify and prioritize the key issues for a standard questionnaire and template to distribute to the study’s 32 international experts on country-specific laws and research ethics.
- Distribute the questionnaires to the international experts, consult with and advise them as they prepare their responses to the questionnaires and summaries of country-specific legal and ethical issues, compile and analyze the responses, and draft conclusions and policy options.
- Distribute the draft conclusions and policy options to the three expert working groups, international consultants, and advisory board members, and obtain their feedback; analyze the responses and use them to prepare a final draft; write and publish articles presenting the findings of the study; and disseminate the results in presentations to various groups of stakeholders.
Considerations for Research:
- Current regulatory structures significantly predated the technology necessary to conduct this type of research, and yet required investigators and ethics review boards to ensure the research they conduct and review be acceptable under theregulations, applicable law, and standards of professional conduct and practice.
- The planned guidance must address a critical question of how to establish whose laws apply; those of the researcher or the research participant, and when to assist researchers in avoiding running afoul of country-specific rules and regulations and what additional role should community beliefs play in this calculous.
- A framework must be developed governing use of the internet to recruit and/or collect information from research participants across international borders.
- A framework must be developed for governance of such materials once collected to ensure subsequent uses remain within participants’ prior informed consent and cultural beliefs.
Recent concerns with privacy risks from online communities and forums suggest this work is long overdue. With research, technological credos like “fail fast and worry about consequences later” are not palatable and can prevent meaningful and well-intentioned research for decades. This important work will build on the legitimacy of the research enterprise and will, in particular, boost efforts to study and address rare diseases. Kinetiq was proud to take part as Kinetiq has received and assisted with many inquiries regarding the considerations necessary to conducting international based research and how best to approach ethics review and compliance with country-specific laws and regulations.
For more information about the grant, please click here: http://grantome.com/grant/NIH/R01-HG009914-01