# Regulation of International Direct-to-Participant Genomic Research

> **NIH NIH R01** · UNIVERSITY OF LOUISVILLE · 2020 · $478,055

## Abstract

Project Summary
New techniques for genomic research are being developed to take advantage of the ability to
contact research participants directly, without utilizing physicians, hospitals, or biobanks.
Researchers are now able to use the internet to recruit and enroll research participants in
genomic studies by using an online application and consent process. Participants send their
health records electronically and ship a sample of blood or saliva to the researchers. Although
this process has been approved by IRBs for domestic studies, it is unclear whether this process
is lawful for international research because of the diverse laws and policies of the countries
where the participants reside.
This research will study the important, but complex, question of whether international direct-to-
participant genomic research is lawful in a sample of 32 countries. It will also consider what
steps are necessary to facilitate this efficient, diversity-enhancing research while still protecting
the welfare of research participants.
The project has the following three aims:
Aim 1: 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.
Aim 2: 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.
Aim 3: 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.

## Key facts

- **NIH application ID:** 9858389
- **Project number:** 5R01HG009914-03
- **Recipient organization:** UNIVERSITY OF LOUISVILLE
- **Principal Investigator:** Bartha Maria M. Knoppers
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $478,055
- **Award type:** 5
- **Project period:** 2018-03-01 → 2022-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9858389

## Citation

> US National Institutes of Health, RePORTER application 9858389, Regulation of International Direct-to-Participant Genomic Research (5R01HG009914-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9858389. Licensed CC0.

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