What About Sharing Research Data?

In 2007, the National Human Genome Research Institute (NHGRI) established the Electronic Medical Records and Genomics (eMERGE) Consortium to develop, disseminate, and apply approaches to research that combine DNA biorepositories with electronic medical record (EMR) systems for large-scale, high-throughput genetic research.

As you can imagine, sharing research data presents technical, administrative, and ethical challenges in a world that seems to be divided into those who want to primarily protect and those who want to primarily share their information. Resolving the tension is a major challenge and opportunity to advance genetically and genomically based treatments and diagnostics.

A partial list of issues include:

1. Complying with rules and regulations.

2. IRB approval processes.

3. Intra- and inter-institutional barriers and firewalls to data exchange.

4. Ethical obligations to community partners when sharing data with others.

5. Data decision rights concerning who should decide which data to share with whom.

6. EMR clinical and research data interfaces.

7. Privacy, security, and confidentiality.

8. How to disseminate information and encourage stakeholder engagement.

9. Concerns about sharing data with commercial entities.

10. How to harmonize data across sites and large research consortiums.

Sharing big clinical data has its own set of challenges. Add to that sharing and integrating big research data and things start to get interesting.

The Society of Quality Assurance will be hosting their National Data Integrity Conference to chew on some of these issues in Denver in a few months. Given the complexity of the issues, my guess is that it will take a while to digest everything and some parts will be hard to swallow.