Compliance and Legal Issues

Some research topics have extra considerations that could affect your data management choices. Do you conduct research with human subjects? Do you create research products that have intellectual property concerns or commercialization prospects? If so, see the relevant information on this page.

Compliance

Emory’s Office of Research Compliance and Regulatory Affairs (RCRA) oversees all matters on campus for complying with regulations, including research funded by federal agencies like the National Institutes of Health (NIH) and the National Science Foundation (NSF). They provide training and consultations for investigators and others involved with sponsored research at Emory:

Human Subjects Research

Institutional Review Board (IRB)

When preparing to collect data from human subjects, consult with Emory’s Institutional Review Board (IRB). Their templates for informed consent forms will help ensure you consent all subjects in a way that allows for future data sharing where appropriate:

HIPAA Compliance

Several units at Emory fall within scope of the “Emory Covered Entity” as health care providers. Researchers employed in or working with these units must follow the rules and regulations of the Health Insurance Portability and Accountability Act (HIPAA). If your research data will be subject to HIPAA, it’s best to familiarize yourself with the rules and resources to support compliance at Emory:

Clinical Research

For clinical trials and research studies on the effects of different controls on human subjects, researchers should work with Emory’s Office for Clinical Research (OCR). To check if your study should be reviewed by the OCR, consult their resources:

Software for Research using Identifiable Information

List of services that have been reviewed and approved by Emory's Office of Information Technology (OIT) for processing and storing Identifiable Information as electronic data, including ePHI. Even though these services have been reviewed, you are still responsible for ensuring that your use of them meets all of Emory’s applicable IT security and HIPAA policies, as well as any applicable rules of behavior.

Intellectual Property

Office of Technology Transfer (OTT)

If your research is likely to generate products with intellectual property or commercialization prospects, Emory’s Office of Technology Transfer (OTT) aids in the innovation disclosure process and related matters.