Be Sensitive About the Use of Sensitive Data
When a study seeks to answer a research question that is directly related to sensitive information, it’s usually easy to determine what data you’ll want to collect, and why it’s important to answer the research question. Other times, the need to access sensitive data will only arise sporadically. This can be the case when tracking such metrics like health care utilization that can encompass data from a wide range of health care interactions. In these cases, it becomes more likely that sensitive information will be captured in some form; more so if you’re accessing a large data set. Thinking about what kind of data is and is not useful to answering your specific research question during the planning phase of your research can help you to anticipate when and how to justify the use of sensitive information. This will help you and the IRB meet the ‘Minimum Necessary’ standard of HIPAA regulations. Remember, if you have appropriate security measures in place, the IRB is unlikely to restrict the use of sensitive data, but it’s important to have the rationale documented in the protocol.
Sensitive data includes collecting information from research subjects such as:
- Genetic test results
- Sexual attitudes and/or activities
- HIV/AIDS, and other sexually transmitted diseases
- Use of alcohol, drugs, or addictive products
- Mental health diagnosis and/or records
- Visits designated “confidential” in HealthConnect
- Illegal conduct, which could reasonably lead to social stigmatization, discrimination, or legal proceedings and/or, if disclosed, could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation
You can ensure you’re familiar with how to handle sensitive data by reviewing either of our protocol templates, under Privacy, Confidentiality and Data Security. Note that we’ve recently added a new category to account for member encounters or visits designated “confidential” in HealthConnect. As always, if you have any questions about the use of sensitive data in research, contact your friendly neighborhood IRB Coordinator.