Data is considered sensitive when disclosure of identifying information could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation. This includes information related to alcohol or drug use, traumatic experiences, child/elder abuse, or illegal behavior, or where disclosure outside of the research study has the potential to place participants at risk of criminal or civil liability or be damaging to their financial standing, employability, educational advancement, or reputation.
If your project involves the collection of sensitive data, it might not qualify for exempt review. It will depend on whether the disclosure of the information would put subjects at more than minimal risk and if the privacy and confidentiality protections you have in place limit this risk. You will be asked to describe the steps you are taking to limit risk to subjects on the application. Common procedures include:
- Allowing subjects to skip questions that make them feel uncomfortable.
- Disclosing in the consent form the type of questions that may induce emotional distress, etc. Also, providing a list of resources subjects can utilize should the need further help dealing with their distress.
- Providing subjects with a copy of the questions in advance.
- Collecting data anonymously OR using pseudonyms so that identifiers are not stored with their data.
- Obtaining a Certificate of Confidentiality
- If your project involves the collection of sensitive data that could put subjects at risk of criminal or civil liability, you may be asked to obtain a Certificate of Confidentiality (CoC) from NIH. CoCs are issued to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level.
- NIH funded researchers are automatically issued a CoC through their award. Other Department of Health and Human Services (HHS) agencies issue CoCs to researchers they fund. Researchers not funded by HHS can continue to apply to NIH or the FDA as appropriate to request a CoC for HHS-mission relevant research.
- Researchers must inform participants in the consent document of the protections and limitations of certificates of confidentiality. Typically, this is added to the “Will information about me be kept private?” section of the consent. See our “Example Consent Text for Study-Specific Items” in the templates section of our Researcher Resources page.
The IRB staff would notify you if you submitted exempt, but the study needs to be bumped to expedited or full board review.