Certification for IRB Professionals (CIP) Practice Exam

What type of data requires additional consent to be disclosed when it includes identifiable information?

1. Aggregated data.

2. De-identified data.

3. Identifiable data concerning sensitive topics.

4. Publicly available data.

The correct answer is: Identifiable data concerning sensitive topics.

The correct choice highlights that identifiable data concerning sensitive topics requires additional consent for disclosure due to the heightened ethical considerations surrounding individual privacy and potential risks of harm. Sensitive topics can include areas such as mental health, sexual orientation, or substance abuse, where disclosing identifiable information could lead to stigma, discrimination, or other negative repercussions for individuals. In the context of regulatory frameworks, such as the Common Rule and HIPAA (Health Insurance Portability and Accountability Act), there are stricter guidelines for handling sensitive information, necessitating explicit consent to protect participants' privacy. This requirement reflects a commitment to ethical research practices and the safeguarding of vulnerable populations. Other types of data, such as aggregated data and de-identified data, do not carry the same risks and therefore do not require additional consent to the same extent. Aggregated data is typically anonymized and combined in such a way that individuals cannot be easily identified, while de-identified data has had identifying features removed, making it less sensitive. Publicly available data, on the other hand, does not inherently require additional consent because it is accessible to anyone.