CRS CRS Research Data Management & Security 1 — Questions and Answers
Question 1: What does HIPAA stand for, and why is it relevant to research data?
- Health Information Privacy and Accountability Act
- Health Insurance Portability and Accountability Act (Correct answer)
- Human Identifiable Patient Assurance Act
- Healthcare Information Protection and Access Act
Correct answer: Health Insurance Portability and Accountability Act
HIPAA (Health Insurance Portability and Accountability Act) includes a Privacy Rule that governs the use and disclosure of individually identifiable health information in research.
Question 2: Under HIPAA, a de-identified dataset is one from which:
- All data has been encrypted
- All 18 specified identifiers have been removed (Correct answer)
- Only the PI can access the data
- The data is stored in an offline system
Correct answer: All 18 specified identifiers have been removed
HIPAA defines de-identification as the removal of all 18 specified identifiers that could link health information back to an individual.
Question 3: What is a Data Management Plan (DMP) in research?
- A plan for performing statistical analyses
- A formal document describing how research data will be collected, stored, secured, and shared (Correct answer)
- A budget for purchasing data analysis software
- A required attachment to every IRB submission
Correct answer: A formal document describing how research data will be collected, stored, secured, and shared
A DMP is a formal document describing how research data will be managed throughout a study's lifecycle, including collection, storage, security, and long-term sharing.
Question 4: Which of the following is a best practice for securing sensitive research data?
- Storing data on personal USB drives for portability
- Using encryption and role-based access controls (Correct answer)
- Sharing login credentials among all team members for convenience
- Keeping raw data in email attachments for easy sharing
Correct answer: Using encryption and role-based access controls
Encrypting sensitive data and implementing role-based access controls are fundamental security practices that protect against unauthorized access.
Question 5: What is the primary purpose of a Data Use Agreement (DUA) in research?
- To authorize IRB review of a study protocol
- To specify the permitted uses and protections governing a shared dataset (Correct answer)
- To approve a study's funding from a federal agency
- To document participant consent for data collection
Correct answer: To specify the permitted uses and protections governing a shared dataset
A DUA is a legal contract between data providers and recipients that defines permitted uses, required protections, and limitations when sharing research datasets.
Question 6: The FAIR data principles in research stand for:
- Fast, Accurate, Integrated, Reliable
- Findable, Accessible, Interoperable, Reusable (Correct answer)
- Formatted, Archived, Indexed, Reviewed
- Funded, Approved, Institutional, Regulated
Correct answer: Findable, Accessible, Interoperable, Reusable
The FAIR principles guide researchers to make data Findable, Accessible, Interoperable, and Reusable to maximize scientific benefit and data utility.
CRS CRS Research Data Management & Security 1
What does HIPAA stand for, and why is it relevant to research data?