From the Guidelines
The correct option is E. A, B, and D. To ensure the confidentiality of research participants, proper practices include disposing of paper documents containing identifiers, requiring passwords for computerized records, and storing paper records in secure places 1. Option C (using a participant's SSN instead of their full name) is actually not a good confidentiality practice, as SSNs are sensitive personal identifiers that require even greater protection than names. Using SSNs as identifiers increases rather than decreases confidentiality risks. Good confidentiality practices focus on limiting access to identifiable information through physical security measures (locked cabinets, secure rooms), electronic protections (password requirements), and proper disposal of sensitive documents when they're no longer needed. These measures are essential for maintaining participant trust and complying with ethical research standards in clinical trials.
Some key points to consider when ensuring confidentiality include:
- Disposing of paper documents containing identifiers in a secure manner 1
- Requiring passwords to access computerized records to limit access to authorized personnel 1
- Storing paper records in secure places, such as locked cabinets or secure rooms, to prevent unauthorized access 1
- Being transparent with participants about the potential risks and benefits of data sharing, and obtaining their consent to share data 1
By following these best practices, researchers can help ensure the confidentiality of research participants and maintain their trust. It's also important to note that confidentiality agreements should be limited to a reasonable duration, such as five years or until the end of the study, whichever is longer 1.
From the Research
Ensuring Confidentiality of Research Participants
To ensure the confidentiality of research participants, several practices can be employed. These include:
- Properly disposing of all paper documents containing identifiers (SSN, address, DOB, etc.) 2
- Requiring passwords to access computerized records 2
- Storing paper records in a secure place (secure room, locked cabinet, safe, etc.) 2 It is essential to note that using the participant's SSN instead of the participant's full name may not be an effective method to ensure confidentiality, as SSN is also a sensitive identifier.
Correct Option for GCP Certification
Based on the provided information, the correct option for GCP certification would be: E. A, B, and D This option includes properly disposing of paper documents, requiring passwords for computerized records, and storing paper records securely, all of which are essential practices for ensuring the confidentiality of research participants 2.