From the Guidelines
The correct answer is E. A, C, and D. Researchers must implement multiple safeguards to ensure participant confidentiality in clinical research. Properly disposing of documentation containing Protected Health Information (PHI) identifiers prevents unauthorized access after the information is no longer needed, as suggested by the need for safe disposal policies 1. Storing participant paper records in locked cabinets provides physical security against unauthorized access, which is in line with measures to ensure the physical security of confidential records 1. Assigning security codes to electronic records creates an additional layer of protection for digital information.
Option B is incorrect because maintaining a notebook of participant addresses and names in a researcher's personal papers would violate confidentiality principles by potentially exposing sensitive information. Good Clinical Practice (GCP) guidelines require comprehensive protection of participant information through multiple security measures working together, which is why the combination of proper disposal, secure physical storage, and electronic safeguards represents the correct approach to maintaining confidentiality. Furthermore, ensuring participant confidentiality is crucial for maintaining trust and facilitating open communication, especially in sensitive research areas where data sharing and participant consent are critical 1.
Key considerations for ensuring participant confidentiality include:
- Proper disposal of documentation with PHI identifiers
- Secure physical storage of participant records
- Electronic safeguards such as assigning security codes to electronic records
- Transparent communication with participants about data sharing and risks, as well as providing mechanisms for withdrawal from studies and data removal 1.
From the Research
Ensuring Participant Confidentiality
To ensure participant confidentiality, researchers use various practices, including:
- Disposing properly of all documentation with Protected Health Information (PHI) identifiers
- Storing participant paper records in a locked cabinet
- Assigning security codes to electronic records
Correct Option
The correct option for ensuring participant confidentiality is:
- E. A, C, and D
Justification
There are no research papers provided that directly assist in answering this question regarding the correct practices for ensuring participant confidentiality in the context of GCP certification. However, general principles of confidentiality and data protection suggest that disposing of documentation with PHI identifiers, storing records in a locked cabinet, and assigning security codes to electronic records are all appropriate measures 2, 3, 4, 5, 6 do not provide relevant information on this topic.