Picture yourself as a researcher, leading an important study, or as a participant, having just shared your personal information with a research project. The data you handle or provide isn’t just a collection of numbers and facts; it’s a mosaic of personal stories, confidential insights, and trust. In this blog, we explore the crucial responsibility of storing this data, not just as a routine task, but as a commitment to ethical research conduct. We’re not just talking about keeping data safe in a digital locker; it’s about safeguarding the privacy, dignity, and rights of every individual who contributed to your research, long after the final results are published. This isn’t merely about compliance; it’s about honouring a silent pact made with participants, a pact of trust and respect. Honouring this pact makes the participant confident to take part again in further studies, trusting that his/her information will always be kept safe by the researchers. Join us in exploring how to uphold this trust, ensuring that the data you gather or provide is treated with the utmost integrity.

Key Concepts in Ethical Archiving

Before delving into ethical archiving methods, let’s clarify some essential concepts:

• Disclosure in Archiving: In archiving medical research data, disclosure focuses on responsibly revealing patient information without compromising privacy. When accessing archived data, researchers must ensure that any release of identifiable patient details aligns with ethical guidelines and participant consent. This careful approach safeguards patient privacy while maintaining the integrity of the research
• Confidentiality in Archiving: In the archiving process, confidentiality means securely handling and storing participants’ personal information. Researchers must ensure that identifiable data is accessed only as permitted under the terms of informed consent, protecting it from unauthorized use or exposure. This practice is crucial for maintaining participant trust and upholding ethical research standards.
• Archiving: In medical research, archiving involves securely storing both active and inactive data, ensuring it remains accessible yet protected from unauthorized access. This process includes careful management and preservation of records, maintaining their integrity and confidentiality over time. It’s a critical task that upholds the ethical standards of research by safeguarding participant information.

Maintaining Data Confidentiality During Archiving

To maintain anonymity during archiving, it’s best to retain research data without any identifiers. This ensures individual participation remains anonymous, and the collected data cannot be linked back to individuals. Methods for keeping data confidential vary, from simple precautions like using codes for participant identifiers and storing data in locked cabinets, to more complex strategies like statistical methods or data encryption. It’s important to consider data security and retention requirements throughout and after the study. For instance, encrypted storage is essential for protected health information, especially on portable devices or when transmitted electronically.

Practical Steps for Archiving Patient Information

Here are some methods for archiving patient information ethically:

1. Replace Patient Identifiable Information (PII) like names and phone numbers with research identification codes (study ID).
2. Remove PII from completed survey instruments before archiving.
3. Limit access to master code lists or key codes to essential research personnel.
4. Store master lists separately from data and destroy them as soon as feasible, following country regulations.
5. Destroy contact lists, recruitment records, or documents containing PII when no longer needed (at least 2 years after data collection according to Good Clinical Practice Guidelines).
6. Password-protect and encrypt files containing electronic data, especially during transfer or transport.
7. Store research data/specimens in secure, locked locations (preferably dry and far from humidity).
8. Ensure electronic data is stored on password-protected computers or files.
9. Close files containing electronic data when computers are left unattended.
10. Keep all documents out of unauthorized individuals and animal reach (especially rodents. This means that you shouldn’t attract them indirectly by eating or drinking near the files).
11. Train research staff in approved data management and storage methods.
12. Securely dispose of research materials no longer needed, using methods like shredding, compacting, and burning, or employing secure discard services.

Conclusion

Ethically archiving participant information is vital for maintaining confidentiality and preventing undue disclosure. Various methods, from de-identifying PII to restricting access, ensure confidentiality during archiving. This guide provides a framework for researchers to ethically manage both hard copy and electronic data, ensuring only authorized team members have access. The infographic below summarizes this blog succinctly.

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References

• Secure Data MGT. 2015. “What is Archiving And Why is it Important?” [Online] Available at: Secure Data Management
• Office for Civil Rights (OCR). 2012. “Guidance Regarding Methods for De-identification of Protected Health Information in Accordance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule.” [Online] Available at: HHS.gov
• Vancouver Island University. “Data Retention and Destruction | Research Ethics Board.” [Online] Available at: VIU Research Ethics Board
• Elsevier Author Services. 2022. “Research Data Storage and Retention.” [Online] Available at: Elsevier Blog