For research institutions, using secure email for participant communication isn’t just about meeting compliance—it’s also a way to build trust and strengthen study outcomes. When research teams follow secure communication practices, they create better participant relationships, make study logistics easier, and contribute to ethical research practices.
The role of communication in participant engagement and retention
Effective communication with research participants can benefit recruitment, informed consent, study instructions, and follow-up engagement. Studies show that transparent and responsive communication can improve participant retention and data quality by fostering a sense of involvement and trust. For instance, a study in The Journal of Clinical Trials found that participants who received regular, clear updates were more likely to complete the study and follow protocol.
However, communicating with participants, especially in clinical trials or health-related research, involves handling sensitive health data. HIPAA (Health Insurance Portability and Accountability Act) sets strict guidelines for protecting this data, and compliance is required whenever PHI is transmitted electronically. Using HIPAA compliant email platforms provides a secure, accessible way to maintain communication without compromising participant privacy.
Learn more: HIPAA Compliant Email: The Definitive Guide
Advantages of HIPAA compliant email in research communication
- Enhanced data privacy and trust: HIPAA compliant email platforms encrypt communications, ensuring only authorized individuals can access PHI. This level of security helps build trust with participants, who can be assured that their personal information is handled responsibly. A 2019 survey by Research Ethics found that over 70% of participants were more willing to share information when they knew it would be securely transmitted and protected.
- Efficient recruitment and onboarding: For studies requiring participant recruitment, HIPAA compliant email allows research teams to send secure invitations, consent forms, and initial questionnaires. Maintaining secure communication from the beginning allows teams to reduce dropout rates by creating a safe onboarding experience.
- Clear, consistent communication: Email allows research teams to keep participants informed about study timelines, requirements, and any changes. Consistent communication fosters transparency and helps participants stay engaged. Additionally, automated email reminders sent via a HIPAA compliant platform can remind participants about study appointments or survey deadlines, improving adherence to study protocols.
- Comprehensive documentation: Email provides a documented record of all participant communications, which can be beneficial for audits, study documentation, and compliance with ethical guidelines. Informed consent forms, follow-up instructions, and other documents sent via email create a paper trail that demonstrates adherence to research protocols and participant rights.
Implementing HIPAA compliant email in research settings
To effectively integrate HIPAA compliant email into research communication, research teams should follow these practices:
- Choose a HIPAA compliant email service: Not all email providers meet HIPAA standards. Research institutions should use HIPAA compliant platforms such as Paubox which offer seamless encryption, secure data storage, and access controls.
- Obtain informed consent for electronic communication: Before beginning a study, research teams should obtain participants’ consent to receive information via email which can be included as part of the informed consent process, clearly explaining the security measures in place and providing participants with the option to choose an alternative communication method if preferred.
- Limit PHI sharing in emails: While HIPAA compliant email is secure, researchers should avoid sharing extensive health details in email messages unless necessary. Instead, emails can include general study updates, this approach minimizes the exposure of PHI and ensures that privacy is maintained.
- Regular staff training on HIPAA compliance: All research staff involved in participant communication should undergo training on HIPAA regulations and secure communication practices. Training should cover how to use secure email platforms, recognize phishing threats, and handle participant data responsibly, ensuring that HIPAA compliance is maintained throughout the study.
Related: HIPAA compliant email during clinical trials
FAQs
Can researchers use email to recruit participants for clinical trials?
Yes, researchers can use email for recruitment purposes.
How do HIPAA rules change when emailing international participants in a clinical trial?
HIPAA rules apply within the United States. However, when emailing international participants, it's necessary to comply with local data protection laws (like GDPR in Europe) in addition to maintaining HIPAA for any data that is handled or stored in the U.S.
Are there specific encryption standards required for emails containing PHI in clinical trials?
HIPAA does not specify exact encryption standards but requires the use of an encryption method that meets NIST (National Institute of Standards and Technology) guidelines to ensure the confidentiality and integrity of PHI such as TLS 1, 2, and higher.
Farah Amod
