Human Research Protection Program (HRPP) & Institutional Review Board (IRB)

Protecting Participants. Advancing Ethical Research.

At Phronetik, protecting the dignity, rights, and welfare of human research participants is our highest priority. Through our Human Research Protection Program (HRPP) and Institutional Review Board (IRB), we ensure every study meets rigorous ethical standards, complies with federal regulations, and promotes public trust in biomedical and behavioral research.

What We Do

The Phronetik HRPP oversees the entire lifecycle of human subjects research—from protocol design and review through study closeout—whether conducted internally or with external collaborators. Our registered Institutional Review Board (IRB) is responsible for ethical and regulatory review of all human subjects research conducted under our auspices or in collaboration with our investigators. The HRPP is comprised of two (2) groups:

Institutional Review Board (IRB), which reviews human subject research studies.
Quality Improvement (QI), which conducts monitoring, education, and other QI activities.

Key Functions Include:

Initial and continuing IRB review of research protocols
Informed consent review and monitoring
Review of protocol amendments and adverse events
HIPAA and privacy compliance for studies involving protected health information (PHI)
Support for reliance agreements and single IRB (sIRB) arrangements
Training and education for investigators and research staff

IRB Oversight at Phronetik

Phronetik maintains a current Federalwide Assurance (FWA) with the U.S. Department of Health & Human Services (HHS), which signifies our commitment to the ethical conduct of human research under the Common Rule (45 CFR 46). Our IRB is registered with the Office for Human Research Protections (OHRP) and operates in accordance with all federal guidelines.

FWA Number: FWA00033081
IRB Organization Registration Number: IORG0011628

You can verify Phronetik’s FWA and IRB status at the OHRP Registration Database by entering the numbers above.

For Sponsors & Collaborating Institutions

We welcome partnerships with academic institutions, federal agencies, CROs, and private sponsors. Our HRPP offers:

Efficient IRB review and turnaround timelines
Robust policies aligned with 45 CFR 46, 21 CFR 56, and ICH-GCP
Single IRB services and reliance agreement support
Expertise in clinical trials, translational research, genomics, informatics, and digital health studies
Experience with multisite research, VA partnerships, and federally funded studies

To initiate a collaboration or request IRB reliance, please contact:
irb@phronetik.com

For Prospective Research Participants

Your participation in research helps drive innovation in healthcare and science. Phronetik is committed to:

Transparent, understandable informed consent
Respect for your privacy and personal data
Oversight by independent ethical review
The right to withdraw from a study at any time

Learn more about your rights as a research participant:
Participant Rights & Responsibilities →
Frequently Asked Questions →

Investigator & Study Team Resources

Whether you’re initiating a new study or managing an ongoing one, our HRPP supports you at every step.

Resources Available:

IRB submission guidance and templates
CITI Program training and certification requirements
SOPs and best practices for human subjects protection
Support for FDA-regulated and NIH-funded research

Access the Investigator Toolkit →

Contact Us

Phronetik Office for Research

Office of Sponsored Research

IRB/HRPP
📧 osr@phronetik.com
📞 844.871.3575
🌐 www.research.phronetik.com
📍 Serving nationwide with offices in Plano, TX

Quick Access

[IRB Submission Portal]
[Request a Single IRB (sIRB) Agreement]
[Report an Adverse Event or Protocol Deviation]
[IRB Policies & SOPs]
[Data Privacy & HIPAA Guidelines]