Independent IRB review for pharmacogenomics research
The PGNI Institutional Review Board (IRB).
PGNI's IRB provides independent ethical and regulatory review of human-subjects research under the federal Common Rule, for Affiliated Researchers, independent and practice-based researchers, and, through reliance agreements, outside institutions.
Independent, accessible ethical review for pharmacogenomics research
PGNI is a nonprofit organization, and its IRB was created to address a primary barrier to health care practitioners conducting pharmacogenomics-based research: access to independent IRB review. Unlike health providers who work in university and hospital settings, most pharmacogenomics scientists outside of academic settings do not have an institutional IRB.
The mission of PGNI's IRB is to provide an accessible, pharmacogenomics-specialized pathway for researchers to submit research protocols for independent ethical review. A core feature of PGNI's mission is to help promote the ethical practice of research in real-world settings, in pharmacogenomics, across different therapeutic areas: Cardiovascular, Neurology, Psychiatry, Oncology, Pain Management, Infectious, Respiratory, Gastroenterology, Rheumatology, Endocrinology, Rare Diseases, and Others, including Nutrition and Herbal Medicine.
Dr. Lydia Sholy
PharmD, PhD in Social Pharmacy and Ethics
Dr. Sholy is a licensed pharmacist with over ten years of experience in teaching and mentoring. She is passionate about ethical research practices, and is committed to promoting research integrity, safeguarding participants' rights and welfare, and fostering responsible research through collaborative leadership, education, and continuous professional development.
45 CFR 46 & 21 CFR 50, 56
The federal Common Rule and FDA human-subjects regulations govern the IRB's review standards and procedures. PGNI holds a Federalwide Assurance (FWA) with the Office for Human Research Protections (OHRP). The IRB's review authority is independent.
Check these numbers in the OHRP registry search by entering each number in the matching field.
PGNI's IRB was established to provide independent review
PGNI's Institutional Review Board (IRB) is established to provide independent ethical and regulatory review of research involving human subjects submitted to it by Affiliated Researchers, independent researchers, and outside institutions under reliance agreements. The IRB conducts its reviews in accordance with applicable federal requirements, including the Common Rule (45 CFR Part 46) and, where applicable, FDA requirements governing human-subjects research (21 CFR Parts 50 and 56). IRB members with a conflicting interest in a study do not take part in its review (45 CFR 46.107(e)).
IRB members complete standardized human-subjects training
Before reviewing protocols, PGNI's IRB members and reviewers complete recognized training in the protection of human research participants, including CITI Program training in Human Subjects Research and training aligned with guidance from the Office for Human Research Protections (OHRP).
Human Subjects Research
Completion of CITI Program coursework in human-subjects research, widely recognized across academic and independent IRBs.
Federal human-subjects guidance
Member training aligned with guidance from the Office for Human Research Protections (OHRP), the federal office overseeing Common Rule compliance.
How to get started with PGNI's IRB
Choose the path that fits your situation.
Have your own research project reviewed
Independent or practice-based researchers with their own pharmacogenomics-related research project can submit it to PGNI's IRB for independent, pharmacogenomics-specialized ethical and regulatory review, without needing to join PGNI as an Affiliated Researcher.
Review fees are listed on the IRB fees page.
Apply for reviewJoin PGNI's research community
PGNI Affiliated Researchers, including PGNI alumni, are part of PGNI's own research community and have ongoing access to PGNI's IRB. Outside institutions may also arrange a formal reliance agreement.
Become affiliatedJoin the IRB Reviewers Committee
PGNI's IRB relies on committee reviewers with expertise across pharmacogenomics, clinical practice, and research ethics to conduct its reviews. Committee reviewers are provided an honorarium for completed reviews.
Join IRB Reviewers CommitteeOther questions about IRB review or a reliance agreement? Contact PGNI.