At Univo IRB, we’re committed to offering a new and better IRB experience to patients and clients.

As such, our institutional review board (IRB) and advisory committee are comprised of diverse groups of professionals with a wealth of clinical research experience, offering valuable and fair perspectives as opposed to theoretical knowledge. Furthermore, all members have long histories demonstrating a commitment to protecting the safety and welfare of all patients and human subject participants. 

Our Institutional Review Board  

Univo IRB consists of some of the most talented individuals in the clinical research space, each providing granular levels of understanding in their lines of expertise and real-world insight.  

Our IRB includes individuals with experience as research patients as well as strong backgrounds and certifications in a range of regulatory affairs, good clinical practice, and human research protection areas (refer to TAs under Drug & Biologics):

  • Bone marrow/stem cell transplant
  • Cardiology
  • Emergency medicine
  • Family medicine
  • Gastroenterology
  • Hematology/oncology
  • Hepatology
  • Intensive care
  • Internal medicine
  • Medical device/IVD studies
  • Neonatal care
  • Neuroscience
  • Obstetrics and gynecology
  • Pediatrics
  • Pharmacology
  • Podiatry
  • Psychiatry
  • Women’s health
  • Extensive device experience in the IVD, biotech, and life science industries in areas of:
    • Cardiovascular Devices (heart failure, dyslipidemia, venous access ports)
    • Kidney disease (Chronic Kidney Disease – CKD and Acute Kidney Injury – AKI,
    • Coagulation disorders
    • Toxicology / Substance Abuse
    • Cancer (companion diagnostics) – cancer biomarkers and diagnostic tests in oncology clinical trials including various cancers (dermatological, melanoma, lung, prostate, breast
    • Dermatological – Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC), Melanoma, Autoimmune Conditions including blistering disorders, Inflammatory – Hives, Urticaria
    • Women’s health (contraception, menstrual disorders)
    • Genitourinary conditions
    • Human Papilloma Virus (HPV) testing systems
    • Studies on contraceptive devices
    • Study on a device to treat menorrhagia
    • Study on noninvasive prenatal testing
  • Experience including co-development of companion diagnostics, point-of-care tests, clinical laboratory tests, and home use systems
  • Laboratory Developed Tests (LDTs)
  • Experience with PMA approvals, de novo classifications, 510(k) clearances, and CLIA waivers for IVDs
  • Expertise in device global regulatory strategies
  • Laboratory Proficiency Testing
  • Chair leadership with Regulatory Affairs Certificate in Medical Devices from the Regulatory Affairs Professionals Society (RAPS), Medical Device Professional – ACRP
  • Compassionate use, treatment use, continued access for investigational devices
  • Anthropology
  • Mental illness/addiction
  • Psychology
  • Social work
  • Hospice
  • Home health/community care
  • Law
    • Criminal defense
    • Life sciences
    • Intellectual property
    • Prisoner advocacy
  • Education/Counseling
    • Children
    • Individuals with diminished capacity
    • Pregnant women
  • Technology including digital health and artificial intelligence (AI)
  • Laboratory operations
  • Life sciences
  • Quality improvement
  • Finance
  • Public administration

The diverse expertise of our IRB members ensures a comprehensive and ethical review of research protocols, safeguarding the welfare of research participants.

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