Office Personnel & Emergencies/On-Call

EMERGENCIES/ON-CALL

If you have an emergency related to human subject research and you need to reach the IRBMED, please call our office during business hours or, after hours, the UM operator at (734) 936-4000 and ask them to page the designated Chair on-call.

Examples of emergency situations include (but are not limited to):

  • Serious, research-related unanticipated problem that requires immediate IRB attention
  • “Emergency use” (i.e., treatment) of a patient with an agent unapproved by the FDA when that treatment must commence within 24 hours
  • Enrollment of a ward of the state on a study approved under 45 CFR 46.406 or 407.
  • Enrollment of a patient who is also a prisoner onto a research trial (when the study has not been previously approved under the prisoner regulations and certified with OHRP). See “Subject Incarceration” guidance for more information.
  • Health and well-being reasons to continue a research intervention on a subject who becomes incarcerated (when the study has not been previously approved under the prisoner regulations and certified with OHRP). See “Subject Incarceration” guidance for more information.

IRBMED team group photo

IRBMED OFFICE

Judy Birk, JD
Director
S. Joseph Austin, JD, LL.M
Assistant Director, Regulatory Operations
Corey Zolondek, PhD, CIP
Assistant Director, Daily Operations
David Andrews, BA, MA
Board Secretary
Patti Meredith
Receptionist

COORDINATORS

Ray-Nitra Reynolds, MLIS, CIP
Education Coordinator
Claudia Krcmarik, BS
QA/Compliance Coordinator
Farideh Almani, MPH
Authorization Agreements
Angela Faber, BS, CIP
Ceding Applications

Meeting Minutes Writer (Position currently open)
Brian Seabolt, BA
Technical Writer
Lark Speyer, BS, CIP
Exempt/Not-Regulated/Quality Improvement Projects

EXPEDITED REVIEWERS

Jennifer Rasmussen, MHA, CIP
Robin Sedman, MSN, M.Ed

REGULATORY TEAM A1

Specialty areas:

  • Behavioral Medicine (AP)
  • Center for Growth & Development
  • Complementary Medicine (CAM)
  • Family Medicine
  • Health Behavior & Education
  • General Internal Medicine
  • Internal Medicine (see also B1)
  • Learning Health Sciences Department
  • General Pediatrics
  • Nursing
  • Ophthalmology (AP)
  • Pathology
  • Psychiatry
    • Depression Center
    • Mental Health Research Institute
    • Neuropsychology (AP)
  • Radiology
  • Magnetic Resonance Imaging
  • Social Work/Social Sciences

Team members:

REGULATORY TEAM A2

Specialty areas:

  • Geriatrics
  • Kinesiology (AP)
  • Neurology (AP)
  • Neurosurgery (AP)
  • Obstetrics and Gynecology
  • Otolaryngology (AP)
  • Physical Medicine and Rehabilitation (AP)
  • Surgery (Non-Cancer)
    • General
    • Orthopedic
    • Head and Neck
    • Pediatric
    • Plastic
  • Thoracic Surgery (AP)

Team members:

REGULATORY TEAM B1

Specialty areas:

  • Allergy (AP)
  • Anesthesiology/Pain (AP)
  • Bacteriology
  • Dentistry / Surgical Dentistry (AP)
  • Dermatology (AP)
  • Emergency Medicine
  • Gastroenterology (AP)
  • Hepatic and Pancreatic (AP)
  • Infectious Diseases (AP)
    • HIV/AIDS
  • Microbiology
  • Nephrology
  • Pharmacology
  • Urology — Surgical

Team members:

REGULATORY TEAM B2

Specialty areas:

  • Cardiac Electrophysiology (AP)
  • Cardiology (AP)
  • Cardio-Thoracic Surgery (AP)
  • Endocrinology / Metabolism (AP)
    • Diabetes
  • Hypertension (AP)
  • Pulmonology (AP)
    • Lung/Pulmonary Diseases
  • Rheumatology (AP)
  • Transplant (AP)
    • Heart (Cardiac)
    • Lung (Pulmonary)
    • Kidney (Renal)
    • Liver (Hepatic)
  • Vascular Surgery

Team members:

REGULATORY TEAM C1

Specialty areas:

  • Oncology / Cancer (AP)
    • Bone Marrow Transplant (BMT)
    • Pediatric
    • Surgical
  • Departments
    • Hematology
    • Hematology / Oncology
    • Urology — Oncologic
  • Medical Oncology
  • CTO studies
  • Radiation Oncology

Team members:

CHAIRS

Co-Chairs
Michael Geisser, PhD A2, B1, C1 mgeisser@umich.edu 0069 763-6501
Alan Sugar, MD A1, B2 asugar@umich.edu 2017 763-1415
Vice-Chairs
R. Alexander Blackwood, MD B1 rab@umich.edu   615-3203
Robertson Davenport, MD C1 rddvnprt@umich.edu   763-6932
Macdonald Dick, MD A2 mdick@umich.edu   936-7418
William Ensminger, MD C1 ensminger@umich.edu   764-5468
Amy Filbrun, MD A1 afilbrun@umich.edu   734-764-4123
Kevin Flaherty, MD B2 flaherty@umich.edu   763-2540

ADDITIONAL RESOURCES

IRBMED Roster - updated 05-01-18

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University of Michigan Federal Wide Assurance

University of Michigan Registration with FDA and OHRP

The University of Michigan's Institutional Review Boards (IRBs) are registered with the HHS Office of Human Research Protections and, in compliance with the new HHS Food and Drug Administration (FDA) rule issued on July 14, 2009, with FDA. 

FDA’s new requirement operates in coordination with the Office for Human Research Protections (OHRP), which already requires registration for IRBs reviewing federally-supported research.  A single database of all U.S. IRBs, regardless of whether they review research regulated by FDA or other federal agencies, has been established.

Registration information can be accessed via the HHS Registration page. In the search field "Institution/Organization" enter "U of Michigan" to verify UM registration.

If you have any questions about this information please contact the IRBMED Office.

Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)

2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory.