Services

IRB DOCUMENTS

Email the following documents for review to [email protected]:

  • The final protocol
  • The cv of the principal Investigator
  • The informed consent document
  • A product description ( formula for device, drug, etc)
  • All relevant safety data
  • The investigator’s brochure, if relevant
  • Recruitment documents, if any
  • A description of special populations (prison populations, special needs subjects, language barriers, etc.)

Submit one week in advance of our Thursday meetings, we report by Thursday mid day (Rush reviews are sometimes available)

Expedited reviews are applicable to devices when the risk to the subjects is minimal, meets regulatory criteria and is essentially the same as those risks that a person can be confronted with in everyday life. The IRB Chairman alone can decide if a protocol meets those criteria.

VOTING MEMBERS

Michael Burck, M.S. - Ethicist (Minister)

Mr. Burck serves the Allendale IRB as an ethicist. He has previously served on an IRB for Schmid Labs reviewing, among other topics, AIDS related research programs. Mr. Burck has 19 years experience on IRB’s

Kathy DuVernay,-LPN - Nurse

Ms. DuVerney is a practicing OB/GYN nurse. She has been engaged in clinical research. Ms. DuVerney has served the Allendale IRB for eighteen years.

Robert J. Staab (II) - Data Storage Administrator

He is current employed as a Data Storage Administrator by IBM, routinely consulting in Information Protection and Disaster Recovery. He has taken course work at Stevens Institute of Technology, and Colorado Technical University in computer engineering and computer science. Robert has previous experience as a certified mergency medical technician on the Allendale Ambulance Corps.

John Rokoszak, M.S. Counselor

Mr. Rokoszak is a marriage and family counselor with over 25 years of experience working with parents and adolescents. He has served the AIRB for 14 years.

Robert J. Staab, Ph.D. - Clinical/Preclinical Toxicologist

The Allendale IRB is the third IRB to have Dr. Staab serve as chairman. Previously, he has chaired the IRB for Tambrands (Tampax, First Response Diagnostics) nd for Schmid Labs (Koromex, Ramses condoms etc.) Dr. Staab, board certified in Toxicology, Regulatory Affairs and Safety, has served IRB’s for 25 years. 860 434 5872.

Alternates upon request

Revision: 10/1/09

 

ELEMENTS OF INFORMED CONSENT

Every i.c. document must have the following:

  • The study involves research
  • Expected duration of the subject’s participation
  • Procedures to be followed
  • Any experimental procedures
  • Risks to discomforts that can reasonably be foreseen
  • Any benefits to the subjects or others
  • A disclosure of alternative procedures that may be available
  • A statement that the records are confidential; IRB and FDA may view those records
  • If more than minimal risk is anticipated, any compensation, medical treatments in the event of injury, a source for further information.
  • Who to contact for further information concerning subject rights (AIRB 860 434 5872) or injury (your 24 hour contact number)
  • A statement that participation is voluntary, refusal to participate results in no loss of benefit, subjects can discontinue at any time

Additional elements if appropriate are added to i.c.

  • Treatment that may involve risk to a subject or fetus
  • Reasons why an investigator may terminate a subject
  • Costs to the subject
  • Consequences of withdrawal
  • Number of subjects in the investigation