IRB Form 4 – Expedited Request

IRB Form 4
Farmingdale State College
Institutional Review Board
Categories of Research that may be reviewed by the IRB through an
Expedited Review Procedure (New Protocols)
(Form Approved: February 2007)
Does the research involve minimal risk?
Does the research involve the collection of information where identification of the subject’s or their
responses could place them at risk of criminal or civil liability or be damaging to the subjects’ financial
standing, employability, insurability, reputation, or be stigmatizing?
If yes, are there protections in place so that risk related to invasion of privacy and breach of
confidentiality is no more than minimal?
Does the research involve genetic research?
No (If yes, protocol cannot be expedited)
Principal Investigator:
Protocol Title:
In order to qualify for expedited status, the research must involve no more than minimal risk and fall into
one of the following categories. For an expanded description of these categories, see IRB Policy 1).
Clinical studies of drugs and medical devices when an IND or IDE is not required.
Collection of blood samples by finger/heel/ear stick or venipuncture from:
● Healthy, non-pregnant adult (weighing at least 110 lbs.) up to 550 ml in an 8 week period, nor
more than 2x per week
● Others, no more than the lesser of 50 ml or 3ml/kg in an 8 week period, nor more than 2x per
Biological specimens by non-invasive means (hair/nail clippings, deciduous or extracted teeth,
excreta and external secretions (e.g. sweat), saliva, placenta, amniotic fluid (at time of rupture),
dental plaque, mucosal/skin cells obtained via swabbing, sputum.
Data from non-invasive procedures (not involving general anesthesia or sedation) routinely
employed in clinical practice excluding procedures involving x-rays or microwaves.
Research involving materials collected for non-research purposes (data, documents, records,
specimens). [Note: Research in this category may qualify as exempt]
Data from voice, video, digital or image recordings made for research purposes.
Research on individual/group characteristics or behavior, or research involving survey, interviews,
oral history, focus group, program evaluation, human factors evaluation, or quality assurance
methodologies. [Note: Research in this category may qualify as exempt]
Principal Investigator Signature
IRB Office Use Only:
Expedited Review Request: __ Approved __ Denied
Consent Required: __ Yes __ No
IRB Reviewer _________________________