Download Saint Alphonsus Institutional Review Board

INSTITUTIONAL REVIEW BOARD – REQUEST FOR EXPEDITED REVIEW
This TYPED form must be returned if requesting expedited review to:
Office of Research Integrity
1055 N. Curtis Road
Boise, ID 83706
Phone: (208) 367-8897
Fax: (208) 367-6821
Date of submission: _________________________
Study Title:
______________________ Protocol version date: _______________
This is a request for expedited review of a:
New Study Application (Complete Sections I and IV)
Study Re-approval (Complete Sections II and IV) IRB Protocol #
Study Amendment (Complete Sections III and IV) IRB Protocol #
I. New Study (You must also complete and submit the Initial Protocol Submission form)
In order to qualify for expedited review, Principal Investigators must demonstrate eligibility based upon the following
requirements:
A. This study presents only minimal risk:
Yes
No (This study is not eligible for expedited review)
B. AND involves only procedures listed in one or more of the following categories (check all that apply):
Research on drugs for which an investigational new drug application is not required
Research on medical devices for which an investigational device exemption application is not required or the
medical device is being used in accordance with it’s cleared or approved labeling.
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture. (For healthy, non-pregnant
adults that weigh 110 pounds or more, no more than 550 ml may be drawn in an 8-week period and no more
frequently than twice a week.) (For other adults and children, the age, weight, and health, collection
procedure, the amount of blood, and the frequency must be considered. The amount drawn may not exceed
the lesser of 50ml or 3ml per kg in an eight-week period and may not occur more than twice in one week.).
Prospective collection of biological specimens for research purposes by noninvasive means.
Collection of data through noninvasive procedures routinely used in clinical practice, excluding x-rays or
procedures using microwaves
Research involving materials (data, documents, records, or specimens) that have been collected, or will be
collected solely for non-research purposes.
Collection of data from voice, digital, or image recordings made for research purposes.
Confidential pursuant to Idaho Code
IRB Form
Revised 03/2013
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Principal Investigator’s Last Name: ______________________________
Research on individual or group characteristics or behavior or research employing survey, interview, oral
history, program evaluation, human factors evaluation, or quality assurance methods.
II. Study Re-approval (You must also complete and submit the Research Study Re-approval form)
In order for a study re-approval to qualify for expedited review, it must meet at least one of the following
(mark those that apply):
The study has been previously reviewed and approved by the IRB using expedited procedure OR
The research conditions/protocol has not changed such that the research continues to be eligible for
expedited review OR
Research is permanently closed to enrollment of new subjects, all subjects have completed all
research-related interventions, AND the research remains active only for long-term follow-up of
subjects OR
No subjects have been enrolled and no additional risks have been identified OR
The remaining research activities are limited to data analysis OR
The research is not conducted under an investigational new drug application or investigational device
exemption and does not meet any of the above criteria, but the IRB has determined and documented
at a previous convened meeting that the research involves no greater than minimal risk AND no
major protocol changes have been made or additional risks identified.
III. Study Amendment (You must also complete and submit the Request for Amendment form)
In order for a study amendment to be eligible for expedited review, it must meet at least one of the following
criteria (mark all that apply):
This amendment does not change the risk to human subjects
Amendment involves only minor change(s) in approved research during the period of approval
IV. Research Principal Investigator Statement of Integrity
By signing this form, I certify that the information provided is both complete and accurate. As the principal investigator for this
study, I understand that I have the ultimate responsibility to ensure protection of the rights and welfare of human subjects. I am
aware that it is my responsibility to remain current of Saint Alphonsus Health System, state and federal research requirements. I
agree to comply with Saint Alphonsus policy and procedure research requirements and those imposed by the Saint Alphonsus
IRB, as well as any applicable Federal, State, and local laws pertaining to human research subjects.
Principal Investigator (Typed/Printed Name)
Principal Investigator’s Signature
Date Signed
Confidential pursuant to Idaho Code
Revised 03/2013
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