FORM LR-1
Clear Form
IRB LIMITED REVIEW FOR CIRB OVERSIGHT
Section I: Research Proposal Review Facesheet
IRB Project Number:
(Contact IRB Coordinator [832-2330] for assignment.)
Name and Complete Title of Project:
Date of This Request:
Name of Central IRB:
Principal Investigator (Names with appropriate degrees, etc.):
Associate Investigator(s): (May be omitted if listed on the Informed Consent Form.)
Mailing Address:
Telephone:
Fax:
E-mail:
Information Submitted by:
Phone #:
Email Address:
Fax #:
Is the proposal received from an external sponsor or submitted to a granting agency? No
If yes, name of agency or sponsor:
Is the proposal supported or sponsored by the NIH?
Is the proposal supported or sponsored by the FDA?
Is publication of final study results expected to occur?
For devices only, please select type of Risk?
Serious
Yes
No Yes
No Yes
No Yes
Non Serious
After this research proposal receives approval, Cone Health must receive documentation of the CIRBs annual
renewals, closure notices, and any SAEs or Unanticipated Problems regarding Cone Health patients.
Principal Investigator Agreement and Statement of Commitment:
The Principal Investigator, whose signature appears below, recognizes the need to pay specific attention to how
participants are recruited for the research in order to reduce the risk of overt or covert discrimination or inadvertent
exploitation. The Investigator agrees to a continuing exchange of information and advice with the Institutional Review
Board, and therefore agrees to communicate with the Board to obtain its approval before instituting any significant
changes or additions to the project or before continuing the project beyond the approval date. The Principal Investigator
agrees to inform the Board of any local serious adverse events, unanticipated problems, or reporting of serious adverse
events required by the sponsor.
IRB Form LR-01 PI Application (March 2016)
Page 1 of 3
Signature:
Principal Investigator
Date
Section II: Considerations to Assure Protection of Human Subjects and Personnel.
Please indicate on the following checklist the presence of any of the following situations in your study:
RESEARCH STUDY INCLUDES THE FOLLOWING PROCEDURES AND/OR
SITUATIONS:
Ionizing radiation; radioactive isotopes
Experimental devices, instruments or machines
Recombinant DNA research
Fetal tissue
Surgical pathological tissue
Drugs under investigation
Placebo(s)
Protocol approved at collaborating institution
YES
NO
*Please mark "yes" if the research adds any additional risk for Human Subjects beyond that which would be entailed by
conventional and/or routine clinical diagnosis and therapy; otherwise mark “no”.
SITUATIONS INCLUDED IN RESEARCH STUDY
Personnel exposure to hazardous substances
Patients as experimental subjects
Pregnant subjects
Non-patient volunteers
Students and staff as subjects
Minors (less than 18)
Non-English speaking subjects**
Mentally incompetent subjects**
Prisoners and parolees as subjects
Subjects at other institutions
Videotaping, filming or voice recording of subjects
INVOLVED
YES
NO
AT RISK *
YES
NO
** Explain (in informed consent document) methods to be used to obtain reasonable, legal and understood informed consent from
such subjects (or legal sponsor). In special circumstances when alternative forms of obtaining informed consent are used (e.g.,
audio/videotape; telephone calls; special proxy or witnesses), attach to consent document a full explanation with appropriate
signatures for Board review and approval.
Section III: Summary Statement of Proposed Research
Include the following items in order:
IRB Form LR-01 PI Application (March 2016)
Page 2 of 3
1.
Description of project (100 - 400 words): An explanation of the purpose and rationale of the research
study, using lay terminology. Remember that not all members of the IRB are health professionals.
IRB Fee Schedule: (effective January 2014)
Investigators/research agencies, that do not receive support from a private (non-governmental), external sponsor for
their research project, will not be charged for IRB considerations of the research.
Investigators/research agencies that receive funding from a private, external sponsor for their research work will be
charged:
For initial review of project:
For renewal review:
Full Board Review:
Expedited Review:
Limited Review:
Full Board Review:
Expedited Review:
$2,250.00
$1,250.00
$ 500.00
$ 1000.00
$ 750.00
Payment method should be arranged by contacting the IRB Coordinator in advance of filing an application for review.
For IRB completion and return to Principal Investigator:
Action taken:
Full Board Approval
Signature of Cone Health IRB Chair:
IRB Form LR-01 PI Application (March 2016)
Expedited Approval
Exempt
Date:
/
/
Page 3 of 3