Attachment R IRB Approval Page with Signature

Innovation Research and Training, Inc.

IRB Review of Research Involving Human Participants
Adapted from UNC-CH AA-IRB,1998 version

Initial Proposal Cover Sheet
1. IRT-IRB Number: 15-009-1-FEA
2a.
2b.
2c.

Date Submitted: 5-12-15

This IRB form does not supersede any previous request.
This IRB form RELATES to previous application ____________ approved on ___________.
This IRB form SUPERSEDES ____________ which was most recently approved on ___________
3. Principal Investigator
Name: Alison Parker and Tracy Scull
Phone: 919-493-7700
Email: aparker@irtinc.us and tscull@irtinc.us
Fax: 919-493-7720
Affiliation: innovation Research & Training

4. Project Title/Familiar Name: ___Development of web-based resource for youth_____________
5. Grant Name: ___ Web-based resource for youth about clinical research______________________
6. Project Type:

Just-in-Time

Specific Project

7.

Approval required from other institution (e.g., prison, school):
is attached
is pending
Name of institution(s):
8.
Indicate grant number and funding agency: Phase I SBIR contract #HHSN268201400051C and NHLBI
9. Principal Investigator’s Recommendation:
FULL Board Review
Expedited Review; Category number 7 IRB Manual Section VI.B.2
Exempt from further review following initial IRB review; Category number
IRB Manual Section VI.A.2

_______________________
Signed by Principal Investigator

5/12/2015
Date

__________________________
Signed by IRT President

5/12/2015
Date

10. IRB Decision: (IRB use only)
Exempted; no further review needed unless there is a modification.

Approved as Specific Project
45 CFR 46.404 applies—no more than minimal risk to children
45 CFR 46.117 (c) (2) applies—waiver of requirement for documentation of consent through written signature
Approved as “Just-in-Time” (grant proposal) under 45 CFR 46.118. Specific Project approval needed prior to data collection.
Approved with special conditions, see attachment
Not Approved (this decision can only be made by the convened IRB)

5-21-2015
Signed by Chair, iRT IRB
Barbara Davis Goldman, Ph.D.

iRT-IRB Number :

IRT IRB approval of this project EXPIRES 5-20-2016

Approval Date

15-009-1-FEA

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