JHU Revised IRB Approval 21MAR2015

FWA #00000287

Institutional Review Board Office
615 N. Wolfe Street / Room E1100
Baltimore, Maryland 21205-2179
Phone:
410-955-3193
Toll Free: 1-888-262-3242
Fax:
410-502-0584
Email:
[email protected]
Website: www.jhsph.edu/irb

Date:

March 20, 2015

To:

Derek Cummings, PhD
Department of Epidemiology

AMENDMENT APPROVAL NOTICE

From: Elizabeth A. Skinner, MSW
Acting Chair, IRB-X
Re:

Study Title: “Monitoring Cause Specific Absences to Estimate Influenza
Transmission”
IRB No: 00005474

The JHSPH IRB-X reviewed and approved the amendment request described below,
and received by the JHSPH IRB Office on March 16, 2015, at its meeting on
March 19, 2015.
Single Reviewer

Convened

DHHS 46.110 . .
FDA 56.110 . . .

DHHS…....
FDA………

Adult Participant..............
LAR ..................................
One Parent.......................

Category: 3, 5 & 7
GWAS ...................................
Vulnerable Populations:
Children .................................
Foster Care Children ...............
DHHS
46.404 . . . .
46.405. . . .
46.406 . . . .

Consent/Parental
Permission Required From:

FDA
50.51........
50.52........
50.53........

Two Parents ....................
Legal Guardian .................
(Foster Care Children)
Assent Required From:
No children (waived) .. …
Children aged: 5-13……..
Form of Assent:
Written ..........................
Oral ...............................
Assent Statement in
Parent Permission ..........

JHSPH IRB Amendment Approval Notice
V15, 18Sept2014

Form of Consent/Permission:

Study Site(s):

Written Consent…………………….
Waiver of Signature……………….
(Oral Script)

U.S.

Waiver of Informed Consent….
HIPAA Authorization………………

International

List Country(ies):

HIPAA Waiver.……………………….
No Longer Enrolling……………….
Pregnant Women/Fetuses
46.204 ............................

Sample Size:
(screened plus enrolled)

Neonates
46.205 ...........................

11,000
Final Enrollment:

Prisoners
46.305 ...........................
46.306 ...........................
Epidemiological Research ...

Secondary Data Analysis:
(# specimens/participants)

This amendment approval is for the following revisions to the above referenced study:
1). To include the use of two different assent scripts for children; one for
children who are reporting to the nurse's office ill and the other for
children who are reporting to the nurses office after return from an
absence due to illness.
2). To include minor edits to the "Illness Questionnaire Illness Report"
based on feedback from the Office of Management Budget.

and is inclusive of the following revised or newly submitted documentation:

Research Plan (Version #2, 3-15-15)
Absentee Reporting Form (Version #11, 8-29-14)
Surveillance, Monitoring Absenteeism and Respiratory Transmission in
Schools Consent Form (Version #2, 3-19-15)
Oral Script to Obtain Assent Form Children 5-6 (After Return to School
from Absence) (Version #1, 3-19-15)
Oral Script to Obtain Assent from Children 5-6 (In Nurse’s Office)
(Version #1, 3-19-15)
Oral Script to Obtain Assent form Children 7-12 (After Return from
Absence)
(Version #1, 3-19-15)
Oral Script to Obtain Assent form Children 7-12 (In Nurse Office)
(Version #1, 3-19-15)
Oral Script to Obtain Assent form Children 13 (After Return from Absence)
(Version #1, 3-19-15)
Oral Script to Obtain Assent from Children 13 (In Nurse Office)
(Version #1, 3-19-15)

JHSPH IRB Amendment Approval Notice
V15, 18Sept2014

As a reminder, no other changes to this study may be implemented without prior JHSPH
IRB review and approval.
The action taken on this study does not change the IRB expiration date, which remains
August 20, 2015.
If your research involves international travel, please don’t forget to register with the
International Travel Registry https://apps4.jhsph.edu/ITR/Default.aspx so that the
School may locate you in the event of an emergency.
If you have any questions regarding this action, please contact the JHSPH IRB Office at
(410) 955-3193 or via email at [email protected]
EAS/sro

JHSPH IRB Amendment Approval Notice
V15, 18Sept2014