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Institutional Review Board Office
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E-mail Address: jhsph.irboffice@jhu.edu
Website:
www.jhsph.edu/irb
Date:
INITIAL APPLICATION
APPROVAL NOTICE
Date:
August 29, 2014
To:
Derek Cummings, PhD
Department of Epidemiology
From:
Luke C. Mullany, PhD, MHS
Chair, IRB-X
Re:
Study Title: “Monitoring Cause Specific Absences to Estimate Influenza
Transmission”
IRB No: 00005474
The JHSPH IRB-X voted to approve the above referenced application at its meeting on
August 21, 2014. The Board made the following determinations:
Approval of the research is for the period of August 21, 2014 to August 20, 2015 Please submit
a progress report no later than 6 weeks before the approval lapse date. We
recommend that YOU USE YOUR OUTLOOK CALENDAR, OR OTHER ELECTRONIC
REMINDER CALENDAR TOOL, to set a timely reminder notification for this
submission to avoid a lapse in approval.
Single Reviewer Convened
DHHS 46.110 . . DHHS…....
FDA 56.110 . . . FDA………
Category: 3, 5, & 7
GWAS ..................................
Vulnerable Populations:
Children ................................
Foster Care Children ...............
Two Parents....................
Legal Guardian ................
(Foster Care Children)
HIPAA Waiver.……………………….
No Longer Enrolling……………….
Study Site(s):
U.S. International
List Country(ies):
Assent Required From:
No children (waived) . …
Pregnant Women/Fetuses
46.204 ............................
Neonates
46.205 ............................
Sample Size:
(screened plus enrolled)
11,000
Final Enrollment:
Form of Consent/Permission:
Consent/Parental
Permission Required From:
Adult Participant .............
LAR ..................................
Written Consent…………………….
Waiver of Signature……………….
(Oral Script)
One Parent ......................
Children aged: 5 – 13+
JHSPH IRB Initial Application Approval Notice
Version 13, 29May2014
Waiver of Informed Consent….
HIPAA Authorization………………
DHHS FDA
46.404 . . . . 50.51 .......
46.405. . . . 50.52 .......
46.406 . . . . 50.53 .......
Form of Assent:
Written ..........................
Oral ...............................
Assent Statement in
Parent Permission ..........
Prisoners
46.305 ............................
46.306 ............................
Epidemiological Research ....
Secondary Data Analysis:
(# specimens/participants)
This approval is inclusive of the following documentation:
Research Plan (Version #1, 8-27-14)
Consent Form (Version #1, 8-21-14)
Disclosure Document (Version #1, 8-21-14)
Parental Permission: Opt Out Letter (Version #1, 8-21-14)
Oral Assent Script to Obtain Assent from Children 5-6 (Version #1, 8-21-14)
Oral Assent Script to Obtain Assent from Children 7-12 (Version #1, 8-21-14)
Power Point Presentation to Students Parents Teachers Group (Version #1, 8-21-14)
Recruitment Flyer (Version #11, 8-29-14)
Study Flyer (Version #11, 8-29-14)
End of Year Questionnaire (Version #11, 8-29-14)
Enrollment Form (Version #11, 8-29-14)
Illness Questionnaire Illness Report (Version #11, 8-29-14)
As principal investigator of the research, you are responsible for fulfilling the following requirements
of approval:
1) The co-investigators listed on the application should be kept informed of the status of the
research.
2) Submit an Amendment Request Form for any changes in research. These changes in research
are required to be reviewed and approved prior to the activation of the changes, with the
following exceptions:
a) changes made to eliminate an apparent immediate hazard to the research participant
may be instituted immediately and the JHSPH IRB should be informed of such changes
promptly; and
b) changes to IRB Approved questionnaires, interview or focus group guides, other data
collection or recruitment materials – limited to rewording to clarify meaning, correcting
grammatical or typographical errors, or removing items that will not be used in the
research.
JHSPH IRB Initial Application Approval Notice
Version 13, 29May2014
3) Unanticipated problems involving risk of harm to participants or others that are related to the
study procedures must be reported to the JHSPH IRB within 10 days of the time that the PI
learns of such problems. A Problem Event Report Form must be submitted to the IRB
immediately.
4) Only consent forms with a valid JHSPH IRB approval stamp or logo, with the correct IRB
Approved version number and approval date may be presented to participants. All consent
forms signed by subjects enrolled in the study should be retained on file. The Office of Graduate
Education and Research conducts periodic compliance monitoring of study records, and consent
documentation is part of such monitoring.
5) Federal regulations require review of approved research not less than once a year, unless a
shorter period is determined by the IRB. Therefore, a Progress Report for continuing review
must be submitted to the IRB Office no later than six weeks prior to the approval lapse
date. This will allow sufficient time for review of the application to be completed prior to
the approval lapse date. Failure to submit a Progress Report prior to the approval lapse date
will result in termination of the study, at which point new participants may not be enrolled and
currently enrolled participants must discontinue participation in the study. All ongoing research
activities must stop immediately, including data analysis.
6)
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.
LCM/sro
JHSPH IRB Initial Application Approval Notice
Version 13, 29May2014
| File Type | application/pdf |
| File Title | Microsoft Word - 21Aug14_Cummings_Initial Application Approval Notice_FINAL |
| Author | tbradshe |
| File Modified | 2014-09-01 |
| File Created | 2014-08-29 |