Attachment 6 IRB Approval

Knoedler, Ruth
From:
Sent:
To:
Subject:

Tait, Alan
Tuesday, October 30, 2012 2:04 PM
Knoedler, Ruth
IRB approval letter

IRB approval letter 

From: [email protected] [mailto:[email protected]]
Sent: Monday, September 24, 2012 8:40 AM
To: [email protected]
Subject: eResearch Notification: Scheduled Continuing Review Approved

Medical School Institutional Review Board (IRBMED) • 2800 Plymouth Rd., Building 200, Room 2086, Ann Arbor, MI 48109-2800 • phone (734) 763 4768 • fax (734) 763 9603
• [email protected]

To: Dr. Alan Tait
From:
Michael
Alan

Geisser
Sugar

Cc:
Terri
Alan

Voepel-Lewis
Tait

Subject: Scheduled Continuing Review [CR00029836] Approved for [HUM00043187]
SUBMISSION INFORMATION:
Study Title: Interactive informed consent for pediatric clinical trials
Full Study Title (if applicable):
Study eResearch ID: HUM00043187
1

SCR eResearch ID: CR00029836
SCR Title: HUM00043187_Continuing Review - Tue Sep 11 08:40:13 EDT 2012
Date of this Notification from IRB:9/24/2012
Date Approval for this SCR: 9/23/2012
Current IRB Approval Period: 9/23/2012 - 9/22/2013
Expiration Date: Approval for this expires at 11:59 p.m. on 9/22/2013
UM Federalwide Assurance:FWA00004969 expiring on 6/13/2014
OHRP IRB Registration Number(s): IRB00001999
Approved Risk Level(s) as of this Continuing Report:
Name

Risk Level

HUM00043187

No more than minimal risk

NOTICE OF IRB APPROVAL AND CONDITIONS:
The IRBMED has reviewed and approved the scheduled continuing review (SCR) submitted for the study
referenced above. The IRB determined that the proposed research continues to conform with applicable
guidelines, State and federal regulations, and the University of Michigan's Federalwide Assurance (FWA)
with the Department of Health and Human Services (HHS). You must conduct this study in accordance
with the description and information provided in the approved application and associated documents.
APPROVAL PERIOD AND EXPIRATION DATE:
The updated approval period for this study is listed above. Please note the expiration date. If the approval
lapses, you may not conduct work on this study until appropriate approval has been re-established,
except as necessary to eliminate apparent immediate hazards to research subjects or others. Should the
latter occur, you must notify the IRB Office as soon as possible.
IMPORTANT REMINDERS AND ADDITIONAL INFORMATION FOR INVESTIGATORS
APPROVED STUDY DOCUMENTS:
You must use any date-stamped versions of recruitment materials and informed consent documents
available in the eResearch workspace (referenced above). Date-stamped materials are available in the
“Currently Approved Documents” section on the “Documents” tab.
In accordance with 45 CFR 46.111 and IRB practice, consent document(s) and process are considered as
part of Continuing Review to ensure accuracy and completeness. The dates on the consent documents, if
applicable, have been updated to reflect the date of Continuing Review approval.
RENEWAL/TERMINATION:
At least two months prior to the expiration date, you should submit a continuing review application either
to renew or terminate the study. Failure to allow sufficient time for IRB review may result in a lapse of
approval that may also affect any funding associated with the study.
AMENDMENTS:
All proposed changes to the study (e.g., personnel, procedures, or documents), must be approved in
advance by the IRB through the amendment process, except as necessary to eliminate apparent
immediate hazards to research subjects or others. Should the latter occur, you must notify the IRB Office
as soon as possible.
AEs/ORIOs:
You must continue to inform the IRB of all unanticipated events, adverse events (AEs), and other
reportable information and occurrences (ORIOs). These include but are not limited to events and/or
information that may have physical, psychological, social, legal, or economic impact on the research
subjects or others.
Investigators and research staff are responsible for reporting information concerning the approved
research to the IRB in a timely fashion, understanding and adhering to the reporting guidance
(http://www.med.umich.edu/irbmed/ae_orio/index.htm ), and not implementing any changes to the
research without IRB approval of the change via an amendment submission. When changes are necessary
to eliminate apparent immediate hazards to the subject, implement the change and report via an ORIO
2

and/or amendment submission within 7 days after the action is taken. This includes all information with
the potential to impact the risk or benefit assessments of the research.
SUBMITTING VIA eRESEARCH:
You can access the online forms for continuing review, amendments, and AE/ORIO reporting in the
eResearch workspace for this approved study, referenced above.
MORE INFORMATION:
You can find additional information about UM’s Human Research Protection Program (HRPP) in the
Operations Manual and other documents available at: www.research.umich.edu/hrpp.

Michael Geisser
Co-chair, IRBMED

Alan Sugar
Co-chair, IRBMED

3