American Healthy Homes Appendix D IRB Protocol

PROTOCOL APPROVAL WITH MODIFICATIONS
DATE:

7 Dec 2016

TO:

David Cox, Ph.D.
QuanTech, Inc

PROTOCOL:

HUD OHHLHC - AHHS II, American Healthy Homes Survey (AHHS) II
This is a follow-up study to the American Healthy Homes Survey conducted in
2005-2006, funded by the U.S. Department of Housing and Urban
Development (HUD), Office of Lead Hazard Control and Healthy Homes
(OLHCHH). (Pro00019737)

APPROVAL DATE:

30 Nov 2016

EXPIRATION DATE:

30 Nov 2017
IRB APPROVED DOCUMENTATION:

Protocol Version:



Protocol AHHS II (Not Dated).

Consent Form:



Informed Consent Form (Chesapeake IRB Approved Version 6 Dec
2016).

Recruitment Material:



Letter from U.S. Dept. of HUD "Dear Sir or Madam" Longitudinal (Not
Dated).
Letter from U.S. Dept. of HUD "Dear Sir or Madam" (Not Dated).


Other Material:






Resident Instructions: How to Collect a Drinking Water Sample (Not
Dated).
Screening Questionnaire (Not Dated).
I5 Resident Questionnaire - Remaining Portions (Not Dated).
Performance Work Statement (Not Dated).

The IRB approved the above referenced protocol and your site with the modifications listed below on 30 Nov
2016:



Modification to Informed Consent Form
Modification to Screening Questionnaire to add elements of consent and to Waive
Documentation of Consent for use in recruitment purposes.

On December 6, 2016, the IRB reviewed the Principal Investigator’s potential Conflict of Interest with the
Study and approved with modifications the following:
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


Modification to Informed Consent Form to add Financial Disclosure section
Modification to Study Conduct to Restrict PI from being Involved in the Informed Consent
Process or Recruitment for this Study

If you wish to have the IRB reconsider the imposed modifications, you may follow the procedures outlined
below:
1. Submit supporting documentation that addresses the IRB’s concerns.
2. Provide a written justification for relief of any IRB imposed condition.
The above referenced recruitment material is available on your CIRBI workspace under the “IRB Issued
Documents” tab.
If there are any changes to the IRB approved material, IRB approval will be needed prior to use. This
includes changes in relative size and type of font in the material to be viewed by potential subjects.
Please review the IRB Handbook by accessing CIRBI™ (www.cirbi.net). Log on to your CIRBI homepage
(“My Home”) and select the “Reference Materials” tab for IRB requirements and guidance. A copy of the
most recent IRB roster is also available under “Reference Materials”.
Thank you for selecting Chesapeake IRB to provide oversight for your research project.

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