Appendix D IRB Exemption Letter

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460

OFFICE OF THE
SCIENCE ADVISOR

MEMORANDUM

SUBJECT:
REQUEST No.:
DATE:

Exempt from Human Subjects Regulations
HSR-000541
Apr 18, 2016

FROM:

Toby Schonfeld, Ph.D.
Human Subjects Research Review Official

TO:

Juliann Barta
Region 10

I have reviewed the application cited below according to the requirements of EPA Order 1000.17 Change A1
(Policy and Procedures on Protection of Human Research Subjects) and EPA Regulation 40 CFR 26
(Protection of Human Subjects). From the information provided, it appears that this study is exempt from
the regulations cited above.
The purpose of this study is to assess children’s potential exposures to lead, allergens, pesticides, and PCBs
in Pacific Northwest tribal child care centers. Public health officials from the Indian Health Service (IHS)
will administer a questionnaire to child care center directors to assess building characteristics, maintenance
and cleaning protocols, pesticide use, pest infestation history, and aggregate data about the children served.
IHS will also ask pest control companies about pesticide use taking place at the center. None of the
information collected will be identifiable private information. After the data is collected and analyzed, IHS
will inform participating child care centers of research findings and provide recommended actions, indoor air
quality action kits, and training to reduce exposures that exist in their facility. Study findings will also be
compared with the First National Environmental Health Survey of Child Care Centers and other appropriate
studies.
The IRB of record (Portland Area Indian Health Service IRB) has deemed the research to be exempt
according to 40 CFR 26.101(b)(2). While it is not clear that this work constitutes human subjects research as
defined in the regulation, for the purposes of this project I will concur with the IRB’s determination of
exemption and no follow-up with the HSRRO is required.

However, it is expected that any substantive changes to the protocol that result in changes to the risk/benefit
relationship of the study, or to the recruitment or consent process for subjects, will trigger submission of
those changes to the EPA HSRRO immediately. In addition, all researchers are expected to conduct their
work with integrity and with attention to best practices in research ethics regardless of regulatory oversight.
Please refer to the HSRRO application number (HSR-000541) below on all future correspondence.

Application Title:
Principal Investigator:
IRB of Record:

Environmental Health Survey of PNW Tribal Child Care Centers
Nicolle Tulve
Portland Area Indian Health Service IRB