Irb

Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Disease Control

and Prevention (CDC)

M emorandum

Date

d

May 19, 2021

From

Jerrell Little

IRB Administrator

Human Research Protection Office

Subject

IRB Approval of Amendment #6 to CDC Protocol #6881.0, "Collections Related to Synthetic Turf Fields with Crumb Rubber Infill" (Expedited)

To

Kelsey Benson, MPH, BS

NCEH/ATSDR

CDC's IRB-Committee 1 has reviewed and approved your request to amend protocol #6881.0, "Collections Related to Synthetic Turf Fields with Crumb Rubber Infill". The following changes are approved:

The changes to the protocol include modifications to include COVID-19 prevention measures and incorporates the need to practice social distancing, to the extent possible. ATSDR has modified its scripts and forms to let the public know of the COVID-19 precautions that the agency is implementing (Section 9 of the protocol, and Appendix N, Pages 246-295). Participants will be asked about their and their family's health/COVID-19 status prior to the questionnaire administration and specimen collection. For employees in the field, the team lead will monitor the temperature of the field team staff twice daily. The field team lead will also ensure proper use of PPE when participants and examiners are not able to be socially distanced, such as during the transfer of the specimen collection kit. Questionnaire administration and collection of biological samples will occur at the site with social distancing measures.
In addition to the COVID-19 precautions, the key personnel for the principal investigator and primary contact have changed.

The action was reviewed in accordance with the expedited review process outlined in 45 CFR 46.110(b)(2), minor changes to previously approved research during the period of one year for which approval is authorized.

Any problems of a serious nature must be brought to the immediate attention of the CDC IRB, and any proposed changes to the protocol should be submitted as an amendment to the protocol for CDC IRB approval before they are implemented.

If you have any questions, please contact your National Center Human Subjects Contact or the CDC Human Research Protection Office (404) 639-7570 or e-mail:

cc:

NCEH/ATSDR Human Subjects (CDC)