Change Request Form

Request for Non-substantive Change to an Existing Information Collection Request

OMB Approval #0920-1278, expiration date 12/31/2020

Justification for non-substantive change:

To address CDC guidance dated April 14, 2020 'COVID-19 Precautions for Human Research and Continuity of Human Research Protections at CDC', the protocol was updated in order to eliminate face to face meetings between the contractor and participants to reduce risk for COVID-19. As a result, all communications with participants will be by email, mail, phone, and the internet. These are the changes made.

1) The contractor will have no direct interactions with the participants.

2) Four in person meetings between the contractor and participant have will be replaced with four conference calls between the Project Officer and participant.

3) NIOSH study staff will insert the study ID on the actigraph file to begin recordings. Participant will not see their study ID number.

4) The Project Officer will mail the actigraph to the participant at the beginning of the study period and the participant will mail it back to the Project Officer when the study period ends.

The informed consent has been updated to reflect these changes. The recruitment email was revised by deleting the message to contact the contractor, Dr Lois James, for information about the study.

These changes do not increase the time burden for participants. By using four phone calls and mailing the actigraph instead of using four meetings, the study protocol eliminates the need for participants to travel to a meeting site and therefore reduces their time commitment when participating in the study.

The study surveys and online training program have no changes.

Due to time lost because of the pandemic, we request the expiration date to be extended six months to June 31, 2021.