Kothari, Catherine L. http://orcid.org/0000-0001-8072-8920
Corbit, Katherine
Presberry, Joi
Bautista, Terra
O’Rourke, Brenda
Lenz, Debra
Funding for this research was provided by:
Maternal and Child Health Bureau
Article History
Accepted: 18 January 2022
First Online: 17 February 2022
Compliance with Ethical Standards
:
: The authors declare no competing interests.
: The study was conducted in accordance with Helsinki Declaration as revised in 2013. Permission and access to the birth records data were provided by the Michigan Department of Health and Human Services’ Vital Statistics. Institutional Review Board approval was provided by the Michigan Department of Health and Human Services (IRB # 201703-13-EA) and Western Michigan University Homer Stryker MD School of Medicine (IRB #1017-0179) Institutional Review Boards.
: Waiver of the Common Rule requirements for informed consent, as permitted under 45 CFR 46.116(d), was authorized by Michigan Department of Health and Human Services Institutional Review Board for the Protection of Human Research Subjects (IRB #201703-EA). The waiver was obtained for the study because it could not practicably be conducted without it, the waiver would not adversely affect the research subjects, and the research benefits outweighed the privacy risks.