 |
|
Patient Abuse in Rural Midwestern Pregnant Women?-Reply
Barbara P. Yawn, MD, MS;
Roy A. Yawn, MD
Rochester, Minn
Donald Uden, PharmD
Minneapolis, Minn
Arch Fam Med. 1993;2(4):351.
|
|
| Since this article does not have an abstract, we have provided the first 150 words of the full text PDF and any section headings. |
|
|
|
In reply
The design for obtaining data for our study did not include the use of any data or samples collected primarily for this study. The demographic information was taken from data for birth certificates, the maternal urine was the waste material from samples collected for standard testing on every woman in labor, and the meconium was a waste product. The women were not informed of this use of public information or waste products and obviously could not opt out or give consent.
Such studies are given special consideration in the Code of Federal Regulations.1,2 Technically, 45 CFR 46.101(b) states that our research was exempt from the US Health and Human Service's regulations because it was covered by subpart 5. Subpart 5 clarifies the exempt status because our study involved "the collection or study of existing data, documents, records, pathological specimens, if these sources are publicly available or if the information
. . . [Full Text PDF of this Article]
|
