Is there a federal regulation in the CFR regarding consent to research for mothers under 18 and their child?
We are planning a regional research project with a minimal risk intervention (to reduced sugar sweetened beverage intake) with Head Start parent-child dyads and anticipate that there will be minor mothers with children in our target population. Any guidance towards regulations on how to consent them and their child would be helpful.
Answer
Thank you for your question.
You can find information about the Department of Health and Human Services' regulations governing the protection of human subjects in research at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/index.html
The page also has interpretive guidance, decision charts and other information linked in the menu at the left.
Subpart B — Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research provides further information about pregnant women, and paragraph (g) of that subpart has information on children who are pregnant.
Subpart D — Additional Protections for Children Involved as Subjects in Research has further information on children used as subjects in research.
Some tutorials and other education and outreach materials related to research on human subjects is available at https://www.hhs.gov/ohrp/education-and-outreach/index.html
We are not qualified to provide legal advice or interpretation of the laws, but If you have any questions about questions about compliance or about interpretation and application of the HHS regulations for the protection of human subjects in research that are not answered in these materials, you can contact the Office for Human Research Protections. Their contact information is available at https://www.hhs.gov/ohrp/about-ohrp/contact-us/index.html
I hope this information is helpful. If this is not what you need, or if you should require any further assistance, please let us know.
Bobby Griffith
Lead Government Information Reference Associate
Sycamore Library
University of North Texas Libraries
Bobby.Griffith@unt.edu