1. Carol Wagner Professor of Pediatrics
Some lessons learned regarding special populations:
Pregnant women and children of diverse racial and ethnic backgrounds
Carol Wagner
Professor of Pediatrics

2. The pregnant woman
Must have involvement of obstetrical colleagues to recruit subjects
Time study visits with already existing OB visits--this applies to all subjects--try to convenience them, not inconvenience them even if you are giving them compensation
For Hispanic and Spanish-speaking subjects--have a study coordinator who is fluent in the language--before we had a Spanish speaking study coordinator we had recruited 6 patients in 9 months. With Martha on our team, we recruited 20 in 2 months!
We also found having someone who can relate to the subjects and conveys a sense of compassion and caring makes a huge difference

3. Infants and children
You have to have rapport with the mother and/or father
We were more likely to have a dad refuse to participate in a study than a mom--it did not matter if the study coordinator was himself a man
We always plant "the seed" during pregnancy or lactation studies that we may be doing a follow-up study and have recontact on the consent form

4. With children...there must be a perceived benefit or little risk
There are limitations to doing research in children as there are blood/phlebotomy limits that do not exist when studying adults.
Doses of medications have to be prescribed on a per kilogram basis.
Parents are particularly concerned that no harm will come to your infant.
If their child is really sick and you are offering a new, potentially life-saving alternative therapies that may come from the study, then you are more likely to receive consent.
The better your scientific question the more likely you are to receive a positive response.