<< Previous Section | < Previous Page | Next Page > | Next Section >> Case: Prepubertal Girls An investigator proposes to study the effects of dietary restriction and feeding on hormones related to metabolism and reproduction to learn more about the conditions conducive to the onset of menstrual periods in girls. The proposed subjects are healthy girls between 8 and 12 years of age who have not had menarche but who are beginning pubertal development by Tanner Score. The participants would be volunteers with parental consent admitted to the GCRC for 15 days full time during their summer vacation. They would have a 50 cc phlebotomy, be put on an optimal diet for three days, have another 50 cc of blood drawn, be switched to a diet with the same amount of protein but ½ the calories for six days have a third blood draw and then be returned to the optimal diet for six days and have a fourth 50 cc phlebotomy at completion. The children would be given a gift certificate for $100.00 at Borders at completion of the study. You are the IRB member assigned to this protocol. You are very supportive of clinical research. Questions: Is this an appropriate experimental design? Is there a problem with consent? Is there an issue with blood? Is there an issue with the gift certificate? Is there an issue with HIPAA? << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 3 Quick Links Ethics and Study Design Introductory Ethics Design Appropriate Risk to Benefit Ratio Selection of Subject Populations Cases Bibliography Chapter 3 Download (PDF)