<< Previous Section | < Previous Page | Next Page > | Next Section >> Case: Teenage subject (page 1 of 2) Narrator: Dr. Smith, a pediatric diabetologist conceived of an amino acid infusion to accelerate recovery in diabetic ketoacidosis DKA, the most serious emergency associated with childhood diabetes. She got the sterile solutions produced and an IND (investigational new drug) permission to try it from the FDA as well as approval from her local IRB. To show results, the amino acid infusion must begin within four hours of starting the insulin infusion and Dr. Smith makes arrangements for the Pediatric Intensive Care Unit nurses to call her whenever a patient is admitted with DKA. Dr. Smith has a lot at stake in this study. If it works, a company is ready to prepare and market the amino acid solution, giving her and her institution a substantial financial shot in the arm. Scene 1: Dr. Smith's bedroom. She and her husband are sound asleep. Her pager goes off when the clock reads 2:20 AM. She rouses, turns it off and hears a disgusted groan from her husband. Again!, he complains. She picks up the phone and dials. It's the head nurse in the PICU. PICU nurse: We just admitted Janey again in flagrant DKA. Do you know her, the fifteen-year-old who is always getting into trouble with her diabetes? She resents the condition, her family, and about everything else. You might want to ask her and her mother about participating in your study. In fact, I can get them to sign up and give the infusion so you won't have to come in. Dr. Smith: Janey's my clinic patient and I know all about her. She is one of those teenagers who need to grow up, but at the rate she's going she might not live to be an adult. PICU Nurse: Well, do you want me to get things going? Dr. Smith: No, I had better go in. An MD on the protocol must do the consent and the assent. I'll be there in 45 minutes. Meanwhile just keep the regular treatment going. Narrator: Scene 2: The PICU. Dr. Smith and Mrs Granger are standing by a hospital bed in which lies Janey Granger hooked up to monitoring equipment and a couple of IVs. Mrs. Granger: [Steps up to Dr. Smith and grabs her hand.] We are so grateful to you, Dr. Smith for trying to take such good care of Janey, but she got upset again and skipped her insulin for a few days, at least. [wringing her hands]. I can't really watch her every minute and she insists that she is grown up and knows exactly what to do about the diabetes. Dr. Smith: [turning to Janey] Janey, I'm glad you realized that you were out of control and came in here. Your treatment seems to be going well up to now. Janey: This sucks Doc. I can't do anything I want because of this miserable diabetes and my Mom keeps bugging me and worrying all day long. I wish she would leave me alone. << 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)