<< Previous Section | < Previous Page | Next Page > | Next Section >> Case: Teenage subject (page 2 of 2) Dr. Smith: The important thing now is that you're getting better. [turning back to the mother] Mrs. Granger, there is something that I would like to ask you about. [She pulls two folders out of her attaché case] I am conducting a study about a special IV medication that is intended to safely decrease the length of time DKA needs to be treated. I have the consent form here that I would like you to go through carefully and then discuss with me. Since Janey is only 15, you have to give permission for her to be involved in the study. Mrs Granger: Just show me where to sign. I know that you will do nothing to harm Janey. She really loves you and we are so grateful to you for caring for her, even through all her lapses. Dr. Smith: You have to understand. This is a research study and the goal of the research is not to help Janey, but rather to determine whether or not this IV treatment improves the management of DKA for others down the line. Mrs. Granger: Maybe, but you wouldn't give Janey anything that might harm her, so where can I sign? Dr. Smith: No! [not quite losing her cool] We don't understand all the consequences of giving this IV or we wouldn't have to do a study. This is research! [Dr. Smith notices that Janey is listening very carefully to the conversation, still speaking to Mrs. Granger] While you go through the material in the consent form, I am going to talk to Janey and ask her for her assent. [turning to Janey] Janey, I think you heard what your mother and I have been discussing. Do you have any questions about the research? You know it will involve just adding another IV to your current ones. It doesn't even require an additional stick. Janey: Doc, I like you. But I'm feeling better and I want to get out of here as soon as possible. My mother is only thinking about herself. No one cares what I think! Why did you explain everything to my Mom first when I'm the one who's going to be the guinea pig? Dr. Smith: You have a really good point there, Janey. I should have talked to you first, but your Mom has to give permission because you're a minor. What we would do is add an extra infusion to what you're already receiving but it won't add to your time here. It may possibly shorten it. However, we don't know all the possible effects of the infusion because it is research. Here is a copy of the consent form for you to assent to, so why don't you look at it and see whether you want to participate. You don't have to do it at all. It won't affect your care from me whatever you decide. [Janey takes the papers and begins to read.] Mrs. Granger: [points to the papers she has been reading] It says here that you stand to make a lot of money if this works and that none of the subjects will get any part of it. Is that fair? [Somewhat irritated]. Dr. Smith: Well that's the way it has been done. We don't want people to join research programs and take risks because they think that they might win some kind of lottery. Besides, don't you think that the people who thought of the idea and developed it should get the benefits. Mrs. Granger: [annoyed but somewhat mollified] Well, not all the benefits. Since I trust you and am grateful to you I will sign. Janey: It doesn't look like this stuff will hurt me and maybe it will get me out of here a little sooner. That sounds fair [giggles] and it's better if Mom is reluctant. I'll sign because I love you Doc and you're never on my case. She signs the forms. Dr. Smith: Thanks. [Gives Janey a hug] << 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)