Phase I and Consent Mrs. Wilkins, Dr. Blake said, I want to ask you to participate in

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Phase I and Consent

Mrs. Wilkins,” Dr. Blake said, “I want to ask you to participate in what we call a Phase I trial of a new drug called Novamed. The aim of such a trial, is my duty to tell you, isn’t to treat your disease, but to help us determine how toxic Novamed is. What we learn may help us figure out how to help other people.”

“You mean Novamed won’t help me?” Mrs. Wilkins asked.

“I can’t say that it won’t,” Dr. Blake said. “Quite frankly, we just don’t know. That possibility is always there, but that’s not why you should agree to participate. If you do agree, that is.”

“I’ve been told my disease is terminal,” Mrs. Wilkins said. “I’m in the last stage of life right now. So it looks to me like I don’t have anything to lose and, potentially, I’ve got something to gain. Its a gamble, and I’m ready to take it.”

“So long as you know Novamed isn’t likely to help you,” Dr. Blake said. “I’ll get the consent forms, and you can ask me any other questions that occur to you.”

1. Should Mrs. Wilkins consent to participate in a Phase I trial be regarded as informed?
2. Is Mrs. Wilkins as an appropriate candidate to participate in a Phase I clinical trial?
3. How should investigators go about getting people to consent legitimately to Phase I trials?