Tuesday, February 12, 2013

"Respect for person, beneficence and -- mental block": a conversation with the head of research subject protection at the University of Minnesota

From the deposition of Richard Bianco in 2007, when he was the institutional official responsible for research subject protection at the University of Minnesota.

Q. Are you aware of any physician at the University of Minnesota who has ever, in any of the research studies you're aware of, attempted to commit a patient and a few days after that sign them into a research study?

A. I'm not personally aware of that.

Q. Okay. Are you aware of the Belmont report?

A. Yes.

Q. Are you aware of any statements in the Belmont report with regard to importance of having independent assessments of the ability of patients to give informed consent?

A. No.

Q, Are you aware of the Declaration of Helsinki?

A. Yes.

Q. What do you know about it? Can you tell me a little bit about what you know about that?

A. It is one of -- it's a document, I don't remember when it came out, but it provides guidance, in the author's opinion, on how IRBs should relate to certain types of situations. It's basically a statement of ethical principles, similar to the Belmont but a little more detailed.

Q. Who's the author of the Declaration of Helsinki?

A. I think it's a group. I don't know.

Q.  Do you know which group?

A. No.

Q. And you don't know when that was adopted.

A. It's been around a while, but I don't know the dates, no.

Q. Do you have any idea at all?

A. Within the last 20 years.

Q. How about the Belmont report? Who drafted the Belmont report?

A. Well, I met one of the authors, and I can't remember his name, but again, It was another group of ethicists that met and developed some basic principles.

Q. What are the basic principles in the Belmont report?

A. Respect for person, beneficence and-- mental block.  Well, the third one escapes me right this second. Basically, it's a set of principles. Common sense principles.

Q. When was the Belmont report adopted?

A. I believe 15 or so years ago.

Q. Have you ever heard of the Nuremberg Code?

A. Uh-huh. Yes. I'm sorry.

Q. When was that adopted?

A. I don't know.

Q. Do you have any idea at all?

A. No. Sometime after World War II, I would assume.

Q. What does the Nuremberg Code say?

A. Frankly, I'm not that familiar with the Nuremberg Code.

Q. Okay. Have you ever had any training in the ethics of human subjects, experimentation?

A. Yes.

Q. What kind of training have you had?

A. Well, it's continuous training. I served on the IRB for 15 years or so, and some of that as a vice chair. I am very active in the Public Responsibility of Medicine and Research Organization, which is continuous education and those sorts of things. So did I attend a specific class? No. But I'm very involved and with PRMR and other organizations.

Q. Have you had any training in ethics, bioethics?

A. Formal?

Q. Yes, sir.

A. No.

Q. Can you tell me some of the major philosophical schools and thoughts, schools of thought with regard to bioethics?

A. Arthur Caplan school and there's the Jeff Khan school.

1 comment:

  1. "Arthur Caplan school and there's the Jeff Khan school."

    ...at which point my head hit the desk, hard.