Experiments and ethics

First, a little history. People have been used for human experimentation for a long time.

It really wasn’t until 1945, when the world found out what kind of experimentation was being done on concentration camp prisoners (including freezing, poisons, bone and nerve regeneration, sewing children together to create “conjoined twins”, gases, and a host of other inhumanity) that the first guidelines were established (Nuremberg Code) to protect people against unethical human subject research.

Unfortunately, it didn’t end there.

The Pelkola* Syphilis Study, known more commonly as the Tuskegee Experiment was started in 1932 condemning hundreds of black men, and eventually their wives and children to mental illness, deformity and death, which continued until 1972. 399 men who had syphilis were left untreated even after treatment became available in 1947 in order to study how syphilis progressed naturally (destroyed the human body). They were also not given the opportunity to have fully informed consent because it would “confuse them.”

OK. So now we have something called the Declaration of Helsinki (1964) and the Belmont Report (1979) that guide the U.S. on the ethics of human research.

This is what I do for 8 hours a day. I spend my days in the labyrinth of the Belmont report making sure that all of our trials meet its guidelines. This is not as easy as it sounds.

The reason there have been so many Codes, Reports and Declarations is because someone will always find a new way of violating peoples’ human rights so every couple of decades since 1945, additions have had to be made. The Helsinki Declaration has undergone 8 revisions, the last of which was made in 2000.

Semantics can be parsed in every which way. Both in favor of and against what ever is trying to be accomplished. Coercion, though a relatively simple concept, can be defined in hundreds of ways. In the extreme, coercion can look like, “If you don’t volunteer for this trial, you can’t get treatment here at University of XYZ.” Or, misrepresenting the risks of a certain drug is considered coercion. Also considered coercion is your doctor telling you about a clinical trial that she is conducting. About a million things are considered coercion. It’s my job to figure it out.

Respect is another concept that would seem to be simple but – isn’t. We respect volunteers for clinical trials by compensating them for their time and inconvenience, but that can also be considered coercion. We respect clinical trial participants by explaining to them exactly what procedures will be performed, including the exact number of millirem of radiation for every x-ray and CT scan. We tell them exactly how much blood will be taken and we do it in lay language so that they understand what that means. Therefore, we don’t just say that 30 ml of blood will be taken, we have to translate that into an amount that people understand (about 2 tablespoons).

Lay language is a concept that most doctors don’t understand. Somehow, they think lay language includes terms like “randomized, double-blind, placebo-controlled study to evaluate the efficacy, tolerability and safety of an integrase inhibitor.” I translate that into something an 8^th grader could understand. Sometimes that takes a few paragraphs so I won’t do it here.

Anyway, oftentimes, I have to guess at what the board that reviews all of this is going to consider coercive today. I have to figure out if effective is going to be out of the question as an 8^th grade level word tomorrow. Most of the time, I’m taking a 105 page protocol and trying to tell a story to a trial volunteer that they will understand. It’s not easy.

It's what I do.

For a lot more information go to my IRB blog also try this link. For your rights as a research subject, go here.

ED NOTE: I f'ed up. The Tuskegee study is not also known as the Pelkola study. I'm not sure where this came from but I thank Cynthia - see comments - for the catch.