Informed Consent

The idea of informed consent, at least in research, came about after the tragedies and horrors of WWII and the Nazi concentration and death camps. You might remember half-sleeping through your world history teacher's description of something called the Nuremberg Trials (unless you had a rockin' teacher like I did...).

I'm no history buff (we've gone through this...biology, physics, reading, writing, math...just don't make me memorize dates and names! I can't do it!), but this is one part of history that really sticks with me. The whole basis of the Nuremberg Trials was that it is completely NOT ok to conduct an experiment on a human being without their consent. And consent is not to be obtained in the sense of "do this, it's fine" or "do this, or I'll kill you, or kill your family, or torture you." No, consent was to be obtained by explaining to a person what you (the investigator) want to do, why you want to do it, what risks are involved and how likely they are, what benefit a volunteer may or may not receive, and how it might benefit people overall.

As a willing participant in research, you are then supposed to weigh these options, think about what is acceptable to you, and after reaching a decision, provide consent or decline. There is also an underlying understanding that as the owner and master of your body, you are welcome and encouraged to say "stop!" at any time, no questions asked.

The findings of the Nuremberg trials ultimately led to the Belmont Principles (described in the Belmont Report), which are displayed in a frame on the first wall you see when you walk into the IRB office at BUMC (where I work). They are:

1. Respect for Persons- being truthful, not being deceptive, respecting a person's autonomy and providing for informed consent. respecting the word: "no", no matter when or why it comes.

2. Beneficence- "do no harm," and maximize the effectiveness of the research while minimizing risk to participants

3. Justice- procedures and opportunities to participate in and benefit from research are equally and fairly distributed (for example, it's not cool to conduct research only on men, so that men are the only ones to benefit from research knowledge...oh wait, that already happened).

These are three things lie at the heart of what we must consider when evaluating EVERY single research protocol that comes across our desks, or into our online workboxes. And these three principles, in addition to a whole host of guidelines set up by people who have some pretty detailed medical, research and ethical understanding, form the basis of our analysis and evaluation of the acceptability and approve-ability of research.

The basic idea is this: You can't just, on a whim, decide that you're going to do something to people. You need to make sure that it's safe, that it makes sense (this is perhaps the most amusing part of my job...'you mean you want to what?? why???'), and some benefit to society will come as a result.

For a taste of some of the arbitrary and horrific experiments conducted during the Holocaust, I recommend checking out Echoes from Auschwitz: Dr. Mengele's Twins: The Story of Eva & Miriam Mozes. I had the privilege of listening to Eva Mozes Kor speak at a research ethics conference last December. Aside from the fact that this octogenarian is bright, full of humor and spunky like no other person I've met, she has a deep understanding of the importance of respect for persons in research.

Amazingly, she is not at all opposed to research. She credits research with saving her son who developed a disease as a young adult, and she fully understands why research is necessary. Her plea to the doctors in the audience, however, was to simply stop and think about the human on the table in front of them. Her message left me, and many others, in tears. And yes, I waited almost an hour to meet her and have her sign my book.

For those of you who are unfamiliar with even the recent violations of research ethics, there are a few classic examples you should learn about:

1932-1972 Tuskegee Syphilis Study
Researchers withhold treatment from black men infected with syphilis to see it's "natural course" play out.

1946-1948 Guatamala Syphilis Study
Syphilis infected prostitutes were allowed to have unprotected sexual contact with prisoners in Guatamala (some of which was paid for with US tax dollars). Men were also exposed to syphilis by having it poured on wounds or injected.

1956-1971 Willowbrook Hepatitis Studies
Mentally retarded children were deliberately infected with Hepatitis to test the efficacy of a vaccine being developed against Hepatitis.

1960s Milgram Obedience Experiments
Participants were deliberately deceived when asked to participate in the study, and were made to believe that they were hurting (and possibly killing) other people. The study led several participants to suffer severe psychological reactions.

As mentioned, these are just a few of the classic examples that we discuss in class (and that serve as a daily reminder to me why my job matters, which helps me deal with investigators who whine that lumbar puncture and removal of spinal fluid are "minimal risk." FYI: they are NOT)

So let's extend this idea of informing people of what's happening to the medical setting. Not the experimental medical setting, or research, but the day to day setting of health care. If it's not ok to conduct research on a human being who does not consent, is it ok to perform a procedure on a human who does not consent, is misled or uniformed about the risks involved? If you're not sure, the answer is actually no (there are, of course, complex cases...like Terri Schaivo's, that require a little more thinking).

Part of living under the consitution our forefathers wrote is having the freedom not to have our bodies invaded. Bodily invasion counts as assault, and comprises not just being beaten with a stick as your wallet is stolen, but having your uterus taken out when you went in for appendicitis, or having 10 residents come in and practice pelvic exams while you're sedated for a completely unrelated surgery (believe it or not, these things happen). I recommend you read The Rights of Patients: The Authoritative ACLU Guide to the Rights of Patients, Third Edition (American Civil Liberties Union Handbook), which was written by one of my health law professors (George Annas). I think this book is a great resource for navigating the health care system either as a patient or a patient advocate.

And to tie this post in to my last few, let's consider the way a lot of maternity care transpires. How often are women told what all of the risks associated with interventions are? How often are women able to weight the pros and cons of different procedures, especially when some are not medically indicated? To avoid being encouraged to jump into something that isn't safe or necessary, it's best to be educated ahead of time. Luckily, when you find our you're pregnant you have at least 8 months to learn about risks and benefits...unlike when you're rushed to the ER for a broken foot, say.