Monday, October 6, 2008

Translated yet???

I am posting in response to Drew at ThinkGene. He says no one will follow mandates unless they have the history to understand those rules. To lay some background for why medical researchers have policies, rather than gunsling it out I will give some background. From HHS.....

The modern story of human subjects protections begins with the Nuremberg Code, developed for the Nuremberg Military Tribunal as standards by which to judge the human experimentation conducted by the Nazis. The Code captures many of what are now taken to be the basic principles governing the ethical conduct of research involving human subjects.

In case you may have not learned in school or just forgot this lovely wikipedia article will refresh your memory. So will this list:

1 Experiments
1.1 Experiments on twins
1.2 Freezing experiments
1.3 Malaria experiments
1.4 Mustard gas experiments
1.5 Sulfonamide experiments
1.6 Sea water experiments
1.7 Sterilization experiments
1.8 Experiments with poison
1.9 Incendiary bomb experiments
1.10 High altitude experiments

The first provision of the Code states that "the voluntary consent of the human subject is absolutely essential."

Freely given consent to participation in research is thus the cornerstone of ethical experimentation involving human subjects.

The Code goes on to provide the details implied by such a requirement: capacity to consent, freedom from coercion, and comprehension of the risks and benefits involved. Other provisions require the minimization of risk and harm, a favorable risk/benefit ratio, qualified investigators using appropriate research designs, and freedom for the subject to withdraw at any time.

Now 23andMe is not exposing patients to mustard gas or mutilating genitals....But the principles exist not just for unethical research, but for ethical research too!.

From Wired Magazine, a quote from Anne Wojcicki regarding her Gene Journal and risk calculator"A lot of this is unknown. It's totally experimental," Wojcicki told me a few weeks before the science board meeting. "No one has looked at all eight diabetes markers together. They've all been identified individually, but they don't know exactly how they work together. So we've tried to make that clear."To crunch these numbers and determine one person's risk factor, 23andMe has opted to multiply the risks together. But a competing school of thought argues for adding the risk from SNP to SNP. The two approaches can result in wildly different tallies.

Welcome to the first Google driven experiment in genetics, paid for by the customers......Unfortunately that poor author from the NYT demonstrated her clear lack of that understanding. And she is a learned journalist, what's to happen to the layperson who has never had any education in genetics/science?

IRBs were formed to protect research subjects. Why could Dr George Church only get a select few for his first personal genome project? The IRB deemed laypeople unable to give informed consent. How did 23andMe end around the IRB?

23andME "Genetics By Business"
The Mission? Mission Statement23andMe's mission is to be the world's trusted source of personal genetic information

I want to over IRBs history a little more. Because, Trust is a very important word.

In July of 1974, the passage of the National Research Act established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission met from 1974 to 1978. In keeping with its charge, the Commission issued reports and recommendations identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and recommending guidelines to ensure that research is conducted in accordance with those principles.

The Commission's report setting forth the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects is titled The Belmont Report

The Report, named after the Belmont Conference Center at the Smithsonian Institution where the discussions which resulted in its formulation were begun, sets forth the basic ethical principles underlying the acceptable conduct of research involving human subjects. Those principles, respect for persons, beneficence, and justice, are now accepted as the three quintessential requirements for the ethical conduct of research involving human subjects.

While recognizing that the distinction between research and therapy is often blurred, practice is described as "interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success. The purpose of medical or behavioral practice is to provide diagnosis, preventive treatment, or therapy to particular individuals."

The Commission distinguishes research as designat[ing] an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.

"The Report recognizes that "experimental" procedures do not necessarily constitute research, and that research and practice may occur simultaneously. It suggests that the safety and effectiveness of such "experimental" procedures should be investigated early, and

that institutional oversight mechanisms, such as medical practice committees (exist).

So this is why I have a trust issue. Drew points this out at ThinkGene today.

If the Fox is watching the can we have significant trust? Just like the senators getting campaign donations by Freddie and Fannie.....this reeks!

The Sherpa Says: Since 23andME is not practicing genomic medicine, it must be researching genomic medicine. So according to the Belmot Report and Nuremberg code, their "subjects" should be able to withdraw from research and have the benefit of an IRB. As for sample should be justified which tests will be run and patients have the opportunity to refuse or be reconsented.....That's how you win my trust....


Andrew said...

Not having an official IRB for a website that reports SNPs is in no way like being a Nazi, Steve.

Please keep things in perspective.

Steve Murphy MD said...

Bogus argument. You know that. Should Harvard or any other research institution for that matter now give up IRBs because they aren't Hitler either????

The rules were created after Hitler....he died, remember?