Friday, June 15, 2012

BRAIN CASE: one man's waste...

Today's Friday Food for Thought has me thinking long and hard about theoretical arguments Lazzarini, Case, and Thomas presented in "A Walk in the Park: A Case Study in Research Ethics"  published in the Journal of Law, Medicine and Ethics. 

As a fledgling PhD student edging toward candidacy, I'm sending feelers through the fields of medical law, medical technology, communication theory, and organizational change. Sounds dry when I put it that way but Lazzarini's paper is, well, anything but.

The paper argues that used condoms are fair game for HIV researchers willing to troll PSEs (public sex environments, if you must ask) for elusive samples.

Their argument goes:

1. Any semen dredged out of a used condom falls outside the scope of Federal Regulations because the semen does not come from an identified person, and so doesn't fall under human subjects research that would require IRB (institutional review board) oversight.

2. Even if collecting used condom samples IS considered human subjects research, the requirement to obtain a consent form from the semen "donor" can still be waived (largely because the research isn't causing harm to the donor, cannot easily be traced back to an individual (assuming the research remains HIV-focused, and doesn't involve genetics), and is conducted on abandoned samples.)

On board so far? This might be a good time to address why I even care about prying into the depths of a castaway condom... the quick and dirty answer is, I don't personally. Not directly, anyway, since I don't do HIV research. But I *am* trying to figure out some ethical ways to conduct research using tissue samples leftover after cancer patients' surgery.

Lazzarini, argue that conducting research with abandoned semen is somewhat like using tissue bits abandoned after surgery for research. The courts appear to agree so far, as they did in Moore v. Regents of the University of California, when they struck down Moore's claim that he should have gotten some of the profits from a cell line scientists developed under fishy pretenses from his cancerous spleen. Once the diseased tissue leaves the body, it seems, you give up your rights and claims upon it--you've abandoned it, because it's no more good to you (or in you.)

the kind of hairy cell leukemia in Moore's spleen
 Granted, the authors do state:
While the Code of Federal Regulations certainly seems to legally allow research without consent for studies such as this, the ethical principal of avoiding harm to individuals should prevail at all times.
I'm currently involved in trying to ethically prevent harms and to get informed consent from people who, yes, want to abandon their tissue on the operating room floor, but who also presumably want to know what happens if a scientist swoops down, plucks up that tissue bit, and eventually publishes research findings or passes their data on to a for-profit company.

It's a sticky situation: doctors and researchers don't HAVE to get consent, largely because of this supposition of abandonment, and because they're also removing as much personally identifying information from the sample as possible, along with setting up controls to limit access to personal information, theoretically guarding your health status from insurance companies, friends and family, or anyone else out there.

The University of Washington, according to John Slattery at WPBR, wants to blaze an ethical trail by deliberately asking patients for permission to do research with their castaway tissues, (even though the law doesn't require it) as a way to both demonstrate respect and to unite researchers, clinicians, and patients in education and research. I'm thrilled to be involved in the project's design and execution (and even more thrilled I'm not poking around PSEs for samples), and I'm looking forward to sorting through some of these peculiar ethical questions.

It's a peculiar time in biomedical research when your literal biological trash is someone else's treasure trove, and when the prevailing legal argument claims you cede your rights to your cells as soon as they exit your body, even those cells can continue acting after you're done with them.

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