New documents emerge in the genetic privacy v. newborn screening battle

A new round of documents obtained from the Minnesota Department of Health (MDH) regarding the state’s Newborn Screening Program (NBS) show interesting implications about the difference between its role catching certain dangerous genetic diseases, and the various genetic research and testing programs that the samples ultimately get sent to. There’s quite a difference between the "trip-wire" disease screening program and the DNA studies; the role of DNA research as intellectual property suddenly pops up.

The study project authorizations approved by the Department of Health involve DNA research; critics of the policies around the newborn DNA samples want to know what happens to all the genetic data, and who might profit from it. Two big players around here, the Mayo Clinic and the University of Minnesota, do work on the blood samples. The operative contracts, which include defining the "intellectual property" of what could almost be called the "derivative works" of newborn DNA, of the U of M and Mayo were obtained by lawyer Nathan Hansen, working in concert with the Citizens Council on Health Care, via Data Practices requests.

Here is the University’s newborn screening contract and the Mayo’s [PDFs]. Fans of cellular rights might find the parts on the State apparently owning their chromosomes a bit profound! [PIM combined all of Hansen's PDFs, now searchable via optical character recognition. Get it now: 105 MB - Acrobat 8+ required!]

The puzzle over infant DNA data handling revolves around a conflict between the state’s 2006 genetic privacy law, which is fairly protective of individual rights, and the statute that controls the newborn screening program. In March 2007, administrative law judge Barbara Neilson ruled that the Department of Health was not compliant with the privacy law, and in 2008, SF3138, a bill that leaned towards the program (and backed by the Mayo) got vetoed by Gov. Tim Pawlenty over privacy concerns.

From where should the basic principles about intellectual ownership of one’s DNA come, especially when dealing with the property of people that were just born? Parental informed consent is the pathway out. To reform the legally hazy situation, DFLers have basically wanted to make a more clear consent form available to new parents, and roughly speaking, tighten up the sample rules.

If the DNA samples are considered "anonymized" in various ways (generally, but not always, the bloodspots get tied to ID numbers, not with demographic or personal information), then the studies can be exempted from Institutional Review Board examination usually under "Category 4" of 45 CFR 46. This is kind of a misleading idea, though: all those data fields they leave off are just bytes assigned by society; forking out someone’s DNA tells everything about them, to a rather serious extent.

It’s a salient public issue: CCHC Director Twila Brase and Tom Emmer (R-Delano) appeared on the national Glenn Beck show to chat about the nebulous legal nature of the situation. (CCHC also has a infant DNA website up.)

The CCHC is pleased they’ve stopped the latest legislation this year from Rep. Paul Thissen (DFL-Minneapolis), even though Thissen sees his bill as a clarification, tightening rules on sample destruction and the parental consent system.

We’ll make a dare for the Department of Health to try: the new parental informed consent form should have a separate checkbox: if the DoH is going to offer their child’s DNA to research programs, all derivative works and intellectual property should be under the "Creative Commons" license — none of this scooting off the chewed up data into the sphere of corporate patents and trade secrets!

One other factor: as public-private partnerships have moved into the area of genetic research, the compensation structures of various researchers have been shifting. The proposed, so-called "Tubby Smith" shift in data classification of public employee outside compensation would obscure how these are set up — and indeed, if the "derivative works" from the infant DNA data isn’t always traced (let alone handled in a comprehensive ethical framework), what’s really happening to those little red spots? As always, who profits?

One program serves to improve a commercial "Total Galactose" testing kit from the Finnish group Perkin Elmer [PDF], in effect doing the R&D runs. On the documentation like the MDH Institutional Review Board (IRB) "Re-Reviews of Exempt Research," sometimes children are marked affirmatively on the "Vulnerable Populations Checklist" and, at least on some studies, they are supposed to be evaluated because they "are either not competent or not free to give their own consent;" so why are the studies inconsistent as to whether children are actually involved? In any case, the exhaustive social and economic effect of having their DNA poured into to research projects isn’t fully traced in these IRB approvals.

Hansen’s sharing more about where else the paper trail leads at his blog. One funny item from the letters Hansen got from Lynn Belgea at the MDH legal office said MDH [PDF] "does not conduct ‘DNA collection’ from infant children; the department collects dried infant bloodspots, of which DNA is one constituent."

On one IRB review’s HIPAA checklist, it was noted the MDH is not a "covered entity" under HIPAA, and "any health information that MDH has collected or received for public health purposes is not PHI [Protected Health Information] in MDH’s possession." PHI doesn’t seem to extend to the idea of personal ownership of DNA as a kind of "individually identifiable health information" (PHI is described as stuff about payments, health care provisions or the "health condition of an individual") — but even if PHI included your DNA rights, the MDH wouldn’t have any problem distributing it under current HIPAA rules, because it all came in for "public health purposes."

[Get the whole, fully searchable multi-part PDF here, 105 MB including the U of M and Mayo Contracts, the total galactose project, MDH correspondence, years of NBS meeting agendas, and other items. Acrobat 8+ required.]

2 Responses to “New documents emerge in the genetic privacy v. newborn screening battle”

1. Anonymous Says:
   June 13th, 2009 at 1:07 pm

   Well, this is just another perfect instance of MDH doing whatever they want and having virtually no consequences. I have never met anyone from the department that I would cnsider honest or ethical…..

2. The Truth Says:
   February 28th, 2010 at 1:30 am

   …and neither honest nor ethical is any legislator supporting this theft of your children’s personal medical information. If any corporate medical entity passed out any medical information the way the MDH does, that corporation would be subject to fines from 6 figures into millions of dollars. The words, “trust us, we’re from the government and we’re here to help” should strike fear into the hearts of any citizen with any intelligence at all.