A WIN FOR BABY DNA & FAMILIES! Battle Not Over Telling Transcript - "zero" parent consent Last night, citizens won! The baby DNA bill was defeated in the Senate on March 16, 2009 - at least temporarily. Thanks to the nearly 50 concerned citizens that were a very visual (and auditory - think baby) presence in the room (see below). There were individuals, couples, pregnant women, children and babies. There were also other reasons for the defeat (see below). These citizens were there to say NO to SF 1478, a bill that would ELIMINATE: genetic privacy rights from birth informed written parent consent rights for government storage, use and sharing of baby DNA (including genetic research) legal protections of the Government Data Practices Act in regard to government collection and use of genetic data on individuals. The bill would make genetic information state government property...unless the parents figure it out and object. The battle is not over Last night, the Minnesota Senate voted down the Baby DNA Warehouse bill 3 - 6. There was applause from the audience. Senator David Hann (R-Eden Prairie) led the charge for parents and babies (contact him if you wish at sen.david.hann@senate.mn) The battle is far from over, but this was a crucial win! It happened for at least three reasons: 1) The cast and crew of citizens who answered CCHC's call to come to the hearing! There were nearly people with CCHC signs sitting and standing around the room. 2) The anger of Senator Anne Lynch, who talked about how she felt betrayed by the Governor's veto of her Baby DNA bill last year. She wants full access to Baby DNA as she was seeking in last year's bill, not access limited to two years as would be allowed by this year's bill. Sen. Berglin called it a "sad" bill. 3) Discussion of the lawsuit against the health department and concerns that the health department has been violating the state's genetic privacy law. Telling Transcript - "ZERO" Parent Consent (partial) Mark McCann, supervisor of the Minnesota Department of Health's public health laboratory, made it clear that not one parent has given consent for the storage, use, and dissemination of the newborn blood and DNA: (Senate audio tape, start at 2:16:34) Sen. Hann: "Mr. Chairman, Mr. Stein or Mr. McCann, can you tell me how many parents have given their consent to have the blood that's collected from the screening to be stored and used by the Department up to this point? How many parents have given their consent to that? Mark McCann:  "Mr. Chair, Senator Hann, the number of parents who have given consent to store the dried, ah, the residual dried blood spots with the Minnesota Department of Health is ZERO. It's currently not a requirement to use informed consent to store the dried blood spots currently. As a current practice." Hann:  "Mr. Chairman and Mr. McCann, I guess I thought that was a requirement that any collection or storage or use of genetic material had to, it was required that informed consent be a part of that process to do that, so I'm not sure if I understand why you say there's no law that governs that. I thought that we did have a general law that said you can't store this without consent. Mark McCann: "Mr. Chair, Senator Hann, I don't think my response indicated that there wasn't a law, just not a current practice for us to have written informed consent to operate a newborn screening program within the boundaries of program operations, our interpretation of current law. It's well within the boundaries to operate a program, and use those dried blood spots to test and also for quality assurance, quality control and quality improvement outcomes. Hann: Well, Mr. Chairman and Mr. McCann, I really object to that. My understanding is the law on informed consent is pretty clear. It sounds like what you're saying it that you just have not been abiding the law and collecting and storing the material anyway. I've also been told and have reason to believe that there was a administrative law court ruling that pertained to this issue and the response to that was that the Department changed the rule and kept up with the practice. I find this disturbing that the Department has been acting in this fashion when it seems to me to be pretty clear that you need to have informed consent if you're going to collect this kind of material from people and use it for any purpose. And I'm concerned that the Department has been ignoring that law or those provisions. And now you have brought a law [legislation] that is in effect giving you that statutory authority to do what you have been doing without authority. I guess I'd like to know why the informed consent provisions are not or should not be applied in this case. You seem to making the argument that the current practice is that they aren't and they shouldn't be and I'd like to know why they shouldn't be when it seems to me to be a very simple procedure to say to someone we'd like to use this for this kind of purpose sign a form and go thorugh the very simple process of getting people to acknowledge that that's what they're doing. John Stein, MDH - "Mr. Chair. Senator Hann, The Department has not been ignoring the provisions of the law, but has been seeking a resolution to the question about our program operations. We believe that this bill represents a reasonable and balanced approach to the question of how the Department should operate the program and address privacy and privacy rights.  That is our goal in bringing forward this legislation with the support of the support of the Administration." Hann: "Mr. Chairman and Mr. Stein, I appreciate that but I still have not gotten the answer to the question of why isn't informed consent the standard we should apply in this case?...I want to separate. I think the last time we had this debate there was great confusion. People were accusing folks that had concern about informed consent with the idea that we did not want to see newborn screening. At least from my perspective, I'm perfectly glad to have newborn screening and I don't in any way want to impede that. The thing that I'm objecting to is taking the material that is obtained from the screening and then using it for other purposes without consent. That is the thing I'm concerned with and I'd like to know why informed consent as a standard shouldn't be applied in that case. John Stein: Mr. Chair. Senator Hann, the Department believes that the necessity of operating our program to improve the quality assurance of our results, the accuracy of our results is essential to our program. Were we to operate that on the basis of informed consent, we believe that it would compromise our ability to effectively operate the program. This bill does set a period of time of two years during which the department would commit to using those samples solely for the sake of our program improving and maintaining our program operations after which those samples would be destroyed, unless a parent provides written informed consent for retention longer than that. In addition the department is committed to destroying all previously collected samples prior to a date specific and I believe that's the subject of the amendment that may be before you." Hann: "Mr. Chairman. Mr. Stein, I guess one thing that troubles me, is that I for one am a little skeptical that you may in fact do that. It sounds like you're saying that because there are concerns that department's had to use this material they've sort of set aside the informed consent standards say but it's important for us to use to be able to this material to do certain things so we're going to do it. And now we have a bill that says we're going to destroy it after 25 months and I'm guessing that unless something else came up that felt, where the department felt they needed to use the material for a longer period of time then they might continue to do that! And I'm concerned about this. I think the standard ought to be if you're going to collect and save people's genetic material they ought to give you informed consent. I still do not know why, other than for the convenience of the department, we shouldn't adhere to that standard" Hann offered oral amendment to delete the newborn exemption, paragraph b, lines 1.21 - 1.23 "which would in effect preserve the standard that informed consent is what is required to collect, store, use genetic data from medical patients" Chair John Marty: Senator Hann moves to delete the new language on lines 1.21 to 1.23. Scheid (author of the bill): I think it's pretty fundamental to the whole scope of this bill in trying to conform to what the Governor has asked for...I'd hope that the committee would not adopt that amendment. Hann amendment failed (voice vote) Citizens' Council on Health Care 1954 University Avenue West, Suite 8, St. Paul, MN 55104 Phone: 651.646.8935 / Fax: 651.646.0100, e-mail