CRG Testifies Against Rollback of Newborn Privacy Protections

by jeeg 18. March 2014 04:50

March 17, 2014

Chairman John Lesch
House Civil Law Committee Minnesota House of Representatives

RE: HF 2526
Mr. Chairman and Members of the Committee.

Founded in 1983, the Council for Responsible Genetics is the oldest national bioethics organization in the United States. We led successful efforts to enact the federal Genetic Information Nondiscrimination Act and have supported every state and federal genetic privacy initiative in the last thirty years. We are founders of the Genetic Privacy Network and the Forensic Genetics Policy Initiative and have produced many influential books and reports including Genetic Explanations and Biotechnology in our Lives. Our Board of Directors includes leading scientists and public policy professionals.

We stand in strong opposition to HF 2526. We believe this bill is against the interests of parents in making a truly informed choice about whether the state of Minnesota shall permanently retain and use their children’s personal genetic information.

Before they are even a week old, ninety-eight percent of the 4.3 million babies born annually in the United States have a small sample of blood taken from their heels. These newborn bloodspots (NBS) are then screened for a variety of inherited conditions and are often later stored in state-operated databases. Newborn screening itself is an important public health program and some have described these residual sample “biobanks” in equally positive terms. Although there are concrete benefits of newborn testing, there are also troubling consent and privacy issues raised by the screening, storage, and use of the samples.

With respect to sample storage and use, there is little transparency regarding storage procedures or the use of the samples after they have been screened. Indeed, not only do most parents never realize they have “consented” to storage of their children’s biological material, they fail to understand that the actual state government (as opposed to the hospital) is the entity in possession of this sample.

Several studies have shown that the vast majority of parents want the choice as to whether the state should maintain their child’s sample after screening is completed and most oppose the indefinite storage of such samples. Even though parents want informed consent to store and use the samples, many states including Minnesota do not have clearly articulated policies about consent for the storage and use of samples, do not effectively communicate these policies to parents and do not offer parents a truly informed choice about whether to participate in storage procedures.

The concern of parents that states retain their children’s biological information is heightened because storage procedures and security at these state facilities are arcane and we still have few laws that truly protect the privacy of genetic information.

The opt-out model, which is the basis of HF 2526 is not a true model of consent because it does not require any actual form of consent. One problem of the opt-out model is the ambiguity posed by silence. As applied to the case of newborn screening, a parent who does not voice objection to the screening program may still approve of the program and consent to screening and storage even if s/he does not express affirmative consent. On the other hand, that same parent may disapprove of newborn screening and want to opt out of the program, but s/he is either uninformed about or unaware of the program and therefore does not express explicit refusal. In both cases, however, the outcome is the same: the infant will undergo screening and their sample will be stored. Thus, the opt-out model for screening depends upon parents being well informed about the screening programs and their consent options. The reality, however, is that many parents are not well informed about screening programs or consent, due to inopportune methods and timing of information dissemination and the lack of adequate training for medical professionals responsible for communicating the information. Parents, understandably, want to be actively involved in decision making regarding their children’s personal health information.

Finally, affirmative consent for storage is crucial because it promotes greater governmental transparency. Such transparency is especially important because newborn screening and storage is often exempted from state genetic privacy laws. Researchers and administrators working with these samples know very well how alarming newborn blood spot biobanking can sound to most people, which explains why many of these clinicians, researchers and state labs would prefer these projects to keep a low profile. However, public health officials’ desire to avoid controversy must be balanced against parental interest in being informed about the storage and use of their children’s bloodspots.

How many parents, having just had a baby and still in the hospital truly understand what the state may or may not be telling them? Thus, the only way to be sure that someone is truly consenting is to obtain his or her affirmative consent, as required by the opt-in model.

HF 2526 employees a mechanism for storage of newborn bloodspots that stands in direct opposition to recommendations by the Task Force on Genetic Screening, the Newborn Screening Task Force, and the President’s Council on Bioethics. All three organizations propose that the storage of residual bloodspots should be implemented as an opt-in model of consent. Numerous studies have also supported this position. 

 

The absence of clearly articulated and communicated consent policies is particularly problematic because of the mismatch between the promise of maintaining residual sample databases and the actual benefits generated by such storage. As mentioned above, public health officials and patient groups often emphasize the value that these databases represent, but the actual benefits generated are much less dramatic than their statements would suggest. Across the country, state stored blood spots are used almost exclusively for formulating screening tests and ensuring that existing tests meet certain quality standards. While these are beneficial applications of storage, they do not require the scale of current sample storage and can often be done even more effectively in appropriate research facilities. They certainly fall far short of the too often claimed promises of elucidating disease characteristics and generating earlier interventions.

Newborn screening is one of the few forms of genetic testing to which almost everyone is exposed. Yet parental knowledge of newborn screening and storage practices is extremely limited. As the National Institutes of Health (NIH) and other distinguished bodies move toward developing better and more informed consent procedures, HF 2526 would be moving the state of Minnesota in the opposite direction; against historical trends and even more importantly the desires of Minnesota parents.

We strongly encourage you to oppose HF 2526.

 

Testimony Prepared by:

Jeremy Gruber
President
Council for Responsible Genetics
5 Upland Rd, Suite 3
Cambridge, MA 02140
www.councilforresponsiblegenetics.org 

 

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