Blood Samples Raise Questions of Privacy

[MountainLaurel]

This is a rising legal and medical ethics conundrum: Who owns the rights to biological samples taken during medical care, what are the privacy issues involved, can genetic code be patented, etc? Keep an eye out for these issues in the news in the next decades.

Matthew Brzica and his wife hardly noticed when the hospital took a few drops of blood from each of their four newborn children for routine genetic testing. But then they discovered that the state had kept the dried blood samples ever since -- and was making them available to scientists for medical research.

"They're just taking DNA from young kids right out of the womb and putting it into a warehouse," said Brzica, of Victoria, Minn. "DNA is what makes us who we are. It's just not right."

The couple is among a group of parents challenging Minnesota's practice of storing babies' blood samples and allowing researchers to study them without their permission. The confrontation, and a similar one in Texas, has focused attention on the practice at a time when there is increasing interest in using millions of these collected "blood spots" to study diseases.

Michigan, for example, is moving millions of samples from a state warehouse in Lansing to freezers in a new "neonatal biobank" in Detroit in the hopes of helping make the economically downtrodden city a center for biomedical research. The National Institutes of Health, meanwhile, is funding a $13.5 million, five-year project aimed at creating a "virtual repository" of blood samples from around the country.

http://www.washingtonpost.com/wp-dyn/content/article/2009/06/29/AR2009062903118.html

[Gormy Cuss]

1. If the blood samples were stored under a randomly assigned ID with no link to the baby

it would be acceptable under most research standards but this quote suggests that's not true:

said Sharon Terry of the Genetic Alliance, a coalition that promotes genetics research. "We think they offer us the beginnings of a national blood bank to understand disease at an early age and follow people longitudinally over time."

Longitudinal study requires some linkage to individually identifiable data and that's flat out unacceptable under most research protocols unless the subject has given informed consent.

States have long collected data on communicable diseases using individually-identifiable data on the basis of immediate public health risk but that's quite different from collecting for the sake of large scale medical research. IMHO states with laws that bypass consent should be pressured to rectify this omission.

[trotsky]

2. Here's some more clarification from the MN Dept. of Health.

Why MDH stores residual newborn screening specimens

There are a number of reasons why the residual blood spots and the results are kept, many of which benefit Minnesota families.

In some cases, results or samples are requested by the family or the baby's healthcare team:

* The baby’s results can be repeated if needed without getting another blood sample from the baby
* The baby’s sample is available to parents for other health-related testing
* The baby’s sample is available to parents to help identify a missing or deceased child.
* Storage provides a permanent record that MDH completed the screening.

In other cases, all identifying information is removed from the samples (name, demographic information, etc.) so a sample cannot be traced back to a particular baby, and these samples may be used to:

* Make sure the newborn screening laboratory is doing a good job with testing (quality control)
* Develop new tests to screen for more disorders
* Do public health studies and research to help develop newborn screening tests and better understand diseases for the benefit of the general public

link: http://www.health.state.mn.us/newbornscreening/storage.html

[Gormy Cuss]

5. The "other cases" clause is as it should be.

That link also states that outside of the state researchers working under privacy guidelines only the parents and health care provider may obtain access to the results without expressed consent of the parents. That's a decent place to draw the line although once the health care provider has the info so do the insurance companies.

[dotymed]

3. 1984

This is undeniably and frighteningly Orwellian. Just ponder
the ramifications...

 Our "for profit" insurance system can "pull
up" the genetic code of a person before deciding whether
to "insure" them...Unsolved crime?...Check the
database of innocents...Hiring for a job? Let's see what their
genetic markers say about longevity and possibly psychological
profile..

We currently have to take a "drug test",
pre-employment...the CEO's don't and they're making the big
decisions and the big bucks.

Our High School forces "drug tests" on any child
that wants to participate in "extra curricular"
activities, even if they want to be able to drive to school.I
complained to the Superintendent of schools. His response?
We're getting them ready for the real world. All
"jobs" require drug tests...

I thought the main idea behind extra curricular activities was
to steer kids away from drugs..

BIG BROTHER IS ALIVE AND WELL. WE ARE ALL SLAVES IN THIS
COUNTRY, UNLESS YOU CAN AFFORD TO BUY YOUR FREEDOM.

[Gormy Cuss]

6. No one is forcing us to take drug tests. They became common because too few people objected.

With the insurance companies, yes we don't have a choice about the privacy violations other than to go without insurance at all, but even if we choose to divulge our genetic markers there's no guaranteed that the insurers would issue us policies. That's why the people who think a national plan will be a bigger risk need to think it through a bit more clearly. At worst it will require the same level of privacy violation but it will guarantee basic coverage.

[dotymed]

9. NO TEST = NO JOB

Not forcing us? I really don't follow the rest of your post...
I agree though, that not enough people publicly objected. I
did and I don't use illegal drugs.

[Gormy Cuss]

10. You understood correctly, The only reason drug tests are common is because more people didn't say NO

It's coercive in that so many jobs require it and the competition for jobs is so steep but you always have the less practical choice to just say no. There's a risk that it will take longer to get a job but about half of all employers don't require drug tests so depending on the type of job it may be low risk.

Drug tests are tangential to the OP. The rest of the post is dealing with the likely consequence of letting insurance companies use genetic markers as determinants for coverage eligibility vs. a publicly funded health care plan having access to same.

[sailor65]

4. If you want an interesting perspective,

read "Next" by Michael Crichton. Although it's technically a work of fiction, the parallels to reality in term of genetic ownership are striking.

[Why Syzygy]

7. So much for Hipaa

http://www.hhs.gov/ocr/privacy/index.html

.. and the stack of papers the doctor gives you to sign to 'secure' your privacy.

[trotsky]

8. If you didn't censor those whose opinions differ from yours...

you would have seen my post above linking to the MN Department of Health. They even have a page specifically addressing privacy of records:

The MDH Newborn Screening Program is governed by and adheres to the following laws, statutes, or rules regarding individual privacy:

Minnesota Government Data Practices Act, Minnesota Statute, Chapter 13

Minnesota Statutes, Chapter 13 outlines requirements of Minnesota state agencies in the collection, storage, and release of data. The Minnesota Newborn Screening Program strictly adheres to the language in Chapter 13, so as to ensure the protection and privacy of all individuals.

The Health Information Portability and Accountability Act (HIPAA)

This privacy rule governs the use and disclosure of protected health information. HIPAA applies to health plans, health facilities and health care providers. Section 164.512 of HIPAA permits disclosures of health information to MDH by medical providers for public health activities that are required by law and are performed for the purpose of preventing disease (such as newborn screening).

Code of Federal Regulations, Title 45

The Minnesota Department of Health complies with Title 45, part 46 of the Code of Federal Regulations. Any department-sponsored research using newborn screening specimens must be reviewed and approved by an MDH Institutional Review Board (IRB). Institutional review boards are review bodies established to protect the welfare of individuals recruited to participate in research studies. Institutional review boards recognize the principles of respect for persons, beneficence, and justice as laid out in the Belmont Report. Any study being done in collaboration with another institution must be approved by IRBs of both MDH and the collaborating institution.


link: http://www.health.state.mn.us/newbornscreening/privacy.html