Piracy or Privacy? Some Thoughts.

First I want tell everyone how absolutely amazed I am by Misha Angrist. I don't know if you know who he is. But I now tell you that you must. He is one of the PGP 10. I know, it sounds alot like the Oceanic Six...but seriously Misha is way better looking than Jack!

I also want to apologize to Misha....I over-reacted with the article. What article?

The article now in Nature Genetics Reviews addresses the topic of open-consent which has popped up again! Daniel over at Genetic Future points out this excellent article written by "Jeantine E. Lunshof1, Ruth Chadwick2, Daniel B. Vorhaus3 & George M. Church4 "About the authors"

In this beautifully written paper they expound on several issues facing genomic technology and science. From the article:

Current developments in genomics challenge the established framework of biomedical ethics because the empirical facts of the genomic science change too fast for the reflections of ethics to keep pace with.

Whoa!!! Isn't this precisely what we were thinking about when the HGP began? Didn't we anticipate this deluge? I think we did. Science should never trump ethics.....EVER!!!

These developments have ethical, legal and social implications that call for strong cooperation between science and humanities6. While looking for approaches that can adequately address the moral and policy issues that are raised by emerging genomic technologies, ethicists are increasingly aware of the need for a shift in emphasis, even if it ultimately requires revision of key concepts in mainstream biomedical research ethics.

As long as we don't drop the Declaration of Helsinki or Call the Belmont Report trash, in the name of scientific progress.

Consent is relevant in building large-scale databases containing genotype data that are inevitably traceable to individuals, as well as in generating 'personal genomes'. What pragmatic moral guidance can be offered under these new circumstances?
In this article we argue that the reality of the new genetics and genomics urges us to abandon the traditional concept of medical confidentiality.

Just because we can't guarantee complete confidentiality, should we abandon it? Or perhaps just the concept of confidence. This could take some work ladies and gentlemen. We are talking about the social reprogramming of an entire nation!

Comprehensive data sets to establish informatics links among ten thousand to a million human genome sequences and extensive phenotype analyses are needed to effectively generate and test hypotheses, but they also enable the identification of the individuals whose DNA sequences they contain. This puts the validity of the existing consent protocols into question. If promises of privacy and confidentiality need to be abandoned, what are the implications for meaningful consent in the context of genomics research?

Whoa there! Who says we have to abandon promises of privacy and confidentiality? Perhaps they merely need to be modified?

Genetic privacy can be taken to denote a particular instance of the general concept of privacy, although often it is used as a value-laden concept that is qualitatively different from 'normal' privacy14 — a concept that presupposes adherence to genetic exceptionalism15. By contrast, we subscribe to the view that genetic privacy is just one instance of privacy.

I agree. privacy is privacy. Regardless of genomic or proteomic.

They then go on to argue that the whole system is already somewhat a sham. They mention the sickle cell trials in the 70s. The arguement that discrimination existed in a group (African Americans) where individuals existed that were carriers of Sickle Cell Disease.

The experience with sickle-cell anaemia screening in the United States demonstrated, as early as 1972, that stigmatization of individuals on the basis of their membership of a particular group is a real risk18. Whether this is based on genetic or other traits, conventional individual privacy protection misses the point. It does not work in the case of so-called non-distributive generalizations about groups in which the individual profile is indiscernible from the group profile.

They concede that GINA is a hope to help this. But I agree...the new discrimination will not be based on the color of your skin. It rests in your Copy Number Variation and your SNPs. But who is to say "everyone" will have access to your genome? Unless you are GenomeBoy

So I read on......

I did have a little bit of shuddering when I read these next 2 incongruous parts of this article.

Confidentiality implies trust in private and in professional relationships between individuals. The maintenance of confidentiality by professionals is vital to the trust in the profession, for example, to the public trust in physicians, lawyers or members of the clergy.

AND

Although, in clinical medicine, veracity is the legal norm in many jurisdictions, physicians may try to justify the withholding of information by invoking the 'therapeutic privilege'. In research, there is no such privilege, and when seeking informed consent from research subjects, distorted or incomplete information could undermine trust in researchers and in science.

So that upset me a little. Admittedly, trust is important in the relationship between a patient and their physician....but not really.........

Still though, just because someone can identify you....doesn't mean that they will. I have some problems with this argument. Do we use credit cards on the internet? Should we stop using 128 bit SSL because someone CAN steal our card info? How would shoppers feel if they were told in huge letters on the website "YOUR CARD INFORMATION CAN BE STOLEN BY USING THIS SITE?" How many companies would go belly up after that "Veracity"? The public operates under a thin veil of presupposition. All chaos would exist if this were not the case. So I give you the PGP open-consent

Open consent as part of the Personal Genome Project implies that research participants accept that:

• Their data could be included in an open-access public database.
• No guarantees are given regarding anonymity, privacy and confidentiality.
• Participation involves a certain risk of harm to themselves and their relatives.
• Participation does not benefit the participants in any tangible way.
• Compliance with monitoring of their well-being through quarterly questionnaires is required.
• Withdrawal from the study is possible at any time.
• Complete removal of data that have been available in the public domain may not be possible.

The moral goal of open consent is to obtain valid consent by effectuating veracity as a precondition for valid consent and effectuating voluntariness through strict eligibility criteria, as a precondition for substantial informed consent.

This is their Open-Consent option. It makes sense. It sounds like the credit card promise...sorta.

But what gets me is the close.....

Alternative solutions are scarce. Veracity requires broad consent in any case of collection and long-term storage of comprehensive data sets. However, an overly broad consent could become meaningless. The most likely pragmatic solution would entail maximizing data protection while informing people about its limits.............................. The role of ethics is neither that of an alibi nor of a straightjacket.

The Sherpa Says:

As long as this is what it is then I am ok with it. But if this is the introduction of SOMA, Free Love and the Bokanovsky process then I have to call it a day! Seriously is this worth a 60 Minutes episode? I don't think so. We need Informed Consent and that is exactly what it is. Does it mean no privacy? No. It means compromised privacy at best......for now! Tomorrow I will tell you about what the DVPMP is doing in this arena. Stay tuned.