NRPM Symposium: “We are holding health care for ransom, just get naked already!” or “Consent neutrality is non-neutral in effect”

Part Three of Seven-Part Blog Series by Guest Blogger Patrick Taylor

In the previous post of this series, we took a look at how comprehensively certain proposed revisions to human subject research regulations would apply and whether they would, if effective, really fulfill a broad goal of enabling the consent of everyone to researchers’ use of their clinical data.  The answer is a big “No,” based on their scope.  If public trust in science depends, as the government claims, on individuals’ consent reliably and consistently governing research use of their data, then science is in trouble; all the government has proposed is a restriction on the institutions a supermajority of the people trust already to protect their privacy: healthcare providers, researchers funded by the NIH, and a handful of other federal agencies.   Everyone else, from Google to spymaster, drug company to next-door neighbor, is unaffected except to the extent that those entities, or reviewing IRBs, require contracts that say something more, which in this case is left to chance.

The proposed regulations call for government to draft a general blanket consent to govern tissue banking and banked data.  “Blanket” means that it covers everything, in undifferentiated language, with no opt outs – all or nothing.   Such an approach will eliminate most or any choice about what one is consenting to.  It will require consent to any research by anybody using any technique, with any goal in mind.  The options will be to consent to that or not consent at all.

This kind of consent has been criticized as insufficient because of the unknowability of what it refers to. In fact, the highest ethics body in the country, The Presidential Commission for the Study of Bioethical Issues, in 2012, criticized its use for genomically linked clinical data and said that it gives patients too little control over how their information is used.  But the government is proposing it anyway.

It’s important to note that this does not mean that the government can do whatever it wants to your body itself; this component of the proposed rule changes would not govern clinical trials, like comparing a new drug with an existing one in ill people.  Instead, it would mean that – if you provided blanket consent – the government could do what it wants involving research with those pieces of your body that  have been tissue-banked, including giving them to all those many people, corporations, etc. that would not be covered or limited in any way by the proposed regulations.

Okay, but people don’t have to sign the blanket consent, right?  True, no one is making them.  But there are consequences.  If people do not participate, is it only researchers, drug companies and the government that are harmed?   Let’s look at an example.

 Some years back, people were very worried about children being used as research guinea pigs.  So they created extra challenges, and much stricter standards.   It worked. Over time, relatively few children were involved in research, and most research hospitals had few or no pediatric research protocols. Fast forward, and doctors were informing the FDA that there were very few drugs that had been tested and approved for use in children.  But doctors had to do something – they could not just let children die, or do nothing when there was a treatment for adults that was effective.  So doctors were taking drugs approved for adults, and using their best guess about how much to use and when for dosing children.   In some cases, the result was disastrous, and doctors shared their experiences.

Without formal research, the choices were stark: either withhold treatment there was some reason, from research with adults, to believe would work, or turn every clinical encounter into an unstructured informal experiment. Children had been “saved” from formal research participation, but the result was that they were deprived of tested clinical therapies.

Finally, to induce companies to conduct clinical trials involving children, the government had to promise those who conducted them an extra six months of marketing exclusivity.  That means an extra six months after when their patents would normally expire in which a drug company can exclude generic competitors, which means higher prices and a reduced supply.  And still most drugs have not been subjected to formal testing for safety and effectiveness in children.

It is customary to say, if someone is telling this story, that things turned out OK.  And it is true that from one vantage point, fortunately, thanks to smart and dedicated pediatricians, and it must be said the resilience of children, the consequences were not so bad. But the truth is that no one really knows how many kids’ lives would have been saved because we are comparing to an alternative future that did not occur.  Of course, we don’t know how many lives were saved by the stricter rules either.   No one ever subjected them to a controlled trial in which the highly regulated world was compared to a less stringently regulated one.  Instead, the logic of nonexploitation, and the fact that in some situations, like Willowbrook, captive children had been terribly abused by researchers, drove what appeared to be a “just” and appropriate protective approach that ultimately turned out to be “unjust” in the sense that therapies for adults – who are already advantaged by the fact that it is adults who have money, political clout and a sense of entitlement, not kids – became almost the sole target for drug development.

This example is intended to demonstrate the mechanism by which what appear to be neutral consent requirements can have a differential effect, with concrete consequences for those who will not provide blanket consent.  Like restrictions on pediatric research, the blanket consent approach to research with tissue and data proposed in the NPRM can have detrimental consequence – if certain groups of people refuse to provide blanket consent (but would have been willing to provide more limited consent with caveats) then research for those groups of people will be stymied, and medical advances will not be forthcoming.  Like children, these groups will become “scientific orphans.”

Read Parts One and Two of the ongoing Seven-Part Series

The Petrie-Flom Center Staff

The Petrie-Flom Center Staff

The Petrie-Flom Center staff often posts updates, announcements, and guests posts on behalf of others.

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