NPRM Symposium: So many left behind…

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

The development of research benefits depends on research participation.  Research participation, in turn, depends on being asked to participate, and how people evaluate what is being asked of them.  This post focuses on a few, not all, of those disproportionately excluded from research through one mechanism or another.  It illustrates some of what the proposed amendments to the Common Rule governing human subjects research will likely mean in practice absent some special vector that changes the outcome.  We will discuss what such a social vector might look like at the end.

We will start with those people who, understanding the real impact and meaning of providing their “blanket consent” to research, and uncomfortable with the sweeping right to invade and permit others to invade their privacy, refuse to sign it.   Who are they?

It is too well documented to require citation that minorities, including Henrietta Lacks’ own family members, disproportionately decline research participation, including genetic research. Under the proposed regulations, minorities already suspicious of researchers’ intentions must either consent to compete nakedness including with respect to genomically-linked clinical data and unrestricted future research, plus broadest possible access to their data by almost anyone, or forego the benefits of personalized medicine, to the extent personalization depends on specificity and their rare or unique features.  Although the effect is necessarily speculative, it is reasonable to hypothesize that blanket consent embodies every fear they might have, none being disavowed, and that it will be a serious obstacle to minority participation.  Although the regulations are overtly offered as a solution to the exploitation of Henrietta Lacks, they will have the probable effect of disproportionately excluding people of her race from precision medicine and the rest of the revolution in medicine that is promised based on linking specific genes to individualized therapies.  It seems doubtful that having these regulations proposed in her memory is an honor Henrietta Lacks would have accepted.

Blanket consent will also lump together and offend religious people who cannot in good conscience agree to “any” research, everyone who is a member of the pro-life movement if they are aware of what it means, every member of the pro-choice movement based on the exposure of the data of every woman who has had an abortion to any researcher for any purpose, technology-loving millennials who already see the government as untrustworthy and heavy-handed, every person who sides with Apple in the current Apple-FBI controversy regarding the San Bernadino shooting suspect’s cell phone, and technology-hating people who see scientific advances as the road to Brave New World and 1984.   Indeed, it will exclude at least the more than half the country that distrusts corporations and government most of all to protect people from the misuse of genetic .

Anyone else excluded? Under a blanket consent regime, participation in research will be barred not only for those who decline “blank check” consent, but also those who will never be asked.  Recall this odd wrinkle in the proposed regulations: this consent for the benefit of research and research institutions is to be procured by healthcare providers, disconnected from the research, knowing nothing about it, and with no incentive to add a consent form to the stack of papers they give a patient – especially a consent form like this one – and no law that says they have to.

Some proportion, from my experience, will think it violates their professional obligations to ask a patient, when they come in needing care, to sign a paper calling for participation in research: they will think it is coercive and want no part in it.   Others will be disturbed that they are being asked to offer a consent to research that they cannot explain, or of quality they cannot control. They won’t want their patients to be harmed or regret it.

Since research will be being done elsewhere, at an academic teaching hospital that competes against them and is always advertising that it is smarter, better and has the lock on cutting edge cures through research, the thought will certainly cross their minds that they are being asked to send their patients to their academic competitor so that it can wow them with mumbo jumbo to conceal the fact that they are guinea pigs, and steal the patients.

No way!  Would Marcus Welby, M.D., embodiment of physician virtue, offer his patients that consent to sign?  Would House do it or even ask others to route unsuspecting patients his way so he could blow up their privacy?  No way.

So the terms of the blanket consent would have ripples of consequences affecting who is asked.  The only safe bet is that the patients at the academic hospital conducting research will be asked.  There are about 1000 of those in the country out of about 60,000 hospitals.  The 1000 are almost completely urban, and concentrated along the two coasts although many states have one or two of modest size, engaged in serious competition with the nonacademic hospitals that usually charge much less for care but without the research aura.  A subset of fewer than four hundred receive significant NIH funding.  Most receive zero funding from Common Rule agencies. The regulations would not even apply to them.  Yet the regulations will bar academic hospitals from conducting research using clinical data unless nonacademic hospitals where it was collected have obtained consent.  Gee, I wonder if it will cross the minds of anyone in the nonacademic hospitals that they can stop their academic competitors’ research in its tracks, and look like real privacy champions for their patients, if they refuse to obtain that blanket consent!

So also excluded are patients who are never asked for their blanket consent because they are not the patients of NIH-funded teaching hospitals and the NIH has never enlisted their providers in asking them let alone explained what it all means: the patients of the many small or medium-sized rural, community and urban hospitals that are not teaching hospitals, do not receive NIH funding, and may not hear about this policy for years.   Those may be the sole hospitals most people in this country will ever know, in red states and blue states, in liberal states and Atlas Shrugged states.   Whoever they are, they all seek care, they all matter, and so do their children. They pile into the Personalized Medicine train, the whistle blows as the President begins to speak, the train begins to move, but they are all on the train that will never arrive at research participation.  Some may be prepared to give up all privacy; some may even be eager. But it doesn’t matter. Look across the continuum of care: the clinical consent processes of entities that the NIH has no authority to regulate are now either excluded – with all or most of their patients – or their consenting process for any and all clinical encounters is subject to change in complex ways, without even technical assistance with the tricky question of what sort of consent they should adopt for their patients even to be considered.  Those who are not patients of a funded academic hospital will be invisible. Research institutions will not be able to know that they even exist through limited data set research based on their possible research interests or therapeutic needs if they do not already have their consent to participate in research!  Moreover, any research gathering of enough data to find out about those patients will inevitably result in research disclosure of the clinical data of some number who explicitly decline the newly-required blanket consent to access for research.  In unsuccessfully seeking their consent, and receiving an objection, one has already acted inconsistently with their right to decline this  newly created “consent”.

So who gets left out of research participation due to the breadth of this consent, and its enlistment of healthcare providers without telling them anything about it, or countering the disincentives to do it?   Most of the country.  You, unless your hospital is an NIH-funded teaching hospital.   Kiss goodbye the promise of Precision Medicine for you and your family.

The problem is that HHS created this “consent” to do a job: allow ample sharing with companies so they could get their help in speeding up application of the Human Genome Project to real life.   But they forgot to think about who could sign such a consent, who could not, and who would not.    That does not help public trust any more than the rest of the proposed regulation’s problematic provisions.

The regulations do come with a justification that goes on for many pages.   In the next post we will look at whether the principal rationale, that participants would prefer to be asked before tissues and data are used for research, holds water.\

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

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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