Part Five of Seven-Part Blog Series by Guest Blogger Patrick Taylor
The preamble to the NPRM justifies requiring consent for data and specimen research by contending that studies indicate that people want to be asked for permission. However, the literature on this topic is relatively thin. Available evidence suggests that many people, upon being informed that their heath data and tissues could or would be used in research without their consent (and nothing further is said to prompt the idea that research might delve into controversial matters) are generally fine with such use. But when also queried whether they would prefer to have been asked, people say they would. What the literature does not show is that people say: “I object to any use without my consent,” let alone “and I choose that over all the advantages of minimal risk research involving analysis by a computer of digitized files not humanly readable limited to disease-gene associations of thousands of medical records where consent would not be possible but the results will be essential or important to my health, the health of others, and the national health.” Pluralistic discussion of tradeoffs over time, or an extended, candid national dialogue about the reasons for the present rules, were not in the mix. Yet still, people said the opposite of “This must not occur without my consent!”
We have already seen one way in which the claim to be respecting the preference to be asked is untrue – it applies to only some research by some organizations. Now here is another. The commentaries to the NPRM celebrate as fact that a patient need be asked only once, for all time, and then the only acceptable “yes” answer grants permission for any research by anybody. It seems doubtful that a one-time consent to any future scientific research by any researcher for any purpose, without ever going back to inform or re-query, without any regulatory provisions ensuring it was revocable, was what participants meant by “being asked.” Rationally, that option is far worse than no consent, for reasons we shall come to.
Polite people pay attention to each others’ preferences. But they also pay attention to others’ needs, others’ limits and others’ consciences. HHS, as a bureaucracy, is being impolite. It can do better and should. Its proposed “consent” is broad enough to yield access to researchers from the American Civil Liberties Union, the FBI, the Church of Scientology, ISIS, and the “Hackers of Sony” Research Foundation. It should say so.
Of course, someone would prefer being asked. So would I, and so would we all. One might say that about something as trivial as someone “borrowing” a pen, as primal as a waiter clearing away those excellent mashed potatoes about which one’s New Year’s resolution has been wavering, or as substantial as the thievery of one’s fortune; in all cases, one might say I would prefer to have been asked. But the answer to thievery is not to convert thievery to robbery and mandate that henceforth, thieves must ask before taking; it is to address the practice of thievery, or in this case, persuade people that it is not thievery at all, but an occasion of reciprocity. It is not just I who think so, the framers of the ethics of learning healthcare systems, deservedly revered, said so first.
In this case, given the popular support for biomedical research, its positive goals, and the practical and logical connection between data and discovery, it seems likely that properly understood such research could be distinguished from thievery, with edifying dialogue between scientists and people. So why not undertake the conversation? Have some faith that “We the People” can handle such questions as the Common Interest, and even support nuanced answers.
Most recently, look at the evolution of stem cell policy – I am not referring to the outcome as much as the subtlety of the process and principle adopted. What started as a demonizing debate that would have reenacted the painful intractability of the abortion debate, moved via careful media exploration, public ruminations, the appearance of the undeniably ill as people for whom it was their sole hope, to a position that, if not preferred, people could understand and in a pluralistic country accept. The issue required specialized scientific knowledge – so people listened and acquired it. No scientist got everything they could have wished for. It required the humility to recognize where one’s own views depended on views, whether atheistic or religious, that others forgivably might not share. It involved accepting a reality that political pomp often urges us to forget, bathed in some vision of a purer utopia: that we are all here, that we all count, that we are irreducibly pluralistic, and approaches to governing that forget that just waste our time and weaken our country. In the context of consent for research with data and tissues, the answer to meeting scientific needs is not to go fishing for those unaware enough to sign a blanket consent. Instead, it is to connect and treat with the greater respect due to people who have every ability and right to understand and to govern themselves.
So, when so approached competently with complex problems, people as a whole are perceptive and astute. Such an approach is urgent, if indeed, as is claimed, the fate of science, if discordant with such preferences, hangs in the balance. Of course, to be really reciprocal, science and society might have to do a bit of work in the fairness department – sharing proceeds with the patients who help out, lowering domestic drug prices so that ordinary people without pharmaceutical insurance can afford them, engaging participants more directly with results and their meanings. But on these important points to the fairness of the transaction, the proposed regulations do absolutely nothing except reiterate that communication of research results to the donors of data and tissue are optional.
The preamble to the NPRM threatens that without asking for permission to use data and tissues for research purposes, including specifically universalizing consent to any future research use in this completely open-ended way, the scientific enterprise will fail from acting differently than a majority of the citizenry wishes. That claim is already contrary to history: no demand to eliminate the practice rose following publication of The Immortal Life of Henrietta Lacks; not even Libertarians or the Tea Party picked it up. When Congress chose to act, it was in a narrowly drafted provision that limited repurposing of neonatal blood spots without consent. Although the sentiment appears as true as any patriotic truism – legitimacy depends on concordance with some concept of public will — the conclusion to be drawn is quite different than the one offered in order to justify the proposed regulations: despite occasional or even frequent grumbles, many such unpopular laws and regulations, and the things that depend on them, survive just fine. For example, at least the same margin would state, if asked, that they would prefer not to pay taxes. Those who said otherwise would be considering tradeoffs. We do not therefore repeal the Internal Revenue Code and forgive all property taxes. For science and medicine, consider the various practices that may defy public preferences: the frequent creation of chimeras in research, the concept of xenotransplantation, its routine practice in clinical care, and Medicaid. In all such cases, the topic deserves more serious discussion than just yielding to preferences.
In that light, the justification that potential participants would prefer to be consulted is the beginning of discussion, not the end. “Leadership by polling” is not leading, nor even representing, it is not seeking to comprehend or engage, it is merely mindlessly following the public, indifference, or exploiting untutored views to achieve an end of one’s own.
The required democratic answer is not just to capitulate to the public but to ask whether they are right, and to engage with them. In short, where an important cause is involved, the answer is public engagement and political leadership.
That is particularly true here, where a right of individual consent is being created independent of social circumstances by an unelected administrative agency with no particular expertise in the intricacies of democratic theory or political science. Democracies routinely rely on representative consent for policy choices around issues no less personal and higher impact than use of our clinical data. Lawmakers’ obligation is to create and adopt policies that maximize social good and minimize individual costs, including privacy harms – not to give up on policies of protection and prevention, count on individual choice, and substitute dangerous altruistic choices for effective harm-reduction policy. Here, licensing dataminers, extending HIPAA-like constraints to the many non-covered entities, criminal penalties for identification not authorized by law, and consequential liability should all be on the table. To say that individual consent is required is to declare democracy ethically valueless.
The attribution of public distrust to use of clinical data without universalized blanket consent is perhaps the only explanation for public distrust that does not have a substantial literature to support it. I have yet to find even one academic empirical study demonstrating that unconsented data use by researchers has caused public distrust or slowed research progress, let alone that that distrust cannot be overcome. I have found not even one infamous public data release attributed to the bogeymen of an orgy of willful reidentification by those evil researchers, or their gross negligence in security measures. Surveys and the press attribute public dissatisfaction to an absence of cures from the Human Genome Project; and distrust to COIs and uncertainty whether scientists are influenced by morals; the uneven windfall creation of biotech wealth and its complete exclusion of participants; and drug and device domestic pricing, with barely a trace of altruistic reciprocity towards either the patients whose volunteering was critical to regulatory approval, or the taxpayers who supported any contributory academic research.
Indeed, survey findings cited in the 4th post showed that at least two thirds of the public believe that researchers will protect their confidential genetic information from misuse and three-quarters believe their clinicians will; the condition of rampant public distrust for researchers who use data without consent as betrayers of privacy does not exist. But there are some entities that fewer than half the public trusts to protect privacy: the federal government, and for-profit corporate entities.
Mind you, I do not assess whether the public is right. Personally I suspect the public are extrapolating hugely from concerns about the NSA, their opinions of corporate ethics in general, and some hideous cases, like the hacking of innumerable records from the federal Office of Personnel Management.
But to compare apples with apples we must follow the route of government here: we will not ask if the public is right, or whether discussion would help, or tell people about tradeoffs. Instead we will harden any soft edges and sharpen them like a knife, and take that as true. The public will, as supported by data, is that confidential identifying medical information must not be shared, period, with the feds or corporations. The public did not carve out any exception for consent. Where is that from? – Ah of course, government came up with it. Forget this consent stuff, let’s keep it simple. The feds and corporations get zero health data. And don’t bother me with your parade of negative consequences, I do not want to hear it. Remember, preferences without considering tradeoffs is our method. (Gee! It’s fun to think like government!)
In reality, however, the proposed regulatory changes will allow use that contradicts what the evidence would suggest about trust: your data could be given freely to the NSA, the FBI, the CIA, etc. Yes, all of it, even your conversations with a physician in which you discussed your abortion, or the infidelity that led to your venereal disease, or how many drinks you have each day, or the marijuana and other things you tried out in college, and everything that you have mentioned about the diseases of your relatives. (Hey, wouldn’t those relatives prefer to be asked before all that information is given away to the feds, the police and Big Pharma? I’ll bet they would. So why aren’t you asking them?)
So: is it really consent if you do not know all of these details? Is it respecting your preferences not to tell you? Or would you rather have been told? I’ll bet you would rather have been told. Oops. That’s one preference the proposed regulations did not follow. Despite page after page of commentary devoted to discussion of ethics and discussion of preferences, it does not come up.
Eventually people would find out. I don’t think that the effect of this, once they find out the truth, will be to increase the public trust. To at least half the population of the U.S. it will feel like a betrayal. To almost everyone, it will, unfortunately, look like government being sneaky.