A Regulatory Speed Trap Waiting To Be Sprung

DrRich | October 10th, 2011 - 7:07 am

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In a recent post, DrRich described the Regulatory Speed Trap, and alleged that our leaders (long before the Obama administration came along) have learned to use it to intimidate and control selected citizens and institutions when it is to their advantage to do so.

The Regulatory Speed Trap, readers will recall, involves the sudden and arbitrary “reinterpretation” of various confusing, ambiguous, or impracticable regulations which have been on the books for some time, and for which affected citizens and institutions (out of sheer necessity) have established de facto interpretations so that they can continue to function. By their longstanding acquiescence with these de facto interpretations, the Central Authority has at least tacitly endorsed them, and thus commerce is permitted to continue. Until, that is, the time arrives when it behooves the Central Authority to suddenly reinterpret those tangled regulations, and convert selected law-abiding citizens into criminals. By the selective enforcement of ambiguous laws, of course, the goals of Social Justice can be advanced.

As a public service, as a warning to academic medical centers, and as a heads-up to the Central Authority (which DrRich has found in personal encounters to be very scary, and to which he would very much like to endear himself against any future encounters) he will now describe a very serviceable but potentially forgotten Regulatory Speed Trap which was laid more than 15 years ago, and which is ripe for springing.

During the decade of the 1990s, DrRich was chairman of the Institutional Review Board (IRB) in a major teaching hospital. The IRB is the committee that reviews all proposed human research projects in the institution, and assures that the research meets ethical and legal standards as set forth by the Office of Human Research Protections (OHRP) of the HHS, and that the rights and welfare of the human research subjects are protected. The IRB has the duty and the authority to prevent or shut down any research project which is not meeting expected standards. The IRB, unlike any other committee within a hospital, reports directly to the Feds, in order to limit any local influence that may be brought to bear over its decisions by hospital administration, well-endowed researchers, or any other local big wigs.

If the Feds decide that an institution’s IRB is not assuring compliance with all the rules, regulations, guidelines, &c., in all their particulars, then they can arbitrarily and indefinitely terminate all human research in that institution, until such time that sufficient corrections, and sufficient penance, can be made – a process that is typically measured in years. This kind of research “death penalty” – which can ruin an academic institution – has been dealt out more than once.  The prospect is a dreadful one to any academic medical center.

It was, in fact, in his capacity as IRB chair that DrRich first became reasonably adept at reading and interpreting the kinds of obtuse regulations and guidelines commonly promulgated by our government. The official documents under which an IRB must operate are many, lengthy, and often difficult to interpret with absolute surety. Yet, in order for the IRB to function, these regulations and guidelines must be resolved into concrete meanings, which, under scrutiny, would most likely prove acceptable to the Feds. (A difficult task to be sure, but still, not markedly different from the task faced by anyone who wishes to conduct an activity for which the government has devised regulations.)

In any case, readers will understand why it was with some dismay that, in 1994, DrRich received this letter from the OHRP, announcing a new policy regarding diversity in human research.

Now to be sure, such a new policy was needed, since up to that time medical research evaluating new therapies was overwhelmingly performed on adult white males. However, this distribution of the benefits (and risks) of research was not in place because of prejudice against (or in favor of) women or non-whites. Rather, it was there for good and practical reasons. Ever since the thalidomide fiasco, it was verboten to enroll women who might become pregnant (i.e., any woman of childbearing age) in most kinds of clinical research. And African-Americans were understandably and appropriately distrustful of medical researchers ever since the Tuskegee study, and as a group they assiduously avoided participating in clinical research. So the exclusion of these groups was made, for the most part, either out of the desire to protect certain classes of individuals (such as unborn babies), or out of the desire of certain groups of individuals to protect themselves.

Still, DrRich was very sympathetic to efforts to find ways of safely extending research on new products to excluded groups. Otherwise, how could we learn if new medical products were safe and effective in everybody? So he read the letter from the OHRP with interest.

And he was immediately dismayed. While the government’s new policy of diversity in clinical research was advanced for the best of intentions,  the substance of the policy was impracticable past the point of absurdity.

The new policy on diversity in clinical research, in its essentials, stipulated:

1) All minorities and all genders MUST be included in all clinical research studies.
2) Sufficient numbers of subjects MUST be enrolled to allow valid outcome statistics to be performed for each category of participant.
3) Cost is NOT allowed as an acceptable reason not to enroll the stipulated groups in sufficient numbers.

The letter and its supporting documents defined six racial and ethnic categories that must be included: Hispanic or Latino, American Indian or Alaska Native, Asian, Native Hawaiian or Other Pacific Islander, Black or African American, or White.

The letter and its supporting documents defined the three genders that must be included as: Male, Female, Indeterminate or Transgender.

Because each defined subgroup must be included in each study in sufficient numbers to allow for valid outcome statistics to be computed, the new directive seemed to require each research trial to expand its size by 18-fold (to account for six racial/ethic categories, and three genders). So a study which would normally require the randomization of 1,000 patients to achieve statistical surety would now need to enroll 18,000 patients. Notably, the recruiting effort that would be needed to comply with this new policy would be far more than merely 18 times more difficult. For it is one thing to find an “extra” 17,000 people who are willing to risk their health for the sake of medical science, but quite another to find these altruists in just the right distribution, including, for instance, 1,000 indeterminately-sexed Pacific Islanders.

But no matter. The new policy explicitly stipulated that the expense of such a recruiting effort was not a permissible excuse for failing to enroll the proper distribution of subjects.

After carefully examining the letterhead of this document to make sure it did not come from The Onion, DrRich made some well-placed, but gentle and appropriately circumspect, inquiries in an attempt to determine whether he was reading it correctly. How seriously must one take this astounding new federal policy on diversity in research? He quickly learned he needed to stop asking questions. His sources revealed to him that several of the authorities in question actually considered their new directive to be a bit mild – a little too watered-down.

For instance, limiting the number of racial and ethnic categories to only six had been a major concession to practicality. Some of the interest groups that had been instrumental in constructing this new policy apparently had argued, for instance, that each of the 337 federally-recognized American Indian tribes ought to be called out as distinct groups. And the authors had thoughtfully compressed the number of genders to only three (when clearly there are at least four). So the people responsible for this new policy had already carefully considered the issue of practicality, and had mercifully compromised in order to render this policy as reasonable as the principles of research diversity would allow.

So yes, the Central Authority was deadly serious.

As it happened, at this very time DrRich was lodged in the teeth of another Regulatory Speed Trap (which he has described elsewhere), so he took this new OHRP policy very seriously. He knew that while it could not be complied with in all its detail, it also could not be ignored. So he called a special meeting of the IRB to discuss how to respond to the new policy.

A long meeting was held in which this new policy was introduced to the membership, and the members’ reactions were permitted to move through the necessary stages of mirth, horror, disbelief, resignation, and finally, resolution. When sober discussion was finally possible, the members unanimously agreed that encouraging the enrollment of women and minorities in clinical research was an important and laudable goal. We also agreed that if researchers were made to comply with the letter of this new policy, all clinical research in the U.S. would come to an immediate halt. And for this reason, we concluded, it must be true that the policy actually desired by the OHRP must be different from what appeared to be the letter of this policy.

We therefore composed a formal response to this policy, which we placed into the minutes of the meeting, for posterity, and for the benefit of whichever future government agents might burst through the doors with automatic weapons, in order to conduct unspecified investigations. That response went something like this:

Medical research aimed at reducing mortality and limiting pain and suffering is a great boon to mankind, and as long as it is conducted ethically it should be encouraged in every way. Diversity in research is also an important good, and to the extent it is practicable, individuals from all races and genders should be offered an opportunity to participate in clinical research. In deciding which of these laudable goals takes precedence, we note that while research can continue despite imperfect diversity, it will not continue if perfect diversity is an absolute requirement – in which case, one ends up with no research, and no diversity. Such a result, we hold, cannot possibly be the aim of the OHRP.  It therefore seems apparent to the committee that the intent of the diversity policy recently handed down by the OHRP must necessarily be to optimize diversity to the fullest extent practicable, and not to stifle research altogether in service to impossible diversity goals. We therefore interpret this new policy to indicate that all practical efforts must be made to recruit research subjects from all racial and ethnic groups, and from whichever genders we can find, and we will hold researchers in this institution to that policy.

And that’s just what we did.

Our formal interpretation of the OHRP’s diversity policy, it must be admitted, did not follow what certainly appears to be the letter of the policy. But it does work toward the stated intent of the policy, and it has the not-inconsiderable advantages of: a) being actually feasible to implement, and b) allowing medical research to continue. In general, DrRich has found that regulators are somewhat more inclined to look upon your behavior as being relatively benign, if you are able to demonstrate that you have taken their regulations seriously (no matter how absurd they might be) instead of simply disregarding them. Accordingly, our IRB created a record demonstrating that we explicitly acknowledged the new policy, we made a good-faith effort to interpret it in light of universally-recognized truths, and then we acted in accordance with that reasonable interpretation.

DrRich does not know how all the other IRBs in the U.S. responded to this new diversity policy. However, since no institution has stopped doing research on its account, and since no institution has launched massive programs to seek out the tens of thousands of transgender Alaskan Natives that would be required in order to conduct medical research under such a policy, one can only conclude that all those other IRBs also decided not to follow the new diversity policy to the letter. DrRich does not know how many of them took the trouble to make a formal record of their interpretation of that policy, and of their rationale justifying their subsequent behavior. In any case, by the studied inaction of the Central Authority, those interpretations have been allowed to stand for well over a decade, and medical research has proceeded accordingly.

DrRich left the practice of medicine – and the wonderful world of IRBs – at the turn of the millennium. He has no idea how big a deal the issue of “diversity in research” is these days. But to the best of his knowledge the OHRP policy has never been rescinded. Indeed, DrRich finds it extremely unlikely that, at any time during that interval, it would have been politically feasible for any government agency, under any Administration, to soften this or any existing formal policy on diversity.

Most likely, after 17 years, this Regulatory Speed Trap is still set, and waiting to be sprung.

As it happens, the Central Authority today is desperately looking for ways to stifle medical progress, since medical advances are among the chief drivers of increased medical spending. The 1994 diversity policy, whose clear-cut plain-English language is being so universally ignored by medical researchers in every American institution, would seem to offer a fine opportunity for shutting down some of that research.

This Regulatory Speed Trap is not only set and baited, but is swarming with potential victims. Fair warning.

6 Responses to “A Regulatory Speed Trap Waiting To Be Sprung”

  1. Liz says:

    Not being involved in research at the current time, I am luckily able to remain in the stage of mirth about these regulations. I do wonder if another goal of the regulations is to discredit research that has already been done that does not meet the guidelines. Just as we disregard research that was done by hated dictators, maybe one day the makers of clinical guidelines will be able to disregard research that was done on only 2 genders, when it suits their purposes.

    • DrRich says:

      Excellent point, Liz! It may even turn out to be good thing if, for instance, invalidating all that research means I can go back to eating all the ice cream I want.

      Rich

  2. Jerri Lynn Ward says:

    Do you think that the builders of the Tower of Babel were as insane as the Central Authority who wrote this directive?

    • DrRich says:

      Jerri,

      No. The builders of the Tower of Babel actually created a tangible result (at least for a time). The creators of central directives don’t have the legacy of an actual, tangible structure preceding all the chaos they produce. They go directly from the ether to chaos.

      Rich

  3. TMLutas says:

    Thank you for bringing this policy to my attention. The inevitable result of the actual implementation of this policy would be the enrollment of transgendered/indeterminetely-sexed Pacific Islanders in so many medical studies that the result would make Mengele proud. I suggest that the ICC be notified of this regulation as a nascent attempt at genocide. This must not stand.

    Please send checks to…

    • DrRich says:

      C-Boyz,

      Let’s not be too pessimistic here. This absurd policy, if you read the details, actually opens up a brand new opportunity for some enterprising entrepreneur, and if played right, could result in many Jobs! Jobs! Jobs!

      The regulations imply that only the individual him/her/itself can determine their own racial group and gender. So, anybody can be anything they like. Further, there is nothing in the regulations that would prohibit an individual from deciding they are a different race/gender, at any time, and change from one thing to another as many times as they want.

      So, an interesting business would be to operate as a broker for medical researchers, to recruit just the right number of people in just the right racial groups & genders to meet the needs of a particular research trial. An enterprising entrepreneur could recruit a few thousand people who are willing to assert, temporarily and for appropriate remuneration, that they are trangender Alaskan natives, or whatever is needed, and then be enrolled in research trials. This would be quite expensive for drug/medical device companies, of course, since I expect that the amount that research subjects would want to be paid to do this would be quite high. But for those companies it would be a matter of doing very expensive clinical research vs. not doing any clinical research at all.

      Best of all, this kind of enterprise would meet the letter of the regulations, and (I expect) even its spirit.

      Rich

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