Due diligence and ‘practicability’

Due Diligence and ‘Practicability’


Chalmers C. Clark

This case raises questions about a possible waiver of HIPAA privacy regulations for the sake of enrollment in research studies.  Under HIPAA regulations, there are four criteria necessary for a Waiver of privacy restrictions regarding protected health information (PHI).  The first of the four criteria is crucial to granting a Waiver in this case.  It reads: 1. The research could not practicably be conducted without access to and use of the protected health information.

Regarding case particulars, researchers were having difficulty recruiting subjects into a study designed to test the hypothesis that dietary supplementation with chromium could improve impaired glucose tolerance and possibly prevent progression to type 2 diabetes.  Recruitment efforts were initially approved by the IRB, but enrollment was hampered on two key fronts.  First, significant numbers of potential subjects were essentially unaware of their diagnostic eligibility; Second, local primary care providers did not refer many eligible subjects to the study due–at least in part–to a “less than optimal” relationship between the primary care physicians and the researchers.

In light of the problem, investigators approached the IRB and requested a waiver of HIPAA Authorization in order to permit direct access to the hospital’s laboratory data base to gain an identified list of outpatients who met the inclusion criteria for the study.  This protected health information would be used to target eligible candidates with letters informing them of their candidacy and to inviting them to call if they wished more information about the study. 

The Chairman of the IRB, with full knowledge that a complete IRB review would follow, approved an expedited review affirming that the waiver would constitute only minimal risk to the subject population and at the same time would meet Research Category #5 of the Office of Human Research Protections (OHRP) for expedited review.  However, in the meeting of the full IRB, the committee disagreed with the Chair citing that a waiver in this case would create an “unacceptable breach of privacy.”

The argument that a Waiver is justified needs to establish clear grounds that adequately meet the four criteria as well as establish minimal risk regarding the relevant PHI holders.  According to the Case Study, the investigators responded on three principal grounds:  First, the researchers provided a summary of their recruitment efforts to demonstrate good faith.  Second, the investigators noted that increased expenditure of time and funding would likely jeopardize future projects with the funder.  And third, the investigators developed reminders of the importance of the research hypothesis and its value if successfully demonstrated. 

In the first case, we have reference to criteria (1) of the HIPAA waiver regulations.  The key focus is that of “practicably.” In appreciating this notion, in an ethical and regulatory context, there is need to distinguish “practicably” as (i) ‘a means to an end merely’ and (ii) ‘an appropriate means and end’.  This second interpretation engages the Aristotelian view of practical wisdom (phronesis) which rejects separation of the mechanical from valuational. Clearly the IRB focus must address the latter ethically engaged sense of practical wisdom. 

The waiver request involves a proposed breach of privacy protections firmly grounded in the first principle of Belmont; “respect for persons.”  Granting such a waiver requires not only citing practical impediments to the proposed study, but demonstrating efforts to manage those impediments.  Indeed, it appears that the IRB was more cognizant of taking the practicability question through a lens of phronesis than the Chair.  This was evident in the IRB’s statement to the investigators that a “very high threshold for performing ‘due diligence’ in such recruitment efforts” was called for. 

The burden of professional responsibility incumbent in the “respect for persons” principle is heightened diligence against allowing persons to be treated as mere means to the ends of research, no matter how significant the research might be.  A similar heightened standard of professional obligations can be noted in the legal maxim that it isn’t enough to avoid wrong doing, but one must strive to avoid the very appearance of it. 

Appearance issues are further relevant here in that the Chair thought that the IRB objections had “confused human protections with hospital protections” (community appearances).  I believe this distinction needs reconsideration.  As the heart and lungs may be considered distinct organs, crucially they are systemically related.  The health of one has direct bearing on the other.  Similarly, the umbrella notion of the medical profession is that of patient care.  The priority of patient care is a public trust whether in therapeutic medicine, research medicine, public health, or hospital management.  At this level, it is not a confusion to attend to these interrelated aspects of the profession simultaneously. In the professions, appearance issues can be constitutive of the profession itself.

In the second response from the researchers, the argument is especially weak.  Worries about the researcher’s future welfare (vis-a-vis the relationship to the funder), are strikingly beside the point.  The question at issue is whether there is minimal risk regarding the welfare of a vulnerable population and whether a proposed waiver of protections, regarding those vulnerabilities, is justified.  Again the IRB focused well on the heightened matter of responsibility as they concluded that their high threshold for ‘due diligence’, if reached by the investigators, “might lead to a reconsideration of the Waiver request.”

The third response from the investigators is aimed to bolster the importance of the proposed study.  This is certainly appropriate and indeed essential.  Still, the research study, qua research, provides no lock on results.  Further, even if “good” ends do materialize, the charge of human protections requires focused efforts on due diligence regarding the means.  The researches, while well focused on the utilitarian value of prospective fruits, were less attentive to the burdens of due diligence in roots.

A final element of diligence must be noted regarding the “less than optimal” relationship between the investigators and the local primary care physicians.  No details are provided about the reasons for the lower than optimal relationship, but this point should immediately raise red flags regarding diligence in efforts to protect the privacy concerns of patients. 

If enrollment could be bolstered by efforts at reconciliation between the parties, clearly this would be a better way to attempt a solution to the problem of recruitment rather than simply accepting a flawed professional relationship and seeking a Waiver of ethically well-grounded privacy protections.  The IRB again, appeared sensitive to the need for heightened efforts at diligence.  In the final decision, the IRB Committee overwhelmingly rejected the Chairman’s request for expedited approval of the Waiver and concluded that “it was the responsibility of the Chairman to inform the investigators that the amendment had not been approved and to discuss with them alternative approaches to improve subject recruitment.”

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