Spotlight on Compliance

Improved clinical care or medical research?

Defining research comes under court scrutiny

By J. Mark Waxman, JD
General Counsel
CareGroup Healthcare System, Boston

A key issue in determining whether IRB review is necessary is whether the program in question is, in fact, research. While at least one federal regulation defines research as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge" [45 C.F.R. §46.102(d)], the application of the definition provided by the regulation is not always clear.

One recent appellate case, Ancheff v. Hartford Hospital, [260 Conn. 785, 799 A 2d 1067 (2002)], illustrates how tricky the challenge of determining whether a program to simply improve medical care is ongoing clinical activity or medical research can be. In Ancheff, a plaintiff alleged that Hartford Hospital’s program of administering gentamicin could be considered research and therefore should have undergone IRB review, which would have included the informed consent process that would have outlined the risks, benefits and alternatives. The fact that the program did not undergo IRB review violated the applicable standard of care for research activities, the plaintiff alleges.

The facts regarding the gentamicin program in question were presented by the plaintiff as follows:

  1. The program administered a dosage that had not previously been tested on humans and departed from the conventional dosage approved by the Food and Drug Administration.
  2. At the time of the treatment in this case, the hospital was the only hospital in the country that prescribed the dosage involved to entire classes of patients.
  3. The method of administration was not conventional.
  4. The data collected on each patient were maintained apart from what was kept on the medical record.
  5. The program was advertised as a "radical change" from standard dosage and administration of the drug.
  6. The physicians responsible for enacting the program lectured to the medical community on their findings from the program.

In response, the defendant, Hartford Hospital, pointed out that:

  1. The program had been widely studied for many years.
  2. The program was approved by the appropriate hospital departments (e.g., infectious diseases, pharmacy, therapeutics committee, and the hospital’s medical executive committee prior to its initiation).

Based upon these facts, the ultimate issue in the case was what was the appropriate standard of care, and did the hospital follow it. Resolution of this turned on the issue of whether the hospital was required to secure a written consent from the plaintiff because the gentamicin program of administering the medication constituted medical research. The jury found for the hospital — thereby concluding that the program was not a research program, a decision affirmed by the appellate court.

In supporting the jury’s conclusion, the court was seemingly persuaded by several factors. First, it viewed its mission as primarily to determine whether there was adequate evidence to support the court rulings and the jury verdict. Given that expert testimony declared that the program was not research, there was ample evidence in the record. Inherent in this approach was the conclusion that whether the program fit within the definition of medical research was a fact-based question, and not a legal conclusion to be determined by the court. This also meant it was a determination for lay individuals to make, and not solely by experts or the hospital’s administration.

Second, in reviewing the evidence presented at the trial, the Court noted that the evidence submitted by the hospital "tended to prove" that the program did not constitute medical research. In its recitation of the facts, several appeared to be critical and may have been perceived by the jury as ensuring adequate patient protection, even without the IRB-related processes. Specifically, the Court referenced the hospital departments, committees, and physicians who, based on voluminous data, determined that clinical improvement, and not medical research, was the goal of the program.

Third, again in highlighting the facts presented by the hospital, the Court noted that the program was not implemented to test the drug’s safety, but directly to improve patient outcomes, and was "at least as safe and more effective than daily dosing."

Finally, it appears that the fact that standard research processes such as control groups, randomization, and blinding were not employed was also an important factor in the outcome. There was no specific analysis, however, of the implications of data collection and retention separate and apart from the patient’s own medical record, and the ongoing and public dissemination of the program’s results. Each of these factors could well have been interpreted to provide ample evidence of systemization of the process with the goal of contributions to generalized knowledge, but the jury apparently was not convinced that these elements made the gentamicin program research. Similarly, it is quite possible to visualize situations where the interest of the physicians is to do research, but avoid the perceived costs, burdens, and insight, and delay of the IRB process that must be the subject of the patient protection framework.

Whether the same result would obtain in similar cases is hard to predict. The case does, however, reaffirm that:

  1. Every new procedure or advanced treatment program implemented by a hospital is not automatically research.
  2. The fact that the results of these efforts will be publicized to others to advance medical treatment will not in and of themselves make such efforts automatically subject to the IRB processes.
  3. The hospital may be significantly protected from liability exposure where nonresearch new or advanced programs or procedures are implemented as the product of an in-depth record of decision making by qualified physicians and hospital committees.