WASHINGTONWhen the National Coalition of Cancer Research (NCCR)
brought its concerns about the impact of proposed patient privacy
regulations on medical research to Capitol Hill, it got strong
confirmation about its fears from the founder of the House Cancer
Awareness Working Group.
Privacy is going to be, in the next few years, one of our
central research issues, said Rep. Rick Lazio (R-NY), who
voiced agreement with the principle that a patients
confidential data should remain private. The question is
whether we will build a wall around that data so that the legitimate
needs of the research communityand by extension, all of us who
benefit from the researchwill be thwarted by an overly
prescriptive privacy law.
A rising concern among medical researchers is that efforts to ensure
patient privacy will limit or prevent important areas of research.
Several states, including Minnesota and Oregon, have passed privacy
legislation, and the Department of Health and Human Services (HHS)
has proposed a lengthy set of regulations that would govern the
release of health information that might reveal the identity of
Medical research organizations, including NCI, the American Cancer
Society, American Society of Clinical Oncology, and American Society
for Therapeutic Radiology and Oncology, have protested to HHS that
the draft rules would threaten vital health research.
The NCCR briefing was intended to acquaint congressional staffers
with the issues and the dangers perceived by cancer researchers as
the nation debates how best to protect patient privacy. It is
the balance that we are looking at, said oncology nurse Kathi
Mooney, RN, PhD, interim dean for research at the University of Utah
College of Nursing.
Several speakers stressed that the medical community was not
questioning the need for greater privacy protection. They noted that
information can be easily extracted from databases and transmitted,
and that the potential for discrimination in employment and insurance
is becoming even greater with advances in identifying the genetic
basis of many diseases.
There is a mutually necessary and beneficial partnership
between the research community and the patient community, and we
believe very strongly that protection of the patients
confidential medical records is an absolute requirement, said
Anna D. Barker, PhD, president and chief executive officer of
Bio-Nova, Inc., Portland, Oregon. However, we also have to
protect the research that will save those same people.
The issue is neither theoretical nor philosophical, it is a
real problem, added Lee Joseph Melton III, MD, professor of
clinical epidemiology, Mayo Medical School. We cant be in
a position where people are making life and death decisions and
dont have accurate information on which to base those decisions.
Dr. Melton acknowledged that a legitimate conflict exists between an
individuals privacy and the need for access to medical data for
research purposes. Were all patients, he said.
We dont want somebody rummaging around in our medical
records. Yet there is socially important research that we have to do
for the benefit of all of us.
He cited several examples of the types of research that rely on
reviews of medical records and that could suffer under the proposed
HHS regulations: monitoring of population health, identifying risk
factors and high-risk populations, determining the effectiveness of
treatment, quantifying prognosis, assessing the usefulness of
diagnostic and screening tests, and analyzing the cost effectiveness
of tests and treatments.
Under Minnesota law, researchers must ask patients for the right to
use their records for research, and if, after several attempts, a
patient fails to respond in writing, this failure is regarded as
implied consent. Dr. Melton said that at the Mayo Clinic, 79.5% of
patients had given their consent, 3.7% had refused, and 16.8% had
failed to respond. Because of implied consent, this gives Mayo
researchers access to 96.3% of patient records.
If we had to get positive consent, then we would only know 80%
of the results, and all of our research would be questioned, he
However, 96.3% is an overall consent rate. People with certain
conditions that embarrass them or raise fears of employment or
insurance discriminationmost notably, mental illnessesgive
their consent at a lower rate. Right now, at the Mayo Clinic,
I would not do another study of mental health, Dr. Melton said.
Depression is increasingly recognized as a significant problem among
cancer patients, he noted. Yet if Mayo did a study showing depression
was not a major problem, would that be true or would the
findings result because the depressed patients didnt allow use
of their data?
National Law Desired
Dr. Barker said that medical researchers want a national privacy law
to avoid a patchwork of varying and perhaps conflicting privacy laws
at the state level.
We have to preempt these state privacy laws; we have to have
one national set of standards that everyone understands and can live
with, she said. We have to go to realistic standards to
de-identify information, so that the data we need for research have
Today, clinical trials are carried out under what is known as the
Common Rule, which relies heavily on an institutional
review board (IRB) at each center to supervise the work, including
assuring that informed consent is obtained from patients.
IRBs are an effective way of protecting the confidentiality of
patient records and also the individual identification of
patients, Dr. Barker said. The bottom line is that in 40
years of clinical trials from the National Cancer Institute, to our
knowledge, there has never been a breach of confidentiality. We in
the research community believe that we can empower and fund the IRBs
already in place and solve this problem without the added