The report suggests that a conservative approach to data
protection has led health officials to require either that patients
consent individually to the inclusion of their data in research, or
that the data is ‘anonymised’ so that the individual cannot later
be identified.
According to the report Personal data for public good: using
health information in medical research, time and resources
mean that researchers are often unable to obtain sufficient numbers
of consenting patients to produce a worthwhile study.
In addition, where data is stripped of identifying information,
this makes it impossible for researchers to then identify or
contact patients who may be willing to participate in medical
trials.
The report argues that the ‘consent or anonymise’ approach is
not strictly necessary under the current law, which is largely
governed by the Data Protection Act of 1998.
In general terms, says the report, the Act allows the
use of medical data without consent, so long as the use of the data
is necessary and proportionate – bearing in mind privacy
concerns and the public interest. Research without consent should
therefore be permitted, provided that these safeguards are met.
The report then calls for the development of a scheme that will
allow for the assessment of proposals using such data, and guidance
on when approval will be granted. Good practice guidance for
researchers, setting out how best they can comply with the data
protection requirements, is also recommended, together with
research into how the public really feels about the use of personal
data in medical studies.
Responding to the report, Information Commissioner
Richard Thomas wrote to The Times this week, saying the
Data Protection Act is not to blame.
"The central issue here is patient confidentiality," he wrote.
"Since the days of Hippocrates, medical records that identify
patients have been protected by the doctor’s duty of
confidentiality. Patients do not expect our doctors to pass on
their medical details to others without their knowledge or consent,
even to medical researchers."
He continued: "Most medical research uses anonymised
information. Where named records are essential, my office stands
ready to help researchers to find solutions, which do exist. It is
not normally a problem for patients to be informed about the use of
records for research, and for concerns to be taken into account.
The law also recognises that consent is not required in every
situation."
