For some of the epidemiologic challenges, such as anticipating the spread of new viral strains and drug-resistant bacteria, we are likely to face consent-based models that are scientifically inappropriate for the research questions being asked.
CONFIDENTIALITY ISSUES IN
EPIDEMIOLOGY STUDIES
For
some of the epidemiologic challenges, such as anticipating the spread of new
viral strains and drug-resistant bacteria, we are likely to face consent-based
models that are scientifically inappropriate for the research questions being
asked. Validity depends on the characteristics of the sampling criteria used in
compiling the database: if data subjects are self-selected, each epidemiologic
analysis will likely require a separate analysis of the impact of the
self-selection factors on the research findings. In some cases, this will mean
that it is not possible to obtain a valid answer to an important research
question.
Research
using information collected for other purposes, such as health care delivery or
health bene-fits administration, is critically important as we enter the century
of discoveries based on genomic science. Pinpointing differences in health or
health care qual-ity based on geography, demography, health history or
co-morbidities will become ever more important for clinical research, for
public health planning and for ensuring access to appropriate care. We do not
have the luxury of time and resources to collect consents and obtain data from
volunteers and evaluate the validity of the sample for testing every unique
data hypothesis.
Public
health surveillance is typically conducted under specific laws authorizing or
requiring the collec-tion of certain types of data in the public interest (See,
e.g. Chapter 1). The new medical privacy regu-lations, for example, have
explicit exemptions from the prohibitions on disclosure where the data are
being collected under various public health surveillance laws.8 In
enacting the mandatory reporting laws, the state legislature has been persuaded
that the individ-ual’s interest in privacy can be achieved in other ways that
are not anathema to the public interest in phar-macovigilance and other public
health surveillance. They have required public health authorities and
regu-lated entities to simultaneously protect the privacy interests of
individuals while making the requisite reports and appropriately using and
safeguarding the collected data.
But
most epidemiologic studies do not have the legislatively protected status of
public health surveil-lance. With respect to follow-up studies of drug safety,
many registries and outcomes research more gener-ally, confidentiality issues
generally are subject to the informed consent and authorization laws, and not
the spontaneous and/or mandatory reporting laws appli-cable to
pharmacovigilance. The challenge in North America and the European Union is to
create a system in which patient needs for confidentiality protec-tions can be
achieved while also facilitating impor-tant public health research. If society
moves too far in the direction of providing absolute protection to seal off
access to health information from secondary uses, such as formal studies of
drug safety, then we are at risk of eroding the information foundation that
supports public health planning and health care qual-ity, including societal
judgements on the benefits and risks of medications.
Follow-up
studies of drug or medical device safety fall into the broad general category
of ‘research’, which is defined in US laws regulating research (discussed
below) as ‘a systematic investigation designed to develop or contribute to generalizable
knowledge’.9 As noted above, instead of an exemption from the
prohibitions on use or disclosure of patient data, the HIPAA medical privacy
regulation subjects disclo-sure or use of information for research purposes to
an additional, entirely new patient authorization process.10 The
same attention to the public interest in both
privacy and research results that is seen in event reporting laws is not
evident in US laws regulating data access for epidemiologic and outcomes
research.
Admittedly,
the ‘worst case’ damage to a given individual from a security breach and misuse
of personal information may be highly significant. Yet, the potential damage or
risk from the non-research misuse of personal information is precisely the same
risk that adheres to pharmacovigilance and public health reporting. Indeed,
with respect to the types of conditions that often are the subject of mandatory
public health reporting – sexually transmitted diseases (STDs), child abuse,
substance abuse – the potential damage from stigmatization or prejudice
arguably is at its greatest.
Arguably,
what is required is some mechanism for evaluating (1) the researcher’s bona
fides and (2) the arrangements for securing the data from unauthorized use by
employees and/or contractors and from external security breaches. However,
neither of these can be found in existing law.
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