"CASE
REPORTING" AND RESEARCH LIMITED TO MEDICAL RECORDS
Background
and Rationale
Clinical experiences are often the genesis of research
questions and the design and development of clinical research
protocols. In an academic medical center it is not unusual
for unique and interesting clinical cases to be written
up as case reports for publication in medical journals
or presentation at medical or scientific meetings. This
policy is designed to provide guidance on when publication/presentation
of case report(s) constitutes human-subjects research
and requires prospective IRB approval.
Medical
Case Reporting
The Federal Policy for the Protection of Human Subjects
(45 CFR 46.102(d) defines "research" as a systematic
investigation, including research development, testing
and evaluation, designed to develop or contribute to generalizable
knowledge. In general, the review of medical records for
publication of "case reports" of typically three
or fewer patients is NOT considered human-subject research
and does NOT typically require IRB review and approval
because case reporting on a small series of patients does
not involve the formulation of a research hypothesis that
is subsequently investigated prospectively and systematically
for publication or presentation. Reporting or publication
is not typically envisioned when one interacts clinically
with the subject.
When
larger series of patients are being reported, investigators
usually begin to ask specific research questions and formal
systematic collection of data occurs, moving these activities
closer to prospectively designed research. The boundaries
between case reporting and formal medical records research
may be unclear for a series of one's own patients. Researchers
are advised to consult with the IRB or submit larger case
series reports for IRB review when uncertainty exists
about whether formal and systematic collection of human
subjects research is occurring.
It
should also be noted that teaching, and soliciting colleagues'
advice on clinical care of a specific patient or groups
of patients during presentation of a case at departmental
conferences DOES NOT require IRB review. Generalized commentary
by a clinician on the outcome of their clinical care of
patients in accepted venues for discussion of clinical
management is also not considered research requiring IRB
review, if there is no prospective research plan no formal,
systematic and prospective collection of information.
This type of communication may occur at hospital or practice
meetings, in continuing education venues, or in editorials,
where the comments are explicitly identified as personal
experience and not formal clinical research.
Confidentiality:
Patient confidentiality should be respected in all clinical
situations involving identifiable medical information
from patients. All clinicians are reminded of the following
points:
- Names,
dates of birth, social security numbers, and other "codes"
or combinations of identifiers, which might easily allow
someone to identify a subject, should never be used
in publications or external presentations.
- Unique
family trees or pedigrees should be masked or disguised
when such information could identify individuals or
kindreds.
- Photographs
should be appropriately masked to preclude identification
of subjects.
- Partner's
Office of General Counsel strongly recommends that patients
provide written consent to allow publication or electronic
dissemination of pictures or other information (e.g.
videos, voice recordings, transcripts), which might
in any way identify them. Contact the Human Research
or Public Affairs office, as appropriate, for sample
research and non-research consent forms for use of identifiable
material. When photographs will ONLY be used in confidential
medical records or as part of direct clinical care of
the patient (for example, photograph of a characteristic
rash which would be retained in a record for documentation
or shown to colleagues in the provision of clinical
care), it is appropriate and acceptable to obtain and
document verbal consent.
- Clinicians
should be sensitive to the "small cell problem":
the existence of individuals with such unique or unusual
diagnoses or illnesses, that it might be possible for
others (or patients and families themselves) to identify
the individuals in case reports or medical text books
based upon limited information, such as state or city
of residence, age and diagnosis.
Formal
Prospective Research Involving Retrospective Review of
Medical Records
Formal, prospective medical records review to answer specific
research questions DOES constitute systematic, prospective
medical records research on identifiable human subjects,
and does require IRB review and approval (Submit the Health/Medical
Records form within the Humans module of Insight.) Federal regulations state that if data is abstracted without
retaining any link to specific individuals, some medical
records research may be considered exempt from IRB review.
The IRB, not the investigator, must make this determination.
At BWH and MGH, institutional policy mandates that ALL
systematic, prospective, formal records review requests
are reviewed and approved by expedited IRB review mechanisms,
rather than "exempted."
Investigators
are reminded that they should abstract and retain only
the minimum relevant clinical information. Investigators
should discard links to human subjects when the research
has been completed and published, or when relevant research
goals requiring links to individuals are accomplished.
Institutional and governmental policies on the duration
of retention of research records vary and are discussed
in a separate policy. Links to identifiable subjects may
be maintained to be in compliance with these policies,
but should not, in general, be retained indefinitely.
NB:
This policy was created in part based upon information
provided by Michael Carome MD at the December 2001 PRIMR/ARENA
Meeting, Boston MA.
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