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How
can we identify and/or recruit subjects?
If
you are already directly involved in a patient's standard
medical treatment, you do not need to do anything special
to approach him/her about your study. However, if this
is not the case, there are certain steps which must be
followed in order to legally identify and recruit subjects.
Our Identifying
and Recruiting Research Subjects table presents several
of the most common methods of identifying and recruiting
subjects, what you need to do in order to use the method
within federal regulations, as well as what NOT to do
when identifying & recruiting subjects.
A
patient of another physician is participating in my research
study. Can I report any lab results or other research related
results to the treating physician, particularly if the results
might be relevant to the patient/research subject's routine
treatment? What if the treating physician is not part of
Shands/UF or the VA?
Sharing
information solely for the purposes of treatment is not
strictly considered a disclosure of PHI, regardless of
whether the information is generated as part of normal
treatment or research. As such, a HIPAA authorization
would not be required to share the information with the
treating physician, regardless of whether the physician
is part of your hospital or not. If the research subject
is only seeing you for research purposes (i.e. not part
of a clinic or hospital visit), then the subject must
be provided with a copy of the hospital's or the clinic's
"Notice of Privacy" before sharing any information
with the treating physician.
IMPORTANT NOTE: if the PHI is being generated by a
test or other measure that is investigational and not
part of a CLEA approved lab, then the information alone
cannot guide clinical treatment. If the
results from investigational tests/measures suggest changing
clinical treatment, these results must be validated by
standard tests from a CLEA approved lab before treatment
is altered.
Help!
How do we answer the authorization questions? How specific
should we get? What is meaningful?
Put
yourself in the patient's position. If you were the subject/patient,
what would you want to know? Specific and meaningful means
you are giving the subject enough information that they
understand what you are collecting/using/disclosing, who's
doing this, who you're giving it to, etc. If you get too
specific the information could be less meaningful, and
could run into problems with having to revise the consent/authorization
anytime your protocol was revised. We have taken a preliminary
peek at a couple of authorizations and believe the following
example does a good job of meeting the HIPAA regulations.
The answers or type of answers provided in this example
may not be ideal for your study - you may need to
be more or less specific. This example is merely meant
to serve as a starting point for you to see one way to
answer the questions. Remember: how you answer the question
depends on your study's content - the answers will rarely
if ever be similar between any two different protocols.
What
identifiers need to be removed from data in order to meet
HIPAA de-identification standards?
According
to the October 2002 Privacy Rule §
164.514.(b).2. page 20 the following information may
not be recorded in order to meet HIPAA de-identification
standards:
"(A)
Names;
(B) All geographic subdivisions smaller than a State,
including street address, city, county, precinct, zip
code, and their equivalent geocodes, except for the initial
three digits of a zip code if, according to the current
publicly available data from the Bureau of the Census:
(1)
The geographic unit formed by combining all zip codes
with the same three initial digits contains more than
20,000 people; and
(2) The initial three digits of a zip code for all such
geographic units containing 20,000 or fewer people is
changed to 000.
(C)
All elements of dates (except year) for dates directly
related to an individual, including birth date, admission
date, discharge date, date of death; and all ages over
89 and all elements of dates (including year) indicative
of such age, except that such ages and elements may be
aggregated into a single category of age 90 or older;
(D) Telephone numbers;
(E) Fax numbers;
(F) Electronic mail addresses;
(G) Social security numbers;
(H) Medical record numbers;
(I) Health plan beneficiary numbers;
(J) Account numbers;
(K) Certificate/license numbers;
(L) Vehicle identifiers and serial numbers, including
license plate numbers;
(M) Device identifiers and serial numbers;
(N) Web Universal Resource Locators (URLs);
(O) Internet Protocol (IP) address numbers;
(P) Biometric identifiers, including finger and voice
prints;
(Q) Full face photographic images and any comparable images;
and
(R) Any other unique identifying number, characteristic,
or code, except as permitted by paragraph (c) of this
section;"
Note,
it is possible for some of the elements to be included
IF "a person with appropriate knowledge of
and experience with generally accepted statistical and
scientific principles and methods for rendering information
not individually identifiable: (i) Applying such principles
and methods, determines that the risk is very small that
the information could be used, alone or in combination
with other reasonably available information, by an anticipated
recipient to identify an individual who is a subject of
the information; and (ii) Documents the methods and results
of the analysis that justify such determination".
(§
164.514.(b).1. page 20).
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