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THE COMMITTEE ON HUMAN RESEARCH
HIPAA - ABBREVIATED RECRUITMENT GUIDELINES
8 Acceptable Methods of Potential Subject Contact June 2003
| Full UCSF Subject Recruitment Guidelines |
The following eight methods of recruiting subjects
have been approved by the CHR for use in studies being conducted
at UCSF and its affiliated institutions. The method of recruitment
should be discussed within the CHR application and noted on the HIPAA
Supplement.
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1. |
Clinics maintain a separate CHR-approved recruitment
protocol that asks patients if they will agree ahead
of time to be contacted for research. See sample Consent
Form to be contacted for future research. Investigators
contact patients about particular studies in accord with their
signed consent. |
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2. |
Study investigators enter recruitment information
into the UCSF
Seeking Clinical Trials Volunteers web page or another website
similarly managed. Subjects then contact the study investigators. |
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3. |
Advertisements, notices,
and/or media are
used to recruit subjects. The CHR must first approve the text
of these. Subjects who respond to these will contact the study
investigators. Note: No HIPAA-regulated Protected
Health Information is used in this recruitment strategy. |
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4. |
Study investigators provide their colleagues
with a "Dear
Patient" letter describing
the study. This letter can be signed by the treating physicians
and would inform the patients how to contact the study investigators.
The study investigators are prohibited from having access to
patient names, addresses, or phone numbers; patients must initiate
contact. |
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5. |
Study investigators send a CHR-approved letter
to colleagues asking for referrals of eligible patients
interested in the study. The study investigators may provide
the referring physicians a CHR-approved information sheet about
the study to give to the patients. If interested, the patient
will contact the PI. Or, with documented permission from the
patient (e.g., note in medical record indicates primary care
provider spoke with patient who agreed to be contacted), the
PI may be allowed to contact patients about enrollment. |
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6. |
Study investigators who are also clinicians providing
direct care recruit their own patients directly.
Nurses or staff working with the investigators also may approach
the patients. |
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7. |
Study investigators recruit potential subjects
who are unknown to them. Examples include snowball sampling,
use of social networks, direct approach to unknown people in
public situations, and random digit dialing. Recruitment process
should be explained in protocol. |
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8. |
Study investigators request
a Waiver of Consent/Authorization for recruitment purposes. In
all cases the waiver must be justified in the CHR application
and the Waiver of Consent/Authorization form
must be completed. Waivers are granted in three primary situations: |
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a. |
In minimal risk studies in which subjects
will be not be contacted (e.g., many chart review
studies) researchers request a complete waiver of consent/authorization.
The application must explain why the study cannot be done without
the waiver. |
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b. |
If the study requires researchers to review
charts to identify prospective subjects who will then
be contacted and asked to be in the study, the justification
for
the waiver to review charts must show why the study cannot
be done without the waiver. The waiver covers collecting only
the minimum amount of information needed to make contact; the
subject's consent is obtained before additional information
is gathered.
The CHR’s usual policy is that patients identified through
chart review should be approached by someone already involved in
their care. “Already involved in their care” includes
health care professionals directly involved in their care as well
as administrative and research staff working with the health care
professionals.
In some circumstances it may be necessary for members of the research
team who are not involved in the patient’s care to make the
approach, either in person or by phone or letter. The application
should explain why the study cannot be done unless the researchers
approach subjects directly. Direct approach by someone not involved
in the patient’s care is an exception to the usual policy but
may be approved in exceptional circumstances such as emergency care
research. |
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c. |
Large-scale epidemiological studies
and other population-based studies may need to identify
subjects through registries, medical records in multiple institutions,
or other sources. The researchers may need to contact prospective
subjects directly rather than through professionals involved
in the prospective subjects’ health care. This approach
involves a greater invasion of privacy than other methods,
because researchers without approval from patients gather significant
private health information about the patients, and then contact
the patients directly. Because this approach is an exception
to the CHR’s usual policies, the application must explain
in detail why it is impossible to do the study unless the CHR
(1) waives authorization/consent to obtain subjects’ identities
and (2) allows researchers to contact subjects directly. |
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