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THE COMMITTEE ON HUMAN RESEARCH (CHR)
UCSF GUIDANCE
ON RESEARCH TOPICS AND ISSUES
Mandatory Companion Studies - Registries,
Data Banks, Collections Of Biological Specimens Or Genetic Materials
(February 2005)
• Brief Overview: Ethical Issue
• The Preferred Method for Including a Companion or Ancillary Study
in a Protocol
• Exceptions: Circumstances Where a Mandatory Companion Study May
Be Allowed
• General Consent Guidance and Links to Detailed Information
Brief Overview
This page explains the CHR’s guidelines for
mandatory companion studies including those involving registries,
data repositories,
and collection of biological specimens and/or genetic materials.
Some national study groups and study sponsors want to require that
participants in treatment studies also participate in other research
activities. Such mandatory companion studies raise a serious ethical
issue and conflict with regulations pertaining to human subjects
research:
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Participation in research should be voluntary.
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Undue pressure
is created if subjects are told they cannot receive a potentially
beneficial (though experimental) treatment unless
they also agree to participate in the additional study.
The Preferred Method for Including
a Companion or Ancillary Study in a Protocol
Participation in ancillary
studies should not be required for enrollment in any study involving
experimental treatment that might benefit
subjects. The CHR generally will not approve such linked studies,
but will instead ask that the ancillary study be made optional,
with provisions for separate voluntary consent either as:
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A
separate consent form (preferred); or
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A separate section of the
main consent form with separate lines for initials.
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See General
Consent Guidance and Links to Detailed
Information for
a more detailed discussion on consent forms.
IMPORTANT
NOTE: Applications for approval of banks or registries
using personally identifiable health information must describe
how participants’ identities will be shared and protected.
Exceptions: Circumstances Where
a Mandatory Companion Study May Be Allowed
Under the circumstances
described below, participation in a companion study may be required
as a condition of enrollment in the main
study; eligible participants who from the onset do not wish to
participate in the ancillary study may be denied enrollment in
the main study.
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Main Study Has No Potential Direct Benefit
to Subjects: If there is no potential direct benefit to participants
in the main study,
it is permissible to require participation in registries, data
banking, collection of biological specimens or genetic material,
and similar ancillary activities as a condition of enrollment in
the main study.
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Ancillary Activities Necessary to Answer Main
Research Question: Participation in the ancillary activities
may be required if it
can be shown that results of the ancillary activities are necessary
to answer the questions asked in the main study – in other
words, there would be no scientific knowledge gained from participants
who did not take part in the ancillary studies. In these circumstances,
the CHR encourages—but does not require—incorporating
a minimum of extra procedures into the main study rather than
requiring enrollment in a separate registry or bank.
IMPORTANT
NOTE: Applications for approval of ancillary activities must
describe how participants’ personally
identifiable health information will be shared and protected.
Use of a limited data
set under HIPAA may be appropriate.
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Participation Required by
Law: Participation in a very few registries
is required by law. Examples include tumor registries and
sexually
transmitted disease reporting. Because participation is not voluntary
participants are not asked for consent.
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It may be appropriate to
mention other required reporting in
a research consent form, if participation in the study may directly
lead to the reporting. The form might say, for example, “If
the study tests show you have certain sexually transmitted diseases,
we are required to report those results to the city’s Department
of Public Health, who may contact you and your sexual partners.”
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Cancer
patients are enrolled in the tumor registries regardless
of their participation in research studies; it is not
necessary
to mention the registry in research consent forms. Upon admission
patients are informed about the state cancer registry in
the Terms and Conditions of Admission to UCSF form.
General Consent Guidance and Links to Detailed Information
A
few general guidelines to keep in mind about obtaining and documenting
consent for participation in companion studies:
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The preferred
method is to use a separate consent form.
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Alternatively, include
a separate section within the main consent form and provide
separate lines for initials.
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The companion study consent form must be written
in the UCSF format; do not submit an unedited sample form from
the cooperative group or sponsor.
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The CHR provides extensive guidance
on subject recruitment and the consent process on its website.
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Additional guidance on consent requirements for most types
of companion studies is provided in Research Using
Human Biological Specimens. In particular, the
table “Consent
Topics Pertaining to Specimen Collection for Research and/or
Banking” presents
important issues to consider and/or include in consent materials
used for ancillary studies.
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