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THE COMMITTEE ON HUMAN RESEARCH (CHR)
UCSF GUIDANCE ON RESEARCH TOPICS AND
ISSUES
General Instructions:
Completing the SFVAMC Supplement to the
UCSF Status Report for Renewals and Major Modifications (Continuing
Review) Form
Brief Overview
VA Policies for the Protection of Human Subjects are, in some
cases, more stringent than the minimum standards established by
the common rule. In particular, the VA requires documentation that
all persons involved in research with human subjects, human tissue
or human subjects’ data have appropriate education and experience;
that we track details about our research participants; and, that
we reimburse the medical center for services that are performed
solely for research.
In order to document compliance with these policies, each study
for which the San Francisco Veterans Affairs Medical Center (SFVAMC)
is a participating site must complete a VA Supplement each time
a “Status Report for Renewals & Major Modifications (Continuing
Review) Form” is completed.
Instructions
The SFVAMC
Supplement for Continuing Review of Approved Research documents
those subjects who have participated in research at the SFVAMC.
Indicate the number of participants
at all UCSF sites:
This is
for reference and should match the number on your renewal application
(Section 2c).
Persons seen in the VA CCRC
or under sub-contract:
Some research
provides for limited procedures to be undertaken at the SFVAMC
while the majority of procedures are at a collaborating institution.
In these cases the SFVAMC will be working under a sub-contract
or Memorandum of Understanding and participants seen as a result
of such an agreement should be documented in this section. [After
completing this section, if no participants were enrolled at the
SFVAMC, you may skip to sections B & C.]
Persons gave consent to
participate in research at the SFVAMC (those who sign a VA 10-1086 Consent Form). If the research is
being conducted at both the SFVAMC and UCSF, patients who are enrolled
at the UCSF site (using the UCSF consent form) would not be included
on this portion of the VA supplement. When the SFVAMC is the only
site, all enrolled subjects would be reported on the VA supplement.
Example: If you have enrolled 20 subjects
locally (at sites under the jurisdiction of the UCSF CHR) and
12 of those were enrolled at the SFVAMC, your UCSF “Status Report” would
show the 20 enrollments, while the VA Supplement would have detailed
data ONLY for the 12 enrolled at the SFVAMC.
Additional cumulative data is collected to meet federal reporting
requirements and to assist with compliance activities. These include:
Veteran status:
VA policies allow enrolling non-veterans only
when there are not adequate qualified veterans to complete the
research. The form seeks the number of veterans and non-veterans
enrolled in your research. It is not necessary to differentiate
for those who routinely obtain their care at a VA facility; only
whether or not they are US veterans.
Please describe what steps were taken to provide priority access
to this research to veterans if non-veterans were enrolled at this
site.
Gender:
Please provide a tally of the number of males and females
(based on gender at birth) for all enrolled subjects.
Minority Status:
Please provide the best available information
on the minority status of all enrolled subjects. It is not necessary
to inquire of participants how they identify themselves; if you
are unsure or the data is not available, a category is provided
for this purpose.
Vulnerable Populations:
If you are enrolling individuals who are
considered vulnerable populations as defined in the federal regulations,
please provide a count of these persons in this section.
Withdrawals:
It is important to identify those from whom research
consent was obtained, but who later withdrew (or were withdrawn)
from the study. Several common reasons for withdrawal are provided,
as well as an ‘other’ category where the suggested
reasons are not appropriate.
Persons engaged in research
at the SFVAMC:
This section of the
SFVAMC Supplement requires a list of all persons who are engaged
in research activities at the SFVAMC. This will expand on the ‘key
personnel’ list in the CHR application and should include
research coordinators, phlebotomists, residents and fellows, etc.,
who will interact with participants or their data, as well as laboratory
personnel that will work with human subjects’ specimens.
It is not necessary to list collaborators from other institutions.
Investigators are reminded that each person engaged in research
at the SFVAMC is required to provide certain credentials and document,
at a minimum, annual training in the protection of human subjects
and good clinical practice. Please consult the SFVAMC Clinical
Research Office, or their website, for current detailed requirements.
Billing for Clinical Services:
In order to coordinate care, the
SFVAMC provides various clinical services, such as pharmacy, laboratory,
radiology/imaging, etc. in support of research activities. When
the provided services are a part of the routine clinical care of
a patient, the cost of service is provided at no cost to the research.
However, when the service is solely for research purposes, federal
regulations require that the medical center be reimbursed for that
service.
The SFVAMC Clinical Research Office can provide additional assistance
on how to document and pay for these services. The supplement only
inquires what services you are using as a part of your research,
in excess of the clinical use.
Example: If a patient’s clinical
care requires an annual chest x-ray, but the research requires
imaging every 6 months, the additional film (6 month) would be
a cost of the research and the medical center would need to be
compensated for that x-ray.
Additional Assistance
If you have additional questions, please contact
the Human Protection Advisors at the SFVAMC 415 221 4810 (x4655
or x3394).
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