Communication with the UCSB HSC
I. Disapprovals, Conditions and Requirements
for Modification
A. Compliance
Responses
1. Disapproval. When the Human
Subjects Committee disapproves
a project, the investigator and,
when appropriate, the investigator's
faculty advisor will be notified
in writing of the disapproval and
the reasons for it. Whenever possible,
the investigator may also be notified
by telephone, but in all cases,
notifications will occur as quickly
as possible. A disapproval requires
no response, but the investigator
or the faculty advisor may respond
if (s)he so chooses.
2. Approval with Condition. Assurance
of compliance and an explanation
of steps that have been or will
be taken to comply with the condition
should be submitted in a memorandum
(with 2 copies) to the HSC Coordinator.
3. Requirement for Modifications.
When the consent form and/or protocol
have been modified as required,
the revised original protocol form
and/or consent form must be submitted
to the HSC Coordinator. Number
of copies and any other information
required will be specified by the
Committee Coordinator.
B. Request for
Reconsideration of Decision
An investigator may request
reconsideration of any Human Subjects
Committee decision in accordance
with III.B below. Any new information,
explanations, or arguments must
be submitted with the request for
reconsideration.
II. Other Communications
There
may be other circumstances under
which investigators or others
may wish to communicate with the
Human Subjects Committee. As appropriate,
these communications may follow
the procedures under III.A or III.B
III. Procedures
A. Informal
1. In order to obtain information
or to make informal comments or
suggestions, investigators and
others may contact the staff of
the Human Subjects Committee either
in person, by mail, by e-mail,
or by telephone. (See IV.)
2. On request, these informal
communications will be relayed
to the Chairperson or to the full
Committee, either orally or by
inclusion in the monthly agenda.
B. Formal
1. All pertinent information should
be included in a memorandum to
the HSC. The number of copies of
all applicable material that should
be submitted will be determined
by the HSC Coordinator.
2. If the opportunity to make
an oral presentation is requested,
the Chairperson will determine
whether the presentation may be
made at the meeting at which the
written communication is to be
considered or whether the question
of an oral presentation will be
decided after consideration by
the full Committee.
3. Each formal, written communication
will be considered by the Human
Subjects Committee in a convened
meeting.
4. Oral presentations should be
limited to ten minutes or less
if possible. Persons invited to
speak at a convened meeting of
the Human Subjects Committee will
be notified of the time and place
by the HSC Coordinator.
IV. Address
and Telephone Number
Human Subjects Committee
Office of Research
University of California
Santa Barbara, CA 93106
HSC Coordinator: Kathy Graham
Telephone:
(805) 893-3807
graham@research.ucsb.edu
|