http://www.oprs.ucla.edu/human/hspcmanual/7C
Student Research
All UCLA research which includes the participation of human volunteers is
subject to federal regulation. The HSPCs are charged with protecting the rights
and welfare of all research subjects, not just those subjects who participate
in federally funded projects. UCLA has filed a formal MPA with the OPRR which
pledges that all research irrespective of funding: (1) involving human
subjects; (2) using records gathered on human subjects; or, (3) involving human
tissue, will receive HSPC/OPRS review prior to initiation.
Student initiated research involving human subjects, whether dissertation,
thesis, or other research projects, should be supervised by a faculty advisor
and submitted to the HSPC/OPRS for review. HSPC/OPRS review and final approval
should take place during the proposal stage of the dissertation or thesis. By
signing on as sponsor of a student project, faculty advisors take the
responsibility for ensuring that all research procedures comply with federal,
State and University policies pertaining to the protection of human subjects.
Classroom Research
Some projects assigned to students in a class may have a research component
or constitute training in research methodology. If such projects are intended
to contribute to generalizable knowledge (e.g., through publication), they are
subject to the regulations and are required to undergo HSPC/OPRS review.
Classroom projects that are exclusively for instructional purposes need not
undergo review by the HSPC/OPRS. However, instructors and students are
encouraged to follow federal guidelines and University policy when designing
and conducting class projects with human volunteers.
Research Files
Principal investigators are required to maintain a research file. The
requirements for a research file include but are not limited to, all
correspondence with the HSPC and the sponsor (as applicable), and documentation
of subject eligibility as well as a copy of the signed consent forms obtained
from all subjects participating in and/or who have participated in the protocol
regardless of whether or not the subjects completed the study. The protocol
files should also contain any data derived from the study. This file will act
as the investigator’s documentation regarding the proper performance of the
study. This information will be reviewed by the HSPC, federal, State or local
authorities, sponsors, and other authorized individuals to ensure proper
performance of the study. These rules also apply to student researchers.
For medically invasive studies involving patients as research subjects, the
investigator should ensure that a copy of the HSPC approved consent form,
signed by the subject or his/her legal representative, is inserted into each
subject’s medical record. The investigator is responsible for ensuring that a
copy of the consent form is provided to each subject enrolled in the study.
Contact OPRS
October 29, 2004
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