1. Introduction
The University of California, Los Angeles (UCLA), Office for
Protection of Research Subjects (OPRS), Investigator’s
Manual for the Protection of Human Subjects is your reference
book detailing the policies and regulations governing research
with human subjects and the requirements for submitting research
proposals for review by the UCLA, Human Subject Protection
Committees (HSPCs).
Sections of the manual describe and explain the various
aspects of the review process and regulatory requirements.
Investigators should familiarize themselves with the contents of
the manual. In addition, they should carefully review the
sections of the manual that address their specific research
activities before submitting proposals to the HSPC.
This manual presents the most current information for
reference by potential investigators and their staff. Since the
field of human subject protection is constantly evolving,
sections of the manual may be subject to change. The HSPC support
staff, which is part of the OPRS, will keep the UCLA research
community apprised of all developments. The manual is in a loose
leaf binder in order to facilitate the updating of pertinent
sections as the need arises.
Research
Defined
Virtually all federally funded research with human subjects is
governed by federal regulations patterned on those of the DHHS,
found at Title 45 Code
of Federal Regulations Part 46 (45 CFR 46) (Please
see Appendix 1,
"45 CFR
46" for more information). The list of other
agencies’ pertinent regulations are included in Appendices
2-5.
Research is defined in 45 CFR 46 as, "a
systematic investigation, including research development, testing
and evaluation, designed to develop or contribute to
generalizable knowledge." Human subjects are
defined by the regulations as "living individual(s) about
whom an investigator (whether professional or student) conducting
research obtains (1) data through intervention or interaction
with the individual, or (2) identifiable private
information." The Institutional Review Boards (IRBs) at
UCLA commonly referred to as the HSPCs, are required by federal
regulations to review all University affiliated human subject
research, regardless of funding, to ensure the rights, welfare,
and protection of all subjects.
Research: A
Shared Responsibility
The review of research performed by faculty, students, or
employees of UCLA is conducted by three HSPCs. Currently, UCLA
has one HSPC primarily responsible for reviewing socio-behavioral
research applications, called the General Human Subject
Protection Committee (GHSPC), and two additional HSPCs, called
the Medical Human Subject Protection Committee 1 and 2 (MHSPC 1
and 2) which are primarily responsible for reviewing applications
involving medically invasive procedures. The HSPCs are comprised
of faculty representatives from various academic disciplines at
UCLA, clinicians, researchers, non-scientific members, and
community subject representatives who are not affiliated with the
university. The Committees operate within the federal guidelines
with respect to the review and approval of research protocols
involving human subjects. For the purposes of this manual, all
sections pertain equally to both the GHSPC and the MHSPC.
The dignity and welfare of individuals who participate in
research is a central concern of everyone involved with the
protection of human subjects. Our primary goal is to develop a
fair and explicit process in which subjects voluntarily decide to
participate in a study based on an intelligent and knowledgeable
assessment of the risks and benefits of the research.
The university, investigators and their research staff, and
the HSPCs/OPRS, share the collective responsibility for the
ethical conduct of research. This collaboration must exist in a
culture of trust, complete openness, and honesty by upholding the
highest ethical principles in the conduct of research. By
upholding the highest standards, we build public support for the
pursuit of greater knowledge in a safe research environment.
The HSPCs are charged with a twofold mission: 1) to determine
and certify that all projects reviewed by the Committees conform
to the regulations and policies set forth by the Department of
Health and Human Services (DHHS) regarding the health, welfare,
safety, rights, and privileges of human subjects; and 2) assist
investigators in conducting ethical research which complies with
the DHHS regulations in a way that permits accomplishment of the
research activity.
The mission is accomplished through an educational process of
Committee review of protocols, negotiation between investigators
and the HSPCs for approval of research, and HSPC/OPRS outreach to
the research community. The process serves to ensure the safe and
ethical conduct of research that ultimately will protect the
rights and welfare of human subjects.
Ethics and ethical review are a potentially dynamic and
humanizing element in the search for knowledge. In preparing a
protocol, the investigator is creating an ethical strategy that
should reflect the norms and standards of the scientific
community and the society served by the research. The process of
creating a written protocol should enable the researcher to
become a reviewer of his or her own research before submitting a
project to the HSPCs.
Contact OPRS
October 29, 2004
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