Mount Saint Mary's University Committee for the Protection of Human Subjects
serves as the Institutional Review Board (IRB) for the university as
required by federal regulations in Title 45 Part 46. The role of the IRB
is to ensure that research involving the participation of human
subjects meets all federal guidelines, created to protect participants
from harm, as well as providing a means for informing participants of
their rights. The establishment of IRBs was a direct result of the
Nuremburg Code in 1947, that set standards for ethical research with
human subjects. In 1964, The Declaration of Helsinki set guidelines for
biomedical research with human subjects. In 1974, as a response to
unethical research being conducted in the United States, the National
Research Act (PL 93-348) was enacted. Furthermore, in 1978, the Belmont
Report was published by the National Commission for the Protection of
Human Subjects of Biomedical and Behavioral Research, leading to the
revision and expansion of the regulations that safeguard the rights of
humans participating in research. [45 CFR 46 subparts A through D]
order to ensure that research conducted by MSMU faculty and/or students
meets the guidelines for the protection of human subjects, an
application to the Human Subjects Committee must be completed,
submitted, and approved prior to the implementation of any actual
Download the application form and fill it out
electronically. The application is a Word document that uses fill-in
forms and requires you to enable macros if you are prompted. All
applications to the Committee must contain a copy of the Assurance
Training Certificate for all personnel who are to participate in the
proposed research. Certificates can be obtained as the result of on-line
training at the following website: http://phrp.nihtraining.com/users/login.php?l=3
the completed application form as an attachment, along with any other
required documents, to the Human Subjects Protection Committee Chair, Robin L. Gordon. Please also print and sign a hard copy of the completed application and send it to:
Dr. Robin L. Gordon
Department of Education
Mount Saint Mary's University
10 Chester Place
Los Angeles, CA 90007
applications occurs on a rolling basis and begins as soon as the
Principal Investigator (PI) has submitted all application materials.
Reviews typically can be completed within 2-3 weeks, at which time the
Committee Chair will contact the PI with the committee's decision.
For more information on the regulations for using human subjects in research, please go to the website for the Office for Human Research Protections (OHRP).
Example: Students are asked to administer a questionnaire at a mall
(age, gender, ethnicity, work schedule, time they like to shop) for a
class project, data will be analyzed by the class, data will be
destroyed after the assignment, and the activity is used to teach
students how to do this type of research.
Does not need review by the IRB
although it does: a) involve humans, b) the individual could be possibly
identified, but c) questions are not private, i.e. ones they would
avoid disclosing in public.
Expedited, Full Review, Exempt status: Exempt does not mean the project is exempt from IRB review. It means that the IRB appointee decides that if there is minimal risk, there may not need to be a review by the full board review; however, the researcher done not make this call. The process is described below.
Expedited: Risk is minimal and only minor changed in an existing protocol are being made.
Full Review: Everything else.
Conducting observations with minors must undergo submission of a research protocol to the IRB, even if risk is minimal.
D. Note for nursing: may qualify for expedited/exempt from
full review but must still submit to IRB as the workplace does not
qualify as a typical educational setting.
Investigators who feel their projects fall under this category must file a memorandum along with a copy of the instruments to be used
to the Chair of COPHS which briefly describes the nature of the project
and explains how anonymity will be guaranteed at least two weeks before
commencing with the project for determination of exemption.
The project does not meet the criteria for Category I and involves no more than minimal risk to the subject.
Minimal risk is defined as "the risks of harm, anticipated in the
proposed research are not greater, considering probability and
magnitude, than those ordinarily encountered in daily life or during the
performance of routine physical or psychological examinations or tests"
(Code of Federal Regulations). Projects that require expedited review
include the following:
12001 Chalon Road
Los Angeles, CA 90049
10 Chester Place
Los Angeles, CA 90007
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