Human Subjects Protection Committee (HSC)
Institutional Review Board
The 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]
In 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 research.
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
Email 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
Review of Applications
Review of 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.
Policies on the Use of Human Subjects in Research
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).
Does research assigned to students for teaching research methods need review by the IRB?+-
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.
- However, if the mall management wants to see the data to make a decision about mall hours, this project would need submission to the IRB.
- Or, if a student wanted to use the data for a research project to be done at a later date – needs IRB review.
- The issue is: if the activity is to be used to teach or practice a method but the results are not going to be “published,” it is exempt from IRB review.
I am conducting a research project in the school in which I teach or am an administrator. Do I need IRB approval?+-
Yes. The Mount Saint Mary's University Human Subjects Committee requests that you complete an IRB application with the approval of your faculty advisor. Even if the study involves normal classroom strategies, you are required to submit the application in order for the committee to make the decision that the research is qualifies as exempt: the researcher may not make the decision.
What do the terms, such as exempt or expedited, mean?+-
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.
The applications reviewed by the IRB appointee to decide whether:
Expedited: Risk is minimal and only minor changed in an existing protocol are being made.
Full Review: Everything else.
Is passive consent acceptable?+-
The researcher may not use passive consent in school settings (participant or parents agree to participate by not returning an informed consent form).
My subjects are minors. Do I need IRB approval?+-
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.
The Research Categories To Be Considered+-
Category I - Exempt Research (Limited COPHS review required)
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.
- Projects involving collection of data through the use of opinion surveys, questionnaires or interviews (e.g., opinion surveys, marketing surveys, exit interviews) for which response is voluntary and completely anonymous. When data gathered concerns issues of personal sensitivity (e.g., drug use, criminal behavior, sexual behavior, or employability, financial standing or reputation) careful attention is needed to assure complete anonymity with no linkable, individually identifiable data.
- Projects limited to activities involving normal educational practices in commonly accepted educational settings (e.g., in-class demonstration studies, laboratory exercises, and studies of curriculum or teaching strategies).
- Usually, any study, which requires that subjects be removed from their normal classroom situation for testing, and or involves minor children, is not exempt.
- Projects limited to the observation of public behavior for which anonymity of subjects is maintained.
- Projects limited to the examination and analysis of existing data or specimens so long as these are publicly available and individual subjects will not be identified in any report of the research.
Category II - Research Activities Subject to Expedited Review
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:
- Most laboratory investigations of cognition, perception, social behavior and personality.
- Any long term investigation of the same individuals where identifying information (including coding schemes) must be maintained with the subject's data.
- Studies that require the examination of existing data or specimens that are not publicly available.
- Studies involving the collection of voice or video recordings.
- Studies of healthy individuals involved in moderate exercise.
Category III - Research Activities Subject to Full COPHS Review
- Projects that do not meet the criteria for Category II because subjects will be exposed to more than minimal risk (e.g., use of invasive techniques or unusual therapeutic techniques such as hypnosis).
- Projects requiring the use of deception.
- Projects requiring the use of subjects from populations in need of special protection (e.g., prisoners, individuals with disabilities, victims of abuse, pregnant women, and children).