About the IRB
Welcome to the Western University of Health Sciences’ (WesternU) Institutional Review Board website. Institutions that conduct federally funded research using humans as research subjects are required by federal law to establish a committee responsible for reviewing such proposed research to ensure that the rights and welfare of the subjects are protected. To comply with this requirement, WesternU has established the Institutional Review Board for the Protection of Human Subjects, i.e., “The IRB”. WesternU investigators, the IRB and the University have a shared responsibility and work together to ensure the protection of human research subjects.
All proposed research projects that meet the federal definition of human subjects research must be reviewed and approved by the IRB prior to initiating the research.
Investigators may find it useful to consult the Decision Charts provided by the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) in determining if an activity is research involving human subjects that must be reviewed by the IRB under the requirements of HHS regulations (45 CFR 46). Contact the IRB Office at 909-469-5606 if questions remain.
NOTE: All WesternU faculty, staff or students contemplating conducting human subjects research, including survey-only research, in a foreign country MUST have WesternU IRB approval prior to conducting the research. Investigators are strongly urged to contact the IRB Chair or Vice-Chair and review section 7.11, International Research, of the IRB Manual prior to making arrangements to conduct such research in foreign country. A copy of the IRB Manual may be found by clicking on the IRB Manual navigation bar on the left side of this page.
Investigators must complete human subjects protection training prior to engaging in human subjects research. Proof of training must be submitted along with any IRB protocol application. Click on Training in the column on the left for more information regarding required training.
The IRB has adopted a new electronic submission platform called IRBNet. Within IRBNet, you may download and submit protocol applications and supporting documents for each project. Refer to Submission Process on the left for guidance in submitting a) a new proposal, b) a progress, final or premature closure report, c) a reportable event, d) an amendment request or e) a Request for Determination. For help, contact the IRB Office at email@example.com or 909-469-5606.
Surveys and questionnaires are commonly used to gather research data and generally qualify for Exempt status under Criteria Code 2. Investigators are referred to the IRB Manual for a full description of the Criteria Codes. The link at the left provides several resources to guide investigators in constructing a valid survey or questionnaire.
Below are the answers to some of the most frequently asked questions that investigators may find helpful when considering engaging in human subjects research. Additional information may be found by clicking here.
Q: Whom should I contact for information about initiating research involving human subjects?
A: Contact the IRB Coordinator at IRBsubmission@westernu.edu or 909-469-5606.
Q: When will my application be reviewed?
A: The IRB generally meets monthly. Timely submissions will be reviewed at the next regularly scheduled meeting.
Q: When can I expect to hear from the IRB?
A: Within 90 days for protocols requiring full board review, within 60 days for protocols qualifying for expedited review and within 30 days for exempt protocols. A Request for Determination will be responded to within five business days.