Institutional Review Board

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.

Please reference the IRB Policy and Procedure Manual or reach out to ORRA with questions regarding research involving human subjects.

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.

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 here for instructions on how to register and access CITI Training.

Guidelines for Submitting an IRB Protocol through IRBNet

Each Step is accompanied by a Training Energizer (IRBNet step by step instructions) and Video tutorial.
Topics covered are listed below each step.

* For further guidance please contact: ORRA or 909-469-5606

Terms used within IRBNet:
Project= Protocol
Package= All subsequent documents (i.e. protocol application, informed consent, survey, questionnaire)

Submitting an IRB Protocol through IRBNet Each Step is accompanied by a Training Energizer (IRBNet step by step instructions)

Topics covered are listed below each step

Step 1) IRBNet Access: www.irbnet.org

Step 2) Self Register: New User Registration

• Create and activate your account in IRBNet
• Manage affiliations from User Profile
• Add and submit necessary Training & Credential Records
• Maintain T&C records

Step 3) Create and Submit Project:  New Project Submission

• Access Forms from Forms and Templates Library
• Create New Electronic Project
• Design and Assemble Project Submission
• Share submission with Research Team
• Send project email to Research team
• Sign project package
• Submit project package for review
• Manage Projects from you My Projects Page
• Revise Incomplete Submission

Step 4) Post- Submission; Revisions, Annual Renewals:  Post-Submission Advanced Topics

• Review Project Messages and Alerts
• Create a New Package for your Project (Revisions, Annual Renewals, Amendments)
• Add and Revise Documents
• Complete and Submit Subsequent Package
• Perform My Project Management
• Manage My Reminders

IRB related forms can be found in the IRBnet Forms/templates library www.irbnet.org under Western University of Health Sciences IRB – Documents for Researchers. For questions about IRB forms or IRBNet please contact IRBSubmission@westernu.edu 909-469-5606.

From your IRBnet page: select Forms/Templates tab, then Select the Library “Western University of Health Sciences IRB Documents for Researchers” from the drop down.

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.

What is the difference between a survey and a questionnaire? Although the terms are often used interchangeably, they are not synonymous.

A questionnaire is a type of survey that uses oral or written questions to elicit information from a group of respondents. The focus is generally to collect quantitative data. The questions should be in the positive and should not have more than on answer. Questionnaires are distributed, not conducted.

A survey is a means of gathering data that can involve multiple data collection methods, including a questionnaire. Interviews are another form of survey and can be open-ended and in depth. Surveys have a larger scope and are used to form an opinion about a particular group of people. A questionnaire may be the means by which this goal is achieved. Surveys are conducted, not distributed.

All surveys and questionnaires must have an introductory paragraph that contains at a minimum the following information:

• Who is conducting the research and why.
• How long it will take to complete.
• May be submitted anonymously. If not anonymous, explain.
• Participation is voluntary.
• Subjects may refuse to participate without penalty or repercussion.
• Submission is taken as informed consent to use the results in possible future presentations or publications.

Investigators may find the following links useful when preparing a survey or questionnaire.

SurveyMonkey: Surveys 101 – Design surveys, collect responses, and analyze the data like a pro

Qualtrics: 4 Guidelines for Writing Clear and Effective Survey Questions

Fact Sheet: A Step-by-Step Guide to Developing Effective Questionnaires and Survey Procedures for Program Evaluation & Research

Pew Research Center: Questionnaire design

Samples: of Surveys and Related Evaluation Tools

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.