SWAG视频

All聽proposed research projects that meet the聽聽of human subjects research must be reviewed and approved by the IRB聽prior聽to initiating the research.

Investigators may find it useful to consult the聽聽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 ().聽Contact the IRB Office at 909-469-5606 if questions remain.

Please reference the or reach out to ORRA with questions regarding research involving human subjects.

狈翱罢贰:听All SWAG视频 faculty, staff or students contemplating conducting human subjects research, including survey-only research, in a foreign country MUST have SWAG视频 IRB approval聽prior聽to conducting the research.聽Investigators are strongly urged to contact the IRB Chair or Vice-Chair聽and聽review section 7.11, International Research, of the IRB Manual聽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:

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: 聽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: 聽Post-Submission Advanced Topics

• Review Project Messages and Alerts
• Create a New Package for your Project (Revisions,聽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聽聽under Western University of Health Sciences IRB 鈥� Documents for Researchers. For questions about IRB forms or IRBNet please contact聽IRBSubmission@westernu.edu听909-469-5606.

From your IRBnet page: select Forms/Templates tab, then Select the Library 鈥淲estern University of Health Sciences IRB Documents for Researchers鈥� 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?聽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.聽The focus is generally to collect quantitative data.聽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.聽Interviews are another form of survey and can be open-ended and in depth.聽Surveys have a larger scope and are used to form an opinion about a particular group of people.聽A questionnaire may be the means by which this goal is achieved.聽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.聽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.

:聽Surveys 101 鈥� Design surveys, collect responses, and analyze the data like a pro

:聽4 Guidelines for Writing Clear and Effective Survey Questions

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

: Questionnaire design

: 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.