Institutional Review Board
Institutional Review Board
Western University of Health Sciences Institutional Review Board ( WesternU IRB) is an administrative committee designated to provide ethical and regulatory oversight of research that involves human subjects. IRBs exist to protect the rights, safety, and welfare of human subjects involved in research projects, consistent with ethical principles and federal, state and local regulations. For human subject research conducted internationally, additional local regulations and international standards apply and are overseen by ethics committees in respective countries along with WesternU IRB oversight.
IRBs are enacted under federal regulation, specifically 45 CFR 46, and are regulated by the Office for Human Research Protections (OHRP) within the U.S. Department of Health & Human Services (HHS). There are additional requirements for IRBs overseeing clinical trials of drugs involved in new drug applications from the Food and Drug Administration (21 CFR 56.111) and for studies supported by the Department of Defense.
IRB Resources
IRB Guiding Principles
We abide by principles put forth by the Belmont Report and the Common Rule, which guide the Office of Human Research Protections at the U.S. Department of Health and Human Services. Further information on human subjects research is available from
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.
Investigators are referred to the IRB Policy and Procedures Manual for information pertaining to the required elements of informed consent, format for informed consent forms, special consent circumstances and waiver of informed consent. The Office of Human Research Protection (OHRP) has provided the following video links that investigators may find useful when planning clinical studies and patient interviews for the purpose of obtaining informed consent and for the latest changes to the Common Rule as it pertains to informed consent.
General Informed Consent Requirements begins with a short meeting between an investigator and an IRB member regarding the requirements for obtaining informed consent for a proposed study on the effects of a test drug on cognitive function in schizophrenic patients. Issues pertaining to capacity to consent and obtaining consent from a legally authorized representative are discussed. The video continues with an interview between the investigator and a prospective subject in which the investigator explains the study and the patient’s rights, giving the subject an opportunity to ask questions.
Complex Issues with Research Involving Vulnerable Populations is a question and answer session between representatives from OHRP and audience members. Topics discussed include human subjects research involving patients with diminished capacity to give informed consent; research involving prisoners, minors, non-English speaking populations, and emergency research on vulnerable populations.
What’s New in Informed Consent: Revisions to the Common Rule [July 12, 2018] discusses the general improvements to informed consent. It begins with a case involving a woman with breast cancer who underwent surgery and chemotherapy. The clinical trial was to determine if adding radiation therapy would reduce the risk of breast cancer reoccurrence. However, the informed consent made no mention as to whether or not minimizing the risk of the cancer reoccurring would actually increase the chance of survival. Other topics covered in the video include:
- Using the “Reasonable Person” standard to decide what information to include in the informed consent;
- Possible future use of data stripped of identifiers;
- Possible commercial profit;
- If clinically relevant research results will be given to the study subjects;
- If the research will include whole genome sequencing;
- Posting of a clinical trial consent form;
- Use of a legally authorized representative;
- Future use of identifiable biospecimens for unspecified future research.
Broad Consent in the Revised Common Rule [June 22, 2018] discusses an option called “Broad Consent” that is intended to facilitate minimal risk research and allow subjects to permit secondary research use of identifiable private information or biospecimens for future unspecified research. It further explains the differences between Broad Consent and existing options for conducting secondary research and the limitations on the use of Broad Consent that might not make it the preferred option.
Informational Videos
The U.S. Government’s Office for Human Research Protections has created the following videos with basic information about research to assist potential subjects in determining whether or not to participate in a research study.
The first is a 3 minute video, titled “What is Research?” and provides basic information about scientific research, the goals of research and how clinical research differs from medical care. Click on the image or link to watch this video. Play Video: What is Research?
The second video, titled “Clinical Trials” is about 4½ minutes long and covers types of human research. It explains common terms that potential participants should know. Click on the image or link to watch this video. Play Video: Clinical Trials
Next is a 4¾ minute video titled “Questions to Ask” that emphasizes that participation in research is voluntary and encourages participants to ask questions to obtain the information they need to decide whether or not to participate. Click on the image or link to watch this video. Play Video: Questions to Ask
This video, titled “Randomization”, explains what is meant by randomization and what you need to know when volunteering for a study using randomized design. It last about 7½ minutes. Click on the image or link to watch this video. Play Video: Randomization
The video titled “Institutional Review Boards (IRBs)” explains how it is ensured that clinical research studies meet ethical standards and regulatory requirements. It is 6¾ minutes long. Click on the image or link to watch this video. Play Video: Institutional Review Boards (IRBs)
By pressing Ctrl + click on this 6 minute video, titled “Participating in Social & Behavioral Health Research”, you will learn how social and behavioral health research differs from clinical research. Click on the image or link to watch this video. Play Video: Participating in Social & Behavioral Health Research
This last video is titled “Research Use of Information and Samples from Patient Care” and lasts about 5¼ minutes. It explains how leftover tissue and fluid samples or information obtained from clinical care may be used. Click on the image or link to watch this video. Play Video: Research Use of Information and Samples from Patient Care