1. What is an Institutional Review Board (IRB)?

An Institutional Review Board (IRB) is a committee that reviews and oversees all research at Westcliff University to ensure ethical standards are met. It protects participants’ rights, safety, and confidentiality while ensuring compliance with applicable regulations. At Westcliff University anyone conducting research not directly mandated by most class assignments must obtain IRB approval before conducting research studies.

2. What is the purpose of the IRB?

The purpose of the Institutional Review Board (IRB) is to ensure the ethical standards for all research are upheld. This includes protecting the rights, welfare, and privacy of human research participants. The IRB determines whether participants in a research study will be placed at any risk, as well as what risk is involved, to ensure that the following conditions are met.

3. Does the IRB approve research?

The IRB shall review and have the authority to approve, defer and require modifications (to secure approval), require full board review, or deny any research applications at Westcliff University

4. How do I know if I need IRB certification (approval) to conduct research?

All research conducted at Westcliff University must be reviewed by the IRB This includes research that does not have human-subjects so the IRB can make a determination that the research does not involve human subjects.

5. Do I need IRB approval to conduct a survey or analyze a public database for research purposes?

Yes. All research conducted at Westcliff University needs IRB approval. Although your research may be completed using a database that is publicly available, this does not mean the data is available for research purposes. It is the researcher’s responsibility to determine the user restrictions and obtain permissions as appropriate.

6. What conditions must be met for the IRB to approve human-subjects research study?

The IRB reviews all applications to ensure the following conditions are met.

• Participant risks are identified, minimized, and clearly explained. Risks are allowed only when outweighed by potential benefits.
• Participation is voluntary, and individuals may withdraw at any time without penalty.
• Compensation cannot be coercive.
• Participants’ rights, privacy, and welfare are protected.
• Informed consent will follow the Westcliff University template guidelines.
• Any previously collected data will be used only within the scope of the original consent.

7. Do classroom research projects conducted by Westcliff students need IRB approval?

Most class assignments are for learning purposes and not systematic investigations, so they do not require IRB review. However, student or faculty projects that involve more than minimal risk to participants do require IRB approval. Instructors are responsible for teaching students basic research ethics and participant protection. Faculty and students may consult the IRB for guidance on specific assignments.

8. My research will be done in another country. Do I need IRB approval?

Yes. For international research, the guidelines established by the OHRP in the U.S. Department of Health and Human Services apply. The OHRP International Program works to ensure that human subjects outside of the United States who participate in research projects receive an equal level of protection as research participants inside the United States.

The guidelines can be found at http://www.hhs.gov/ohrp/international/index.html

The Westcliff University Policy on International Research.

9. Can the IRB approve a project retroactively after data has been collected?

There is no provision in the federal regulations that allow for IRB approval of research that has already been conducted. If data were collected for purposes that the IRB determines to be non-research (e.g., program evaluations for library or educational programs not initially intended to be used for research), the data cannot be used for the research unless the participants were informed in the Informed Consent that their data may be used for research in the future.

10. Am I allowed to conduct a pilot test before obtaining IRB approval?

A pilot study is a small, exploratory test (typically under 10 participants) used to assess the feasibility of a research plan and refine procedures, instruments, or design. Because it does not produce general knowledge, it usually does not require IRB review, though standard protections for participants (e.g., consent, confidentiality) still apply. If the study involves sensitive data, vulnerable populations, or more-than-minimal risk, the researcher must consult the IRB Chair, and the IRB may require a full review if warranted. A complete report of the pilot study results must be provided with the application. The IRB retains the right to require review of a project characterized by the principal investigator as exploratory (pilot) in nature.

11. Do I need to submit the results of the pilot study with my application?

If the pilot study is being conducted for instrument validation, then a report of the pilot study’s results must be provided with the application.

12. When may I begin recruiting my study participants?

Participant recruitment must not begin until the study has received IRB approval. All plans for recruitment and recruitment documents must be submitted with the application. Recruiting participants prior to the IRB approval will result in deferral of the application. After the IRB approves the research, new participants will need to be recruited.

13. Who can give approval for research?

Only the IRB can give approval for research compliance with applicable ethical and legal standards. The IRB approval is required before any contact can be made with potential participants or any data collection.

14. What if I need to conduct my research immediately?

No research can be conducted without IRB approval.

1. When should I submit an IRB application?

You should submit your IRB application before beginning any research data collection. No contact with potential research participants may be initiated before IRB approval is obtained. The application must be submitted, and approval must be granted, prior to participant recruitment and data collection. Dissertation students should submit an application after a successful proposal defense. Refer to your faculty chair for assistance.

2. At what point in the dissertation process should a student begin preparing for IRB submission?

You should submit your IRB application before beginning any research data collection. No contact with potential research participants may be initiated before IRB approval is obtained. Dissertation students should submit an application after a successful proposal defense. Refer to your faculty chair for assistance. The application must be submitted, and approval must be granted, prior to participant recruitment and data collection.

3. What are the training requirements to apply for IRB approval?

At Westcliff University, all investigators, faculty supervisors, and any research staff are required to successfully complete the CITI Program training prior to submitting the IRB Application. A completion certificate for each CITI program course is required from the principal investigator and all committee members or research advisors when submitting an application for review.

The following CITI program courses are required:

• Social and Behavioral Responsible Conduct of Research
• Human Subjects Research

The CITI program training must be updated at least once every three years. Faculty and students also have access to additional courses through their Westcliff University CITI account. Please review the CIT Program Training requirements at https://writingcenter.westcliff.edu/westcliff-irb/resources/

4. What is the timeline for application review?

The review of the application normally takes 10 business days. Upon the end of this period, the application may be approved, deferred with modifications required, recommended for a full board review, or denied. The full board review takes at least 30 business days. Each resubmission of the application after the modifications are made based on the reviewer’s feedback will entail a new 10 business days review period.

5. What documents and materials are required when submitting an IRB application?

All information provided to human participants must be submitted (e.g., recruitment letters, informed consent forms, instruments used for data collection). Site permission letters must be submitted to obtain data that is not publicly available. Site permission letters may also be required if organizations provide help to the researcher (e.g., email contact information for potential participants, contacting potential participants for the researcher).

6. What are the most common mistakes researchers make when submitting their IRB application?

• Not providing all required supplemental documents (e.g., site permission, instruments, informed consent, recruitment letters).
• Application and supplemental documents have differing information (e.g., inclusion criteria).
• Instruments have not had reliability and validity processes conducted adequately.

7. Can dissertation students submit their IRB application before their full dissertation proposal is approved?

Dissertation students should submit an application after a successful proposal defense. Refer to your faculty chair for assistance.

8. If my research plan changes after the IRB approval, what should I do?

If any changes need to be made to the research plan after IRB approval has been secured, the principal investigator must submit the amendment request (Westcliff IRB | Writing Center | Westcliff University) to the IRB, and receive the IRB approval of the amendments, prior to implementing any changes to the research plan.

9. If the faculty advisor/dissertation chair changes, does the IRB submission need to be updated?

The IRB only needs to be notified if the research plan changes. The principal investigator must submit an amendment request to the IRB, and receive the IRB approval of the amendments, prior to implementing any changes to the research plan. All further research activities must be in compliance with the Amendment Process found on the IRB website.

10. Where can I get help before submitting my IRB application?

You may email questions to IRB@Westcliff.edu. Bi-monthly IRB Q&A sessions are available. Email the dissertationdept@westcliff.edu for a schedule.

11. What types of participant risks are most likely to raise red flags during IRB review?

Risks to confidentiality and risks to physical or severe emotional harm are the most likely to raise concerns during the review process.

1. What are the differences between exempt, expedited, and full IRB reviews?

Currently, there is no difference between exempt and expedited reviews. Full Board IRB reviews are required for research conducted with participants from a vulnerable population and in case of an appeal process.

2. What happens if my application is deferred?

The IRB will provide you with feedback that includes required modifications or missing documentation. All deferred applications can be revised based on feedback and resubmitted for review.

3. What happens if an IRB application is deferred more than once — are there any limits or consequences?

The IRB application process may involve multiple rounds of review, and each resubmission can take up to 10 business days to be reviewed. Therefore, researchers should plan their timelines accordingly. Students are strongly encouraged to carefully review all feedback and address all requested changes before submitting a second revision to avoid unnecessary delays in the research process. The goal should be to obtain approval by the first or second submission.

4. Can a researcher reapply for IRB with a new research design if the original design is deferred?

Yes.

5. What happens if my application is denied?

There is no resubmittal or appeal for an application denied after full board review. The research cannot be conducted.

6. What is the difference between a deferred application and a denied application?

A deferral implies the possibility to modify the application, based on the feedback, to meet the ethical standards for later approval. A denial means that the study cannot be conducted due to major ethical concern(s).

7. If my application is not approved, is there an appeals process?

If a principal investigator wishes to appeal the IRB decision, they may make a written request to the IRB Chair for the IRB full board review. If the IRB full board does not approve of the research, no further appeal is available.

8. What criteria does the IRB use to evaluate survey instruments or interview questions?

Reliability and validity must be established for all instruments. If the interview questions do not align with the research questions, or if they are not developed in accordance with established research guidelines, they will be rejected. Please refer to the Westcliff University Instrument Validation Policy for further guidance.

9. If a data collection tool is not approved, can the IRB provide guidance to revise it?

Faculty supervisors should be consulted first, then the IRB may be consulted. The IRB does not always provide specific guidance for instrument approval other than the Westcliff Policy on Instrumentation Validation.

1. What is the timeline for application review?

The review of the application normally takes 10 business days. Upon the end of this period, the application may be approved, deferred with modifications required, recommended for a full board review, or denied. The full board review takes at least 30 business days.

2. How long does the IRB approval last?

IRB approval is valid for one year. If the study lasts more than a year, it is the responsibility of the principal investigator to request an extension by submitting an extension request at least a month prior to the expiration of the valid IRB approval.

3. When may I begin recruiting my study participants?

Only after IRB approval. No contact with potential participants can be initiated before IRB approval.

4. When may I begin data collection?

Data collection must not begin prior to IRB approval. Data collection plans and all instrumentation must be submitted with the application. Data collection prior to the IRB approval will result in denial of the application and new data will need to be collected.

5. Can I recruit Westcliff faculty or staff for participation in my research?

Westcliff University faculty, staff, and students may only be recruited for participation with the permission of the Chief Academic Officer which must be secured before submitting the IRB Application. This process starts with a site permission request letter being sent to research@westcliff.edu.

1. Can a student change their sample size or population criteria after IRB approval due to low response rates?

An Amendment request must be submitted to the IRB and approved. Westcliff IRB | Writing Center | Westcliff University

2. What should a student do if they need to alter their research design after IRB approval?

An Amendment request must be submitted to the IRB and approved. Westcliff IRB | Writing Center | Westcliff University

 3. What should a student do if they miss the IRB deadline or fall behind schedule for their approved timeline?

If the research takes longer than 1 year, an Extension request must be filed at least 30 days before the 1-year approval period expires.

 4. What happens if an IRB application gets deferred more than once — are there any limits or consequences?

No limits or consequences exist with the IRB. Consult your faculty advisor.

 5. Is it possible to pause or delay my research after I receive IRB approval?

The IRB approval lasts for 1 year regardless of circumstances. An Extension request must be filed at least 30 days before the 1-year approval period expires.

 6. Are there penalties or academic consequences if a student collects data without IRB approval by mistake?

Yes. The project must be stopped immediately until further notice. The College Program Chair and the Dissertation Department will determine the consequences in accord with the specific details of each situation.

 7. If a researcher wants to add new research questions or demographic items during data collection, is resubmission required?

Yes. An Amendment request must be submitted to the IRB.

 8. If I discover an error in my data collection method during the study, what should I do?

If any changes need to be made to the data collection method after IRB approval has been secured, the principal investigator must submit the amendment request (Westcliff IRB | Writing Center | Westcliff University) to the IRB, and receive the IRB approval of the amendments, prior to implementing any changes to the research plan.

 9. What should be done if participants withdraw after partial data collection — can the data still be used?

If the data collection was anonymous, then the data may be able to be used. If the data was not anonymous, the data must be removed at the participant’s request if withdrawal occurs before publication even if that means that data analysis would need to be conducted again. The process used to withdraw the data depends upon the researcher’s process developed in case of partial data collection.

 10. If the research timeline is impacted by external delays, how should the IRB be notified?

An Extension request must be submitted at least 30 days before the 1-year approval time expires. Westcliff IRB | Writing Center | Westcliff University

 11. Can a researcher change their research topic after IRB approval?

No. Any time a researcher initiates a new study, a new IRB application must be submitted for review and approval.

 12. What must the researcher provide to prove data confidentiality when using third-party platforms like Google Forms or SurveyMonkey?

Researchers using Google Forms or SurveyMonkey do not need to provide additional information about the platform security measure. However, if other platforms are to be used, then information from the platform must be provided that shows the data will be collected and held by the platform confidentially.

 13. What are the best practices for demonstrating participant confidentiality and data protection?

All personal identifying information is deleted from data records. Only the researcher(s), faculty supervisors, and the IRB can have access to the data. Data for human-subject research must be kept secure for a period of 3 years after the research project has been completed then the data must be destroyed. The university strongly recommends that data for non-human subject research be kept for a period of 3 years after the data can be deleted.

1. If I plan to publish my findings in the future, are there specific IRB considerations I should address now?

There is nothing different that needs to be considered.

2. If my study involves international participants, are there additional IRB considerations I should be aware of?

In international research, the guidelines established by the OHRP in the U.S. Department of Health and Human Services apply. The OHRP International Program works to ensure that human subjects outside of the United States who participate in research projects receive an equal level of protection as research participants inside the United States.The guidelines can be found at: International | HHS.gov

 3. How should I proceed if I want to include a vulnerable population (e.g., minors, prisoners) in my research?

You must notify the IRB in your application and special steps must be taken to protect their rights. Your planning should focus on addressing the potential for coercion, undue influence, and diminished autonomy among vulnerable participants

 4. In a new research study, can researchers use previously collected data (e.g., from internships, class surveys, past research) retroactively with IRB approval?

If the participants in the previous study were notified that their data might be used for research purposes, then the data might be able to be used. Email the IRB@westcliff.edu if you have questions prior to submitting your application. 

 5. How do I ensure that my online survey complies with IRB requirements for informed consent and data security?

Submit the online survey with your application. Explain in the application the informed consent process and method to keep the data secure. The informed consent form should follow the Westcliff IRB Informed Consent template on the IRB website. The data must be stored securely (e.g., password-protected cloud storage, data encryption).

 6. If I receive unexpected feedback from participants that suggests potential harm or distress caused by the study, what are my obligations?

Westcliff University policy requires principal investigators to promptly report any unanticipated deviation or adverse event related to the conduct of research regardless of the severity. An unanticipated deviation or adverse event is defined as any potential for harm or risks to participants or others.

The Adverse Event must be reported with an Adverse Event process within 10 days of the incident and all research activities must be suspended until the IRB has completed a review. Failure to adhere to these guidelines will be considered an act of noncompliance and the principal investigator could have their research suspended. Westcliff IRB | Writing Center | Westcliff University