Westcliff’s 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. Researchers must obtain IRB approval before conducting research studies.

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.

• Risks to participants, whether physical, psychological, social, or economic, are identified and minimized through sound research design and appropriate safety measures. Participants in the study (and/or their guardians) are fully aware of the risks and that individuals may withdraw from the study at any time without any form of penalty and the need to explain the reasons for withdrawal.
• Research activities, designed to yield fruitful results for the benefit of individual participants or society in general, may incur risks to the participants provided such risks to the participants are outweighed by the potential benefits to be derived from the study.
• The participants are fully informed about the risks and accept those risks voluntarily.
• Compensation to the participants should never be such as to constitute an undue inducement to participate..
• Rights, privacy and welfare of any participants will be adequately protected.
• Legally effective informed consent will be obtained by adequate and appropriate methods in accordance with the provisions of the Westcliff University IRB Handbook.
• If stored data or other information collected for a different purpose is used in the study, it will be used within the scope of the original consent provided by the participants.

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.

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 activity.

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-day review period.

The IRB will provide you with the feedback that includes requirements for modifications. All deferred applications can be revised based on the feedback and resubmitted after modifications.

There is no resubmittal or appeal for an application denied after full board review.

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).

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 a renewal request at least a month prior to the expiration of the valid IRB approval.

Yes, the IRB has to review and approve all research conducted at Westcliff University.

Yes, you need to submit your application to the IRB. 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.

Most class assignments do not fall within the definition of systematic investigation, because the focus is on gathering information for training/educational purposes as opposed to collecting data for a scholarly research project that may lead to dissertation completion, research publication, presentation, or public dissemination. Therefore, they do not require the IRB review and approval.

However, some research conducted by students as part of their class assignments as well as class research conducted by professors in their work with students may be subject to IRB review. If the research poses more than minimal risks to the participants, IRB review and approval is required.

The course instructor has the responsibility to ensure that the student is educated on the general principles of research ethics, human participant protection, and investigator training. Faculty and students may contact the IRB to discuss the assignment and obtain assistance.

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

Generally, a pilot study is a preliminary investigation to determine the feasibility of a study. It is usually done on a small scale (fewer than 10 participants) and is exploratory in nature. Its purpose is to refine data collection procedures, instruments, or research design. Thus, pilot studies do not qualify as research generating generalizable knowledge, and therefore do not need IRB review and approval. Nonetheless, it is assumed that the proper steps will be taken to protect human subjects (e.g., use of informed consent, confidentiality, etc.).

However, if sensitive data, vulnerable populations, or methods with more than minimal risk are to be used, a consultation with the IRB Chair must occur before data collection. The IRB retains the right to require review of a project characterized by the principal investigator as exploratory (pilot) in nature.

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 denial of the application. After the IRB approves the research, new participants will need to be recruited.

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.

No. 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.

At Westcliff University, all investigators and research staff are required to successfully complete the CITI Program training prior to submitting the IRB Application. The CITI program training must be updated at least once every three years. A completion certificate for each CITI program completed course is required from the principal investigator and any 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

Additionally, the applicants may take more courses that are available.

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 (Addendums and Extensions | Writing Center | Westcliff University) to the IRB, and receive the IRB approval of the amendments, prior to implementing any changes to the research plan.

Westcliff University faculty, staff, and students may only be recruited for participation with the permission of the Chief Academic Officer which should be secured before submitting the IRB Application.

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 the research, no further appeal is available. No faculty member or administrator may conduct or approve a research project involving human participants that has not been approved by the IRB as in compliance with applicable ethical and legal standards.