Institutional Review Board

i. Review the Research Handbook and formulate your research proposal according to its guidelines and suggestions. For Regent doctoral students, this process typically involves completing the dissertation proposal defense first.

ii. Undertake or update your training in human ethics via the CITI Certification process. Complete other types of certifications that may be required as part of the submission process.

i. Determine the type of application relevant to your research: exempt, expedited, or full board review (see above or review the Research Handbook).

ii. All Regent research investigators MUST have a Cayuse account.

iii. Login to the Cayuse IRB portal and follow the steps in the video below to create a submission.

Note:

• Incomplete, incorrect, or improperly formatted applications will be returned to the Principal Investigator for re-submission.
• Applications are accepted exclusively via the Cayuse Regent Portal.
• Reviews take approximately 4-10 weeks depending upon the degree of risk to participants in the study. Also, please be aware that the IRB may not be operational during certain University holidays.

After the review, one of the following will be communicated to the researcher:

i. The research is approved as submitted.

ii. The research requires modifications for approval, overseen by the IRB Chair or a designated representative.

iii. Significant revisions are needed. In such cases, the applicant will be asked to amend and resubmit. The revised application will be reviewed by the original panel or the full board, as determined by the IRB.

iv. The research is not approved. You have the option to petition this decision. You can do so by writing a formal letter to the IRB at irb@regent.edu, noting your request for a re-consideration. At the discretion of the IRB chair, you may present your appeal either in writing or in person to the board. An appeal of the disapproved project must be deliberated upon at a subsequent full board meeting.

The Institutional Review Board (IRB) ensures the protection of the rights, welfare, and privacy of human subjects involved in research. It reviews, assesses, and oversees research to ensure compliance with ethical standards.

Anyone conducting research involving human subjects at Regent University must apply for IRB approval. This includes faculty, students, and external researchers affiliated with the university.

Research projects that are (1) part of normal, typical coursework, and (2) not intended for dissemination (e.g., publication) are generally not required to undergo human subjects review even if human subjects are involved. Additionally, surveys or other data collection efforts for the purpose of program or institutional improvement (e.g., Student Evaluations of Teaching) and are not intended for dissemination are generally not required to undergo review.

Regardless, all research conducted at Regent University must follow ethical guidelines for the protection of human subjects. To that end, all researchers employing human subjects for any purpose must complete the CITI (Collaborative Institutional Training Initiative) training course whether or not their research needs IRB approval.

Human subjects data collected in non-IRB research may not be used in future publications or presentations. There will be no ex post facto approval of such activities to legitimize turning these studies into approved human research.

Research involving human subjects, vulnerable populations, or identifiable private information typically requires IRB approval. Specific activities like surveys, interviews, and clinical trials fall under this category.

When we speak of a human subject we mean “a living individual about whom an investigator (whether professional or student) when conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information (see Code of Federal Regulations 45 CFR 46.102(f)).

Research can be defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” (see Code of Federal Regulations at 45 CFR 46.102(d)).

Research proposals can be submitted online through the IRB’s Cayuse submission portal. Ensure your submission includes all required documents, such as the research proposal, informed consent forms, and any supplementary materials. Make sure to follow these steps in preparation for submission your proposal.

There are three types of IRB review: Exempt Review, Expedited Review, and Full Board Review. The type of review depends on the nature and risk level of the research.

Exempt Review applies to research involving minimal risk with a low potential for harm or distress to the participants and is typically anonymous research, such as educational practices, anonymous, or observational studies that are non-invasive. Even exempt research must comply with ethical standards, but it does not require full board approval.

Anonymous research is research that can never be traced back to a participant (e.g., a number on a questionnaire), not even by the researcher. Confidential research is research in which names and information are only known to researcher, and not revealed to anyone else.

Expedited Review is for research involving minimal risk but does not qualify for exemption due primarily to non-anonymous confidential data collection (e.g., surveys, interviews with voice, video, or digital records). This may also include studies with minor changes to previously approved research.

Full Board Review is required for research involving more than minimal risk to participants. This includes studies with vulnerable populations (e.g., minors, pregnant women, prisoners, cognitively impaired) or research involving sensitive topics.

The review process timeline varies based on the stage and type of review (which can take up to 4-10 weeks). Exempt and Expedited Reviews typically take a few weeks (2 – 4 weeks), while Full Board Reviews may take longer (4-10 weeks), depending on the complexity of the research.

Informed consent is the process of providing potential research participants with all necessary information about the study, including its purpose, procedures, risks, and benefits, ensuring they voluntarily agree to participate.

Your informed consent document should be clear and concise, using language understandable to the participants. It must include the purpose of the study, procedures, risks, benefits, and the participant’s right to withdraw at any time. You can download an Informed Consent Form template under the Resources page on the IRB homepage.

In certain circumstances, the IRB may waive the requirement for informed consent or the documentation of consent. This is typically considered when the research involves minimal risk and obtaining consent is impractical.

You will receive an initial email letter from the IRB office responding to your application being submitted, and you must wait for a second email letter of approval from the IRB office before beginning any research.

Any modifications to the research protocol must be submitted via Cayuse to the IRB for review and approval before implementation. This ensures continued compliance with ethical standards.

Report any adverse events or unanticipated problems to the IRB immediately (irb@regent.edu) and submit an incident report via Cayuse. Provide a detailed description of the incident and any steps taken to address it.

All researchers must complete mandatory training on human subjects protection, from the Collaborative Institutional Training Initiative (CITI) program, to demonstrate understanding and adherence to ethical research practices.

Researchers must disclose any potential conflicts of interest to the IRB. If a conflict is identified, the researcher may need to recuse themselves from the study or take steps to mitigate the conflict.

Researchers must maintain thorough records and documentation of all research activities, including informed consent forms, data collection, and correspondence with the IRB. These records must be kept for a specified period, typically three years after the study’s completion.

The IRB investigates allegations of research misconduct, which includes fabrication, falsification, and plagiarism. If misconduct is confirmed, appropriate actions, including potential disciplinary measures, will be taken.

Yes, collaborations with external entities are permitted, but they must comply with all IRB and institutional policies. An inter-institutional agreement may be required to outline the responsibilities of each party.

The IRB provides various resources, including templates, checklists, additional readings and videos, to assist researchers in preparing their submissions and conducting ethical research.

This is normal, you need to continue your login by going to the drop-down menu that says Products and select Human Ethics, then you should see your personalized dashboard with a tab to start a New Study.

The best file format for uploading any documents that are part of the research proposal submission is the PDF format – please convert all documents to PDFs which will allow the IRB office to “stamp” your document as approved for your use. 

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