Before You Start a New Study
1. Determine the Principal Investigator
Every research study requires a Principal Investigator (PI). At BYU, this person is generally a tenure-track faculty member (SOP 106). This person takes full responsibility for the conduct of the study.
If you are not a tenure-track faculty member but may qualify under an approved exception, you must complete a Memorandum of Understanding (MOU). The MOU must be signed and approved by your Department Chair. The form is available on the Forms page.
After approval, upload the signed MOU to your OneAegis PI profile along with your CV and any required licenses or training documentation. Please note that students are not permitted to serve as Principal Investigators (PIs).
2. Identify the Research Personnel
Research personnel are individuals engaged in human subjects research. Identify if research personnel are BYU associates or external collaborators. Determine whether any research personnel have a financial conflict of interest in research as defined in the University Policy and (SOP 104 1.2).
**Individuals are considered engaged in human subjects research if they have contact with human subjects and/or have access to identifiable human subject data. Examples include individuals who:
- Direct research or serve as the principal investigator for the study
- Enroll research subjects (including obtaining subjects’ informed consent or screening potential subjects)
- Make decisions related to eligibility to participate in research
- Conduct study procedures
- Are involved with collecting, reporting, or analyzing identifiable subject data
3. Complete Human Subject Protection Training
All research personnel must complete the training for Social & Behavioral Research Investigators/Mentors. This training is valid for 5 years and then must be renewed. Brigham Young University subscribes to the Collaborative Institutional Training Initiative (CITI) for required ongoing education and training in the protection of human subjects in research. Click here for more information about the training.
4. Register in OneAegis
To add BYU research personnel, the individual will have to log in to byu.oneaegis.com for the system to pull in the individual’s credentials. The individual will need to have completed CITI training.
To add a non-BYU collaborator, click here. Please note that for security reasons, external researchers are not given access to OneAegis. The PI can download the application and provide a copy to the external investigator.
5. Develop the Study Protocol
Before initiating an IRB application, investigators must prepare a comprehensive study protocol that clearly outlines the purpose and design of the research. The protocol should address the study’s objectives, methodology, participant population and selection criteria, potential risks and anticipated benefits, recruitment strategies, consent procedures, and plans for data management and security. A complete and well-developed protocol ensures that the IRB can accurately evaluate the ethical and scientific integrity of the proposed research.
6. International Research
Research conducted outside the United States remains subject to all University policies and oversight. Although the University does not require international collaborators to adopt our specific documentation formats, we uphold the same standards for ethical conduct, participant protection, and comprehensive consent and assent processes in all research settings. Investigators planning international research must review SOP 503 and the University’s International Research Guidance before preparing an IRB submission.
Researchers are responsible for understanding and complying with all applicable data privacy and security laws within the countries or regions where data will be collected. This obligation applies equally to in-person and online studies, as internet-based research may also fall under foreign data protection regulations. Given the complexity of country-specific requirements, investigators should anticipate additional lead time to obtain necessary approvals, permissions, or agreements prior to initiating data collection abroad.
An increasing number of international regulations govern general data protection and may impose specific requirements on data handling, storage, transfer, and retention. The University’s Chief Information Privacy Officer is available to advise investigators on navigating international data collection and ensuring compliance with relevant privacy and data protection standards.
7. Data Use Agreements
A Data Use Agreement (DUA) is a written contract used to govern the transfer of research data between organizations. These agreements can be set up between academic institutions, government agencies, and/or corporate entities. For more information see the Data Security section here.
8. Support Documents
Investigators should be prepared to upload multiple supporting documents as part of their IRB submission. Each file must be clearly labeled with a descriptive title (e.g., Child Assent – Group A, Parental Permission – Control Group, Participant Instructions, etc.) to facilitate review. In OneAegis, investigators will be prompted to upload required documents throughout the application and will also be provided with a designated section at the end of the submission for any additional supporting materials. All documents should include accurate dates and version numbers to ensure proper tracking.
Examples of supporting documents include, but are not limited to:
- Scientific Review Checklist, if different than the in-system questions
- MRI or imaging facility approval
- School district or site authorization
- Participant instruction sheets
- Diagrams, images, or study flowcharts
- Recruitment materials
- Data collection instruments
For helpful templates and forms, here.
9. Post-Submission Process
Once all sections of the application have been completed in OneAegis and all supporting documents have been uploaded, investigators should conduct a final review to ensure the submission is accurate, consistent, and complete. Confirm that all documents are clearly labeled, dated, and versioned, and that the information in the application aligns with all attachments.
Submission by the Principal Investigator
If research staff or research assistants have prepared or entered information into the application, it is essential that the Principal Investigator (PI) is notified promptly once the submission is ready. Only the PI has the authority to submit the application in OneAegis. Timely communication within the research team ensures that the PI can review and submit the materials without unnecessary delays, helping the process move smoothly into IRB review.Administrative Pre-Review
After PI submission, the application enters the IRB administrative pre-review stage. During this step, IRB staff assess the submission for completeness, internal consistency, and adherence to institutional requirements. Investigators may be contacted to provide clarifications, additional details, or revised documents. Prompt responses to these requests support efficient processing.IRB Review
Following pre-review, the application will be routed to the appropriate level of IRB review—exempt, expedited, or full board—based on the nature of the study. During this phase, investigators may receive reviewer questions or requests for modifications. All required revisions must be addressed and approved before the study can move forward.- Final Determination and Approval
Once the IRB has completed its review and all required modifications have been accepted, investigators will receive a formal determination through OneAegis. No research activities—including recruitment, screening, or data collection—may begin until official IRB approval has been issued.