New Study Requirements
Before Submitting a New Application
1. Determine the Principal Investigator
Every research study requires a Principal Investigator (PI). At BYU, this person is generally a tenured-track faculty (SOP 106). This person takes full responsibility for the conduct of the study.
If you are not a tenured-track faculty but may fall under an exception, a memo of understanding (MOU) must be signed and approved by the Department Chair. The MOU must be uploaded in the PI’s iRIS profile along with your CV and other special license and training documentation.
Students cannot be listed as PI.
2. Identify the Research Personnel
Research personnel members are individuals engaged in human subjects research. Identify if research personnel are BYU associates or external collaborators. Determine whether any member of the team has a financial interest related to the research (SOP 104.1.2).
**Individuals are considered engaged in human subjects research if they will have contact with human subjects and/or access to identifiable human subject data. Examples are:
- 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 training for Social & Behavioral Research Investigators/Mentors within the past 5 years. 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. See the Getting Started section for more information about the training.
4. Register in iRIS
To add research personnel to a study they must be registered in iRIS.
5. Develop the Study Protocol
Before initiating an application, researchers must have a clear idea of the study’s objectives, procedures, research subject selection, risks, benefits, recruitment, consent processes, and data security methods.
6. International Research
Research conducted in foreign countries remains under University purview and guidelines. While we do not impose our standards for written documentation on other cultures, we do not relax our standards for ethical conduct of research or a meaningful consent and assent process. If you are conducting international research, please refer to SOP 503 and the International Research Guidance link.
Researchers should be informed about data security laws that govern each country/region.
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 following link: Data Use Agreements
8. Support Documents
Be prepared to attach several files to your submission. When attaching each file, please be sure to use a name that describes the document (Child Assent, Group A; Parental Permission, Control group, etc.). In iRIS, be sure to update the date and version of the files. Examples of support documents include: Scientific Review Checklist, MRI Approval, School District Approval, participant instruction form, diagrams and images, etc.