Guidance for Researchers

All human subjects research must be reviewed and approved by the IRB.

Federal regulations define a human subject as “a living individual about whom an investigator conducting research obtains (1) information or biospecimens through interventions or interaction with the individual, and uses, studies, or analyzes the information or biospecimens, or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens (45CRF46.102(f)(1),(2).”

Federal regulations define research as “a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45CFR46.102(d)).”

Generalizable knowledge is defined as information where the intended use of the research findings can be applied to populations or situations beyond that being studied.

The FHSU IRB has developed a form to help faculty, staff, and students determine if an activity meets the federal definition of “research” as noted above. If you are unsure if your activity is research or not, complete and submit the Not Human Subjects Research Determination Form to IRB (see submission process below). If your activity is determined “not research,” then a full IRB application is not required.

If your activity is determined research, all researchers associated with the project must complete the appropriate CITI Training prior to submission to the IRB. The IRB administrator can verify CITI transcripts, but to expedite the process, researchers may include documentation of CITI training with the application. See CITI training for more information.

All research projects should be submitted to IRBNet for review by either the IRB or IACUC. Please review Instructions for Registering with IRBNet to create an account.

Check out these video tutorials for more information on how to register with CITI and IRBNet.

• If your study is a new study, review Instructions for Creating a New Study which includes links to IRBNet where you will submit your completed application.
• If you are revising an existing and approved study, review Instructions for Submitting a Revision.
•  If you need to request an extension on an existing and approved study, review Instructions for Requesting a Continuing Review.
•  If you are conducting FHSU research, but you are not affiliated with FHSU (as faculty, staff, or student) and/or your research qualifies for a single-IRB review, please contact the IRB Administrator (IRB@fhsu.edu).

 Check out this video tutorial with instructions and tips for submitting your IRB application.

Follow the instructions above to find the correct forms for the type of application you are submitting to IRBNet (e.g., new, revised, continuation/extension). 

Completed applications must be signed in IRBNet by all researchers associated with the project.

Student researchers must sign their application and share it with their faculty research supervisor. The faculty research supervisor will review the application. If the application is ready for IRB review, the faculty researcher must also sign the package before it is submitted. Failure to obtain a signature from the faculty research sponsor may delay review of the package.

When submitting your application on IRBNet, please ensure that it is being submitted to the IRB (Human Subjects Research) and not IACUC (Animal Research).

Prior to applications being sent to the IRB, the IRB administrator reviews the package to ensure that all required documents (including the IRB application and supplemental documents), signatures, and documentation of CITI training for all project researchers are included. The IRB Administrator will conduct an initial review of the project to determine the level of review (categories listed below) and may ask the researcher to revise the package as needed before approval occurs.

• Exempt/Administrative Review: Reviewed by the IRB administrator. Process can be completed in approximately 3-5 business days, if no revisions are required.
• Limited Review: Reviewed by the IRB Administrator and IRB Chair. Process can be completed in approximately 7 business days, if no revisions are required.
• Expedited Review: Reviewed by the IRB Administrator and two designated IRB members. Process can be completed in approximately 14 days, if no revisions are required. Note: If more than minimal revisions are required, full board review may be needed.
• Full Board Review: The IRB meets monthly (see IRB meeting schedule). The IRB administrator will contact the researcher regarding the review determination following the monthly meeting in which the study is reviewed. Determinations include approved, modifications required (instructions will be provided in the notification), or not approved. 
• Appeals of IRB Decisions: If the IRB makes a decision that the researcher believes to be unduly restrictive on the proposed research, the investigator may request appeal by the full IRB committee. If the full IRB committee makes a decision that the investigator believes to be unduly restrictive on the proposed research, the investigator may submit a formal appeal in writing stating the rationale and providing any additional supporting documentation. The IRB will reconsider the appeal based upon the new information provided. The IRB's determination following appeal is final. The investigator may submit a revised protocol for consideration. 

At any level of review, the IRB may ask that modifications be made in order for your project to be approved. Please refer to the Instructions for Submitting Required Modifications for more information.

Research Timeline: The lead researcher is notified 90, 60, and 30 days prior to expiration of an approved study. If continuing review is needed, the lead researcher should submit that request no later than 45 days prior to the expiration date. However, if the study is due to expire during the summer session, the PI is strongly encouraged to submit the request for continuing review in time for the IRB's last meeting of the spring semester. Expired studies will be closed by the IRB Administrator on the date of expiration. When a study is closed, all research activities must stop, including recruitment, registration, consent, interventions, interactions, and data collection, unless the IRB finds that it is in the best interests of individual subjects' to continue participating in the research interventions or interactions.

Adverse Events: All members of the campus community involved in human subject research are expected to comply with the highest standards of ethical and professional conduct in accordance with federal and state regulations and institutional policies governing the conduct of research involving human subjects. Anything that causes concern regarding the protection of human subjects (including complaints, reports of noncompliance, unanticipated problems, and/or adverse events) should be promptly reported to the IRB Administrator (IRB@fhsu.edu) by investigators, research participants, and others.

When you have completed your research in the allocated time approved by the IRB, review and complete the steps in Instructions for Submitting a Final Report.

If you have any questions or concerns please contact the IRB Administrator (IRB@fhsu.edu).