IRB FAQs

Submission timelines for Full Board review applications are available here: IRB Meeting Schedule (PDF).

There are no submission deadlines for Exempt and Expedited level review applications. Submissions are processed as received. We recommend submitting your application at least 30-45 days before your anticipated start date. Exempt and Expedited applications are generally processed between 2-4 weeks.

Our review process includes a pre-screen by the IRB staff before your application is sent to the reviewer for final approval. Please submit your packet to the IRB using InfoEd, and we will let you know if anything further is needed to complete the review.

No, the IRB does not grant retroactive approval. Contact the IRB office to determine if your project meets the criteria for secondary analysis review.

A complete IRB packet includes: IRB application, recruitment materials, informed consent documents, copy of data collection instruments and site support letters, if applicable. All required documents are listed in the IRB application.

All study personnel are required to complete the CITI training.

If the project is still active, an amendment request is required to change the PI on the protocol. The protocol may be closed if the project is no longer active at Clemson.

If a team member is not affiliated with another institution with an IRB office, then they will have to complete the CITI training for Clemson researchers.

Protocols may be closed if data collection is complete or the data collected do not include any identifiable private information or are linked to identifiable private information, in this case, research no longer involves human subjects.

The federal regulations require investigators to retain study records and signed informed consent forms for at least three years after completion of the research.

What document types may I upload into the online system?

Only PDF documents or images are accepted for upload into the system.

You may access the video and text tutorial on the InfoEd education page.

If you do not see your protocol under Locate My Records, send an email to the IRB office with your IRB number. Amendment requests must be submitted through InfoEd. Follow the steps on the Forms page.

Send an e-mail to the IRB office with the person's name. Currently, only Clemson employees have access to the system.

Send an e-mail to the IRB office with the student’s name. Currently, only Clemson employees have access to the system.

A description of the Exempt categories (PDF) are available on the resources page.

No, Exempt is a review level in the federal regulations and not an exclusion determination. Only the IRB office may determine whether or not a project constitutes research involving human subjects. Researchers may not determine which studies are excluded from IRB review.

Research conducted in an established or commonly accepted educational settings, involving normal educational practices. Refer to the Category 1 guidance (B1 Exemption) for more information.

An amendment is required if you are making substantial changes to your IRB approved protocol. Substantial changes include modification to the study purpose, study sample, informed consent process, incentives or research methods and instruments. Amendment requests must be submitted through InfoEd. Follow the steps on the Forms page.

You are only required to submit an amendment if the PI or IRB Editors on an Exempt approved protocol changes. You are not required to report other study personnel changes.

You have to submit an amendment request detailing the changes to the study. If there are significant changes to the protocol, the reviewer might request a new IRB application. All changes should be reported to the IRB office, no matter how insignificant, before implementation. This includes changes to the research team, study sample, incentives, informed consent process, research methods and/or instruments, or new advertising or promotions to recruit participants.

No, all changes must be reported immediately and before they are implemented. Deviating from the approved protocol without IRB approval would be out of compliance with federal regulations and institutional policies.

Local context review is required on international research if the country where the study will be conducted does not have human subjects regulations that require local (in-country) review of the research. Local context review is sometimes required for subcultures within the US as well.

Countries do not require local context reviews. This is something that is required by the Clemson University Office of Research Compliance (ORC) / Institutional Review Board (IRB) in order to ensure that we are appropriately assessing risk to participants in cultures we are not familiar with. 

However, unrelated to the fact that local context reviews are a requirement of the CU ORC / IRB, there are significant differences in the regulation of human subjects research across different countries. Some countries have human subjects regulations and require governmental approval for all research being conducted in the country, and some countries do not have any regulations, or have regulations that only address biomedical human subjects research. If a country requires local review, the CU ORC / IRB will accept that review in lieu of an independent local context review. 

If you are interested in learning more about the regulations in a particular country, the Office for Human Research Protections (OHRP) publishes a list of international regulations related to human subjects research on an annual basis.

Yes, it is required on exempt research. The CU ORC / IRB does not always have the expertise needed to determine the level of risk involved in research that will take place in a culture other than our own.