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IRB FAQs
General Questions
What needs IRB review?
IRB review is required for all research activities involving human subjects conducted by faculty, staff, and students, regardless of the funding support and study location.
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.
Where can I find the review timelines?
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.
If I send my application, will you look it over before I officially submit it for review?
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.
Does the IRB approve a project retroactively?
No, the IRB does not grant retroactive approval. Contact the IRB office to determine if your project meets the criteria for secondary analysis review.
What documents are required for IRB 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.
Who is required to complete the human subjects training?
All study personnel are required to complete the CITI training.
What should I do if the PI has left or will be leaving Clemson University?
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 The protocol may be closed if the project is no longer active at Clemson.
What training is required for team members not affiliated with Clemson University?
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.
When should I close my protocol?
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.
How long do I have to keep my IRB records?
The federal regulations require investigators to retain study records and signed informed consent forms for at least three years after completion of the research.
IRB Online Submission System (InfoEd)
What document types may I upload into the online system?
Only PDF documents or images are accepted for upload into the system.
Where are the tutorials on how to use InfoEd?
You may access the video and text tutorial on the InfoEd education page.
I am trying to submit an Amendment in InfoEd but cannot find my protocol record, who do I contact?
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.
I am trying to add an Clemson person as an IRB Editor to my application but did not find their name on the picklist, what do I do?
Send an e-mail to the IRB office with the person's name. Currently, only Clemson employees have access to the system.
My graduate student is completing the application on my behalf, but does not have access to InfoEd. Who do I contact?
Send an e-mail to the IRB office with the student’s name. Currently, only Clemson employees have access to the system.
Exempt Level Review
Where can I find a list of the Exempt level categories?
A description of the Exempt categories (PDF) are available on the resources page.
If my research study falls under one of the Exempt level categories, does that mean my study is exempt from IRB review?
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.
What type of research studies qualify for Exempt review under Category 1?
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.
Do I need to submit an amendment if there are changes to the protocol?
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.
Do I have to notify the IRB if there are changes to my research team?
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.
Expedited and Full Board Level Reviews
My project has changed. What do I do?
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.
May I wait until I submit my progress report to make changes to the protocol?
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.
International Studies
When is a local context review required?
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.
Is local context review required for Exempt research protocols?
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.
How does the IRB ensure that the local context reviewer is trained in the field of study and has expertise to judge the research in question?
Local context reviewers do not judge the research and do not have to be expert in any particular field, but they must have knowledge of the region and its cultural mores. The CU ORC / IRB asks their opinions on very specific questions having to do with the local culture and the potential risk for participants in that cultural system.
The ORC / IRB may ask the researcher for suggestions of people who might be appropriate to serve as local context reviewers.
When are translated documents required for IRB review?
If a research protocol requires expedited or full board review, and study materials will be presented to participants in a language other than English (either verbally or in writing), the study materials must be submitted to the CU IRB in both English and the other language(s) being used.
Additionally, for expedited reviews, the IRB requires a letter from the person who is doing the translations for the study. This letter should state that this person has translated (or read and edited) the materials, believes that the materials will be understandable to the potential participants, and believes that the materials communicate the same message as is expressed in the corresponding English-language materials. The letter should also provide contact information for the translator.
In the case of a protocol requiring full board review, it is likely that a certified translation will be required. This determination will be made by the ORC / IRB on a case-by-case basis.
