Before you call us, we might be able to answer some of your questions here.
1. What do I do to get started?
2. I can’t download the forms. What do I do now?
3. I have some questions on Clemson University’s policies and regulations governing the use of human participants at the University. Who do I call?
4. If I send you my application, will you look it over before I submit it to the IRB?
5. My project has changed quite a bit. What do I do?
6. Can I wait until the annual review?
7. My project is finished. Do I need to tell anyone?
8. What are my CITI username and password?
9. Do you still need help?
10. How long do I have to keep my IRB records?
11. When is a local context review required?
12. Is local context review required for exempt research protocols?
13. 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?
14. When are translated documents required for IRB review?
15. When should faculty, students and staff contact the Export Control Officer for assistance?
16. When should I close my protocol?
17. What should be done if the PI has left Clemson?
18. When should a protocol remain open?
19. How do I request an extension on my exempt protocol?
Go to our Getting Started page.
You may contact the IRB staff for assistance.
You may contact the IRB staff.
Our review process includes a pre-screen by the IRB staff before your application is sent to the IRB for review. Please submit your application and we will let you know if anything further is needed before it will be sent out for review.
You will have to file an Amendment Request. The amendment will be reviewed by the IRB. The reviewers might then ask you to submit a new protocol depending on how significant the changes actually are. Please remember that all changes should be reported to the IRB, no matter how insignificant you might think they are. This includes changes in study personnel, changes in expected participants, new advertising or promotions to recruit participants, changes to incentives offered, even the slightest change to the protocol, or even a one-word change to the informed consent document. These must be reviewed and approved PRIOR to application or initiation. (Changes in personnel no longer require an Amendment Request. They may be submitted in the form of an e-mail requesting the addition and/or removal of specific research team members.)
No. That would be out of compliance with federal regulations. Please contact the IRB staff for further assistance.
If you know the e-mail address you used when you first registered with CITI, you may retrieve your username and password here. If you do not remember what e-mail address you used, you may contact the IRB staff.
For additional questions, concerns or suggestions, please contact the IRB staff.
The federal regulations require investigators to maintain signed participant informed consent forms (if applicable) for three years following completion of a study. They don’t require the retention of any other human subjects research records. However, please note that the Clemson University Research Data Access and Retention Policy does require that research records be retained for a certain amount of time. For details, please consult the Faculty Manual (Part X, C, 5, August 2012, pp. 88-89) here.
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, http://www.hhs.gov/ohrp/international/intlcompilation/intlcompilation.html.
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.
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.
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.
Faculty, students and staff should contact the Export Control Officer for assistance before:
Protocols should be closed if:
To close a protocol, the PI should send an email to IRB@clemson.edu. Please include the IRB number and title. The e-mail must come directly from the PI.
If a PI has left or is planning to leave the university, the protocol has to be amended to name a new PI, or closed if the protocol will no longer be active at Clemson University. To name a new PI, the current PI (or Department Chair if the PI has already left Clemson) should send an Amendment Request for this change to IRB@clemson.edu.
If the PI will continue to work on an active IRB protocol at their new institution, they should contact the IRB at their new institution since they will no longer be covered by the Clemson University IRB approval of the research.
IRB protocols must remain open if you are currently enrolling new subjects, collecting data, or conducting analysis of individually identifiable data (whether directly identifiable or through coding).
If the research extends beyond the assigned expiration date, the PI has to request an extension by completing the Exempt Protocol Extension Request form. The PI should send the extension request to IRB@clemson.edu at least three weeks before the protocol expiration date.