Frequently Asked Questions
COVID-19 and Human Subjects Research
- What approvals are required to resume in-person research activities?
Detailed information on how to resume in-person research is available on the COVID-19 and Human Subjects Research page.
- Is study personnel required to complete COVID-19 training to resume in-person research?
Clemson employees are required to complete the “United as Tigers - Return to Workplace Training” developed by the university. The training is available on Tiger Training. The COVID-19 training does not replace the CITI human subjects training required for IRB approval.
- Does the risk of contracting COVID-19 need to be added as a risk to the IRB protocol?
No. The protection procedures described in the in-person research checklist have been designed to minimize the risk of transmission of the virus while allowing in-person research to resume. Provided that the research is conducted in full compliance with these protection procedures, the IRB does not consider the risk of contracting COVID-19 to be a risk that is specific to participation in the research. Therefore, the IRB does not require the risk language in the informed consent form to be updated in order to resume in-person research.
- Do I need to report to the IRB if a research participant or study personnel tests positive for COVID-19 and/or is hospitalized or dies as a result?
No, follow CU guidelines regarding testing and reporting for study personnel who may have been exposed.
- What needs IRB review?
IRB review is required for all research activities involving human subjects conducted by faculty, staff, and students, on and off campus, regardless of the funding support.
- Where can I find the review timelines?
Review timelines are provided on the forms page.
- 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, 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 to determine if your project meets the criteria for secondary data analysis.
- Who do I contact if I am having problems downloading the forms or templates?
You may contact the IRB staff for assistance.
- Where do I submit my IRB packet for review?
Send complete packets to IRB@clemson.edu.
- What documents are required for IRB review?
A complete IRB packet includes: IRB application, recruitment materials, informed consent documents, and copy of data collection instruments.
- Where can I find a list of the Exempt categories?
A description of the Exempt categories are available on the resources page.
- What type of research study qualifies for exemption under Exempt Category B1?
Research conducted in an established or commonly accepted educational settings, involving normal educational practices. Refer to the B1 guidance for more information.
- Do I need to submit an amendment if there are changes to the protocol?
No, an amendment is not required for protocols that meet the criteria for Exempt review. You are required to notify the IRB if you are making substantial changes to the protocol that may potentially change the review level. Researchers who modify the study purpose, study sample, or research methods and instruments in ways not covered by the exempt categories will need to submit an expedited or full board review application.
- Do I have to notify the IRB if there are changes to my research team?
You are only required to notify the IRB if the PI on the protocol changes.
- Who is required to complete the human subjects training?
Only the PI is required to have current training. Other research personnel only involved with exempt studies are recommended to complete the CITI training.
Expedited and Full Board Reviews
- My project has changed. What do I do?
You have to file an amendment request. If there are significant changes to the protocol, the reviewer might request a new IRB packet. All changes should be reported to the IRB, 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 the annual review to submit my changes?
No, that would be out of compliance with federal regulations.
- 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 project. 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?
- When should I close my protocol?
Protocols should 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 maintain signed informed consent forms for three years following completion of a study.
- Who is required to complete the human subjects training?
All team members involved with expedited and full board review studies are required to complete the CITI training.
- 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, http://www.hhs.gov/ohrp/international/intlcompilation/intlcompilation.html.
- 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.
- Institutional Review Board
- Institutional Animal Care and Use Committee
- Institutional Biosafety Committee
- Responsible Conduct of Research
- Research Misconduct