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Frequently Asked Questions

New Human Subjects Regulations

  • When will the new regulations be implemented?

    The new regulations will be implemented on January 21, 2019. A summary of the changes is available here.

  • When will the new IRB forms and templates be available?

    IRB forms will be updated to comply with the new regulations and will be available for download after January 11, 2019. The new forms will be required for all submissions received in the IRB office after January 11, 2019.

  • I am in the middle of preparing a new IRB submission. How do the changes affect new submissions?

    IRB submissions received in the office before January 11, 2019, will be processed using the current forms and regulations.

    The new IRB forms will be required for submissions received in the office after January 11, 2019 and will be reviewed under the new regulations.

    IRB submissions received in the office before January 11, 2019 but not approved before January 21, 2019 will be reviewed under the new regulations and may require new forms.

  • How do these changes affect my existing or ongoing research and what do I need to do now?

    For existing studies, researchers do not need to take any action at this time beyond maintaining active IRB approval. The IRB office will notify you if any changes are required for studies approved before January 21, 2019.

  • Will existing studies be transitioned to comply with the new regulations?

    Studies approved before January 21, 2019 are not required to comply with the new regulations. Oversight of these studies will remain under the current regulations.

  • Will the Exempt review process change with the revised regulations?

    Clemson University’s internal review process will not change but there are substantial changes to the Exempt categories. You may view a list of the new categories here.

  • Will the Expedited review process change with the revised regulations?

    The Expedited categories have not changed but the requirements for annual review have changed.

    Annual reviews will not be required for Expedited review protocols approved after January 21, 2019, unless the IRB finds and documents the need to require a continuing review to enhance the protections of research subjects. The new regulations will allow the IRB office flexibility when issuing approval dates. A progress report will still be required at the end of each approval period.

    Annual reviews will still be required for Expedited review protocols approved before January 21, 2019.

  • Will the Full Board review process change with the revised regulations?

    No. There are no changes to Full Board reviews.

  • Will the informed consent templates change with the revised regulations?

    Yes. The revised regulations include new process requirements for the content, presentation and organization of information so potential participants have all the information they need to make an informed decision. Consent forms will need to include key information at the beginning of the form and be presented at the outset of the consent discussion with participants to explain the research in an easy-to-understand and clear manner. Consent forms must be concise while also giving the full context of a study, including its risks and benefits. Consent forms will also need to include information regarding the potential for future use of de-identified data and biospecimens.

    The IRB office will update the informed consent templates, and the new templates will be required for IRB submissions received in the office after January 11, 2019.

General Questions

Exempt Reviews

 Expedited and Full Board Reviews 

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, 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.