- Institutional Review Board
- Institutional Animal Care and Use Committee
- Institutional Biosafety Committee
- Export Controls
- Responsible Conduct of Research
- Research Misconduct
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.
Will they have access to the identifiable data or assist with data collection? If so, they will need to be listed on the team member form.
Protocols should be closed if:
1. data collection is complete and the data collected do not include any individually identifiable information or any link to individually identifiable information; in this case, research no longer involves human subjects.
2. student investigator has graduated and their thesis/dissertation/project has been completed.
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.
Anyone who is engaged in the study will need to complete a Individuals Investigator Agreement if they will have access to the identifiable data and/or assist with data collection. They will also need to do the CITI training in order to be added as a team member.
The IRB recommends that team members not affiliated with Clemson University complete the Human Subjects Protections training.