Under certain specific circumstances, the IRB may determine that certain activities do not constitute human subjects research.
Research involving coded private information or secondary analysis of de-identified data or samples are not considered human subject research at Tufts if Tufts investigators cannot readily ascertain the identities of the individuals to whom the data or samples belong.
Note: The Principal Investigator should not make the final determination as to whether a project constitutes human subject research or not; that determination may only be made by the IRB.
Please review the following definitions:
According to HHS, information is considered to be coded if it meets the following criteria.
Samples are considered to be de-identified if no information comes attached to them which would allow researchers to link sample/data to an individual.
For research involving coded private information to be considered Not Human Subjects Research at Tufts, the following conditions must be met:
For more information please consult:
If you think that the project you are planning to conduct might be considered research involving coded private data or analysis of de-identified data, please review the information below. The IRB considers these points in making its determination, so please ensure that the information covered below is addressed in your submission:
Please provide the information requested above in a cover letter addressed to the IRB. Please ensure that any applicable supporting documents (e.g., IRB approval letters, letters from another institution regarding the study) are included in the submission.
For projects involving the use of coded data/samples, please also provide an explicit statement from both the Tufts Principal Investigator that he/she will not attempt to ascertain the identity of individuals, and a statement from the holder of the key that he/she will not share the key with Tufts researchers. If you have questions about what documents and information should be included, please do not hesitate to call the IRB Office.