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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.

  • Identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., the code); and
  • A key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.

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:

  • Neither you or any member of your research team is engaged in the research through which information or specimens were collected; and
  • Tufts investigators cannot readily ascertain the identity of the individuals to whom information or specimens belong.

For more information please consult:

What do I need to submit to the IRB?

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:

  • Which study activities will take place at Tufts.
  • What information Tufts researchers are accessing (e.g. , in the case of data, what data will researchers have access to, in the case of samples, what identifiers/information will come with the samples).
  • Whether anyone at Tufts or elsewhere holds an identifier key and whether it will be shared with Tufts researchers.
  • Whether Tufts researchers will have or have had interaction with study subjects to whom data/samples belong.
  • What the purpose of this project is.

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.

Additional Responsibilities of the Investigator

  • If Tufts is acting as a sub-site or subcontractor on a larger grant, please ensure that you have contacted the Tufts grants and contracts office.
  • Please inquire with the originating site as to whether they have obtained IRB approval in the original collection of data or samples. This is the responsibility of the investigator to ensure that samples/data have been obtained in accordance with laws and regulations.
  • The principal investigator should have on file a copy of the IRB approval letter from collaborating sites that documents the approval of collection of data/samples.