science

Coded or De-identified Data

Research solely involving secondary analysis of coded private information or de-identified data/specimens are not considered human subject research at Tufts Medicine / Tufts University if Tufts investigators and their collaborators cannot readily ascertain the identities of the individuals to whom the data or samples belong or if data is publicly available.

If you are assisting or collaborating on another institution’s study which involves identifiable information or other Human Subjects Research activities, see instructions for engagement determinations.

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. In addition, many journals and/or national organizations require a formal determination from the IRB in order to submit a manuscript or abstract.

Please review the following definitions:

1. According to HHS, information and specimens are considered to be coded if it meets the following criteria.

  • Identifying information (such as name or medical record 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.

For research involving coded private information or specimens to be considered Not Human Subjects Research at Tufts, the following conditions must be met:

  • There is no active collaboration between you or any member of your research team and the party that provided data and/or specimens and holds the key to the code; and
  • Tufts investigators cannot and will not attempt to readily ascertain the identity of the individuals to whom information or specimens belong.

2. Information and specimens are considered to be de-identified if all direct personal identifiers are permanently removed, no code or key exists to link the information or materials to their original source, and the remaining information cannot reasonably be used by anyone to identify the source.

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 Not Human Subject Research involving coded private data or analysis of de-identified data, submit the study in eIRB. Include the items listed below and follow the instructions on the Step-by-Step Guide to Submitting a New Study.

Note: Question #5 in the eIRB smart form is: “Will an external IRB act as the IRB of record for this study?” Choose No, even if another IRB has reviewed and approved the research. This question is asking whether Tufts will need to formally cede review to another IRB with a reliance agreement. If Tufts’ involvement is Not Human Subjects Research, a reliance agreement will not be necessary.

1. In place of a Protocol, complete Form 14: Not Human Subjects to describe your project.

2. Letter of Support Form – Providing De-identified Specimens or Data; or if the data is publicly available, provide documentation so that the IRB may verify that it is de-identified.

  • 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 (TuftsMCGrantsContracts@tuftsmedicine.org) or Tufts University Research Administration. 
  • 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 applicable 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.

The IRB will review the submission and may contact you for additional information and/or request additional documentation once the level of required review for the project is determined.

If you have questions about what documents and information should be included, please do not hesitate to call the IRB Office.