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Research involving coded private information or secondary analysis of de-identified data/samples are not considered human subject research at Tufts Medical Center / Tufts University if Tufts investigators cannot readily ascertain the identities of the individuals to whom the data or samples belong or if data is publically available.

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:

1. 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.

For research involving coded private information 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 an institution that that provided data and/or specimens; and
  • Tufts investigators cannot and will not attempt to readily ascertain the identity of the individuals to whom information or specimens belong.

2. Samples 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, or publically available data please submit documents referenced below in hard (paper copy) with original PI signature. The IRB considers these points in making its determination, so please ensure that the information covered below is addressed in your submission:

For secondary analysis of de-identified or coded data/specimens:

1. Cover letter that includes:

  • Project title
  • The funding source for the project, if any
  • The purpose of this research
  • The study activities that will take place at Tufts University Health Sciences and/or Tufts Medical Center
  • The source of data/specimen
  • Confirm whether Tufts researchers will have interaction/intervention with study subjects
  • A statement from the Tufts Principal Investigator that s/he 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 (for analysis of coded data)
  • State whether data/specimen will be obtained for secondary analysis (i.e. independent analysis of data/samples collected as part of another study)
  • Any other information you would like to convey about the project

2. A letter from the source of the data/specimens confirming the following:

  • Specimens will be de-identified
  • The study team will have no access to the key code (the list that matches the code to the subject identifiers, if one exists),
  • Data/specimens being used in this study were previously collected with Informed Consent (if applicable) and the use is within the scope of the original ICF. A copy of the original ICF may be requested for confirmation.
For analysis of publically available data:

1. Cover Letter that includes:

  • Project title
  • The funding source for the project, if any
  • The purpose of this research
  • The study activities that will take place at Tufts University Health Sciences and/or Tufts Medical Center
  • The source of data
  • Confirm whether Tufts researchers will have interaction/intervention with study subjects
  • Confirm that data is publically available
  •  A statement from the Tufts Principal Investigator that s/he 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 (for analysis of coded data)
  • Any other information you would like to convey about the project
  • 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.
  • The IRB considers these points in making its determination, so please ensure that the information covered below is addressed in your submission:
  • Whether Tufts researchers will have interaction or intervention with study subjects
  • Whether research is secondary analysis
  • Whether there is active collaboration with an institution that holds the key to the code for this project

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.

The IRB considers these points in making its determination, so please ensure that the information covered below is addressed in your submission:

  • Whether Tufts researchers will have interaction or intervention with study subjects
  • Whether research is secondary analysis
  • Whether there is active collaboration with an institution that holds the key to the code for this project

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 at (tuftsmcgrants&contra@tuftsmedicalcenter.org).
  • 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.