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IRB-HSR > Protocol Review Process > Levels of Review > Coded Research







Coded Research Involving Private Information or Biological Specimens

Additional types of projects may meet the DHHS definition of "Coded Research Involving Private Information or Biological Specimens". In order to meet the DHHS definition the following criteria must be met:

  1. The material/data, in its entirety, was or will be collected for purposes other than this project (e.g. the material was or will be collected solely for clinical purposes, or for unrelated research purposes, with no "extra" material collected for the purpose of this project).The person providing the materials/data to the researcher will not otherwise be involved in this project, such as in interpretation or analysis of the data or creation and publication or presentation of research results.
  2. The material/ data is given to the researcher with a code. The researcher receiving the specimens/ data will never have access to the key to the code. The code cannot be derived from or related to information about the individual (e.g. initials, last 4 digits of Social Security #, mother's maiden name, first 3 letters of last name.)

If 2 above is checked one of the following is required:

  • The key to decipher the code is destroyed before the research begins
  • A signed agreement is required between the person releasing the specimens/ data and the researcher receiving the specimens/data stipulating the key to the code will never be released to the researcher.
  • Confirmation of IRB approval of written policies and operating procedures for a repository or data management center that prohibit the release of the key to the researchers under any circumstances, until the individuals from whom the information or specimens were collected are deceased.

If your project meets the criteria of "Coded Research Involving Private Information or Biological Specimens"- an alternate submission process is required.

IRB-HSR Submission Process - Proceed to Protocol Builder and answer the question Does this study meet the criteria for research only involving coded private information or biological specimens? YES. Protocol Builder will then provide you with the appropriate documents to complete. NOTE: This is a DHHS definition. Therefore this alternate application process does not apply if the protocol involves FDA oversight.