Studies Proposing the Use of Human Specimens and/or Data That Do Not Constitute the Use of Human Subjects

Guidelines for Human Data/Specimens Only

This page is meant to help researchers and staff prepare NIH applications that involve the use of human data and/or specimens but that do NOT meet the definition of the use of human subjects. You may meet this definition if your proposed research involves the use of coded private information or biological specimens if the conditions of the OHRP Guidance on Research Involving Coded Private Information or Biological Specimens have been met.

Guidelines: Provide an explanation of why the application does not involve human subjects research (attachment, required)