Your [tissue, specimen will be labeled with your [name, blood, etc.] medical record number, etc.]. [If any individual research records or specimens will be transmitted during the study, explain whether or not the information will contain identifier or be sent using an encrypted method, and whether specimens will be labeled with a code. For example:] Your identifiable research records will be transmitted using an encrypted method (not regular email), where your information is replaced with a code and password only known to the entities below. [OR] Your research records will be labeled with a code (will not contain any identifiable information about you) when transmitted. Your [tissue, will be labeled with a code when transmitted. [OR] Your blood, etc.] [tissue, will be transmitted in an identifiable form. blood, etc.] [If coded research records or specimens will be sent to an external research site(s), explain whether or not the master key/list that links the subject’s name with the code will be maintained at the local investigative site.] A master key/list links your name with the code on your [research record and/or will be maintained at [name specimen] the location or site of the repository]. [For any repository that involves identifiable private information and/or identifiable biospecimens, add one of the following statements. NOTE that if this is an exempt repository, then the regulations require that the 2nd statement below MUST be included.] Identifiers might be removed from your [choose one or leave both, as applicable: private information or biospecimens], and after such removal, the information or biospecimens could be used for future research studies outside the objectives of this repository, or distributed to another investigator for future research studies without additional informed consent from you. [OR] Even if identifiers are removed from your [choose one or leave both, as applicable: private information or biospecimens] collected for the repository, these materials will not be used or distributed for research studies outside the objectives of this repository.
Your [tissue, blood, etc.] specimen will be labeled with your [name, medical record number, etc.]. [If any individual research records or specimens will be transmitted during the study, explain whether or not the information will contain identifier or be sent using an encrypted method, and whether specimens will be labeled with a code. For example:] Your identifiable research records will be transmitted using an encrypted method (not regular email), where your information is replaced with a code and password only known to the entities below. [OR] Your research records will be labeled with a code (will not contain any identifiable information about you) when transmitted. Your [tissue, blood, etc.] will be labeled with a code when transmitted. [OR] Your [tissue, blood, etc.] will be transmitted in an identifiable form. [If coded research records or specimens will be sent to an external research site(s), explain whether or not the master key/list that links the subject’s name with the code will be maintained at the local investigative site.] A master key/list links your name with the code on your [research record and/or specimen] will be maintained at [name the location or site of the repository]. [For any repository that involves identifiable private information and/or identifiable biospecimens, add one of the following statements. NOTE that if this is an exempt repository, then the regulations require that the 2nd statement below MUST be included.] Identifiers might be removed from your [choose one or leave both, as applicable: private information or biospecimens], and after such removal, the information or biospecimens could be used for future research studies outside the objectives of this repository, or distributed to another investigator for future research studies without additional informed consent from you. [OR] Even if identifiers are removed from your [choose one or leave both, as applicable: private information or biospecimens] collected for the repository, these materials will not be used or distributed for research studies outside the objectives of this repository.