Checklist for Establishing a New Specimen Or Data Repository*

Checklist for Establishing a New Specimen Or Data Repository*

Checklist for Establishing a New Specimen

or Data Repository*

*This is for a new “free-standing” repository, not for the storage of specimens obtained as part of a single, specific research protocol (See policy HSP-086).

Repository Policy Overview:

Input / Repository / Output
Research or non-research data, specimens, existing databases and specimen collections.
Input limited by repository rules (protocol). / IRB approved protocol for collection, protection, distribution of data or samples for research / Released to investigators per repository rules after documentation of IRB review.
Each new use requires a separate submission for IRB approval or IRB determination that use is not human subject research.

The following must be included in your IRB submission:

Application for Initial Review by the IRB
Investigator Agreements / Financial Disclosure for all key personnel
A repository protocol that includes the following elements:
  • The purpose(s) of the repository
  • Detailed description of the type(s) of specimens / data that will be included in the repository.
  • Detailed description of the physical mechanism(s) for the receipt, storage, and distribution of the bank’s contents, including procedures for assuring the confidentiality of contents.
  • Description of the conditions under which data and/or specimens will be released to investigators, e.g. documentation of IRB approved protocol, IRB exemption, or non- Human research determination.
  • A detailed, specific description of the method to be used to de-identify released bank contents, when de-identification is required and assurance that Investigators cannot re-identify shared data and/or specimens. If a key, or code system is used, that system should be fully described.
  • The repository and Investigator may enter into an agreement prohibiting the release of the key or code to the investigator, or,
  • The repository protocol approved by the IRB may contain a policy prohibiting the release of the key or code to the Investigator
  • A detailed, specific description of the procedure used to assure that specimens and/or data are used only for purposes consented to by the donor (when the informed consent permits options or restrictions).

Parental Permission / Informed Consent / Assents for donors of data / specimens to the repository utilizing the most current Nemours templates(s)

Or

A description of the process that will be used to assure prior IRB approval and documentation of informed consent for specimens and data received from non-Nemours sites or other Nemours approved protocols.

Or

Application for waiver of consent for use of existing data originally collected for non-research purposes.
A complete submission includes signatures and documentation of human subjects protection training for all members of the research team listed in the Initial Application.
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