Proposed Procedure for Requesting the Disposal or Sharing / Release of NIH Biospecimens

The following policy has not yet been finalized by the NIH Office of Intramural Research (OIR). The basic steps below have been adopted from the NCI/DCEG process. For further information, please contact the NCI/DCEG Special Assistant.

Background

With the passage of time there may be occasions when sample collections, or subsets of collections are no longer deemed valuable enough to the DCEG to warrant the high cost of sample storage. There also may be occasions where custodianship of samples is transferred to a new investigator outside of DCEG. Due to the need for careful tracking of all samples that permanently leave DCEG biorepositories and of changes in custodianship to investigators outside of DCEG, a procedure has been developed that will allow for the review and monitoring of these changes. The procedure described here applies to all collections or any subset thereof, regardless of whether or not the study maintains an “open” or “closed” status.

Procedure

1. Prepare an E-mail request to have the samples either destroyed or transferred to a new owner outside of DCEG. Include the following information with your request:
   • Principal Investigator name
   • Branch name
   • A description of the collection or subset thereof, on which this request is based.
   • Indicate the action for which you are requesting approval (e.g., sample destruction, sample sharing or custodianship transfer)
   • BSI study ID(s) and name
   • CAS study code and name
   • Please note if the collection has special value based on non-scientific attention (media, advocacy, Congress, etc.) or based on the ethnic/racial population represented.
   • Indicate what paper and electronic records are associated with the samples.
   • If the samples are to be shared or if the custodianship is to be transferred, please indicate the name of the individual and organization to whom the material will be transferred.
   • Indicate how any charges incurred in the destruction or transfer will be covered. A one-time charge for destruction or transfer of the samples will be made to the study.
2. 2. Send your e-mail to your Branch Chief, Program Director, and the DCEG Special Assistant for Biological Resources. The following steps will ensue:
   • The DCEG Special Assistant for Biological Resources will e-mail all investigators about the pending request. Following the receipt of any feedback from the Branch Chiefs, Program Directors and PIs, the request will be evaluated by DCEG senior management. Allow 14 days for processing the request. You will be notified of the outcome of your request by the Special Assistant.
   • If the request is approved and was for sample destruction, the DCEG Special Assistant for Biological Resources will notify the originating study manager and ask that they enter a BSI-II requisition for the samples to be destroyed. Confirmation of this requisition should be provided to the DCEG Special Assistant for Biological Resources at the time of entry.
   • If the request is approved and the collection will be physically transferred from its current storage location, the DCEG Special Assistant will work with you to facilitate the physical transfer of the samples to their new destination. It is likely that a Material Transfer Agreement will be needed. For guidance as to what steps should be taken to put an agreement in place, please view the following resources:
     • Human Subjects Issues, SOPs 5 and 6
     • Material Transfer Agreement
   • If the transfer relates to a new custodian within DCEG, the Special Assistant will see that the biorepository has the appropriate new CAS code for to cover future storage and specimen processing activities.
   • If the request is not approved, notification of the decision and its rationale will be provided. Resubmission with additional information may be considered.