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TJUHBB

Withdrawal of Consent

Standard Operating Procedure (SOP 02.006)

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PURPOSE

Participation in the tumor biobank program is voluntary. As part of the informed consent process, participants are informed that they can withdraw consent at any time and for any reason. For example, if patients have social, philosophical, religious or family concerns they may decide to withdraw consent.

SCOPE

The scope of this standard operating procedure (SOP) is to outline the general procedures that should be undertaken to deal with this situation so as to uphold the rights of the participant when consent for the participant is withdrawn.

These steps may be adopted as is, or modified by specific TJUH member biobanks at their collection sites to allow for the incorporation of site-specific details, conditions and Research Ethics Board (IRB) requirements provided none of the changes alter the spirit of the SOP or result in a reduction of the protection of the rights of the participant.

REFERENCE TO OTHER TJUHBB SOPS OR POLICIES

  • TJUHBB Informed Consent
  • TJUHBB SOP 02.001.1 Participant Recruitment into a Tumor Biobank Program

ROLES AND RESPONSIBILITIES

This SOP applies to all qualified tumor biobank personnel and clinical staff at the collection centers that are involved in recruiting patients and the acquisition of informed and voluntary consent. This may include the following personnel:

Tumor Biobank PersonnelResponsibility
Clinical Research Coordinator, Tumor Biobank Manager, Oncology Physician at hospital or their designatesReceiving request for withdrawal of consent; forwards the request to the Tumor Bank Manager and Biobank Director
Tumor Biobank Manager or DirectorIssues a directive to deem the samples un-bankable, ensures that the materials and data have been processed

Take follow-up action after consent is withdrawn to delete patient information (paper and electronic), and discard samples as required.

MATERIALS, EQUIPMENT AND FORMS

The materials, equipment and forms listed in the following list are recommendations only and may be substituted by alternative/equivalent products more suitable for the site-specific task or procedure.

Materials & EquipmentSite Specific Materials
Withdraw consent request (written or oral)
Confirmation documentation that sample has been removed from records
Inventory system and databaseOpenSpecimen
Unused samples from participant revoking consent

DEFINITIONS

See the TJUHBB Glossary.

PROCEDURES

The participant may withdraw consent at any time. Personnel at the tumor biobank should take appropriate steps to respect the will of the participant and ensure that the participant is able to withdraw without consequence.

Request to Withdraw Consent

  • A donor or an authorized third party may withdraw consent at anytime.
  • The request to withdraw consent may be made verbally or in writing and addressed to responsible personnel at the collection sites or tumor biobank.
  • Document the reason if voluntarily provided by the donor or authorized third party.
  • Document withdrawal of consent.

Follow-up Action After Receiving the Request for Withdrawal

  • After receiving the request for withdrawal of consent the personnel should re-assure the participant that there would be no consequences or negative impact on their normal course of treatment and care.
  • Notify the biobank director or assigned delegate that the participant’s consent has been withdrawn and the samples are deemed un-bankable.
  • Upon receipt of a withdrawal instruction, the biobank director issues an instruction to withdraw to the relevant biobank personnel involved in both biospecimen and data aspects, instructing them to implement and comply with the procedure above.
  • When required as per institutional policy documentation of withdrawal may be provided to the IRB and/or a certificate of destruction may be provided to the participant.

Follow-up Action After Receiving the “Instruction to Withdraw”

There are two scenarios to consider; the biospecimen and/or data have been collected by the biobank but a) not distributed for research or, b) all or a portion has been distributed for research.

  • Upon receipt of an “Instruction to Withdraw” the tumor biobank staff will determine whether scenario a) or b) applies.
  • Under both scenarios, ensure that unused tissue and other unprocessed biological samples from the participant that remain in the biobank are destroyed.
  • Under both scenarios, delete all personal identifying information. In scenario a) all electronic and physical records are deleted or destroyed. In scenario b) in accordance with institutional policy anonymized records and samples may be maintained. IRBs may require that the original paper copy of the consent be maintained.
  • Do not collect any additional information about the individual from any source.
  • According to institutional policy samples such as embedded tissue blocks may need to be returned to the pathology department.
  • If required, store a log of all purged and discarded samples from withdrawn consent patients.
  • Should a back up of the inventory database/informatics system ever be restored, the director should ensure that identifying records are not restored.

APPLICABLE REFERENCES, REGULATIONS AND GUIDELINES

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