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TJUHBB

Notification of Significant and Relevant Findings

Standard Operating Procedure (SOP 02.007)

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PURPOSE

Biospecimens donated to the tumor biobank are intended for research studies. In most cases the research findings have no immediate clinical relevance to individual participants. Very rarely the research may yield data that might be relevant to the participant’s immediate treatment, outcome, wellbeing or future health or have impact on their family. There are many social, ethical, and clinical considerations attached to the decision to make disclosure of research findings directly to the patient.

SCOPE

This standard operating procedure (SOP) covers the procedures for handling disclosure of significant and relevant research study findings to the tumor biobank participant.

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, local laws and regulations, conditions and Institutional Review Board (IRB) requirements.

REFERENCE TO OTHER TJUHBB SOPS OR POLICIES

  • TJUHBB SOP 02.005 Obtaining Informed Consent

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
Tumor Biobank Manager, Principal Investigator, Tumor Biobank DirectorAnalyzing research data and determining if the data is significant and relevant; coordinating notification with the consulting physician in a sensitive, timely, and confidential manner
IRBReviewing research data and determining if the data is significant or relevant; deciding if and how the notification will occur

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
Current ethical guidelinesIRB
Relevant Provincial legislation
Research Findings

DEFINITIONS

See the TJUHBB Glossary.

PROCEDURES

The primary goal of the tumor biobank is to facilitate research that can advance the practice of oncology and preventative medicine. However, the biobanks are responsible for ensuring that patients’ rights are upheld and this may lead to involvement in return of significant information.

Plan for Dealing with Significant and Relevant Findings

If a potential and significant finding comes to light as a result of donating biospecimens to a biobank, the biobank is under no obligation to engage with relevant parties regarding the return of research data unless otherwise specified for specific research aims.

Findings Review, Considerations and Consultation

If specific research aims allow for/require reporting of significant and relevant research findings, the aforementioned findings should only be disclosed after careful consideration of the following:

  • Provincial laws and regulations
  • Whether or not individual results disclosure was covered by the consent process,
  • Confidence levels that the test/research results have been adequately validated and correctly interpreted,
  • The findings have significant implications for the participants health concerns and diagnosis,
  • A course of action or options to ameliorate or treat the participants health concerns are readily available,
  • The well-being of the participant should take precedence over the interests of science and society,
  • Whether contact with the participant is feasible.
  • In the event that the participant cannot be contacted, the effects of disclosure on family members who may be affected by the information (such as in the case of genetic or hereditary research),
  • Complete confidentiality is maintained and that results are not disclosed to insurance agencies or employers.
  • The availability of both pre and post-disclosure counselling.
  • The advice of the IRB that has been obtained.

APPLICABLE REFERENCES, REGULATIONS AND GUIDELINES

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