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ISBER

The International Society for Biological and Environmental Repositories (ISBER) has produced a document in 2004 that includes best practices for tissue repositories and research on repository tissue. Ethical practices are as follows:

Best Practice: The collection, storage and use of human specimens and associated data must be done in a way that respects the individual and maintains privacy and confidentiality.

Best Practice: All procedures related to the collection, storage and use of human specimens must be in accord with relevant laws and policies.

Best Practice: Subject consent should be obtained unless waived by an authorized ethics review board constituted in accordance with applicable law or regulation. Consent can be for a specific research use or for future unspecified uses. If the use is unspecified, an ethics review board review of the research must be conducted to assure that the use is consistent with the original consent.

Best Practice: Collection of specimens for research must under no circumstances interfere with appropriate patient diagnosis.

Best Practice: Patient tissue specimens must be reviewed by a pathologist who will decide what material can be made available for research.

Best Practice: Blood and other body fluids that are not required for diagnosis can be collected in accordance with approved protocols and do not require pathologic review.

Best Practice: Processes and procedures of repositories for storage of human specimens for research should be reviewed by an ethics review board to assure that they are appropriate.

Best Practice: Subjects shall always retain the right to withdraw consent and to have specimens and data removed from the repository once that consent is withdrawn. The logistics for such withdrawal of consent must be clearly defined and conveyed to all subjects at the time of consent. Even if an opt-out procedure is used, patient notification must include instructions for later withdrawal of consent.

Best Practice: Users of the specimens and data must sign an agreement specifying how the specimens and data will be used, who they may be transferred to and for unidentified specimens and data, an explicit agreement not to seek information about the subject's identity.

Best Practice: Specimens should only be made available for studies that are expected to expand medical knowledge and contribute to the well-being of the world's people. The rigor of the review shall be related to the value of the specimens and data that are available. As a general rule the greater the data annotating a specimen the more rigorous the review should be and the more important the expected result of the research should be.

For more information, see the ISBER site.