The purpose of this policy is to describe the requirements for Pfizer’s practices regarding the collection, acquisition, management, use, and distribution of Human Biological Specimens (i.e., biospecimens). Pfizer adheres to high ethical principles and complies with all applicable laws, rules and regulations. Pfizer requires ethical review and, in most cases, the prior informed consent (and assent, where appropriate) of the donor or their legal representative before the collection or acquisition of biospecimens for use in research. Exceptions where biospecimens may be used without individual donor consent are addressed in Section Use of Biospecimens. Throughout this policy, the use of legal representative refers to, where appropriate, the donor’s parent, guardian, legally authorized representative, or legally acceptable representative. In some cases, applicable laws, rules, guidances and regulations providing clear and comprehensive instruction on the use of biospecimens are absent; accordingly, this policy sets a minimum global standard. This policy is in addition to other applicable Pfizer policies and procedures.
Pfizer collects biospecimens with the documented informed consent (and assent, where appropriate) of the donor or the donor’s legal representative.
The informed consent document must:
- Be reviewed and approved by a qualified Institutional Review Board / Independent Ethics Committee (IRB/IEC) and, if applicable, regulatory authority, in accordance with recognized international standards for the protection of human research subject(s).
- Be signed by the donor or the donor's legal representative.
- Identify both the material to be collected and its anticipated use.
A donor or donor’s legal representative may request the destruction or return of the collected biospecimens. Furthermore, biospecimens may be destroyed in order to fulfill ethical requirements, including the terms of the informed consent document and protocol.
Acquisition of Biospecimens
Pfizer’s acquisition of biospecimens from other parties (e.g., academic centers or a commercial biospecimen supplier) will include a contractual assurance that the biospecimens were collected in accordance with the informed consent (and assent, where appropriate) requirements and/or ethical approvals described in this policy. The purposes for which Pfizer can use the biospecimens, as well as any obligations upon Pfizer regarding the handling and use of the biospecimens, must be clearly stated in the contract. In addition, the contract must indicate there are no legal, ethical, or other restrictions against transferring the materials to Pfizer, nor against Pfizer's use of them. It is not necessary for Pfizer to perform first-hand review of the informed consent document(s) under which the biospecimens were collected. However, if Pfizer does review these materials, due diligence must be applied such that the planned biospecimen use is consistent with the terms outlined in the informed consent document.
Management of Biospecimens
Pfizer attends to the following in its management of biospecimens:
- Adherence to the terms of the informed consent document or contract through which they were obtained;
- Training of those performing biospecimen-related activities; and,
- Proper receipt, storage, use and disposition of biospecimens.
Furthermore, Pfizer is committed to protecting the privacy of the individuals from whom the biospecimens were/are obtained, such that neither the biospecimens nor any information associated with them, or data generated during research involving biospecimens are inappropriately disclosed to third parties. To that end, biospecimens are coded to protect the confidentiality of the individuals from whom they were obtained. In some cases, biospecimens may be anonymized prior to use consistent with applicable laws, rules, and regulations. In the event research findings are disseminated (e.g., through scientific publications or presentations), the identities of the biospecimen donors are not revealed.
Use of Biospecimens
The informed consent document describes the planned and potential future uses of the collected biospecimens, and Pfizer is bound by that description, unless further IRB/IEC and/or local approvals, as needed, are obtained. The IRB/IEC may require that new consent be obtained from the biospecimen donors or the donor’s legal representative. For biospecimens obtained from Pfizer clinical trials, it may be necessary to consult the protocol and/or other study-related documents to fully understand the use(s) of the biospecimens which the IRB/IEC approved.
If a proposed Pfizer use is not encompassed within this description of the uses, additional measures, if appropriate, must be taken before the biospecimens are used. Such measures may include new IRB/IEC and/or local approvals, and, as needed, the consent of the donor or the donor’s legal representative, and/or anonymization.
For biospecimens procured from external sources (refer to Section Acquisition of Biospecimens), the use of biospecimens for other purposes that are not described in the contract requires a new or amended contract with the provider that states the additional use(s) which may be made of the biospecimens and warrants that these use(s) are in accordance with the terms of the informed consent document.
Distribution of Biospecimens
When distributing biospecimens to external parties (e.g., vendors, academic collaborators), Pfizer will take steps to ensure that the proposed uses will be aligned with the informed consent document and/or ethical or other local approvals (for biospecimens procured through Pfizer-sponsored studies) or in the contract under which Pfizer procured the biospecimens (for biospecimens acquired externally which Pfizer is permitted to provide to third parties). The receiving party must agree in writing to use the biospecimens consistent with the terms of the contract including employing measures to ensure the confidentiality of the biospecimen donors and access to biospecimens is controlled and limited to legitimate purposes. Shipment of biospecimens must adhere to all applicable laws, rules, and regulations.