Use of Human Tissue

1. Purpose

The purpose of this policy and associated Appendices is to describe Pfizer's practices regarding the collection, acquisition, storage and use of human tissue.

For samples of human tissue collected via clinical trials that will be used in research not directly related to clinical trial/study endpoints, this policy describes the overall process for obtaining, banking, and coding human biological samples data to conduct such exploratory research.

Pfizer adheres to high ethical principles and complies with all applicable laws, rules and regulations. Pfizer obtains ethical review and, in most cases, a prior consent of the donor before the collection, acquisition or use of human tissue. Exceptions where human tissue samples may be used without individual donor consent are addressed in Section 3.1 below.

In many cases applicable laws, rules and regulations do not provide clear or comprehensive guidance on the use of human tissue; accordingly, this policy sets a minimum global standard. This policy is in addition to any other applicable Pfizer policies and procedures.

2. Scope

This policy applies to Pfizer colleagues and to those parties with whom Pfizer contracts (e.g., CROs/vendors or consultants) who are involved in the activities or services described in this policy.

This policy applies globally to the collection, acquisition, and use of human tissue which under this policy human tissue shall include but is not limited to, the following:

• Fluid samples such as blood, blood derivatives (e.g., serum, plasma), urine, and cerebro-spinal fluid
• Tissue samples such as excised tumors, biopsy materials, and fetal tissue
• Materials processed from human tissue such as cell lines, microsomes, DNA, RNA, and Stem cells, except, and to the extent that laws, rules, or regulations applicable to such research and research samples (e.g., Human Tissue Act 2004, in the UK) specify that any such processed materials do not qualify as human tissue. Please consult with Pfizer Legal to confirm the position on this issue.
• Human organs, including, without limitation, the brain

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3. Policy

3.1 Collection of Human Tissue

Pfizer will not collect human tissue without the documented consent of the donor or the donor's legal representative (e.g., if the donor is deceased). The consent document must:

• (a) Be reviewed and approved by a qualified Institutional Review Board / Independent Ethics Committee (IRB/IEC) in accordance with recognized international standards for the protection of human research subject(s)
• (b) Be signed by the donor or the donor's legal representative
• (c) Identify both the tissue to be collected and its anticipated future use

For samples of human tissue collected during the course of a clinical study, and where Pfizer's proposed use of the human tissue is not directly related to an endpoint of that clinical study, the donor's participation in the study shall not be conditioned upon his or her consent to the tissue collection. The study documents (e.g., informed consent) should clearly indicate that the human tissue samples will be used outside of the subject clinical study. See CT29 Global02 Collection, Banking and Use of Retained Pharmacogenomic Samples from Clinical Trials.

3.2 Acquisition of Human Tissue

Pfizer will not acquire human tissue from others (e.g., a tissue banking service) without their contractual assurance that the tissue was collected in accordance with the consent requirements in section 3.1 of this policy, and are in accordance with all applicable laws, rules and regulations.

Consent must be obtained for general research use of donated samples, if the samples will be used for such purposes.

3.3 Banking of Human Tissue

As part of its research program, Pfizer collects, stores (i.e., "banks"), and uses biological samples from human subjects for exploratory research.

Fundamental Pfizer principles governing human tissue sample banking include the following:

• Full disclosure — Pfizer will bank biological samples for use in exploratory research only in ways consistent with the informed consent under which the human tissue samples were obtained, and as approved by an ethical review board independent of Pfizer after full disclosure of how the samples were obtained and the type of testing that will be performed.
• Confidentiality and Security — Pfizer is committed to the protection of the privacy of the individuals from whom the human tissue samples were/are obtained for exploratory research, and to ensuring that neither the human tissue samples nor any information associated with such samples or data generated during research involving such samples are inappropriately disclosed to any third party. In the case of banked human tissue samples collected via Pfizer clinical trials, samples for exploratory research will be coded to protect the confidentiality of the individuals from whom they were obtained.
• Compliance with applicable regulations and recognized ethical guidelines — Pfizer is committed to ensuring that its banking activities (whether performed by Pfizer or its contractual partners) are conducted in accordance with applicable laws, rules and regulations and established ethical principles. These include the standards and principles articulated by the United States Department of Health and Human Services as well as those set forth by The Nuremburg Code (1946), The Declaration of Helsinki (1996), The Belmont Report (1978), relevant provisions of the United States Code of Federal Regulations (45 CFR 46) relating to research involving humans, the UK Human Tissue Act 2004, the Data Protection Directive (95/46/EC).

Pfizer has designated a "BioBank Custodian," who has stewardship responsibility for the human tissue samples stored at its BioBank facility on Pfizer's behalf. Responsibility includes an obligation for such BioBank Custodian to adhere to all applicable laws, rules, regulations, ethical standards, and Pfizer policies. In recognition that human research is a dynamic field, Pfizer will review its practices on a regular basis and will continue to monitor international public discourse on this subject. External ethical experts have been, and will continue to be, engaged by Pfizer as necessary.

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3.4 Use of Human Tissue

The consent document describes the planned and potential future uses of the collected human tissue in research and manufacturing activities, and Pfizer is bound by that description. For tissues obtained from Pfizer clinical trials, it may be necessary to consult the protocol and/or other study documents to confirm that the IRB/IEC approved the full scope of the use described in the consent. If a proposed Pfizer use is not encompassed within this description, or if the scope of use in the consent document is unclear, additional ethical review and, in appropriate cases, donor consent is obtained before the tissue is used. Consent can be obtained by the following:

• If the donor's identity can be determined, Pfizer will, after approval from an appropriate IRB/IEC, make reasonable attempts to contact the original donor or his/her legal representative and obtain consent to the new use. If such contact is impossible or impractical, Pfizer will, where permitted by applicable law and regulation, seek a waiver of consent from an appropriate IRB/IEC.
• If the donor's identity cannot be determined (e.g., because the human tissue samples have been stripped of identifying information to protect donor privacy), Pfizer will, where permitted by applicable law, rule and/or regulation, seek a waiver of consent from an appropriate IRB/IEC. However, human tissue samples must not be stripped of identifying information for the purpose of avoiding the consent obligations described above.

If appropriate, additional data protection measures may be applied to samples before use, for example, in accordance with the new consent or IRB/IEC waiver requirements.

3.5 Special Population: Pfizer Employee

Pfizer recognizes that employees are a special population and their donation of human tissue for Pfizer activities requires additional safeguards to avoid any appearance of coercion. Pfizer employees should not be precluded from donating tissue based solely on their status as Pfizer employees.

4. Responsibilities

A designated member of the Pfizer team that proposes to collect, acquire, store or use human tissue in a research or manufacturing activity is responsible for ensuring that the criteria contained in this policy are met.

Exceptions to this policy require approval of senior management, including the Chief Medical Officer and Legal.

5. Process

N/A

6. Appendices

CT29-01 Country-Specific Legal and Regulatory Requirements

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