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Biobanking of Human Samples

Purpose

The purpose of this Policy (POL) is to set forth the Amgen Biobanking of Human Samples collected during the course of research studies.

Scope

This Biobanking of Human Samples POL applies globally to all Amgen research studies that collect human samples for future research.

In addition, this POL applies to any service provider, consultant, contract worker, and temporary staff member contracted by Amgen to perform activities described in this POL.

Policy

Amgen stores biological samples collected in human research studies, hereafter referred to as human samples. These samples are stored in order that they may be used for potential future research as described in the informed consent form. Samples can be of various types, including but not limited to serum, plasma, cell pellets, DNA, urine, and tissue. The storage period is defined in the informed consent form and samples are kept no longer than the duration specified.

Objectives of the Biobank

Human samples play a vital role in Amgen’s research and help build a deeper understanding of human disease and underlying mechanism(s) of action. These samples are used to predict the safety and effectiveness of potential new therapies and to identify people most or least likely to benefit from these therapies. The samples collected from Amgen research studies are valuable in the drug discovery process because they allow correlation of molecular mechanisms with clinical response.

Ethical Review

Amgen-sponsored trial protocols and informed consent documents undergo an ethical review, as required, by a qualified independent committee (Institutional Review Board/Independent Ethics Committee) prior to trial initiation.

Privacy and Confidentiality

All samples are labeled with a code number (unique identifier). Only the investigator and his or her staff have access to the name of research participants and the associated code. Amgen receives only the code number when receiving samples and does not receive personal information allowing for direct identification of a research participant. All data associated with samples are kept in a secure database with restricted access.

Informed Consent

Amgen requires voluntary informed consent from research participants prior to carrying out any protocol-specified procedures. Informed consent outlines the known benefits and risks of participating in the research study. The Amgen process for obtaining informed consent takes into account local laws, languages, and customs as well as the ability of research participants to understand the information presented. Research participants may withdraw consent at any time without any detriment to their medical care. Amgen ensures that human samples are collected, stored, and utilized solely for the purposes outlined in the informed consent form.

Bioethics Committee

The Amgen Bioethics Committee is comprised of cross-functional members including Research and Development, Legal, and Compliance. The goals of this Committee are to provide oversight of the management of human samples and to address issues related to the ethical use of human samples.

Use of Samples

The samples that are collected and banked by Amgen are obtained as part of Amgen research studies. As such, the informed consent signed by each research participant is approved by an appropriate review board and/or ethics committee. The samples are collected and stored in accordance with the informed consent, including privacy protection and confidentiality. Samples are only used for the purposes described in the approved informed consent form. In the event that a sample is to be used for an additional purpose, (eg, new scientific information or testing method becomes available), Amgen will seek additional approval from the appropriate review board and/or ethics committee.

The use of samples for research purposes is governed by a standard operating procedure. All requests to use samples for research purposes are evaluated by a biorepository liaison and approved by management. As part of the request evaluation, the protocol and informed consent are reviewed to ensure that the use of the samples is in accordance with both documents. Only requests that are in alignment with the protocol and informed consent are approved. Once approved, the requesting scientist is governed by the standard operating procedure for the maintenance of samples and data. Samples are tracked for chain of custody purposes and are returned to the biobank or destroyed after use.

Before samples can be provided to collaborating scientists or external/non-Amgen companies, the same evaluation and approval process is followed. Material transfer agreements or other legal agreements are put in place to ensure samples are used only for the purposes described in the contract.

Security Measures

The samples in the biobank are stored in secured, access-controlled locations. Only staff who are trained and have an active role in managing the biobank have access to the secured areas. The data system housing the sample information is validated and access controlled. Computers used to access the data system are password protected.

Genetic Information (Pharmacogenetics)

The collection of genetic information may be part of the enrollment criteria for a research study. It can also be generated as part of the planned analysis supporting an endpoint. The rationale for mandatory collection and/or generation of genetic information is described in the research study protocol and the informed consent form. Samples may also be collected for future pharmacogenetic research. Such collection is optional and research participants can choose to participate or not without this affecting participation in the main study.

Intellectual Property

A commercial pharmaceutical or diagnostic product(s) may be developed using banked samples, data and/or from medical information collected during research studies. Amgen, other researchers, or research companies may patent or sell discoveries that result from this research. Neither Amgen nor the investigator, or external researchers compensate research participants. Research participants do not have any rights to future inventions in accordance with the applicable local laws and legislation.

Return of Results

Results are typically not returned to individual research participants. If a study generates clinically significant and diagnostically relevant findings for research participants, Amgen addresses such findings in a manner that complies with the local laws and regulations.

Withdrawal of Consent

Research participants may withdraw from a study at any time. If a research participant withdraws from a study, samples may still be used for future research for the duration of the storage period unless the research participant or a legal representative specifically asks the investigator to request that Amgen destroy samples for future research. Any data generated until the date of withdrawal may be used by Amgen. This language is included in the informed consent that is signed by the research participant. If Amgen is notified that a research participant withdraws consent for use of samples for future use, the samples are not used for future research and are destroyed once all protocol-specified procedures are complete. If withdrawal of consent for optional pharmacogenetic analysis is received, banked samples are no longer used for such optional analysis.

Destruction

Samples are retained for no longer than the storage period defined in the informed consent or as described following withdrawal. Samples are destroyed, as appropriate, in accordance with the Amgen Environmental Health and Safety procedure (or equivalent) for the disposal of biohazardous material.

Effective date: Dec. 16, 2013