Biobanking of Human Samples
The purpose of this Policy (POL) is to define Amgen’s standards for Biobanking of Human Samples collected during the course of research studies.
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.
Amgen will store biological samples collected in human research studies, hereafter referred to as samples. These samples will be 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 will be as defined in the informed consent form and samples will be 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 will be generally 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.
Amgen-sponsored trial protocols and informed consent documents will 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 will be labeled with a pseudonym (ie, a unique identification number). Only the investigator and his or her staff will have access to the name of research participants and the associated identification number. Amgen will receive only the identification number when receiving samples and will not receive personal information allowing for the direct identification of a research participant. The samples in the biobank will be stored in secured, access-controlled locations. Only staff who are trained and have an active role in managing the biobank will have access to the secured areas. The data system housing the sample information will be validated and access-controlled. Computers used to access the data system will be protected in accordance with all applicable Amgen policies and standard operating procedures.
Amgen will require 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 will take 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.
Use of Human Samples and Data Committee
The Use of Human Samples and Data Committee will be comprised of cross-functional members including Research and Development, Law, Privacy, and R&D Compliance. This Committee will provide oversight of the management of human samples and address issues related to the ethical use of human samples and data.
Use of Samples
The samples that are collected and banked by Amgen will be obtained as part of Amgen research studies. As such, the informed consent form signed by each research participant will be approved by an appropriate review board and/or ethics committee. Samples will be collected, used and stored in accordance with the informed consent and all applicable privacy laws. Amgen will ensure that human samples are collected, stored, and utilized for the purposes outlined in the informed consent form. In the rare event that a sample is proposed to be used for an additional purpose outside the scope of the informed consent (eg, new scientific information), Amgen will seek additional approval from the subject where practically possible, or the appropriate review board and/or ethics committee.
The use of samples for research purposes will be governed by a standard operating procedure. All requests to use samples for research purposes will be evaluated by a biorepository liaison and approved by R&D management. As part of the request evaluation, the protocol and informed consent form will be 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 will be approved. Once approved, the requesting scientist will be governed by the standard operating procedure for the maintenance of samples and data. Samples will be tracked for chain of custody purposes and 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 will be followed. Material transfer agreements or other legal agreements will be put in place to ensure samples are used only for the purposes described in the contract.
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 are described in the research study protocol and the informed consent form. Samples may also be collected for future pharmacogenetic research. Such collection will be optional and research participants can choose to participate or not without this affecting participation in the main study.
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, nor external researchers will compensate research participants. Research participants will not have any rights to future inventions in accordance with the applicable local laws and legislation.
Return of Results
Results will typically not be returned to individual research participants. If a study generates clinically significant and diagnostically relevant findings for research participants, and/or in order to comply with local laws or regulations, Amgen will address 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 will be used to complete testing that is defined in the protocol and may still be used for future research for the duration of the storage period. A research participant may withdraw consent to have samples used for future research at any time and future research testing will not be conducted on those samples. If the research participant or a legal representative specifically asks the investigator to request that Amgen discard remaining samples for future research, they will be destroyed once applicable required testing is complete. Any data generated until the date of withdrawal may be used by Amgen. This language will be included in the informed consent form that is signed by the research participant. If withdrawal of consent for optional pharmacogenetic analysis is received, banked samples will no longer be used for such optional analysis and will be discarded at the end of the study or sooner if requested.
Samples will be retained for no longer than the storage period defined in the informed consent and applicable law or as described following withdrawal. Samples will be destroyed, as appropriate, in accordance with the Amgen Environmental Health and Safety procedure (or equivalent) for the disposal of biohazardous material.
Effective Date: December 18, 2017