If you have ever wondered what happens to your blood, tissue, or other biological samples after you donate them for research, this blog post is for you. Human tissue collection is an essential part of biomedical research, as it helps scientists and doctors discover new ways to prevent, diagnose, and treat diseases. But donating your tissue is not as simple as giving away your old clothes or books. There are ethical and legal issues that you should be aware of before you sign up for any research project involving human tissue. In this blog post, I will explain some of the key documents and agreements that you may encounter when you decide to donate your tissue for research.
Ethical documents are used to ensure that human tissue is collected in an ethical and responsible manner. These documents include:
- Informed consent: Informed consent is a document that is used to obtain permission from a person to collect their human tissue for research. The informed consent document must be written in clear and understandable language, and it must include information about the risks and benefits of the research, as well as the person's rights as a research participant.
- Institutional review board (IRB): An IRB is a committee that reviews research protocols to ensure that they are ethical. The IRB must approve the informed consent document before the research can begin.
- Nondisclosure agreement (NDA): An NDA is a legal document that is used to protect the confidentiality of information. An NDA is typically used between a researcher and a company that is providing human tissue for research.
- Material transfer agreement (MTA): An MTA is a legal document that is used to transfer materials between two parties. An MTA is typically used between a researcher and a company that is providing human tissue for research.
Informed consent is a process by which you agree to participate in research after being informed about all the relevant details of the research. Informed consent is based on the ethical value of respect for autonomy, which means that you have the right to make your own choices about your body and personal information. Informed consent also builds trust and honesty between you and the researchers.
Informed consent for human tissue collection and research should include information about:
- Where and how your tissue will be collected
- How your tissue samples will be stored and disposed of
- How your tissue will be used and what are the expected outcomes of the research
- How you may benefit or be harmed by the research
- What are your rights and responsibilities as a donor
- How you can change your mind and withdraw your consent at any time
- How your privacy and confidentiality will be protected
- Who you can contact for more information or complaints
Informed consent should be given in writing, unless there are valid reasons for giving it verbally or implicitly. Informed consent should also be given before any tissue collection or research takes place.
Institutional review board (IRB):
An institutional review board (IRB) is a group of people who review and approve human tissue collection and research proposals to make sure that they are ethically sound and follow the relevant laws and rules. An IRB also monitors the conduct of human tissue collection and research to protect your rights and welfare as a donor. An IRB consists of members with different backgrounds and expertise in scientific, medical, ethical, legal, and social aspects of human tissue collection and research.
An IRB has the power to approve, modify, or reject human tissue collection and research proposals based on ethical criteria such as:
- The scientific quality and value of the research
- The balance between harm and benefit to you as a donor
- The adequacy of informed consent procedures
- The protection of privacy and confidentiality
- The respect for cultural diversity and social justice
An IRB also has the duty to oversee the implementation of human tissue collection and research protocols, such as:
- Making sure that informed consent is obtained from you as a donor
- Reviewing any changes or updates to the research plan
- Conducting regular audits or inspections
- Reporting any problems or complaints
- Stopping or ending any unethical or non-compliant research activities
Nondisclosure agreement (NDA)
A non disclosure agreement (NDA) is a legal contract that binds parties to keep certain information secret. A NDA may be used in human tissue collection and research to protect the intellectual property rights, trade secrets, or proprietary data of researchers or institutions. A NDA may also be used to protect your personal information or identity as a donor.
A NDA typically specifies:
- The parties involved in the agreement
- The information that is subject to secrecy
- The duration and scope of the agreement
- The exceptions and limitations of the agreement
- The consequences and remedies for breaching the agreement
A NDA should be signed by all parties who have access to or use of the confidential information, such as researchers, institutions, collaborators, or sponsors.
Material Transfer Agreements
A material transfer agreement (MTA) is a legal contract that governs the transfer of human tissue samples or other materials between parties for research purposes. A MTA may be used in human tissue collection and research to define the rights and obligations of the parties involved in the transfer, such as ownership, use, distribution, publication, or intellectual property. A MTA may also be used to address ethical issues such as informed consent, confidentiality, or biosafety.
A MTA typically specifies:
- The parties involved in the agreement
- The materials to be transferred and their source
- The purpose and scope of the transfer
- The terms and conditions of the transfer
- The rights and responsibilities of the parties regarding the materials
- The ethical and legal compliance of the parties with relevant laws and regulations
A MTA should be signed by all parties who are involved in or affected by the transfer of materials, such as researchers, institutions, donors, or third parties.
Human tissue collection and research is a valuable and important activity that can advance science and medicine. However, it also involves ethical and legal issues that need to be respected and addressed by researchers, donors, and institutions. By understanding some of the key documents and agreements that are involved in human tissue collection and research, you can make informed and responsible decisions about your participation in research. If you have any questions or concerns about human tissue collection and research, you should always consult with the expert clinical team at Cureline, Inc.
1. Do I need to have my own IRB to source the tissue samples from commercial CROs?
That depends on the source and type of tissue samples you are obtaining from commercial contract research organizations (CROs). According to the FDA guidance document, you may not need to have your own IRB if the tissue samples are de-identified or coded and you have no access to the identifiers or the key. However, if the tissue samples are identifiable or linked to personal information, you may need to have your own IRB or obtain a waiver or alteration of informed consent from an IRB that has jurisdiction over the CRO. You should also check the terms and conditions of the material transfer agreement (MTA) with the CRO to ensure that you comply with any ethical or legal requirements for the use of the tissue samples.
2. Who owns the IP to data that is generated from human biospecimen?
The answer to your question may depend on the specific terms and conditions of the material transfer agreement (MTA) that you have with the commercial CROs that provide you with the human biospecimens. A MTA is a legal contract that governs the transfer of human tissue samples or other materials between parties for research purposes. A MTA may define the rights and obligations of the parties involved in the transfer, such as ownership, use, distribution, publication, or intellectual property. A MTA may also address ethical issues such as informed consent, confidentiality, or biosafety.
Therefore, you should carefully review the MTA that you have with the commercial CROs to understand who owns the IP to data that is generated from human biospecimens. You should also be aware of any ethical and legal requirements for the use of human biospecimens and data, such as informed consent, IRB approval, privacy protection, and data sharing policies.
3. Once samples are shipped to me can I share them with third party?
You must also ensure that the MTA allows you to share the human biospecimens with a third party and that you comply with any restrictions or requirements for sharing. You should also consult with your legal counsel before entering into a MTA or sharing human biospecimens with a third party.
Harminder Singh, MD, is the Vice President of Client Relations and Business Development at Cureline.com, a global leader in human tissue research and precision medicine. Dr. Singh is a highly experienced medical doctor and biospecimens expert who has successfully established and maintained strategic partnerships with biotech, pharmaceutical, and academic clients across the globe for over 15 years. He is also actively involved in designing and executing clinical research projects that involve human biospecimens.