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Contracts or Clinical Trial Agreements are necessary to conduct clinical studies between a research site, a study sponsor, and/or CRO. Research sites can be large or small organizations, in academia or private sectors. Contracts should address important legal issues to reduce risks for the study participants, site personnel, as well as the study sponsor. The following points should be addressed in each contract between the contractual parties:
Ethical Reviews: All research involving human participants should go through an Institutional Review Board. The contract should ensure that the study site complies with GCP and HIPAA regulations.
Indemnification: Indemnification is the act of compensation or reimbursing for penalties or liabilities. Study sites should not accept liability (indemnify) for the negligent acts or omissions of anyone other than site personnel. In addition, the study site should not indemnify or hold harmless any organization for the results of any research it has performed. To do so could not only compromise assets of the study site, it could also jeopardize its tax-exempt status, if applicable.
Subject Injury: Contracts for clinical trials should address payment and/or medical care provided to participants enrolled in a research study if an injury occurs. For industry sponsored studies in which the sponsor is the author of the protocol, the sponsor should bear all financial liability for adverse events and injuries to study participants or others caused by the study drug and/or device or by study procedures.
This responsibility should be outlined in the contractual agreement between the sponsor and study site. Specifically, in the event that a participant enrolled in a sponsor-initiated study requires additional medical intervention to treat an injury or illness that is determined by the Principal Investigator to be the direct result of the study participant's participation in the research, the Sponsor should agree to pay for such medical intervention. Study participants should not be required to use their own health insurance to provide or pay for such medical care as this will fall into the lifetime maximum coverage in their health insurance plan.
Reasonable, though not exclusive, limitations on the Sponsor’s obligations include the following conditions:
• To the extent the study is conducted in accordance with the Protocol and without negligence or willful misconduct by study site or study site staff;
• The study participant involved has been given an adequate written informed consent and has been provided prompt diagnosis and medical care;
• Sponsor receives prompt notice of the Research Related Injury, the diagnosis, the care initiated and that anticipated necessary and appropriate follow-up reports;
• To the extent the injury is not directly related to progression of study participant’s medical condition or would have occurred if study participant had not been enrolled in study;
• To the extent, the injury is not the result of the participant’s reckless or willful misconduct.
For industry sponsored observational or registry studies in which the sponsor is the author of the protocol, payment for subject injury by the sponsor may not required by the study site and most likely the industry sponsor will not be willing to contract for this responsibility.
For Principal Investigator initiated or authored studies funded by industry sponsors, compensation or payment of immediate necessary care for injury related to participation in research activities should be provided by the study site employing the principal investigator.
Confidentiality and Publication Rights. When study sites perform clinical trials sponsored by a for-profit company, the company often requires investigators and study sites keep confidential the company's trade secret and proprietary information. Likewise, study sites should ensure the contract protects the confidentiality of its proprietary information and materials. These provisions are often incorporated into the terms of a research agreement. In clinical research agreements, investigators at academic medical centers or other not-for-profit should reserve their rights to publish results of research efforts. However, they often agree to provide the sponsoring company with a draft of any manuscript thirty (30) to ninety (90) days prior to submission for publication or presentation, in order to give the company the chance to prevent disclosure of its trade secret as confidential information. Investigators also often agree to delay publication or research results until after a United States patent application has been filed. The sponsoring organization should not use the name of study site in any publicity, news release, or public announcement without the prior written consent of study site. In addition, the study site should not endorse the use or be liable for the marketability of any product researched at the study site. Study sites should only execute clinical trial contracts that assure the sponsoring agency complies with all governmental laws and regulations and reporting requirements.
Intellectual Property Ownership: Contracts should clearly address ownership of inventions, software, and other intellectual property created through sponsored research. Licensing rights to patents and software are typically negotiated in separate contracts between the parties in the event that a patent results from the sponsored research. It is possible that an intellectual property discovery will start with federal funding and end up with industry funding. When this happens, industry should keep in mind that the federal government retains a royalty-free right to use the technology created with federal funds per the Patent and Trademark Law Amendment Act of l980, more commonly known as the Bayh-Dole Act, which is the legal framework for transfer of university generated, federally funded inventions to the commercial market place. Therefore, it is preferable, whenever possible, not to negotiate licensing terms at the time the clinical trial agreement is negotiated because it is difficult to determine, in the abstract, the value of the intellectual property.
Payments and Billing: The contract should specify the method and dates of payment. Payments are typically generated by the sponsoring company based on specific milestones or events that are detailed in the contract.
Certificates of Insurance: Sponsoring companies and study sites may be require each other to provide a Certificate of Insurance as evidence that they maintain insurance in amounts satisfactory to protect the parties for associated damages or risks during the term of the contract. In addition, all contracts should stipulate that the insurance company give both parties thirty (30) days written notice prior to cancellation or any change in the stated coverage of such insurance.
Definitions:
• Clinical Study: A clinical trial to be conducted pursuant to the terms of a contract.
• Clinical Trial Agreement (CTA): A contract or agreement that establishes contractual terms between 2 or more parties for research with humans.
• Sponsor or Funding Entity: Party to a contract that is providing financial support, drug, device, and/or any other consideration in exchange for work performed pursuant to a protocol or Scope of Work.
• Good Clinical Practices (GCP): Guidelines for human subjects research as adopted by the Food and Drug Administration (FDA). The complete guidelines are codified in E.6 of the International Conference on Harmonization (ICH) Guidelines.
• Health Insurance Portability and Accountability Act (HIPAA): Federal privacy standards implemented to protect patients’ medical records and other health information provided to health plans, doctors, and healthcare providers.
• Institutional Review Board (IRB): A specifically constituted review body established or designated by an entity to protect the rights and welfare of human subjects recruited to participate in biomedical, behavioral, or social science research.
References:
45 CFR 60 National Practitioner Data Bank
http://www.npdb-hipdb.com/
National Practitioner Data Bank Guidebook (September 2001)
45 CFR 61 Healthcare Integrity and Protection Data Bank for Final Adverse Information on Health Care Providers, Suppliers and Practioners
http://www.npdb-hipdb.com/
Healthcare Integrity and Protection Data Bank Guidebook (February 2000)
45 CFR 74 Uniform Administrative Requirements for Awards and Subawards to Institutions of Higher Education, Hospitals, Other Nonprofit Organizations, and Commercial Organizations; and Certain Grants and Agreements With States, Local Governments and Indian Tribal Governments
45 CFR 92 Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments
35 USC 271 Infringement of Patents
37 CFR 401.14 Standard Patent Rights Clauses
External links:
http://grants.nih.gov/grants/guide/notice-files/not95-003.html
https://s-edison.info.nih.gov/iEdison/37CFR401.jsp
Related Files:
Bayh-Dole Act
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