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ORA.1 Organization Policy On Sponsor Responsibilities
The Organization requires a written contract with Sponsors of proposed research and the following terms must be contained in such agreements.
1. Budget Policy:
(A) All direct and indirect costs of each study must be supported by the study budget.
(B) In accordance with applicable laws and regulations and institutional and insurer policies, all non-routine patient care costs must be supported by the study budget and not charged to the study subjects or their medical insurers. Routine care is that which is medically reasonable, necessary, and ordinarily furnished (absent any research study), and appropriate to the medical condition of the patient. The study contract, protocol or consent form will specify who will pay for routine patient care services which may not be covered by third party health insurance payors due to the patient’s study participation, limits on insurance coverage and/or eligibility exclusions.
(C) IRB costs must be paid by commercial sponsors.
(D) It is the policy of the Organization that staff conducting a study may not receive direct personal payments from the sponsor, other than institutional salary support in the study budget, for their performance of the study.
(E) Study agreements may not include a financial bonus or financial penalty specifically targeted at participant recruitment efforts.
2. Sponsor Monitoring, Reporting of Findings and Results, and Access to study data:
(A) Research sponsored by commercial or non-commercial sponsors must be governed by a protocol for all participating sites. The protocol shall explain the monitoring role to be taken by the sponsor, if any.
(B) For studies where the commercial sponsor is responsible for monitoring the research, contracts will contain a provision stating the sponsor has a duty to promptly update the Institutional Official of serious or continuing monitoring findings that influence the conduct of the study or affect the safety of subjects enrolled at sites covered by the Contract.
(C) For studies where the commercial sponsor is responsible for data and safety monitoring for a study, contracts will contain a provision – either express or via incorporation of the protocol document – requiring the sponsor to provide routine data and safety reports periodically, as needed for the IRB’s continuing review of the study; any urgent data and safety reports should be provided promptly.
(D) Contracts accepted by the Office of Research Administration involving sponsor-directed clinical studies should contain a provision requiring the sponsor to inform the Principal Investigator of post study results that directly affect safety of participants for an appropriate time period (e.g., two years) or as otherwise in accord with FDA regulations. The Principal Investigator shall notify the IRB of any such information received. Where appropriate, the IRB shall develop a plan for disseminating such information to the participants and organizational officials.
(E) Contracts should address the Investigator’s access to final study data and analysis and allow retention of a copy of the Johns Hopkins data to document the research.
(F) Sponsors may require confidentiality of Sponsor provided information and study agreement terms and may request that the data generated by the study be treated as confidential information except for academic publication. Neither the existence of the study agreement nor the identity of any sponsor (including prime sponsors) of the research may be confidential.
(G) Research contracts must provide for the Organization’s right to publish and present research results. Contracts for multi-site studies may allow for coordination of first publication of the entire study among the sponsor and participating sites within eighteen (18) months of the completion of the study. Thereafter, each individual site should have the right to independently publish its own study data.
(H) Submission of multi-site and individual site proposed publications to the sponsor and/or a study publication committee for prior review and comment is appropriate. If such review (usually 30 – 60 days) determines that patent filing is needed to protect intellectual property, submission of the proposed publication to a journal may be briefly delayed for an additional period; the total review and patent filing period may not exceed 120 days from the date of the initial submission to the sponsor for review.
3. Intellectual Property (IP):
(A) Sponsors may require assignment of IP directly resulting from performance of a research study where such IP was anticipated by the sponsor’s protocol or dependent on investigator access to the Sponsor’s confidential information, drug/device, or patent claims. Patentable inventions, arising from the study but not in the forgoing categories, shall have their ownership determined by application of US Patent Law regarding inventorship.
(B) The Organization may provide the sponsor with an option to negotiate a royalty-bearing license to the Organization’s interests in sole or joint inventions.
4. Consent Language:
(A) As a general policy, contracts between the Organization and commercial sponsors for human subjects research will not specify language or terms that must be included in a consent form for a specific project.
(B) Contracts that propose to include specific language or terms that vary from the general policy set forth in Section IV(A) above, and/or which may affect statements contained in a protocol-specific consent form, must be agreed to by the designated IRB. The ORA will notify the designated IRB of such terms, and the designated IRB and ORA will work together to ensure that the contract and consent form contain appropriate and consistent language.
(C) The designated IRB may review and approve research in which the commercial sponsor holds the IND or IDE or is providing product for the study before a written contract with the sponsor has been signed. At the time of final IRB action, the PI will receive a notice from OHSR along with the approval documents, stating that the project may not begin until a contract has been signed by JHU.
(A) Clinical research agreements that involve providing Protected Health Information (PHI) to a sponsor, must include the sponsor’s agreement to: (1) refrain from using the PHI to recruit for or advertise additional studies to subjects, (2) refrain from using the PHI to perform marketing or market research, and (3) place the same restriction on any third party to whom sponsor discloses PHI.
6. Indemnification and Medical Care Costs:
The following terms must be contained in contracts negotiated by the Office of Research Administration (ORA) when the research will involve an investigational drug, biologic or device, or where the clinical or preclinical study data and/or IP may be utilized for such products in the future:
(A) Contracts for studies in which a commercial sponsor holds the IND or IDE and also controls the protocol must require the sponsor to provide indemnification coverage and defense of the institutions performing the study, including their trustees, officers, agents, faculty, employees and students, for all claims arising from the institutions’ conduct of the study that are not due to an institution’s negligence or willful misconduct. If the indemnification terms specify types of claims to be covered, the contract must, at a minimum, cover claims arising from (i) study subject injury or illness caused by the product or protocol, (ii) institutions’ proper conduct of the protocol, and (iii) Sponsor’s use of study data and intellectual property assigned to the Sponsor.
(B) Contracts for studies in which a commercial sponsor holds the IND or IDE and also controls the protocol must also require the sponsor to fund medical care costs for any study related injury or illness. The Organization may execute contracts that exclude from such provision (i) injuries or illnesses primarily due to a participant’s underlying medical condition, (ii) known risks of routine patient care portions of the protocol, or (iii) the Organization’s negligence or willful misconduct. Cost of medical care provided for study related injuries or illnesses shall be billed to a participant’s insurance only in accord with the terms of the contract.
(C) Commercial entities providing product for investigational studies that are initiated by a Johns Hopkins faculty investigator and in which the Hopkins investigator holds the IND or IDE and controls the protocol are required to provide indemnification for the commercial entity’s (i) responsibilities in the study (i.e., design, manufacture and shipment of the product), and (ii) use of the data and any intellectual property assigned to the commercial entity.
(D) Investigator-initiated investigational studies do not require provision of medical care costs by the commercial entity providing the investigational product.
(E) Non-commercial entities sponsoring (holding the IND or IDE) and/or providing investigational products are not required to provide indemnification or medical care costs. Commercial entities providing product for investigational studies sponsored by non-commercial entities will not be required to provide indemnification for their design, manufacture and shipment of the investigational product.
Commercial sponsors of non-investigational clinical studies and preclinical studies will be required to provide indemnification for their use of study data and intellectual property assigned to them.
(A) Press releases, marketing and promotional documents naming or referring to Johns Hopkins institutions and/or faculty and staff require prior review and approval by Johns Hopkins regarding the accuracy of the information being released.