UAB Expectations for Research Sponsors - IRB POL005

Abstract:
This policy outlines the requirements for formulating contracts with sponsors of proposed research.
Effective Date:
10/24/2010
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:
UAB Human Research Protection Program

HRPP Document:     POL005
Effective Date:   3/30/07
Revision Date:  3/9/10, 10/24/2010, 7/30/11
Subject:  UAB Expectations for Research Sponsors

INTRODUCTION

UAB requires a written contract with sponsors of proposed research with the following terms contained in such agreements. All contracts and funding agreements should include language that obligates UAB to follow the protocol, applicable law, and its ethical standards.

When a sponsor requires the research is to be conducted in accordance with ICH-GCP guidelines, the Office of Sponsored Programs (OSP) shall notify the OIRB in writing if the contract or funding agreement requires all ICH-GCP guidelines be followed or the extent or limit to which the IRB, researcher, Institution and Sponsor must follow ICH-GCP.

BUDGET POLICY

All direct and indirect costs determined for each study must be supported by the study budget. (See SUP421 UAB INDIRECT COST REIMBURSEMENT POLICY.)

In accord with applicable law and regulation and institutional policies, all non-routine patient care costs must be supported by the study budget and not charged to the patient subjects and/or their medical insurers. Routine care is that which is medically reasonable, necessary, and ordinarily furnished (absent any research study) appropriate to the medical condition of the patient. The study budget must also specify who will be the responsible party for the cost of routine patient care services that 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.

IRB costs, whether internal or independent, must be paid by commercial sponsors.

Under UAB policy 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.

In addition, study agreements may not include a financial bonus or financial penalty specifically targeted at participant recruitment efforts.

SPONSOR MONITORING, REPORTING OF FINDINGS AND RESULTS, AND ACCESS TO STUDY DATA

Research sponsored by commercial or non-commercial sponsors must be governed by a protocol for all participating sites. The protocol and/or contract shall explain the monitoring role to be taken by the sponsor, if any. 

If the sponsor has a regulatory obligation to monitor the conduct of the study, the contract or funding agreement should include language that obligates the sponsor to promptly notify the PI at UAB of the following:

  • Any information discovered by the study monitor that could 
    • Affect the safety of subjects; 
    • Affect the willingness of subjects to continue participation; 
    • Influence the conduct of the study; or 
    • Alter the IRB’s approval to continue the study.
  • Interim findings and post-study results that could affect the human subjects protections associated with the study including information that may 
    • Affect the safety or medical care of current or former participants; or
    • Affect the willingness of participants to continue in the research;
  • Acknowledge that post-study results would be reported in accordance with FDA regulations.

The IRB will develop a plan for disseminating such information to participants.

Contracts should also address the investigator’s access to final study data and analysis for all sites and allow retention of a copy of the data generated at UAB to document the research.

Sponsors may require confidentiality of sponsor-provided information and may request that the data generated by the study be treated as confidential information except for academic publication. The existence of the study agreement may not be confidential.

Multi-site studies should coordinate first publication of the entire study among the sponsor and sites within 18 months of the sponsor’s lock of the study’s database. Thereafter, each individual site should have the right to independently publish its own study data. 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 delayed for a total review and patent filing period not to exceed 120 days from the date of submission to the sponsor for review.

INTELLECTUAL PROPERTY (IP)

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, trade secrets, or patent claims. Patentable inventions, arising from the study but not in the forgoing categories, shall have their ownership determined by application of U.S. Patent Law regarding inventorship. In such cases UAB shall provide the sponsor with an option to negotiate a license to UAB’s interests in sole or joint inventions. (See also: SUP424 UAB PATENT POLICY (Board of Trustees Rule 509).)

CONSENT LANGUAGE

As a general policy, contracts between UAB and commercial sponsors for human subjects’ research will not specify language or terms that must be included in an informed consent document for a specific project.

Contracts that propose to include specific language or terms that would vary from this policy and/or may affect statements contained in a protocol specific informed consent document must be agreed to by the designated IRB. The OSP will notify the designated IRB of such terms, and the designated IRB and OSP will work together to ensure that the contract and informed consent document contain appropriate and consistent language.

The designated IRB is required to 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. The contract will not be returned to the sponsor until IRB approval is received by OSP.

The OIRB will ensure the informed consent document is consistent with the terms of the executed contract.

HIPAA

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 or (2) perform marketing or market research and (3) place the same restriction on any third party to whom sponsor discloses PHI.

INDEMNIFICATION AND MEDICAL CARE COSTS

All contracts and funding agreements should include language that describes who takes responsibility to provide and pay for medical care for research related injury. The following terms must be contained in contracts negotiated by the Office of Sponsored Programs (OSP) 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:

  1. Studies in which a commercial sponsor holds the IND or IDE and also controls the protocol must provide indemnification coverage and defense of UAB for performing the study, including its trustees, officers, agents, faculty, employees and students, for all claims arising from the institution’s 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 (1) study subject injury or illness caused by the product or protocol, (2) institutions’ proper conduct of the protocol, and (3) sponsor’s use of study data and intellectual property assigned to the sponsor.
  2. Commercial sponsors holding INDs or IDEs are encouraged to fund medical care costs for any study related injury. Contracts may exclude medical care costs for illnesses primarily due to a participant’s underlying medical condition, or known risks of routine patient care portions of the protocol.
  3. Commercial entities providing product for investigational studies that are initiated by a non-commercial investigator (e.g., faculty at UAB or a collaborating noncommercial entity holding the IND or IDE and controlling the protocol) are required to provide indemnification for their responsibilities in the study (i.e., design, manufacture, and shipment of the product) and for the sponsor’s use of the data and any intellectual property assigned to sponsor.
  4. Investigator-initiated investigational studies do not require provision of medical care costs by the commercial entity providing the investigational product.
  5. Non-commercial entities sponsoring and/or providing investigational products are not required to provide indemnification or medical care costs.
  6. Commercial sponsors of non-investigational clinical studies and preclinical studies will be required to provide indemnification for their use of data and any assignment of intellectual property to them.

PUBLICITY

Press releases naming or referring to UAB and/or UAB faculty and staff require prior review and approval by UAB regarding the accuracy of the information being released.

Approved on July 30, 2011, by:

Richard B. Marchase, PhD
Vice President for Research and Economic Development

Lynn Stedman
Director, Office of Grants and Contracts Administration