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- Operations Manual - Sponsored Research
Operations Manual - Part 10
The Office of Research and Sponsored Projects (ORSP) enables and safeguards the conduct of research and other sponsored activity for the University of Michigan (U-M). ORSP applies specialized regulatory, statutory and institutional policies in order to balance the University's mission, the sponsor's objectives, and the investigator's intellectual pursuits. ORSP assists faculty and staff members in all aspects of externally funded research projects and other scholarly activities, such as finding funding, preparing and submitting proposals, negotiating sponsor agreements, setting up financial accounts, managing and administering projects and closing out projects.
ORSP submits sponsored research proposals to external agencies, negotiates the terms of agreements consistent with the mission and goals of the HRPP and law and policy applicable to the University, and arranges for the establishment of appropriate financial accounts when a project is awarded. ORSP uses a campus-wide application for electronic Routing and Proposal Management (eRPM) to obtain and record information about the proposed activity. eRPM project information includes whether a research proposal involves human research participants as well as the status of the Institutional Review Board (IRB) approval: either the number/date of approval, exempt status or an indication of pending status, which is signed by the Principal Investigator (PI).
eRPM verification of IRB approval is required before ORSP will set up an account for a project. Awarded funds may not be used for human research activities until ORSP receives confirmation that an IRB has approved the study and other regulatory requirements for the protection of human research participants have been met.
When negotiating sponsor agreements, University policy requires agreements involving human subjects to include provisions addressing the following, when applicable:
- Assurance of compliance with human research protection requirements;
- Medical care for research-related injury;
- Communication of findings that could affect safety of participants, or their willingness to participate, or influence the conduct of the research;
- Dissemination of research findings.
University policy requires that all sponsored activity at the U-M comply with human research protection requirements mandated by federal regulatory agencies, State Laws, accreditation standards and university policy.
In each sponsor agreement, the University includes a provision referencing the University’s responsibility to conduct the research in accordance with applicable law and applicable organizational and industry ethical standards relating to protecting human research participants. In non-clinical research agreements, provisions referencing the University’s responsibility for human research protections are included in the work statement and the sponsored research agreement. In sponsored clinical trial agreements, the University includes additional provisions that incorporate, by reference, the written study protocol and allow the sponsor and regulatory authorities, such as the Food and Drug Administration (FDA), the right to inspect the University’s property and documents related to the performance of a trial to ensure it is being conducted in accordance with the protocol and applicable law.
1. Provisions in Sponsor Agreements
Before any clinical research involving human research participants begins, arrangements for medical care for research-related injuries are defined, including who will provide such care and who will be responsible for paying for the care. Various University personnel including the PI, his/her administrator, the clinical coordinator, clinical research Calendar Review and Analysis Office (CRAO), the clinical trials planning unit, or the ORSP project representative, may conduct discussions with the sponsor concerning this issue. When contracting with sponsors, the University first attempts, when appropriate, to require the sponsor be responsible for the payment of medical care provided for a research-related injury, illness or adverse event.
For more than minimal risk research, the Common Rule requires that researchers present information to research participants about medical and financial responsibility for research-related injuries in the informed consent document so that participants can consider this information before agreeing to participate. The informed consent document must specify financial and medical care responsibility for research-related injuries and include instructions concerning where medical treatment should be sought if injury occurs and whom to contact in the event of a research-related injury.
The sponsor agreement generally sets forth information concerning research-related injuries consistent with the information provided to the research participant for research projects where this is applicable. CRAO compares the informed consent document and the contract provision to ensure that the language in each regarding research-related injuries is in agreement. For research not subject to CRAO review, the IRB should consider the information regarding research-related injuries provided in the informed consent, seeking input from other institutional authorities, as indicated.
Faculty and staff conducting human subjects research clinical trials containing billable items and services must submit a billing calendar as part of the IRB application process. All items and services to be utilized in the study as set forth in the protocol must be documented in the billing calendar at the designated time points with the appropriate designation.
CRAO reviews all human subjects research protocols, informed consent documents, budgets, and contracts containing billable items and services irrespective of payer, and each research protocol undergoes a Medicare Coverage Analysis to ensure billing compliance.
C. Communication of Findings that May Affect the Safety of Human Research Participants or Their Willingness to Participate, or Influence the Conduct of the Research
The University requires sponsors to provide written plans for communicating routine and urgent safety information that could:
- Affect the willingness of participants to continue participation;
- Influence the conduct of the research; or
- Alter the IRB’s approval to continue the study.
The sponsor must also agree to cooperate with the University in communicating results from a research study to participants when those results directly affect their safety or medical care.
The above results may be addressed in a master agreement, a project-specific agreement or any of their respective incorporated attachments such as a study protocol.
Findings that must be communicated to the University by the sponsor include, but are not limited to:
- Findings of non-compliance detected during sponsor’s site monitoring visits;
- Findings of non-compliance detected during sponsor’s monitoring of data and safety reports; and
- Study results that may directly affect the safety or medical care of former participants.
The sponsor agreement may also specify the time frame after closure of the study, during which the sponsor is obligated to communicate such findings and the steps that must be taken to communicate these findings.
The University also complies with sponsor requirements, set forth either in the protocol or in the research agreement, for reporting of any adverse event experienced by a research participant.
The University is free to communicate safety findings to study participants and the IRB. In fact, language in the University’s informed consent template for clinical projects requires investigators to provide research participants with information concerning any new findings that develop during the course of the research that may relate to the participant’s willingness to continue participation. When sponsor-initiated trials require use of sponsor-created informed consents, the IRB reviews those documents to ensure that the consent is consistent with the protocol and that the human research participant is adequately informed of all aspects of the study.
University of Michigan policy on dissemination of research findings, i.e., the Regents' Policy Concerning Research Grants, Contracts and Agreements, is based on the mission of the institution, the principles of open scholarly exchange and academic freedom, and the University’s tradition of conducting research aimed at enhancing human life and the human condition. The Regents’ policy reflects the University’s general reluctance to accept sponsor-imposed restrictions on the openness of research results. The policy states that the University does not normally accept any research agreements that place unreasonable restrictions on the publication or other dissemination of research results. The policy also describes exceptions for certain restrictions.
The Standard Practice Guide 303.01 defines three types of restrictions on dissemination of research findings and the procedures required for each to be made part of a sponsor agreement. “Standard Restrictions,” which include provisions giving a sponsor the right to review and comment and to protect sponsor’s confidential information and intellectual property, do not require special justification or documentation. A regular Proposal Approval Form signed by the PI whose work may be affected by the restriction, his/her department chair/unit head, the relevant Dean or Director and the Vice President for Research (VPR) or his designee is sufficient.
“Non-Standard Restrictions” and “Classified Research Restrictions” require explicit review and approvals.
University policy permits a sponsor a reasonable period of time, usually not to exceed 120 days, to review a proposed publication or other dissemination of research results for:
- Comment (not for prior approval);
- Protection of sponsor’s confidential information;
- Possible participation in protection of sponsor’s intellectual property.
In instances where the investigator wishes to disclose the results in a format other than submission to a journal, (i.e., slides, posters, conference, etc.), negotiation with the sponsor typically provides for a reduced review period. Any publication delay of greater than 120 days must be reported to the Office of the Vice President for Research (OVPR). Under unusual circumstances and with the concurrence of the PI, a time delay of up to 180 days may be allowed.
During the review and comment period, a sponsor may recommend any changes to the publication it reasonably believes are necessary for scientific purposes.
When the University is the only site participating in a sponsored research study (this more typically occurs with an investigator-initiated trial), the publication protection of the research agreement will include the review/comment period and the potential delay for confidential information and intellectual property as well as the right of the sponsor to require the removal of confidential and proprietary information provided by the sponsor prior to publication or dissemination of findings.
In multi-center studies, where numerous sites participate in the study, the sponsor may require the pooling of the information from all the trials and an initial publication based on the data from the various sites. University policy recognizes that multi-site publication may be the best way to assure the integrity of multi-center trial results. The policy allows for a reasonable and determinate time delay for publication by the University of its site results following the initial multi-site publication or after the sponsor indicates that such publication will not take place.
The usual period of delay for the University to publish in such instances is between 12-18 months from the completion of the study at all sites. This delay period is often triggered once data collection from all trial sites is complete and the overall study results database has been locked with the only remaining activity analysis of the aggregate data by the study sponsor. After this delay period has lapsed, the University investigator can present the results from his/her study to the sponsor for the review and comment period. The sponsor is required to provide notice to the University when the study is completed to allow the University to compute the publication delay period.
Sponsor agreement provisions regarding dissemination of research findings must not prevent full compliance with federal disclosure provisions, such as those covered by the Food and Drug Administration Amendments Act requiring reporting of certain results in ClinicalTrials.gov. See Part 11 of this Operations Manual (OM).
When participants request information concerning a completed study, they are provided with information as described in the IRB approved consent form. In addition, if adverse events are experienced at the University or have occurred at other sites involved in the trial and are made known to the University via broadcasting of such instances from the sponsor or other sites, the University may revise the informed consent to include notice of any safety issues and may also require re-consent of the research participants. In sponsor agreements, the University reserves the right to use results, data, information, etc. for, among other things, patient care purposes.
Research sponsors typically provide financial support commensurate with the work required to do the study. Although some sponsors may offer to pay “finders’ fees” or “bonus payments” to encourage participant recruitment efforts, University policy prohibits payment to or receipt by U-M researchers, including staff and students, of these types of payments.
A “finder’s fee” is compensation of any type (e.g., cash, cash equivalent, office or medical supplies, educational stipends, gift certificates, travel cost in excess of normal reimbursement costs, or anything else of value) made to study team members in exchange for referral or recruitment of a participant to a research study (e.g., $10 for every person recruited who signs the consent document to participate in the study). A “bonus payment” is compensation of any type tied to the rate or timing of recruitment or performance or other aspects of a clinical study (e.g., payments that increase based on the number of subjects enrolled within a specified time period).
"Bonus payment" is defined here as compensation tied to the rate or timing of recruitment or performance or other aspects of a clinical study. Examples of bonus payments include the following: the sponsor announces that the highest enrolling site in the nation will receive a $10,000 bonus; the sponsor offers to pay an additional $10,000 beyond the budgeted study costs to any site than enrolls five participants within a week; the sponsor offers to pay an additional $10,000 beyond the budgeted study costs to any site that fulfills its recruitment target by the end of the month; the sponsor offers to pay an additional $1,000 beyond the budgeted study costs for any subject who agrees to enroll within one day of initial contact. Is not permissible to accept bonus payments at U-M.
The policy prohibiting “finders’ fees” and “bonus payments” does not prohibit renegotiation of contract fees when recruitment is progressing much more slowly than anticipated such that additional time and effort are required for recruitment activities than initially anticipated. The policy also does not prohibit compensation for recruitment and screening related activities that are unrelated to whether the participant ultimately enrolls in or completes the research study (such as advertising, administrative, and personnel costs) or for the cost of services provided to those individuals who ultimately do enroll. (This policy does not address payments to research subjects, which are addressed in Part 7.III of this OM.)
Investigators should determine a reasonable budget amount that is directly related to the value of the services provided to the study and document how that amount was determined. Further, any payments to the University for personnel must be reflected in the study budget and in the written agreement that is reviewed by ORSP.
There are numerous applicable and helpful University web sites that provide information concerning University policies, Regental bylaws, and contracting procedures and requirements. Below are just a few of the links to such resources:
- SPG 303.05 - Policy for Research with Human Participants
- U-M Federalwide Assurance of Protection for Human Subjects