Thursday, November 10, 2011

Contract Provisions Help Protect Research Participants

Sponsors play an important role in protecting participants in research. AAHRPP Standard I-8 describes the working relationship that organizations and sponsors must have in order to protect participants. Organizations and sponsors can exert flexibility in negotiating contracts and funding agreements to meet these requirements. Standard I-8 deals with five required provisions for contracts and funding agreements that are designed to contribute to the protection of research participants in sponsored research. The five Elements are described below with explanations for why they are important.

Element I.8.A. The Organization has a written agreement with the Sponsor that addresses medical care for research participants with a research-related injury, when appropriate.

When there is a risk of physical injury from participating in a research study, organizations should work with sponsors to determine who is responsible for paying for care following research-related injury. When agreeing to participate in a research project, participants should be made aware of whether care will be provided when they are injured because of the research project, and who will be responsible for paying for such care. This information should be in the consent document and should be consistent with the terms of the contract or funding agreement with the sponsor.

Although AAHRPP does not require sponsors or organizations to pay for care for research-related injury, AAHRPP does require that organizations define whether or not there is payment for research-related injury in the contract or funding agreement before research starts, so participants can consider this information during the consent process. Organizations should also have a process to confirm that what is in the contract and funding agreement and what is in the consent document are consistent. This Element applies only when there is a potential for research-related physical injury. If the protocol and consent document describe the provision and payment of care for research-related injury and these documents are referenced in the contract or funding agreement, then the Element is satisfied. The laws of some countries, excluding the United States, require the sponsor to pay for care for research-related injury. In that case, contracts and funding agreements should state the specific obligation of the sponsor.

Element I.8.B. In studies where Sponsors conduct research site monitoring visits or conduct monitoring activities remotely, the Organization has a written agreement with the Sponsor that the Sponsor promptly reports to the Organization findings that could affect the safety of participants or influence the conduct of the study.

Often, sponsors or contract research organizations send a monitor to local sites to observe the conduct of the study and check written procedures and records. When the monitor reports finding an issue that could place the participants at that site at risk of harm or change how the study is conducted, the sponsor must notify the organization of the problem so it can take steps to protect current or future participants. For this Element it is required that the organization’s policies and procedures have contracts specify that the sponsor must promptly report any findings from the monitoring that could affect the safety of participants or influence the conduct of the study to the organization and must define what is meant by “promptly.”

Element I.8.C. When the Sponsor has the responsibility to conduct data and safety monitoring, the Organization has a written agreement with the Sponsor that addresses provisions for monitoring the data to ensure the safety of participants and for providing data and safety monitoring reports to the Organization.

For multisite research, particularly clinical trials, IRBs review local serious adverse events and unanticipated problems involving risks to participants or others. It is not productive for local IRBs to review all adverse events from all sites, because they have no context to review any given adverse event. For example, if a participant in a cardiac stent study has a heart attack in Sweden, is that a problem that should be addressed at a site in the U.S.? That is exactly why there are data and safety monitoring committees to review all adverse events, analyze them, and inform the sites of their results through data and safety monitoring reports. These data and safety monitoring reports are essential for local IRBs in conducting continuing review and evaluating risk. 

This Element requires the organization’s policies and procedures to have contracts or other funding agreements that obligate the sponsor to send data and safety monitoring plans and reports to the organization. This should conform to the data and safety monitoring plan that the IRB approved, including time frames for reporting. At a minimum, data and safety monitoring reports should be sent annually, so they can be considered by the IRB at the time of continuing review.

Element I.8.D. Before initiating research, the Organization has a written agreement with the Sponsor about plans for disseminating findings from the research and the roles that Researchers and Sponsors will play in the publication or disclosure of results.

The publication or presentation of research results that contribute to the body of scientific knowledge is a fundamental cornerstone of the research enterprise and the primary justification for exposing participants to the risks associated with research. Element I.8.D. confirms that if an organization has requirements for the dissemination of research results, those requirements must be stated in the contract or funding agreement. This Element does not apply to organizations that do not have publication policies.

For this Element, contracts or other funding agreements require the sponsor to follow the organization’s policies and procedures regarding the publication of findings from sponsored research, or a negotiated statement that includes both the organization's and sponsor's requirements. 

Element I.8.E. When participant safety could be directly affected by study results after the study has ended, the Organization has a written agreement with the Sponsor that the Researcher or Organization will be notified of the results in order to consider informing participants.

Even after a study has ended, issues sometimes arise that can affect the safety of former participants in the research, particularly when the results of the study are analyzed. Study results might show, for example, that some participants are at risk for a side effect of the drug.

This Element calls for policies and procedures to have contracts or other funding agreements require the communication of findings from a closed research study to the researcher or organization when those findings directly affect participant safety. The sponsor’s experience and expertise can be relied upon to specify what the time frame should be for each specific study. Because the time frame may extend beyond the closure of the study at the site, this requirement should be included or referenced in the surviving clauses of the contract. This Element is not applicable to some studies. 

The review of contracts and funding agreements for research is an integral part of the Human Research Protection Program. Since the issues involved in these Elements relate to the protection of participants and IRB decisions as well as the content of contract and funding agreements, it is important for organizations to have good channels of communication between the IRB and the unit that deals with negotiating contracts and funding agreements. This mutually beneficial relationship keeps both parties informed of each other’s activities when they deal with the same research project. 

To comply with Standard I-8, organizations are required to add the five provisions to the contracts and funding agreements they negotiate with sponsors of research. Most organizations have developed processes to include the language (e.g., contract checklists or templates), and some have instituted ongoing monitoring to ensure compliance with this requirement.

Many sponsors have worked with AAHRPP to develop acceptable language. If you let AAHRPP know when you encounter a sponsor that strongly resists the required language, AAHRPP will try to work out acceptable language with the sponsor. When sponsors understand the details and the purpose of these requirements, they are more willing to negotiate language that is mutually acceptable. In fact, industry sponsors are becoming more proactive and working directly with AAHRPP to develop acceptable language for contracts.

The requirements in Standard I-8 are designed to help protect participants by formalizing communication between the organization and sponsors on issues related to the safety of participants. Understanding that goal makes it easier for all parties involved to fulfill these requirements.

No comments:

Post a Comment