Wayne State University

Clinical Trial FAQs

How do I check the status of a Clinical Trial Agreement?

SPA is committed to providing transparency regarding the status of contracts in review. PIs and Departmental Administrators can access the status of all agreements through the Researcher's Dashboard.  (Researcher's Dashboard User Manual)

What are some ways to speed up a clinical trial agreement negotiation?

  • Submit all required documents to SPA via Evisions as soon as they are received,
  • Submit the required documents to the IRB and DMC for simultaneous review to expedite the entire review process.
  • Use the affirmation memo to convey any contract terms that you do not agree with or that you think should be updated
  • Negotiate the budget as early as possible
  • Remember that no one should sign a sponsored agreement unless it has been directed to them by SPA following negotiations with the Sponsor. To do so can negatively impact negotiations and our ability to finalize an agreement. Please see University Policy 04-6 Contract Signatories.
  • Provide the IRB approval and approved informed consent forms as soon as you receive them so that we may proceed with award establishment upon receipt of the fully executed agreement

What is the indirect cost rate used for corporate sponsored clinical trials?

The indirect cost rate charged for non-federally funded clinical trials is 32%. Any exceptions to this rate would require an approved waiver before the contract can be finalized.

View the University Policy 03-05: Facilities and Administrative Costs Distribution Policy.

What are some of the typical contractual areas that delay the completion of a clinical trial agreement negotiation?

AAHRPP

Why it's important:

Language required to retain our accreditation with the Association for the Accreditation of Human Research Protection Programs, Inc. exceeds standard requirements for clinical trials outlined within the federal regulations.  The AAHRPP "promotes high-quality research through an accreditation process that helps organizations worldwide strengthen their human research protection programs (HRPPs)."( http://www.aahrpp.org/learn/about-aahrpp/our-mission). In order to abide by the policies of AAHRPP, there is certain language required in our clinical trial agreements. A summary of this required language can be found on the AAHRPP website, Provisions in Contracts and Funding Agreements.

Budget and payment terms

Why they're important:

As Dr. David Ginsberg mentions in his book, The Investigator's Guide to Clinical Research, "In clinical research, a site needs to anticipate that the time and effort necessary to successfully complete a study will be significantly greater than it would be to treat a similar number of regular-practice patients. It (the site) must negotiate a budget that provides adequate reimbursement for that extra time and effort." You should always ensure that the funding being provided is enough to cover the costs associated with performing the study. Evaluate the protocol to make sure all costs are covered. Because PI's and Research Coordinators know the level of work involved in the study and the costs of procedures, it is the Department's responsibility to ensure that the budget will adequately cover all costs associated with conducting the clinical trial.

Governing law

Why it's important:

The main concern with governing law is that by statute, WSU has a right to be sued only in the Michigan Court of Claims. It is difficult for WSU to waive this by use of another state's law, therefore it is most often requested that the contract either use Michigan law or remain silent on the issue.  Agreeing to be sued in another state or country means the matter will cost the University more than it otherwise would.

Intellectual property ownership and use

Why it's important:

"Some of the best inventions are accidental," states Laura Johnston, Associate General Counsel for Intellectual Property at Wayne State University.  A faculty member may not believe an invention is likely when beginning a research project, but the University's Patent and Copyright Policy requires that WSU maintain the right to use research results if one of our PI's create an invention during the course of research. WSU will only agree that a sponsor may own inventions if they are related to a proprietary compound of the sponsor's. If an invention occurs only because WSU conducted a study, and it is not related to a sponsor's compound/material/study drug, WSU would be able to grant the sponsor a license.

Indemnification

Why it's important:

WSU requests to be indemnified by sponsors when performing work on sponsored projects, and tries to limit its own indemnification obligations under the agreement. The purpose of indemnification is to protect the parties of the contract against the claims of third parties. It requires one contracting party to respond to certain legal responsibilities of the other party in the event expenses, liability, loss or damage as a result of the performance of a sponsored project.  There can be a significant financial commitment involved with accepting an indemnification obligation.

Publication

Why it's important:

One of WSU's primary objectives as a research institution is to be able to freely publish the results of our research studies. In keeping with our Research Policy, WSU can only allow for a maximum total delay of 90 days for publication to allow a sponsor to review the publication and to file for patent protection. In addition, to maintain the classification of fundamental research also dictated by the University's Research Policy, while a sponsor is allowed to comment on our principal investigators (PI) publications, WSU is not able to accept any language that maintains that a sponsor must approve a publication.

In the rare instances where a sponsor is resistant to abide by the aforementioned Research Policy, the PI must request a Waiver for Restricted and Proprietary Research. This waiver process is only to be utilized when all other avenues for compliance have been exhausted. Per the policy, "WSU PI's with grants or contracts under review by the University that would restrict or prohibit the freedom to publish or otherwise disseminate the research results beyond a 90-day review period, may request a waiver from the Vice President for Research that would allow acceptance of the relevant grant or contract, acting in accordance with the University's research policy on restricted and proprietary research." This necessity for a waiver is determined by our Office of General Counsel and initiated by your Contract Officer on a case-by-case basis.

Subject Injury Reimbursement

Why it's important:

WSU requests that sponsors pay for subject injury costs in corporate sponsored clinical trials. We are unable to accept any language that dictates a subject's insurance must be charged first as the Detroit Medical Center considers this a violation of the Medicare Secondary Payer rules by treating study subjects differently based on their insurance coverage.

Warranties   

Why it's important:

Per Ms. Johnston, as a public university, "[i]t is difficult to provide warranties for research, as results cannot be predicted." Warranties are difficult to implement, since one person's research differs from another.  It is extremely difficult to establish "product", in the general sense of a warranty. A sponsor should be responsible for commercial use of the results WSU provides, but WSU cannot warrant that they are fit for any particular use. On the other hand, "[i]t may be appropriate to ask for warranties from the sponsor, if for example they are supplying a drug, a device, or other equipment."

Does SPA need copies of the Informed Consent Form(s)?

Yes. Please ensure that all approved informed consent forms are provided to your SPA Grant & Contract Officer for review once you have received them from the IRB to ensure that Subject Injury Language terms are consistent with the negotiated terms of the CTA.  

When can I begin my study?

In order to begin, you need to obtain IRB approval and have a fully executed agreement. For all studies taking place at the Detroit Medical Center, you must also obtain DMC approval prior to starting any study activities.