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About Mercy

Research and Clinical Trials

Welcome to the Mercy Medical Center Institutional Review Board website.

The IRB is a committee, formally designated by Mercy Medical Center, to review, approve the initiation of, and conduct ongoing review of investigational research involving human subjects.

The purpose of the IRB is to ensure that no investigational research done under the jurisdiction or premises of Mercy Medical Center shall expose persons who participate as subjects to unreasonable risks to their health, general well-being, or privacy. It is the policy of Mercy Medical Center that in all research- related activities involving the participation of human subjects that the:

  • Rights and welfare of the human subjects at risk are adequately protected.
  • Participation of human subjects is based upon uncoerced and otherwise legally-effective informed consent.
  • Risks to human subjects participating are so outweighed by the sum benefit to general human subjects and the importance of the knowledge to be gained as to warrant a decision to allow human subjects to accept these risks.


Additional Online Resources for Patients:

To access the IRB's Policies & Procedures, click:  Mercy Medical Center - DSM IRB Policies & Procedures

Clinical Trials & Research – Investigator Information


The Institutional Review Board (IRB) serves all research sites, clinical sites, and students who are doing research at Mercy Medical Center – Des Moines or one of our clinics.

All human subjects' research carried out at Mercy (or one of its clinics) is required to be reviewed by the IRB.

The IRB processes studies that are supported by industry and involve evaluation of a technology or product such as a drug, surgical procedure, medical device, diagnostic test or technique. Our clinical studies include Phase II – IV studies.


Application Form & Guidelines


In order to determine whether your study will require full board review, can be expedited, or is exempt, contact Susan Allender Volz at irb@mercydesmoines.org for log-in information to IRB Manager.



IRB Oral Presentation Guidelines


Listed below is the information that you will need to present your protocol to the Institutional Review Board. Remember, your presentation is a summary. You will want to keep the information short and the whole presentation around 10 minutes. You will need to present:

  1. Objective of the study
  2. Rationale for the study: Why is it being done?
  3. Research subjects:
    • Disease condition, inclusion & exclusion criteria
    • Number to be enrolled at this site
    • Total number to be enrolled in the study
    • Are the subjects considered vulnerable?
  4. Any unusual aspects about the process of informed consent (i.e. subjects will be decisionally impaired; request waiver of requirement for assent for minor subjects, etc.)
  5. Study sponsor
  6. Potential benefits to subjects
  7. Potential risks to subjects, with estimated probabilities (i.e. very unlikely, likely, highly likely)
  8. Investigator’s assessment of the risk-benefit ratio
  9. Anything else the IRB should know


Initiating an Application to Conduct Research


 

To submit a new study, please contact Susan Allender Volz at irb@mercydesmoines.org

Mercy Medical Center Des Moines IRB now utilizes an online submission system (IRB Manager).  You will need log-in information to access this system.  This will be provided after you contact the IRB office at the email shown above.



Conflict of Interest & Financial Disclosure


What do I need to know about conflict of interest regarding my research?

Federal regulations and Mercy policy require that investigators disclose any significant financial interests that may present an actual or potential conflict of interest in relationship to externally sponsored projects prior to initiation of the study. If you answer, “Yes” to any of the questions on the “Significant Financial Interests in a Sponsored Project – Addendum B” form you must reveal those financial interests on a separate submission before the protocol is reviewed by the full committee.

Federal Code Part 54 requires that investigators disclose financial interests in sponsors of clinical trials. Typically, the corporate sponsor will provide its own disclosure form which details what must be disclosed (royalties, patents, equity interest, etc.) The company’s disclosure form does not serve as a replacement or substitute for the Mercy Financial Disclosure for, and the company’s form should be sent directly to the company, not to the IRB office.

Who is covered?

“Investigator” means the principal investigator, co-investigator, and any other person at Mercy Medical Center who is responsible for the design, conduct, or reporting of research or educational activities funded, or proposed for funding, by an external sponsor. In this context, the term “Investigator” includes the investigator’s family (spouse, domestic partner, and dependent children).

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What must be disclosed?

Each investigator shall disclose all significant financial interests in the funding sponsor that would reasonably appear:

  • To be affected by the research, educational, or service activities funded, or proposed for funding, by an external sponsor, or
  • To present a conflict of interest or the appearance of a conflict of interest in the objective performance of the project.

“Sponsor” means the organization or other entity providing funds.

“Significant financial interests” means anything of monetary value, including, but not limited to, salary or other payments for services (i.e. consulting fees or honoraria); equity interests (i.e. stocks, stock options, or other ownership interests); and intellectual property rights (i.e. patents, copyrights, and royalties from such rights). The term “significant financial interest” includes the following:

  • An entity interest that when aggregated for the investigator and the investigator’s family, meets both of the following tests: exceeds $10,000 in value a determined through reference to public prices or other reasonable measures of fair market value, or, constitutes more than a 5 percent ownership interest in any single entity.
  • Other salary, royalties, or other payments that when aggregated for the investigator and the investigator’s family over the past 12 months does exceeds $10,000 or is anticipated to exceed $10,000 over the 12 month period immediately following the submission execution of the clinical trial agreement.

The term “significant financial interest” does not include the following:

  • Salary, royalties, or other remuneration from Mercy Medical Center.
  • Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities.
  • Income from service on advisory committees or review panels for public or nonprofit entities.

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What is the disclosure procedure?

The principal investigator is responsible for seeing that all investigators disclose their significant financial interest by completing and signing the “Significant Financial Interests in a Sponsored Project – Addendum B” form found with the application. The completed form(s) must be submitted with the Clinical Trial application. By signing the Clinical Trial application the principal investigator certifies that he/she has requested such information from all investigators.

Disclosure material will be considered confidential information to the extent permitted by law.

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