Human Subjects Research

All key personnel involved in human subjects research at the University must have a financial interest disclosure form on file prior to the submission of a Hawk IRB application. If a financial conflict of interest is identified related to a specific project, it must be reviewed and managed prior to the review of the application by the IRB.

This requirement also applies to Non-University of Iowa Team Members named as key personnel on a Hawk IRB application. The Conflict of Interest in Research Office can provide a separate financial interest disclosure form for Non-UI  Team Members. Please contact Martha Hedberg for assistance.

Compelling Justification

Financial conflicts of interest related to human subjects research may present real or perceived risks to the rights and welfare of subjects.   Therefore, such research requires additional scrutiny.  In their report (see aamc_coi_manual.pdf) on this topic, the Association of American Medical Colleges and the Association of American Universities recommend:

"With the welfare of research subjects always of foremost concern, an institution should regard all significant financial interests in human subjects research as potentially problematic and, therefore, as requiring close scrutiny.  Institutional policies should establish the rebuttable presumption that an individual who holds a significant financial interest in research involving human subjects may not conduct such research."

Using this Report as the framework in its Conflict of Interest in Research Policy, the University  will not usually allow an investigator holding a significant financial interest to conduct human studies designed to answer questions about the effects or impact of particular drugs, medical devices, treatments, or diagnostic procedures -- unless there are compelling circumstances for the investigator's participation in the research.    The University takes this position because standard conflict management strategies are inadequate in such research and adequate monitoring plans may be difficult or impossible to implement.  This prohibition applies not only to the principal investigator, but to anyone who is responsible for the design, conduct, or reporting of the research.  Thus, the question for a PI having a significant financial interest is not whether he/she can remain as PI, but whether he/she can remain as an investigator on the study team.

In order  for the Conflict of Interest in Research Committee (CIRC) to determine whether the circumstances surrounding the investigator's involvement are compelling, he/she must provide additional information to the Conflict of Interest in Research Office.  The CIRC will not review the research until the investigator provides the additional information.

The information can be provided in the form of a memorandum.  The memo should include the following:

(1) Nature of the research, including related research conducted by the investigator; goals of the project; phase of the research (early-stage vs. closer to commercialization such as Phase III)

(2) Risk to human subjects

(3) Description of investigator's role in the following activities:

  • subject recruitment
  • determination of subject eligibility
  • consenting subjects for the study
  • data collection
  • conducting study procedures (i.e. administration of study drug; implantation of study device; performance of diagnostic tests/procedures; etc.)
  • assessment of side effects of the study product (adverse events); safety monitoring
  • data analysis
  • publication of study results

(4) The degree to which the investigator's financial interest is related to this project and the extent to which the financial interest could be directly and substantially affected by the outcome of the research

(5) Relevant to the determination of compelling justification, please provide the following information:

  • why the investigator believes that he/she is uniquely qualified by virtue of expertise and experience to conduct the research
  • why the investigator believes the research cannot otherwise be conducted safely or effectively without his/her involvement
  • why the research must be conducted at UI as opposed to another institution
  • why the investigator's participation is necessary in the activities listed in question #3 above

If the CIRC determines that a waiver of the University's policy on prohibition of remaining as an investigator is justified by compelling circumstances, the CIRC will recommend a management strategy to the Vice President for Research and Economic Development.   If approved by the Vice President and signed by the investigator, a copy of the signed management plan will be forwarded to the applicable IRB to use in their deliberations on the project.