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RESEARCH COMPLIANCE: Health Sciences Institutional Review Board. Suspensions of Human Subject Research by OPRR. Rush-Presbyterian-St. Luke’s Medical Center, Chicago University of Illinois, Chicago Duke Medical Center University of Colorado Health Sciences Center

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suspensions of human subject research by oprr
Suspensions of Human Subject Research by OPRR
  • Rush-Presbyterian-St. Luke’s Medical Center, Chicago
  • University of Illinois, Chicago
  • Duke Medical Center
  • University of Colorado Health Sciences Center
  • University of Southern Florida
  • Virginia Commonwealth Univ. & Medical College of Virginia
  • University of Alabama, Birmingham
  • University of Pennsylvania

Not new regulations but better enforcement of existing regulations.

common reasons for suspensions
Common Reasons for Suspensions
  • Human subjects research was conducted without IRB approval.
  • Insufficient continuing reviews of active projects.
  • Lack of adequate training/education programs for IRB members and investigators.
  • Lack of institutional support for IRB personnel and space.
  • Inadequate IRB meetings, discussions, and minutes.
definitions
Research- a systematic investigation, including research development, testing & evaluation, designed to develop or contribute to generalizable knowledge.

HumanSubject - a living individual about whom an investigator (whether professional or student conducting research) obtains

data through intervention or interaction with the individual

identifiable private information

Definitions
institutional review boards
Institutional Review Boards
  • All research involving human subjects at MU must be approved by the IRB priorto initiation of the project.
  • Anychanges in the protocol, consent form, or survey instruments must be approved by the IRB.
irb duties
IRB Duties
  • To protect the rights and welfare of human subjects involved in research projects conducted at or sponsored by UMC.
  • To review, approve, require modification, or disapprove all research activities involving the use of human subjects.
  • To approve changes in previously approved research.
  • To provide continuing review of all research activities.
types of review
Types of Review
  • Exempt: Projects involving very low-risk protocols, such as anonymous surveys, are reviewed by the IRB Compliance Officer.
  • Expedited: Projects involving minimal risk (no greater risk than what one would encounter in everyday life) are reviewed by one or more board members.
  • Full Board: Projects that present greater than minimal risk or significant risk are reviewed by the entire board.
  • It is the determination of the IRB whether what you propose to do constitutes research.
choosing the appropriate forum
Choosing the Appropriate Forum
  • As a student in the Department of Health Management & Informatics, you should apply to the MU Health Sciences IRB
  • The homepage for the Health Sciences IRB can be found at http://www.research.missouri.edu/hsirb
  • Complete online training by logging on at https://irb.missouri.edu/eirb/gen4/User/Login/ with your PawPrint and password then select the link than says compliance training
  • Create a new application by logging on at https://irb.missouri.edu/eirb/gen4/User/Login/ with your PawPrint and password then select the link than says IRB Forms (and then Health Sciences IRB Forms)
something to keep in mind
Something to Keep in Mind
  • Internal and external funds will be held until approval by either the Health Sciences or the Campus IRB is obtained.