RESEARCH COMPLIANCE: Health Sciences Institutional Review Board

1. RESEARCH COMPLIANCE: Health Sciences Institutional Review Board

2. 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.

3. 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.

4. 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

5. 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.

6. 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.

7. 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.

8. 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)

9. 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.