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

• 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

• 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.

• Human Subject - 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

Institutional Review Boards

• All research involving human subjects at MU must be approved by the IRB prior to initiation of the project.

• Any changes in the protocol, consent form, or survey instruments must be approved by the IRB.

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

• 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

• 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

• Internal and external funds will be held until approval by either the Health Sciences or the Campus IRB is obtained.