The Juvenile Justice Professional's Guide to
Human Subjects Protection and the IRB Process
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Assurance and Educational Training
Federalwide Assurance
IRB Membership
IRB Meetings
IRB Voting
IRB Research Review Process
Types of IRB Review
Issues Relevant to the IRB Review Process
Modificationof Amendment of the Research Project
Project Suspension or Termination
Re-certification of Research Project
Non-compliance with Human Subjects Regulations
Assurance and Educational Training
 
OHRP strongly recommends that the Authorized Institutional Official, the IRB Chair, and the IRB Research Administrator to complete the relevant OHRP Assurance Training Modules or comparable training that includes the content of the OHRP modules. These modules describe the major responsibilities that must be fulfilled under the Assurance by these IRB officials.

OHRP recommends that the institution and the IRB develop educational training materials and establish training requirements for IRB members, research investigators, and other institutional personnel who have access to human subjects or to identifying confidential information. Training materials should encompass relevant ethical principles and Federal regulations, state and local laws, OHRP and other applicable training assistance, and institutional policies that protect human research subjects. OHRP further recommends that IRB members should fulfill human subjects protection training requirements before reviewing human subjects research. Likewise, investigators and other relevant personnel should complete this training before conducting human subjects research.

Federal Assurance requires the institution to prepare written procedures and guidelines to be followed by the IRB for initial and continuing review, for reporting its findings and actions to the investigator and to the institution, and for suspending or terminating IRB approval. Procedures must also define investigator reporting processes for research protocol submission, proposed protocol changes, unanticipated risks, and noncompliance with Federal policy or IRB determinations.

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