The IRB is responsible for protecting the rights and welfare of human subjects in research as set forth in the Ethical Principles and Guidelines for the Protection of Human Subjects in Research (Belmont Report) and the Code of Federal Regulations (45 CFR 46 and 21 CFR 56), and for assuring compliance with federal, state and local laws as they may relate to the participation of human subjects in research.
Akron Children's IRB has the authority to approve, require modifications in, or disapprove any human subject research. We follow policies and procedures in accord with OHRP Guidance on Written IRB Procedures.
Criteria for Approval
- Risks minimized
- Risks balanced by benefits
- Selection of subjects is equitable
- Procedures for obtaining informed consent
- Procedures for documentation of consent
- Data monitoring provision
- Privacy and confidentiality measures
- Safeguards for vulnerable subjects
Compliance with the IRB Regulation and Decisions
- Research investigators shall be responsible for complying with IRB decisions, conditions and requirements. Failure to comply with application, amendment, reporting, record keeping, informed consent or any other IRB requirements may result in suspension or termination of the research approval by the IRB.
- Any audits by outside or internal groups of research compliance must be forwarded promptly to the IRB. The IRB may require an audit of research compliance if concerns about conduct are reported to it or complaints are received.
- If there are concerns about statements made on data submitted for review based on discrepancies of IRB files and investigator assertions, the IRB will request an internal review of the conduct of research by the hospital compliance officer.
For information on how to submit to the IRB, contact the IRB coordinator at 330-543-3691 or IRB@akronchildrens.org.
