Guidance Documents

The following information is intended to provide assistance for completing an IRB Protocol Application. Additional instructions and guidance information can be found on OneAegis. You may also contact IRB@msoe.edu for further guidance and to schedule a consultation.

• Informed Consent
  • It is the responsibility of the PI to assess the comprehension of the consent process and only enroll participants who can demonstrate informed understanding of the research study (45CFR46.116).

• Risk Analysis
  • All human research has some degree of risk. PIs will identify potential risks, estimated frequency and magnitude of consequence inherent in the proposed study.

MSOE Grant Policies and Procedures

Please review the MSOE Grant Policies and Procedures webpage for additional information on seeking outside funding and sponsored research.

Additional Resources

• Office for Human Research Protections (OHRP)
  • The Office for Human Research Protections provides clarification and guidance, develops educational programs and materials, maintains regulatory oversight and provides advice on ethical and regulatory issues in biomedical and behavioral research.
• SMART IRB
  • SMART IRB is an online platform designed to ease common challenges associated with initiating multi-site research. To use SMART IRB for a multi-site study, send an email to IRB@msoe.edu