Training & Forms
Institutional Review Board (IRB) Training
All OSCC IRB Members and investigators are required to complete Human Subjects Assurance Training every three years.
Evidence of completed Human Subjects training within the last three years must be submitted to the IRB along with proposals to be reviewed.
Free training modules with a printable certificate of completion are available through the Office of Human Research Protections.
Access Human Subjects Assurance Training
Additional Training
National Institutes of Health Investigators working with the OSCC IRB must complete Protection of Human Subjects Training and provide evidence of completion as part of the documents submitted to the IRB for review.
Access the Protecting Human Research Participants Course
The Health Resources and Services Administration also requires that staff and grantees complete Protecting Human Subjects training and provide evidence of completion as part of the documents submitted for IRB review.
Access the Protecting Human Subjects Training
Resources
The Office for Human Research Protections (OHRP) provides graphic aids to assist IRBs, investigators and institutions in their decision-making process. Topics covered include:
- Whether an activity is research that must be reviewed by an IRB
- Whether the research is eligible for exemption
- Whether the review may be performed by expedited procedures, and
- Whether informed consent or its documentation may be waived
Review the OHRP flowcharts.
Access the Human Subject Regulations Decision Charts
Forms
Complete and send to the IRB Administrator either an Exempt Protocol or Full Protocol form to initiate the IRB process.
Pre-Approval Forms
Under federal regulations, six types of research are exempt from federal policy. The IRB, not the investigator, shall make the determination as to whether a project is or is not exempt.
To obtain an exemption, an investigator must file an exemption request citing the specific exemption category and providing justification for the exemption.
Prospective Principle Investigators (PIs) seeking an exemption will follow the “Guidance for Exempt Human Subjects Protocol Form Completion” and submit one (1) original of the “Exempt Human Subjects Protocol Form” to the IRB Administrator.
The protocol may be submitted electronically as a portable document file (pdf); however, page 2 with original signatures must be provided separately.
View Exempt Human Subjects Protocol Form (PDF)
Review Guidance for Exempt Human Subjects Protocol Form Completion (PDF)
Research topics that do not meet the criteria for exemption will be reviewed by the full IRB. Prospective Principal Investigators (PIs) will follow the “Guidance for Full Human Subjects Protocol Form Completion” and submit one (1) original of the Full Protocol Form to the IRB Administrator. The protocol may be submitted electronically as a portable document file (pdf); however, page 2 with original signatures must be provided separately.
View Guidance for Full Human Subjects Protocol Form Completion (PDF)
The principal investigator will complete the “Permission to Access Resources Form”, submit it to the Vice President of Academic Affairs for signature, and include the signed permission form in the materials provided to the Institutional Review Board for review.
Submit Permission to Access Resources Form (PDF)
Post-Approval Forms
Get Modification Request Form (PDF)
Get Adverse Event Report Form (PDF)