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Institutional Review Board

IRB Training

All OSCC IRB Members must complete Human Subject Assurance Training. To access the sites, click on the link below.

Human Subject Assurance Training

Investigators must also complete training and provide evidence of completion as part of the documents submitted to the IRB for review. An "Investigator 101" CD ROM is available from the OSCC IRB Administrator.

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. To access the Protecting Human Research Participants Course, click on the link below.

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. To access Protecting Human Subjects Training, click on the link below.

Protecting Human Subjects Training

Resources

OSCC IRB Handbook for Investigators - under construction

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.

To access the OHRP flowcharts, click on the link below.
Human Subject Regulations Decision Charts

Forms

Complete and send to 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.

Exempt Human Subjects Protocol Form

Guidance for Exempt Human Subjects Protocol Form Completion

Research topics that do not meet the criteria for exempt 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.

Full Protocol Form

Guidance for Full Human Subjects Protocol Form Completion

The principal investigator will complete the "Permission to Access Resources Form", submit it to the Vice President/Provost for signature, and include the signed permission form in the materials provided to the Institutional Review Board for review.

Permission to Access Resources Form

Post Approval Forms

Modification Request Form

Adverse Event Report Form

Renewal /Completion Form

Continuing Review and/or Final Report Form

Protection of Human Subjects Training Forms

Investigator Training Documentation Form

IRB Member Training Documentation Form

 


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