Documents

IRB Monitoring Report.doc

IRB Sample Amendment form.doc

IRB Summary Report.doc

Unanticipated Problem Report Form.doc

IRB Sample Letter of Authorization.doc

Sample Consent, Assent and Permission Form.pdf

Leadership and Change IRB Guidelines (PDF)

IRB Handbook (PDF)

Office for Human Research Protections (OHRP) Links

OHRP International Regulations & Guidelines

OHRP Decision Tree Questions

OHRP Chart 1 Is an Activity Research Involving Human Subjects?

OHRP Chart 2 Is the Human Subjects Research Eligible for Exemption?

OHRP Chart 3 Does Exemption for Educational Settings Apply?

OHRP Chart 4 Does Exemption for Tests, Surveys, Interviews, Public Behavior Observation Apply?

OHRP Chart 5 Does Exemption for Existing Data, Documents, Records and Specimens Apply?

OHRP Chart 6 Does Exemption for Public Benefit or Service Programs Apply?

OHRP Chart 7 Does Exemption for Food Taste and Acceptance Studies Apply?

OHRP Chart 8 May the IRB Review Be Done by Expedited Procedures?

OHRP Chart 9 May the IRB Continuing Review Be Done by Expedited Procedures?

OHRP Chart 10 May Informed Consent Be Waived or Consent Elements Be Altered?

OHRP Chart 11 May Documentation of Informed Consent Be Waived?