IRB FORMS

NOTICE
Change in Submission of Amendment Requests

As of July 18, 2006, the IRB is no longer accepting Hard Copy/Paper Amendments Requests. All amendments must be submitted electronically.

http://erma.musc.edu/cgi-bin/irb_hrra/admin/index.cgi

 See Decision Charts:
http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm

Select one to initiate IRB submission:
		Not Human Research Request	On-line Form
		Exempt Research	On-line Form
		Human Research Review Application	On-line Form
		(Expedited of Full Board)
Protocol
		Protocol Form
	Attachments (Access attachments for the initial review through the Human Research Review Application)
		Off-Campus Study Site
		Request for Expedited Review
		Internally Sponsored or Unsponsored Research
		Non-Sponsored Budget Form
		Investigational New Drug (IND) Information Sheet (Drug A)
		Marketed Drug(s) Only Information Sheet (Drug B)
		Oncology Group/NCI Protocol Only Drug Information Sheet (Drug C)
		Medical Device (IDE) Information Sheet (Drug D)
		Late Submission Approval (IRB I and II only)
		Human Research Conflict of Interest Disclosure
		PI Statement of Assurance/Signature Page
	Informed Consent
		Guidelines for standard informed consent
		Waiver of Signed Consent
		Waiver of Consent
		Guidelines and consent for tissue collection - excess surgical /diagnostic
		Guidelines and consent for tissue collection - autopsy
HIPAA
		HIPAA Authorization
		HIPAA Waiver of Authorization
		HIPAA De-identication form
		Limited Data Set/Data Use Agreement
Amendments and Change Requests
		Create an Amendment	On-line Form
		Protocol Deviation Report Form
		Cover Page for Updated Investigator Brochure
Continuing Review Form
Adverse Events
		Adverse Events Forms	On-line form
All Veteran's Administration Forms