IRB-01 Forms

myIRB: submit new studies electronically. Click here to learn more.

Last Updated:

Adverse Event Reporting Form
	Reporting Guide , Definitions	-click here to view how the AER form changed on 03/23/2012.

3/23/2012

Study Closure Report: no subjects enrolled

02/10/2012

Study Closure Report: subjects enrolled

02/10/2012

Confidentiality Agreement for Data and/or Specimens
Click here to see what's difference since the last version.

04/20/2012

Continuing Review
	-Continuing Review Requirements (updated 4/16/2007) -When should you submit your Continuing Review Report? -Please read our Announcement about this form.

04/18/2013

Cumulative Adverse Event Table for Continuing Review
	(EXCEL version)

04/29/2004

Cumulative Deviation Table for Continuing Review
	Click here to see how the Deviation table changed on 05/09/13

05/09/2013

Deviation/Non-Compliance Reporting Form (single occurence, reporting in 5 days)
	(Reporting Guide & Definitions, Minor Deviation Table for Continuing Review updated 01/29/09) Click here to see how the Deviation table changed on 01/29/09

06/13/2008

Emergency Use
	Emergency Use Checklist Emergency Use Consent (if one not available from sponsor) Emergency Use Independent Physician Certification

06/13/2008
12/15/2006
12/15/2006
06/13/2008

Explicit Change Response

06/12/2008

Full Board Meeting Correction
-11/26/08: only change was to update the meeting dates that you are requesting the corrections to be considered at.

11/20/2010

HDE - new submission
	(Humanitarian Use Device with Humanitarian Device Exemption) -11/26/08: only change was to update the meeting dates that you are requesting the new HDE to be considered at.

11/26/2008

HDE - Continuing Review/Closure
	(Humanitarian Use Device with Humanitarian Device Exemption)

06/13/2008

HIPAA - Certificate for Preparatory Research (UF/Shands version)

06/22/2007

HIPAA - Certificate for Research with Decedents Info (UF/Shands version).

09/20/2011

HIPAA - Disclosure Tracking Log: Research
	For research that has obtained a Waiver of HIPAA Authorization. Link will take you to the Privacy Website.

HIPAA - Waiver of Authorization
	-What's different since the last version?

05/31/2012

Informed Consent Forms
	Use this link to visit a separate page dedicated to Informed Consent Forms. All of the different templates are available as well as other resources and instructions.

Introductory Questionnaire for Data Transfer Studies
	This is only to be used by faculty who are new to / joining UF who are simply bringing their previously collected research data with them for continued analysis. No additional study interventions or data collection remain.

IQ Addenda:

A: Researcher Assurance

04/20/2012

Introductory Questionnaire for Full Board ~~and Expedited~~ Studies
	Click here to see what's different since the last version

IQ Addenda:	A: Researcher Assurance	K: Children
	B: Banking	L: Conflict of Interest
	C: Drugs	M: Expedited Review
	D: Devices	N: Data Safety Monitoring Plan
	E: Experimental Procedures	P: Prisoners
	F: Radiation or Radioactive Materials	Q: International Research
	G: Gene Therapy or Genetic Testing	S: Behavioral or Psychological Research
	H: Informed Consent Waiver to Enroll Subjects	U: Department of Defense
	I: Deception or Placebo	V: VA
	J: Vulnerable Subjects	W: Pregnant Women, Fetuses, and Neonates

02/24/2012

I~~ntroductory Questionnaire for Nonhuman/Exempt Studies~~
	Revised to update the link to the HIPAA Waiver form.
IQ Addenda:	A~~: Researcher Assurance~~	O~~: Request for Exempt Review~~

NOTE: effective 09/01/2012 we no longer accept new Exempt, Nonhuman, Expedited or Retrospective Record/Chart/Data Review studies on the paper version of the IQ forms above and below. New protocols of these types must be submitted via myIRB. Click here to read our announcment.

07/06/2012

I~~ntroductory Questionnaire for Retrospective Record/Chart/Data Review Studies~~
	Revised to update the link to the HIPAA Waiver form.
IQ Addenda:	~~A: Researcher Assurance~~	~~M: Expedited Review~~
	~~H: Informed Consent Waiver to Enroll Subjects~~	~~R: Review of Shands Medical Records~~

07/05/2012

Introductory Questionnaire for Tissue/Data Banks
	-click here to see what's different since the last version.

IQ Addenda:	A: Researcher Assurance	N: Data Safety Monitoring Plan
	H: Informed Consent Waiver to Enroll Subjects	V: VA

2/28/2013

Principal Investigator Change
	Revision to permanently change the PI - signed by the old/departing PI and the new PI Must also submit the Revision form. Note: changing the PI on a study that is normally reviewed at the full Board must also be reviewed at full Board, so please take note of our full Board deadlines.

06/13/2008

Protocol
	"Sample" protocol with helpful information to remember/consider when writing your protocol. Read Protocol Template Guidelines before completing the protocol form. You may use the sponsor's protocol or GCRC protocol if available.