All (A - Z) Forms

--GLOSSARY OF OIRB TERMS

10-9012, VA Form - Investigational Drug Information Record

Adverse Device Effect - Notification of Possible UADE

Used to report Unanticipated Adverse Device Effects (UADE) not meeting criteria as UPIRSO (Otherwise report on UPIRSO form) Typically this is the case when an adverse device effect is not unexpected when considering the subjects underlying condition or known circumstances (does not meet UPIRSO criteria) but is unexpected based on protocol documents and meets other criteria as a UADE.

Adverse Event Reporting Form / UPIRSO Reporting Form

(Use AE form if event resulted in physical or psychological harm) -Click this link for Help Determining whether an AE is an Unanticipated problem

Adverse Event Tracking Form (Track both UPIRSO and Events and Problems Not Requiring Prompt Reporting)

Option form. For use when no pre-existing tracking system capable of producing reports is available.

Agreement for Investigators Who are Not Affiliated with One of the Institutions Subject to UTHSCSA IRBs for All Research

Alteration to Consent

(All 3 options ((1) Alteration to Consent, (2) Waiver of Informed Consent Process, or (3) Waiver of Documentation of Informed Consent Process) are available on one form) Form F-Instructions

Amendment to Human Use Protocol

-Instructions for completing the form and submission of documents required

Applicable Radiation Safety Committee (Form GG)

This is not a template. This represents the location of the Approval letter (if any) in the completed submission package.

Application for Access to De-identified Data (or Specimens)(Form I)

Complete Form I if you plan to de-identify data

Assurance for Research on Decedent's Information

Form J-1 - This document is used to notify the IRB that an investigator plans to use or disclosure PHI of decedents (deceased persons); to assure the IRB that it is being requested solely for the purpose of research on the PHI of decedents for the Research Project described; and to assure the IRB that it is necessary for conduct of this Research Project. The researcher agrees that upon request by UTHSCSA or affiliated institution’s Covered Component from whom the PHI is sought, he/she will provide documentation establishing that the Individual’s(s’) whose PHI is/are being requested is/are deceased.

Assurance Letter

A letter containing the UTHSCSA FWA number, numbers of the IRBs listed under this FWA and a list of affiliated institutions covered by the IRB under general IRB Authorization Agreements.

Checklist-Exempt

Checklist-Expedited Application

Checklist-Full Review Application

Required to submit with your appliation. Used to assist you in assembly of your materials.

Children (Request for Research Involving Children) (Form W)

Form W-Instructions

Committee Approvals Information Sheet (Other Committees)

Conflict of Interest (COI) (Protocol Related COI) (Form X)

(Also see HOP Conflicts of Interest and Commitment and HOP Institutional Conflict of Interest Policy as applicable). Form X-Instructions

Consent (Form D)

Form D-Instructions

Consent and Authorization for Pregnant Partners of Participants

CONSENT- SHORT FORM (Illit).doc

Use only after IRB approval to add the consent process that utilizes a SHORT FORM consent process for potential subjects or LARs that are unable to see or read English.Instructions for Short Form Consent-Engl Speaking Blind or Illiterate Subject

Consent Template for Emergency Treatment Use of Investigational Drugs Biologics or Devices

Continuing Review (Progress Report Form)

Progress Report Form-Instructions

Copy of package insert or FDA approved label (PDR reference) (Form S)

Included for drug or device studies with study directed use of FDA approved medication/device for approved medical indication.

CTRC Review Committee (Formerly SACI) (Form HH)

No longer referred to as SACI Review Committee. See Form HH - CTRC Review Committee.

Data and Safety Monitoring Plan (Form R Monitoring Participant Safety and Data Integrity)

(Additional Monitoring Plan Guidance.) Form R -Instructions

Deceased persons PHI: Form J-1 Assurance for Research on Decedent's Information

Form J-1 - This document is used to notify the IRB that an investigator plans to use or disclosure PHI of decedents (deceased persons); to assure the IRB that it is being requested solely for the purpose of research on the PHI of decedents for the Research Project described; and to assure the IRB that it is necessary for conduct of this Research Project. The researcher agrees that upon request by UTHSCSA or affiliated institution’s Covered Component from whom the PHI is sought, he/she will provide documentation establishing that the Individual’s(s’) whose PHI is/are being requested is/are deceased.

Decisionally Impaired (Request for Research Involving) (Form T)

Form T-Instructions

Description of Use of the HUD

Deviations Tracking Log

Click here for-Instructions

Device Form (including Humanitarian Use Device) (Form P)

Form P -Instructions

Device proposal and/or the sponsor’s contract (Form DD)

This is not a template. This represents the location of the Device proposal and/or the sponsor’s contract (if any) in the completed submission package.

Drug - Emergency use

DSMP (Form R Monitoring Participant Safety and Data Integrity)

(Additional Monitoring Plan Guidance.) Form R -Instructions

Durable Power of Attorney for Health Care - sample forms

Patient-Centered Guides: Durable Power of Attorney

Durable Power of Attorney for Health Care sample forms

Internet Legal Research Group

Durable Power of Attorney for Health Care sample forms

Internet Legal Research Group - Forms

Emergency Consent - Consent Template for Emergency Treatment Use of Investigational Drugs, Biologics or Devices

Emergency Consent Template

Emergency ID Card (Sample)

Emergency Treatment Use of Investigational Drugs Biologics or Devices-Consent Template

Emergency Use (Humanitarian Use Device - Report of emergency use without IRB approval)

Only used when an HUD is used in an Emergency without prior IRB approval or by a physician not already approved to use the HUD (in a location not approved)

Example Form U - PregWomen Neonates Fetuses- describing Follow up only

Exempt Certificate (Form B-4)

Exempt Research Request - General Information Sheet (Form B-3)

Exempt Submission Checklist

Expedited Application Checklist

Expedited Certification Form (Form B-1)

Form B-1-Instructions

Expedited Repository Certification Form (Under construction)

FDA approved label (PDR reference) (Form S Copy of package insert)

Included for drug or device studies with study directed use of FDA approved medication/device for approved medical indication.

Fetuses &/or Neonates (Form U)

Form U-Instructions

Final Report (Formerly Final Report, now "Request for Inactivation")

Form A - 1 Multipurpose Signature Assurance Sheet

Form A-1-Instructions

Form A - Signature Assurance Sheet

Form A-Instructions

Form AA - Grant Application

This is not a template. This represents the location of the Grant Application (if any) in the completed submission package.

Form B - General Information Sheet

Form B-Instructions

Form B-1 - Expedited Certification Form

Form B-1-Instructions

Form B-2 Study Personnel List

Form B-2-Instructions

Form B-3 - Exempt Research Request - General Information Sheet

Form B-4 - Exempt Certificate

Form BB - Sponsor's detailed drug protocol

This is not a template. This represents the location of the drug protocol (if any) in the completed submission package.

Form C - Research Description

Form C-Instructions

Form C-1 - Local Repository Description

Form CC - Investigator Brochure

This represents the location of the Investigator Brochure (if any) in the completed submission package.

Form D - Research Consent

Form D-Instructions

Form D-1 - VA Research Consent

(D-1 is an easy to edit version without VA required formatting, intended for use until ICD language is approved. Then the ICD may be converted to the Official VA Consent Template. Only place IRB approved language into the Official VA Consent Template after IRB approval of Form D-1). Form D-1 -Instructions

Form D-2 - Spanish Research Consent

Form D-2-Instructions

Form D-3 - VA Spanish Research Consent

Form D-3-Instructions

Form DD - Device proposal and/or the sponsor’s contract

This is not a template. This represents the location of the Device proposal and/or the sponsor’s contract (if any) in the completed submission package.

Form E - Repository Consent

Form E-1 - VA Repository Consent

Form E-2 - Spanish Repository Consent

Form E-3 - VA Spanish Repository Consent (Under Construction)

Form EE - Institutional Biosafety Committee (IBC)

This is not a template. This represents the location of the Approval letter (if any) in the completed submission package.

Form F Alteration to Consent

(All 3 options ((1) Alteration to Consent, (2) Waiver of Informed Consent Process, or (3) Waiver of Documentation of Informed Consent Process) are available on one form) Form F-Instructions

Form F Waiver of Documentation of Informed Consent Process

(All 3 options ((1) Alteration to Consent, (2) Waiver of Informed Consent Process, or (3) Waiver of Documentation of Informed Consent Process) are available on one form) Form F-Instructions

Form F Waiver of Informed Consent Process

(All 3 options ((1) Alteration to Consent, (2) Waiver of Informed Consent Process, or (3) Waiver of Documentation of Informed Consent Process) are available on one form) Form F-Instructions

Form FF - University Radiation Safety Committee

This is not a template. This represents the location of the Approval letter (if any) in the completed submission package. Form FF-Instructions

Form G - If NIH-sponsored Cooperative Group Clinical Trial, attach the NIH model Consent Form (This is not a template. This represents the location of the model consent (if NIH Study) in the completed submission package.)

Form G-Instructions

Form GG - Applicable Radiation Safety Committee

This is not a template. This represents the location of the Approval letter (if any) in the completed submission package.

Form H-1 Translation Certification Form

(Pertains to subjects from any foreign culture) Form H-1-Instructions

Form HH - CTRC Review Committee

This is not a template. This represents the location of the Approval letter (if any) in the completed submission package.

Form I - HIPAA De-identification Agreement Form

Complete Form I if you plan to de-identify data

Form II - Radioactive Drug Research Committee

Form II - This is not a template. This represents the location of the Approval letter (if any) in the completed submission package.

Form J - HIPAA Waiver of Authorization

Waiver of Authorization Guidance. Form J-Instructions

Form J-1 - Assurance for Research on Decedent's Information

Form J-1 - This document is used to notify the IRB that an investigator plans to use or disclosure PHI of decedents (deceased persons); to assure the IRB that it is being requested solely for the purpose of research on the PHI of decedents for the Research Project described; and to assure the IRB that it is necessary for conduct of this Research Project. The researcher agrees that upon request by UTHSCSA or affiliated institution’s Covered Component from whom the PHI is sought, he/she will provide documentation establishing that the Individual’s(s’) whose PHI is/are being requested is/are deceased.

Form JJ - For VA studies: 10-1086;
10-1223 Report of Subcommittee on Human Studies; and 10-9012 Investigational Drug Information Record

For VA studies: Print, complete and submit as appropriate with protocol to IRB.

Form K - Pre-Notification of the Intent to Conduct Research that includes other Institutions

Required to submit with your application. Used to assist you in understanding the requirements of other institutions beyond IRB approval and to notify those institutions of your intent.

Form L - Proposed advertisement(s) of any type for recruiting (This is not a template. This represents the location of the advertisments (if any) in the completed submission package.

(Required to submit with your application. Used to assist you in understanding the requirements of other institutions beyond IRB approval and to notify those institutions of your intent.) Click here for -Guidelines for Advertising

Form M - Proposed data collection instrument(s) (i.e., survey(s), questionnaire(s)) (This is not a template. This represents the location of the collection instrument(s) (if any) in the completed submission package.)

Form M-Instructions

Form N - Off-site research

Form N-Instructions

Form O - Use of a Drug in Research

Form O-Instructions

Form O-1 - Use of Approved Drug(s) for Unapproved Use

Form O-1-Instructions

Form O-2 - Use of a Placebo in Place of Standard Therapy

Form O-2-Instructions

Form O-2 Use of a Placebo in Place of Standard Therapy

Form O-2-Instructions

Form P - Use of Investigational Device Form (May be Exempt from IDE) (including Humanitarian Use Device)

Form P -Instructions

Form Q - Use of Radiation in Human Research (Radiation Exposure Worksheet)

Form Q-Instructions

Form R - Monitoring Participant Safety and Data Integrity

(Additional Monitoring Plan Guidance.) Form R -Instructions

Form S - Copy of package insert or FDA approved label (PDR reference)

Included for drug or device studies with study directed use of FDA approved medication/device for approved medical indication.

Form T - Research Involving the Decisionally Impaired

Form T-Instructions

Form U - Research Involving Pregnant Women, Fetuses, &/or Neonates

Form U-Instructions

Form V - Research Involving Prisoners

Form V-Instructions

Form W - Research Involving Children

Form W-Instructions

Form X - Protocol Related Conflict of Interest (COI) Report

(Also see HOP Conflicts of Interest and Commitment and HOP Institutional Conflict of Interest Policy as applicable). Form X-Instructions

Form Y - Monitoring Plan - Lead PI

Form Z - Scientific/Ethical Pre-review email from IRB

Form Z Instructions. This is the updated method for Scientific-Ethical IRB Pre-review comments to be sent to the PI and for the PI to provide a point by point response to the IRB.

Full Review Application Checklist

Required to submit with your appliation. Used to assist you in assembly of your materials.

General Information Sheet

Form B-Instructions

--GLOSSARY OF OIRB TERMS

Grant Application (Form AA)

This is not a template. This represents the location of the Grant Application (if any) in the completed submission package.

HDE Progress Report Form

HDE Progress Report Form-Instructions

HIPAA De-identification Agreement Form (Form I)

Complete Form I if you plan to de-identify data

HIPAA Waiver of Authorization (Form J)

Waiver of Authorization Guidance. Form J-Instructions

Humanitarian Use Device - Report of Emergency Use (HUD used without IRB approval)

Only used when an HUD is used in an Emergency without prior IRB approval or by a physician not already approved to use the HUD (in a location not approved)

Humanitarian Use Device (Form P)

Form P -Instructions

Impaired Subjects (Form to request inclusion) (Form T)

Form T-Instructions

Incompetent Subjects (Form to request inclusion) (Form T)

Form T-Instructions

Information Sheet / Letter

Checklist for Information sheet

Institutional Biosafety Committee (IBC) (Form EE)

This is not a template. This represents the location of the Approval letter (if any) in the completed submission package.

Instructions for Short Form Consent-non-Engl Speaking Subject-no translation.doc

Used with CONSENT-SHORT FORM

Internet Legal Research Group

Durable Power of Attorney for Health Care sample forms

Internet Legal Research Group - Forms

Durable Power of Attorney for Health Care sample forms

Investigational Drug Information Record, VA Form 10-9012

Investigator Brochure (Form CC)

This represents the location of the Investigator Brochure (if any) in the completed submission package.

IRB Authorization Agreement Form

Letters of Support or Memorandum of Understanding for Off-site Research

Letters of Support Instructions

Local Repository Description (Form C-1)

Log for Tracking Adverse Events (Track both UPIRSO and Events and Problems Not Requiring Prompt Reporting)

Option form. For use when no pre-existing tracking system capable of producing reports is available.

Modification to Human Use Protocol

-Instructions for completing the form and submission of documents required. AKA Amendment to Human Use Protocol Also see Amendment Checklist

Monitoring Participant Safety and Data Integrity (Form R)

(Additional Monitoring Plan Guidance.) Form R -Instructions

Monitoring Plan - Lead PI (Form Y)

Multipurpose Signature Assurance Sheet (Form A-1)

Form A-1-Instructions

Neonates (Form U)

Form U-Instructions

NIH model Consent Form (Form G)

Form G-Instructions

Non-Adverse Event / UPIRSO Reporting Form for Non-AE

(Use Non-AE form where no physical or psychological harm resulted whether medical or nonmedical event) -Click here for Help Determining whether a non_AE is an Unanticipated problem

Noncompliance Report

Used to self report noncompliance with federal regulations or IRB Policies as well as major deviations. -Click here for Instructions for completing the Report of NonCompliance

Non-English/Non-Spanish speaking subjects, attach translated consent document for recruitment (Form H )(This is not a template. This represents the location of the translated consent in the completed submission package.)

(Info pertaining to subjects from a foreign culture) Form H-Instructions

Non-Human Research Request

Non-Research Request

Notification of Adverse Device Effect - Possible UADE

Used to report Unanticipated Adverse Device Effects (UADE) not meeting criteria as UPIRSO (Otherwise report on UPIRSO form) Typically this is the case when an adverse device effect is not unexpected when considering the subjects underlying condition or known circumstances (does not meet UPIRSO criteria) but is unexpected based on protocol documents and meets other criteria as a UADE.

Off-site research (Form N)

Form N-Instructions

Other Committee Approvals Information Sheet

Package insert or FDA approved label (PDR reference) (Copy)

Included for drug or device studies with study directed use of FDA approved medication/device for approved medical indication.

Partner Consent and Authorization (Pregnant Partners of Participants)

Patient-Centered Guides: Durable Power of Attorney

Durable Power of Attorney for Health Care - sample forms

Placebo In Place of Standard Therapy (Form O-2)

Form O-2-Instructions

Pregnant Women Fetuses &/or Neonates (Form U)

Form U-Instructions

Pre-Notification of the Intent to Conduct Research that includes other Institutions (Form K)

Form K - Required to submit with your application. Used to assist you in understanding the requirements of other institutions beyond IRB approval and to notify those institutions of your intent.

Prisoners (Request for Research Involving) (Form V)

Form V-Instructions

Progress Report Form

Progress Report Form-Instructions

Progress Report Form for Repository

Repository Progress Report Form-Instructions

Progress Report Form-HDE

HDE Progress Report Form-Instructions

Proposed advertisement(s) of any type for recruiting (Form L)

(Required to submit with your application. Used to assist you in understanding the requirements of other institutions beyond IRB approval and to notify those institutions of your intent.) Click here for -Guidelines for Advertising

Proposed data collection instrument(s) (i.e. survey(s) questionnaire(s)) (Form M)

Form M-Instructions

Protocol Deviations Tracking Log

Click here for-Instructions

Protocol Related Conflict of Interest (COI) (Form X)

(Also see HOP Conflicts of Interest and Commitment and HOP Institutional Conflict of Interest Policy as applicable). Form X-Instructions

Radiation in Human Research (Radiation Exposure Worksheet) (Form Q)

Form Q-Instructions

Radioactive Drug Research Committee (Form II)

Form II - This is not a template. This represents the location of the Approval letter (if any) in the completed submission package.

Report of Emergency Use (Humanitarian Use Device - HUD used without IRB approval)

Only used when an HUD is used in an Emergency without prior IRB approval or by a physician not already approved to use the HUD (in a location not approved)

Report of Noncompliance

Used to self report noncompliance with federal regulations or IRB Policies as well as major deviations. -Click here for Instructions for completing the Report of NonCompliance

Repository Consent (Form E)

Repository Progress Report Form

Repository Progress Report Form-Instructions

Repository VA Consent (Form E-1)

Request for Inactivation (Formerly "Final Report")

Request for Research Involving Prisoners (Form V)

Form V-Instructions

Request for Review of Project not Involving Research OR Research not Involving Human Subjects

Research Consent (Form D)

Form D-Instructions

Research Description (Form C)

Form C-Instructions

Research Involving Children (Form W)

Form W-Instructions

Research Involving Pregnant Women Fetuses &/or Neonates (Form U)

Form U-Instructions

Research Involving the Decisionally Impaired (Form T)

Form T-Instructions

Research not Involving Human Subjects OR Non-Research

SACI Review Committee (Changed to CTRC Review Cte Form HH)

No longer referred to as SACI Review Committee. See Form HH - CTRC Review Committee.

Scientific/Ethical Pre-review email from IRB (Form Z)

Form Z Instructions. This is the updated method for Scientific-Ethical IRB Pre-review comments to be sent to the PI and for the PI to provide a point by point response to the IRB.

Signature Assurance Sheet (Form A)

Form A-Instructions

Signature Assurance Sheet-Multipurpose (Form A-1)

Form A-1-Instructions

Spanish Repository Consent (Form E-2)

Spanish Repository Consent for VA (Form E-3 ) (Under Construction)

Spanish Research Consent (Form D-2)

Form D-2-Instructions

Spanish Research VA Consent (Form D-3)

Form D-3-Instructions

Sponsor’s detailed drug protocol (Form BB)

This is not a template. This represents the location of the drug protocol (if any) in the completed submission package.

Telephone Script

Tracking Log for Events and Problems (Track both UPIRSO and Events and Problems Not Requiring Prompt Reporting)

Option form. For use when no pre-existing tracking system capable of producing reports is available.

Tracking Log for Protocol Deviations

Click here for-Instructions

Translation Certification for consent forms requiring translation

(Pertains to subjects from any foreign culture) Form H-1-Instructions

UADE Report - Notification of Possible Adverse Device Effect

Used to report Unanticipated Adverse Device Effects (UADE) not meeting criteria as UPIRSO (Otherwise report on UPIRSO form) Typically this is the case when an adverse device effect is not unexpected when considering the subjects underlying condition or known circumstances (does not meet UPIRSO criteria) but is unexpected based on protocol documents and meets other criteria as a UADE.

University Radiation Safety Committee (Form FF)

This is not a template. This represents the location of the Approval letter (if any) in the completed submission package. Form FF-Instructions

UPIRSO Reporting Form / Adverse Event

(Use AE form if event resulted in physical or psychological harm) -Click this link for Help Determining whether an AE is an Unanticipated problem

UPIRSO Reporting Form / Adverse Event (Resuled in physical or psychological harm)

(Use AE form if event resulted in physical or psychological harm) -Click this link for Help Determining whether an AE is an Unanticipated problem

UPIRSO Reporting Form / Non-Adverse Event (Medical or nonmedical but no physical or psychological harm resulted)

(Use Non-AE form where no physical or psychological harm resulted whether medical or nonmedical event) -Click here for Help Determining whether a non_AE is an Unanticipated problem

UPIRSO Tracking Log for Events and Problems (Track both UPIRSO and Events and Problems Not Requiring Prompt Reporting)

Option form. For use when no pre-existing tracking system capable of producing reports is available.

Use of a Drug in Research (Form O)

Form O-Instructions

Use of Approved Drug(s) for Unapproved Use (Form O-1)

Form O-1-Instructions

Use of Device Form (including Humanitarian Use Device) (Form P)

Form P -Instructions

Use of Radiation in Human Research (Radiation Exposure Worksheet) (Form Q)

Form Q-Instructions

UTHSCSA UPIRSO Policy

VA Form 10-9012 Investigational Drug Information Record

VA Repository Consent (Form E-1)

VA Research Consent (Form D-1)

(D-1 is an easy to edit version without VA required formatting, intended for use until ICD language is approved. Then the ICD may be converted to the Official VA Consent Template. Only place IRB approved language into the Official VA Consent Template after IRB approval of Form D-1). Form D-1 -Instructions

VA Spanish Repository Consent (Form E-3) (Under Construction)

VA Spanish Research Consent (Form D-3)

Form D-3-Instructions

VA studies (Form JJ): 10-1086;
10-1223 Report of Subcommittee on Human Studies; and 10-9012 Investigational Drug Information Record

For VA studies: Print, complete and submit as appropriate with protocol to IRB.

Waiver of Documentation of Informed Consent Process

(All 3 options ((1) Alteration to Consent, (2) Waiver of Informed Consent Process, or (3) Waiver of Documentation of Informed Consent Process) are available on one form) Form F-Instructions

Waiver of Informed Consent Process

(All 3 options ((1) Alteration to Consent, (2) Waiver of Informed Consent Process, or (3) Waiver of Documentation of Informed Consent Process) are available on one form) Form F-Instructions

Worksheet to Determine Whether an Activity is Human Research