GLOSSARY OF OIRB TERMS

10-9012, VA Form - Investigational Drug Information Record (Form Inst-F)

Adverse Event Reporting / UPIRSO Reporting
(Prompt 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)

Optional 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
     (One Non-Affiliated Investigator, One Study)

Agreement for Investigators Who are Not Affiliated with One of the Institutions Subject to UTHSCSA IRBs for All Research
    (Multiple Non-Affiliated Investigators, One Study)

• Submit:
  • Signed Part A for each unaffiliated investigator
  • Signed Part B for each study listing all unaffiliated investigators

Alteration to Consent

This is a BLANK template for when consent will be obtained but not all required elements of consent will be presented to the subject (i.e., verbal consent)

Amendment to Human Use Protocol

Assent Waiver Request

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.

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

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

See HOP Conflicts of Interest in Scholarly, Research, and Clinical Activity, HOP Conflict of Commitment, and HOP Institutional Conflict of Interest Policy as applicable.

Consent (Form D)

For non-VA studies only.
Combined research consent + HIPAA authorization.
For research studies contributing to another repository, refer to the informed consent instructions for repositories.

Consent and Authorization for Pregnant Partners of Participants

CONSENT- SHORT FORM - ENGLISH

Submit an amendment to request IRB approval to utilize a SHORT FORM consent process for potential subjects or LARs that are non-English speaking and there is not enough time to obtain a translation (the English version is provided here to be translated in the appropriate language).

CONSENT- SHORT FORM - SPANISH

Submit an amendment to request IRB approval to utilize a SHORT FORM consent process for potential subjects or LARs that are non-English speaking and there is not enough time to obtain a translation. This is the Spanish version.

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

Continuing Review (Progress Report Form)

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)

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)

Deviations Tracking Log

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

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

This is not an IRB template. Include the form (if applicable) with your submission.

Drug - Emergency use - Consent

Drug Information Record (Investigational Drug Information Record) (Form Inst-F)

DSMP (Form R Monitoring Participant Safety and Data Integrity)

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 ID Card (Sample)

Emergency Use of Investigational Drugs Biologics or Devices-Consent Template

Exception Request Form

Refer to the Modifications and Amendments Policy and Procedure

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

Expedited Certification Form (Form B-1)

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 (Form U)

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

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

Form A - 1 Multipurpose Signature Assurance Sheet

Should be submitted with all forms required after approval (amendments, progress reports, prompt reporting).

How to digitally sign Adobe forms.

Form A - Signature Assurance Sheet

Required for initial submission.

How to digitally sign Adobe forms.

Form AA - Grant Application

This is not an IRB template. Include the document (if applicable) with your submission.

Form B-1 - Expedited Certification Form

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

Form BB - Sponsor's protocol

This is not an IRB template. Include the document (if applicable) with your submission.

Form C-1 - Local Repository Description

Form CC - Investigator Brochure

This is not an IRB template. Include the document (if applicable) with your submission.

Form D - Research Consent

For non-VA studies only.
Combined research consent + HIPAA authorization.
For research studies contributing to another repository, refer to the informed consent instructions for repositories.

Form D-1 - VA Research Consent

For VA studies and studies where VA is a site.
Research consent only (does not include HIPAA authorization - Refer to Forms H-UT & H-VA)

For research studies contributing to another repository, refer to the informed consent instructions for repositories.

Form D-2 - Spanish Research Consent

Form D-IS (Information Sheet)

Template to use when developing informatiton sheet. Differs from consent in that it does not contain a signature section.

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

This is not an IRB template. Include the document (if applicable) with your submission.

Form E - Repository Consent

Form E-1 - VA Repository Consent

Form E - 2 - Spanish Repository Consent

Form EE - Institutional Biosafety Committee (IBC)

This is not an IRB template. Include the document (if applicable) with your submission.

Form F - BLANK Template

This is a BLANK template for one of the following: (1) Alteration to Consent (not all required elements of consent will be presented) (2) Waiver of Informed Consent Process (When consent is not obtained) (3) Waiver of Documentation of Informed Consent Process (consent will be obtained but a signature will not)

Form F - SAMPLE waiver of consent for Chart Review Study

This is PRE-POPULATED form which contains acceptable template wording when requesting a waiver of consent to complete a chart review study.

Form F - SAMPLE Alteration and waiver of documentation of consent for research procedures prior to full consent

This is PRE-POPULATED form which contains acceptable template wording when requesting an alteration and waiver of signature to obtain abbreviated verbal consent for procedures completed prior to full informed consent (e.g. request subject to answer screening questions or attend screening visit in fasting state). Include the Form L – Phone Script in the submission.

Form F - SAMPLE waiver of consent for Recruitment

This is PRE-POPULATED form which contains acceptable template wording when requesting a waiver of consent to identify eligible subjects for recruitment.

Form G - Model Consent Form

This is not an IRB template. Include the document (if applicable) with your submission.

Form GG - Applicable Radiation Safety Committee

This is not an IRB template. Include the document (if applicable) with your submission.

Form H-1 Translation Certification Form

To be turned in with translated consent form. Pertains to subjects from any foreign culture.

Form HH - CTRC Review Committee

This is not an IRB template. Include the document (if applicable) with your submission.

Form I - HIPAA De-identification Agreement Form

Complete Form I if a covered entity will remove the identifiers. The de-identified data or specimens will be released to the PI from a covered entity.

Form II - Radioactive Drug Research Committee

Form Inst-F - Investigational Drug Information Record

Form J - HIPAA Waiver of Authorization

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

This is not an IRB template. Include the document (if applicable) with your submission. Guidelines for Advertising

Form M - Proposed data collection instrument(s) used to record data (i.e., CRF, Excel spreadsheet, survey, questionnaire)

This is not an IRB template. Include the document (if applicable) with your submission.

Form O - Use of a Drug in Research

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

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

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

Form R - Monitoring Participant Safety and Data Integrity

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 tA (Treatment Use)

For use in a form of Expanded Access called "Treatment Use" or Investigational Treatment Use of an Unapproved drug/device.

Form tB - General Information Sheet (Treatment Use)

For use in a form of Expanded Access called "Treatment Use" or Investigational Treatment Use of an Unapproved drug/device.

Form tB-2 - Study Personnel List (Treatment Use)

For use in a form of Expanded Access called "Treatment Use" or Investigational Treatment Use of an Unapproved drug/device.

Form tC - Research Description (Treatment Use)

For use in a form of Expanded Access called "Treatment Use" or Investigational Treatment Use of an Unapproved drug/device.

Form tO - Investigational New Drug (Treatment Use)

For use in a form of Expanded Access called "Treatment Use" or Investigational Treatment Use of an Unapproved drug/device.

Form tO-1 - Approved Drug Unapproved Use (Treatment Use)

For use in a form of Expanded Access called "Treatment Use" or Investigational Treatment Use of an Unapproved drug/device.

Form tP - Investigational Device (Treatment Use)

For use in a form of Expanded Access called "Treatment Use" or Investigational Treatment Use of an Unapproved drug/device.

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

Form U - Pregnant Women, Neonates, Fetuses- describing Follow up only

Form V - Research Involving Prisoners

Form W - Research Involving Children

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

See HOP Conflicts of Interest in Scholarly, Research, and Clinical Activity, HOP Conflict of Commitment, and HOP Institutional Conflict of Interest Policy as applicable.

GLOSSARY OF OIRB TERMS

Grant Application (Form AA)

This is not an IRB template. Include the document (if applicable) with your submission.

HDE Progress Report Form

HIPAA De-identification Agreement Form
(Form I)

Complete Form I if a covered entity will remove the identifiers. The de-identified data or specimens will be released to the PI from a covered entity.

HIPAA Waiver of Authorization (Form J)

Waiver of Authorization Guidance.

Humanitarian Use Device (Form P)

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

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

Institutional Biosafety Committee (IBC) (Form EE)

This is not an IRB template. Include the document (if applicable) with your submission.

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 (Form Inst-F)

Investigator Brochure (Form CC)

This is not an IRB template. Include the document (if applicable) with your submission.

IRB Authorization Agreement Form

Contact the IRB Director if you need to negotiate an agreement.

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

This is not an IRB template. Include the letters (if applicable) with your submission.

Local Repository Description (Form C-1)

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

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

Model Consent Form (Form G)

This is not an IRB template. Include the document (if applicable) with your submission.

Modification to Human Use Protocol

See also Amendment

Monitoring Participant Safety and Data Integrity (Form R)

Multipurpose Signature Assurance Sheet (Form A-1)

Should be submitted with all forms required after approval (amendments, progress reports, prompt reporting).

How to digitally sign Adobe forms.

Neonatal Research (Viability not in question)

Neonates - Nonviable (Form U)

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

Neonates of uncertain viability (Form U)

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

Non-Adverse Event / UPIRSO Reporting for Non-AE
(Prompt Reporting Form)

(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 Reporting
(Prompt Reporting Form)

Used to self report noncompliance with federal regulations or IRB Policies as well as major deviations.

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.

Parental Permission - Request for Waiver

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)

Pregnant Women (Form U)

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

Pregnant Women, Neonates, Fetuses- describing Follow up only

Prisoners (Request for Research Involving) (Form V)

Progress Report Form

Progress Report Form for Repository

Progress Report Form-HDE

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

This is not an IRB template. Include the document (if applicable) with your submission. Guidelines for Advertising

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

This is not an IRB template. Include the document (if applicable) with your submission.

Protocol Deviations Tracking Log

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

See HOP Conflicts of Interest in Scholarly, Research, and Clinical Activity, HOP Conflict of Commitment, and HOP Institutional Conflict of Interest Policy as applicable.

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

Radioactive Drug Research Committee (Form II)

Reporting Noncompliance
(Prompt Reporting Form)

Used to self report noncompliance with federal regulations or IRB Policies as well as major deviations.

Repository Consent (Form E )

Repository Progress Report Form

Repository Spanish Consent (Form E - 2)

Repository VA Consent (Form E-1)

Request for Inactivation (Formerly "Final Report")

Request for Research Involving Prisoners (Form V)

Research Consent (Form D)

For non-VA studies only.
Combined research consent + HIPAA authorization.
For research studies contributing to another repository, refer to the informed consent instructions for repositories.

Research Involving Children (Form W)

Research involving healthy neonates (Viablility not in question)

Research Involving the Decisionally Impaired (Form T)

Signature Assurance Sheet (Form A)

Required with initial submission.

How to digitally sign Adobe forms.

Signature Assurance Sheet-Multipurpose (Form A-1)

Should be included with all forms required after approval (amendments, progress reports, prompt reporting)

How to digitally sign Adobe forms.

Spanish Repository Consent - Form E - 2

Spanish Research Consent (Form D-2)

Sponsor’s protocol (Form BB)

This is not an IRB template. Include the document (if applicable) with your submission.

Telephone Script

This is not an IRB template. Include the document (if applicable) with your submission.

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

Translation Certification for consent forms requiring translation

Pertains to subjects from any foreign culture

UPIRSO Reporting / Adverse Event (Resulted in physical or psychological harm)
(Prompt 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

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

(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.

VA Repository Consent (Form E-1)

VA Research Consent (Form D-1)

For VA studies and studies where VA is a site.
Research consent only (does not include HIPAA authorization - Refer to Forms H-UT & H-VA)

For research studies contributing to another repository, refer to the informed consent instructions for repositories.

Waiver of Assent Request

Waiver of Documentation of Informed Consent Process

This is a BLANK template for when consent will be obtained but a signature will not (i.e., verbal consent)

Waiver of Informed Consent Process

This is a BLANK template for when consent will not be obtained (written or verbally)

Waiver of Parental Permission