Forms

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Animal Use

IACUC FAQ

Biohazardous Material Use

IBC Forms

IBC Templates

IBC Guidance

IBC Facility Requirements

Export Control

Financial Conflict of Interest

Human Subjects Research

Submission Forms

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                        600.01 Work Instructions, Downloading Forms from Website

Request a Determination on whether IRB is required
                        600.02 Form, Not Human Subjects Research Request (new as of 11/5/2018)

                        600.02 Form, Application for Teaching Research Methods (new as of 11/5/2018)
Initial Submission
                        Initial Submission Form 

                        700.04 PI Eligibility Exception Form (new as of 11/5/2018)
Ongoing Submissions
                        Amendment Submission Form (new as of 11/5/2018) 

                        Continuing Review Submission Form (new as of 11/5/2018) 

                        Request for Continued Participation During Protocol Lapse (new as of 11/5/2018) 

                        Reportable Event Submission Form (new as of 11/5/ 2018)

                        Study Closure Form (new as of 11/5/2018)
Request to Rely

                        1400.01 Form, Request to Rely

                        Checklist, Request to Rely (new as of 11/5/2018) 

                        Template, IRB Reliance Agreement (new as of 11/5/2018)

Protocol Templates
                        600.01          Template, Protocol Template (new as of 11/5/2018) 

                        600.01          Template, Protocol Template - Retrospective Data Review (new as of 11/5/2018) 

                        600.01          Template, Data Collection Sheet (new as of 11/5/2018)

                        600.02          Template, Procedures for Use of Honest Broker (new as of 11/5/2018) 

                        600.02          Template, Quality Improvement Project (new as of 11/5/2018)

                        600.02          Template, Teaching Research Methods - Student Project Verification (new as of 11/7/2018)

                        600.02          Template, Additional Course Project Description (new as of 11/7/2018)

                        700.03          Regulatory Binder Checklist

                        700.03          Regulatory Binder Tabs

                        700.06          Template, Repository Protocol

                        1300.03         Template, Log of Protocol Changes (new as of 11/7/2018)

                       1300.04         Template, Adverse Event Log (new as of 11/7/2018)


Recruitment Templates
                        800.01          Worksheet, Investigator Recruitment Plan (new as of 11/7/2018)   

                        800.01          Checklist, Recruitment Materials (new as of 11/7/2018)

                        800.01          Template, Flyer that is not study specific (new as of 11/7/2018)

                        800.01          Template, Flyer for Study (new as of 11/7/2018) 

                        800.01          Template, Advertisement – Survey Study (new as of 11/7/2018) 

                        800.01          Template, Classroom recruitment script (new as of 11/7/2018) 

                        800.01          Template, Dear Subject Letter (new as of 11/7/2018) 

                        800.01          Facebook Recruitment Script (new as of 11/7/2018) 

                        800.01          Template, Letter of Support for Non-TAMU-CC Sites (new as of 11/7/2018) 

                        700.05          Template, School Permission to Conduct Research (new as of 11/7/2018)
Informed Consent Templates
General
                         1200.02        Template, Tiered Informed Consent Template - Social Behavioral (new as of 11/5/2018) 

                         1200.02        Template, Tiered Informed Consent Template - Interventional (new as of 11/7/2018)
Studies with a waiver of consent documentation
                         1200.03        Template, Information Sheet (new as of 11/5/2018) 

                         1200.03        Template, Information Sheet for Classroom Projects (new as of 11/5/2018)

                         1200.03        Template, Information Sheet for Classroom Projects Previously Completed (new as of 11/5/2018)
Telephone consent
                         1200.07        Template, Dear Subject Letter Send Consent Form for Telephone Consent (new as of 11/7/2018) 

                         1200.07        Worksheet, Telephone Consent Script (new as of 11/7/2018)
Studies enrolling children
                         1200.02        Template, Assent Only - Social Behavioral (new as of 11/7/2018) 

                         1200.02        Template, Tiered Informed Permission-Assent Template - Social Behavioral (new as of 11/5/2018) 

                         1200.02        Template, Tiered Informed Permission-Assent & Consent Template-Social Behavioral (new as of 11/5/2018)
Studies enrolling non-English speaking persons
                         1200.02        Template, Short Form (Spanish) (new as of 11/7/2018)
Studies with Deception
                         800.02          Template, Information Sheet with Authorized Deception (new as of 11/7/2018) 

                         800.02          Template, Post De-Brief Consent (new as of 11/7/2018) 

                         800.02          Template, Post De-Brief Consent for audio or video without knowledge (new as of 11/7/2018)
Other
                         1200.02        Template, Videotaping Activity warning posted (new as of 11/7/2018)

                         1200.02        Template, Case Report (new as of 11/5/2018)
International Research
                         Cultural Evaluation of International Research (new as of 11/7/2018) 

Translations for Non-English Speaking Participants
                         1100.09        Form, Translation Certification (new as of 11/7/2018) 

                         1100.09        Form, Interpreter Certificate (new as of 11/7/2018) 

Frequently Asked Questions by Topic
Scope of IRB Review
                         600.02          FAQ, Not Human Subjects Determinations (new as of 11/5/2018) 

                         600.02          FAQ, Class Room Activities Involving Research Methods (new as of 11/5/2018)
Exempt Research
                         600.03          Checklist, Exempt Determination Pre and Post 2018 Comparison (new as of 11/7/2018) 

                         600.03          FAQ, Exempt Category 3 - What is a benign behavioral intervention (new as of 11/7/2018) 
Personnel Questions
                         700.04          FAQ, CITI Training Requirements (new as of 11/5/2018) 

                         700.04          FAQ, When Do I List Persons on the IRB Protocol (new as of 11/5/2018) 

                         700.04          FAQ, Who can be Listed as a PI (new as of 11/5/2018)
Compensation
                         900.01          Decision Tree, Compensation (new as of 6/8/2018) 

                         900.01          FAQ, Compensation (new as of 11/5/2018)
Recruitment
                         800.01          FAQ, Recruitment Materials (new as of 11/7/2018) 

                         800.01          Checklist, Recruitment Materials (new as of 11/7/2018)

                         800.03          FAQ, Using Crowd Sourcing to Recruit
Vulnerable Populations
                         1100.01        Guidance for Enrolling Participants with Institutional or Deferential Vulnerability (new as of 11/7/2018)  

                         1100.01        Guidance for Enrollment of Economically Disadvantaged Persons (new as of 11/7/2018)  

                         1100.01        Guidance for Enrollment of Educationally Disadvantaged (new as of 11/7/2018) 

                         1100.01        Guidance for Enrollment of Illiterate or Physically Impaired Subjects (new as of 11/7/2018) 

                         1100.09        Worksheet, Consenting Non-English Speaking Persons (new as of 11/7/2018)  

                         1100.10        Worksheet, Capacity to Consent (new as of 11/7/2018) 

                         1300.07        Worksheet, Withdraw and Termination of Subject
Informed Consent
                         1200.01        FAQ: TAMU-CC Implementation of Revised Common Rule Informed Consent Changes (new as of 11/7/2018) 
                         1200.03        Checklist, Waiver of Consent Process (new as of 11/7/2018) 

                         1200.03        Checklist, Waiver of Documentation (new as of 11/5/2018)

                         1200.03        FAQ – When is it not practicable to obtain informed consent (new as of 6/15/2018)

                         1200.04        Checklist, Long Form Consent Process (new as of 11/5/2018)

                         1200.04        Worksheet, Informed Consent Process (new as of 11/5/2018)
Continuing Review
                         1300.02        FAQ, TAU-CC Implementation of Revised Common Rule Continuing Review Changes (new as of 11/7/2018)

                         1300.01        Checklist, When is Continuing Review Required (new as of 11/7/2018)

                         1300.05        Checklist, When can a study be closed (new as of 11/7/2018)

                         1300.05        FAQ, When can a Study be Closed

Instructions: Click the link on the document to open.  The forms are read only and require you to download to your local desktop to edit.