- Bloomington & Regionals
- Indianapolis
- External
Disclaimer: The list of forms is not all-inclusive. Additional forms will be added as the site grows.
Proposal Forms
Proposal Samples:
- Subcontractor Letter of Support: From IU to the Prime Contractor or Recipient (Word)
- Subcontractor Letter of Support: To IU from the Subaward Recipient (Word)
- Human Subjects Education Certification Sample Letter
- NIH Policy on Model Organisms: IU Template Statement
Financial Management
Compliance Forms:
Material Transfer Agreement (MTA) Forms
Animal Care & Use Forms
Templates:
Conflict of Interest
IRB Human Subjects Forms
- Amendment Form (v10/01/12)
- Application for GWAS Submission (v09/01/10)
- Application for Non-Human Subjects Research (v04/01/11)
- Application for Non-Research Student Projects (v09/01/10)
- Assent Template (v09/01/10)
- Assent Template – Spanish (v09/01/10)
- Authorization Template (v10/01/11)
NOTE: This is the standard HIPAA Authorization form. Use when access to subjects’ medical records is necessary.
- Authorization Template – Spanish (v10/01/11)
- Authorization – Healthy Subjects Template (v10/01/11)
NOTE: This HIPAA Authorization does NOT allow access to subjects’ medical records. Only PHI obtained directly from the subject may be used for research.
- Authorization – Healthy Subjects Template – Spanish (v10/01/11)
- Authorization – Minors Template (v10/01/11)
- Authorization – Minors Template – Spanish (v10/01/11)
- Certificate of Translation (v01/21/11)
- Closeout Form (v09/01/10)
- Continuing Review - Closeout Instructions (v12/01/12)
- Continuing Review – Data Analysis Only (v01/11/2013)
- Continuing Review Form – Closed to Enrollment (v01/11/13)
- Continuing Review Form – Open to Enrollment (v12/01/12)
- Covered Entity Checklist
- Delegation of Authority to Consent (v05/01/09)
- Documentation of Review and Approval (v12/01/12)
- Drug or Biological Products Form (v12/15/12)
- Exempt Research Checklist (v12/19/12)
- Expedited Research Checklist (v10/01/12)
- HIPAA & Recruitment Checklist (v12/01/12)
- Informed Consent Statement Short Form Arabic
- Informed Consent Statement Short Form Burmese
- Informed Consent Statement Short Form Chinese
- Informed Consent Statement Short Form English
- Informed Consent Statement Short Form French
- Informed Consent Statement Short Form Russian
- Informed Consent Statement Short Form Spanish
- Informed Consent Statement Short Form Vietnamese
- Short Form Translation Certificates
- Informed Consent Statement Template (v04/01/11)
- Informed Consent Statement Template Repository (v01/21/11)
- Informed Consent Statement Template – Spanish (v12/01/10)
- Investigator List (v12/01/2012)
- IRB Authorization Agreement
- IU-PU Request for Deferral
- NCI Facilitated Review Cover Sheet (v10/01/12)
- Medical Device Form (v12/15/12)
- NCI Summary Safeguard Statement (v09/01/10)
- Non-Affiliated Investigator Agreement (v06/01/2010)
- Noncompliance Reporting Form (v09/01/10)
- Prompt Reporting Form (v09/01/10)
- Protocol Template (v05/01/09)
- Repository Use Agreement – Sample
- Request Form - IVD with Remnant Samples (v10/01/2012)
- Request for Waiver of Informed Consent for Planned Emergency Research (v09/01/10)
- Request to Defer Review (v01/21/2011)
- Request Form for the Inclusion of Children in Research (v10/01/12)
- Request Form for the Inclusion of Cognitively Impaired Individuals in Research (v09/01/10)
- Request Form for the Inclusion of Pregnant Women, Human Fetuses, and Neonates in Research (v09/01/10)
- Request Form for the Inclusion of Prisoners in Research (v10/01/12)
- Request Form – Transnational Research (v04/01/11)
- Study Information Sheet - Exempt Template (v09/04/12)
- Study Information Sheet - Expedited Template (v09/04/12)
- Submittal Agreement for Biologic Specimens - Sample
- Summary Safeguard Statement (v10/01/12)
- Summary Safeguard Statement – HDE (v10/01/12)
- Test Articles Supplement (v10/01/12)
NEW FORM required for all active biomedical studies involving drugs, biological products, or devices which have a currently approved Summary Safeguard Statement (v01/01/12) or earlier.
Biological Safety Forms
The Institutional Biosafety Committee (IBC) protocol submission forms have been updated as of November, 2010.
Form I is submitted for ALL research. Include all appropriate forms along with Form I.
- Form I - IU Institutional Biosafety Committee (IBC) Protocol Registration Form
- Form II - Human or Nonhuman Primate Tissues, Fluids, or Cell Lines, Biological and Chemical Hazards (includes culturing pathogenic microorganisms, with or without recombinant DNA. Also, animal tissues known, or suspected to be contaminated with infectious viral agents)
- Form IIA - Biological Toxins or Venoms
- Form III - Recombinant DNA utilizing Microorganisms (Bacteria, viruses, cell culture, fungi, etc)
- Form IIIA - Recombinant DNA utilizing Viral Vectors (including viral sequences present in plasmids)
- Form IIIB - EXEMPT Recombinant DNA Research Utilizing Microorganisms (Exempt recombinant DNA research still requires registration with the IBC)
- Form IV - Recombinant DNA Utilizing Animals other than Arthropods (genetically modified animal, or wild type animal with associated genetically modified microorganism)
- Form IVA - Recombinant DNA Utilizing Arthropods (including Drosophila)
- Form V - Recombinant DNA Utilizing Plants (genetically modified plant or whole plant having an associated animal, arthropod, or microorganism)
- Form VI - Select Agent Identification (diagnostic or environmental samples)
Disclaimer: The list of forms is not all-inclusive. Additional forms will be added as the site grows.
Proposal Forms
Proposal Samples:
Financial Management
Compliance Forms
- Conflict of Interest: Non-IU Affiliated Researchers COI Disclosure form
- State COI Form
- State Conflict of Interest Form Instructions
Compliance Samples:
- Human Subjects Education Certification Sample Letter
- Indiana Economic Impact - State Form 51778 (Word) - Indianapolis
Material Transfer Agreement (MTA) Forms
Animal Care & Use Forms
- IACUC Animal Protocol Form
Word form to be used to submit new protocols
- Breeding Form
To be used with the word form
- PI Submission Checklist
To help PI's when submitting. You don't need to send
with when you submit the protocol to the IACUC. - IACUC Funding Update Form
To be used to update funding on a protocol - New Protocol Associate Request Form
Required for new protocol associates who are not
already listed in the TOPAZ system or existing
associates to existing protocols. - Continuing Review Form
For TOPAZ and WORD protocols
IRB Human Subjects Forms
- Amendment Form (v10/01/12)
- Application for GWAS Submission (v09/01/10)
- Application for Non-Human Subjects Research (v04/01/11)
- Application for Non-Research Student Projects (v09/01/10)
- Assent Template (v09/01/10)
- Assent Template – Spanish (v09/01/10)
- Authorization Template (v10/01/11)
NOTE: This is the standard HIPAA Authorization form. Use when access to subjects’ medical records is necessary.
- Authorization Template – Spanish (v10/01/11)
- Authorization – Healthy Subjects Template (v10/01/11)
NOTE: This HIPAA Authorization does NOT allow access to subjects’ medical records. Only PHI obtained directly from the subject may be used for research.
- Authorization – Healthy Subjects Template – Spanish (v10/01/11)
- Authorization – Minors Template (v10/01/11)
- Authorization – Minors Template – Spanish (v10/01/11)
- Certificate of Translation (v01/21/11)
- Closeout Form (v09/01/10)
- Continuing Review - Closeout Instructions (v12/01/12)
- Continuing Review – Data Analysis Only (v01/11/13)
- Continuing Review Form – Closed to Enrollment (v01/11/13)
- Continuing Review Form – Open to Enrollment (v12/01/12)
- Covered Entity Checklist
- Delegation of Authority to Consent (v05/01/09)
- Documentation of Review and Approval (v12/01/12)
- Drug or Biological Products Form (v12/15/12)
- Exempt Research Checklist (v12/19/12)
- Expedited Research Checklist (v10/01/12)
- HIPAA & Recruitment Checklist (v12/01/12)
- Informed Consent Statement Short Form Arabic
- Informed Consent Statement Short Form Burmese
- Informed Consent Statement Short Form Chinese
- Informed Consent Statement Short Form English
- Informed Consent Statement Short Form French
- Informed Consent Statement Short Form Russian
- Informed Consent Statement Short Form Spanish
- Informed Consent Statement Short Form Vietnamese
- Short Form Translation Certificates
- Informed Consent Statement Template (v04/01/11)
- Informed Consent Statement Template Repository (v01/21/11)
- Informed Consent Statement Template – Spanish (v12/01/10)
- Investigator List (v12/01/2012)
- IRB Authorization Agreement
- IU-PU Request for Deferral
- Medical Device Form (v12/15/12)
- NCI Facilitated Review Cover Sheet (v10/01/12)
- NCI Summary Safeguard Statement (v09/01/10)
- Non-Affiliated Investigator Agreement (v06/01/2010)
- Noncompliance Reporting Form (v09/01/10)
- Prompt Reporting Form (v09/01/10)
- Protocol Template (v05/01/09)
- Repository Use Agreement – Sample
- Request Form - IVD with Remnant Samples (v10/01/2012)
- Request for Waiver of Informed Consent for Planned Emergency Research (v09/01/10)
- Request to Defer Review (v01/21/2011)
- Request Form for the Inclusion of Children in Research (v10/01/12)
- Request Form for the Inclusion of Cognitively Impaired Individuals in Research (v09/01/10)
- Request Form for the Inclusion of Pregnant Women, Human Fetuses, and Neonates in Research (v09/01/10)
- Request Form for the Inclusion of Prisoners in Research (v10/01/12)
- Request Form – Transnational Research (v04/01/11)
- Study Information Sheet - Exempt Template (v09/04/12)
- Study Information Sheet - Expedited Template (v09/04/12)
- Submittal Agreement for Biologic Specimens - Sample
- Summary Safeguard Statement (v10/01/12)
- Summary Safeguard Statement – HDE (v10/01/12)
- Test Articles Supplement (v10/01/12)
NEW FORM required for all active biomedical studies involving drugs, biological products, or devices which have a currently approved Summary Safeguard Statement (v01/01/12) or earlier.
SRC Forms:
- Clinical Trials Monitoring Committee Charter - Includes Data Safety Monitoring Plan
- SRC Application
- SRC Submission Packet
- Study Feasibility Checklist (replaces Program Support Letter)
- SRC - 2013 Submission Deadlines and Meeting Dates
- SRC - Support Letter Advocates
- Oncore Data Entry SOP
VA Research Forms:
- Request Form for VA Research (v01/01/12)
- VA Attachment B – Collaborative Protocol Separation (v12/01/12)
- VA Authorization Form (v12/01/12)
- VA Authorization Form – Healthy Subjects (v12/01/12)
- VA Guidance on Collaborative Research (v01/01/12)
- VA Informed Consent Template - VA Form 10-1086 (v12/01/12)
- VA Investigator Data Sheet - VA Form 10-5368
- VA Investigational Drug Information Record - VA Form 10-9012
- VA Memo for Authorization to Transport VA Sensitive Information
- VA Pathology and Laboratory Impact Estimation Worksheet
- VA Project Data Sheet - VA Form 10-1436
- VA R&D Committee Research Study Submission Form
- VA Research Project Submission Checklist
- VA Prompt Reporting Form (v12/01/2012)
- VA Research Protocol Safety Evaluation - VA Form 10-0398
- VA Security/Privacy Checklist (v04/2011)
- VA Security/Privacy Checklist Instructions (v04/2011)
- VA Security/Privacy Checklist Source Document (v12/01/12)
- VA Security/Privacy Flow Chart (v06/14/11)
- VA Waivers for Recruitment (v05/01/09)
WIRB (Western Institutional Review Board) Forms:
Biological Safety Forms
IBC Recombinant DNA Forms:
- IBC Protocol Submission Form
(includes instructions and forms for new protocol submissions involving rDNA)
IBC Safety Procedures Information Sheets:
- IBC Amendment should be completed and sent to the IBC for all proposed changes to an existing research study involving rDNA
- IBC Continuing Review
Radiation Safety Forms
A-1 Form - Radionuclide Use Permit Application
This form is not available online. Please request this form, along with a 'Radiation Safety Procedures Manual', from the Radiation Safety Office.
The A-1a form below has the same intent as the A-1 form but must be completed for human-use research.
- SUPPLEMENT - Radiation Dosimetry (rev 6)
- Radiation Risk Wording for All Human Research Subjects (Rev. Sept. 2010)
- Radiation Risk Wording for Female Research Subjects of Child-Bearing Potential
- Effective Doses from X-rays and CT Scans (Rev. Nov. 2008)
- SUPPLEMENT - Radiation Dosimetry (rev 6)
- Radiation Risk Wording for All Human Research Subjects (Rev. Sept. 2010)
- Radiation Risk Wording for Female Research Subjects of Child-Bearing Potential
A-2 Form - Radionuclide Use Permit Amendment (Rev. July 2007)
A-3 Form - Authorization to Use Radioactive Materials (Rev. Feb. 2010)
A-3x Form - Authorization to Use X-ray Equipment For Non-human Use (Rev. July 2009)
A-3xb Form - Radiation Safety Training for Fluoroscopic Non-Human Research (Non-Operator)
A-4 Form - Application for Radionuclide Laboratory Approval (Rev. Apr. 2009)
A-5 Form - Request for Personnel Monitoring Service (Rev. June 2013)
- Reg. Guide 8.13 (To be read by all females)
A-6 Form - Radionuclide Use Permit Progress Report
A-7 Form - Notice of Pregnancy (Rev. July 2007)
A-8 Form - Radionuclide Use Permit
A-9 Form - Shipping Paper (Rev. July 2007)
A-10 Form - Precautions for Animals Containing Radioactive Materials
A-10a Form - Precautions for Animals Containing PET Radiopharmaceuticals
A-11 Form - Contamination Survey for Animal Care Facilities (Rev. Aug. 1998)
A-12 Form - Log Sheet for Animal Bedding Contaminated with Radioactive Materials (Rev. Dec. 1998)
A-13 Form - Employee Status Change (Rev. June 2011)
A-13 E-Form Submit A-13 Form electronically via the website
A-14 Form - Radiation Survey Data Sheet (Rev. July 2007)
A-16 Form, - Removal of Radionuclide Lab(s) (Rev. July 2007)
A-16 E-Form Submit A-16 Form electronically via the website
A-17 Form - Cancellation of Radionuclide Use Permit (Rev. July 2007)
NIH Proposal Samples
- Human Subjects Education Certification Sample Letter
- NIH Policy on Model Organisms: IU Template Statement
Additional Agency Forms
- DOE: Department of Energy
- EPA: Environmental Protection Agency
- Forms.Gov The U.S. Government's official hub for federal forms
- NASA: National Aeronautics and Space Administration
- NEH: National Endowment for the Humanities
- NIH: National Institutes of Health
- NSF: National Science Foundation
- USDA/CSREES: U.S. Department of Agriculture Cooperative State Research, Education, and Extension Service
- USDE: U.S. Department of Education




