Forms

Disclaimer: The list of forms is not all-inclusive. Additional forms will be added as the site grows.

Proposal Forms

• Electronic IU Routing Form (ERA) for internal proposal approvals
  Send Email to ERA_ADMIN@indiana.edu for assistance in getting started.
• NIH Human Subjects Education Documentation Form (Word)

Proposal Samples

• Cover Page sample when no format provided by sponsor
• SF424 for NIH Proposals
• Subcontractor Letter of Support: From IU to the Prime Contractor or Recipient (Word)
• Subcontractor Letter of Support: To IU to the Prime Contractor or Recipient (Word)
• Budget: One Year with Cost Share
• Budget: Two Year
• Human Subjects Education Certification Sample Letter
• NIH Policy on Model Organisms: IU Template Statement

Compliance Forms:

Animal Care & Use Forms

• Protocol Form
• List of LAR-approved animal vendors
• Minor Amendment Form
• Amendment to Add or Remove Personnel Form
• Breeding Colony Form
• Permission to Order Custom Antibodies Form
• List of IACUC-approved custom antibody vendors
• Drug Guidelines
• Animal adoption form

Templates:

• Group Surgery Template
• Group Surgery (completed sample)
• Pain Scale and Surgery Follow-up Template

Conflict of Interest:

• Conflict of Interest: IU Disclosure Form
• Conflict of Interest: Non-IU Affiliated Researchers COI Disclosure form

IRB Human Subjects Forms

Tech Tip! Each IRB form is available in two different formats, .rtf (rich text format) and .doc (Microsoft Word). MAC and Linux-based operating system users should use the .doc (Microsoft Word) format only as we have experienced problems upon receiving .rtf forms from those users.

• .rtf   .doc   Amendment Form
• .rtf   .doc   Application for Non-Human Subjects Research
• .rtf   .doc   Application for Non-Research Student Projects
• .rtf   .doc   Assent To Participate in Research Template
• .rtf   .doc   Authorization for the Release of Health Information for Research
• .rtf   .doc   Children Request Form
• .rtf   .doc   Closeout Report
• .rtf   .doc   Continuing Review - Open to Enrollment
• .rtf   .doc   Continuing Review - Closed to Enrollment
• .rtf   .doc   Documentation of Review and Approval
• .rtf   .doc   Exempt Research Checklist
• .rtf   .doc   Expedited Research Checklist
• .rtf   .doc   Informed Consent Template
• .rtf   .doc   Inclusion of Cognitively Impaired Individuals
• .rtf   .doc   Inclusion Pregnant Women, Human Fetuses, and Neonates
• .rtf   .doc   Noncompliance Reporting Form
• .rtf   .doc   Prisoner Request Form
• .rtf   .doc   Prompt Reporting Form
• .rtf   .doc   Recruitment Checklist
• .rtf   .doc   Sample Protocol Template
• .rtf   .doc   Summary Safeguard Statement
• .rtf   .doc   Human Subjects Education Certification Sample Letter


•  IUB Standard Operating Procedures
  The IUPUI SOPs were adopted by Indiana University Bloomington (IUB) on 08/18/08. The IUB Office of Research Administration is in the process of reviewing and revising these procedures, as necessary and will post them once they are approved.

Biological Safety Forms

• Form I - IU IBC BHC Protocol Registration Form (general information)
• Form II - Biohazards (includes biohazards and human tissues fluids and cell lines)
• Form III - Exempt Host Vector Systems (E. coli, B subtilis, S. cerevisiae, etc)
• Form IV - Recombinant DNA Utilizing Microorganisms (Bacteria, viruses, cell culture, fungi)
• Form V - Recombinant DNA Utilizing Animals (genetically modified animal, or wild type animal with associated genetically modified microorganism)
• Form VI - Recombinant DNA Utilizing Plants (genetically modified plant or whole plant with associated animal, arthropod, or microorganism)
• Form VII - Recombinant DNA Utilizing Arthropods (including Drosophila)
• Form VIII - Recombinant DNA Utilizing Viral Vectors (including viral sequences present in plasmids)
• Form IX - Biological Toxins (recombinant DNA and biohazard combined)
• Form X - Select Agent Identification (diagnostic samples, no recombinant DNA)

Additional Resources, extracted from the NIH Guidelines:

• Appendix A - Sublist of Natural Exchangers
• Appendix B - Risk Group 1
• Appendix B - Risk Group 2
• Appendix B - Risk Group 3
• Appendix B - Risk Group 4 and Restricted Agents
• Appendix C - Extrachromosomal Elements of Gram Positive Organisms
• Appendix E - Certified Host Vector Systems
• Appendix F - Toxin List

Additional Resources, NIH Office of Biotechnology Activities Guidance Documents:

• Exempt Experiment FAQs
• Animal Activities (great resource for animal and arthropod experiment questions)
• Animal FAQs (resource for transgenic animals, especially rodents)
• Major Action FAQs (more information about recombinant DNA experiments utilizing antibiotic resistance)
• Toxin LD50
• Toxin LD50 Reference
• Biosafety Considerations for Research with Lentiviruses
• Biological Safety Practices for Research with Potentially Highly Pathogenic Influenza Virus Strains
• Incident Reporting FAQs

Radiation Safety Forms

Radioactive Material Safety:

• RS-1 Form
• RS-2 Form
• RS-4 Form
• RS-5 Form
• Radioactive Waste Management
• Radiation Safety Manual (Printable Word Doc)

X-ray Devices Safety:

• X-ray Device Registration Form (XS-1)
• Training Documentation Form (XS-2)
• Analytical X-Ray Safety Guide (Printable Word Doc)

Laser Safety:

• Laser Registration Form (LS-1)
• Training Documentation Form (LS-2)
• Eye Examination Form (LS-3)
• Laser Safety Manual (Printable Word Doc)

Disclaimer: The list of forms is not all-inclusive. Additional forms will be added as the site grows.

Clinical Trials Services

W-9 Form

Proposal Forms

• Internal Routing Form - ERA
• NIH Modular Applications: Budget Information Sheet - All Campuses

Proposal Samples

• SF 424 Form Set – Used in Grants.gov electronic submissions (PDF) - Indianapolis
• Cover Page for Proposals - Indianapolis
• NIH Policy on Model Organisms: IU Template Statement

Compliance Forms

• Conflict of Interest: IU Disclosure Form
• Conflict of Interest: Non-IU Affiliated Researchers COI Disclosure form
• Conflict of Interest: State Disclosure Form (PDF) - All Campuses
• Human Subjects Education Documentation Form (Word) - All Campuses
• IBC rDNA Forms  - Indianapolis
• Intellectual Property Agreement - Indianapolis faculty should contact their Dean's office
• Invention Disclosure Form - All Campuses
• IRB Forms - Indianapolis
• BioHazard Committee Forms - Indianapolis

Compliance Samples

• Human Subjects Education Certification Sample Letter
• Indiana Economic Impact - State Form 51778 (Word) - Indianapolis

Material Transfer Agreement (MTA) Forms

• Information Sheet - IU as Provider
• Information Sheet - IU as Recipient

IRB Human Subjects Forms

Tech Tip! Each form is available in two different formats, .rtf (rich text format) and .doc (Microsoft Word). MAC and Linux-based operating system users should use the .doc (Microsoft Word) format only as we have experienced problems upon receiving .rtf forms from those users.

Submission Forms:

• .rtf   .doc   Amendment Form (v05/01/09)
• .rtf   .doc   Application for Non-Research Student Projects (v05/01/09)
• .rtf   .doc   Application for Non-Human Subjects Research (v05/01/09)
 
• Assent Templates:
• .rtf   .doc   Assent To Participate in Research Template (v05/01/09)
• .rtf   .doc   Assent To Participate in Research Template Spanish (v05/01/09)
 
• Authorization Templates:
  
• .rtf   .doc   Authorized Medical Record Request Form
• .rtf   .doc   Authorization - Template for the Release of Health Information (v05/01/09)
• .rtf   .doc   Authorization - Template for the Release of Health Information Spanish - (v05/01/09)
• .rtf   .doc   Authorization - Healthy Subjects (v05/01/09)
• .rtf   .doc   Authorization - Healthy Subjects Spanish - (v05/01/09)
• .rtf   .doc   Authorization - Minors Template (v05/01/09)
• .rtf   .doc   Authorization - Minors Template Spanish - (v05/01/09)
 
• .rtf   .doc   Checklist for Determining Whether an Activity Requires IRB Reviews (v05/01/09)
• .rtf   .doc   Co-Investigator Update Form (v05/01/09)
 
• IRB Continuing Review and Closeout Forms:
• .rtf   .doc   Continuing Review/Closeout Report Instructions (v05/01/09)
• .rtf   .doc   Continuing Review Open to Enrollment (v05/01/09)
• .rtf   .doc   Continuing Review Closed to Enrollment (v05/01/09)
• .rtf   .doc   Closeout Report (v05/01/09)
 
• .rtf   .doc   Covered Entity Checklist (v05/01/09)
• .rtf   .doc   Documentation of Review and Approval (DRA) (v05/01/09)
• .rtf   .doc   Exempt Research Checklist (v05/01/09)
• .rtf   .doc   Expedited Research Checklist (v05/01/09)
• .rtf   .doc   IDE Checklist (v05/01/09)
• .rtf   .doc   IND Checklist (v05/01/09)
 
• Informed Consent:
  
• .rtf   .doc   Informed Consent Checklist (v05/01/09)
.rtf   .doc   Informed Consent Template (v05/01/09)
• .rtf   .doc   Informed Consent Template - Spanish (v05/01/09)
• .rtf   .doc   Delegation of Authority to Consent(v05/01/09)
• .rtf   .doc   Request Form for Waiver of Informed Consent for Planned Emergency Research (v05/01/09)
 
• .rtf   .doc   NCI CIRB Facilitated Review Form (v05/01/09)
• .rtf   .doc   NCI CIRB Review Cover Sheet (v05/01/09)
• .rtf   .doc   Noncompliance Reporting Form (v05/01/09)
• .rtf   .doc   Prompt Reporting Form (v05/01/09)
• .rtf   .doc   Protocol Template (v05/01/09)
• .rtf   .doc   Recruitment Checklist v05/01/09)
• .rtf   .doc   Summary Safeguard Statement (SSS) (v05/01/09)
• .rtf   .doc   VA Waivers for Recruitment (v03/01/08)
 
• Vulnerable Population Request Forms:
• .rtf   .doc   Request Form for the Inclusion of Children in Research (v05/01/09)
• .rtf   .doc   Request Form for the Inclusion of Cognitively Impaired Individuals in Research (v05/01/09)
• .rtf   .doc   Request Form for the Inclusion of Pregnant Women, Human Fetuses and Neonates in Research (v05/01/09)
• .rtf   .doc   Request Form for the Inclusion of Prisoners in Research (v05/01/09)
 
• VA Research Forms:
• .rtf   .doc   VA Research Project Submission Checklist
• .rtf   .doc   Investigator Data Sheet - VA Form 10-5368
• .rtf   .doc   Project Data Sheet - VA Form 10-1436
• .rtf   .doc   VA Data Security Appendix (C-D)
• .rtf   .doc   VA R&D Committee Research Study Submission Form
•    Application for An Off-Site Tissue Banking Waiver - VA Form 10-0436
• .rtf   .doc   VA Consent Form - VA Form 10-1086
• .rtf   .doc   Investigational Drug Information Record - VA Form 10-9012
• .rtf   .doc   Research Protocol Safety Evaluation - VA Form 10-0398
• .rtf   .doc   Pathology and Laboratory Impact Estimation Worksheet
• .rtf   .doc   Memo for Authorization to Transport VA Sensitive Information
 
• WIRB (Western Institutional Review Board) Forms:
• .rtf   .doc   WIRB Standard Operating Procedures
• .rtf   .doc   WIRB Eligibility Checklist
• .rtf   .doc   IU Application for Protocol Review by WIRB
• .rtf   .doc   IU WIRB Informed Consent Template
• WIRB Initial Review Submission Form    
• WIRB Investigator Submission Form for Multi-Center Protocols

NIH Proposal Samples

• SF424 for NIH Proposals
• Human Subjects Education Certification Sample Letter
• NIH Policy on Model Organisms: IU Template Statement

Additional Agency Forms

• DOE: U.S 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