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Exemption Certification Application
Medical and Nonmedical IRB
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INSTRUCTIONS:
There are seven sections to the IRB application. Depending on the nature of your research, some sections will apply to your research, some will not. Please review each section to determine applicability to your research, and include the Forms appropriate for your study in your Exemption application submission. The number of copies required for submission of a complete application is noted below, and within the instructions for each section.
Each component of the application has been assigned a letter of the alphabet (as shown under the left-hand "Form" column). For each Form, there are guidelines/instructions to assist you in completing that component. When preparing your application, sort applicable materials alphabetically and then collate into the required number of packets (i.e. each packet has applicable forms A-Z). Un-collated or insufficient number of applications are subject to being sent back to the PI.
Note: The Sections include a combination of Forms to fill out, and guidance/ instruction for documents you may need to provide copies of or that you may need to develop. Forms to fill out (when applicable to your research) are denoted by the option to download either a WORD or RTF document.
Core Application - required
Include 3 copies.
Exemption Certification Request (application) [WORD] [RTF] This packet describes the specified categories in which all of the research activities involving human subjects must fall to qualify for exemption from the Federal Policy for the Protection of Human Subjects. The packet contains the instructions and form for preparing an IRB Exemption Certification Application. |
Click here for additional informational documents on Exemptions |
Informed Consent/Assent Process
Select applicable item(s) from Form C - F and include 3 copies of each applicable item. Attach 3 copies of "Form H" if applicable to your research.
| Medical IRB Form C | Informed Consent Template: Informed Consent/HIPAA Combined Template: English-NEW 4/5/13 [WORD] [RTF]; Spanish-NEW 4/5/13 [WORD] [RTF] |
Form C Instructions [HTML] |
| Medical IRB Form D | Assent Form Template: Revised 6/22/07 |
Form D Instructions [HTML] |
| Nonmed IRB Form C | Informed Consent Template: |
Form C Instructions [HTML] |
| Nonmed IRB Form D | Assent Form Template: Revised 6/21/07 |
Form D Instructions [HTML] |
| Form E | Request for Waiver of Informed Consent Process [WORD] [RTF] Revised 7/28/06 |
Form E Instructions [HTML] |
| Form F | Request for Waiver of Documentation of Informed Consent Process [WORD] [RTF] Revised 8/4/06 Cover Letter Template for survey/questionnaire |
Form F Instructions [HTML] |
| Form H | For recruitment of Non-English speaking subjects, attach translated consent document | Form H Instructions & info pertaining to subjects from a foreign culture [HTML] |
HIPAA (Health Insurance Portability and Accountability Act)
If HIPAA applies to your research, attach 3 copies of each applicable item. [visit ORI's Health Insurance Portability and Accountability Act (HIPAA) web page to determine if your research falls under the HIPAA Privacy Regulation.]
| Form I | HIPAA De-identification Certification Form [WORD] [RTF] Revised 11/16/12 |
Complete Form I if you plan to de-identify the data. |
| Form J | HIPAA Authorization Template: Revised 4/5/13 |
Use Form J to create your proposed HIPAA Authorization Form. Authorization Form Guidance [HTML] |
| Form K | Waiver of Authorization Guidance [HTML] |
Additional Study Materials
Complete/attach all of the below items that apply to your research; include 3 copies of each applicable form.
| Form L | Proposed advertisement(s) of any type for recruiting subjects |
Form L Instructions [HTML] |
| Form M | Proposed data collection instrument(s) (i.e., survey(s), questionnaire(s)) | Form M Instructions [HTML] |
| Form N | Off-site research [WORD] [RTF] Revised 7/21/09 | Form N Instructions [HTML] |
| Form R | VA Form 10-1223 [PDF] | Include Form R for research using Veterans Affairs (VA) subjects, facilities, or resources. Form R Instructions [HTML] |
Vulnerable Populations
Complete all of the forms below that apply to your research; include 3 copies of each applicable form.
| Form T | Adults with Impaired Consent Capacity: Web-Based Tool [to determine research risk level and likelihood of consent impairment] |
Form T Instructions [HTML] |
| Form W | Form W Instructions [HTML] |
Materials for Primary Reviewer and Detailed Protocol/Grant Application Review
Attach the number of copies of each applicable form as indicated below.
| Form X Form Y | Note "Form X" and "Form Y" for Disclosure of Financial Interest (DFI) have been replaced by a question in "Form A" and the Office of Sponsored Projects Administration (OSPA) online financial disclosure form. | Instructions for OSPA's online financial disclosure form [PDF] OSPA's Disclosure of Financial Interest Survey Sample [PDF] |
| Form AA | Grant/Contract Application |
2 copies if seeking a grant or a grant received. |
Other Required Committee/Review Approvals
For research falling under the purview of any of the below committees or offices, attach 2 copies of the review or final approval materials (1 for IRB records and 1 for the IRB Exemption Reviewer).
| Form II | Medical Center/College of Medicine | [For involvement of Medical Center students and/or College of Medicine students as research subjects.] Form II Instructions [HTML] |
| Form JJ | Veterans Affairs Research & Development Committee (VA R&DC) | Form JJ Information Links [HTML] |
If you have questions concerning submission of an Exemption Certification Request, please call the Office of Research Integrity at 859-257-9084.