Exempt Research

In order to qualify for exemption, the research must be minimal risk and all the research activities must completely fit within one or more of the categories listed in the Exempt Study Request Form.

Note:  These forms are best downloaded using Internet Explorer (IE) as your web browser but then click "Save" because they are best opened in Microsoft Word from after being saved to your computer (Click the picture for an example).  If you are experiencing problems downloading a form from our page, and using an alternate browser has not helped (i.e., Netscape Navigator, Internet Explorer), please call the Office of the IRB at 210-567-2351.

There are seven sections to the Exempt IRB application.  Depending on the nature of your research, some sections will apply to your Exempt research, some will not.   Please review each section to determine applicability to your Exempt research, and include the Forms appropriate for your study in your IRB application submission. 

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, be sure to collate all applicable materials in the assigned alphabetical order.

Instructions for completing forms are also available by clicking a hyperlink available in each form.

 

Section 1:  Core Application [Forms A, B, B-1, B-2, & C]

Section 2:  Informed Consent/Assent Process [Forms D-H]

Section 3:  HIPAA Materials [Forms I-K]

Section 4:  Additional Study Material [Forms L-S]

Section 5:  Vulnerable Populations [Forms T-W]

Section 6:  Materials for Primary Reviewer and Detailed Protocol/Grant Application Review [Forms X-DD]

Section 7:  Other Committee/ Review Approval [Forms EE-JJ]

 

Section 1

Core Application - completion of A & B is required

Chklst	Exempt Submission Checklist	Required to submit with your application. Used to assist you in assembly of your materials.
Form A	Signature Assurance Sheet	Form A Instructions
Form B-2	Study Personnel List	Form B-2 Instructions
Form B-3	Exempt Research Request - General Information Sheet	Form B-3 Instructions
Form B-4	Exempt Certificate	Form B-4 Instructions

Back to Table of Contents

Section 2

Informed Consent Process

You may or may not require one or more of the following item(s) from for Exempt Research.

	Information Sheet / Letter	Checklist for Information sheet
	Telephone Script	Telephone Script Instructions

Back to Table of Contents

Section 3

HIPAA (Health Insurance Portability and Accountability Act)

If HIPAA applies to your research, the following forms may be applicable to your research.

Form I	HIPAA De-identification Certification Form	Complete Form I if you plan to de-identify data
Form J	HIPAA Waiver of Authorization	Waiver of authorization Guidance

Back to Table of Contents

Section 4

Additional Study Materials

Complete/attach all of the below items that apply to your Exempt research.

Form L	Proposed advertisement(s) of any type for recruiting (This is not a template. This represents the location of the advertisments (if any) in the completed submission package.)	Form L Instructions
Form M	Proposed data collection instrument(s) (i.e., survey(s), questionnaire(s)) (This is not a template. This represents the location of the collection instrument(s) (if any) in the completed submission package.)	Form M Instructions
	Letters of Support or Memorandum of Understanding for Off-site Research	Letters of Support Instructions

Back to Table of Contents

Section 5

Vulnerable Populations

Not Applicable to Exempt research.

Not in use

Back to Table of Contents

Section 6

Materials for Primary Reviewer and Detailed Protocol/Grant Application Review

Attach as applicable. Forms AA is actually just a placeholder for a grant attachment.

Form X	Protocol Related Conflict of Interest (COI)	Form X Guidance
Form AA	Grant Application	This is not a template. This represents the location of the Grant Application (if any) in the completed submission package.

Back to Table of Contents

Section 7

Other Required Committee/Review Approvals

For Exempt research falling under the purview of any of the below committees or offices, attach a copy of the review or final approval materials.

Forms EE and HH are actually just placeholders for parts of the submission package you may be sending in as attachments.

Form EE	Institutional Biosafety Committee (IBC)	This is not a template. This represents the location of the Approval letter (if necessary) in the completed submission package.
Form HH	SACI Review Committee	This is not a template. This represents the location of the Approval letter (if necessary) in the completed submission package.