Human Use Application

For

Full Board Review

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.

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 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	Full Review Application Checklist	Required to submit with your application. Used to assist you in assembly of your materials.
Form A	Signature Assurance Sheet	Form A Instructions [HTML]
Form B	General Information sheet	Click here for help
Form B-1	Expedited Certification Form	Form B-1 Instructions [HTML]
Form B-2	Study Personnel List	Form B-2 Instructions [HTML]
Form C	Research Description	Form C Instructions [HTML]

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Section 2

Informed Consent Process

You must select applicable item(s) from Form D - H.

Form D	Research Consent	Form D Instructions
Form D-1	VA Research Consent (An easy to edit version without VA required formatting, intended for use until ICD language is approved. Then the ICD may be converted to the Official VA Consent Template	Form D-1 Instructions Only place IRB approved language into the Official VA Consent Template after IRB approval of Form D-1
Form D-2	Spanish Research Consent	Form D-2 Instructions
Form D-3	VA Spanish Research Consent	Form D-3 Instructions
Form F	When consent is not obtained or requires alteration to basic required elements: Request for one of the following (Note: HIPAA waiver is in Section 3): (1) Alteration to Consent (2) Waiver of Informed Consent Process (3) Waiver of Documentation of Informed Consent Process	Form F Instructions (all 3 options are available on one form) [HTML]
Form G	If NIH-sponsored Cooperative Group Clinical Trial, attach the NIH model Consent Form (This is not a template. This represents the location of the model consent (if NIH Study) in the completed submission package.)	Form G Instructions [HTML]
Form H	For recruitment of Non-English/Non-Spanish speaking subjects, attach translated consent document	Form H Instructions & Info pertaining to subjects from a Non-English/Non-Spanish foreign culture [HTML]
Form H-1	Translation Certification form (Turned in with translated consent form)	Form H-1 Instructions & Info pertaining to subjects from any foreign culture [HTML]

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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 [HTML]
Form K	Not in use

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Section 4

Additional Study Materials

Complete/attach all of the below items that apply to your 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 [HTML]
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 [HTML]
Form N	Off-site research	Form N Instructions [HTML]
Form O	Use of a Drug in Research	Form O Instructions [HTML]
Form O-1	Use of Approved Drug(s) for Unapproved Use	Form O-1 Instructions [HTML]
Form O-2	Use of A Placebo In Place of Standard Therapy	Form O-2 Instructions [HTML]
Form P	Use of New Device Form (including Humanitarian Use Device)	Form P Instructions [HTML]
Form Q	Use of Radiation in Human Research (Radiation Exposure Worksheet)	Form Q Instructions [HTML]
Form R	Monitoring Participant Safety and Data Integrity	Form R Instructions [HTML] Additional Monitoring Plan Guidance
Form S	Copy of package insert or FDA approved label (PDR reference) (This is not a template. This represents the location of the drug label (if any) in the completed submission package.)	Include for drug or device studies using the FDA approved medication/device for approved medical indication.

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Section 5

Vulnerable Populations

Complete all of the forms below that apply to your research.

Form T	Research Involving the Decisionally Impaired
Form U	Research Involving Pregnant Women, Fetuses, &/or Neonates	Form U Instructions [HTML]
Form V	Research Involving Prisoners
Form W	Research Involving Children	Form W Instructions [HTML]

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Section 6

Materials for Primary Reviewer and Detailed Protocol/Grant Application Review

Attach as applicable. Forms AA-DD are actually just placeholders for parts of the submission package you may be sending in as attachments.

Form X	Protocol Related Conflict of Interest (COI)	Form X Guidance [HTML]
Form Y	Scientific/Ethical Pre-review email from IRB	If received, attach the email sent to you by the IRB members responsible for Scientific/Ethical Pre-review (not the administrative pre-review email)
Form Z	Not in Use
Form AA	Grant Application	This is not a template. This represents the location of the Grant Application (if any) in the completed submission package.
Form BB	Sponsor’s detailed drug protocol	This is not a template. This represents the location of the drug protocol (if any) in the completed submission package.
Form CC	Investigator Brochure	This is not a template. This represents the location of the IB (if any) in the completed submission package.
Form DD	Device proposal and/or the sponsor’s contract	This is not a template. This represents the location of the Device proposal/contract (if any) in the completed submission package.

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Section 7

Other Required Committee/Review Approvals

For 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-JJ 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 FF	University Radiation Safety Committee	This is not a template. This represents the location of the Approval letter (if necessary) in the completed submission package.
Form GG	Applicable Radiation Safety Committee	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.
Form II	Radioactive Drug Research Committee	This is not a template. This represents the location of the Approval letter (if necessary) in the completed submission package.
Form JJ	For VA studies: 10-1086; 10-1223 Report of Subcommittee on Human Studies; and 10-9012 Investigational Drug Information Record	Print, complete and submit with protocol to IRB.

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Protocols are assigned on a "first come, first served" basis, and will be placed on the next available agenda. You are encouraged to submit your protocol as early as possible.

Full reviews require an administrative pre-review by the IRB Office and members of the IRB. Pre-review is intended to review the application and allow sufficient time for the investigator to make revisions prior to the final deadline for submission for IRB review. A Pre-review date will be assigned to the protocol at the time of submission. If the PI is not available on this date, this should be made clear to OIRB staff.

If you have questions concerning submission of a research protocol for IRB review, please call the Office of the IRB at 210-567-2351.

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