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Human Use Application Expedited Review

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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. 

 

 

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]

 

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.

Also referenced through hyperlinks in each form, Protocol and ICD Instructions are also available by clicking here.

Section 1

Core Application - completion of A & B is required

Chklst

Expedited 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 also available in [rtf]

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 [HTML]

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 [HTML] 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 [HTML]

Form D-3

VA Spanish Research Consent

Form D-3 Instructions [HTML]

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 foreign culture [HTML]

Form H-1

Translation Certification form (Turned in with translated consent form)

Form E Instructions [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

Not utilized in Expedited Submissions.

Form O-1

Use of Approved Drug(s) for Unapproved Use (Although only section 1 should apply, if Section 2 is needed the study does not qualify for expedited review)

Form O-1 Instructions [HTML]

Form O-2

Use of A Placebo In Place of Standard Therapy

Not utilized in Expedited Submissions.

Form P

Use of Investigational Device Form (May be Exempt from IDE) (including Humanitarian Use Device)

Must not require prior submission to the FDA to be Expedite reviewed

Form Q

Use of Radiation in Human Research (Radiation Exposure Worksheet)

Not utilized in Expedited Submissions.

Form R

Monitoring Participant Safety and Data Integrity

Not required in Expedited Submissions. If a Data and Safety monitoring plan is to be submitted anyway the form is available on the full board page.

Form S

Copy of package insert or FDA approved label (PDR reference)

Included for drug or device studies with study directed use of FDA approved medication/device for approved medical indication, although not often utilized in Expedited Submissions. If a necessary it is available on the full board page. Contact the OIRB at (210) 567-2351.

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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

Not in Use

 

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

Not often used in Expedited submissions.

Form CC

Investigator Brochure

Not often used in Expedited submissions.

Form DD

Device proposal and/or the sponsor’s contract

Not often used in Expedited submissions.

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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)

Not utilized in Expedited Submissions.

Form FF

University Radiation Safety Committee

Not utilized in Expedited Submissions.

Form GG

Applicable Radiation Safety Committee

Not utilized in Expedited Submissions.

Form HH

SACI Review Committee

Not often utilized in Expedited Submissions.

Form II

Radioactive Drug Research Committee

Not utilized in Expedited Submissions.

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 as appropriate with protocol to IRB.

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.