IRB Question and Answer

IRB Submission

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How do I submit a protocol to the IRB?

Please submit all protocols to the Office of Research Compliance located in CBH Suite 160 during business hours.

Exempt Review:

(1) Exempt application (with original PI signature)

(2) CITI training Certificates for EACH listed Key Personnel

If applicable...

(3) Informed Consent or Cover Letter

(4) Data collection tools or instruments (survey, questionnaires, etc.)

(5) Recruitment Materials (flyers, emails, advertisements, etc.)

(6) Telephone scripts/oral scripts

(7) Waiver of Written or Documentation of Informed Consent...This may require a Cover or Recruitment Letter. Please contact OReC staff or view on-line guidance for further assistance.

(8) Waiver of HIPAA Authorization for the use of health information...Please contact OReC staff for further guidance before submitting the application.

(9) Research Agreements

(10) Letters of permission or cooperation, and/or approvals from other IRBs


Please submit all protocols to the Office of Research Compliance located in CBH Suite 160 during business hours.

Expedited Review:

(1) Two (2) Copies of Expedited Review IRB Application (with original PI signature)

(2) Two (2) Copies of Protocol Synopsis and supporting research documents (see below for examples)

(3) Two (2) Copies of Informed Consent Form or Cover Letter (in lieu of Informed Consent)

(4) One (1) Copy of (signed) Conflict of Interest Form for EACH listed Key Personnel

(5) One (1) Copy of CITI training Certificate for EACH listed Key Personnel

If applicable...

(6) Grant Application

(7) Recruitment Materials (flyers, emails, advertisements, etc.)

(8) Surveys/Questionnaires

(9) Telephone scripts/oral scripts

(10) Assent Forms/Parental Permission Forms

(11) Research Agreements with other institutions for the use of data or specimens

(12) Letters of permission or cooperation, and/or approvals from other IRBs

(13) HIPAA Research Waiver

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Please submit all protocols to the Office of Research Compliance located in CBH Suite 160 during business hours.

Note that investigators must submit the appropriate amount of hard-copies for proper IRB review. No E-versions of research-related documents will be accepted. 

New IRB Full Board Protocol:

(1) Signed Original of the IRB New Protocol Application

(2) Six (6) Copies of the following documents:

(3) Four (4) Copies of the following documents:

  • Federal grant application (if applicable)
  • Clinical Protocol (for Clinical Trials)
  • Investigator's Brochure (if applicable and for Clinical Trials)
  • All Correspondence related to this protocol for the Sponsor

(4) One (1) Copy of the following documents:

  • Curriculum Vitae of Principal Investigator
  • Conflict of Interest (COI) for EACH listed key personnel on project
  • Certificate of Training for Human Subject Research (CITI) for EACH listed key personnel on project
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Please submit all protocols to the Office of Research Compliance located in CBH Suite 160 during business hours.

Note that investigators must submit the appropriate amount of hard-copies for proper IRB review. No E-versions of research-related documents will be accepted.  

Continuing Review for Expedited Review:

(1) Three (3) hard-copies of the following documents:

  • Progress Report Form (with original SIGNED copy)
  • Protocol Synopsis (current IRB-stamped version)
  • CONSENT FORM (current IRB-stamped version)
  • Clean ("unstamped") copy of the Consent Form
  • Other IRB approved research-related documents (i.e. flyers, questionnaires, etc.)

(2) One (1) hard-copy of the following documents:

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Please submit all protocols to the Office of Research Compliance located in CBH Suite 160 during business hours.

Note that investigators must submit the appropriate amount of hard-copies for proper IRB review. No E-versions of research-related documents will be accepted.  

Continuing Review for Full Board:

(1) Original SIGNED Progress Report with a CLEAN (hard) copy of EACH Consent Form

(2) Six (6) hard-copies of the following documents:

  • Progress Report
  • EACH Informed Consent (current IRB stamped version)
  • Recruitment ads, flyers, questionnaires, etc.

(3) One (1) hard-copy of the following documents:

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Please submit all protocols to the Office of Research Compliance located in CBH Suite 160 during business hours.

Minor Modifications to Protocol (not Full Board Amendment):

(1) SIGNED original memo from the PI requesting protocol amendment. The memo should include the elements or modifications found within the proposed amendment and provide brief justification.

(2)  One (1) Copy of the following:

  • Track changes version of the modified research documents (i.e. informed consent, protocol synopsis, etc.) reflecting proposed amendment

(3) A CLEAN Copy of the modified research document(s) reflecting proposed amendment (to be stamped)

NOTE: Protocol modifications, just as in a protocol review, are initially reviewed by OReC Executive Director and staff to determine risk to subject. If the IRB Chairperson concurs with OReC staff that the modifications are "minimal risk" to subject, it is then processed in an "expedited" manner. 

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Please submit all protocols to the Office of Research Compliance located in CBH Suite 160 during business hours.

Note that investigators must submit the appropriate amount of hard-copies for proper IRB review. No E-versions of research-related documents will be accepted.  

Full Board Amendment:

(1) SIGNED original memo from the PI requesting protocol amendment. The memo should include the elements or modifications found within the proposed amendment and provide brief justification.

(2) Six (6) Copies of the following:

  • Signed Memo
  • Track changes version of the modified research documents (i.e. informed consent, protocol synopsis, etc.) reflecting proposed amendment

(3) A CLEAN Copy of the modified research document(s) reflecting proposed amendment (to be stamped)

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Please submit all protocols to the Office of Research Compliance located in CBH Suite 160 during business hours.

Final Report:

(1) One (1) copy of the following documents:

  • SIGNED original Progress Report (check final report)
  • Current IRB-stamped Informed Consent

This page last updated 20th Mar 2015