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Modification Request Form Kentucky State University • Institutional Review Board (IRB)

PI Name:

Principal Investigator name

IRB protocol number

IRB #:

Instructions

Use this form to request IRB approval of the following:

Proposed changes to your current IRB-approved protocol.

A proposed change which impacts an individual subject but does not change the overall protocol (i.e., exception and deviation).

Do NOT use this form:

To report a change to the currently approved protocol which has already been implemented without prior IRB approval.

In emergency situations involving unanticipated problems involving risk to human subjects or others (contact ORI staff immediately at 502-597-6530).

To close a study or to report that a study has been completed (contact ORI).

Please be sure to...

Revise consent and assent forms, as needed, based on the proposed changes.

Complete and attach appropriate forms.

If you are adding new study personnel, confirm that all new members have completed the mandatory human-subject-protections CITI training BEFORE you submit your modification request.

Have the PI sign on the line provided at the top of the form (next page).

Attach two copies – one marked and one clean – of all documents affected by the modification (i.e., consent form). On the track-changes copy, underline or highlight each change being made.

Allow ample time for processing this modification request. NOTE: changes may not be implemented prior to receiving IRB approval.

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PI Signature

The quick brown fox jumps over the lazy dog.

Date

PI signature

Date

Modification Details

1 Address change for protocol correspondence?

If yes, indicate new address:

Yes

6 No

New address

Study title

2 Study Title:

Title change? 6 Yes

6 Yes

If yes, indicate new title:

6 No

New title

3 Is this a one-time request for a deviation from the currently approved protocol, or an exception to the currently approved enrollment criteria? Yes No

Yes

4 Consent / Assent Form change?

6 No

Yes

If yes, be sure changes are reflected in all revised consent/assent documents and any applicable HIPAA documents.

5 Check one:

6 This modification does NOT increase risk to study participants. 6 This modification may or will increase risk to study participants.

no_increase

6 Is this modification request due to an Unanticipated Problem or Adverse Event? Yes No

Yes

7 In your professional opinion, does this modification involve information that might relate to a subject's willingness to continue to take part in the research? Yes No If yes, state how the information will be communicated to subjects (i.e., re-consent, send letter, etc.):

Yes

How communicated

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Modification Request Form

8. Changes Made To — check all that apply and attach appropriate documents

Form A: General Information Sheet

Form B: Research Description & Appendices

Anticipated Project End Date

a_end_date

□ Estimated # of Subjects

a_num_subjects

□ Objectives

b_objectives

Inclusion / Exclusion Criteria

b_incl_excl

☐ Subject Population

a_subject_pop

□ Vulnerable Subject Population

a_vuln_pop

☐ Subject Recruitment

b_recruitment

□ Procedures / Materials

b_procedures_mat

Impaired Consent Capacity

a_vuln_impaired

Research Procedures

b_research_proc

☐ Children age 17 or less ☐ Grant Application

a_vuln_children

b_grant

Pregnant Women

a_vuln_pregnant

□ Sponsor Protocol; Investigator Brochure

b_sponsor

□ Prisoners

a_vuln_prisoners

Waiver of Informed Consent

b_waiver_consent

□ Other vulnerable population

a_vuln_other

□ Funding / Support

a_funding

□ Study Personnel

a_personnel

□ Other – Describe:

a_other

Waiver of Documentation of Informed Consent

b_waiver_doc

Other - describe

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Describe Each Modification

REQUIRED: For each proposed modification, describe the currently approved procedures, forms, etc., then summarize the proposed change, addition, etc. Include a justification for the modification request. Add additional sheets if necessary.

Example

Currently Approved: study staff as listed on attached SP List Template.

Proposed Revision: add Jane Doe, MD, as co-investigator. Dr. Doe has completed human-subject-protections training, is a new faculty member who will work with subjects on this protocol, and is authorized to obtain consent.

1 Currently Approved

Proposed Revision

Currently approved 1

Proposed revision 1

2 Currently Approved

Proposed Revision

Currently approved 2

Proposed revision 2

3 Currently Approved

Proposed Revision

Currently approved 3

Proposed revision 3

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