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pageInstitutional Effectiveness Documentation

CITI Requirement

POLICY DEVELOPMENT

Issuing Office:

Institutional Review Board

Policy Author:

G. Michele Baker

Contributing Offices:

The School of Education

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CITI Requirement

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titlePolicy Information

Issuing Office

The Graduate School

Affected Parties

All human subjects researchers seeking IRB approval

Complete Wording of New or Revised Policy:

Policy Language

Researchers, faculty advisors who have agreed to oversee student research projects, and some research assistants, depending on the nature of their roles, are required to complete CITI training prior to receiving IRB approval. CITI courses have been created for LU departments and disciplines, which include modules specific to the types of research typically conducted.

Courses contain a set of core modules along with a set of electives. Modules consist of written material followed by a short quiz. CITI courses are free to LU-affiliated individuals, but there are fees for participants wishing to obtain continuing education credits. 

CITI is located at https://www.citiprogram.org/. To begin taking CITI courses, researchers will first need to create a login. The IRB has prepared login instructions to assist researchers in getting started.

Policy Rationale

:

PROCEDURES FOR IMPLEMENTATION AND REVIEW

Policy Administrators:

G. Michele Baker and Fernando Garzon, Psy.D.

Policy Review Cycle:

As needed

Procedures:

Researcher training

Other Regulatory Criteria:

45 CFR 46.112, 114

Policy Keywords:

CITI training

Definition of Glossary Terms

None specified

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Procedures

The IRB receives a completion report from CITI each time a researcher completes CITI training.

Sanctions

:

Research applications are not approved until CITI training is completed.

Exceptions

:

DMin candidates

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University Policy Template

Policy Name:

Permission Statement

Submission Date:

7/15/14

Policy Area:

University-wide

Unit-specific X (all human subjects researchers)

 

Applies To:

Resident

Online

Both X

 

Action Being Taken:

Revision

New Policy

Migration X

Discontinue

Permission Level:

Public X

Student

Staff

Admin

 

POLICY DEVELOPMENT

Issuing Office:

Institutional Review Board

Policy Author:

G. Michele Baker

Contributing Offices:

The School of Education

Affected Parties:

All students/staff/faculty conducting human subjects research

Location where Existing Policy can be Viewed:

http://www.liberty.edu/academics/graduate/irb/index.cfm?PID=29532; http://www.liberty.edu/academics/graduate/irb/index.cfm?PID=29539; http://www.liberty.edu/academics/graduate/irb/index.cfm?PID=29733

Complete Wording of New or Revised Policy:

Researchers must seek written permission from research sites.

Policy Rationale:

Respect for the autonomy of research site authorities, protection of the researcher

SACS Criteria:

Enter SACS Criteria here.

Other Regulatory Criteria:

45 CFR 46.112, 114

Definition of Glossary Terms:

Enter Definition of Terms here.

Policy Keywords:

Permission

Implementation Description:

Currently implemented

PROCEDURES FOR IMPLEMENTATION AND REVIEW

Policy Administrators:

G. Michele Baker and Fernando Garzon, Psy.D.

Policy Review Cycle:

Enter Policy Review Cycle here.

Procedures:

LU students, faculty, and staff who plan to conduct research at institutions, organizations, facilities, or events—schools, churches, businesses, conferences, etc.—that are unaffiliated with the University are required to seek written permission from those outside groups to utilize them for research studies. This will involve requesting permission in person or writing a permission request letter to the appropriate party. It is the responsibility of the researcher to determine from whom to seek permission.

The IRB provides a permission request letter template on its webpage at http://www.liberty.edu/academics/graduate/irb/index.cfm?PID=20088, and we invite researchers to utilize the template to prepare their permission requests. The permission request letter does not need to be submitted to the IRB.

A sample scenario might involve a researcher who plans to conduct his or her study at a public school(s). The researcher would need to gain written permission from the district superintendent and provide a copy of that permission to the IRB. Although the superintendent may require the researcher to also gain permission from the school principal, documentation of the principal’s permission would not be necessary for IRB approval.

Researchers should request that permission letters be provided on approved letterhead and include the signature(s) of the appropriate official(s). Permission documentation that is not provided on letterhead with signature(s) (i.e., emailed permission) will have to be confirmed by the IRB. Confirmation is accomplished by email or a phone call to the party listed on the permission documentation.

Permission letters should consist of a broad statement indicating that the researcher will be allowed to conduct his or her study procedures at a specific facility or function. If the individual providing permission lists permissible procedures on the permission letter, the researcher should make sure that he or she has been granted permission to conduct all of the procedures outlined on the IRB application. If the researcher is not granted permission to conduct all of his or her planned procedures, the IRB will not be able to grant its approval, and the researcher may need to reconsider and possibly revise his or her planned protocol and IRB application.

If a facility refuses to grant permission prior to the researcher receiving LU IRB approval and the researcher has completed all requested IRB revisions to his or her research application, the IRB will conditionally approve the research application and issue a conditional approval letter to the researcher for the specified research study. Conditional approval WILL NOT allow the researcher to begin recruiting participants and collecting data, but the researcher will be able to provide the conditional approval letter to the appropriate official(s) to gain the needed permission letter.

Once received, permission letters will need to be submitted to the IRB. We will not be able to issue a complete approval prior to receiving all necessary permission letters. Copies of permission letters may be submitted by email as scanned pdfs to irb@liberty.edu; by fax to 434-522-0506; or by mail, campus mail, or hand delivery to Green Hall, suite 1837. The IRB will save and file the letters with the researcher’s application and supporting documents and issue an approval letter enabling the researcher to begin his or her research study.  

Sanctions:

Studies will not receive complete IRB approval until all permission letters are submitted.

Exceptions:

Enter Exceptions here.

Other Policy Link Locations:

Enter Policy Link Locations here.

POLICY APPROVAL (Official Approver Use Only)

Need for Legal Counsel Review?

Yes         ☐ No

Approved By:

Enter Policy Approver here.

Approval Date:

Enter Policy Approval Date here.

Implementation Date:

Enter Policy Implementation Date here.

Final Policy Number:

Enter Final Policy Number here.