Institutional Review Board (IRB) - PowerPoint Presentation

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Institutional Review Board (IRB)

IRB Application and Review Process

The primary responsibility of the Institutional Review Board is to protect the rights, welfare, and privacy of all individuals participating in research sponsored by Cal Lutheran.  The IRB reviews all research studies involving human subjects for safety and compliance with regulations and ethical standards.

The Purpose of the IRB

IRB Review Process

Pre-review (administrative level) conducted by IRB Coordinator

Modifications/additions/further clarification may be requested and sent to Principal Investigator (PI)

When ready, IRB Application is sent to the IRB Chair to determine type of review:

Reviewed by IRB Chair (Exempt/Expedited Determination)

Reviewed by a Designated Reviewer (Exempt/Expedited Determination)Full Board ReviewConsidered more than Minimal RiskMinimal Risk: The probability and magnitude of harm or discomfort anticipated in the research that are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.Vulnerable PopulationAny study with a Full Board Approval will require Continuing Review

Documents submitted via email to

irb@callutheran.edu

IRB Application Documents

HRP-211 Basic Study Information Form

HRP-211 Basic Study Information Form

HRP-503a Template Protocol

HRP-502 Template Informed Consent Form

Child Assent Form (if applicable)Human Subjects Research Training (CITI Training (preferred) or NIH Training within the last 3 years)Recruitment MaterialsInterview/Survey Questions and/or other measuresSchool Approval Letter (if applicable)

Basic Study Information Form

“Will this institution’s IRB act as the IRB of record for other participating sites?”  NO

This would only be checked YES if you were conducting your study along with other institutions (Multi-site study)

Multi-site: The same protocol is being conducted at several different sites, each under the control of a local participating Investigator

Investigator Acknowledgement Section – Page 2

Name and dateAppendix A: Personnel List Faculty Advisor/Dissertation Chair Make sure to check who will be involved in obtaining Informed ConsentGuidance for completing the Form:

Protocol

Template with “comments” provided to assist with completing the document

Do not delete any sections; put N/A for any sections that do not apply. You can delete out all the italicized instructions once you have either completed the section or put N/A

Describe study procedures in detail

Make sure to carefully describe/detail your recruitment efforts; provide template/language that you are using for any emails/phone calls, letters, etc., these can be submitted as separate documents

Section 15.0 - Risk – “potential loss of confidentiality” should be includedGuidance for completing the Template:

Informed Consent Form

See Template with “comments”

Please do not delete any main sections, but rather put N/A or delete the specific language that does not apply

“Who can I talk to?” (Page 3)

This should be the contact information of the Principal Investigator and faculty advisor (if applicable)

Detailed Risks (Page 4)Potential loss of confidentialityPotential of discomfort/uncomfortable feelings from Survey/Interview questions, if applicableDelete any signature blocks that do not applyOnline Informed ConsentDelete signature blocksUse Electronic Consent Language with Check Boxes with “I Consent” or “I Do Not Consent”, along with a reference to being 18 years of age or older.

Informed Consent Form (cont.)

Information is consistent with what has been provided in the Protocol

Clearly documents if you are recording interviews

Audio Recording only

Audio and Video Recording

Recruitment incentivesDocumentation retention timeframesInterview/survey timeframesInstructions in red text can be deletedFor subjects that are <18 years old an ASSENT Form is required in addition to the Informed Consent FormThe Informed Consent would be written for the Parent/Guardian asking for their permission to allow their child to participateThe Assent would be given to the subject who is a minor in language that is age-appropriate

Additional Information to Consider

Is it necessary to collect personal/identifiable information?

How you will maintain the privacy/confidentiality of the subjects?

Anonymity vs. Confidentiality

Not anonymous if:

Collecting names, email addresses, IP Addresses or any other personal identifiable informationConducting face to face interviews/Zoom interviewsRecording interviewsAlways add “potential loss of confidentiality” as a risk to both the Protocol and Informed Consent FormInformation should be consistent across all documentsi.e. Protocol, Informed Consent, Recruitment MaterialsRaffles/Lotteries are not allowed as a form of Compensation

IRB Website

Home

Guidance on making changes to already approved study

Researchers Tab

https://www.callutheran.edu/research/irb/researchers.html

Forms and TemplatesTraining InformationInvestigator ManualZoom GuidelinesRole of the Faculty AdvisorHighly recommend to view the CLU IRB Website as a lot of new information has been posted within the last year

Contact IRB

For any questions, please email at irb@callutheran.edu