Institutional Review Board IRB IRB Application and Review

Institutional Review Board (IRB) IRB Application and Review Process

The Purpose of the IRB • 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.

IRB Review Process Documents submitted via email to irb@callutheran. edu • • 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: 1. Reviewed by IRB Chair (Exempt/Expedited Determination) 2. Reviewed by a Designated Reviewer (Exempt/Expedited Determination) 3. Full Board Review I. Considered more than Minimal 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. II. Vulnerable Population III. Any study with a Full Board Approval will require Continuing Review

IRB Application Documents • HRP-211 Basic Study Information Form • • • HRP-211 Basic Study Information Form HRP-503 a 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 Materials Interview/Survey Questions and/or other measures School Approval Letter (if applicable) • • •

Basic Study Information Form Guidance for completing the 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 Acknowledgement Section – Page 2 – Name and date Appendix A: Personnel – List Faculty Advisor/Dissertation Chair – Make sure to check who will be involved in obtaining Informed Consent

Protocol Guidance for completing the Template: • • • 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 included

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 confidentiality – Potential of discomfort/uncomfortable feelings from Survey/Interview questions, if applicable Delete any signature blocks that do not apply Online Informed Consent – Delete signature blocks – Use 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 incentives Documentation retention timeframes Interview/survey timeframes Instructions in red text can be deleted For subjects that are <18 years old an ASSENT Form is required in addition to the Informed Consent Form – The Informed Consent would be written for the Parent/Guardian asking for their permission to allow their child to participate – The 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 information • Conducting face to face interviews/Zoom interviews • Recording interviews Always add “potential loss of confidentiality” as a risk to both the Protocol and Informed Consent Form Information should be consistent across all documents – i. e. Protocol, Informed Consent, Recruitment Materials Raffles/Lotteries are not allowed as a form of Compensation

IRB Website Highly recommend to view the CLU IRB Website as a lot of new information has been posted within the last year • • Home – Guidance on making changes to already approved study Researchers Tab – https: //www. callutheran. edu/research/irb/researchers. html – Forms and Templates – Training Information – Investigator Manual – Zoom Guidelines – Role of the Faculty Advisor

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