1. Institutional Review Board
Nuts and Bolts of
CGU IRB Procedures
Hours: 8:30AM-5:00PM
Phone:
Website:
Location: 135 E. 12th St. (next to Writing Center) Mail Address: Office of Research and Sponsored Programs
150 E. 10th St., Claremont, CA 91711

2. What is the IRB? IRB = Institutional Review Board
Tasked with assuring the policies of OHRP, DHHS, and the FDA
According to the Office of Human Research Protection:
“The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.”

3. The Purpose of IRB Review
Assure compliance with federal regulations and university policies
The IRB did not author those policies but is responsible to implement them
Charged to assure that faculty and students meet specific ethical standards in all research that involves human participants
All such research must conform to the Belmont Principles for protection of human participants

4. IRB Process in a Nutshell
Accepts written applications to review specific study designs (“protocols”) from CGU, HMC and KGI faculty or from students with faculty endorsement
One or more IRB staff AND one or more IRB members reads each entire application package
Research is designated by the risk level into exempt, expedited, or full board review

5. IRB Process, continued
Usually the IRB seeks written clarification or revision of one or more elements of the application
After one or more written exchanges with the applicant, the IRB almost always approves the protocol
The IRB reviews and approves around 200 new applications per year
This does not include amendments and renewals

6. Why do we need an IRB?
Human subjects research was unregulated until the mid-20th century, triggered by highly troubling medical studies, including:
Medical experiments in Nazi prison camps
Tuskegee syphilis experiment
Human radiation exposure experiment
Willowbrook hepatitis study
Recognition of ethical issues led to push for acceptance of Nuremberg Code, Belmont Principles, and finally the Common Rule
Human subjects research was unregulated until the mid-20th century, triggered by highly troubling medical studies, including:
Medical experiments in Nazi prison camps
Tuskegee syphilis experiment
Human radiation exposure experiment
Willowbrook hepatitis study
Recognition of ethical issues led to push for acceptance of Nuremberg Code, Belmont Principles, and finally the Common Rule
In 1975, the Department of Health, Education and Welfare (DHEW) created regulation which included the recommendations laid out in the NIH's 1966 Policies for the Protection of Human Subjects. Title 45 of the Code of Federal Regulations, known as "The Common Rule," requires that institutional review boards (IRBs) oversee experiments using human subjects.

7. IRB DNA: The Belmont Principles
Beneficence
Do no harm
Maximize benefits & minimize harm
Justice
Equitable distribution of burden and benefits
Respect for persons
Individual autonomy is respected
Persons with diminished autonomy need extra protection (special populations)
Beneficence
Do no harm
Maximize benefits & minimize harm
Justice
Equitable distribution of burden and benefits
Respect for persons
Individual autonomy is respected
Persons with diminished autonomy need extra protection (special populations)

8. Do You Need IRB Review? Determining the Applicability of 45 CFR Part 46
Consider the following questions:
Does the activity involve Research?
Does the activity involve Human Participants?
Is the activity eligible for Exemption?
Human Subject Regulations Decision Charts:
Consider the following questions:
Does the activity involve Research?
Research is “a systematic investigation designed to develop or contribute to generalizable knowledge.”
Does the activity involve Human Participants?
Human participants are “living individuals, about whom an investigator obtains data through intervention or interaction with the individual or identifiable private information from some other sources.”
Is the activity eligible for Exemption?
Certain studies are considered exempt from review. If you aren’t 100% sure, you should still submit an application.

11. IRB Classifications
Exempt. Studies to improve or evaluate standard practices in educational institutions; fully anonymous non-sensitive surveys; analysis of pre-existing anonymous data; other specific exemptions
Expedited. No more than minimal risk, no special populations such as pregnant women, prisoners, minors, mentally disabled
Standard (Full Board Review). Higher than minimal risks or studies of special populations

12. Writing the Application (1)
The current IRB application forms (Regular, MTurk):

13. Writing the Application (2)
Checklist for Initial Review
IRB protocol completely filled out (MTurk or Regular?!)
Signature of PI, Faculty Advisor, and Co-PI (if applicable)
Two (2) copies of IRB application, unstapled
Informed Consent form / Assent form (minors)
Recruitment scripts, , or flyers
Copies of all Questionnaires or other Research Materials (if applicable)
Protecting Human Subjects training certificate
Timeline
Minimum 2-3 wks (Exempt & Expedited)--seasonally longer
Full Board Review may require additional time; note the IRB calendar deadline for assuring review by the next monthly full board meeting

14. Informed Consent Consent = subjects over 18 years of age
Consent form vs. Assent form
Consent = subjects over 18 years of age
Assent = minors (under 18 years of age)
Waiver of Signed Consent
(1) When the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality.
(2) When the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

15. Consent Components
Study leadership (who is the PI? Who is the faculty advisor?)
Sponsorship (if applicable)
Purpose of the study
Eligibility (inclusion and exclusion criteria)
Participation (what will participants be asked to do, for how long?)
Risks of participation
Benefits of participation (remember: helping you out with a study is NOT a benefit to participants)
Compensation
Voluntary participation**
Confidentiality
Further information
Consent statement (either signed or click-box)
See “Informed Consent Form with Embedded Instructions“ for in-depth instructions

17. Pay Attention to…. Consent Vs. Assent (samples on website)
Deception (Temporary only!  Is it really necessary? Causes extra scrutiny)
Confidentiality (keeping it secret) Vs. Anonymity (no names are taken or learned)
Special populations
Clarity and Organization
Grammar and Spelling

18. How to Respond to IRB Questions and Comments
IRB Responses are sent via to the PI and Faculty Advisor--responses can be sent via to or drop off hard copy
Respond directly to each IRB point using different font, italics, or bold text to highlight your response
Submit revised materials two ways: with bold or other markers to show changes, and in a final (clean) version

19. Aftermath: Amendment Vs. Renewal Vs. Addendum
When to use the Amendment form?
For any changes to approved protocols, use the amendment form at
When to use the Renewal and Closure form?
To request continuation of approved research or if the Research has been completed, to close out the IRB process, use the form at:
When to submit an Addendum?
For unsolicited changes to a protocol that has not yet been approved, send a cover letter indicating what changes are proposed and include all documents that are being modified, with changes clearly marked

20. Most Common Mistakes Using the wrong form Missing signatures
Missing documents/materials
On response, submitting entire IRB application instead of revisions only
Not marking changes clearly
Expecting a different, quicker review process for exempt protocols
Need only CGU IRB approval for multiple institutions study
Got IRB approval don’t need permission letter
IF YOU DID NOT GET IRB APPROVAL FOR A STUDY YOU ALREADY FINISHED, YOU MUST STILL SEEK RETROACTIVE APPROVAL PRIOR TO PUBLISHING OR PRESENTING AT ACADEMIC CONFERENCE!

21. More Information: Frequently Asked Questions
Contact the IRB for clarifications
Phone: