1. 1 Claremont Graduate University Institutional Review Board Nuts and Bolts of CGU IRB Procedures Dean R. Gerstein, PhD, Vice Provost for Research Krissyvan Khamvongsa, MA, Assistant Director of Research February 6, 2009

2. 2 The Purpose of IRB Review The IRB’s sole purpose is to assure compliance with well-defined federal regulations and university policies. The IRB did not author those policies but is responsible to implement them The IRB’s sole purpose is to assure compliance with well-defined federal regulations and university policies. The IRB did not author those policies but is responsible to implement them Specifically, the IRB is charged to assure that faculty and students meet specific ethical standards in all research that involves human participants Specifically, the IRB is 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 All such research must conform to the Belmont Principles for protection of human participants

3. 3 IRB Process in a Nutshell The IRB accepts written applications to review specific study designs (“protocols”) from CGU faculty or from students with faculty endorsement The IRB accepts written applications to review specific study designs (“protocols”) from CGU faculty or from students with faculty endorsement The IRB encourages students to ask questions or discuss protocol issues with the IRB staff before submitting applications The IRB encourages students to ask questions or discuss protocol issues with the IRB staff before submitting applications One or more IRB staff AND one or more IRB members reads each entire application package (about ¼ of the time, the entire Board and staff read the application—this is “Full Board Review”) One or more IRB staff AND one or more IRB members reads each entire application package (about ¼ of the time, the entire Board and staff read the application—this is “Full Board Review”)

4. 4 IRB Process, continued Usually, but not always, the IRB seeks written clarification or revision of one or more elements of the application Usually, but not always, 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—about 200 per year After one or more written exchanges with the applicant, the IRB almost always approves the protocol—about 200 per year The total elapsed time from receipt of application to approval is a median of one month The total elapsed time from receipt of application to approval is a median of one month However, there is wide variation in the time frame, mostly depending on how long the applicant takes to respond to IRB questions and comments However, there is wide variation in the time frame, mostly depending on how long the applicant takes to respond to IRB questions and comments

5. 5 IRB DNA: The Belmont Principles http://ohsr.od.nih.gov/guidelines/index.html http://ohsr.od.nih.gov/guidelines/index.htmlhttp://ohsr.od.nih.gov/guidelines/index.html Beneficence Beneficence Do no harm Do no harm Maximize benefits & minimize harm Maximize benefits & minimize harm Justice Justice Equitable distribution of burden and benefits Equitable distribution of burden and benefits Respect for persons Respect for persons Individual autonomy is respected Individual autonomy is respected Persons with diminished autonomy need extra protection (special populations) Persons with diminished autonomy need extra protection (special populations)

6. 6 Determining the Applicability of 45 CFR Part 46 Consider the following questions: Consider the following questions: Does the activity involve Research? Does the activity involve Research? Research is “a systematic investigation designed to develop or contribute to generalizable knowledge.” Does the activity involve Human Participants? 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? Is the activity eligible for Exemption?

7. 7 IRB Classifications Human Subject Regulations Decision Charts: Human Subject Regulations Decision Charts: http://hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm http://hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm 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 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.101 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 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.101 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.101 Expedited. No more than minimal risk, no special populations such as pregnant women, prisoners, minors, mentally disabled Expedited. No more than minimal risk, no special populations such as pregnant women, prisoners, minors, mentally disabled http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htmhttp://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm Standard (Full Board Review). Higher than minimal risks or studies of special populations Standard (Full Board Review). Higher than minimal risks or studies of special populations

8. 8 Writing the Application (1) The IRB encourages students to ask questions or discuss protocol issues with the IRB staff before submitting applications The IRB encourages students to ask questions or discuss protocol issues with the IRB staff before submitting applications

9. 9 Writing the Application (2) Use the current IRB application form: Use the current IRB application form: http://www.cgu.edu/pages/1075.asp The application, including the description of the research protocol, should be written for an audience that includes non-scientists who are not impressed by esoteric knowledge—so minimize and clearly define all jargon. The application, including the description of the research protocol, should be written for an audience that includes non-scientists who are not impressed by esoteric knowledge—so minimize and clearly define all jargon. Write clearly and concisely with linear logic, include everything the application specifically asks for, avoid duplication, and avoid TMI Write clearly and concisely with linear logic, include everything the application specifically asks for, avoid duplication, and avoid TMI How to fill out the IRB application—Do it right the first time and the review process will be completed much faster How to fill out the IRB application—Do it right the first time and the review process will be completed much faster

10. 10 Writing the Application (3) Checklist for Initial Review Checklist for Initial Review  IRB protocol completely filled out  Signature of PI, Faculty Advisor, and Co-PI (if applicable)  Two (2) copies of IRB application  Informed Consent form / Assent form (minors)  Recruitment scripts, email, or flyers  Copies of all Questionnaires or other Research Materials (if applicable) Timeline Timeline Minimum 2 to 3 weeks (Exempt & Expedited) Minimum 2 to 3 weeks (Exempt & Expedited) Full Board Review may require additional time; note the IRB calendar deadline for assuring review by the next monthly full board meeting Full Board Review may require additional time; note the IRB calendar deadline for assuring review by the next monthly full board meeting

11. 11 How to Respond to IRB Questions and Comments IRB Responses are sent via email to the PI and Faculty Advisor--responses can be sent via email or hard copy (new signature pages require hard copy) IRB Responses are sent via email to the PI and Faculty Advisor--responses can be sent via email or hard copy (new signature pages require hard copy) Respond directly to each IRB point using different font, italics, or bold text to highlight your response 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 Submit revised materials two ways: with bold or other markers to show changes, and in a final (clean) version

12. 12 Aftermath: Amendment Vs. Continuing Review vs. Addendum When to use the Amendment form? When to use the Amendment form? For any changes to approved protocols, use the amendment form at http://www.cgu.edu/pages/1837.asp For any changes to approved protocols, use the amendment form at http://www.cgu.edu/pages/1837.asp http://www.cgu.edu/pages/1837.asp When to use the Update 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: http://www.cgu.edu/pages/1837.asp To request continuation of approved research or if the Research has been completed, to close out the IRB process, use the form at: http://www.cgu.edu/pages/1837.asp http://www.cgu.edu/pages/1837.asp When to submit an Addendum? 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 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

13. 13 Informed Consent Consent form vs. Assent form Consent form vs. Assent form Consent = parents and/or subjects over 18 years of age Consent = parents and/or subjects over 18 years of age Assent = minors (under 18 years of age) Assent = minors (under 18 years of age) Waiver of Signed Consent 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. (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. (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.

14. 14 Pay Attention to…. Consent Vs. Assent Consent Vs. Assent (samples on website) Deception (Is it absolutely necessary?) Deception (Is it absolutely necessary?) Confidentiality (keeping it secret) Vs. Anonymity (no names are taken or learned) Confidentiality (keeping it secret) Vs. Anonymity (no names are taken or learned) Special Populations Special Populations Clarity and Organization Clarity and Organization Grammar and Spelling Grammar and Spelling

15. 15 Most Common Mistakes Using the wrong Form Using the wrong Form Missing signatures Missing signatures Missing documents/materials Missing documents/materials On response, submitting entire IRB application instead of revisions only On response, submitting entire IRB application instead of revisions only Expecting a different, quicker review process for exempt protocols Expecting a different, quicker review process for exempt protocols Failing to contact the IRB for clarifications Failing to contact the IRB for clarifications Email: irb@cgu.edu Phone: 909-607-9406 Email: irb@cgu.edu Phone: 909-607-9406irb@cgu.edu Location: Harper Hall Rm.152 Location: Harper Hall Rm.152 Hours: 8:30AM- 5:00PM Hours: 8:30AM- 5:00PM