Presentation on theme: "Institutional Review Board"— Presentation transcript:
1Institutional Review Board Nuts and Bolts ofCGU IRB ProceduresHours: 8:30AM-5:00PMPhone:Website:Location: 135 E. 12th St. (next to Writing Center) Mail Address: Office of Research and Sponsored Programs150 E. 10th St., Claremont, CA 91711
2What is the IRB? IRB = Institutional Review Board Tasked with assuring the policies of OHRP, DHHS, and the FDAAccording 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.”
3The Purpose of IRB Review Assure compliance with federal regulations and university policiesThe IRB did not author those policies but is responsible to implement themCharged to assure that faculty and students meet specific ethical standards in all research that involves human participantsAll such research must conform to the Belmont Principles for protection of human participants
4IRB Process in a Nutshell Accepts written applications to review specific study designs (“protocols”) from CGU, HMC and KGI faculty or from students with faculty endorsementOne or more IRB staff AND one or more IRB members reads each entire application packageResearch is designated by the risk level into exempt, expedited, or full board review
5IRB Process, continuedUsually the IRB seeks written clarification or revision of one or more elements of the applicationAfter one or more written exchanges with the applicant, the IRB almost always approves the protocolThe IRB reviews and approves around 200 new applications per yearThis does not include amendments and renewals
6Why 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 campsTuskegee syphilis experimentHuman radiation exposure experimentWillowbrook hepatitis studyRecognition of ethical issues led to push for acceptance of Nuremberg Code, Belmont Principles, and finally the Common RuleHuman subjects research was unregulated until the mid-20th century, triggered by highly troubling medical studies, including:Medical experiments in Nazi prison campsTuskegee syphilis experimentHuman radiation exposure experimentWillowbrook hepatitis studyRecognition of ethical issues led to push for acceptance of Nuremberg Code, Belmont Principles, and finally the Common RuleIn 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.
7IRB DNA: The Belmont Principles BeneficenceDo no harmMaximize benefits & minimize harmJusticeEquitable distribution of burden and benefitsRespect for personsIndividual autonomy is respectedPersons with diminished autonomy need extra protection (special populations)BeneficenceDo no harmMaximize benefits & minimize harmJusticeEquitable distribution of burden and benefitsRespect for personsIndividual autonomy is respectedPersons with diminished autonomy need extra protection (special populations)
8Do 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.
11IRB ClassificationsExempt. Studies to improve or evaluate standard practices in educational institutions; fully anonymous non-sensitive surveys; analysis of pre-existing anonymous data; other specific exemptionsExpedited. No more than minimal risk, no special populations such as pregnant women, prisoners, minors, mentally disabledStandard (Full Board Review). Higher than minimal risks or studies of special populations
12Writing the Application (1) The current IRB application forms (Regular, MTurk):
13Writing the Application (2) Checklist for Initial ReviewIRB protocol completely filled out (MTurk or Regular?!)Signature of PI, Faculty Advisor, and Co-PI (if applicable)Two (2) copies of IRB application, unstapledInformed Consent form / Assent form (minors)Recruitment scripts, , or flyersCopies of all Questionnaires or other Research Materials (if applicable)Protecting Human Subjects training certificateTimelineMinimum 2-3 wks (Exempt & Expedited)--seasonally longerFull Board Review may require additional time; note the IRB calendar deadline for assuring review by the next monthly full board meeting
14Informed Consent Consent = subjects over 18 years of age Consent form vs. Assent formConsent = subjects over 18 years of ageAssent = 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.
15Consent ComponentsStudy leadership (who is the PI? Who is the faculty advisor?)Sponsorship (if applicable)Purpose of the studyEligibility (inclusion and exclusion criteria)Participation (what will participants be asked to do, for how long?)Risks of participationBenefits of participation (remember: helping you out with a study is NOT a benefit to participants)CompensationVoluntary participation**ConfidentialityFurther informationConsent statement (either signed or click-box)See “Informed Consent Form with Embedded Instructions“ for in-depth instructions
17Pay 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 populationsClarity and OrganizationGrammar and Spelling
18How 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 copyRespond directly to each IRB point using different font, italics, or bold text to highlight your responseSubmit revised materials two ways: with bold or other markers to show changes, and in a final (clean) version
19Aftermath: Amendment Vs. Renewal Vs. Addendum When to use the Amendment form?For any changes to approved protocols, use the amendment form atWhen 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
20Most Common Mistakes Using the wrong form Missing signatures Missing documents/materialsOn response, submitting entire IRB application instead of revisions onlyNot marking changes clearlyExpecting a different, quicker review process for exempt protocolsNeed only CGU IRB approval for multiple institutions studyGot IRB approval don’t need permission letterIF 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!
21More Information: Frequently Asked Questions Contact the IRB for clarificationsPhone: