core: ethics from an irb perspective
TRANSCRIPT
C.O.R.E Webinar Series: Ethics from an IRB Perspec;ve
Culture of Research and Educa;on (CORE)
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Dr. Heidi Sato Chair -‐ Ins3tu3onal Review Board Director of Ins3tu3onal Research
Dr. Stefan Hanson Program Director,
B.S.B.A., B.S.H.R.M., and B.S.L Ins3tu3onal Review Board Member
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1. What is an IRB and its purpose? 2. What requires IRB review and approval? 3. What are the different types of IRB review? 4. What is the process for submiKng an IRB
applica;on? 5. What criteria must be met for IRB approval? 6. What are the possible outcomes of an IRB
review?
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Which of the following agenda items is the most important that you would like to have covered in this webinar? Select from the following: A) What is an IRB and its purpose? B) What requires IRB review and approval? C) What are the different types of IRB review? D) What is the process for submiMng an IRB applica3on? E) What criteria must be met for IRB approval? 3
True or False? As long as a researcher does not obtain the data directly from human subjects, then the study would always be considered as research that does not involve human subjects
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¡ Ins3tu3onal Review Board (IRB) § A review commiSee established to ensure that the rights and welfare of human research subjects are protected
§ IRB ensures adherence to ▪ Federal, state and local regula3ons ▪ Established ethical principles (the Belmont Report): ▪ Respect for Persons ▪ Beneficence ▪ Jus3ce
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¡ IRB Membership ¡ Federal regula3ons require that an IRB have at least five members with professional exper3se and competence and of diverse backgrounds
¡ The Trident IRB § Director of Ins3tu3onal Research (Chair) § Ins3tu3onal Research Analyst (Permanent Member) § Four representa3ve faculty members (with at least one faculty member mee3ng defini3on of a scien3st member)
§ One non-‐scien3st staff member § At least one community member, not affiliated with Trident § Chief Compliance Officer (Ex-‐officio member)
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¡ Research with Human Subjects requires IRB review and approval.
¡ “Research” means a systema3c inves3ga3on, including research development, tes3ng, and evalua3on, designed to develop or contribute to generalizable knowledge”
¡ And where
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¡ Human Subject” means a living individual about whom a researcher (whether professional or student) conduc3ng research obtains the following:
§ Data through interven3on or interac3on with the individual
§ Iden3fiable private informa3on
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¡ If a project meets the defini3on of Research with Human Subjects then it is subject to IRB review
¡ The next step-‐ § What type of review?
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¡ The Categories of IRB Review are:
¡ Exempt ¡ Expedited Review ¡ Full/Convened IRB Review
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¡ Exempt Research ¡ An IRB can determine that some Research with Human Subjects is Exempt (45 CFR 46.101) when the research involves:
§ Educa3onal SeMngs § Tests, surveys, observa3onal research § Exis3ng data
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¡ Expedited Review ¡ Research with Human Subjects that poses no more than minimal risk to subjects is eligible for expedited review
¡ Minimal risk: “The probability and magnitude of harm or discomfort an3cipated in the research are not greater in and of themselves from those ordinarily encountered in daily life or during the performance of rou3ne physical or psychological examina3ons or tests” 45 CFR 46. 102 (i)
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¡ Full/Convened IRB Review ¡ All members of the IRB meet and review proposals that expose subjects to more than minimal risk
¡ Research involving protected groups are subject to Full/Convened Review
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Which of the following would be considered exempt? A) Any study that involves only exis3ng data B) A primary researcher surveys children in a school seMng C) An anonymous survey conducted on a healthy adult popula3on regarding a previous medical condi3on D) Any study that involves minimal risk E) Studies in which par3cipants provide informed consent 14
True or False? Exempt studies do not need to be reviewed by the IRB.
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¡ Step 1: Complete online IRB training hSps://phrp.nihtraining.com
¡ Step 2: Obtain approval from PhD Director on disserta3on proposal (for PhD students)
¡ Step 3: Complete pre-‐IRB review (star3ng in Oct) ¡ Step 4: Obtain permission from study site ¡ Step 5: Submit IRB applica3on in TLC ¡ Step 6: Send an email to [email protected] ¡ Step 7: Make requested revisions ¡ Step 8: Receive results of IRB review
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Required for all Studies: [ ] Cer3ficate of comple3on of online training [ ] Completed IRB applica3on [ ] Approved research protocol/methodology [ ] All data instruments [ ] Permission to administer study Required for Studies Involving Data Collec;on: [ ] Informed Consent Form [ ] All documents used to recruit par3cipants _____ *Addi3onal requirements may be required for certain types of studies
1. The risks to subjects are minimized. 2. The risks are reasonable in rela3on to benefits. 3. The selec3on of subjects is equitable. 4. Informed consent will be sought. 5. Informed consent will be documented. 6. Safety of subjects will be ensured. 7. Privacy of subjects will be protected and
confiden3ality of data maintained. 8. Safeguards against undue influence or coercion Source: Code of Federal Regula3ons (45 CFR Part 46.111)
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1. Exempt 2. Approved 3. Modifica3ons or addi3onal documents required 4. Deferred un3l full IRB CommiSee review 5. Disapproved
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Which of the following is an example of minimizing risks to subjects? A) Not collec3ng personal iden3fiers from subjects
when sensi3ve data is being collected B) Having a teacher present when a researcher is
interviewing children C) Both A and B D) Neither A nor B
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Which of the following does not apply for informed consent? A) Subject or legal representa3ve must give consent B) Language must be 8th grade level C) Coercion must be avoided or minimized D) It must disclose purpose, benefits, risks,
procedures, benefits, risks, and how confiden3ality will be maintained,
E) None of the above
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¡ Primary purpose of IRB: to protect the rights and welfare of human subjects
¡ Federal regula3ons require IRB review for all research involving human subjects
¡ Three different types of IRB review: exempt, expedited, and full review
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¡ Key documents required documents for all studies: 1) cer3ficate of comple3on of online IRB training, 2) completed IRB applica3on, 3) approved research methodology, 4) all data instruments, 5) permission to administer study
¡ Key criteria that must be met for IRB approval: 1) Clear documenta3on on how risks to subjects are minimized, 2) Informed consent that includes required items (if ac3ve data collec3on)
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Visit hSps://www.trident.edu/webinars/core/
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ASen3on Faculty, Students, Alumni and Guest Speakers in Business, Health Sciences, and Educa3on: ¡ Have you wanted to present your ongoing scholarly and professional work to a general audience?
¡ CORE Grand Rounds provides a plaporm for professional development and increased engagement to receive construc3ve feedback from peers and scholars-‐in-‐training.
¡ Email Dr. Bernice B. Rumala at [email protected] to sign up
¡ To receive more informa3on about C.O.R.E. please visit the C.O.R.E. webpage at: www.trident.edu/webinars/core
¡ For further informa3on about Trident’s doctoral programs in educa3onal leadership, business and health sciences please visit : hSps://www.trident.edu/degrees/doctoral/
¡ Do you have any comments for C.O.R.E., you may email Dr. Bernice B. Rumala, C.O.R.E. Chair, at: [email protected]
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Contact Ins3tu3onal Review Board ¡ Email: [email protected] ¡ Phone:
Ø Dr. Heidi Sato, Chair (x2189) Ø Ms. Yan Ma, IRB Member (x2617)
¡ IRB website: hSps://www.trident.edu/students-‐and-‐alumni/ins3tu3onal-‐review-‐board/
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