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IRB AND HUMAN SUBJECTS REVIEW

IRB AND HUMAN SUBJECTS REVIEW. Kris Clarke, Ph.D. POLICY. ALL PROJECTS/THESES NEED A DEPARTMENT REVIEW , INCLUDING EXEMPT STUDIES EVEN IF YOUR WORK IS UNDER AN EXISTING APPROVED STUDY VULNERABLE POPULATIONS &/OR FUNDED RESEARCH NEEDS UNIVERSITY REVIEW AS WELL. HUMAN SUBJECTS.

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IRB AND HUMAN SUBJECTS REVIEW

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  1. IRB AND HUMAN SUBJECTS REVIEW Kris Clarke, Ph.D.

  2. POLICY • ALL PROJECTS/THESES NEED A DEPARTMENT REVIEW, INCLUDING EXEMPT STUDIES • EVEN IF YOUR WORK IS UNDER AN EXISTING APPROVED STUDY • VULNERABLE POPULATIONS &/OR FUNDED RESEARCH NEEDS UNIVERSITY REVIEW AS WELL

  3. HUMAN SUBJECTS UNIVERSITY SITE: Http://www.csufresno.edu/humansubjects/ Policies Application Checklist Sample memos Sample forms

  4. MAJOR ETHICAL ISSUES THAT GET ATTENTION VOLUNTARY PARTICIPATION INFORMED CONSENT RIGHT TO SERVICES/DENIAL OF TREATMENT NO HARM ANONYMITY/CONFIDENTIALITY & EXCEPTIONS COMPENSATION RESEARCHER DECEPTION, FRAUD AND MISREPRESENTATION

  5. VULNERABLE POPULATIONS • FEDERAL GUIDELINES • PREGNANT WOMEN • MINORS • INSTITUTIONALIZED PERSONS • BUT DON’T SOCIAL WORKERS TYPICALLY WORK WITH OTHER “VULNERABLE POPULATIONS”?

  6. ABILITY TO MAKE INFORMED DECISION TO PARTICIPATE & IMPLICATIONS OF THE STUDY ACTIVITY • Cognitive impairment compromising understanding/ability to consent • Activities that create undue risk • Practice & Research are inherently unequal – with social worker/researcher having more power/authority • Sources of influence on behavior • Compensation (e.g., money, benefits) • Control over other “goods” (e.g. service benefits, grades) • Social desirability

  7. BE KIND TO REVIEWERS(DON’T UPSET THEM) TRY TO KEEP TO THE UNIVERSITY OUTLINE INCLUDE ALL EXPECTED INFO PLUS ATTACHMENTS & DETAILS RELEVANT TO YOUR STUDY WRITE CLEARLY – SPELL CHECK, GRAMMAR CHECK REMEMBER TO EXPLAIN – THEY DON’T KNOW WHAT YOU ARE DOING

  8. DSWE DEPARTMENT REVIEW • PREPARE YOUR PROPOSAL USING UNIVERSITY OUTLINE/CH. 3 • REMEMBER TO ADAPT/ADDRESS THINGS RELEVANT TO YOUR WORK • IF ONLY NEED DEPT REVIEW, YOU DO NOT NEED ABSTRACT & RESEARCHER QUALIFICATIONS STATEMENTS • ATTACH ALL FORMS, INSTRUMENTS, LETTERS OF SUPPORT (COPIES) • ATTACH COPY OF HUMAN SUBJECTS TRAINING CERTS (YOU & CHAIR)

  9. DSWE DEPARTMENT REVIEW • SUBMIT TO YOUR 292 INSTRUCTOR • IF NEEDING FURTHER WORK, S/HE WILL RETURN IT TO YOU FOR REVISION • HE/SHE REVIEWS & FORWARDS TO DR. CLARKE, IF READY • DR. CLARKE CIRCULATES TO FACULTY FOR REVIEW • APPROVED (POSSIBLY WITH COMMENTS) • APPROVAL WITHHELD PENDING REVISIONS • REVIEW USUALLY TAKES A FEW DAYS TO 1 WEEK

  10. DSWE RESPONSE GOES TO YOUR 292 INSTRUCTOR WHO REVIEWS RESPONSE WITH YOU IF APPROVED, RECOMMENDED REVISIONS OVERSEEN BY CHAIR IF APPROVAL WITHHELD, DOCUMENT NEEDS REVISION & RE-REVIEW HIGHLIGHT CHANGES IN REVISION; PROVIDE A BRIEF OVERVIEW OF REVISIONS/ISSUES ADDRESSED

  11. UNIVERSITY REVIEW • PREPARE YOUR PROPOSAL USING UNIVERSITY OUTLINE • REMEMBER TO ADAPT/ADDRESS THINGS RELEVANT TO YOUR WORK • STICK TO GENERAL OUTLINE AS MUCH AS POSSIBLE; MAKES IT EASIER ON REVIEWERS • ATTACH ALL FORMS, INSTRUMENTS, LETTERS OF SUPPORT (COPIES) • ATTACH COPY OF TRAINING CERTS (YOU & CHAIR)

  12. UNIVERSITY REVIEW • ELECTRONIC SUBMISSION: SCANNED DEPT REVIEW SHEET W/ SIGNATURES AND PROTOCOL (PDF OR SCANNED). OR SUBMIT ORIGINAL TO UNIVERSITY HUMAN SUBJECTS (ARRANGE SUBMISSION WITH YOUR CHAIR) • REVIEW TAKES ABOUT 2 WEEKS • DECISIONS • Approve • Approval withheld • Need meeting review • CHAIR NOTIFIED OF DECISION IN WRITING

  13. SHOULD YOUR PROPOSAL NEED REVISION PROVIDE A COVER LETTER/MEMO THAT OUTLINES THE CHANGES HIGHLIGHT CHANGES, E.G., ITALICIZE SECTIONS RESUBMIT AS REQUESTED (sometimes a single copy to C. Jones is all that is required) FULL REVIEW VS. CHAIR REVIEW

  14. HUMAN SUBJECTS TRAININGS http://137.187.172.153/CBTs/Assurance/login.asp http://www.ogc.fullerton.edu/tutorial/humanIntro.asp http://phrp.nihtraining.com/users/login.php

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