Guide to Successful IRB Applications Process
Understand the importance of an Institutional Review Board (IRB) for ethical research conduct. Learn about the purpose of an IRB, dispelling myths, roles of faculty advisors and students, and the approval process. Double IRBs may be required in certain cases. Follow the outlined steps for a successful IRB application process.
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Tips for Successful IRB Tips for Successful IRB Applications Applications https://www.saintleo.edu/institutional- review-board
Agenda Agenda Why an IRB? Purpose of IRB Myths IRB Process Double IRB If something changes or goes wrong Role of Faculty Advisor Role of student Tips
WHY an IRB? WHY an IRB? Historically- unethical studies Stanford Prison Study Tea Room trade UCLA Schizophrenia study Tuskegee Syphilis Study Law- In 1974, Congress passed the National Research Act which established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (CPHS) University Core Values- Respect and Integrity
The IRB is responsible for weighing the risks to participants vs. the benefits of the research The IRB cannot approve research where risks are judged unreasonable in relation to the anticipated benefits. Purpose of IRB Purpose of IRB Physical harm Psychological harm Invasion of Privacy Social and Economic harm
Myths about the IRB Myths about the IRB Hinder and stop research Big bureaucracy Judging my research study Takes months to complete Cmte. members are against me Tell me how to do my study This Photo by Unknown author is licensed under CC BY-NC-ND.
Partnership Partnership Student Faculty Advisor IRB
The Process The Process- -https://www.saintleo.edu/institutional-review-board Read everything Citi Certificates- student and advisor- students take student modules Complete applications and consent/assent forms Get ancillary docs.- Authoriz. letter, measures, recruitment materials Submit as ONE file 15 days for review (roughly) Approved, Revise and Resubmit, Rejected If SLU employees are participants- must get another approval- 15 days Study only starts after approval
Certain Organizations have their own IRB's: Hospitals, Schools, Corrections Most of the time, you will have to get approval from both the Organization's and SLU's IRBs Double IRB's Double IRB's Ask questions and read all information and directions for both IRBs
If Something changes or goes wrong If Something changes or goes wrong Notify your Faculty advisor immediately Email the IRB Modification
Role of Faculty Role of Faculty Advisor Advisor You are responsible for this study and the participants Weigh the risks of a study carefully- steer student to minimal risk Rigorous study does not = high risk Be sure there is enough expertise and experience to do the study Be sure it is feasible- timeline, participants, organizations Try to avoid using SLU employees Be sure your student knows how to do this, will follow directions, will be ethical Be sure to thoroughly read/check IRB application and all materials Be sure you are cc d on email submission to IRB Assist the student with the revision and resubmission
Role of Role of Student Student Faculty Advisor is your "go to person" Everything in the IRB application must be followed exactly- study should go as you outlined it If something goes wrong or there's a change- inform your advisor immediately, then inform the IRB Think about the IRB application from IRB POV- safety of participants Be detailed in your IRB application Think about the study from the participants' POV Consent form Focus on minimal risk studies and avoid using SLU employees Be sure your Faculty Advisor is cc d on your email submission to IRB
Tips Tips FOLLOW DIRECTIONS, ALL DIRECTIONS, ALL THE TIME COMPLETE THE ENTIRE APPLICATION- USE N/A IF NEEDED CONSENT FORM IS CRUCIAL SHOULD BE CONSISTENT THROUGHOUT STUDENT OR FACULTY ADVISOR CAN TALK TO IRB TO GET CLARIFICATION & VERY DETAILED
Keep it to minimal risk if possible (careful of vulnerable pops.) Keep Find the safest way possible to answer your research questions/hypotheses Find Tips Tips Try not to use SLU employees---avoid double review and chance that the answer is no Try If a double IRB is needed, talk with both IRB's to understand procedures beforehand Talk
More Tips More Tips LETTER OF AUTHORIZATION ON LETTERHEAD & GIVES TYPE IN SIGNATURES IMPLIED CONSENT IS FOR ONLINE SURVEYS IF STUDY IS ONLY FOR 18 OR OVER STUDENTS FOR WORK NOTE IT IN STUDENT AND FACULTY ADVISOR CLOSELY WITH FACULTY ADVISOR ASSENT FOR KIDS IMPLIED CONSENT PERMISSION FOR CONSENT FOR ADULTS FORM STUDY
Inmates in Correctional Facilities Inmates in Correctional Facilities We cannot review IRB applications which use Inmates in Correctional facilities as research participants. Inmates are a protected group
https://www.saintleo.edu/institutional-review-board SLU- IRB homepage https://www.saintleo.edu/application-directions-and- forms Application directions and forms Questions? Questions? https://www.saintleo.edu/irb-faqs Minimal Risk https://mediaweb.saintleo.edu/courses/IRBVideo/IRBV3. mp4?ictd[master]=vid~67cf3104-9e5d-4b2b-966d- 76b23842a9e5&ictd[il2539]=land~2_15982_direct_76005 caf0b297c7d074387e431223266~rlt~1519309877 Video- How to Fill out the form
