Navigating IRB Submission Process for New Studies
Learn the steps involved in submitting a new study to the IRB, including creating an initial submission, selecting the level of review, and completing the HS-ERA application. Understand Penn policy requirements, different review categories, and be prepared to answer key questions during the process for successful IRB approval.
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Presentation Transcript
Part IV: Submitting a New Study to the IRB DIANA FLOEGEL, MLIS, PHD SENIOR REGULATORY ANALYST FLOEGELD@UPENN.EDU
Step 1: Creating an initial submission For more information, visit our website
It is Penn policy that a faculty member be listed as the PI in HS- ERA Make sure they completed CITI training A note on student submissions List yourself as a Study Contact Your PI and department chair have to approve your initial submission before the IRB sees it Factor that into your timeline
Step 2: Selecting your level of review level of review There are three categories of review Exempt Lowest risk Common categories for students: Research conducted in commonly accepted educational settings (category 1) Research with adults using minimal risk tests, surveys, interviews, observations (category 2) Research with adults involving benign behavioral interventions (category 3) Secondary research using identifiable private information (category 4) Expedited Minimal risk and not eligible for exemption Common categories for students Collection of data from voice, video, digital, or image recordings made for research (category 6) Research on individual or group characteristics or behaviors employing survey, interview, focus group, or evaluation methods (cat. 7) Convened/Full Risk level is unclear or greater than minimal Will be reviewed by a panel of experts who convene monthly Uncommon for student research
Questions about your level of review? Contact a Senior Analyst using our directory or sign up for the IRB s office hours!
Be prepared to answer questions about: Objectives Methods and Design Duration of the project Inclusion/exclusion criteria Recruitment Compensation Timeline of study procedures Privacy and Confidentiality plans Consent/HIPAA authorization process(es) Risks and benefits Step 3: Complete the HS-ERA Application
Tips for the HS-ERA application Use plain language Tell us about what you will do, how you will do it, when you will do it, and where you will do it Have clear plans for de-identifying data and securely storing data NOTE: Give yourself plenty of time to submit.
Grant applications if your study is funded or pending funding Recruitment script(s) and/or notice(s) Documents we need to review Consent form(s) and/or script(s) May require HIPAA authorization Data collection instrument(s) Local site approvals/letters of study support Looking for templates? Check out our website!
Additional documents Subparts for vulnerable populations: Children/minors Pregnant people, fetuses, neonates IF the study may affect the pregnant person and/or their fetus Incarcerated people You can find subparts forms on our website
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