Professional Development SRC/IRB Workshop Fall Hosted by: Farmingdale State College University in the High School

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1 Professional Development SRC/IRB Workshop Fall 2015 Hosted by: Farmingdale State College University in the High School

2 Form 1- Checklist for Adult Sponsor Form 1A Student Checklist Attach Research Plan discussed in General Session Attach Post Summary discussed in General Session Form 1B Approval Form

3 Prior Approvals & Extra Forms: Non-Exempt Humans Studies Vertebrate Studies Non-Exempt PHBA Studies Extra Forms Only: Hazardous Chemicals, Activities and Devices Those named in Note Work done at RRI or project was mentored Continuations

4 New Question #5 Who answers Yes? How does this affect Question 7? Starred Questions 6 and 8 Indicate extra forms needed Should agree with item 5, Form 1 If yes to 6, attach Previous Year(s) Abstract & Research Plan to Form 7

5 PRIOR APPROVAL HOME/SCHOOL/FIELD AFFIRMATION AFTER RRI org/overview-forms-and-dates

6 Human Participants Research Vertebrate Animal Research Tissue Studies Potentially Hazardous Biological Agents (PHBAs) Prior Approvals needed (IRB, IACUC, cells, tissues) BSL1 vs. BSL2 and beyond Proper Supervisors for activities Necessary Forms

7 Exempt or Non-Exempt from IRB Review? 4 types exempt, all others must have IRB documented review 1. Test of student invention on self/minimal risk 2. Data/record review of publicly available data-sets 3. Behavior OBSERVATIONS 4. Student receives pre-existing de-identified data REQUIRES WRITTEN LETTER FROM THE PROFESSIONAL ATTESTING TO THE DE-IDENTIFIED NATURE OF THE DATA AND THAT ALL PRIVACY AND HIPAA LAWS OBSERVED. At NO time can there be interaction with humans or manipulation of environment or the study becomes NON_EXEMPT and must have IRB Review. Pilot Studies must also undergo IRB Review if Non-Exempt.

8 IRB Approval Documented In each setting, LOCAL IRB, on Form 4, determines: Level of Risk If Qualified Scientist/Designated Supervisor needed (Form 2) Written documentation of Minor Assent, Parental Permission and Informed Consent of Adults (Sample Consent) Signature of 3 members of IRB Medical/Mental Health Professional Educator School Administrator In each Regulated Research Institution, their IRB must approve. Complete Student portion of Form 4 and attach Institution s IRB determination.

9 IRB must now also indicate whether a DS is needed LISEF does not allow Expedited Review by the IRB

10 Children ASSENT, Adults CONSENT Copies are required for submission What if RRI will not release them? What if Adult Consent given Online?

11 Qualified Scientist for Human Participants Research should be a person that is an expert in the student s area of research!

12 Participants Recruitment Methods Risk Assessment Risks vs. Benefits Protection of Privacy Informed Consent Process

13 Do NOT check HUMANS if this is an EXEMPT study All Non-Exempt Studies REQUIRE Form 4 The IRB may require Qualified Scientist (Form 2) The IRB may require WRITTEN assents/consents

14 See Pages of Rulebook, e-animals Approvals needed: IACUC and SRC: when? No exempt studies Vertebrate Animal Rules Vertebrates vs. tissue studies Home/Field vs. Regulated Research Institution Toxicity, Pain, Euthanasia, death of animals Forms needed: When? 5A, 5B, 6A, 6B

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19 Human tissue/cell lines, primate tissue/cell lines vs. other animal models (e.g. mice) ATCC How do they classify the cell line? And don t forget about Form 1 and the Research Plan

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22 See Pages of Rulebook, ly-hazardous-biological-agents Exempt Studies Microorganisms (bacteria, viruses, viroids, prions, fungi, parasites) Recombinant DNA Human/animal fresh/frozen tissues Blood Body fluids Forms needed (also see form 1,2, 3)

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26 BSL1 vs. BSL2 (see Pg. 17 of Rule Book) Your classroom environment: is it BSL1 or BSL2? Class 2, type A, BSC What is it?

27 Which committees: SRC vs. IACUC Supervisors needed: When is a Qualified Scientist needed? Who can be a Qualified Scientist? What about a Designated Supervisor? Which forms?

28 Form 7 Replication of previous experiments does NOT constitute new data Definition of a new variable 1 st year of work is a training year should still have a Form 7 What are you allowed to present to judges/place on the poster board?

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30 RTFM Questions will come up that even we can t answer But ask BEFORE, and ISEF s SRC can be contacted for advise Our LISEF SRC thinking: we want clean paperwork that indicates compliance with ISEF rules because we do NOT want students to face ISEF disqualification (and we would really like to avoid LISEF disqualification which is why we are having this workshop.

31 Thank you for coming and for your participation Our website with important information is: Contact us at: Use the Contact Us link at