Professional Development

SRC/IRB Workshop Fall 2015

Hosted by: Farmingdale State College—University in the High School

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

‣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

‣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

PRIOR APPROVAL HOME/SCHOOL/FIELD

AFFIRMATION AFTER RRI

https://student.societyforscience.org/overview-forms-and-dates

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

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.

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.

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

•Children ASSENT, Adults CONSENT •Copies are required for submission

•What if RRI will not release them? •What if Adult Consent given Online?

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

•Participants •Recruitment •Methods •Risk Assessment

– Risks vs. Benefits

•Protection of Privacy •Informed Consent Process

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

See Pages 11-13 of Rulebook, https://student.societyforscience.org/vertebrate-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

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

See Pages 14-17 of Rulebook, https://student.societyforscience.org/Potentially-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)

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?

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?

Form 7

Replication of previous experiments does NOT constitute new data

Definition of a “new variable”

1st 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?

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.

Thank you for coming and for your participation

Our website with important information is: ◦ www.LISEF.org

Contact us at: ◦ src@lisef.org

◦ Use the “Contact Us” link at www.LISEF.org