LISEF Update of SRC Rules for 20092010 - PowerPoint PPT Presentation

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LISEF Update of SRC Rules for 20092010

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The LISEF SRC now follows the ISEF SRC plan for review of paperwork ... Data/record review involving pre-existing data sets-no interaction with human subjects ... – PowerPoint PPT presentation

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Title: LISEF Update of SRC Rules for 20092010


1
LISEF Update of SRC Rules for 2009-2010
Dont Get Disqualified!!
Special Meeting for Research Teachers Thursday,
May 28, 2009 Syosset High School LISEF Monthly
Board of Trustees Meeting
2
LISEF Update of SRC Rules for 2009-2010
  • A Report on ISEF 2009
  • There were 1,223 sets of paperwork submitted for
    review
  • Review was divided into 3 teams
  • Intragroup communication about questions/problems
  • E-mail messages sent to participants about
    problems
  • New paperwork submitted, if necessary
  • Re-review/approval
  • Full group communication regarding questionable
    projects
  • Re-review with approval or FTQ

3
LISEF Update of SRC Rules for 2009-2010
  • A Report on ISEF 2009
  • There were 28 no-shows at ISEF (mainly due to
    swine flu concerns)
  • There were 8 FTQs
  • 4 Vertebrate Studies (Euthanasia questions no
    prior SRC approval)
  • 2 PCBE
  • 2 Too many team members

4
LISEF Update of SRC Rules for 2009-2010
  • Meet your LISEF SRC
  • Allen SachsCo-chair for committee logistics
  • Dr. Pat BossertCo-chair for Natural Science
    Projects
  • Elaine LabroccaCo-chair for Behavioral Science
    Projects

5
LISEF Update of SRC Rules for 2009-2010
  • Overall New Rules Guidelines developed for
    conducting research
  • Protect the rights and welfare of the student
    researcher human subjects
  • Protect the health and well-being of vertebrate
    animal subjects
  • Follow federal regulations governing research
  • Offer guidance to affiliated fairs
  • Use safe laboratory practices
  • Address environmental concerns
  • In summary
  • Provide a safe environment for students to
    perform their research
  • Save the environment

6
LISEF Update of SRC Rules for 2009-2010
  • Some Key Points
  • A Regional Fair (i.e. LISEF) may be more
    restrictive than the general ISEF rules
  • These restrictions will be posted on the LISEF
    website
  • The LISEF SRC now follows the ISEF SRC plan for
    review of paperwork
  • Your school IRB (and any ancillary IRBs) MUST
    MEET as a group to discuss projects
  • Your school SRC (and any ancillary SRCs) MUST
    MEET as a group to discuss projects

7
LISEF Update of SRC Rules for 2009-2010
  • Some Key Points And Finally.
  • PLEASE read the rulebook (available online at
    http//www.societyforscience.org/isef/document/Rul
    e2010.pdf
  • PLEASE have your students read the rulebook AND
    have them show the rulebook to their mentors
  • Yes, its long and it takes time, but you should
    really review all parts of
  • the Rules Index
  • The SRC 101 powerpoint
  • The FAQs

All available at http//www.societyforscience.or
g/isef/about/rules_regulations.asp
8
LISEF Update of SRC Rules for 2009-2010
  • Changes Modifications for 2009-May 2010
  • Human Subjects (will be addressed by Ms.
    Labrocca)
  • Vertebrate Animals (will be addressed by Dr.
    Bossert)
  • Potentially Hazardous Biological Agents (PHBAs)
    (will be addressed by Dr. Bossert)
  • Forms Changes (will be addressed by Ms. Labrocca
    and Dr. Bossert w/in their presentations)

9
LISEF Update of SRC Rules for 2009-2010
  • Some Final Summary Items to Remember
  • Provide a safe environment for students to
    perform research
  • LISEFs SRC deems the protection of the
    researcher and the human subjects as the most
    important consideration when determining whether
    a project qualifies for the LISEF fair.
  • SRCs and IRBs MUST MEET as a group
  • For projects involving Human Subjects Be sure
    to read the Risk Assessment on Page 15 of the
    Rules book
  • Be sure to consider Special Risk Groups
    (including newly added ones
  • The on-line Risk Assessment guide was greatly
    expanded by Dr. Jennifer Green
  • Informed Consent is for subjects over 18
  • Assent is for subjects under 18
  • Permission is given by a subjects
    parent/guardian

10
LISEF Update of SRC Rules for 2009-2010
  • Some Final Summary Items to Remember (cont.)
  • Form Changes include
  • Form 4
  • Photo Release Form (see Page 8, 5 of Rulebook
    for replacement)
  • Form 7 (Former 1A is no longer needed)
  • Immediate Previous year Abstract Research Plan
  • 2 3 years prior only Abstract
  • Research Plan Human Subjects sub-section is
    expanded to 7 bulleted items
  • Tissue studies Use 6A AND 6B

11
LISEF Update of SRC Rules for 2009-2010
  • Some Final Summary Items to Remember (cont.)
  • Vertebrate Animal Studies rule change is on Page
    18, 3 of rule book
  • Potentially Hazardous Biological Agents rule
    changes include
  • Page 21Rule 5 is NEW
  • Page 21Rule 6 is expanded
  • Page 21Rule 13, part B, 3 is new
  • Laboratory Training in a previous year IS a
    continuation if the techniques, etc. trained for
    are used in the present years study
  • Longitudinal studies are allowed IF they are
    studying the CHANGE across years
  • ALL COMPONENTS of the sample Informed Consent
    Form (Page 37 of rule book) must be included in
    YOUR Consent Form
  • PLEASE consult with the LISEF SRC about any
    questions, especially concerning IRB and SRC
    decisions! (see the contact us link on
    lisef.org)

12
LISEF Update of SRC Rules for 2009-2010
  • Some Final Summary Items to Remember (cont.)
  • Safety Training for student lab researchers is
    imperative!
  • LISEF has developed a collaboration with SUNY
    Stony Brook safety officer Kim Auletta to
    facilitate this (see the Important Safety
    Training Announcement link on the lisef.org
    website)
  • Check the lisef.org website often and repeatedly
    for important announcements, links, dates, etc.
  • Contact us with ANY questions and concerns

LISEF Postal Address Long Island Science
Engineering Fair, Inc. 998 Old Country Road STE C
PMB 164 Plainview, NY 11803 Or use the contact
us email link at www.lisef.org
LISEF, Inc. OfficersPresident Angela Lukaszewski
Vice-President Peter Guastella Treasurer Elaine 
Labrocca Corresponding Secretary Patricia Bossert
, Ph.D. Recording Secretary Allen Sachs
Additional Trustees Heather Hall Mary Hendrickson
, Ph.D. Christopher Hoppner Phyllis Serfaty Michae
l Vaccariello
13
A Guide to Forms
  • Remember There are Always EXCEPTIONS
  • No One Answer Fits All Contingencies

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20
ISEF 2010 Rules Guidelines
  • Human Behavior

21
2010 ISEF Changes
  • New Make-up of IRB
  • No longer requires a Science Teacher instead
    requires an Educator
  • Reorganization of Human Subject Rules
  • Additional resources on the website Risk
    Assessment Guideline
  • New Form 4 (more detail to follow)

22
Exempt Studies(no Form 4 necessary)
  • Testing student designed invention, program,
    Form 3 recommended
  • Data/record review involving pre-existing data
    sets-no interaction with human subjects
  • Behavioral observations (without interaction,
    manipulation personally identifiable data)
  • Receipt of data in de-identified/anonymous format
    in compliance with privacy/HIPAA laws
  • but better to be safe than sorry!

23
Role of the IRB
  • Review the entire Research Plan
  • Determine Risk Level
  • Minimal Risk
  • More than Minimal Risk
  • Determine if documentation of informed consent,
    minor assent and/or parental permission is
    required
  • Review Informed Consent Form/Process
  • Determine if QS is needed

24
Determine if QS necessary
  • Study about depression, suicide, anxiety, abuse
  • With MMR physical/medical risks
  • When anonymity or confidentiality is especially
    important
  • Others?

25
Waiver of Documentation of IC, MA, and/or PP
  • Subjects must ALWAYS be informed about the study
    and voluntary nature!
  • Documentation and/or parental permission can
    SOMETIMES be waived, when
  • Data are Anonymous
  • Minimal Risk
  • One of the following
  • Normal educational practices
  • Individual or group behavior and researcher
    doesnt manipulate environment/behavior
  • Some surveys/questionnaires
  • Some physical activity/exercise studies

26
IRB Responsibilities
  • Consider the MOST conservative member of your
    schools community
  • Design of IRB should fit the research
  • Assist students in designing protocol to diminish
    risk, to ascertain that benefits outweigh risks,
    to protect privacy/confidentiality issues and to
    suggest methods for special protection of At Risk
    groups
  • Oversees only research conducted in that
    institution (elementary school recommendation)

27
Research Plan
  • Subjects Describe participants identify
    vulnerable populations
  • Recruitment
  • Methods Include tasks, surveys, frequency
    length of time involved
  • Risks Benefits Benefits gt Risks
  • Protection of Privacy
  • Informed Consent Process
  • Even though you might be asking for a waiver of
    documentation of informed consent/assent, you
    must still respond to the questions being asked.
  • SEND BACK TO STUDENT, IF ALL CATEGORIES NOT
    ADDRESSED

28
Invasion of Privacy/Breech of Confidentiality
  • Important to consider when research activities
    involve collection of
  • personal information (e.g., history of abuse,
    alcohol use, opinions, emotional/psychological
    functioning, grades, intelligence) or
  • health-related data (e.g., health history, BMI,
    genetic material)
  • Consider negative consequences for the subjects
    due to invasion of privacy or breech of
    confidentiality
  • Embarrassment, social distress, emotional
    distress
  • Legal/school discipline problems

29
Suggestions for reducing risks
  • Store data securely
  • Collect anonymous data
  • Try to gather as few Personal Identifiers as
    possible
  • Make anonymous AFTER collection
  • Remove responsibility on researcher of knowing
    information about peers
  • Provide special protection of Risk Groups
  • Reduce psychological risks
  • Consider having school counselor available or
    statement directing subject to talk with school
    counselor if distressed

30
Ingestion of commonly available food or drink
evaluated for risk
Controversial areas include suicide/depression,
drugs/alcohol use, personal health info,
GPA/SAT/Edu. Test Scores
Do not include demographics if the population has
a limited number of a subject type
Persons with learning disorders and those covered
by Disabilities Education Act have been added to
At-Risk Groups
31
Reorganization of Form 4
  • Form 4 no longer serves as informed consent
  • New Sample of Informed Consent Form
  • No longer contains photo consent (see D S)
  • Asks for Experience/Training of QS
  • Asks for Degrees of IRB members
  • Has places to indicate whether waivers are sought
  • IRB indicates whether project is approved or NOT
  • If approved, risk level indicated and other
    conditions involving assent/consent

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NEW LISEF Requirements
  • The survey/questionnaire must be attached to the
    consent form and a signed statement(parent/guardia
    n) of acknowledgment indicating that the measure
    was reviewed (can be done on the reverse side)
  • The Qualified Scientist must have experience
    related to the project
  • Any measure distributed to Human Subjects,
    including those used in pilots, that may cause
    physical or psychological harm should go through
    the IRB approval process

35
LISEFs SRC deems the protection of the
researcher and the human subjects as the most
important consideration when determining whether
a project qualifies for the LISEF fair.
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