LISEF Update of SRC Rules for 20092010

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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
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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

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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

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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

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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

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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

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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
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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)

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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

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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

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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)

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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
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A Guide to Forms

• Remember There are Always EXCEPTIONS
• No One Answer Fits All Contingencies

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ISEF 2010 Rules Guidelines

• Human Behavior

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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)

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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!

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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

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Determine if QS necessary

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

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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

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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)

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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

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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

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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

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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
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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

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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.