Title: LISEF Update of SRC Rules for 20092010
1LISEF 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
2LISEF 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
3LISEF 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
4LISEF 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
5LISEF 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
6LISEF 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
7LISEF 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
8LISEF 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)
9LISEF 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
10LISEF 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
11LISEF 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)
12LISEF 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
13A Guide to Forms
- Remember There are Always EXCEPTIONS
- No One Answer Fits All Contingencies
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20ISEF 2010 Rules Guidelines
212010 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)
22Exempt 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!
23Role 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
24Determine if QS necessary
- Study about depression, suicide, anxiety, abuse
- With MMR physical/medical risks
- When anonymity or confidentiality is especially
important - Others?
25Waiver 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
26IRB 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)
27Research 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
28Invasion 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
29Suggestions 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
30Ingestion 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
31Reorganization 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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34NEW 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
35LISEFs 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.