Covestro Pittsburgh Regional Science & Engineering Fair

Common SRC Problems

78th Covestro Pittsburgh Regional Science & Engineering Fair

March 31-April 1, 2017

Table of Contents

Overview……………………………………………………… 3Incomplete Research Plan……………………………. 5Approval Dates Order………………………............. 8 Bacteria Studies.………………………………………….11Human Participant Studies…………………………..15Hazardous Chemicals, Activities, or Devices…21Vertebrate Animals Studies………………………….25

Summary……………………………………………………..29

Covestro PRSEF Scientific Review

Covestro PRSEF’s Scientific Review Committee (SRC) reviews all forms (>1000 projects) to ensure the following:

• Protect the rights and welfare of the student researcher and human subjects

• Protect the health and well-being of vertebrate animal subjects

• Follow federal regulations governing research

• Use safe laboratory practices

• Address environmental concerns

• Consistency with Intel International Science & Engineering Fair requirements

Note: Covestro PRSEF's SRC and IRB has final approval of all projects submitted to the competition.

Covestro PRSEF Form Improvements

• More than half require further information for approval by the SRC

• Common issues include:

– Incomplete research plan

– Approval dates out of order

– Studies requiring additional review and approvals

• Bacteria

• Human participants

• Hazardous chemicals, activities, or devices

• Vertebrate animals

RESEARCH PLAN

If we knew what it was we were doing, it would not be called research, would it?

Albert Einstein

Failing to plan is planning to fail.

Alan Lakein

Bibliography

Help

Acceptable Research Plans Include

• Problem statement

• Hypothesis

• Detailed procedure

–Data analysis

• Bibliography

–At least 5 valid references

Detailed Requirements

Common Research Plan Problems

• Procedure is not described sufficiently

– Reviewers cannot understand what project involves

• Safety precautions are not identified

• Student’s fail to perform a literature review such as Science journal articles, books, internet sites

– References are missing or inadequate

– Non-reputable sources are cited

www.google.com, www.ask.com, www.wikipedia.com

APPROVAL DATES

Approval Dates Order

Dates must be in order

• Student and parent/guardian must approve BEFORE adult sponsor

– Form 1B BEFORE Form 1 dates

• Experimentation begins AFTER student, parent/guardian, and adult sponsor approve• Form 1A AFTER Forms 1 and 1B dates

Examples where dates must be ordered properly

Projects that require CovestroPRSEF approval prior to

experimentation• Studies requiring review and approval prior to

experimentation

– Bacteria

– Human participants (School and Covestro PRSEF IRB must review)

– Hazardous chemicals, activities, or devices

– Vertebrate animals

• Covestro PRSEF’s SRC must review all these projects prior to experimentation

BACTERIA STUDIES

Bacteria Studies• Bacteria is a Potentially Hazardous Biological Agent

• Student and adults must conduct a risk assessment (Form 6A)

– Defines the potential level of harm, injury or disease to plants, animals and humans that may occur when working with biological agents

• The risk assessment determines a biosafety level to determine

– if the project can proceed, and if so,

– laboratory facilities, equipment, training, and supervision required

These projects require approval from the Covestro PRSEF SRC prior to experimentation

Bacteria Studies

• Visit https://member.societyforscience.org/document.doc?id=747, page 15-18 for the complete rules and guidelines for PBHA studies.

– Which studies are exempt from prior Covestro PRSEF SRC review and require no additional forms

– Which studies are exempt from prior Covestro PRSEF SRC review, but require a Risk Assessment Form 3

– Learn what types of tissue studies do not need to be treated as potentially hazardous biological agents

– Learn how to assess the risk involved in PHBA studies

– Learn the four levels of biological containment (Biosafety Level 1–4). Each level has guidelines for laboratory facilities, safety equipment and laboratory practices and techniques.

Bacteria Studies - Common Problems• Approval was not requested prior to experimentation (before project was

started)

• Projects involving mold were not terminated at first evidence of mold

• Growing bacteria at home. Experimentation involving the culturing of potentially hazardous biological agents, even BSL-1 organisms, is prohibited in a home environment. However, specimens may be collected at home as long as they are immediately transported to a laboratory with the BSL containment determined by Covestro PRSEF.

• Hair and teeth do not need to be considered a PHBA study. However, teeth are to be sterilized to kill any blood-borne pathogen that may be present. Chemical disinfection or autoclaving at 121 degrees Celsius for 20 minutes is recommended.

• Form 2 (Qualified Scientist) and/or Form 6A (Potentially Hazardous Biological Agents Risk Assessment Form) was not submitted

• Proper disposal techniques were not described

• Proper safety equipment were not used

HUMAN PARTICIPANTS

You accept failure as a possible outcome of some of the experiments. If you don't get failures, you're not pushing hard enough on the objectives.

John Poindexter

Human Participant Studies

• Human participant studies involve living individuals where there is:

– Intervention or interaction with participantsand/or

– Collection of identifiable private information

These projects require approval from the Covestro PRSEF SRC prior to experimentation

Prohibited Human Participant StudiesModifications

• Projects involving the consumption, ingesting, tasting, applying, absorbing, smelling of any substance are prohibited even those conducted in a Regulated Research Institution.

• Experiments may result in dangerous health consequences

– Potential for severe reaction from allergic reactions

– Lack of research and regulation associated with energy drinks

• Please contact the Covestro PRSEF office for any

clarifications.

Human Participant Studies

• The Covestro PRSEF’s and School’s IRB must review and approve the research plan before experimentation begins

• Research participants 18 years of age or older must give informed consent

• Research participants under 18 must give assent and their parents may be required to give permission

Sample Informed Consent Form

Human Participant Studies

• Visit https://member.societyforscience.org/document.doc?id=747, page 8-11 for the complete rules and guidelines for Human Participants studies

– Learn when pre-approval is not required

– Learn when pre-approval AND human participant forms are not required

– Learn about other exempt studies such as behavioral observations

– Learn how to assess risk

– Learn when informed consent is required

– Learn about studies that involve the collection of data via use of the internet (e.g., email, web-based surveys)

Human Participant Studies Common Problems

• Approval was not submitted prior to start of experiment

• Data was identifiable

• Missing one or all of the following forms:

– Form 4 (Human Participant Form)

– Informed Consent – Only one sample is needed

– Form 2 (Qualified Scientist)

HAZARDOUS CHEMICALS, ACTIVITIES, OR DEVICES

Hazardous Chemicals, Activities, or Devices

Examples of hazards

• Chemicals

• Equipment

• DEA-Controlled Substances

• Prescription Drugs

• Alcohol and Tobacco

• Firearms and Explosives

• Radiation

Hazardous Chemicals, Activities, or Devices

As a rule:

• Studies do not require prior SRC review and approval

• However, prior review may be requested and is strongly suggested to avoid problems

• All studies require a Risk Assessment documented on Form 3

• Substances that are DEA - controlled require a Qualified Scientist

• All other studies require a Designated Supervisor

Risk Assessment Form

Hazardous Chemicals, Activities, or DevicesCommon Problems

• Risk Assessment was not documented on Form 3

• Form 2 (Qualified Scientist) was not submitted when required

• Adult Sponsor did not realize risk involved

Learn more about all hazardous chemicals, activities and devices at https://member.societyforscience.org/document.doc?id=747, page 19-21.

VERTEBRATE ANIMALS

Vertebrate Animals

What are vertebrate animals? For research purposes as indicated by the ISEF rules, vertebrate animals are:

• Live, nonhuman vertebrate mammalian embryos or fetuses

• Tadpoles

• Bird and reptile eggs within 3 days of hatching

• All other nonhuman vertebrates (including fish) at hatching or birth

• Zebrafish embryos 7 days (168 hours) post fertilization

Vertebrate Animals Studies• Visit https://member.societyforscience.org/document.doc?id=747

for complete rules and guidelines, pages 12-14– Learn when approval prior to experimentation is required

– Learn when behavioral observations require approval prior to experimentation or are exempt

– Learn what types of studies can be conducted in the home/school/field versus studies that must be conducted in a Regulated Research Institution

Common Problems• Form 5A or 5B (Vertebrate Animal Form ) was not completed

• Form 2 (Qualified Scientist) was not submitted when required

• Bibliography missing animal care reference – at least one of these references must be an animal care reference

• Lack of alternatives for the use of vertebrate animals for research are not explored or discussed in the research plan

Helpful Hints• Visit www.pittsburghsciencefair.org for complete rules and

guidelines

• Visit https://member.societyforscience.org/document.doc?id=747for the Intel International Science & Engineering Fair rules/guidelines/forms

• Visit http://www.scitechfestival.org/pdf/RequiredForms.pdf for required Covestro PRSEF forms

• Visit http://www.scitechfestival.org/pdf/2017TeacherInventoryForm.pdffor Teacher Inventory Form to track what forms are submitted.

SUMMARY

The best scientist is open to experience and begins with romance - the idea that anything is possible.

Ray Bradbury

Summary

Common issues identified by the SRC

1. All students must submit a complete research plan

– This includes at least 5 reputable citations

2. Dates must be in order

– Form 1B dates must be before Form 1

– Experimentation dates (Form 1A) must be AFTER Form 1 and 1B

Summary3. Bacteria projects are considered Potentially

Hazardous Biological Agents (PHBA)– All PHBA projects must be approved by Covestro PRSEF

prior to experimentation (before the project is started)

– Most bacteria projects CANNOT be conducted at home• BSL1 or BSL2 are required with proper supervision and safety

equipment

– Mold projects can be conducted at home but must be terminated at the first evidence of mold unless conducted in an appropriate lab

– Hair, teeth, hooves, nails, and feathers do not need to be considered PHBA• Sterilize teeth

Summary4. Human Participants Studies

– All projects involving the consumption, ingesting, tasting, applying, absorbing, smelling of any substance are prohibited even those conducted in a Regulated Research Institution.

– Informed consent is required for all human participants studies

– All human participant studies must be approved by Covestro PRSEF’s and the School’s IRB prior to experimentation

5. Hazardous Chemicals, Activities and Devices– Must include Form 3 and address all risks involved

6. Vertebrate Animals– All studies on animals must be pre-approved

Please email Lisa Kosick, kosickl@carnegiesciencecenter.org to confirm your review of this document. Otherwise, students may not be able

to participate at Covestro PRSEF.

Thank you!

DETAILED SLIDES

Please follow these instructions. Please note that CovestroPRSEF does not require a Post-Project Summary (#2)

Return to last slide

NOT A SOURCE:A library, Google, Wikipedia or any search engineEXAMPLES:Carnegie Library of Pittsburgh,www.google.com, orwww.wikipedia.com

A REPUTABLE SOURCEA specific bookA specific Journal articleA specific article resulting from a successful search using a search engineVisit sites such as How to Write a Research Paper for further help

EXAMPLES:Factory and trade waste -- Environmental aspects., Gorgan, Joseph M., ISBN0873710010

Factors Related to the Oxygen Tolerance of Anaerobic Bacteria

Rial D. Rolfe, David J. Hentges, Benedict J. Campbell, James T. Barrett

Appl Environ Microbiol. 1978 August; 36(2): 306–313. Return

to last slide

Bibliography Help

A reference must take the reader to a specific

book or article

Approval Dates Out of Order

This date MUST be after these dates

Next Slide

Dates Out of Order

These dates must be BEFORE these dates

Return to last slide

Informed ConsentIMPORTANT: Please attach one copy of the informed consent/assent or parental permission when submitting your Covestro PRSEF paperwork. You may use this copy or use a similar version of your own.

Return to last slide

Risk Assessment (Form 3)

Please complete all sections and include all risks, safety precautions (goggles/lab coats/gloves), source of safety information. When in doubt, fill it out!

Return to last slide

Bibliography

• Photographs and clip art used in presentation was taken from the following internet websites

• Slide 5: http://www.tml.tkk.fi/Studies/T-111.590/2004/ResearchPlan.gif

• Slide 8: http://img.docstoccdn.com/thumb/orig/48921218.png

• Slide 8: http://3.bp.blogspot.com/-cBn3bhBSDQA/TZJbkF5bg9I/AAAAAAAAADU/Q5kwhXwIRdQ/s1600/ImportantDate.jpg

• Slide 11: http://bangkokscoop.com/wp-content/uploads/2011/06/salmonella-bacteria.jpg

• Slide 15: http://www.sjsu.edu/gradstudies/pics/human_subjects.jpg

• Slide 21: http://www.duhaime.org/Portals/duhaime/images/ultrahazardous.gif

• Slide 21: http://www.hazsigns.com.au/images/products/500/HAZARDOUS CHEMICALS.jpg

• Slide 21: http://kenoshapolice.com/UserFiles/Image/hdsExp.jpg

• Slide 25: http://ww2.valdosta.edu/~jmlabroad/vertebrates 1.jpg

• Slide 29: http://www.morgridge.wisc.edu/programs/awards/studentawardeligibility.html