Covestro Pittsburgh Regional Science & Engineering Fair Common SRC Problems

Transcription

1 Covestro Pittsburgh Regional Science & Engineering Fair Common SRC Problems 79 th Covestro Pittsburgh Regional Science & Engineering Fair March 23-24, 2018

2 Table of Contents Overview 3 Incomplete Research Plan. 5 Approval Dates Order... 8 Bacteria Studies..11 Human Participant Studies..15 Hazardous Chemicals, Activities, or Devices 21 Vertebrate Animals Studies.25 Summary..29

3 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 Follow federal regulations governing research Use safe laboratory practices Address environmental concerns Protect the health and well-being of vertebrate animal subjects 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.

4 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

5 Failing to plan is planning to fail. Alan Lakein RESEARCH PLAN If we knew what it was we were doing, it would not be called research, would it? Albert Einstein

6 Acceptable Research Plans Include Problem statement Hypothesis Detailed procedure Data analysis Bibliography At least 5 valid references Detailed Requirements Bibliography Help

7 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

8 APPROVAL DATES

9 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

10 Projects that require Covestro PRSEF 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

11 BACTERIA STUDIES

12 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

13 Bacteria Studies Visit Intel 2018 Rules and Guidelines booklet, page 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.

14 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

15 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 PARTICIPANTS

16 Human Participant Studies Human participant studies involve living individuals where there is: Intervention or interaction with participants and/or Collection of identifiable private information These projects require approval from the Covestro PRSEF SRC prior to experimentation

17 Prohibited Human Participant Studies Modifications 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.

18 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

19 Human Participant Studies Visit Intel 2018 Rules and Guidelines booklet, 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., , web-based surveys)

20 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)

21 HAZARDOUS CHEMICALS, ACTIVITIES, OR DEVICES

22 Hazardous Chemicals, Activities, or Devices Examples of hazards Chemicals Equipment DEA-Controlled Substances Prescription Drugs Alcohol and Tobacco Firearms and Explosives Radiation

23 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

24 Hazardous Chemicals, Activities, or Devices Common 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 Intel 2018 Rules and Guidelines booklet, page

25 VERTEBRATE ANIMALS

26 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

27 Vertebrate Animals Studies Visit Intel 2018 Rules and Guidelines booklet for complete rules and guidelines, pages 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

28 Helpful Hints Visit Covestro PRSEF for complete rules and guidelines Visit Intel 2018 Rules and Guidelines booklet for the Intel International Science & Engineering Fair rules/guidelines/forms Visit Covestro PRSEF Forms for required forms The Teacher Inventory Form is used to track what forms are submitted

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

30 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

31 Summary 3. 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

32 Summary 4. 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

33 Please Lisa Kosick, to confirm your review of this document. Otherwise, students may not be able to participate at Covestro PRSEF. Thank you!

34 DETAILED SLIDES

35 Please follow these instructions. Please note 1b regarding any changes to original research submitted. Return to last slide

36 Bibliography Help NOT A SOURCE: A library, Google, Wikipedia or any search engine EXAMPLES: Carnegie Library of Pittsburgh, or A reference must take the reader to a specific book or article A REPUTABLE SOURCE A specific book A specific Journal article A specific article resulting from a successful search using a search engine Visit sites such as How to Write a Research Paper for further help EXAMPLES: Factory and trade waste -- Environmental aspects., Gorgan, Joseph M., ISBN Factors Related to the Oxygen Tolerance of Anaerobic Bacteria Rial D. Rolfe, David J. Hentges, Benedict J. Campbell, James T. Barrett Appl Environ Microbiol August; 36(2): Return to last slide

37 Approval Dates Out of Order Next Slide This date MUST be after these dates

38 Dates Out of Order These dates must be BEFORE these dates Return to last slide

39 Informed Consent IMPORTANT: 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

40 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

41 Bibliography Photographs and clip art used in presentation was taken from the following internet websites Slide 5: Slide 8: Slide 8: Slide 11: Slide 15: Slide 21: Slide 21: CHEMICALS.jpg Slide 21: Slide 25: 1.jpg Slide 29: