Scientific Review Committee 2019 Rules and Guidelines. Intel International Science and Engineering Fair

Transcription

1 Scientific Review Committee 2019 Rules and Guidelines Intel International Science and Engineering Fair

2 2019 Rule Clarifications and Changes

3 Introductions & Acknowledgements

4 SRC Members Ms. Michele Glidden, Chief Program Officer Ms. Susan Appel Mr. Henry Disston Dr. Jennifer Green Dr. Paula Johnson Dr. Timothy Martin Mrs. Evelyn Montalvo Mr. Joseph Scott Dr. Jason Shuffitt Mrs. Andrea Spencer Consultant: Dr. Erin Rumpke

5 Total Projects = Participants from 81 Countries No Shows = 12 Guests = 2 FTQ = 4 Projects Competing = 1383 Project Summary

6 General Summary of Changes New section on Digital Paperwork & Signatures All sections have been realigned to state general rules first and then exemptions.

7 Summary of Changes Human Participants Removed expedited review Clarified Regulated Research Institution versus School IRBs.

8 Summary of Changes Human Participants New section on human participant involvement in student designed inventions, prototypes, etc.

9 Summary of Changes Vertebrate Animals Provide more guidance for studies involving potential weight loss to the animals

10 PHBAs Describes conditions under which various rdna technologies may be conducted Summary of Update to the use of Multi-Drug resistant organisms Changes

11 Summary of Changes Hazardous Chemicals, Activities & Devices Clarifies sections on regulated drones and radiation

12 Summary of Changes Engineering Projects Guide Provides checklist for hazardous chemicals, substances, devices; human participants; vertebrate animals; PHBAs

13 Summary of Changes Forms Form 1C (RRI/Industrial Setting) now 2 pages Form 7 Only requests current and previous year s work

14 HUMAN PARTICIPANTS

15 Human Participant Projects Any medical procedure Psychological, educational and opinion studies (e.g., surveys, questionnaires, tests) Studies in which the researcher is the subject of the research Testing of student designed invention, prototype or computer application by human participants other than student researcher Data/record review projects that include data that are not de- identified/anonymous

16 School IRB Conducted at school, at home or in the community that are not affiliated with a Regulated Research Institution (RRI) must be reviewed and approved by the School IRB before the student may begin recruiting and/or interacting with human participants. The School IRB must assess the risk and document its determination of risk on Form 4.

17 RRI IRB Projects that are conducted at a Regulated Research Institution (RRI) (e.g., university, hospital, medical center, government lab) must have IRB approval from the RRI. A copy of the IRB approval for the entire project must be obtained. A letter from an adult mentor and/or Qualified Scientist is not sufficient documentation of the RRI IRB review and approval process.

18 Expedited Review

19 Types of Human Participants Approval FULL IRB Student invention tested by anyone other than the student researcher Medical device inventions and prototypes must be conducted in an RRI EXEMPT Student researcher is the only person testing the invention and does not pose a safety hazard Review page 8 Exempt studies

20 Exempt Human Studies Student-designed Invention, Prototype, Computer Applications or Engineering/Design Project in which the student researcher is the only person testing the invention, prototype or computer application and the testing does not pose a health or safety hazard. It is recommended that a Risk Assessment Form (3) be completed.

21 Student-designed Invention, Prototype, Computer Application & Engineering/Design Projects Full IRB review and pre-approval is necessary when the student- designed invention, prototype, application, etc. is tested by human participants other than the student researcher(s). This includes surveys conducted regarding potential use, review of the product and/or opinions regarding the project. Projects in which the invention, prototype or project involves a medical diagnosis or intervention (as defined by the FDA or Medical Practices Act) and is tested on human participants must be conducted at a Regulated Research Institution (RRI) with a Qualified Scientist and receive IRB Approval from the Institution. A Risk Assessment Form 3 is recommended for all student- designed inventions or prototypes.

22 VERTEBRATE ANIMALS

23 Original Wording rule 9.: Vertebrate Animals clarification Because significant weight loss is one sign of stress, the maximum permissible weight loss or growth retardation (compared to controls) of any experimental or control animal is 15%

24 Vertebrate Animals clarification Now Rule 6: Because significant weight loss is one sign of stress, weight must be recorded at least weekly with 15% being the maximum permissible weight loss. Additionally body conditioning scoring (BCS) systems are available for most species of animals utilized in research A BCS system should be included in the design of any study utilizing live vertebrate animals and results regularly recorded.

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26 PHBA changes 2019 Projects Involving Recombinant DNA (rdna) Technologies Rule B5 Genome editing studies that include alteration of germline cells, insertion of gene drives, RTDS: BSL-2 Conducted at RRI Approved by IBC fro the institution Exempt Tissues Eggs and pasteurized milk have been added

27 PHBA changes New section on laboratory studies designed to culture multidrug resistant organisms (MDROs) Written justification for usage Conducted at RRI Minimum of BSL-2 containment Documented IBC and approval Includes, but not limited to MRSA, VISA/VRSA, VRE, CRE, ESBLs, fungi with known resistance to antifungal agents.

28 Most Common SRC Challenges

29 Frequent SRC Issues Missing Forms Form 1C Regulated Research Institute/Industrial Setting Form 3 Risk Assessment Human Informed Consent Form Forms 6A & 6B Potentially Hazardous Biological Agents Form 7 Continuation Projects Form RRI letters of approval from IRB and/or IACUC

30 Frequent SRC Issues Improperly Completed Forms Form 4 Human Participants Form

31 Frequent SRC Issues Missing Signatures Qualified Scientist Form 1C Regulated Research Institute/Industrial Setting Form 6A Potentially Hazardous Biological Agents IRB or SRC Chair/Members Form 1B Approval Form Form 4 Human Participants Form Form 5A Vertebrate Animal Form Forms 6A Potentially Hazardous Biological Agents Risk Assessment Form

32 Missing Information Frequent SRC Issues Research Plan/Project Summary Project Start and End Dates Source of Cell Cultures ATCC vs fresh tissue Strain of Bacteria, esp. E. coli Source of public available Data

33 Frequent SRC Issues Too Much Information Previous Years Work described in Abstract Description of Mentor s work versus Student s experiment Signed Human Consent Forms References to Patents or Copyrights MSDS Sheets

34 Top Reasons for FTQ Study conducted prior to January 2017 Genetically engineering organisms with multiple drug resistance traits. Toxicity study utilizing vertebrate animals Behavioral experiment using conditioning with aversive stimuli

35 Remember If the intent of a student-designed project falls into an area prohibited by ISEF (e.g. vertebrate animal study or BSL-3 study) and the prohibited segment is performed by others, the project fails to qualify even if the student actually did only the allowable segments.

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37 SUGGESTIONS FOR RULE CHANGES/CLARIFICATIONS ARE ALWAYS APPRECIATED AND CAN BE ED TO:

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