Everything You Always Wanted to Know About ISEF Regulations but Where Afraid to Ask

Transcription

1 Everything You Always Wanted to Know About ISEF Regulations but Where Afraid to Ask Got Questions? For complete Intel International Science and Engineering Fair (ISEF) rules go to: ScienceMONTGOMERY web site updated by 1Nov12: Use Rules Wizard (under Student heading) to correctly complete Forms For all ScienceMONTGOMERY safety-related (i.e. SRC or IRB) questions go to: For all other ScienceMONTGOMERY questions go to: 1

2 Key Dates for 2013 ScienceMONTGOMERY Science Fair February 1, 2013 ALL paperwork in Mail hardcopy to 4117 Barnsley Lane, Olney MD or Send electronically to: March 15, 2013 Project Setup FDA White Oak Campus, New Hampshire Ave Silver Spring MD March 16, 2013 Science Fair Judging FDA White Oak Campus March 17, 2012 Awards Ceremony Albert Einstein High School, Newport Mill Rd, Kensington, MD

3 Outline of 2013 ISEF Safety Guidelines The Players Paperwork Required of All Projects Projects Involving Human Subjects Projects Involving Vertebrate Animals Projects Using Potentially Hazardous Biological Agents 3

4 The Players The Student Researcher-- Responsible for all aspects of the research project including: 1. Enlisting the aid of any required supervisory adults (Adult Sponsor, Qualified Scientist, etc.) 2. Obtaining necessary approvals (SRC, IRB, etc.) 3. Following the Rules & Guidelines of the Intel ISEF 4. Timely submission of all paperwork to ScienceMONTGOMERY Parent or Guardian--Need to sign Registration Form and Approval Form (1B) Adult Sponsor--Teacher, Parent or Professional Scientist in whose lab the student is working 1. This individual must have a solid background in science and should have close contact with the student during the course of the project 2. Responsible for: a) Evaluating project s safety risks; b) Reviewing Student Checklist (1A) and Research Plan; c) Ensuring forms are completed and signed by other required adults 4

5 The Players (continued) The Designated Supervisor (DS)--Adult who is directly responsible for overseeing student experimentation 1. Advanced degree NOT required, but must be thoroughly familiar with the student s project, and area of research (e.g. classroom science teacher) 2. Supervision at the DS level or higher required for: a) All Biosafety Level-1 (BSL-1) projects, b) All non-observational Vertebrate Animal studies; c) All studies with Hazardous Chemicals 3. The Designated Supervisor may serve as the Adult Sponsor The Qualified Scientist (QS)--Scientist with advanced degree related to the student s area of research 1. Advanced degrees required such as: PhD, MD, DVM or MS with experience in the student s area of research (MS must be approved by SRC) 2. Supervision at the QS level required for: a) All Biosafety Level-2 (BSL-2) projects; b) Some studies with Hazardous Chemicals; c) Some studies with Human Subjects 3. The Qualified Scientist may serve as the Adult Sponsor 5

6 The Players (continued) Institutional Review Board (IRB) 1. Prior to study initiation, all proposed human research must be reviewed and approved by an IRB 2. This includes review of any surveys or questionnaires to be used in a project as well as the Informed Consent Form and the Research Plan with human participant risk assessment Institutional Animal Care and Use Committee (IACUC) 1. Prior to study initiation, must approve all Vertebrate Studies conducted at a Regulated Research Institution (e.g. NIH, a college, a biotech company) Scientific Review Committee (SRC) 1. Prior to study initiation, must approve all projects involving Potentially Hazardous Biological Agents 2. Prior to study initiation, must approve all Vertebrate Studies conducted at a Non-Regulated Research Institution (e.g. school, home, farm) 6

7 Paperwork Required for ALL Projects Registration form signed by each Student and Guardian Student Processing Fee of $10.00 (per student) Research Plan. Include 1. Question 2. Hypothesis 3. Methods 4. Bibliography (minimum of 5 references) 5. Additional info needed based on project (e.g. Human Subjects, Vertebrate Animals or Potentially Hazardous Biological Agents) Abstract Checklist for Adult Sponsor (Form 1) 1. Include contact information and signature from Adult Sponsor 7

8 Paperwork Required for ALL Projects (continued) Student Checklist (Form 1A) 1. Include Project Start and Finish dates Approval Form (Form 1B) 1. Signed by each Student and Parent/Guardian 2. Other approval as necessary (e.g. IRB or SRC) Regulated Research Institutional Setting Form (Form 1C) 1. ONLY required if work is done at a Regulated Research Institution (NOT school) 2. Signed by Designated Supervisor or Qualified Scientist at the Research Institution (NOT a school teacher or school official) 3. Form 1C to be completed after project is finished Form 1, 1A, 1B, Research Plan--To be completed prior to initiation of project 8

9 Human Subject Studies 9

10 Human Subject Studies and the Institutional Review Board (IRB) Student researchers must follow Federal guidelines to protect the human research participants and the student researcher. Most human participant studies require preapproval from an Institutional Review Board (IRB) and Informed Consent from the research participant. An Institutional Review Board (IRB) is a committee that, according to Federal regulations (45-CFR-46), must evaluate the potential physical or psychological risk of research on humans. This includes: 1. Research Plan including human participant risk assessment 2. Any Survey or Questionnaire to be used in the project 3. The Informed Consent Form 4. Anything else a human subject might see in the course of the study IRB approval must be obtained BEFORE initiation of the study 10

11 Human Subject Studies and the Institutional Review Board (IRB) (continued) IRBs must be composed of at least 3 people: An individual who is knowledgeable about and capable of evaluating the physical and/or psychological risk involved in a given study. 1. This may be a physician, physician s assistant, registered nurse, psychologist, licensed social worker or clinical professional counselor A School Administrator (preferably Principal or Vice Principal) An Educator (e.g. Classroom Teacher) DISQUALIFIED from serving on the IRB: 1) Adult Sponsor; 2) Parent or other relative; 3) Qualified Scientist; 4) Designated Supervisor If the Teacher is serving in any of the aforementioned capacities then he/she is also DISQUALIFIED from serving on the IRB 11

12 Human Subject Studies Exempt from IRB Review Think your study is Exempt? Double check with the ScienceMONTGOMERY SRC before proceeding Testing of a student-designed product (invention, concept program, etc.) where: 1. Feedback is a direct reference to the product 2. Where personal data is not collected 3. Where the testing does not pose a safety hazard 4. It is recommended that Risk Assessment (Form 3) be completed Data review studies (e.g., baseball statistics,etc.) in which: 1. The data are from pre-existing public data sets 2. The study does not involve direct interaction with humans 12

13 Human Subject Studies Exempt from IRB Review (continued) Behavioral observations in unrestricted, public settings (e.g., shopping mall, public park) in which the Researcher: 1. Has no interaction with the individuals being observed 2. Does not manipulate the environment in any way 3. Does not record any personally identifiable data Projects in which the student receives the data in a deidentified/anonymous format in which complies with both of the following conditions: 1. The professional providing the data certifies in writing that the data have been appropriately de-identified and are in compliance with all privacy and HIPAA laws 2. The affiliated fair SRC ensures that the data were appropriately de-identified by review of the written documentation provided 13

14 Human Subject Studies Subject to IRB Review Subjects participating in physical activities (e.g., physical exertion, ingestion of any substance, etc.) Psychological, educational and opinion studies (e.g. surveys, questionnaires, tests) Studies in which the researcher is the subject of the research Behavioral observations that: 1. Involve interaction with the observed individual or modification of the environment (e.g., posts a sign or places an object). 2. Occur in non-public or restricted access settings (e.g., day care setting, doctor s office) 3. Involve the recording of personally identifiable information Data/record review projects that include data that are not deidentified (e.g., name, birth date, phone number) 14

15 Human Subject Studies Subject to IRB Review (continued) Before initiating study, student researchers must submit to the IRB: 1. Completed Research Plan with human participant risk assessment 2. Any Survey or Questionnaire to be used in the study 3. Informed Consent Form to be used (see sample form at: Assuming IRB approval is obtained, human subjects cannot participate until a signed Informed Consent form is on file 1. Those 18 yrs and above can sign the Informed Consent form themselves 2. Minors (those <18 yr old) must have the Informed Consent form signed by a Parent/Guardian who must have the opportunity to read the survey 3. It is rare that Informed Consent is waived, so to be safe, obtain signed Informed Consent from ALL participants 15

16 ISEF Safety Guidelines Paperwork Required for Projects Involving Human Subjects Standard Forms for all Projects: 1. Registration form; Research Plan; Abstract; Adult Sponsor Checklist (1); Student Checklist (1A); Approval Form (1B) Regulated Research Institutional Setting Form (Form 1C) 1. ONLY required if work is done at a Regulated Research Institution (NOT school) 2. Signed by Designated Supervisor or Qualified Scientist at the Research Institution (NOT teacher or school official) Qualified Scientist Form (Form 2) 1. To be completed and signed by Qualified Scientist or Designated Supervisor when the Qualified Scientist cannot directly supervise 16

17 ISEF Safety Guidelines Paperwork Required for Projects Involving Human Subjects (continued) Human Participants Form (Form 4) Signed by all three members of the IRB 1. Medical or Mental Health Professional (a psychologist, medical doctor, licensed social worker, licensed clinical professional counselor, physician s assistant, or registered nurse) 2. School Administrator 3. Educator (NOT Adult Sponsor, Designated Supervisor or Qualified Scientist) Include copy of Survey or Questionnaire Include unsigned copy of the Informed Consent form 1. NOT the actual signed forms Keep the signed forms on file for possible future documentation Complete Human Participant Risk Assessment and include in Research Plan 17

18 Projects Involving Vertebrate Animals 18

19 ISEF Safety Guidelines for Projects Involving Vertebrate Animals Definition of Vertebrate Animal Studies Live, nonhuman vertebrate mammalian embryos or fetuses Bird and reptile eggs within three days (72 hours) of hatching All other nonhuman vertebrates (including fish) from the time of hatching or birth Tadpoles Zebra fish embryos 7 days (168 hours) post-fertilization The above mentioned studies require approval from either a Scientific Review Committee (SRC) or an Institutional Animal Care and Use Committee (IACUC) prior to study initiation 19

20 ISEF Safety Guidelines for Projects Involving Vertebrate Animals (continued) All vertebrate animal studies must have a research plan that includes: 1. Justification why animals must be used, including the reasons for the choice of species, the source of animals and the number of animals to be used 2. Describe any alternatives to animal use that were considered, and the reasons these alternatives were unacceptable 3. Description of how the animals will be used. Include methods and procedures, such as experimental design and data analysis 4. Describe the procedures that will minimize the potential for discomfort, distress, pain and injury 20

21 Exempt Animal Studies NO Additional Forms or Review Needed Studies involving invertebrates (e.g. planaria, earthworms) Zebrafish embryos < 7 days post-fertilization Behavioral Observations of animals if: 1. There is no interaction with the animals being observed 2. There is no manipulation of the animal environment 3. The study meets all federal and state agriculture, fish, game and wildlife laws and regulations 21

22 Restrictions on Animal Studies Vertebrate animal studies may be conducted at a home, school, farm, ranch, or in the field. This includes: 1. Studies of animals in their natural environment 2. Studies of zoo animals 3. Studies of livestock 4. Studies of domesticated animals (i.e. pets) The above animal studies must be approved by an SRC with a veterinarian or an experienced animal care provider, providing: 1. The research involves only behavioral, observational or supplemental nutritional studies AND 2. The research involves only non-invasive methods that do not negatively affect the animal s health or well-being 3. Animals must be treated kindly and cared for properly 4. A Designated Supervisor is required to vouch for the daily animal husbandry 5. A veterinarian must certify experiments that involve supplemental nutrition, administration of prescription drugs and/or activities that would not be ordinarily encountered in the animal s daily life 22

23 Restrictions on Animal Studies (continued) If tissue is obtained from an animal that was euthanized for a purpose other than the student s project, then the study is NOT considered a vertebrate animal study 1. However, documentation is required of the IACUC approval for the original animal study from which tissues are obtained 2. Conversely, if tissue is obtained from an animal that was euthanized solely for the student s project, then the study is considered a vertebrate animal study and requires the requisite justification If an approved study causes severe illness, or weight loss 15%, it must terminated immediately Justification is required for an experimental design that involves food or fluid restriction and must be appropriate to the species. If the restriction exceeds 18 hours, the project must be approved by an IACUC at a Regulated Research Insti. Animals may not be captured from or released into the wild without approval of authorized wildlife official Fish may be obtained from the wild only if the researcher releases the fish unharmed and adheres to state, local and national fishing laws and regulations 23

24 Prohibited Animal Studies Research projects which cause more than momentary or slight pain or distress If the experimental procedure in an approved study causes death, that project will fail to qualify for the fair (even if the death was unexpected) Studies that are designed or anticipated to cause vertebrate animal death Induced toxicity studies with known toxic substances that could impair health or end life (e.g. alcohol, acid rain, pesticides, heavy metals) Behavioral experiments using conditioning with aversive stimuli, mother/infant separation or induced helplessness 24

25 Prohibited Animal Studies (continued) Studies of Pain Predator/Vertebrate Prey experiments Electrofishing Euthanasia for tissue or pathological analysis is NOT permitted for a project conducted in a school or home 1. Permitted at a Regulated Research Institution 2. However, student researchers at the Regulated Research Institution are prohibited from performing the actual euthanasia 25

26 Paperwork Required for Projects Involving Vertebrate Animals Standard Forms for all Projects: 1. Registration form; Research Plan; Abstract; Adult Sponsor Checklist (1); Student Checklist (1A); Approval Form (1B) Regulated Research Institutional Setting Form (Form 1C) 1. ONLY required if work is done at a Regulated Research Institution (NOT school) 2. Signed by Designated Supervisor or Qualified Scientist at the Research Institution (NOT teacher or school official) Qualified Scientist Form (Form 2) 1. To be completed and signed by Qualified Scientist or Designated Supervisor when the Qualified Scientist cannot directly supervise 26

27 Paperwork Required for Projects Involving Vertebrate Animals (continued) Vertebrate Animal Form (5A) 1. ONLY for research conducted in a school, home, farm or zoo 2. SRC approval required BEFORE study is initiated 3. Signed by Qualified Scientist or Designated Supervisor as well as SRC chair 4. SRC decides whether Veterinarian signature is needed Vertebrate Animal Form (5B) ONLY for research conducted at Regulated Research Institution SRC approval required BEFORE study is initiated Signed by Qualified Scientist A copy of the IACUC Approval and Project No. must be included (NOT just a letter from the Qualified Scientist) 27

28 Paperwork Required for Projects Involving Vertebrate Animals (continued) Potentially Hazardous Biological Agents Risk Assessment Form (Form 6A) 1. Required ONLY for research involving fresh/frozen tissue blood or body fluids. Signed by SRC Chair and Qualified Scientist or Designated Supervisor prior to initiation of study Human and Vertebrate Animal Tissue Form (Form 6B) 1. Required ONLY for research involving fresh/frozen tissue blood or body fluids. Signed by Qualified Scientist or Designated Supervisor prior to initiation of study Risk Assessment Form (Form 3) 1. Required ONLY for projects involving Hazardous Chemicals (e.g. Controlled Substances; Prescription Drugs, Alcohol; Tobacco; Explosives) 28

29 Potentially Hazardous Biological Agents (PHBA) 29

30 Exempt Biological Agents NOT Hazardous--NO Additional Forms or Review Needed Studies involving baker s yeast and brewer s yeast Studies involving Lactobacillus, Bacillus thurengiensis, nitrogenfixing, oil-eating or algae-eating bacteria in their natural environment. (NOT exempt if cultured in a petri dish) Studies of mold growth on food if experiment terminated at the first evidence of mold Naturally occurring plant pathogens may be studied (NOT cultured) at home Plant tissue Plant and non-primate established cell lines (e.g., obtained from the American Type Culture Collection, ATCC). The source and/or catalog number of the cultures must be identified 30

31 Exempt Biological Agents NOT Hazardous--NO Additional Forms or Review Needed (continued) Fresh or frozen meat, meat by-products, pasteurized milk or eggs obtained from food stores, restaurants, or packing houses Hair Teeth that have been sterilized to kill any blood- borne pathogen that may be present Fossilized tissue or archeological specimens Prepared fixed tissue Self-sampling of capillary blood for analysis (e.g. glucometer reading) 31

32 Low Risk Biological Agents NO SRC (Scientific Review Committee) Needed but Risk Assessment (Form 3) Required Studies involving protists and archaea microorganisms Research using manure for composting, fuel production, or other non-culturing experiments. Commercially-available color change coliform water test kits. These kits must remain sealed and must be properly disposed 32

33 Potentially Hazardous Biological Agents (PHBA) and the SRC ALL microorganisms not SPECIFICALLY mentioned in the previous slides are considered to be Potentially Hazardous Biological Agents (PHBA) and require: 1. Completion of additional forms (depending upon the project) and 2. SRC (Scientific Review Committee) approval PRIOR to initiation of the study (unless waived in writing by the relevant Regulated Research Institution) The job of the SRC is to ensure that all ISEF safety rules are followed throughout the project, including: 1. Evidence of proper supervision 2. Use of accepted research techniques 3. Correctly completed forms, signatures and dates 4. Humane treatment of animals 5. Compliance with rules and laws governing human or animal research and research involving Potentially Hazardous Biological Agents 33

34 Potentially Hazardous Biological Agents (PHBA) and the SRC (continued) SRC approval must be obtained BEFORE starting the study SRCs must be composed of at least 3 people: 1. A Biomedical Scientist in the relevant field (e.g. Ph.D., M.D., D.V.M. etc) 2. An Educator 3. An additional member (often with relevant scientific background) DISQUALIFIED from serving on the SRC are the following: 1. Adult Sponsor 2. Parent or other relative 3. Qualified Scientist 4. Designated Supervisor If the Teacher is acting in any of the above capacities then he/she is also DISQUALIFIED from serving on the SRC 34

35 Potentially Hazardous Biological Agents (PHBA) and the SRC (continued) Pre-study approval from an SRC can come from: 1. A school SRC 2. The standing ScienceMONTGOMERY SRC 3. An SRC or IBC (Institutional Biosafety Committee) from the relevant Regulated Research Institution(RRI), for example, NIH a University or a Biotech Company A. Documentation of pre-approval from the RRI's safety committee required (e.g. SRC/IBC/IACUC approval letter, NOT a letter from the Qualified Scientist in the lab) Note that ALL projects must STILL undergo post-study approval by the ScienceMONTGOMERY SRC before exhibition at the science fair Winners picked to advance, are subject to review by official ISEF SRC 35

36 Waiver of Pre-study SRC Approval Associated with Potentially Hazardous Biological Agents If the Regulated Research Institution (RRI) does not require pre-study approval, then a letter stating that must be written by an Institutional Official not involved with the research itself (NOT the Qualified Scientist) who can speak on behalf of the Institution (e.g., Department Head, Branch Chief, etc.) The language that should be used in the waiver of Institutional SRC approval is as follows: The RRI does not require approval for this type of study. The student has received proper training and the project complies with Intel ISEF rules. Examples of studies where an SRC waiver letter from an RRI have been supplied include: 1) rdna studies with BSL-1 organisms; 2) Culturing of BSL-1 class bacteria Intel ISEF recommends that projects not requiring pre-approval by an institution and even those receiving pre-approval by an institution still get pre-approval by the local fair SRC because the ISEF rules are slightly more stringent than those governing general research. 36

37 Potentially Hazardous Biological Agents (PHBA): Biological Safety Level-1 (BSL-1) vs. Biological Safety Level-2 (BSL-2) Potentially Hazardous Biological Agents: 1. Microorganisms (e.g. bacteria, viruses, prions, rickettsia, fungi, parasites) 2. Recombinant DNA technologies 3. Human and animal fresh or frozen tissues 4. Human and animal blood and body fluids NO MICROORGANISMS NOT SPECIFICALLY EXEMPTED IN THE PREVIOUS SLIDES CAN BE CULTURED OR INCUBATED AT HOME 1. Samples can be collected at home and immediately transported to the laboratory Under the appropriate conditions, students may work with organisms classified as: 1) Biological Safety Level-1 (BSL-1) or 2) Biological Safety Level-2 (BSL-2) 37

38 Potentially Hazardous Biological Agents (PHBA): Biological Safety Level-1 (BSL-1) Rules Biological agents that pose low risk to personnel and the environment. Highly unlikely to cause disease Work can be done on an open bench or in a fume hood using standard microbiological practices Decontamination can be achieved by treating with chemical disinfectants or by steam autoclaving Lab coats are required and gloves recommended Must be supervised by Designated Supervisor or Qualified Scientist with general training in microbiology Typical setting is high school classroom or college introductory microbiology course 38

39 Potentially Hazardous Biological Agents (PHBA): Biological Safety Level-2 (BSL-2) Rules Biological agents that pose moderate risk to personnel. Risk of spread is limited Effective treatment and preventive measures are available in the event that an infection occurs Biological safety cabinets must be used. An autoclave should be readily available for decontamination Lab coats, gloves and face protection are required The laboratory work must be supervised by a Qualified Scientist Typical setting is Regulated Research Institution (but schools can qualify if right equipment and personnel are on site) 39

40 Potentially Hazardous Biological Agents: BSL-1 Agents Bacteria cultures such as: 1. Escherichia coli K12 2. Agrobacterium tumifaciens 3. Micrococcus luteus 4. Neurospora crassa 5. Bacillus subtilis Research with Unknown Microorganisms: 1. From the environment (e.g. soil, water household surfaces, skin) 2. Cultured in a standard non-breakable container 3. SEALED throughout the experiment rdna technology studies involving BSL-1 organisms and host vector systems 1. E. coli K12 2. S. cerevesiae 3. B. subtilis host-vector systems 40

41 Potentially Hazardous Biological Agents: BSL-1 Agents (continued) Commercially available rdna kits using BSL-1 organisms Human and non-human primate established cell lines (e.g., from ATCC) may be either a BSL-1 or BSL-2 level organism depending on source information. The culture source and/or catalog number must be identified Tissue studies with fresh/frozen tissue or body fluids, (excluding blood) from a non-infectious source with little likelihood of microorganisms present (e.g. organs from inbred rodents except gastrointestinal tract) Studies involving domestic or laboratory animal blood 41

42 Potentially Hazardous Biological Agents: BSL-2 Agents Bacteria cultures such as: 1) Mycobacterium; 2) Streptococcus pneumonia; 3) Salmonella choleraesuis MRSA (Methicillin resistant Staphlococcus aureus), VRE (Vancomycin resistant Enterococci) and KPC (Klebsiella pneumonia) Must be conducted in a Regulated Research Institution w. SRC/IBC approval A culture container with unknown microorganisms opened during the course of the study rdna study using BSL-1 agents that may convert to BSL-2 agents rdna technology studies involving BSL-2 organisms and/or BSL-2 host vector systems Must be conducted in a Regulated Research Institution w. SRC/IBC approval Human and primate established cell lines (e.g., from ATCC) may be BSL-1 or BSL-2 level organisms depending on source information. The culture source and/or catalog number must be identified 42

43 Potentially Hazardous Biological Agents: BSL-2 Agents (continued) Tissue studies with fresh/frozen tissues or body fluids that may contain microorganisms even if they are BSL-1 organisms (e.g. collection of primary gut tissue) Must be conducted in a Regulated Research Institution in a BSL-2 laboratory under supervision of a Qualified Scientist Human blood or blood products Wild animal blood or blood products Human breast milk of unknown origin, unless certified free of HIV and Hepatitis C Domestic unpasteurized animal milk The culturing of human or animal waste, including sewage sludge 43

44 Paperwork Required for Potentially Hazardous BSL-1 and BSL-2 Biological Agents Standard Forms for all Projects: 1. Registration form; Research Plan; Abstract; Adult Sponsor Checklist (1); Student Checklist (1A); Approval Form (1B) Regulated Research Institutional Setting Form (Form 1C) 1. ONLY required if work is done at a Regulated Research Institution (NOT school) 2. Signed by Designated Supervisor or Qualified Scientist at the Research Institution (NOT teacher or school official) Qualified Scientist Form (Form 2) 1. To be completed and signed by Qualified Scientist or Designated Supervisor when the Qualified Scientist cannot directly supervise 44

45 Paperwork Required for Potentially Hazardous BSL-1 and BSL-2 Biological Agents (continued) Potentially Hazardous Biological Agents Risk Assessment Form (Form 6A) 1. Completed by Student and Qualified Scientist (QS) or Designated Supervisor (DS). Signed by QS/DS and SRC chair Human and Vertebrate Animal Tissue Form (Form 6B) 1. Required ONLY for research involving fresh/frozen tissue blood, blood products or body fluids. Signed by Qualified Scientist or Designated Supervisor prior to initiation of study Risk Assessment Form (Form 3) 1. Required for biology projects involving: a) Protists; b) Archaea; c) Manure for composting; d) Coliform kits 2. Hazardous chemicals (e.g. Controlled substances; Prescription Drugs, Alcohol; Tobacco; Explosives) 45