This document discusses ways that employees try to cheat on drug tests and how employers can prevent cheating. It describes the common methods employees use, like dilution, substitution, and adulteration of urine samples. It then provides strategies for employers, such as observing collections, testing sample validity, and enforcing clear consequences for cheating. The document also compares different drug testing methods and explains how hair and oral fluid tests are harder to cheat on than urine tests alone.
Investigators Responsibilities during Clinical trialsBHAVYARAJAN2
This Presentation was presented by Pruthvi raj, Tejaswini, and myself Bhavya Rajan at Clinosol Research Pvt Ltd. We would like to thank Clinosol and Mujeeb sir for this opportunity. for constantly supporting and encouraging us
Investigators Responsibilities during Clinical trialsBHAVYARAJAN2
This Presentation was presented by Pruthvi raj, Tejaswini, and myself Bhavya Rajan at Clinosol Research Pvt Ltd. We would like to thank Clinosol and Mujeeb sir for this opportunity. for constantly supporting and encouraging us
This presentation explains the benefits of performing drug tests on your employees. It also explains when to properly administer them to your work force.
The Belmont Report (Three Benchmark Rules)ClinosolIndia
The Belmont Report, published in 1979, is a seminal document in the field of research ethics. It was developed by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in response to unethical research practices, particularly the infamous Tuskegee Syphilis Study. The report sets forth three fundamental ethical principles, often referred to as the "Three Benchmark Rules," that guide the ethical conduct of research involving human subjects. These principles are:
Respect for Persons:
The principle of respect for persons emphasizes the autonomy and dignity of individuals. It requires that individuals be treated as autonomous agents capable of making informed decisions about their participation in research. Researchers must obtain informed consent from potential subjects and provide them with all relevant information regarding the purpose, risks, benefits, and alternatives of the study. Special provisions must be made for individuals with diminished autonomy, such as children or those with cognitive impairments, to ensure their rights and welfare are protected.
Beneficence:
The principle of beneficence emphasizes the obligation to maximize benefits and minimize harm to research subjects. Researchers must ensure that the potential benefits of the study outweigh the potential risks. They should conduct a thorough risk-benefit analysis and design their studies to maximize potential benefits while minimizing any potential harm or discomfort to participants. Additionally, researchers must make ongoing assessments of the risks and benefits throughout the course of the study and take necessary steps to minimize harm and maximize benefits.
Justice:
The principle of justice requires the fair distribution of the burdens and benefits of research. It emphasizes the need for equal access to participation in research, regardless of factors such as race, gender, socioeconomic status, or other characteristics. Researchers must ensure that the selection of research subjects is fair and avoid exploiting vulnerable populations. Additionally, the benefits derived from research should be distributed equitably, ensuring that the burdens of research are not borne solely by disadvantaged groups while the benefits accrue to others.
These Three Benchmark Rules provided in the Belmont Report serve as the foundation for modern ethical guidelines and regulations governing research involving human subjects. They have significantly influenced the development of ethical review boards and informed consent processes, ensuring the protection of individuals' rights and well-being in research studies.
Presented to VT League of Cities and Towns at their Municipal Personnel Administration Forum on May 13, 2010. Focuses on drug testing do's and don'ts for employers in Vermont.
Roles and Responsibilities in Clinical Trials of Investigator, Study Coordinator, Sponsor, Monitor, a Contract research organization.
The clinical trial, definition, description, Different types of clinical trials, phases of clinical trial.
The clinical trial study team.
Requirements of the clinical trial study team.
Clinical research team role.
GCP- Good clinical practices.
PRECLINICAL SCREENING MODELS
In vitro methods
• Patch clamp technique in kidney cells
• Perfusion of isolated kidney tubules
• Isolated perfused kidney
In vivo methods
• Diuretic activity in rats (LIPSCHITZ test)
• Saluretic activity in rats
• Diuretic and saluretic activity in dogs
• Clearance methods
• Micro puncture techniques in the rat
• Stop-flow technique
Forensic Genetics in the 21st century – meeting the challenges of biological ...Thermo Fisher Scientific
"Forensic Genetics in the 21st century – meeting the challenges of biological evidence
Presented by Peter M. Schneider, Institute of Legal Medicine
University of Cologne, Germany Human Identification Solutions Conference – Madrid, Spain
March 4, 2015 CO014206"
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
Presentation on Roles and Responsibilities of sponsor in conducting clinical trials as per GCP-ICH for pursuing a subject in the course of PharmD programme under RGUHS
This presentation explains the benefits of performing drug tests on your employees. It also explains when to properly administer them to your work force.
The Belmont Report (Three Benchmark Rules)ClinosolIndia
The Belmont Report, published in 1979, is a seminal document in the field of research ethics. It was developed by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in response to unethical research practices, particularly the infamous Tuskegee Syphilis Study. The report sets forth three fundamental ethical principles, often referred to as the "Three Benchmark Rules," that guide the ethical conduct of research involving human subjects. These principles are:
Respect for Persons:
The principle of respect for persons emphasizes the autonomy and dignity of individuals. It requires that individuals be treated as autonomous agents capable of making informed decisions about their participation in research. Researchers must obtain informed consent from potential subjects and provide them with all relevant information regarding the purpose, risks, benefits, and alternatives of the study. Special provisions must be made for individuals with diminished autonomy, such as children or those with cognitive impairments, to ensure their rights and welfare are protected.
Beneficence:
The principle of beneficence emphasizes the obligation to maximize benefits and minimize harm to research subjects. Researchers must ensure that the potential benefits of the study outweigh the potential risks. They should conduct a thorough risk-benefit analysis and design their studies to maximize potential benefits while minimizing any potential harm or discomfort to participants. Additionally, researchers must make ongoing assessments of the risks and benefits throughout the course of the study and take necessary steps to minimize harm and maximize benefits.
Justice:
The principle of justice requires the fair distribution of the burdens and benefits of research. It emphasizes the need for equal access to participation in research, regardless of factors such as race, gender, socioeconomic status, or other characteristics. Researchers must ensure that the selection of research subjects is fair and avoid exploiting vulnerable populations. Additionally, the benefits derived from research should be distributed equitably, ensuring that the burdens of research are not borne solely by disadvantaged groups while the benefits accrue to others.
These Three Benchmark Rules provided in the Belmont Report serve as the foundation for modern ethical guidelines and regulations governing research involving human subjects. They have significantly influenced the development of ethical review boards and informed consent processes, ensuring the protection of individuals' rights and well-being in research studies.
Presented to VT League of Cities and Towns at their Municipal Personnel Administration Forum on May 13, 2010. Focuses on drug testing do's and don'ts for employers in Vermont.
Roles and Responsibilities in Clinical Trials of Investigator, Study Coordinator, Sponsor, Monitor, a Contract research organization.
The clinical trial, definition, description, Different types of clinical trials, phases of clinical trial.
The clinical trial study team.
Requirements of the clinical trial study team.
Clinical research team role.
GCP- Good clinical practices.
PRECLINICAL SCREENING MODELS
In vitro methods
• Patch clamp technique in kidney cells
• Perfusion of isolated kidney tubules
• Isolated perfused kidney
In vivo methods
• Diuretic activity in rats (LIPSCHITZ test)
• Saluretic activity in rats
• Diuretic and saluretic activity in dogs
• Clearance methods
• Micro puncture techniques in the rat
• Stop-flow technique
Forensic Genetics in the 21st century – meeting the challenges of biological ...Thermo Fisher Scientific
"Forensic Genetics in the 21st century – meeting the challenges of biological evidence
Presented by Peter M. Schneider, Institute of Legal Medicine
University of Cologne, Germany Human Identification Solutions Conference – Madrid, Spain
March 4, 2015 CO014206"
Roles and Responsibilities of sponsor in conducting clinical trials as per GC...Dr B Naga Raju
Presentation on Roles and Responsibilities of sponsor in conducting clinical trials as per GCP-ICH for pursuing a subject in the course of PharmD programme under RGUHS
This is the presentation I made to the National Cancer Institute's Cancer Research in the Media workshop for Latin American journalists in Guadalajara on November 8, 2011. It is step-by-step advice about things to consider about each of the 10 criteria we apply to the review of health care news stories about treatments, tests, products & procedures.
Real plus certified pee diagnostic tests tend to be led with medical examination since this is an approach to choose no matter whether an individual will be suit or otherwise to have an vocation position. Irregardless, one or two persons immeasurably make use of pee designed for express as well as person good reasons.
The slide provides a basic understanding about Clinical Research process and the various Phases of Drug Discovery and Development. It also explains about the various trial designs and techniques in research such as blinding and randomization. It may be useful for giving a basic class for Fourth Year B.Pharm Students.
This module is intended to introduce the students of biotechnology to obtain an overview of the pharmaceutical industry. The concept of clinical trials is discussed in brief.
Clinical trials are divided into several phases to ensure the safety and effectiveness of new medical interventions, such as drugs, treatments, or medical devices, before they are approved for widespread use. Here are the typical phases of clinical trials:
Phase 0: Exploratory Study
Phase 0 trials are relatively new and not always a part of the clinical trial process. They involve a small number of participants and aim to gather initial data on how the drug or treatment behaves in the human body. These trials help researchers decide whether to move forward with larger Phase 1 trials.
Phase 1: Safety and Dosage Study
Phase 1 trials involve a small number of healthy volunteers or patients and focus on assessing the safety of the intervention and determining the appropriate dosage range. Researchers closely monitor participants for any adverse effects, evaluate how the intervention is metabolized, and gather initial data on its efficacy.
Phase 2: Expanded Safety and Efficacy Study
Phase 2 trials involve a larger number of patients who have the condition the intervention is intended to treat. These trials continue to assess safety, evaluate dosage regimens, and gather more data on the intervention's efficacy. Researchers may also explore different patient populations, dosages, or combinations with other treatments.
Phase 3: Confirmatory Study
Phase 3 trials are large-scale studies involving a significant number of patients to confirm the intervention's safety, effectiveness, and monitor any side effects. These trials often include a randomized and controlled design, comparing the new intervention against existing standard treatments or placebos. Phase 3 trials provide critical data for regulatory agencies to evaluate whether the intervention should be approved for widespread use.
Phase 4: Post-Marketing Surveillance Study
Phase 4 trials take place after the intervention has received regulatory approval and is available to the general public. They aim to monitor the intervention's long-term safety, effectiveness, and identify any rare or long-term side effects. Phase 4 trials may involve a larger and more diverse population than earlier phases.
process of discovery of a new drug
what are clinical trials
why clinical trials are conducted
overview of phases in a clinical trial
details about every phase
focus and purpose of conducting clinical trial
2. Quest Diagnostics Confidential – Do not copy or distribute | 2
Bill Current
• Founded WFC & Associates, LLC in 1998
• Author of 10 books, including “Why Drug Testing?”
• Publisher of the On-Line Ultimate Guide to State
Drug Testing Laws at StateDrugTestingLaws.com
• Director of the Annual Survey of Drug Testing Industry Trends
now in its 14th year
• Former Executive Director of the American Council for Drug Education,
Director of the Institute for a Drug-Free Workplace, and Vice President of
Consulting for a national third-party administrator
3. Quest Diagnostics
Good News and Bad News…
A man takes a drug test and the next day
they call him to share the results.
Good News:
“Your drug test came back negative.”
BUT
Bad News:
“You’re pregnant!”
Confidential – Do not copy or distribute | 3
4. Quest Diagnostics
SAMHSA’s National Survey on Drug Use and Health
• “The use of illicit drugs among Americans increased between 2008 and 2010 according
to a national survey conducted by the Substance Abuse and Mental Health Services
Administration (SAMHSA). The National Survey on Drug Use and Health (NSDUH)
shows that 22.6 million Americans 12 or older (8.9 percent of the population) were
current illicit drug users. The rate of use in 2010 was similar to the rate in 2009 (8.7
percent), but remained above the 2008 rate (8 percent).”
• “An increased rate in the current use of marijuana seems to be one of the prime factors
in the overall rise in illicit drug use. In 2010, 17.4 million Americans were current users
of marijuana - compared to 14.4 million in 2007. This represents an increase in the
rate of current marijuana use in the population 12 and older from 5.8 percent in
2007 to 6.9 percent in 2010.”
• “Another disturbing trend is the continuing rise in the rate of current illicit drug use
among young adults aged 18 to 25 - from 19.6 percent in 2008 to 21.2 percent in 2009
and 21.5 percent in 2010. This increase was also driven in large part by a rise in the
rate of current marijuana use among this population.”
Source: http://www.samhsa.gov/newsroom/advisories/1109075503.aspx
Confidential – Do not copy or distribute | 4
5. Quest Diagnostics
Drug Testing
• According to research conducted by WFC & Associates, more than 50 million
drug testing samples are tested annually generating $1.7 billion dollars in
revenue in the United States alone.
• This includes workplace, drug treatment, criminal justice, law enforcement,
military and other government entities, schools, professional sports and other
markets that have embraced drug testing.
• It includes traditional lab-based urine testing as well as alternative methods
that are increasing in popularity such as instant testing and oral fluid testing.
Why so much drug testing?
• Because drug testing works as both a deterrent to
use and as a way to identify people who need help.
Confidential – Do not copy or distribute | 5
6. Quest Diagnostics Confidential – Do not copy or distribute | 6
How They Cheat and How to Stop Them
• The Triple Play of Cheating
– Dilution, Substitution, Adulteration
• Making It Harder for Cheaters to Cheat
– Protect Yourself
– Test the Test
– Lay Down the Law
• Alternative Testing Methods that Work
– Oral Fluid Testing
– Hair Testing
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The Triple Play of Cheating
1. Dilution
2. Substitution
3. Adulteration
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Dilution
• Watering down the sample by consuming large amounts of liquids.
This is done to dilute the drug concentration in a person’s system.
• Though a water-diluted urine sample does not automatically mean
the individual is a drug user or drug test cheater, the specimen may
be reported by a laboratory as diluted.
• Some instant urine testing devices have built-in strips to verify the
concentration level of the specimen. Add-on adulteration strips (or
dipstick devices) are also available.
• An instant specimen should be sent to a lab if reasonable suspicion
exists.
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Substitution
• The substitution method is just that… the substituting of one
person’s urine with that of someone (or something) else’s.
• There are obvious complications. The substitute urine might be dirty.
Or the container with the substitute urine might break or leak before
the urine can be poured into the collection vial.
• Some people have even resorted to injecting substitute urine directly
into their bladder or using the urine of an animal.
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Adulteration
• With the adulteration or additive method the user adds something to
the urine after the specimen has been voided.
• Common additives include bleach, vinegar, various juices, eye drops,
dish soap, and even drain cleaners among many possibilities. There
are also a variety of commercial products that claim to interfere with
the testing process.
• Adulteration requires donors to smuggle some type of additive
substance into the bathroom inside their underclothing or somewhere
on their body.
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Internet Research: Turning the Tables on Cheaters
• There are countless websites on the Internet that offer products that
claim to help donors successfully cheat on a drug test.
• There are just as many websites that offer advice about how to mask
the presence of drugs in person’s urine.
• If you’re in the business of administering drug tests, these websites
can be an invaluable resource. You can learn a lot just by reading
what they have to say about adulterants, dilution methods and
substitution techniques.
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Good Advice to Stop Cheaters
One of my favorites is Spectrum Labs better known as Urine Luck.
www.urine-luck.co.uk
• Review their product offerings
• Read their claims
• Search the FAQ section
• Study their “Information On How to Pass a Drug Test”
14. Quest Diagnostics Confidential – Do not copy or distribute | 14
Some Websites Coach Cheaters
• What are the qualitative and quantitative levels of the adulterant found in the
urine?
• What two separate methodologies were run to determine the presence of this
adulterant as required by DOT guidelines?
• Was one of these methodologies a wet chemistry test or just a simple
dipstick?
• Can I see the documentation showing that this adulterant is not supposed to
be found in urine?
• Can I see a report of this information above printed on your company's
letterhead?
• Is it with in my rights to see the previously requested report?
15. Quest Diagnostics Confidential – Do not copy or distribute | 15
What Can Be Done: Prevention
There are three broad categories of prevention:
1. Protect Yourself with Precautions
2. Test the Test with Validity Testing
3. Lay Down the Law with Prohibitions & Consequences
16. Quest Diagnostics Confidential – Do not copy or distribute | 16
Basics in Precautionary Measures
• Ensure that the collection takes place in a secured area.
• Require the donor to wash his or her hands prior to voiding the sample.
• Add colored dye to toilet water in the donor stalls.
• Turn off running water (or hot water) during the collection process.
• Ask donors to leave outer clothing
such as coats and jackets outside
the stall.
• Read the temperature of all
samples immediately after voiding.
17. Quest Diagnostics
Basics in Validity Testing
• To detect if a specimen was diluted, adulterated or substituted a validity test
can be conducted for each collected specimen.
• Quest Diagnostics specimen validity test is called TestSure™. When client’s
request TestSure, specimens are screened for a variety of adulterant
compounds by using state-of-the-art secondary testing methods.
Note: Keep in mind that cheaters may know
how to dilute and tamper with their urine samples to
get them below the drug detection cutoffs and still fall
within the acceptable range of creatinine and
specific gravity!
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Consequences
• One of the most effective deterrents to drug test cheating is
education and consequences.
• Let donors know that adulteration attempts will be considered the
same as a positive test results.
• Let them know that you read the same websites they read and that
you know how cheaters cheat.
19. Quest Diagnostics Confidential – Do not copy or distribute | 19
Policy Language Example
Prohibited Conduct
• “Switching, tampering with or adulterating any specimen or sample collected
under the Company’s policy for the purpose of testing for drugs or alcohol.”
Consequences
• “Individuals who attempt to alter a drug or
alcohol test result or a test sample by means
of tampering with, adulterating, switching,
or diluting a specimen will be treated as
if they had a positive test result.”
20. Quest Diagnostics Confidential – Do not copy or distribute | 20
Observed Collections
Federal drug testing protocols as found in 49 CFR part 40 require an
observed collection under a multitude of circumstances, including when…
1. The laboratory reports to a Medical Review Officer (MRO) that a
specimen is invalid, and the MRO reported to you that there was not an
adequate medical explanation for the result;
2. The MRO reported to you that the original positive, adulterated, or
substituted result had to be cancelled because the test of the split
specimen could not be performed; or
3. The laboratory reported to the MRO that the specimen was negative-
dilute with a creatinine concentration greater than or equal to 2 mg/dL
but less than or equal to 5 mg/dL, and the MRO reported the specimen
to you as negative-dilute and that a second collection must take place
under direct observation (see §40.197(b)(1)).
21. Quest Diagnostics
Observed DOT Collections
Or when…
• The reason for a drug test is a “return-to-duty” or “follow-up” drug test
• When there is suspicion or direct observation of an attempt to tamper with a
specimen
• When the temperature of the original specimen was outside the proper range
Confidential – Do not copy or distribute | 21
22. Quest Diagnostics
Drug Testing Methods and Cheating Methods
Method Dilution Substitution Additive
Urine Yes Yes Yes
Hair No No Yes
Oral Fluid No No No
Confidential – Do not copy or distribute | 22
23. Quest Diagnostics Confidential – Do not copy or distribute | 23
Hair Testing
Considerations
• Longer window of detection
• Less invasive collection
• Directly observed collection
• Difficult to cheat using standard methods
24. Quest Diagnostics Confidential – Do not copy or distribute | 24
Advice from One Website on Cheating a Hair Testing
1. When you get home, saturate your hair with the vinegar. You will
probably gag, but its worth it! I dumped it on slowly, over a 10 minute
period to get maximum saturation.
2. Let the vinegar sit for 15-20 minutes. DO NOT RINSE. Now you want to
soak your hair with the salicylic acid acne treatment. Again, pour slowly, let
it take a few minutes, so you get the most absorption. I left both vinegar
and acne treatment in my hair for about 30 minutes.
3. Do not rinse the vinegar and acid out of your hair. Pour the liquid
detergent on your hair and rub it in real good. Concentrate these products
on more the back of your head, as that's where the sample will be taken
from. I did liquid first, then added a little water to the powder to make a
paste. I scrubbed this into my scalp and hair. Let sit for about 20-30
minutes.
4. Rinse all the products out of your hair, but do not wash or condition.
5. Dye the hair! The box said 25 minutes, I left it in for about 40. Then rinse
the dye, use the little conditioner that comes in it.
Source: http://www.wikihow.com/Pass-a-Hair-Follicle-Drug-Test
25. Quest Diagnostics Confidential – Do not copy or distribute | 25
Oral Fluid Testing
Considerations
• Recent use detection
• Less invasive collection
• Directly observed collection
• On-site collection
• Virtually adulteration proof
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Oral Fluid Testing
One of my favorite websites for oral fluid drug test cheating is wikihow.com/
pass-a-drug-test.
Quoting directly from the website:
“Try to avoid the test. If one is being tested and has used in the past 3 days
you will need to overcome the saliva collection. To do this, you will have to
avoid submitting saliva and perform the steps requested of you by the
instructor.”
Another offers this advice:
“To pass this [an oral fluid test] you should always know the detection time of
the drug you have taken. Marijuana can be detected via saliva drug testing
from an hour after ingestion up to 24 hours depending on use. Between these
periods of time, you must avoid being screened or you will surely test positive.”
27. Quest Diagnostics Confidential – Do not copy or distribute | 27
Practice Makes Perfect (Cheaters)
At cannibis.com, you will find a very entertaining story about the step-
by-step process that one cheater followed to successful cheat on a
urine drug test.
Highlights:
• Educated himself
• Practiced until he had it right
• Armed himself with the necessary tools
• Executed his plan
Source: http://boards.cannabis.com/drug-testing/195500-passing-quest-diagnostics-ua-drug-test.html
28. Quest Diagnostics
Conclusion
• The drug problem is still here and getting worse.
• Drug testing remains the most effective way to address the problem.
• Drug test cheating is common. Cheating methods are plentiful and readily
available.
• Knowing what the cheaters know is critical.
• Precautions, validity testing and firm consequences are keys to turning the
tables on the cheaters.
• If drug test cheating is a concern, alternative testing methods may be worth
considering.
• Hair testing offers a broader window of detection is difficult to cheat.
• Oral fluid testing is the best at detecting recent drug use and is virtually
adulteration proof.
Confidential – Do not copy or distribute | 28
29. Quest Diagnostics
Questions
Confidential – Do not copy or distribute | 29
For more information about drug testing services, please visit
www.EmployerSolutions.com or call 800-877-7484.