Law Practice Quiz Questions

What are some of the requirements for an experiment to be approved by the IRB

- A risk/benefit analysis is performed and the risks to subjects are determined to be minimized - The informed consent procedure is outlined and documented - There are provisions for monitoring of the data to ensure ongoing subject safety

What are some of the powers of the IRB

- Approve research - Suggest modifications to research - Observe ongoing research

What is true regarding DDT

- DDT was used to effectively reduce malaria - DDT is a persistent organic pollutant that can bioaccumulate and biomagnify - Silent Spring was written about the overuse of DDT - DDT would have fallen out of use even without Rachel Carson due to mosquitos evolving resistance

Which resulted in an increase in animal experimentation

- Federal Food Drug and Cosmetic Act - Declaration of Helsinki

The Pure Food and Drug act provided what protections to consumers following its passing in 1906

- Forfeiture of goods and possible civil fines for good found in violation - Created partially in response to the publication of The Jungle as well as the rise of patent medicines

What is true regarding the informed consent process?

- If there are alternative choices in treatment they must be described to the subject - Even in long term studies subjects maintain the right to withdraw from the experiment at any time - Children can give their assent to experiment and the experiment must be explained in age-appropriate language

What is true regarding air pollution

- Increased ocean acidification due to increased levels of atmospheric CO2 - Air pollution is believed to cause over 7 million deaths per year

What is true regarding the EPA

- It has the power to initiate judicial proceedings - it enforces the Clean Air Act and the Clean Water Act - The punishment for violating EPA regulations can include jail time

What is not a power of the IRB

- Terminate employment of a researcher found in violation - Hire researchers for positions

What are factors on the Hazard Ranking System

- There is a likelihood that a site has released or will release hazardous substances into the environment - People or sensitive environments would be affected by the waste

What are requirements to add an animal to the endangered species list?

- There is a recovery plan - Animals must meet one of the 5 criteria for listing

Which program would provide funds for the Hassayampa Landfill if it did not receive a high score on the NPL but was within a city and was causing blight in a neighborhood?

Brownfields Program

Which provides funds for the Hassayampa Landfill if it receives a high score on the National Priorities List?

CERCLA

Subpart D of the Common Rule is which group

Children

Which of the laws/regulations lay out the requirements for Institutional Review Boards membership, function, operations, review of research, and record keeping.

Common Rule

If the primary reasoning for most groups to call for clean river water is so that the people of Flint have cleaner water to drink. The cleanup of the river would be which environmental attitude?

Conservation

Which was the first to specifically address the needs of vulnerable populations during humans subjects research?

Declaration of Helsinki

(T/F) The Nuremberg code, whose most important finding was the role of voluntary human consent, was adopted into law in the US and carries both civil and criminal punishments if violated

False - NOT adapted into Federal law, but did inspire other laws; cant "break" the Nuremberg code in America

Law that was passed following the accidental poisoning deaths of over 100 people with sulfanilamide mixed with diethylene glycol: "This law required a new Drug Application and evidence of drug safety but not that the drug worked"

Food, Drug, and Cosmetic Act as it was originally enacted in 1938

The ARRIVE guidelines are a critical component to ethical animal use in scientific research. These guidelines are most important ___.

For a researcher when they are writing up their data in a paper for publication

What is false regarding the informed consent process?

Informed consent can be obtained during the experimental process

Which is incorrect regarding the EPA

It initiates legislations and passes laws

Which is not a requirement to add an animal to the endangered species list?

It is of value to the economy

If people of Central and South American countries bore the burden of testing, but were not able to receive the benefits of the drug being approved for sale. The concept that no single group should bear the burdens of human subjects research falls under which precept of the Belmont Report?

Justice

Which is an example of "refinement" as per expectations of the 3 R's

Mary decides to modify an experiment by adding a new, more effective, analgesic to her post-surgical care of her rats to decrease their pain

If Alex interviewed people and maintained contact info to follow up with them latter would it be considered anonymous?

No

What is NOT a requirement for experiments to be approved by the IRB

No vulnerable subjects are included as they are ineligible for human subjects research

If someone pours a toxic substance down the drain what type of water pollution is it?

Point source

Subpart B of the Common Rule is which group

Pregnant Women

Subpart C of the Common Rule addresses which group

Prisoners

If an individual was concerned about her neighbors seeing her enter a Planned Parenthood Clinic, the concern an individual may have about controlling access to their personal information would be?

Privacy

If IACUC suggests a modification to use planarians instead of rats, what suggestion would this be?

Replacement

Henrietta Lacks' cells were taken and turned into the first immortalized cell line. The DNA from these cells was sequenced and for a time was available to the general public. The fact that Henrietta Lacks did not provide informed consent would today be considered a violation of which tenet of the Belmont report?

Respect for Persons

What is incorrect regarding air pollution

The Air Pollution Act of 1955 was the first to impose fines for breaking air pollution laws

If a researcher developed a experiment with poor conditions for animals, they were convicted of 6 counts of violating what?

The Animal Welfare Act

Which did not result in an increase in animal experimentation

The Common Rule

The anti-vivisectionist crusade was critical to this act being passed through legislature

The Cruelty to Animals Act

In 1986 the NIH established the Chimp Breeding & Research Program in response to what event?

The HIV/AIDs epidemic so they could act as models of this devastating disease

If a lab at a large state university decides to only remove hazardous chemicals every 5 years. What act are they violating?

The Resource Conservation and Recovery Act (Subpart K)

If a researcher proposes an experiment comparing cortisol metabolites in children who attend a lower socioeconomic school, what is the reason the experiment falls under full review as per federal requirements?

The fact that it uses children

What is not one of the three factors on the Hazard Ranking System?

The waste falls on the dirty dozen list of Persistent Organic Pollutants as regulated by the Stockholm Convention

What is the job of IACUC?

Their power is similar to IRB's. They primarily ensure that harm to animals is minimized while still doing the most productive science possible

Which would not result in the Arizona cliffrose being de-listed (removed) from the endangered species list?

There is a lack of funds or economic interest in the Arizona cliffrose

What is true regarding IACUCs

They are required to have a member of the public who is unaffiliated with the institutions

What would be an example of the Tragedy of the Commons

When individuals pump too much groundwater, the resource is depleted before it can be replenished.