Exam 1

The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies? A). Harvard "Tastes, Ties, and Time (T3)" study (2006-2009)" study B). The Tuskegee study C). Milgram's "Obedience to Authority" study D). Zimbardo's "Stanford Prison Experiment

A). Harvard "Tastes, Ties, and Time (T3)" study (2006-2009)" study

When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider: A). Is there a power differential between researchers and subjects? B).Are there adequate resources to conduct the study? C)Are the research procedures greater than minimal risk of harm? D). Has the researcher completed required training?

A). Is there a power differential between researchers and subjects?

Subjects with a serious illness may be at risk for exploitation since they may be desperate for a possible cure. This is an example of A).Medical Vulnerability B).Therapeutic misconception C).Deferential vulnerability D). Economic vulnerability

A).Medical Vulnerability

As part of the consent process, the federal regulations require researchers to: A. Provide potential subjects with information at the appropriate reading comprehension level. B. Provide a list of the IRB members who reviewed the protocol. C. Recommend that potential subjects discuss their decision to participate with family members. D. Describe penalties that may be imposed for non-participation.

A. Provide potential subjects with information at the appropriate reading comprehension level.

Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of: A. Respect for persons. B. Justice. C. Beneficence.

A. Respect for persons.

Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human subject protection? A. The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male. B. Stanford Prison Experiment (Zimbardo). C. The Harvard T3 study. D. Tearoom Trade Study (Humphreys).

A. The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.

According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB? A. The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations B. The study is required for a student research project C. The study does not require informed consent or survey instruments. D. The study includes only research subjects that are healthy volunteers.

A. The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations

What is the most regulated profession? A).Nurses B). Physicians C). Pharmacists D). Dentists

C). Pharmacists

The Belmont principle of beneficence requires that: A).Subjects derive individual benefit from study participation. B).The study makes a significant contribution to generalizable knowledge. C). Potential benefits justify the risks of harm. D).Risks are managed so that they are no more than minimal.

C). Potential benefits justify the risks of harm.

Identify the following groups that are protected by the federal regulations?(45CFR 46), specifically in parts B, C, D with additional protections? A). Children, prisoners, and individuals critically ill B). Prisoners, children, older adults C). Pregnant women, prisoners, children D). Pregnant women, prisoners, children, individuals economically disadvantaged

C). Pregnant women, prisoners, children

How long is an investigator required to keep consent documents, IRB correspondence, and research records? A. Until the study is closed B. Until data analysis is complete C. For a minimum of three years after completion of the study D. As long as the investigator is at that institution

C. For a minimum of three years after completion of the study

According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: A. Beneficence. B. Respect for persons. C. Justice.

C. Justice

Data are made anonymous by A. Keeping the key linking names to responses in a secure location. B. Reporting data in aggregate form in publications resulting from the research. C. Requiring all members of the research team to sign confidentiality agreements. D. Destroying all identifiers connected to the data.

D. Destroying all identifiers connected to the data.

Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects? A. Ensuring that subjects understand that participation is voluntary. B. Ensuring that the selection of subjects is fair. C. Providing detailed information about the study to potential subjects. D. Ensuring that risks are reasonable in relationship to anticipated benefits.

D. Ensuring that risks are reasonable in relationship to anticipated benefits.

IRB continuing review of an approved protocol must: A. Be conducted by a convened IRB. B. Include copies of all signed consent forms. C. Occur only when the level of risk changes. D. Occur at least annually.

D. Occur at least annually.

What is the other name of Kefauver‐Harris Amendment (1962)?

Drug Efficiency Amendment

Where are intermediate appellate courts found?

In higher populated areas

Whose name is present first in the title of the case?

Plaintiff's name

What is Durham‐Humphrey Amendment 1951 also known by?

Prescription Drug Amendments

What is a monopoly and what is an example?

When the fixed costs of providing a good are high relative to the variable costs of producing the good. Ex: Drugs still within their patent time

What is an externality and what is an example?

When the production or consumption of a good affects someone who does not fully consent to the effect and when the costs of the good are not fully incorporated in the price of the good Ex: overuse of antibiotics

What is Stare decisis?

the legal principle of determining points in litigation according to precedent.

T or F: statutes of limitations vary by lawsuit?

true

When do common and statutory law merge?

when courts are required to interpret the meaning of statutes.

When are expert witnesses called?

when the factual subject matter is beyond the scope of jurors

What courts have very limited jurisdiction?

- traffic - small claims

What is the role of the president?

- veto bill - sign bill

What was the catalyst for the FDCA?

- question of equality over penicillin sulfonamide mix

What are some other names for trial courts? What is their jurisdiction?

- superior court - county court - district court - They have nearly unlimited jurisdiction

What must the plaintiff prove?

- that the challenged conduct has caused the plaintiff injury and that there is a legally protectable interest

What happened in the United States v Sullivan, 332 U.S. 689 case?

- the defendant claimed federal law didn't apply to interstate transactions

Why were administrative agencies created?

- to delegate enforcement

What is a Motion for directed verdict?

- After the introduction of evidence, the parties allege that the other lacks sufficient evidence.

What state agencies deal with pharmacy?

- Board of Pharmacy - Dept of Health - Medicaid - Dept of Labor and Training

What is a Judicial opinion?

- Decisions of the court - Enforceable as law Binding on lower courts in the same jurisdiction

What federal agencies deal with pharmacy?

- FDA - CMS - DEA - OSHA - EPA - Dept of Justice

Where do you find federal regulations?

- Federal Register - Code of Federal Regulations (CFR)

What is the "nucleus of today's law"?

- Food and Drug Cosmetic Act (FDCA)

What is the legislative function of administrative agency law?

- Promulgate Regulations -

What is a law?

- Requirements for human conduct applying to all persons within their jurisdiction - Not black and white (flexible)

What label changes were made from Durham‐Humphrey Amendment?

- Rx labels must contain adequate directions for use - OTC labels must contain adequate information for use

What are the three courts in the state court system?

- Supreme - Intermediate appellate court - Trial court

What drug was the catalyst for the Kefauver‐Harris Amendment (1962)?

- Thalidomide

When in a conflict who wins? State or Federal?

- The more restrictive law - Federal wins unless State is more strict

Who makes statutory laws?

- U.S Congress (federal laws) - State Constitutions (state amendments) - Political Subdivisions (ordinances)

What legend changes were made from Durham‐Humphrey Amendment?

- addition of "Caution, federal law prohibits dispensing without Rx" to prescription drug legends

What does the Color Additive Amendments (1960) apply to?

- additives in food/drug/cosmetic

What did United States v Johnson, U.S. 488 bring about?

- amendment in 1912 on prohibition of false efficacy claims

What is a subpoena?? What happens if you ignore it?

- an order to appear in court - ignoring it could cause you to be held in contempt of court

What are limits of the law?

- certain human relationships - De Minimin - punishment must fit crime - protecting individual freedoms while preventing harm to others - society shapes law

What did the Medical Device Amendment (1976) do?

- classified devices as drugs to protect public - establish performance standard, GMP, Premarket approval of devices

What is Common Law?

- common and statutory law made when courts are required to interpret meaning of statutes

What did Food Additives Amendment (1958) say?

- components added to food must receive pre-market approval

Before the Pure Food & Drug Act of 1906 why were people dying?

- contaminated meats

What did Durham‐Humphrey Amendment create?

- created classes of Rx and OTC - ability for oral Rx and refills

What did the orphan drug act (1983) do?

- created tax incentives for companies to create orphan drugs - orphan drugs are needed by few people with rare diseases -

What do regulations do?

- interpret, define and add detail to statutes

Who creates administrative agencies?

- legislature

What changes were made as a result of the Kefauver‐Harris Amendment (1962)?

- making sure drugs are safe and effective (not retroactive to drugs from 1938-1962) - transfer drug advertising oversight to FDA - Establish GMP - required consent of clinical trial particpants - report ADR

What was the case United States v Johnson, U.S. 488 about?

- manufacturer claimed the drug treated cancer when it didn't - court ruled that misbranding only applies to drug identity...not fake or misleading claims

What does the 10th amendment do?

- power to state of people

What does it mean to have a tripartite system, who has authority to write laws?

-Three branches of government ( Judicial, Legislative, Executive) - All three can write laws

What are the 3 Principles of interpretation of statutes?

1. Determining legislative intent if possible. 2. Ordinary meaning of words 3. Due process rights of the individual

What is the process that agencies undergo in the writing of a regulation?

1. Generate regulation 2. Post in Federal Register 3. Comment period 4. Modification/Approval 5. Post in CFR

A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent: A. A study in which subjects were told that they performed in the third quartile on an anagram task when in reality students were randomly assigned scores that were not related to their actual performance. B. A study in which researchers told students that they would be given a quiz after reading some study materials when the researchers did not intend to use a quiz, but were attempting to focus subjects' attention on the material. C. A study involving decision-making games in which subjects were led to believe that they were interacting with another student in another room, but were actually interacting with a computer programmed to provide consistent responses to all subjects. D. A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.

A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.

Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)? A). A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified. B). A researcher asks cocaine users to provide names and contact information of other cocaine users who might qualify for a study. C).In order to eliminate the effect of observation on behavior, a researcher attends a support group and records interactions without informing the attendees. D). A researcher, who is a guest, audio-records conversations at a series of private dinner parties to assess gender roles, without informing participants.

A). A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.

A subject participates in a drug study because treatment is available at no or reduced cost, and he could not otherwise afford it. This is an example of A).Economic vulnerability B).Social vulnerability C).Institutional vulnerability D). Communicative vulnerability

A). Economic vulnerability

How many supreme courts are in a state?

At least one

NBAC proposed a concept of vulnerability in research based on features of potential subjects or of their situation. Which of the following was NOT included as possibly leading to vulnerability? A).Difficulty providing voluntary, informed consent arising from or situational circumstances B).High potential for individual benefit from participating in research C). Difficulty providing voluntary, informed consent arising from limitations in decision-making capacity D). High risk for exploitation

B). High potential for individual benefit from participating in research

A waiver of the requirement for documentation of informed consent may be granted when: A. The subjects are literate in their own language; however, they do not read, write, or speak English B. The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. C. Potential subjects might find some of the research questions embarrassing, personal, or intrusive D. The investigator has no convenient place to store signed consent forms separate from the research data

B). The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.

A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct? A. The superintendent of the school system can give permission for children to be in the study; therefore, the therapist doesn't have to ask the parents for permission. B. The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children. C. If it is the best interests of the community that the children participate in the study, parental permission is optional. D. The therapist creates her clients' records; therefore, she does not need parents' permission to use the information for research purposes.

B. The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children.

A subject participates in a drug study because treatment is available at no or reduced cost and he could not otherwise not afford it. This is an example of: A).Social Vulnerability B). Communicative vulnerability C). Institutional vulnerability D). Economic vulnerability

D). Economic vulnerability

According to the authors, there are four common abuses that historically are described as giving rise to vulnerability . Which response below contains the correct four? A).Prejudice, physical control, manipulation and coercion B). Coercion, undue influence, neglect and disrespect C). Physical control, coercion, undue influence and neglect D).Physical control, coercion, undue influence, and manipulation

D). Physical control, coercion, undue influence, and manipulation

A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence? A. Do not report the adverse drug experience to the IRB since it is a common adverse experience. B. Report the adverse drug experience to the IRB only if there are several other occurrences. C. Report the adverse drug experience as part of the continuing review report. D. Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB.

D. Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB.

In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information? A. Waiving documentation of consent. B. Using pseudonyms in research reports. C. Using data encryption for stored files. D. Securing a Certificate of Confidentiality.

D. Securing a Certificate of Confidentiality.

A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language? A. In the event of any distress you may have related to this research, you will be given access to appropriate resources. B. The researcher may stop you from taking part in this research without your consent if you experience side effects that make your emotional condition worse. If you become too emotionally distressed during the research, you may have to drop out. C. Your participation in this research is voluntary. If you choose not to participate, or change your mind later, your decision will not affect your relationship with the researcher or your right to other services that you may be eligible for. D. Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.

D. Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.

Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if: A. The investigator keeps careful records of all changes and includes them in the final report. B. They only involve changes to the consent form. C. They are eligible for review using expedited procedures. D. The changes must be immediately implemented for the health and well being of the subject.

D. The changes must be immediately implemented for the health and well being of the subject.

When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct? A. Using pseudonyms in reports removes the concern about any confidences shared in the group. B. If group participants sign confidentiality agreements, the researcher can guarantee confidentiality. C. If group members know each other confidentiality is not an issue. D. The researcher cannot control what participants repeat about others outside the group.

D. The researcher cannot control what participants repeat about others outside the group.

A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred? A. Confidentiality of the data has been breached B. There was both a violation of privacy and a breach of confidentiality. C. The subjects' privacy has been violated. D. There was neither a violation of privacy nor a breach of confidentiality

D. There was neither a violation of privacy nor a breach of confidentiality

What courts have limited jurisdiction?

Family Probate Juvenile

Federal authority to regulate drugs general arises from ...?

Interstate Commerce Clause of the U.S. Constitution

Before the Medical Device Amendment (1976) could the FDA regulate devices?

NO

What are public goods and what are some examples?

Necessary and beneficial commodities that private entities will not supply because there is no incentive. Ex: vaccines, orphan drugs

Is legislative history easy to find at the state level?

No, fewer written records of committee hearings and reports

What is a Motion for summary judgment?

One party attempts to convince the judge that the other sides claims have no merit even if correct

What is the legislative function of judicial agency law?

Render decisions pursuant to "hearings" resembling court proceedings

Who oversees Rx and OTC drug advertisement?

Rx - FDA oversees it OTC - FTC

When federal and state law conflict, federal law will preempt state law under what clause?

Supremacy Clause of constitution

What does it mean by Judgment notwithstanding the verdict (NOV)?

The judge may rule contrary to the jury if the jury clearly reached the wrong verdict

How are regulations enacted?

Via Notice and Comment - a notice is given about a regulation is given - the public can comment on the proposed regulation - modifications are made and the regulation is published and enacted

What is Information Asymmetry? What is an example?

When the consumer is uninformed about the true value of a good Ex: Purchasing a car or meal. You can only evaluate the good after buying

Can congress override veto?

Yes with 2/3 vote

Can a party appeal a judgement from a jury?

Yes you can go higher and higher

Who is a plaintiff?

a person who brings a case against another in a court of law.

The Delaney clause prevents what?

adding anything to food that can cause cancer

When are decisions subject to judicial review?

after exhausting all legal remedies at the administrative level

What does it mean by "conference committee must rectify differences"?

an identical bill must be signed by both sides

Who is a defendant?

an individual, company, or institution sued or accused in a court of law.

How is state legislature modeled?

generally modeled after congress

When is a mistrial granted?

if a major error or violation of law or procedure occurred during the trial.