Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Biostats > Exam 1 - Research and Ethics > Flashcards

Exam 1 - Research and Ethics Flashcards

1
Q

Basic research

A

Systematic study that aims to expand knowledge of a subject or phenomenon WITHOUT specific applications in mind (how, what why)

Ex. Biology, physiology, biochemistry, genetics

(Uses the basic topics [because those are classes we already took^^] for research)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
1
Q

Biomedical research

A

Research in biological and medical sciences to understand and improve the health of patients

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Applied research

A

Systematic study to gain knowledge or understanding necessary to determine the means by which a recognized and specific need may be met (find solutions to problems; develop new med)

Ex. Pharmacology, medicinal chemistry

(Applying pharmacology and medicinal chem to find new solutions)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Clinical research

A

Involves humans as study subjects; useful for understanding products for prevention, diagnosis, treatment, and cure of diseases in humans

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Pharmaceutical practice and policy research (clinical research)

A

Deals with issues related to:
- pharmaceuticals
- pharmacist services
- pharmacy systems

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Translational research

A

Transferring knowledge across the research and practice continuum

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

3 ways translational research is accomplished

A
  • applying discoveries to clinical research
  • adoption of best practices
  • adopt evidence-based patient care practices
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

What diseases is translational research most essential for

A

Cancer
AIDS

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Empiricism

A

Collection of info based on human experience

All aspects of science should be observed and measured to be considered scientific evidence

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Objectivity

A

There is no subjectivity or bias in any aspect of research including:
- definition
- measurement
- design
- analysis

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

Theory

A

Provides an understanding or explanation of a natural phenomenon

Provides the rationale and logic for research questions and hypotheses

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Ethics

A

Provides the moral societal standards for responsible research conduct, being:
- respect
- fairness
- wellbeing of research participants

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Who governs ethics of research conduct

A

Institutional Review Board (IRB)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Steps in research/scientific inquiry

A

Research question & hypothesis
Research plan
Data collection & analysis
Research report

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Evidence based medicine

A

Integration of best research evidence w/ clinical expertise & patient values (translate scientific evidence to pt care)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

2 types of research plans

A

Experimental: RCTs

Observational: cohort or cross-sectional studies (weaker due to bias)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Phase I clinical trials

A

Testing drug in a small group of humans w/ intent of establishing the initial toxicity profile of the substance

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Pre-clinical studies (drug development)

A

Drug candidates are tested in animal models of the disease for pharmacologic effects and toxicity

Promising candidates are selected for clinical testing in humans

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Phase II clinical trials

A

Randomized trials involving ~100 participants & short term studies (<1 yr) are designed to provide the preliminary safety and efficacy

15
Q

Phase IV clinical trials

A

AKA post-marketing studies

Used to generate longer-term safety/toxicity data

16
Q

Phase III clinical trials

A

Randomized control trial often involving blinding and placebo

Hundreds of thousands of subjects

Can be long term (over 1 yr)

Safety/efficacy data obtained to see risk/benefit relationship

17
Q

What is the gold standard for conducting clinical research

A

Randomized controlled trials

18
Q

_____ oversees development of new drugs, governed by _____ regulations

A

FDA
IND

19
Q

When a sponsor believes drug development data will sponsor drug approval, it is submitted as a ____ for FDA approval

A

NDA

20
Q

Right to try act

A

Intended to allow patients to obtain investigational medications outside of clinical trials

Makes drugs available to target pt after it has cleared phase I trials

21
Q

Institutional review board (IRB)

A

Protects rights & welfare of human subjects of research and ensured everything is ethical

21
Q

Numberg code

A

Participation in clinical research must be voluntary and should never cause deliberate harm

22
Q

Belmont report

A

States that research w/ human subjects must follow the fundamental ethical principles:
- respect for persons
- beneficence
- justice

22
Q

What are the fundamental ethical principles

A

Respect for persons
Beneficence
Justice

23
Q

Respect for persons

A

Individuals must be treated as autonomous agents

informed consent

23
Q

Beneficence

A

Secures the wellbeing of human subjects by maximizing possible benefits & minimizing possible harms

24
Q

Components of a research report (IMRaD)

A

Introduction
Methods
Results
Discussion

24
Q

Justice

A

Sense of fairness in distributing the burdens & benefits of research

25
Q

Necessary factors for an IRB to approve a protocol

A

Risk to subjects are minimized

Risk to subjects are reasonable in terms of benefit

Selection of subjects is equitable

Informed consent obtained & appropriately documented

Monitoring data collected to ensure safety of subjects

Protect privacy of subjects and confidentiality of data

26
Q

Case control

A

Compare people w/ and without disease to find common exposures

27
Q

Cohort

A

A population group unified by a specific common characteristic

28
Q

PICO

A

Framework to develop a good clinical research question

29
Q

What does PICO stand for

A

Population
Intervention
Comparator
Outcome

30
Q

EBM components

A

Asking appropriate/answerable question

Finding evidence

Appraising evidence (validity & applicability)

Applying evidence to practice

(Ask, find, appraise, apply)

30
Q

Membership of IRBs

A
  • 5 members
  • at least 1 scientist & 1 non-scientist
  • 1 member who is NOT affiliated w/ institution
  • must be diverse
  • pharmacist for biomedical research
31
Q

Internal validity

A

Findings are correct

32
Q

Eternal validity

A

Findings are applicable/generalizable to population

33
Q

3 types of IRB review

A

Full review
Exemption
Expedited

34
Q

Expedited review by chair or designee

A

Minimal risk protocols that do not meet one of the exemptions

35
Q

Exemption

A

Surveys/interviews
Use of existing data
Specimens without identifier

36
Q

Full review by whole board

A

All protocols involving greater than minimal risk

Biostats (17 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions