Exam 1 - Research and Ethics Flashcards
Basic research
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)
Biomedical research
Research in biological and medical sciences to understand and improve the health of patients
Applied research
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)
Clinical research
Involves humans as study subjects; useful for understanding products for prevention, diagnosis, treatment, and cure of diseases in humans
Pharmaceutical practice and policy research (clinical research)
Deals with issues related to:
- pharmaceuticals
- pharmacist services
- pharmacy systems
Translational research
Transferring knowledge across the research and practice continuum
3 ways translational research is accomplished
- applying discoveries to clinical research
- adoption of best practices
- adopt evidence-based patient care practices
What diseases is translational research most essential for
Cancer
AIDS
Empiricism
Collection of info based on human experience
All aspects of science should be observed and measured to be considered scientific evidence
Objectivity
There is no subjectivity or bias in any aspect of research including:
- definition
- measurement
- design
- analysis
Theory
Provides an understanding or explanation of a natural phenomenon
Provides the rationale and logic for research questions and hypotheses
Ethics
Provides the moral societal standards for responsible research conduct, being:
- respect
- fairness
- wellbeing of research participants
Who governs ethics of research conduct
Institutional Review Board (IRB)
Steps in research/scientific inquiry
Research question & hypothesis
Research plan
Data collection & analysis
Research report
Evidence based medicine
Integration of best research evidence w/ clinical expertise & patient values (translate scientific evidence to pt care)
2 types of research plans
Experimental: RCTs
Observational: cohort or cross-sectional studies (weaker due to bias)
Phase I clinical trials
Testing drug in a small group of humans w/ intent of establishing the initial toxicity profile of the substance
Pre-clinical studies (drug development)
Drug candidates are tested in animal models of the disease for pharmacologic effects and toxicity
Promising candidates are selected for clinical testing in humans
Phase II clinical trials
Randomized trials involving ~100 participants & short term studies (<1 yr) are designed to provide the preliminary safety and efficacy
Phase IV clinical trials
AKA post-marketing studies
Used to generate longer-term safety/toxicity data
Phase III clinical trials
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
What is the gold standard for conducting clinical research
Randomized controlled trials
_____ oversees development of new drugs, governed by _____ regulations
FDA
IND
When a sponsor believes drug development data will sponsor drug approval, it is submitted as a ____ for FDA approval
NDA
Right to try act
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
Institutional review board (IRB)
Protects rights & welfare of human subjects of research and ensured everything is ethical
Numberg code
Participation in clinical research must be voluntary and should never cause deliberate harm
Belmont report
States that research w/ human subjects must follow the fundamental ethical principles:
- respect for persons
- beneficence
- justice
What are the fundamental ethical principles
Respect for persons
Beneficence
Justice
Respect for persons
Individuals must be treated as autonomous agents
informed consent
Beneficence
Secures the wellbeing of human subjects by maximizing possible benefits & minimizing possible harms
Components of a research report (IMRaD)
Introduction
Methods
Results
Discussion
Justice
Sense of fairness in distributing the burdens & benefits of research
Necessary factors for an IRB to approve a protocol
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
Case control
Compare people w/ and without disease to find common exposures
Cohort
A population group unified by a specific common characteristic
PICO
Framework to develop a good clinical research question
What does PICO stand for
Population
Intervention
Comparator
Outcome
EBM components
Asking appropriate/answerable question
Finding evidence
Appraising evidence (validity & applicability)
Applying evidence to practice
(Ask, find, appraise, apply)
Membership of IRBs
- 5 members
- at least 1 scientist & 1 non-scientist
- 1 member who is NOT affiliated w/ institution
- must be diverse
- pharmacist for biomedical research
Internal validity
Findings are correct
Eternal validity
Findings are applicable/generalizable to population
3 types of IRB review
Full review
Exemption
Expedited
Expedited review by chair or designee
Minimal risk protocols that do not meet one of the exemptions
Exemption
Surveys/interviews
Use of existing data
Specimens without identifier
Full review by whole board
All protocols involving greater than minimal risk
