Exam 3 Flashcards
1) What are the two recognized scientific methods?
a) Induction and empiricism-scientists record specific observations about everything they encounter and research a general conclusion without preconceptions
b) Hypothetico-Deductive method-the standard scientific method where observations lead to a hypothesis that is thoroughly tested to see if results support your initial general thought. From general to specific.
2) What are the major steps of the hypothetico- deductive method?
a) Observations
b) Asking a question that turns into a hypothesis
c) Testing predictions through experiments and collecting facts/data
d) Formulating specific conclusions based on the results of the experiments
3) Remember these points that scientists should apply when do research
- Scientists should not favor one outcome or another of an experiment
- Avoid bias interpretation of the results.
- Scientist shouldn’t ignore any data that do not support the hypothesis.
4) What is the definition of the scientific hypothesis?
a) An imaginative explanation to a scientific question that can be tested and possibly falsified
5) What are the 4 different activities when testing hypotheses?
a) The hypothesis should be internally consistent
b) Hypotheses should be tested for explanatory value not simply asking a question but providing a reason why something occurs.
c) Hypotheses should be consistent with theories commonly held in that field of science but there are certain exceptions.
d) Hypotheses should be put on trial/examined closely through experiments
6) What are the critical points in designing an experiment, collecting data and making conclusions?
a) One must design experiments such that the results with either support or disprove the hypothesis while avoiding personal bias.
i) Must have controls, a valid technique that has been proven to work, and a valid technique to quantify/collect data
b) Utilize a valid method of data analysis while maintaining objectivity
c) Arrive at conclusions based off of the results and if the results are supportive they should be reproducible.
What is an interventional study (clinical trial)?
An interventional study, or clinical trial, is meant to add medical knowledge through research. Participants receive specific interventions according to a research protocol created by the investigators. These interventions can be medical products (drugs or devices), procedures, or a change in behavior (such as diet). Specific outcomes are measured to evaluate safety and efficacy and these trials used in drug development are described by phases defined by the FDA.
(Versus an observational study where no interventions are given)
Who Conducts Clinical Studies?
A Principle Investigator (PI, often a medical doc) leads the study and works with a research team (Docs,RNs, social workers, etc).
Pharmaceutical companies, academic medical centers, private organizations, or federal agencies may conduct and fund the studies.
What are the seven Requirements for determining whether a research trial is Ethical?
1- Social/ Scientific value (outcome will improve health and well being or increase knowledge)
2- Scientific validity (clear objective using scientific principles to produce reliable and valid data, null hypothesis when comparing therapies)
3- Fair subject selection (based on minimizing risks and enhancing benefits to subjects and science)
4- Risk/benefit ratio (risks to subject are proportional to benefits to subject and society)
5- Independent review (unaffiliated with the research, minimize conflict of interest and protect the public)
6- Informed consent (subject autonomy respected, subjects can make voluntary decision)
7- Respect subjects (privacy, ability to withdraw freely, welfare carefully monitored, informed of new insight gained during trial)
What is a conflict of interest?
COI is when a person in a position of trust has competing private and professional interests that make it more difficult to fulfill professional duties without bias. (COI exists even if no improper acts occur).
In biomedical research, COI can endanger judgment, cause harm, undermine credibility, and even cause studies to be designed to be biased.
What were the suggestions to mitigate the conflict of interest?
- Develop clinical practice guidelines
- Increase awareness
- More robust disclosure
- Regulatory reform initiatives (such as when the Institute of Medicine issues recommendations to reform the FDA)
Who is an author?
- Authorship credit should be based only on:
o Substantial contributions of conception and design or acquisition of data or analysis and interpretation of data
o Drafting the articlce or revising it critically for important intellectual content
o Final approval of the version to be published
• Conditions 1,2,3 must all be met. Acquisition of funding, the collection of data, or general supervision of the research group, by themselves, do not justify authorship
What is Research misconduct?
- Misconduct
o Fabrication: making up data or results and recording or reporting them
o Falsification: manipulating research materials, equipment, or processes
• Changing or omitting data or results
o Plagiarism: appropriating another person’s ideas, processes, results or words without giving appropriate credit
• Plagiarism in proposing or reviewing research or in preparing or reporting research results
o Research misconduct does not include honest errors or differences of opinion
• An act of misconduct must be committed intentionally or knowingly
Why Does Research misconduct happen?
- Pressure
- Prestige/fame
- Lenient implementation of weak ethical policy
What is off-label use and should the FDA have the power to regulate such practices?
Off-label use is the use of drugs for a purpose that the drug was not originally approved for.
