BMS 301 Final Exam

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  1. Research Definition
    process of systematically investigating a particular topic in order to learn more about that topic
  2. Ways of acquiring knowledge
    • RAISE
    • rationalism
    • authority
    • intuition
    • science
    • empiricism
  3. Rationalism
    • Reasoning - 'if, then'
    • Problem: people reach diff conclusions from same set of facts; how do you know which is right?
  4. Authority
    Problem: unquestioned
  5. Intuition
    • I believe/feel...
    • Problem: No mechanism to separate accurate/inaccurate; not necessarily fact
  6. Science
    uses a process to find what is true
  7. Empiricism
    • Experiential
    • Problem: can only understand if experienced it
  8. Scientific Methods
    formulation and testing of hypotheses through systematic observation, measurement and experimentation
  9. Reasoning
    • to develop hypotheses
    • inductive or deductive
  10. Inductive Reasoning
    specific to general - observe something, must  happen everywhere
  11. Deductive Reasoning
    general to specific - usually happens so must happen to them
  12. Process of scientific method
    • 1. formulate question (literature)
    • 2. hypothesis to address question - null/alternative
    • 3. predict outcome (based on literature)
    • 4. test hypothesis (supported or not? use controls!)
    • 5. analyze results (stats)
  13. Null hypothesis
    • NEVER proven, but FALSIFIABLE
    • directionality (1,2 tail test)
    • typically something doesn't change
  14. Alternative hypothesis
    • typically something does change
    • probability, types of error
  15. Type I Error
    • Null hypothesis was true but rejected it
    • alpha
  16. Type II Error
    • Null hypothesis is false but failed to reject
    • beta (power: 1-beta)
  17. Basic Assumptions of scientific method
    • uniformity
    • reality
    • discoverable
    • objective and unbiased
  18. Uniformity (in nature)
    determinism (causality - something leads to something else)
  19. Characteristics of scientific method
    • replicates
    • controls
  20. Replicates
    one study doesn't make a theory and results must be replicable
  21. Controls
    • minimize impact of confounding variables; placebo effect; blinding
    • this is where most people go wrong
  22. Research Objectives
    • DEEE
    • Descriptive - describe a phenomenon
    • Exploratory - pilot
    • Explanatory - explain why it occurs
    • Evaluation - to predict
  23. Ex of target, source, sample, study populations
    • Target: blood pressure of everyone in US
    • Source: MI residents
    • Sample: people in West MI
    • Study: people who go into Dr. ofc in W MI
  24. Census
    measure of entire population; not cost effective
  25. Random selection
    • everyone has = probablitiy to be selected
    • simple, stratified, cluster, systematic
  26. Simple sampling
    with or w/o replacement
  27. Stratified sampling
    divide into groups; proportional/disproportional
  28. Cluster sampling
    • select groups randomly, not individuals
    • one stage: select groups and what's in it
    • two stage: randomly select group and randomly select indi's
  29. Systematic sampling
    • use intervals; population/sample size
    • ex: 150/25 = 6 so you do every 6 people
  30. Non Random Selection
    • Convenience - most available, ex: mall
    • Quota - key is # people in group
    • Purposive - characteristic to choose indi's (ex: females)
    • Snowball - each person is asked to ID new subject. Ex: do you have a friend here?
  31. Replicates
    • Inter-individual variability - between groups
    • How much is enough?
    • Pseudoreplicates
  32. Replicates: How much is enough?
    • must sample enough replicates
    • Diff between experimental groups due to what was ascribed
    • Replicates should be INDEPENDENT of one another!
  33. Pseudoreplicates
    • NO indepenence
    • ex: vessel cut in half
  34. Selection criteria
    • whom to include/exclude: has impact on conclusion
    • types of data
  35. Types of data
    • Categorical (dichotomous, nominal, ordinal)
    • Continuous/ordered discrete variables
  36. Categorical
    • uses non-parametric stats
    • dichotomous
    • nominal
    • ordinal
  37. Dichotomous data
    • one or the other
    • ex: male or female
  38. Nominal data
    • more than 2
    • ex: blood type
  39. Ordinal data
    • scale
    • ex: degree of pain 1-10
  40. Continuous/ordered discrete
    • uses parametric stats
    • ex: height across broad range
  41. Confidence interval
    estimation of how close to population the sample is
  42. Power
    1-beta; to maximize sample
  43. Impact on power
    • effect size (how diff are they?)
    • amount of variability
    • number of replicates
  44. if power not known:
    pilot - determines variability if power is not known
  45. Smaller sample size if:
    • continuous
    • paired (within subject) - where subject acts as own control
    • reduced variability - refine measure
  46. Hypothesis
    • version of research question summarizing main elements of study
    • sample, predictor variable, outcome variable
  47. Primary study design
    • Observational: Case, Cross sectional, Cohort, Qualitative
    • Experimental
  48. Case study
    • describes subjects with disease/procedure
    • Report (1)
    • Series (>1)
    • Control - compare to healthy population
  49. Case study: report/series strengths and weaknesses
    • no control available, descriptive stats included
    • Strengths: works for rare diseases
    • Weakness: poorly generalized/weak design (no control)
  50. Case Study control strength and weakness
    • Strength: Few subjects, better for rare diseases
    • Weakness: risk of bias because size and selection (misclassification and recollection)
  51. Cross Sectional study strengths and weaknesses
    • collect data at ONE PT in time, hope to establish causality
    • Strength: inexpensive, starting point
    • Weakness: No causality, impractical for rare disease
  52. Cohort study
    • Longitudinal = strongest design
    • Prospective or Retrospective
  53. Prospective Cohort study strengths and weaknesses
    • ID people in advance and follow.
    • Strength: internal control, can determine incidence, causal factors, can measure all variables
    • Weakness: still confounding variables, expensive
  54. Retrospective cohort study strengths and weaknesses
    • use data already collected
    • Strengths: same as prospective but cheaper
    • Weakness: limited control over data = incomplete, inaccurate
  55. Qualitative Study
    • vased on experience. Researcher becomes observer
    • Phenomenological, grounded theory, ethnography
  56. Phenomenological qualitative study
    how people understand, interpret, and find meaning in unique life experiences
  57. Grounded theory qualitative study
    inductive reasoning that uses observation to explain human behav
  58. Ethnography qualitative study
    develop insider view of how a particular culture views their world
  59. Experimental Primary Design
    • use to determine causality
    • controls
    • blinding (single and double)
    • efficacy
  60. Efficacy
    those in control who had unfavorable outcome that would have been expected to be favorable if treated
  61. Secondary study design
    includes ecological: looking for who's exposed and what their risk is
  62. Tertiary study design
    includes meta analysis
  63. 3 Guiding principles of ethical research
    • beneficence
    • autonomy
    • justice
  64. Beneficence
    "do good." scientifically sound; risk acceptable relative to benefits - balance between physical and psychosocial
  65. Autonomy
    • right of person
    • rights adn welfare of indi must be respected
    • informed consent - voluntary
    • protect those who may be impaired (must be competent to consent; parent/caregiver
  66. Justice
    benefits/burden be fairly distributed
  67. Central considerations for ensuring the 3 guiding principles
    • compensation
    • contribution
    • confidentiality
    • consent
    • collaboration
    • conflict
    • committee
    • community
  68. Broader ethical issues
    • SCARR
    • scientific misconduct
    • conflict of interest
    • authorship
    • randomized trials
    • research on previously collected data
  69. Scientific misconduct
    • fabrication
    • falsification
    • plagiarism
  70. Fabrication
    making up results and recording or reporting them
  71. Falsification
    • manipulating research material, equip, or procedures
    • changing or omitting data to misrepresent findings
  72. Plagiarism
    appropriating another's idea, results, words without giving credit
  73. Authorship (requirements)
    • conception/design or data interpretation
    • Drafting or revising the manuscript
    • Final approval (all authors must give approval)
  74. Conflict of Interest
    • Goal to minimize impaired objective of researcher
    • Dual role - clinician/investigator
    • Financial conflict (ex: hold stock and do research for same co.)
    • Minimize conflicts by blinding investigator (or double blinding)
  75. Randomized trials
    (remember: RANDOM DANCING fingers)
    • likelihood of outcomes (placebo)
    • indi's/physician may not agree - not be involved
    • Unethical to continue once know not correct - or not answer
    • Control group (give standard rather than withhold - do no harm; placebo for more short term studies - reduce risk)
  76. Research on previously collected data
    • consent for future research is problematic
    • Large blood bank, tissue sample banks
    • No one can anticipate nature of the research
  77. Nuremberg Code - April 1947
    • voluntary consent
    • anticipate scientific benefits
    • benefits must outweigh risks
    • animal experiments first
    • avoid suffering
    • no intentional death or disability
    • do no harm
    • subject may withdraw at any time
    • investigators must be qualified
    • investigation will stop if harm occurs
  78. Belmont commission
    • directed to consider:
    • boundaries of research
    • assessment of risk-benefit criteria
    • appropriate guidelines for selection of humans
    • nature and definition of informed consent
  79. Institutional Review Board Roles
    • Minimize risks to participants
    • Risks relative to benefits
    • Selection of subjects is equal
    • Consent obtained
    • Confidentiality maintained
  80. Criticisms of IRBs
    • Too much emphasis on consent form
    • Not adequately inspecting research design
    • No police protocol (don't check up)
  81. Composition of IRB
    • 5 members:
    • 1 science member
    • 1 non-science member
    • 1 not otherwise affiliated with institution and not part of immediate family of person affiliated
    • Not on committee: members with conflicting interest!
  82. Outcomes for research proposals (3 options)
    • Approve
    • Require modifications
    • Disapprove
  83. Exemptions from review
    • Normal educational practices
    • Educational test, surveys, interviews, observations (non-exempt if appointed or elected public officials)
    • Existing data/specimens if non-senstivie, de-identified or publicly available
    • Study of federal agency programs
    • Food taste and quality evaluation
  84. Expedited review
    • minimal risk studies
    • blood samples (if healthy, >110 lbs)
    • non-invasive biodata collection (like MRI, excludes xrays)
    • Audio/vid recordings of sensitive info
    • Continuing review of Full Board protocols if closed, no accrual, or data analysis only
    • Studies where IND/IDE application not required
    • non-invasive biological specimen collection
    • data previously collected for non-research purposes
    • non-exempt surveys, interviews
    • contin review of min risk full board study where above do no apply & no add'l risks identified
  85. Consent form compensation
    • nature (research, purpose, how recruited)
    • procedures
    • risks and potentials benefits of study
    • all research involving humans must be reviewed by HRRC prior to start
    • 15 members
    • GVSU Research Integrity Office (Jon Jellema)
  87. Animal Welfare Act 1966
    USDA 1st to implement and enforce law; started with housing an licensing dealers and facilities
  88. Public Health Services (PHS)
    • 1971 - became involved due to NIH policy on care/tx of lab animals
    • Introduced idea of local committee to assess housing conditions
  89. Enforcement
    • AWA enforced by USDA (branch: Animal/Plant Health Inspection Service)
    • Regulates institutions doing research on vertebrates except mice, rats, farm animals, and birds bred for research
  90. Guide for care and use of lab animals
    • has become standard of care
    • 1st published 1963
    • includes: housing, transportation, vet. care
  91. Instit Animal Care and Use Committee (IACUC) Composition
    • 5 members:
    • vet
    • non-affiliated
    • practicing scientist
    • non-scientist
  92. IACUC involved with:
    • Properly constituted committee - appt duration
    • Adeq vet care
    • Occupational health safety program
    • Personnel training
    • Facilities management
  93. IACUC Functions
    • generate assurance letter (2x/yr)
    • ongoing assessment of animal care and use
    • establish mech's for receipt and review of concerns regarding care/use
    • review all proposed animal research
    • review all signific changes to protocols
    • regular inspection of facilities and animal use areas
    • regular review of program
    • suspend any animal activity due to non-compliance
  94. Key Principles of Russell and Burch 1959 (3 R's)
    • Replacement
    • Refinement
    • Reduction
  95. Replacement
    use methods that do not require animals
  96. Refinement
    Modification of husbandry and protocol to enhance well being (less stress) or minimize pain and distress (sedation)
  97. Reduction
    use min # of animals required; max info obtained from each animal (can't reuse)
  98. Designated Member Review (DMR)
    • Protocol goes to committee (some, full committee)
    • DMR if not required by full committee (1 member)
    • DMR can only approve or require modific's - cannot disapprove - would have to go to full committee
  99. Continuing review
    3 years (1 year if USDA animal)
  100. Research requires money for
    • Direct costs (equip, supplies, incentives, travel, animals, publication)
    • Indirect costs (water, electric)
  101. Sources of grant $
    Agencies (Fed, State, Private)
  102. NIH grant types
    • RO1 - most common; 500k/yr; 3-5 yrs
    • RO3 - 150k/yr; 2 yrs
    • R13 - conference
    • R15 - schools; 800k/yr; 3 yrs; career development and program grants
  103. What is in a grant proposal?
    • specific aims
    • long term goals
    • background
    • methods/procedures
    • results
    • preliminary data
    • budget
    • dissemination plan (how to publish)
    • timeline
  104. Submit/review - score reflects..
    • 1st review: goes to scientific review officer make sure at right place and assigned to right grant
    • 2nd review: review group meets between jun and jul to score the grant.
    • Score reflects: overall impact of grant
    • 3rd: goes to advisory council to determine funding (aug.)
    • Decision: release funds in Sep
  105. Principle Investigator
    can be >1
  106. Indirect $
    • goes to institutions, janitorial staff, electric, agreement
    • At GVSU: 40.5% indirect rates
  107. Not allowable expenses
    • entertainment
    • fines/penalties
    • lobbying
    • proposal costs
    • student activity costs
    • meeting/conferences
  108. GVSU Office of sponsored programs
    • facilitate grant submissions
    • administrators sign off on grants
    • budget correct
    • makes sure space/resources available
    • matching funds
    • award management
    • inform local regulatory bodies of grants
  109. Internal grants
    • smaller
    • center for scholarly and creative excellence
    • involves less writing, small amount of $ involved
  110. NIH grants in MI
    1583 total in MI
  111. NIH grants at GVSU
  112. Clinical trials - Human trials through FDA
    • drug developed
    • animal testing
    • investigational new drug application
    • phases
  113. drug developed
    synthesized chemical molecule (what does it do?)
  114. animal testing
    must follow good review practices; does drug work?
  115. Investigational new drug application
    how does this benefit human health?
  116. Phases 1st 3: determine side effects
    • SECA
    • 1. Safety - make sure drug is safe for HEALTHY people; how drug is metabolized and excreted
    • 2. Effectiveness - does drug work with people WITH DISEASE/COND.? Usually compared to placebo; short term, with about 100 people
    • 3. Combined - work out details: figure out dosing, drug combinations, differential study populations (study idff pops that it works best in), typically involves 1000s of people, longer
    • 4. on-going assessment - can re-submit if denied, rely on doctors to report negative impact, if have this (-) impact goes to DRUG SAFETY OVERSIGHT BOARD (DSOB)
  117. New drug application
    • review process takes ~60 days
    • have to apply to use drug
    • approval for tx
  118. Abbreviated new drugs
    generics: when patent has run out, must determine bioequivalence of drug (basically same molec makeup and dosing)
  119. Biologicals
    • non-vaccine therapeutic tx's
    • immunotherapies: using antibodies for IN VIVO (body)
  120. Database
    relevant numbers regarding trials
  121. FDA regulates (besides human drugs)
    • Vet drugs - similar to humans but must address residue if human food source
    • Cosmetics - only ensures labels are accurate and it is safe for consume
    • Dietary supplements - don't need approval, but need safe and accurate claims
    • Food - grocery suppliers/restaurants need to ensure that labeling is correct in accordance to whether it's natural diet or organic
    • Medical Devices - pacemakers
    • Tobacco products
    • Vaccines and biologicals
    • Radiation emitting products - x-ray and MRI
  122. Publication - Journals
    • printing run by publisher
    • open access
    • editors are members of sci society
    • quality
    • topic of interest
  123. Article types - new work
    • CRR
    • Communication
    • Research article
    • Review
  124. Communication article
    short, abbreviated, usually 1 piece of evidence, less developed, claim work as own
  125. Research article
    • more general, well-developed, about 4-5 pieces of evidence, tells story of findings, provide evi that supports conclusion
    • INCLUDES LPUs (least publishable units)
  126. Review article
    summary of above on particle topic
  127. Components of article
    • title
    • abstract
    • intro (hypothesis at end)
    • methods
    • results
    • discussion
    • conclusion
    • literature cited
  128. Conferences
    • present preliminary data
    • run by sci societies
    • get feedback
    • do posters and talks
  129. How to choose where to publish
    pick best journal for work: aim, scope, audience, cost, requirements
  130. For peer review
    • key to science
    • need cover letter, usually electronic submission, sign away copyright when do so, must have ALL authors sign, goes to editor, editor assigns to 1 associate editor (about 15 per editor)m reviewers have ~2 wks to evaluate, if split decision it takes longer, evaluate whether it is new or unique
  131. Revising
    they read comments, address concerns, write response, resubmit
  132. Accepted
    • first available electronically (gets DOI - digital object identifier)
    • may take up to 6 mo's to be published in journal
    • used to have to buy copies
Card Set:
BMS 301 Final Exam
2013-04-20 04:26:40
Research final exam

301 Exam Questions and Review Sheets
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