The Responsible Conduct of Research

Question 1

describe the goal of research vs the goal of clinical practice

Answer 1

• goal of research
  
  • truth
  • understand disease (mechanisms, treatments, prevention)
  • help populations and future patients
• goal of clinical practice
  
  • application of truth to patient care
    
    • improve patient care and outcomes

Question 2

how do conflict of interests challenge responsible conduct of research?

Answer 2

• disrupt objectivity
  
  • academic and business values may clash
  • unreliable results threaten ability to earn and keep public support

Question 3

list 3 problems with animal models

Answer 3

1. human exposure typically low concentration but animal models use large concentration
2. use inbred animals but humans are heterogeneous
3. rely on rats/mice but their toxicity predicts human toxicity only 43%
   
   • rat toxicity predicts mouse only 57%

Question 4

describe the 3 R’s with animal models

Answer 4

• replace
  
  • alternative include inanimate systems
• reduce
  
  • maximize info per animal to reduce #s
• refine
  
  • modifiy husbandry, study design, procedures to minimize pain and distress; and enhance animal welfare from birth until death

Question 5

describe publication ethics

Answer 5

• aim to review best practice and ethical standards in the conduct and reporting of research
  
  • help authors, editors, others create accurate, clear, reproducible, unbiased articles

Question 6

describe authorship

Answer 6

• all designated as authors should meet all 4 criteria, and all who meet the 4 criteria should be authors
  
  • those who do not meet all 4 criteria should be acknowledged

1. substantial contributions to the conception or design of the work
2. drafting the work or revising it critically for important intellectual content
3. final approval of the version to be published
4. agreement to be accountable for all aspects of the work in ensuring that questions related to the accuract or integrity of any part of the work are appropriately investigated and resolved

Question 7

describe the significance of peer review

Answer 7

• helps distinguish whether new knowledge has been produced, has value to society
• confirms reliability
  
  • data obtained is acceptable evidence
• adds authority to literature
  
  • research outcomes are iterative
  • evaluated over time through the collective wisdom of many experts
• grounds publications, grants, policies

Question 8

evidence comes from ____ from many sources

Answer 8

evidence comes from incremental contributions from many sources