Ethical issues in Research

Ethical issues in Research

1. Principles

   • humans and animals
     • Respect for humans
       • Autonomy
       • Privacy
         • Protections
           • IRB
           • HIPAA
           • The Belmont Report
           • HHS
           • FDA
           • NIH
       • Informed consent
     • Justice
       • Fairness in selection
     • Beneficence
       • Risk/ Benefit Analysis
       • Minimum harm
   • Public health crisis
     • Urgency
     • TIme constraints
     • Speed while maintaining scientific rigor
     • Collaboration
     • Vulnerabilty

2. Placebo Trials

   • Control group
   • Experimental group

3. Conflicts of interest

   • Types
     • Financial
     • Professional
     • Prejudicial
     • Personal
   • Consequences
     • Impaired judgement
     • Lack of trust
     • Prison
     • Lack of credibility

4. Animals in research

   • Species
     • Major
     • Minor
   • Protection
     • Animal welfare act
     • IACUC
     • USDA
   • Three R's
     • Replacement
     • Reduction
     • Refinement

5. Malfeasance and Misconduct

   • Types
     • Misappropriation of Ideas
     • Plagiarism
       • Self-plagairism
     • Impropriety of Authorship
     • . Failure to Comply with Legislative and Regulatory Requirements
     • Violation of Generally Accepted Research Practices
     • Falsification of Data
     • Failure to Support Validation of Your Research
     • Failure to Respond to Known Cases of Unsuccessful Validation Attempts
     • Inappropriate Behavior

6. Genetics

   • Stem cell Therapy
     • Reprogrammed somatic cells that activates silent genes in the somatic cells
   • Gene therapy
     • Transfer of a new gene with a vector and is delivered directly into a cell
   • Ethical concerns
     • Modifying genetic makeup
     • long term effects are unknown and unpredictable
     • Irreversible

7. Ghost Authorship and DTC (Direct-to-Consumer) Advertising

   • Ghost Authorship
     • contributing substantially to a written work but not being credited as authors
   • Guest Authorship
     • listing someoneas first or co-author, but has done very little toward the work, the research, or the paper
   • Academic detailing
     • Targeted toward healthcare providers
   • DTC
     • Advertising of prescription products to the consumer.

8. Ethics

   • norms for conduct that distinguish between acceptable and unacceptable behavior.
     • Bioethics
       • that studies moral values in the biomedical sciences.”
       • Hippocratic oath
       • Veterinarian's Oath
   • Ethical Research must haves
     • Social Value
     • Scientific Validity
     • Fair subject selection
     • Favorable risk benefit ratio
     • Independent review
     • Informed Consent
     • Respect for enrolled subjects