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Ethics Final
Ethics Final Terms & Concepts
| Term | Definition |
|---|---|
| The 4 A's for Ethical Decision Making | 1. Acquire Facts 2. Alternative Solutions 3. Assessment 4. Action |
| Acquire Facts | Define uncertainties, clarify ambiguities |
| Alternative Solutions | Consider alternative solutions |
| Assessment (What is being assessed) | >Moral Theories of virtue, justice, duty, rights and utilitarianism >Stakeholders : Identify and prioritize |
| Action | Decide on a plan of action, be open to new options |
| Virtue | Defines a good person as someone with courage, wisdom, loyalty, fairness. |
| Justice (for moral theories) | Treat everyone equally without favoritism or bias. |
| Duty | The individual "knows" what is right. |
| Rights | People are essentially good and able to act for the common good. |
| Utilitarianism | Favored the majority versus the few. |
| Principles That Guide Human Experimentation | 1. Autonomy 2. Beneficence 3. Non-Malfeasance 4. Justice |
| Autonomy | Self rule. |
| Benficence | Doing good, no subject of research be exposed to risks disproportional to the potential for benefits to be gained by others. |
| Non-malfeasance | Doing no harm, avoiding injury or unnecessary risk. |
| Justice (for human experimentation principles) | Individuals are selected without bias to a particular class or group. |
| Three Topics Presented in The Belmont Report | Part A: Boundaries Between Practice & Research Part B : Basic Ethical Principles Part C: Applications |
| The Belmont Report, Part A: Boundaries Between Practice & Research | Practice - Research - Experimental - |
| The Belmont Report, Part B: Basic Ethical Principles | 1. Respect for Persons 2. Beneficence 3. Justice |
| The Belmont Report, Part B: Basic Ethical Principles - Respect for Persons | Who do we protect? >Individuals should be treated as autonomous agents > Persons with diminished autonomy are entitled to protection |
| The Belmont Report, Part B: Basic Ethical Principles - Beneficence | > Do not harm > Maximize possible benefits and minimize possible harms |
| The Belmont Report, Part B: Basic Ethical Principles - Justice | Who out to receive the benefits of research and bear its burdens? > To each person an equal share > ___ according to individual need > ___ according to individual effort > ___ according to societal contribution > ___ according to merit |
| The Belmont Report, Part C: Applications | >Informed Consent >Risk Assessment >Selection of Subjects |
| The Belmont Report, Part C: Applications - Informed Consent | What is it? What aspects are considered? |
| The Belmont Report, Part C: Applications - Risk Assessment | Can you give an example? |
| The Belmont Report, Part C: Applications - Selection of Subjects | |
| Guidelines for Ethical Research | >Social & Clinical Value >Scientific Validity >Fair Subject Selection >Favorable Risk/Benefit Ratio >Independent Review >Informed Consent >Respect for Potential & Enrolled Participants For Animals: Replacement, Reduction, Refinement |
| Definition of Scientific Misconduct | >Fabrication >Falsification >Plagiarism |
| Conditions of Scientific Misconduct | >Departure from accepted practices >Intentionally, knowingly or recklessly committed >Must be proven with sufficient evidence |
| Examples of Unethical Conduct | > Cover-up of errors > Misuse funds > Fabrication of data > Deletion of data > Protocol deviations > Data manipulation > Unauthorized experiments > Plagiarism of originality |
| Discovery of Misconduct & Whistleblowing Criteria | Need: Impending harm or danger Proximity: Must have firsthand knowledge Capability: High probability of stopping the activity Last Resort: Anyone else more proximate or capable? Adequate documentation: Reasonableness to determine action taken |
| Goal for the Asilomar Conference | Review progress in recombinant DNA research & discuss how to minimize biohazards of this work |
| Who was at the Asilomar Conference | Scientists from across the country, lawyers, journalists, & government officials |
| What was decided at the Asilomar Conference | > Definitions for Minimal, Low, Moderate, & High Risk Categories of Containment > Different experimental standards for prokaryotes/bacteria, animals viruses, and eukaryotes |
| BMES Code of Ethics - Standards for Research & Technology Development | > Conduct research & development honestly & thoroughly > Commit to authentic stewardship of the scientific record > Due diligence when studying or developing biomedical technology |
| Corporate Responsibilities - Employees | > Fair, ethical, and nondiscriminatory hiring practices > Fair pay & benefits > Safe working environment |
| Corporate Responsibilities - Title VII of the Civil Rights Act of 1964 | > Prohibits discrimination based on race, color, religion, sex, or national origin > Defines types of harassment |
| Corporate Responsibilities | > Employees > Public > Ecosystem |
| 510(k) | A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is as safe and effective as the predicate. |
| A device is substantially equivalent if, in comparison to a predicate device it: | Has same intended use AND technological characteristics OR Has same intended use & different technological characteristics, AND doesn't raise different questions of safety & effectiveness |
Created by:
cpotter.45