Ethics in Research Flashcards
Examples of Unethical Practices in Research
- Nazi experiments during WWII
- Tuskegee Syphilis Study
History of Ethical guidelines
- Nuremberg code (1947)
- Helsinki Declaration (1964)
- Belmont Report (1979)
- Good Clinical practice guidelines
- CIOMS Guidelines
This historical landmark established the importance of voluntary consent in research
Nuremberg code
Statement of ethical principles for medical
research involving human subjects
Helsinki Declaration
Developed by the National Commission for the
Protection of Human Subjects of Biomedical and Behavioral Research
Belmont Report
Developed by the International Council for
Harmonization of Technical Requirements for
Pharmaceuticals for Human Use
Good Clinical Practice Guidelines
International Ethical Guidelines for Health related Research Involving Humans
CIOMS Guidelines
Emphasis of Transitional Epidemiology
Application of population health research
findings to efforts addressing disparities and public health issues
Components of Transitional Epidemiology
○ Developing interventions based on research results
○ Turning data into actionable health information that can be readily used by healthcare providers, legislators, policymakers, and the general public
Basic Ethical Principles in Research
- Respect for Persons
- Beneficence
- Non-maleficence
- Justice
“Protect those with impaired or diminished autonomy from harm” falls under what basic ethical principle?
Respect for persons
A status in which some people may struggle to protect their interests or beat greater risk of being exploited.
Vulnerability
Obligation to secure the well-being of research
participants
Beneficence
The moral duty not to cause harm to others through interventions
Non-maleficence
Related to the concept of equity in health research
Justice
Elements of Research Ethics
- Informed Consent
- Social Value
- Vulnerability of Research Participants
- Benefits, risks, and safety
- Privacy and Confidentiality
- Transparency
- Justice
Refers to the contribution of the study to an existing social or health problems
Social Value
Individuals make an explicit choice to participate (or receive intervention) in a study after having been fully informed about the study and one’s rights (risk, potential benefits, etc.)
Informed Consent
Children are asked for their _____ to participate; parents asked for their ____
Assent
Consent
Inclusion of vulnerable is only justified when:
- It is necessary to promote the welfare of the
population represented - If research cannot be performed on non-vulnerable persons
Probability of physical, psychological, social, or economic harm as a result of participation in a research
Risk
Interim analysis is performed _______ of the study
Before the end
Interim analyses is done to assess _____
Preliminary outcomes
Protecting one’s space, decisions, and personal life from intrusion
Privacy
The obligation of researchers to protect personal information from being disclosed to unauthorized parties
Confidentiality
TRUE OR FALSE: Confidentiality must ALWAYS be observed
False, Where there is likelihood or opportunity for the researcher to observe the occurrence of illegal or harmful behaviors, explicitly indicate limits to confidentiality
Equitable distribution of both benefits and burdens of research participation
Justice
Data Privacy Act of _____
2012
Elements of Informed Consent
- Information to be provided to potential participant
- Documentation of Consent
- Waiver of informed consent
- Renewing consent
Ethical guidelines for epidemiologic research
- Scientific validity
- Informed consent
- Risks and benefits
- Privacy and confidentiality
- Sharing of study result with participants
- Compensation for participants
- Managing of conflict of interest of researcher
