ETHICS IN RESEARCH Flashcards
(25 cards)
framework that applies broad, ethical principles to the responsible conduct of research and to the use of any outcome resulting from research
ethics in research
what is unethical research
- participants have been harmed
- public has been harmed
- Academic dishonesty/scientific misconduct
- Steal credits for results
- Disputes over funding
- Review own articles
- Plagiarism
Deliberate falsification or distortion of scientific data in proposing, performing, reporting or reviewing research and other violations of the internal norms of scientific investigation
scientific misconduct
a set of ten ethical principles for human experimentation, developed in 1947 following the Nuremberg Trials of Nazi doctors accused of conducting inhumane experiments on concentration camp inmates
nuremberg code
a set of ethical principles for medical research involving human subjects. It was initially adopted in 1964 and has been revised multiple times. The declaration emphasizes the importance of patient welfare and the ethical considerations of research.
WMA Declaration of Helsinki
a foundational document in research ethics, outlining three core principles for protecting human subjects in research: respect for persons, beneficence, and justice
The Belmont Report
why should we be ethical in our research
because we could harm…
Direct or indirect
Intended or unintended
Potential or actual
At various levels: individual, household, community, nation
better understanding of health or social problems or promotion of wellbeing of individual, families or communities.
social value
state of the problem and how study will arrive at a solution
significance
methodology is able to generate information/knowledge supporting the objectives of the study
scientific validity
Primacy of man over science, researcher, research, institution or society
“Considerations of well being of research participants take precedence over the interests of science or society (Helsinki)”
ethical soundness - value and protect the participants
what are the elements of research ethics (complete)
Social Value
Informed Consent Process
Vulnerability of Research Participants
Risks, Benefits and Safety
Privacy and Confidentiality of Information
Justice
Transparency
Adherence of Application Provisions of Data Privacy Acrt
a person with inherent dignity who should be:
Protected against harm
Benefited as an end and not a means (+Benefits/Risks)
Respected as a person (Informed Consent)
Equal to other persons (Justice)
National policy making body on health research ethics
philippine health research ethics board
national unified health research agenda:
Disease management
Halal in health
Health security, emergency, and disaster risk management
Health technology and innovation
Health of vulnerable populations
Health promotion
Health systems strengthening towards UHC
Maternal, newborn, and child health
Mental health
Nutrition and food security
Sexual and reproductive health
basic ethical principles from the belmont report
- respect for persons
- beneficence
- justice
The term “___” refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success.
practice
By contrast, the term “___’ designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge
research
the belmont report - applications
informed consent
assessment of risk and benefits
selection of subjects
ethical decision making process
Researchers must be committed to ethical principles.
Researchers must determine the authenticity of the facts.
Any researcher who contributes substantially to a research project or paper needs to get credit.
Researchers need to ensure that they do not wield undue influence over others.
a process that incorporates established ethical and scientific quality standards for the design, conduct, recording and reporting of clinical research involving the participation of human subjects.
Good Clinical Research Practice (GCP)
types of ethics review
exempted
expedited
full board
do not involve more than minimal risks or harms
Protocols that neither involve human participants nor identifiable human tissue, biological samples, and data (e.g., meta-analysis protocols, systematic review of literature, scoping review)
exempted review
with minimal risks to the study participants and minor revisions in the protocol or informed consent.
expedited review