Ethics In Research Flashcards
should arise out of our commitment to ethical practice and to improve client outcomes
EBP
can be used to bring about change for one patient, across a system, or for the profession
Evidence
True/False: Commitment to the protection of patients’ rights and dignity must be the most important aspect when designing and conducting clinical research.
True
Research with human subjects requires adherence to 3 basic principles:
- Autonomy
- Beneficence
- Justice
the capacity of the individual to make decisions affecting their lives and to act on those decisions
Autonomy
When must an individual have a surrogate decision maker
For Children and patients with cognitive difficulties may be unable to understand their involvement in the research
the obligation to attend to the well-being of individuals
Beneficence
refers to the fairness in the research process
Justice
Examples of abuse in research
Tuskegee Study
Nazi Experiments
Clearly emphasized that every individual should voluntarily consent to participate as a research subject.
Nuremberg Code of 1949
“the research should be conducted only by scientifically qualified persons”
Nuremberg Code of 1949
declares that reports of research that has not been conducted according to stated principles should not be accepted for publication
Declaration of Helsinki
first document that addressed the concept of independent review of research
Declaration of Helsinki
Developed to ensure the protection and rights of human subjects in research and are now considered “standard” throughout the United States
National Research Act 1974
National Research Act 1974 demands
research have a fully developed research proposal
Informed consent MUST be obtained
Governs conduct of research ion United States
Belmont Report
DHHS regulations protect individual confidentiality is known as
The common rule
IRB
Institutional Review Board
IRB is composed of 5 members:
Cannot be all males or all females
Cannot be all members of one professional group
At least one member must be concerned primarily with nonscientific issues and may be a lawyer, clergyman, etc.
One member must be a ”public” member and must not be associated with the institution (university or hospital, etc.) where the research is to be completed
Responsibility of IRB
Review research proposals at convened meetings.
The decision to approve, require modifications in, defer or deny approval of a proposal must be that of a majority
Must consider the scientific merit of the project, the competence of the investigators, the risk to subjects, and the feasibility based on identified resources.
3 elements of informed consent
- Information Elements
- Consent Elements
- Authorization
Subjects must be fully informed:
1. a written statement of the purpose of the study
2. a fair explanation of the procedures to be used & how they are to be applied
3. The explanation must be complete and there must be NO deception
Information elements
Consent must be voluntary
Vulnerable Subjects – special considerations must be given to children, subjects with mental illness, diminished mental capacity, or developmental disability. In these cases, consent must be given by a legal guardian or advocate.
Consent elements
This allows or authorizes the researcher to use data in a manner specified in the protocol
Authorization
9 Elements of Informed Consent
- Purpose of the research project
2.Procedures
3.Risks and discomforts
4.Benefits
5.Alternatives to participation
6.Confidentiality
7.Request for more information
8.Refusal or withdrawal
9.Injury statement
10.Consent statement
11.Signatures
CITI
The Collaborative Institutional Training Initiative (CITI Program)
dedicated to promoting the public’s trust in the research enterprise.
CITI
CITI was founded in
2000
5 unethical principles of research
- Data falsification
- Data fabrication
- Unintentional plagiarism
- Intentional plagiarism
- Conflict of interest
Ways to address unethical research
Be up to date on ethical guideline’s
Don’t be afraid
See something, say something
Educate others
