unit 3 research ethics Flashcards
numberg code
first internationally recognized sets of ethical standards after the nuremberg trails
declaration of helsinki
international standard adopted by 1964 by the world medical assembly
code of ethics
the fundamental ethical principle established by a discipline or institution to guide researchers’ conduct in research with human (or animal subjects)
CNA first published document entitled ethical guideline for nursing research involving human particpants
the goal of this document is to provide nurses in all area of professional practice with guidelines relating to research activities
code of ethics for registered nurse
developed in 2002 revised in a centennial edition (2008)
does international council of nurse have a code of conduct?
yes
health canada adopted which guideline?
the good clinical practice consolidated guideline
name of the guideline that protects human subjects in all types of research
tri council policy statement: ethical conduct for research involving humans (TCPS)
what does TCPS stand for
tri council policy statement: ethical conduct for research involving humans (TCPS)
REB
research ethics board
ethical dilemmas
there are situations u which the rights of participants and the demands f the study are put in direct conflict
ethical framework
established by TCPS on a desire to balance the need for research-which is viewed as a fundamental moral commitment to advance human welfare
8 guiding ethical principles
>>respect for human dignity >>respect for free and informed consent, >> respect for vulnerable persons >>respect for privacy and confidentiality >>respect for justice and inclusiveness >>balancing harms and benefits >>minimizing harm >>maximizing benefit
self determination
means that prospective participants have the right to decide voluntarily whether to participate in a study, without risk of incurring adverse consequences
coercion
involves explicit or implicit threats of penalty for failing to participate in a study or excessive rewards for agreeing to participate
stipend
monetary incentive
full disclosure
means that a researcher has fully described the nature of the study, the persons right to refuse participation, the researcher responsibility, and the likely risk and benefit that would be incurred
informed consent
means that participant have adequate information about the research comprehend the information
based on then sometimes result in two types of biases right of self-determination ad full disclosure
informed consent
full disclosure can sometimes result in two biases
> > results from inaccurate data
|»_space; stemming from difficulty recruiting a good sample
convert data collection or consealment
the collection of information without participants’ knowledge and this without their consent
deception
involve wither deliberately with doling information about the study or providing participants with false information
authors consent
dilemma relating full disclosure regarding collection of data from people over the internet
vulnerable subjects
people with diminished competence or decision making ability
confidentiality
pledge to participants that any information they provide will not be publicly reports or made accessible to parties not involved in the research
justice
connotes fairness and equality
distributive justice also
imposes duties to neither neglect nor discriminate against individuals and groups who may benefit from advances in research
research is often undertaken under conditions of
uncertainity
beneficence
which imposes a duty on researcher to maximize net benefits
nonmaleficnce
researchers’ duty to avoid or minimize harm to participants
also involves ensuring freedom from exploitation
major potential benefits to particpants
access to an intervention
comfort in being able to discuss their situation or problem with a friendly, objective person
increase knowledge about themselves or condition
escape normal routine
satisfaction that information they provide may help
direct monetary or material gain
major risk to particpants
physical harm physical discomfort psychological or emotional distress social risks loss of privacy loss of time monetary costs
risk/benefit assessment
is designed to determine whether the benefits of participating in a study are in study are in line with the costs, be they financial, physical, emotional or social
minimal risk
is defined as risks anticipated to be no greater than those ordinarily encountered in a daily life or during routine tests or procedure
consent form
this forms includes information about the study purpose, specific, expectation regarding participation, the voluntary nature of participation, and potential cost and benefits
implied consent
the assumption, however, is not always warranted
process consent
when the research design emerges during data collection and analysis, researcher may not know the exact nature of the data to be collected, what the risk and benefits will be nor, how much of a time commitment will be required
» continuously renegotiate the consent allowing participants to play a collaborative role in the decision making process regarding their ongoing participation
anonymity
occurs when even the researcher can not link a participant with his or her data
debriefing session
after data collection is completed to permit participants to ask questions or air complaints
children, mentally or emotionally disabled people, physically disabled, pregnant or breast feeding, terminally ill, institutionalized peopl
are vulnerable groups
REB
research ethics board -mandated to reject, propose modification to , or terminate any research conducted within the institution or by member s affiliated with it if ethical transgressions are noted.
other ethical issues
using animals, research misconduct
research misconduct
fabrication, falsification, plagiarism or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting or reporting research
3 fundamental aspects of research intergrity
`truthfulness, scrupulousness (crediting original courses), probity int he use of research funds.
fabrication
involves making up study results and reporting them
falsification
involves manipulating research materials, equipment or processes
plagiarism
involves the appropriation of someone’s ideas or results without giving due credit
critiquing ethical aspects of a study
> was the study approved and monitored by a research ethics board
were study participants subjected to any physical harm, discomfort or psychological distress
did the benefits to participant outweigh any potential risk or actual discomfort
was any types of coercion or undue influence used
were participants deceived in any way
were appropriate informed consent procedures used with all participants
were adequate steps taken to safeguard the privacy or participants
were vulnerable groups involved in the research
were groups omitted from the inquiry without a justifiable rationale
