research ethics Flashcards
—– refers to the norms and guidelines that distinguish between acceptable and unacceptable behaviour in the field of research. It encompasses the principles and standards that guide researchers in conducting their studies with integrity, respect for life, and adherence to human rights
research ethics
researcher ethics is guided by:
—- : : to the country in which research is conducted and where they collect and store data (eg Irish Health Research Regulations)
—- : established by professional bodies to guide the conduct of its members
—- : : informal rules regulating the behaviours of people within the society in which they live.
—- : : behavioural choices that individuals make of their own will.
legal obligation ( highest level)
professional obligation
cultural obligations
personal obligations
we regulate research ( the need to advance research to provide — to current n future patients vs mandate to protect potentially vulnerable participation from exploitation )
such as:
- benefit
-Past abuses necessitates ongoing oversight
-Commercialisation, globalisation and for-profit experimentation
-Novel ethical challenges from new biotechnologies
ways in which research can harm:
- forcible participation
- participants kept unaware of research
- withholding of proven therapies
- use of vulnerable individuals
- limited availability of treatment
- risk of lower standards of care in developing countries
- exclusion from research
- fraud and miscounduct
principle for ethical research:
1- —– : research must respect people’s right to make their own decisions – in accordance with their own values and beliefs.
2- —– : research should create sufficient value to outweigh any risks, inconveniences, or burdens associated with the study
3- —- : research must not cause harm. Not involving unnecessarily many participants, not subjecting participants to indefensible risks, not carrying out unnecessary experimental procedures, not wasting participants’ time,
4- —- : research must be fair. A reasonable distribution of the benefits and burdens arising from a scientific trial must be ensured, unnecessary inclusion of vulnerable populations should be avoided, and equal opportunities to participate in scientific trials should be secured.
autonomy
beneficence
non maleficence
justice
research integrity:
* —– in ensuring the quality of research, reflected in the design, methodology, analysis, and use of resources.
- —– in developing, undertaking, reviewing, reporting, and communicating research in a transparent, fair, full, and unbiased way.
- —– for colleagues, research participants, research subjects, society, ecosystems, cultural heritage, and the environment.
- —- for the research from idea to publication, for its management and organisation, for training, supervision and mentoring, and for its wider societal impacts.
reliability
honesty
respect
accountability
-Failure to conduct research with integrity results in — which can have — effect on society
- examples of this is:
- doesnt include:
- Numerous potential victims: patients; policy/decision makers; research funders (taxpayer or company); the research record; reputation of research; the public
-misconduct
-negative
-Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research or reporting the results.
- doesnt include:
-honest error/differences in interpretations or judgments of data.
-authorship or credit disputes.
1- —– :
-Intentionally making up results &
-Recording them as if they were real.
2- —– :
-Manipulating research processes.
-Changing or omitting data.
3- —- :
- the appropriation of others ideas and research n words
- without giving them credit
fabrication
falsification
plagiarism
check slide 17,18
- ethical framework for biomedical research:
1- —- : Community should collaborate in research
2- —- : Must have social/scientific/clinical value to society
3- —: Must be methodologically sound
4- —–: Do not target vulnerable individuals
5- —-: Study design minimises risk and maximises benefit
6- —-: Review by a body not affiliated with researchers
7- —-: individuals should be informed about the research and provide voluntary consent
8- —- : Privacy should be protected, opportunity to withdraw
- Collaborative partnership
- Social value
- Scientific validity
- Fair participant selection
- Favourable risk-benefit ratio
- Independent review
- Informed consent
- Respect for participants
-Research to be undertaken with not on people
-Public and patient involvement in research
-Community determines whether research is acceptable
is known as:
collaborative partnership
( participation — > patients and public are tested as subject of a study , engagement —> researchers sharing info n knowledge ab research usually after its complete . involvement –> patients and public working in partnership with researchers to plan design manage evaluate and disseminate research
-Must have the potential to:
- lead to improvements in health/well-being and/or
-increase knowledge
social/scientific value
the 4 benchmarks of social value are:
-Who will benefit?
-What is the potential value of the research for beneficiaries?
-Mechanisms to enhance the social value?
-Impact of research on existing health infrastructure?
Study must be carried out in a methodologically rigorous manner
- soundly designed
- feasible ( easy n convenient) and unbiased
- clear aims & objectives
- plausible data analysis plan
scientific validity
In clinical research which compares different therapies, there must be a genuine lack of consensus within the scientific community as to whether or not the new intervention is more effective than the standard therapy
this is in —-
scientific validity - equipoise ( meaning balance of sources or interest )
-Recruitment strategies must be based on the study goals, not convenience
-Minimise risk to participants
-Participant selection to enhance benefits to individuals, groups & social value
-Safeguards for vulnerability
fair participatant selection
