WorksheetsNCM 108 LP3
Total questions: 25
Worksheet time: 6hrs 1mins
The benefits, risks, burdens and effectiveness of a new intervention
must be tested against those of the best proven intervention(s),
Use of Placebo
Post-Trial Provisions
Privacy and Confidentiality
Informed Consent
A set of ethical principles regarding human
experimentation developed for the medical community by the World Medical
Association (WMA).
(a)
Privacy and Confidentiality
Every precaution must be taken to protect the privacy of research
involving human subjects must conform to generally
accepted scientific principles, be based on a thorough knowledge of the
scientific literature, other relevant sources of information, and adequate
laboratory and, as appropriate, animal experimentation.
Participation by individuals capable of giving informed consent as
subjects in medical research must be voluntary.
particularly vulnerable and may have
an increased likelihood of being wronged or of incurring additional harm.
Risks, Burden and Benefits
Medical research should be conducted in a manner that minimizes
possible harm to the environment.
Groups that are underrepresented in medical research should be
provided appropriate access to participation in research.
Medical research involving human subjects may only be conducted if
the importance of the objective outweighs the risks and burdens to the
research subjects.
Ethical principles for medical research
involving human subjects, including research on identifiable human
material and data.
Preamble
General Principles
Post-Trial Provisions
Potential subject must be adequately informed of the
aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and
potential risks of the study and the discomfort it may entail, post-study
provisions and any other relevant aspects of the study.
(a)
a set of research ethics
principles for human experimentation created as a result of the Nuremberg trials at
the end of the Second World War.
(a)
Which of the following belongs to the NUREMBERG CODE'S ETHICAL GUIDELINES FOR RESEARCH
The risks should never exceed the benefits
Voluntary consent is essential
Experiments should be conducted by avoiding physical/mental suffering and
injury.
The scientist in charge must be prepared to terminate the experiment when injury, disability, or death is likely to occur.
8.Experiments should be conducted only by qualified scientists
“The health of my patient will be my first consideration,” and
the International Code of Medical Ethics declares that, “A physician
shall act in the patient’s best interest when providing medical care.”
(a)
Some groups and individuals are particularly vulnerable and may have
an increased likelihood of being wronged or of incurring additional harm.
Preamble
Scientific Requirements and Research Protocols
Vulnerable Groups and Individuals
research involving human subjects must conform to generally
accepted scientific principles, be based on a thorough knowledge of the
scientific literature, other relevant sources of information, and adequate
laboratory and, as appropriate, animal experimentation.
Preamble
Medical Research
Scientific Requirements and Research Protocols
Use of Placebo
Privacy and Confidentiality
no proven intervention exists, the use of placebo, or no
intervention, is acceptable
medical research using identifiable human material or data, such
as research on material or data contained in biobanks or similar repositories, physicians must seek informed consent for its collection , storage and/or reuse.
a research study
the physician must be particularly cautious if the potential subject is in a
dependent relationship with the physician or may consent under duress.
precaution must be taken to protect the privacy of research
subjects and the confidentiality of their personal information.
research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the
study begins.
(a)
advance of a clinical trial, sponsors, researchers and host country
governments should make provisions for post-trial access for all participants
who still need an intervention identified as beneficial in the trial.
Research Registration and Publication and Dissemination of Results
Research Ethics Committees
Placebo
Post-Trial Provisions
Every research study involving human subjects must be registered in a
publicly accessible database before recruitment of the first subject.
Research Registration and Publication and Dissemination of Results
Post-Trial Provisions
Scientific Requirements and Research Protocols
Medical research
treatment of an individual patient, where proven interventions
do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a
legally authorized representative, may use an unproven intervention if in the
physician’s judgement it offers hope of saving life, re-establishing health or
alleviating suffering.
(a)
- one of the leading works concerning ethics and health care research.
- Its primary purpose is to protect subjects and participants in
clinical trials or research studies.
(a)
Belmont Report consists of 3 Principles which are the?
(a)
Protecting the autonomy of all people and treating them with
courtesy and respect and allowing for informed consent.
Justice
Beneficence
Respect for persons
The philosophy of "Do no harm" while maximizing benefits for the
research project and minimizing risks to the research subjects
Justice
Beneficence
Respect for persons
ensuring reasonable, non-exploitative, and well-considered procedures
are administered fairly — the fair distribution of costs and benefits to potential
research participants — and equally.
Justice
Beneficence
Respect for persons
This are the Principles to conduct research that requires careful consideration;
(a)
This is the concern to all nurses.
(a)
refer to the rules and principles of right
conduct
(a)
are created when a choice must be made between difficult
alternatives or when important principles conflict.
Ethical dilemmas
Ethics
Tough Call
