ethical dimension of research proposal Flashcards
govern the complex nature of
human behavior
ETHICS
determines: why one act is better than the other; to have an orderly social life.
ethics
Consent process. Protection of subjects from harm. The balance of benefits and risks in a study.
Nuremberg code (1949)
Investigators should protect life. Investigators should exercise greater care to protect subjects from harm in non-therapeutic research. Investigator should conduct research only when the importance of the objective outweighs the inherent risks and burdens to the subjects.
Declaration of Helsinki (1964)
Encompasses the maxim: above all, do no harm
Beneficence
Includes participants right to fair treatment and their right
to privacy.
Justice
Humans should be treated as autonomous agents, capable of controlling their own activities. Prospective participants have the right to decide voluntarily whether to participate in a study, without risking any penalty or prejudicial treatment.
Right to Self-Determination
It means that prospective participants have the right to know the details of treatment.
Right to Full Disclosure
something that is due to someone by law or by tradition. It
is the fair selection and treatment of subjects during the course of a research study.
Right to fair treatment
An ethical principle in research which states that researchers do not cause direct harm nor inflict unnecessary pain to the subjects of the study, although unanticipated harm may occur during its course.
NON MALEFICENCE
Special groups of people whose rights in research studies need special protection because of their inability to provide meaningful informed consent or because their circumstances place them at higher-than-average-risk of adverse effects; examples include young children, the mentally retarded and unconscious patients.
VULNERABLE SUBJECTS
participants have adequate information regarding the research, can comprehend the information, and have the power of free choice, enabling them to consent to or decline participation voluntarily.
Informed consent
responsible for reviewing in universities, clinical agencies, and managed care centers involving human subjects for the express purpose of determining if the potential benefits of the investigation outweigh any risk that may be present to the subject.
Institutional review boards
no apparent risk or harm to the subjects.
Exempt from review
minimal risk or harm to the
subjects
Expedited review