COMPLETE DIGEST FEATURING CORRECT
RESPONSES
◉Vulnerable populations. Answer: incapable of giving fully informed
consent or may be at high risk of unintended side effects.
Include:
-Children- legally and ethically do not have the competence to give
informed consent so consent of parent/guardians should be
obtained; if child is at least 7 should obtain child's assent as well.
-Mentally or emotionally detached people- disability makes it
impossible for them to make informed decisions (cognitive
impairment, coma); cannot legally provide informed consent;
written consent must be obtained from legal guardians
-Severely ill or physically disabled people- very ill or undergoing
certain treatments (mechanical ventilation); may be necessary to
assess ability to make reasoned decisions; for certain disabilities
special consent procedures may be required (can't read or write)
, -The terminally ill- can seldom expect to benefit personally from
research; risk/benefit ratio needs to be carefully assessed
-Institutionalized people- hospitalized/institutionalized people may
feel like their care would be jeopardized by failure to cooperate;
inmates fall into this category; researchers should emphasize the
voluntary nature of participation
-Pregnant women- reflect desire to safeguard both the pregnant
woman, who may be at heightened physical or psychological risk,
and the fetus, who cannot give informed consent. The regulations
stipulate that a pregnant woman cannot be involved in a study
unless risks are minimal.
◉Informed assent. Answer: child's affirmative agreement to
participate.
◉Confidentiality. Answer: a pledge that any information participants
provide will not be publicly reported in a manner that identifies
them and will not be made accessible to others
◉Anonymity. Answer: most secure means of protecting
confidentiality, occurs when the researcher cannot link participants
to their data (questionnaires without identifying data)