Exam (elaborations)
LCR4802 ASSIGNMENT 1 SOLUTIONS FOR SEMESTER 1 YEAR 2024
- Institution
- University Of South Africa (Unisa)
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LCR4802SECOND SEMESTER ASSIGNMENT 2
YEAR 2022 AUGUST
WE ALIGHT TUTORIALS
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, (1) Identify and briefly set out the contents of any statutory provisions that
have a bearing on the issue of informed consent to medical experiments. (6)
Subsection (2) of Section 12 of the Constitution1, which deals with personal freedom
and security, states the following: Every person has the right to physical and
psychological integrity, which includes the rights to: (a) regulate their own
reproductive decisions; (b) feel secure in and in charge of their body; and (c) not be
exposed to medical or scientific experimentation without their informed agreement.
Examples of unfair activities in the health care industry are included in the Schedule
to Act 4 of 2000,2 including exposing people to medical experiments without getting
their informed permission.
Research on and experimenting on human beings are governed by Sections 11 and
71 of the National Health Act 61 of 2003.3 Before providing any user with a health
service for experimental or research purposes, the health establishment must notify
the user in the manner specified by law that the service is being provided for
experimental or research purposes or as part of an experiment (s. 11(1)).
The user, the healthcare provider primarily responsible for the user's treatment, the
head of the health establishment in question, the relevant health research ethics
committee, or any other person to whom that authority has been delegated, must all
approve the provision of a health service in advance for experimental or research
purposes (s. 11(2)).
Article 71 (1) ) stipulates that research or experimentation on a living person may
only be conducted (a) in the prescribed manner, and (b) with the written consent of
the person after he or she has been informed of the objects of the research or
experimentation and any possible positive or negative consequences on his or her
health.4
Section 71(3) governs research or experimentation to be conducted on a minor for a
non- therapeutic purpose. Paragraph (a) provides that such research or
experimentation may only be conducted.
(i) in such a manner and on such conditions as may be prescribed
(ii) with the consent of the Minister of Health
(iii) with the consent of the parent or guardian of the minor, and
1
The Constitution of South Africa 1996
2
Schedule to Act 4 of 2000
3
National Health Act 61 of 2003.
4
National Health Act 61 of 2003.
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