Local legislation for research
Retha Britz
1
Retha Britz Copyright 2013 All
rights reserved for this
presentation
Animal Research

Animals protection Act No. 71 of 1962



2
Protects animals meaning “any equine, bovine,
sheep, goat, pig, fowl, ostrich, dog, cat or other
domestic animal or bird or any wild animal, wild
bird, or reptile which is in captivity or under the
control of any person”
May be an offence to kill or interfere with the wellbeing of an animal for scientific and educational
purposes without justification
Animal research ethics committees
e.g. KZN, UP
Human Research




3
Act No. 108 of 1996 The Constitution of the
Republic of South Africa
Act No. 61 of 2003 National Health Act
Act No. 38 of 2005 The South African
Children’s Act
Act No. 101 of 1965 (as amended) Medicines
and Related Substances Act
Act No. 108 of 1996 The Constitution
of the Republic of South Africa
4
Section 12(2)(b) & (c)
“Everyone has the right to bodily and psychological integrity which
includes the right b) to security in and control over their body and c) not
to be subjected to medical or scientific experiments without their
informed consent.”
 Only Constitution in the world that requires IC for clinical research
participation
 Research conducted without IC amount to violation of the right to
security in and control over one’s body
 No distinction between therapeutic (medical) and non-therapeutic
(scientific) experimentation
 Various other rights guaranteed in the Constitution find application to
research pts e.g. right to dignity, privacy, access to health care
Act No. 108 of 1996 The Constitution of
the Republic of South Africa (continue)
Section 28(3)
A person under the age of 18 is considered to be a child
5
Act No. 61 of 2003 National Health Act
Sections 7 & 71(1)(b)
Research or experiments on living persons may only be conducted
with written consent of the person…
Section 72
The Minister to establish a National Health Research Ethics
Council (NHREC)
6
Section 72(6)
(a) RECs mandated to follow the guidelines in the “Blue book”
(b) Audit Health RECs
Act No. 61 of 2003 National Health Act (continue)
Section 73
Mandates Health RECs registered with the NHREC
Section 90(1)(s)
Regulations for health research
Government Gazette of 29 May 2013: Regulations relating to
research on human subjects incl
–
–
–
–
–
–
7
–
Principles of Health Research
Obligations of researchers
Participation of special classes of persons in research studies
Other types of research that need additional consideration
Informed Consent (pts to be informed of 14 aspects)
Review of research proposals by RECs
Ministerial consent for non-therapeutic research
Act No. 38 of 2005 The South African
Children’s Act
Section 17
A child becomes a major upon reaching the age of 18 years (legal
majority)
8
Act No. 101 of 1965 (as amended)
Medicines and Related Substances Act
Section 34
Clinical researchers must abide by the GCPs
GCPs official guidelines that are recognised or referred to in
enacted legislation (soft law) i.e. no legal force by itself but does
attain a special status due to its association with the particular
statue (also DoH & “Blue Book”)
Violations of soft law may have indirect legal consequences.
9
References

SOUTH AFRICA. 2003. Constitution of the Republic of South Africa no. 108 of 1996.
Chapter 2: Bill of Rights. http://www.info.gov.za/documents/constitution/ 1996/a108-96.pdf
Date of access: 21 May 2010.

SOUTH AFRICA. 2003. Medicines and Related Substances Control Act no. 101 of 1965
as amended. Government gazette, 4594:68, 2 May 2003. (Regulation gazette no. 16254.)

SOUTH AFRICA. 2005a. The Children’s Act no. 38 of 2005. Government gazette,
492:38, 19 June 2006. (Regulation gazette no. 28944.)

SOUTH AFRICA. 2005b. National Health Act no. 61 of 2003. Government gazette,
469:1-94, 23 July 2004. (Regulation gazette no. 26595.)