Research Involving Children - Faculty of Health Sciences

Research Involving Children
Standard Operating Procedure
Human Research Ethics Committee, Faculty of Health Sciences, University of Cape Town
Research Involving Children
Policy
Research involving children requires additional ethical, regulatory and legal protections.
Although Section 71 in the National Health Act of 2003, governing research with children,
was enacted in March 2012, regulations needed to interpret pivotal requirements in s 71
must still be gazetted. To address existing gaps in the legislative framework, Dr Max Price,
Vice-Chancellor of the University of Cape Town, has issued an interim policy statement
(Appendix 1) which allows the University to conduct research with minors in accordance
with existing Department of Health Research Ethics Guidelines1. It is important that
researchers and the Human Research Ethics Committee deal with discrepancies between
the legislation and existing ethical guidelines in the best way possible and not allow current
uncertainty to discourage necessary research with children. If it transpires that in the future
children will be unfairly excluded from important research, researchers and the Committee
may need to adopt an advocacy role aimed at promoting the inclusion of children and
adolescents in relevant research which is not against their best interests.
Section 71: In December 2012, the Chairperson of the National Health Research Ethics
(NHREC) notified the Chairpersons of registered HRECs that the Council had met with the
Director General (DG), the Deputy-Minister of Health and the Minister of Health during 2012
to present its concerns about Section 71. The Council was invited to make formal
submissions to the DG’s office regarding a delegation of power to RECs for low-risk nontherapeutic research with children (as a short-term measure) as well as proposals for law
reform to Section 71. The Council has done so and is awaiting feedback from the
Department of Health. The NHREC will keep HRECs informed of progress.
Sexual Offences Act 32 of 2007: On 15 January 2013, Judge Rabie declared Sections 15 and
16 of the Act invalid as they are deemed inconsistent with the Constitution. Reactions from
the Department of Justice and Constitutional Development and the Centre for Chid Law are
provided in Appendix 3. The impact of this ruling on research with children will be included
in a revised SOP in the near future.
The Human Research Ethics Committee should include members with adequate expertise
and experience to evaluate the distinctive features of neonatal, child and adolescent
research.
The Human Research Ethics Committee must determine whether the risks to minors are
sufficiently minimised, informed consent and assent are appropriate and that privacy and
confidentiality protections are adequate. If the Committee believes a reportable
observation or revelation of suspected harm to a child might occur during the research, it
may require that the informed consent and assent form include a warning of the limits to
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research confidentiality and advise participants of the investigator’s duty to report known or
suspected abuse or neglect to appropriate authorities, including the police.
Purpose
The purpose of this policy is to outline general and specific ethical, regulatory and legal
requirements for conducting research with children and adolescents.
Central Ethical Issues in Research with Children in the South African Context
Children are Vulnerable:
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Their physical, cognitive and emotional development is incomplete.
They are dependent on others for their wellbeing.
They are legally unable to make independent decisions about whether to take part in
research.
Children living in poverty are particularly vulnerable; for example, parents may have a
poor understanding of research and may be more susceptible to pressures of enrolment,
such as access to better health care.
Generally, children ought not to bear the burdens of research unless absolutely necessary;
yet, if they are to benefit from health-related advances then children must take part in
relevant health research:
Researchers face the ethical dilemma of how to balance protection and access: fairness
demands protection and opportunity for inclusion. The extensive off-label use of diagnostic
and therapeutic interventions to treat children has led to the conclusion that children are
already being used as research participants without the benefit of ethical and regulatory
oversight, or a systematic commitment to discover what works best. Some argue that offlabel use of diagnostic and therapeutic interventions has become the standard of care for
many children. If new interventions are only tested in adults but are used in children, then
children are exposed to risks from interventions not specifically proven safe and effective in
this population. Clinicians face difficult choices when treating children. If they use untested
interventions they face dangers of underdosing, overdosing or prescribing unsuitable
paediatric formulations. If, on the other hand, clinicians use only proven interventions, they
are severely limited in their diagnostic and therapeutic options. So, in our efforts to protect
children from harm, we may actually deprive them of the benefits of medical research.
Researchers must resolve the tension between advancing knowledge to benefit future
children and limiting potential harm to individual children:
The most intractable ethical issues arise in non-beneficial research where there is no
prospect of direct benefit to individual minor-participants but there is risk of harm. Is it a
greater wrong to use individual children where there is no prospect of individual benefit (i.e.
to serve societal rather than the child’s own interests) or to fail to obtain vitally important
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information that may benefit all children, such as vaccine research? Researchers must
balance the best interests of the individual child with the best interests of children as a
class.
Determining the minimal risk standard in research with children:
Minimal risk is a useful sorting mechanism which draws attention to riskier research and
acts as a threshold limiting the amount of non-therapeutic risk in research. Minimal risk
means that the probability and magnitude of harm or discomfort anticipated in research are
not greater than the harms or discomfort ordinarily encountered in daily life or during the
performance of routine physical or psychological examinations or tests. This is also called
the ‘everyday risks standard’ or the ‘routine examination’ standard. The ‘everyday risks
standard’ raises the ethical question of what risks count as the risks of daily life: should risks
of daily life be measured against the risks healthy children typically face in everyday life (i.e.
an absolute interpretation) or against actual risks in the background of children who take
part in research (i.e. a relativistic interpretation). Arguments against a relative standard of
minimal risk claim that it would impose a disproportionate burden of research on sick or
disadvantaged children. According to this view, children with a specific disease or condition
face certain risks such as extra lumbar punctures or venipunctures because they have a
specific disease or condition. Hence these risks are already part of their daily lives, that is to
say they are already risks of daily life. This raises the ethical question of how a relativistic
argument could be justified without violating the principle of justice. Justice demands that
research not unduly involve groups unlikely to benefit from research; but in this case
children with a specific disease or condition may benefit from the research. If the only way
to provide some benefit is to conduct research among these groups of children then a
relative standard may be justified by the prospect of future benefits among those most
likely to gain from the findings of the research. In summary, reasonable differences exist
regarding the interpretation of the minimal risk standard in research involving children.
Definitions and Distinctions in Research with Children
Child
A child is a person under the age of 18 years. The terms minor and child are used
interchangeably. A child becomes a legal major at the age of eighteen. This means that from
the age of 18 young persons can consent independently to any form of research.
Guardianship
Every person < 18years requires a legal guardian to assist with decisions with legal
consequences, such as consent to research participation. Both parents, if married, are legal
guardians. If a child is born out of wedlock, the mother is natural guardian. If the unmarried
mother is herself a minor, her mother (i.e. the maternal grandmother) would be the child’s
guardian. An unmarried father may apply to be a child’s guardian. If parents are dead, a
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guardian may be appointed by way of a will or the High Court. Occasionally, a child without
a parent or guardian is placed in the custody of a person (e.g. a foster parent) or institution
(e.g. a children’s home) without a guardian being appointed. In this case, the High Court
may act as the guardian of a child.
Assent and Dissent
Assent derives from the ethical principle of respect for persons. In the case of children, the
investigator must respect a minor-participant’s emerging autonomy which translates into
the requirement for assent, respect for dissent and respect for a participant’s confidentiality
(within legally allowable parameters). It includes respect for diminished autonomy and a
child’s right to protection through the legal requirement for parental or a legal guardian’s
consent.
Assent means a minor’s affirmative agreement to participate in research. Mere failure to
object should not be interpreted as assent. A child’s refusal must be respected. The earliest
age at which assent is recommended is set at 7 years. However, the assent process should
be developmentally appropriate depending on a child’s age, maturity and experience with a
disease or condition. The child must agree whether the research as he or she understands it
is an activity which he or she wants to take part in. Researchers must be sensitive to a child’s
non-verbal cues reflecting his or her willingness or unwillingness to take part. The older the
minor, the more an assent form will mirror a parental consent form. According to Section
71(2)(d) in the National Health Act, if a minor is capable of understanding, the child must
provide consent.
The following language may be included in consent forms in studies involving young children
or children of any age who have a major developmental delay or other significant
deficiencies in expressive vocabulary. Because these children may not have the same ability
to express their desire to withdraw, investigators are advised to identify dissenting
behaviors. This language may be modified to fit study procedures:
For protocol description:
For children below age 7, we will read an assent script, asking the child whether he/she
agrees to participate. During the project, research assistants/the investigator will monitor
children for behavior indicating that they no longer wish to take part such as refusing to
cooperate or crying. If a child demonstrates such behavior, the procedures will be
discontinued.
For parent consent form:
The research staff will watch your child for signs of being upset, such as whining, crying, or
struggling. If your child becomes upset we will stop the session for a short break of 5-10
minutes. If he or she remains upset, we will stop the sessions for that day.
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Best Interests Criterion
The Constitution in Section 28(2) requires the best interests of the child to be the
paramount consideration in all matters concerning the child and this would include
decisions relating to whether a child should take part in medical research.
According to Section 7 of the Children’s Act No. 38 of 2005, the following are among the
criteria which must be considered when determining a child’s ‘best interests’:
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age, maturity and stage of development
background
the child’s intellectual, emotional, social and cultural development
any disability a child may have
any chronic illness from which a child may suffer
Therapeutic and Non-therapeutic Research
The National Health Act of 2003 includes special protections for children related to the
degree of risk involved in a study and the extent to which the research is likely to benefit the
minor-participant. In line with the Act, researchers and the Human Research Ethics
Committee will need to categorise research as therapeutic or non-therapeutic.
Therapeutic research would include studies which provide direct health-related benefits to
minor-participants. The Committee may only approve non-therapeutic research with
children if:
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The Minister of Health gives consent;
A parent or legal guardian provides consent; and
A minor who is capable of understanding provides consent.
The Minister may not give consent in circumstances where:
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The objectives of the research can be achieved if conducted on adults;
The research is not likely to significantly improve scientific understanding of the minor’s
condition, disease or disorder to such an extent that it will result in significant benefit to
the minor or other minors;
The reasons for the consent to the research by the parent or guardian are contrary to
public policy;
The research poses a significant risk to the health of the minor; or
There is some risk to the health or wellbeing of the minor and the potential benefit of
the research do not significantly outweigh that risk.
In practice, the distinction between therapeutic and non-therapeutic research is misleading
as most studies include a mixture of both therapeutic and non-therapeutic components. For
example, in HIV prevention research, risk reduction counselling, high quality voluntary
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testing and counselling (VCT) and diagnosis and treatment of sexually transmitted infections
are direct benefits of participation. In comparison, extra blood tests, storage of biological
specimens for future research and completing questionnaires are non-therapeutic
interventions with no direct benefit for minor-participants. Researchers and Committee
members will need to evaluate these components separately using the appropriate risk
standards as defined in the National Health Act.
Informed Consent in Research with Children:
Ethical and Legal Framework
Who may consent to a minor’s participation in research?
National Health Act of 2003
If a study is categorised as therapeutic, the researcher must obtain written consent from
the:
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Parent or guardian; and
Minor, if capable of understanding.
If a study is categorised as non-therapeutic, the researcher must obtain written consent
from the:
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Minister of Health; and
Parent or guardian of the minor; and
Minor, if capable of understanding.
Department of Health. Ethics in Health Research: Principles, Structures and Processes
2004.¹
These guidelines require consent from the:
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Parent or legal guardian; and
Minor if competent to decide; and
Any person required by law.
No other caregiver can consent on behalf of a child to participate in research.
Unassisted Consent
At present, researchers may request that adolescents be allowed to provide ‘unassisted
consent’ to take part in research. In certain research situations such as sensitive surveys
about high risk behaviours, adolescents may not want their parent or legal guardian to know
they are taking part in a study. The Human Research Ethics Committee may approve the use
of ‘unassisted consent’ if a study meets the following conditions:
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The study is no more than minimal risk; and
The nature of the research is acceptable to the Committee, parents or legal guardians or
the community at large. The Committee’s opinion must be based on information from
the community concerned and lay Committee members; and
Justification for why adolescents are needed in the study; and
Justification for why adolescents should consent unassisted.
Once regulations for Section 71 of the National Health Act are gazetted, the Human
Research Ethics Committee will no longer have discretion to permit unassisted consent for
minors’ participation in any kind of research. Written consent from a parent or legal
guardian will be a legal requirement for their inclusion.
Department of Health. Guidelines for Good Practice in the Conduct of Clinical Trials with
Human Participants in South Africa, 2006.²
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Consent from a parent or legal guardian in all but exceptional circumstances (e.g.
emergencies).
Consent from a caregiver.
Assent from the minor if capable of understanding.
A ‘caregiver’ is defined as any person other than a parent or guardian who factually
cares for a child and includes:
o A foster parent.
o A person who cares for a child with implied or express consent of a parent or
guardian of the child.
o A person who cares for a child whilst the child is in temporary safe care.
o The person at the head of a child and youth centre where a child has been placed,
o The person at the head of a shelter.
o A child and youth care worker who cares for a child who is without appropriate
family care in the community.
These provisions conflict with the legal consent requirements in the National Health Act of
2003 and the Department of Health’s research ethics guidelines of 2004. Once regulations
for Section 71 of the National Health Act are gazetted, the consent requirements specified
in the National Health Act of 2003 will apply.
Consent for Research when Minors Reach Eighteen
Minors taking part in ongoing or long-term studies must provide independent informed
consent when they become adults at eighteen. Participants must be reminded of their right
to withdraw, including rights to use of their stored human tissue, where this is possible.
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Consent, Medical Treatment and Participation in Research
For purposes of consent, treatment and research are treated differently under the law.3,4
Under existing law a child can consent independently to medical treatment from the age of
12, but can only consent independently to take part in research at the age of eighteen. All
children of 12 years of age, or below 12 years of age with sufficient capacity, may consent
independently to HIV testing. This means that if a study includes HIV testing, participants
from age 12 will be able to consent independently to this procedure. HIV testing must
include pre- and post-test counselling.
General Pointers for Protocol Review
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Children may be included in research only if their participation is necessary to answer
the scientific question being investigated. This means that researchers must always
justify the inclusion of children in a study. This justification should appear in the synopsis
and protocol.
Consider potential benefits, harms and discomforts from the child’s perspective:
o The research environment should be child-friendly with age-appropriate furniture,
play equipment and food.
o Where possible, coordinate the collection of clinical and research samples.5
o Only research staff with paediatric expertise and/or experience should perform
research-related procedures.
o Where possible, use topical anaesthesia such as EMLA during potentially painful
procedures.
o Researchers may not make more than two attempts to draw blood intended solely
for research purposes.
o Where appropriate, protocols must include data monitoring mechanisms that allow
rapid termination in the face of unexpected problems or adverse events.
o Where possible, use laboratories experienced in handling small volumes of blood.
The Committee views informed consent as a process of communication between the
researcher, parent and minor-participant.6 The protocol must indicate:
o Who will request assent and consent (preferably someone with paediatric expertise
or experience).
o How and when assent and consent will be requested. This is particularly important
when children with a serious and/or critical condition and their parents are
approached to enrol in research. If standard therapy has failed, parents may see a
trial as the only option for survival. In such a situation, the informed consent
document must describe possible burdens of participation and alternative forms of
care such as palliation.
o If a parent or guardian will be present when assent or consent is obtained.
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o Sometimes it may be appropriate for the researcher to spend time alone with a child
or adolescent. This may make it easier for a child or adolescent to ask questions and
not feel pressured or inhibited by a parent or guardian.
o How the researcher will assess a minor-participant’s decision-making capacity.
o How the researcher will assess the minor-participant’s understanding of information
exchanged during the assent or consent process.
o The Committee should carefully consider the age of child participants. Selfevidently, most young children (for argument’s sake ≤12 years) are less capable of
independent decision-making than children ≥12 years. This is confirmed by the law’s
recognition that children ≥12 years can independently consent to certain medical
interventions. The views of older children should carry substantial weight in
decisions to take part in research. This is also consistent with the Children’s Act 38 of
2005 which states that children’s voices must be heard in all matters affecting them.
o The burden of ensuring that parents, guardians and minor-participants understand
what will happen during a study rests with the investigator.
o Researchers need to explore innovative and creative approaches to obtaining assent
or consent from minor-participants.7 Examples might include:
 Videotapes or photographs of research procedures.
 Pre-visits to the research site to see equipment such as MRIs.
 Design comics or illustrated assent/consent forms that explain the nature of the
research.
 Encouraging families to speak to other families and minor-participants who have
taken part in similar research.
Statutory Reporting Requirements for Neglect and Physical & Sexual Abuse:
If during a study a researcher learns that a minor-participant is being neglected or abused,
the researcher has a legal obligation to report the circumstances to the relevant authorities.
Depending on the nature of a study, researchers need to inform children and parents or
legal guardians in the assent and consent documents of researchers’ obligations to report illtreatment. Based on this information, parents and minors may choose not to take part in a
study. Examples of wording for the Confidentiality section of the informed consent and
assent forms:
Consent form:
The researcher(s) may not be able to maintain as confidential, information about known or
reasonably suspected incidents of deliberate neglect or physical, sexual or emotional abuse
of a child. If a researcher is given such information, he or she may report it to the authorities
such as child welfare or the police.
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Assent form:
We will not tell anyone what you tell us without your permission unless there is something
that could cause harm to you or someone else. If you tell us that someone is or has been
hurting you, we may have to tell that to people who are responsible for protecting children
so they can make sure you are safe.
Researchers should familiarise themselves with the statutory definitions of terms such as
‘abuse’ and sexual offences and the procedures for reporting incidents to appropriate
authorities. See Appendix 2 and 3 for a detailed account of the Sexual Offences Act and its
likely impact on research.
Privacy Rights of Minor Research Participants
Since the law does not deal directly with a minor’s privacy rights in research, researchers
must rely on general legal principles relating to privacy. Researchers must specify what
privacy rights a parent or legal guardian and a minor-participant have in a research study.
Although a parent or a legal guardian must consent to a minor’s participation based on a
detailed description of all diagnostic and therapeutic interventions in the study, the minorparticipant retains privacy rights with respect to medical interventions to which he or she
consents independently in the study, provided this is in the minor’s best interests. South
African courts have ruled that a person has the right to privacy if the person can show that:
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He or she has a legitimate expectation of privacy; and
This expectation would be considered reasonable by the community.
The privacy rights of adolescents in research are especially challenging, as it would have to
be determined for each element of a study whether adolescents have an expectation of
privacy and whether society would regard this expectation as reasonable. For example,
adolescents may have an expectation of privacy regarding treatment of a sexually
transmitted infection if they have consented independently to such treatment. Besides, if
they are over the age of 16 and having lawful sex this expectation of privacy may be
regarded as reasonable by society. In contrast, if an adolescent tests HIV positive, even if
she has consented independently to the test and expects privacy, society may not regard
this as reasonable since HIV is a life-threatening condition requiring long-term chronic care.
There is no blanket right to privacy for adolescents in research; their best interests would
always have to be considered and rights can be waived in certain circumstances.
References
1. Department of Health. Ethics in Health Research: Principles, Structures and
Processes. Research Ethics Guidelines. Department of Health, Pretoria, 2004.
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2. Department of Health. Guidelines for Good Practice in the Conduct of Clinical Trials
with Human Participants in South Africa. Department of Health, 2nd Edition.
Pretoria, 2006.
3. Strode A, Slack C, Essack Z. Child consent in South African law: implications for
researchers, service providers and policy-makers. South African Medical Journal
2010;100:247-249.
4. Strode A, Slack C, Essack Z. Child consent in South African law - implications for
researchers, service providers and policy-makers. Letter to the editor. South African
Medical Journal 2011;101:604-606.
5. Howie SRC. Blood sample volumes in child health research: review of safe limits.
Bulletin of the World Health Organization 2011;89:46-53.
6. Institute of Medicine. Ethical Conduct of Clinical Research Involving Children. Field
MJ and Behrman RE editors. The National Academies Press, Washington, DC, 2004.
7. Schenk K, Williamson J. Ethical Approaches to Gathering Information from Children
and Adolescents in International Settings: Guidelines and Resources. Washington,
D.C. Population Council, 2005.
http://www.popcouncil.org/pdfs/horizons/childrenethics.pdf
Appendix 1
Statement from Dr Max Price, Vice-Chancellor of the University of Cape Town about
Research Involving Humans and s71 of the National Health Act, 4 May 2012
On 1 March 2012 section 71 of the National Health Act came into effect. This information
was made known only on the 23 March. Subsequently, a letter from the National Health
Research Ethics Council (NHREC) dated 3 April 2012 explained that the section was
promulgated without its accompanying regulations.
Section 71 has a drastic and material effect on the logistics of doing research with human
participants, especially with minors. Specifically, s71 introduces new requirements for
health research, including that there must be written consent; consent from a parent or
guardian for research with minors; that ‘therapeutic research’ must be in a minor’s best
interest, and that consent from the Minister must be obtained for ‘non-therapeutic’
research with minors. These requirements mean that the previously acceptable manner and
methods of obtaining informed consent from potential human participants, especially
minors, are changed by this provision. However, it is not possible for researchers to change
to the new methods because there are no regulations to guide one to know e.g. how to get
ministerial consent now required for ‘non-therapeutic’ research on minors.
The letter from the NHREC indicates that it is trying to obtain clarity on how researchers are
to meet the new requirements, especially that regarding ministerial consent. It indicates
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also that the NHREC is aware of the consequent conflict between the newly promulgated
legal requirements and the current national research ethics guidelines.
Necessarily, therefore, this state of affairs presents a logistical conundrum for researchers at
UCT regarding how to go forward in the immediate future. One option is to halt all affected
research until the technical problem is cleared up. Quite clearly this option is to be avoided
if at all possible because the detrimental effects would be considerable.
Another option is to continue to follow the procedures and decision-making patterns of the
immediate past i.e. in use prior to 1 March 2012, on the basis that these patterns are
ethically acceptable and comply with the prevailing research ethics guidelines. In light of the
letter from the NHREC, it is our view that the second option is preferable for the immediate
future at UCT.
Consequently, we hereby indicate our support for the continuation of procedures and
decision-making patterns as they were implemented immediately before 1 March 2012 until
such time as the conundrum is removed. It is important that all researchers, especially those
who use minors as research participants, must ensure that informed consent processes are
carefully carried out in accordance with current (2004) Department of Health Research
Ethics Guidelines. It is important also to note the imminent likelihood of the drastic change
and to make contingency plans for the medium term. The ORI, EiRC and Faculty-level RECs
will keep researchers informed as matters change.
Appendix 2
Implications of the Sexual Offences Act of 2007 for research with minors
The following guidance is drawn from a presentation by Paula Proudlock, from the
Children’s Institute, at a workshop on Statutory Requirements Relating to Research with
Children and Conflicting Laws Relating to Mandatory Reporting hosted by Assoc. Professor
Lillian Artz of the Gender, Health and Justice Research Unit, October 1, 2012:
What must be reported?
Children’s Act 38 of 2005 (as amended by Act 41 of 2007)
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Physical abuse causing injury
Deliberate neglect
Sexual abuse which includes sexual offences.
The Criminal Law (Sexual Offences and Related Matters) Amendment Act No.32 of 2007
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Rape and sexual assault
Statutory rape and sexual assault
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Consensual sexual penetration or other sexual activity
Who must report?
Children’s Act
Any correctional official, dentist, homeopath, immigration official, labour inspector, legal
practitioner, medical practitioner, midwife, minister of religion, occupational therapist,
nurse, physiotherapist, psychologist, religious leader, social service professional, social
worker, speech therapist, teacher, traditional leader, traditional health practitioner, leader
or member of staff, or volunteer worker at a partial care facility, drop-in centre or child and
youth care centre.
Sexual Offences Act
‘A person’
When must you report?
Children’s Act
If you ‘conclude on reasonable grounds’ that a child has been:
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Abused in a manner causing physical injury
Sexually abused
Deliberately neglected
Sexual Offences Act
‘A person who has knowledge that a sexual offence has been committed against a child
Who must you report to?
Children’s Act
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A designated child protection organisation (e.g. Child Welfare Society)
The provincial department of social development
A police official
Sexual Offences Act
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Immediately to a police official
What is a sexual offence?
Sexual Offences Act
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‘Sexual penetration’ includes any act which causes penetration to any extent whatsoever
by:
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The genital organs of one person into or beyond the genital organs, anus, or mouth of
another person
Any other part of the body of one person or, any object including any part of the body of
an animal, into or beyond the genital organs or anus of another person; or
The genital organs of an animal, into or beyond the mouth of another person.
‘Sexual violation’ includes any act which causes:
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Direct or indirect contact between the:
o genital organs or anus of one person or, in the case of a female, her breasts, and any
part of the body of another person or an animal, or any object, including any object
resembling or representing the genital organs or anus of a person or an animal;
o mouth of one person and:
 the genital organs or anus of another person or, in the case of a female, her
breasts;
 the mouth of another person;
 any other part of the body of another person, other than the genital organs or
anus of that person or, in the case of a female, her breasts which could:
 be used in an act of sexual penetration;
 cause sexual arousal or stimulation thereby; or
 be sexually aroused or stimulated thereby; or
 any object resembling the genital organs or anus of an animal;
o the mouth of the complainant and the genital organs or anus of an animal
The masturbation of one person by another person; or
The insertion of any object resembling or representing the genital organs of a person or
animal, into or beyond the mouth of another person, but does not include an act of
sexual penetration.
Implications for Research into Sexual Offences
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The researcher needs to inform the parent or minor of:
o Your reporting obligation
o What you are obliged to report
o Who you are obliged to report to
o What is likely to happen after you have reported (potential consequences for the
child and the offender – it is important not to create expectations of support when
support is not guaranteed).
The researcher needs to have a referral system and accessible counsellors and social
workers to provide support and protection services to a child who discloses.
The researcher has an obligation to minimise harm to the child
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Standard Operating Procedure
Human Research Ethics Committee, Faculty of Health Sciences, University of Cape Town
Consequences of informing the child of your reporting obligation
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Many parents and children will be deterred from participating in the research or being
honest, especially those who have been abused and who have chosen not to report the
offence.
Many children may see it as an opportunity to get help and the researcher must:
o Manage these expectations honestly
o Provide counselling within 48 hours after interviews if sexual offences are revealed
(e.g., via Childline)
o Have a referral system to manage the protection response (e.g., social workers)
Adolescents engaged in consensual sexual activity (with adults and/ or other children)
are unlikely to want to reveal this unless confidentiality is assured and they know you
will not report them.
Further Reading
1. Adler D. Inclusion of South African adolescents in HIV vaccine research. Journal of AIDS
and HIV Research 2012;4:30-35.
2. Bhana A, Swartz S, Davids A. Standards for the reporting of sex/sexual activity of minors
in a research context. South African Medical Journal 2010;100;643-644.
3. McQuoid-Mason D. Mandatory reporting of sexual abuse under the Sexual Offences Act
and ‘the best interests of the child’. South African Journal of Law and Bioethics
2011;4:74-78.
Appendix 3
Comments on Judge Rabie’s Ruling on the Sexual Offences Act 32 of 2007
Department of Justice and Constitutional Development
On 16 January 2013 the following notice was posted on the Department’s Website:
The Department of Justice and Constitutional Development has noted the judgment by
Rabie J in the matter between Teddy Bear Clinic for Abused Children and Rapcan versus
Minister of Justice and National Director of Public Prosecutions. His judgment declared
certain sections of the Sexual Offences (and Related Matters) Amendment Act 32 of 2007
invalid as they are inconsistent with the Constitution. These are section 15 and 16 which
criminalize consensual penetration between children under the age of 16 years and above
12 years and Section 56 (2)(b) of the Act.
We are currently studying the judgment and reflecting on all the legal issues canvassed
therein with a view to exploring whether there are valid grounds upon which an appeal can
be lodged as this judgment has far-reaching implications in the escalating rate of sexual
violence among children under the age of 16 years as seen in many cases dealt with by law
enforcement and our courts.
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Human Research Ethics Committee, Faculty of Health Sciences, University of Cape Town
The decision to appeal or not will be determined after a proper analysis of the judgment and
will take into consideration the interest and rights of the children as dictated by the
Constitution.
Teddy Bear Clinic and Rapcan
On 16 January 2013 the following notice was published in Legalbrief Today:
The Teddy Bear Clinic for Abused Children and Rapcan (Resources Aimed at the Prevention
of Child Abuse and Neglect) represented by the Centre for Child Law hail this as a victory, as
children will no longer be unnecessarily exposed to the criminal justice system and will again
be able to seek advice and support without the risk of being reported to the police.
Judge Rabie ruled in favour of the applicants stating that the provisions in the Sexual
Offences Act ‘criminalize significant numbers of children for engaging in consensual sexual
activities.’ ‘These consensual sexual activities are a wide range of acts that would commonly
be performed by children engaging in ordinary sexual exploration … [including] French
kissing’. Criminalisation would therefore ‘constitute an unjustified intrusion of control into
the intimate and private sphere of children’s personal relationships, in a manner that would
cause harm to them’.
The Court also recognised that even if children were diverted away, they would still not
avoid the substantial trauma or harm created by the exposure to earlier processes in the
criminal justice system such as arrest, questioning by police officials and detention in police
cells. The questioning will have negative effects on the dignity of children, and arrest and
detention will obviously exacerbate the negative effects. The court also recognized that
‘public exposure and humiliation is a real risk…as negative labelling and social stigma would
result and add victimisation of the children involved’.
The judge also notes that ‘Criminalisation of consensual sexual acts (especially coupled with
the duty to report) limits the ability of support organisations to educate, empower, guide
and support adolescents in their sexual development. This they cannot do, because they
cannot be seen to promote behaviour that is illegal. The implication of the impugned
provisions is that abstinence-only sex education should be the only available form of
guidance to adolescents.’
Rapcan applauds the judgment as recognition of the importance of children’s right to
dignity, privacy and their right to participate in decisions about sexuality, especially when
engaging with their own peer group. Professionals and parents are now able to provide
children with the necessary support and guidance about sexuality to make informed
decisions without fear of incriminating the child or themselves.
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Human Research Ethics Committee, Faculty of Health Sciences, University of Cape Town
Shaheda Omar from the Teddy Bear Clinic also stated that they ‘consider this ruling a great
victory for the constitutional rights of children. Firstly, because it is promoting the best
interests of children and secondly protecting children from being violated by the very
system that is supposed to protect them’.
We would like to emphasise that this case does not affect or deal with any acts of sexual
violence perpetrated by children. It deals exclusively with consensual sexual acts between
children. Any non-consensual violent sexual offences committed by children will be dealt
with in the criminal justice system in line with the Child Justice Act. The statement by the
Department of Justice and Constitutional Development that this case will have negative
implications in relation to sexual violence between children is therefore a gross
misstatement of the nature of the case and the issues at stake.
The matter will now proceed to the Constitutional Court for confirmation of the declaration
of unconstitutionality.
For further debate about this decision visit Pierre de Vos, constitutional law expert and
provocateur at http://constitutionallyspeaking.co.za/why-the-criminalisation-of-consensualsexual-exploration-between-teenagers-is-unconstitutional/ where Professor de Vos
examines the question: Why the criminalisation of consensual sexual exploration between
teenagers is unconstitutional, posted on 17 January 2013.
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