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 Last Revised January 2013 1 Research Involving Children Standard Operating Procedure Human Research Ethics Committee, Faculty of Health Sciences, University of Cape Town 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: 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 Last Revised January 2013 2 Research Involving Children Standard Operating Procedure Human Research Ethics Committee, Faculty of Health Sciences, University of Cape Town 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 Last Revised January 2013 3 Research Involving Children Standard Operating Procedure Human Research Ethics Committee, Faculty of Health Sciences, University of Cape Town 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. Last Revised January 2013 4 Research Involving Children Standard Operating Procedure Human Research Ethics Committee, Faculty of Health Sciences, University of Cape Town 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’: 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: 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: 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 Last Revised January 2013 5 Research Involving Children Standard Operating Procedure Human Research Ethics Committee, Faculty of Health Sciences, University of Cape Town 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: 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: 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: 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: Last Revised January 2013 6 Research Involving Children Standard Operating Procedure Human Research Ethics Committee, Faculty of Health Sciences, University of Cape Town 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 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. Last Revised January 2013 7 Research Involving Children Standard Operating Procedure Human Research Ethics Committee, Faculty of Health Sciences, University of Cape Town 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 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. Last Revised January 2013 8 Research Involving Children Standard Operating Procedure Human Research Ethics Committee, Faculty of Health Sciences, University of Cape Town 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. Last Revised January 2013 9 Research Involving Children Standard Operating Procedure Human Research Ethics Committee, Faculty of Health Sciences, University of Cape Town 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: 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. Last Revised January 2013 10 Research Involving Children Standard Operating Procedure Human Research Ethics Committee, Faculty of Health Sciences, University of Cape Town 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 Last Revised January 2013 11 Research Involving Children Standard Operating Procedure Human Research Ethics Committee, Faculty of Health Sciences, University of Cape Town 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) 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 Rape and sexual assault Statutory rape and sexual assault Last Revised January 2013 12 Research Involving Children Standard Operating Procedure Human Research Ethics Committee, Faculty of Health Sciences, University of Cape Town 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: 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 A designated child protection organisation (e.g. Child Welfare Society) The provincial department of social development A police official Sexual Offences Act Immediately to a police official What is a sexual offence? Sexual Offences Act Last Revised January 2013 13 Research Involving Children Standard Operating Procedure Human Research Ethics Committee, Faculty of Health Sciences, University of Cape Town ‘Sexual penetration’ includes any act which causes penetration to any extent whatsoever by: 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: 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 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 Last Revised January 2013 14 Research Involving Children Standard Operating Procedure Human Research Ethics Committee, Faculty of Health Sciences, University of Cape Town Consequences of informing the child of your reporting obligation 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. Last Revised January 2013 15 Research Involving Children Standard Operating Procedure 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. Last Revised January 2013 16 Research Involving Children Standard Operating Procedure 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. Last Revised January 2013 17