Ethical challenges of conducting HIV related research in adolescents

1. Ethical challenges of conducting HIV related research in adolescents Dr Harry Moultrie Head of Epidemiology and Biostatistics Wits Institute for Reproductive Health & HIV

2. Disclaimer • I’m not an ethicist

4. First add a few million adolescents and an HIV epidemic

5. Adolescents “The period of physical and psychological development from the onset of puberty to maturity” WHO uses 10-20 years • Who am I? • Am I okay? • Do I like my family/lot in life? • What do I believe? • Progressive development of the ability to reason and think abstractly and with a future perspective • Evolving responsibilities, independence, self esteem and autonomy • Romantic interests blossom • Adolescents are extraordinarily self conscious (generally) • Many of their health related problems are associated with behaviours that they find • secret/private; shameful; embarrassing

6. Adolescents

7. Working with adolescents What not to do: • Don’t treat them like a child • Don’t treat them like an adult • Don’t ignore them or speak about them in the 3rd person • Don’t humiliate them (careful of jokes about teens) • Don’t dismiss their emotions (i.e. fear of the blood draw) • Don’t take on the authority of parent • Don’t take on the attitude of the patient • Don’t take personal offense, remain objective and professional, factual, be careful of tone

8. Working with adolescents What to do: Respect their progressive autonomy: • Engage them – aim for bidirectional communication • Include them directly (decrease communication with the adult in the room, consider asking them to leave after hearing their concerns) • What do you think about this? • Do you understand? • Do you have any questions or suggestions? • LISTEN to them • Educate them - do 1 minute topic talks

9. 2008 Youth Risk Behaviour Survey • 38% of learners had reported ever having had sex, with 13% of them reporting their age of debut under 14 years. • 10% had ever been forced to have sex • 9% had forced someone else to have sex • In the past six months 24% had experienced feelings of sadness or hopelessness, and 21% had attempted suicide; • 50% reported ever having drunk alcohol, and 29% for having engaged in binge drinking in the past month. • Does not differentiate between HIV-infected and HIV-uninfected adolescents.

10. HIV incidence in adolescents • Annual HIV incidence rate in 15-19 year old women in South Africa in 2010 estimated to be ~2.5% (ASSA2008) • Mental health, substance abuse, and alcohol all associated with risky sexual behaviour HSRC, National HIV Prevalence, Incidence, Behaviour and Communication survey, 2008

11. Emergence of perinatally HIV-infected Adolescents

12. Prevalence of perinatally HIV-infected adolescents • Estimated that 36% of HIV-infected infants are slow progressors with median survival of 16 years (Ferrand, AIDS 2009) South Africa Zimbabwe

13. South Africa’s death statistics: young women

14. Specific issues in HIV positive adolescents • Disclosure is a pre-requisite • HIV is a sexually transmissible infection, which is a complex burden for a young person developing their sexual identity to carry. • HIV remains a stigmatised condition so it is hard to share with peers • Many perinatally HIV-infected teens are double orphans: • Unresolved grief and continued loss • Often have multiple caregivers and move around a great deal • Absence of a legal guardian • Tendency for families and services to shelter or overprotect these childrenhindering their drive to autonomy • Possibility of increased risk taking behaviour such as alcohol, drugs, sex as a result of discounting future though little data from SSA • Adolescents VERY concerned about their reproductive potential and how to conceive safely • Many have learning difficulties and are sexually delayed so school can be tough...

15. ...add in a bunch of statutes

16. Relevant South African Laws • Bill of Rights • National Health Care Act • Children’s Act • Sexual Offences and Related Matters Amendment Act • Choice on Termination of Pregnancy Act • South African Schools Act • The Basic Conditions of Employment Act

17. Legal issues • No clear statute governing research in children (yet) • When Section 71 of the National Health Act is implemented: • parental/legal guardian consent will be a legal requirement for all health research (trial and non-trial) involving minors • MoH approval will be required for non-therapeutic research • Inconsistent maturity requirements • Inconsistent requirements regarding when consent from legal guardian/parent vs care-giver is required

18. Age of consent for health Legal guide to age thresholds for children and young people, Children’s Institute, University of Cape Town, April 2011

19. ... season with some ethical guidelines

20. Ethical Principles • Autonomy • Beneficence • Non-maleficence • Justice

21. Guidelines on consent for research • The DoH GCP (2006) guidelines provide that minors cannot consent on their own to participation in clinical trials and that consent must be obtained from a parent or a LG. • The National Health Research Ethics Council guidelines (2004) allow that adolescents can only consent unassisted to minimal risk research (where research risks are approximate to those of the child’s everyday life). Clinical trials are generally held to present a higher standard of risk than this, therefore, consent from a parent or LG must be secured. • MRC Guidelines for Medical Research: “Therapeutic research, therefore, may be undertaken with the consent of a minor over the age of 14 years if it takes the form of treatment, and with the consent of a minor over the age of 18 years if it involves an operation. Such minors‘ competence to consent accordingly extends to health research which is tantamount to treatment or an operation and, hence, to therapeutic research only. (In addition, consent from a parent or legal guardian is desirable.)”

22. ...and mix well.

23. Key ethical-legal complexities (in prevention trials) • Who consents for trial enrolment? Who consents to the range of health-related interventions that may be provided as part of the trial? • What components of the trial should adolescents enjoy confidentiality for? • What disclosures are likely to trigger reporting obligations? • What should researchers do to intervene to assist adolescents when key problems are picked up? Strode, A. & Slack, C. (2010). Selective Ethical-legal norms in adolescent HIV prevention trials: Consent, confidentiality and mandatory reporting. European and Developing Countries Clinical Trials Partnership (EDCTP): 2010. DRAFT FOR COMMENT

24. Norm 1: A parent or LG must provide consent for adolescents to take part in trials Currently, there is no clear legal standard specifying when children can independently consent to research, however, there are ethical norms: • The DoH GCP guidelines • The National Health Research Ethics Council guidelines Strode, A. & Slack, C. (2010)

25. Counter arguments to Norm 1 Children’s act recognises the (limited) autonomy of adolescents Requirement of parental/LG is inflexible to “best interests” of children (Children’s Act) Burden of disease – Joint UN programme on HIV/AIDS (Justice) Child-headed households and children not in care of their parents/LGs (Justice) ‘Emancipated’ minors (CIOMS) (Autonomy) “Parental knowledge of the subject matter may place the adolescents at some risk of questioning or even intimidation by their parents”. (CIOMS) (Non-maleficence)

26. Norm 2: Adolescents should consent independently to key trial components, even though their parents/LGs will be providing consent to trial enrolment Adolescents can consent independently to : • Terminations of Pregnancy • HIV testing • Medical treatment, including STI and HIV treatment provided sufficient maturity • Contraceptives Strode, A. & Slack, C. (2010)

27. Norm 3: Adolescents should enjoy confidentiality for key trial components (1) Adolescents have the right to confidentiality for interventions that they consented to independently: • Adolescents of 12 years and older (and not their parents) should receive HIV and STI test results; • Adolescents of 12 years and older should enjoy confidentiality for access to contraceptives; • Adolescent TPs (and not their parents) should get results of pregnancy tests and/ or enjoy confidentiality for TOPs. Strode, A. & Slack, C. (2010)

28. Norm 3: Adolescents should enjoy confidentiality for key trial components (2) • Adolescents have a right to privacy if there is an expectation of privacy that society regards as reasonable. • Where the law is silent on whether a right to privacy exists, one can use the “legitimate expectation test” to establish if something should be kept private. • It can be argued that adolescents who are 16 years and older have the right to confidentiality regarding their sexual risk data. That is, older adolescents (and not their parents) should get the results of sexual risk assessments. Strode, A. & Slack, C. (2010)

29. Norm 4: Adolescents’ right to confidentiality can be limited • In law, a child’s right to confidentiality regarding their health status can be limited where this is in their best interests. • In ethics, respect for emerging autonomy can be balanced by the need to minimize harms and promote welfare. • In law, South African courts have generally held that the best interests of children require a wide range of factors, including those which promote a child’s physical, moral, emotional and spiritual welfare, to be considered during decision-making. • Adolescents, who acquire conditions or a health status with long-term complications that need on-going support, should be asked to disclose to a trusted adult within a reasonable time-frame, based on the principle of best interests. Strode, A. & Slack, C. (2010)

30. Norm 5: Both the parent and the adolescent should consent to confidentiality parameters • In law, consent is valid only if it based on a full appreciation of information most people would consider very important to know. • In ethics, consent is only meaningful if it is based on a full understanding of the personal implications of research participation. • In prevention trials, it is possible that the parent/LG may refuses enrolment when they understand these matters, or the child may refuse to take part. Strode, A. & Slack, C. (2010)

31. Norm 6: If adolescents are being abused or neglected, this should be reported to authorities • Requirement to report any child that has been sexually abused, deliberately neglected or physically abused • medical practitioners, nurses, psychologists, social service professionals, social workers and volunteers • Researchers should assist children by referring them for various kinds of support • Assistance could involve encouraging adolescents to reach out for all forms of adult support, including their reaching out to their parents, where this seems helpful. Strode, A. & Slack, C. (2010)

32. Norm 7: If adolescents are engaged in sexual offences, this should be reported to the authorities Adolescents’ right to confidentiality is expressly limited when the disclosed conduct constitutes a sexual offense (rape and CSW) • In ethics, respect for emerging autonomy can be balanced by the need to minimize harms and promote welfare. • In law, the Sexual Offences and Related Matters Amendment Act, requires any person who is aware of a sexual offence having been committed against a child to report this to the South African Police Service. Strode, A. & Slack, C. (2010)

33. Norm 8: There is no legal obligation to report other offenses but adolescents should be assisted Where adolescents contravene other laws, there may be no legal obligation to report this, but there is an ethical responsibility to assist. • The South African Schools Act requires all children between the ages of 7 – 15 to attend school. • Trial attendance should not interfere with the school attendance. • The Basic Conditions of Employment Act asserts that it is illegal for children under the age of 15 to work. • A researcher is not under a legal obligation to take further steps when a research participant informs the researcher of a third party ,who has been the “victim” of a crime or has “committed” a crime. • But there is an ethical responsibility to assist adolescents Strode, A. & Slack, C. (2010)

34. Norm 9: Both parent and adolescent should consent to confidentiality limits posed by reporting • The last norm is that both parents and adolescents must understand what information will be kept confidential and what will be disclosed to authorities. • In prevention trials, it should be explained to parents that the researchers are not necessarily required by law to tell parents if a report is made to authorities. • However, each case will be approached on a individual basis with the best interests of the child being the basis for deciding whether parents should be informed. Strode, A. & Slack, C. (2010)

37. Case Study: Adolescent Risk-taking Behaviour and Psychosocial Health Survey

38. Background Complex relationships between internal identity, social context, self-efficacy, mental health, substance abuse and sexual activity in youth. Data often inconsistent, few longitudinal studies. • Depressive symptoms associated in with transactional sex, IPV and rape in both young men and women (Nduna) • Depressive symptoms associated with high risk behaviour in SA adult population (Smit) • Childhood adversity associated with later high risk behaviour, alcohol, depression and HIV (Jewkes) • Some studies show evidence of increased psychiatric disorders or mental health problems among PHIV+ youth whereas others have found no difference (Chernoff, Mellins, Elkington) • HIV- Orphans have worse mental health on all measures of mental health. Strongly mediated through poverty (Cluver) • PTSD: 38% of HIV- kids in Cape Town (n=58) diagnosed with PTSD. Similar to rates found in positive adults. No data in HIV+ children

39. Objectives • To describe and compare the adolescent populations attending Harriet Shezi Children’s Clinic and the Youth Friendly Service at Esselen Street Clinic with regards to: • Demographics, socio-economic status, household structure and schooling • Risk taking behaviour including sexual, alcohol and drug use • Mental health including symptoms of depression and PTSD • To explore the associations between high risk sexual activity, substance abuse and psychosocial factors within and between HIV+ and HIV- adolescents attending the clinics

40. Study Design Cross-sectional study • Self administered questionnaires and structured interviews • Medical record review Population: • Age ≥14 and <18 years Consent: • To avoid undue parental/LG/care-giver pressure on adolescents to participate, study staff will only discuss the study with parents/care-givers after adolescent assent has been obtained. • Caregivers/parents/LGs will then be asked to give permission for their child/ward to participate in the survey, however since both adolescent clinics, and in particular the YFS, are explicitly sexual and reproductive health services, in order to protect the confidentiality of the adolescents the parents/care-givers will not be informed by the study team of the nature of the clinical services

41. Reporting of abuse protocol • Limitations on confidentiality expressly stated in ICF • under-age non-consensual sex or abuse to be reported to authorities • Participant informed that s/he has reported abuse in interview and that, as per the information in the consent form, it is the obligation of study staff to report this matter • The participant will be counseled and will: • Establish whether there is a close family/community member who can be included in the discussion and the reporting process to offer support to the participant. • together with the participant and family member if desired/possible, report the abuse to the social worker closest to the participant’s home. • If the social worker thinks reporting the abuse to the VEP and South African Police Services is an appropriate method of action, they will discuss this with the participant.

42. Would you approve the study?

43. What are the issues?

44. What are the issues? • Is this a limited risk study? • Some risk is present – psychological distress • But, some benefit too – bringing issues into the open • Includes consent from care-givers and not necessarily parents • Participants could independently consent to any medical/psychological treatment required as a result of participation in the survey if have sufficient maturity • Reporting of abuse / non-consensual under-age sex protocol in place • MRC Youth behaviour survey was approved, but was anonymous and consent was obtained from parents first

45. Response from ethics committee • Adolescents to be approached for consent first. Could be viewed as disrespectful of the parent-child relationship. • For noting-the adolescents are attending sexual reproductive clinics for services may be doing so without parental knowledge. • The naughtiest child is the least supervised child and may be missed-how will researchers get around this? • Recommend use 18 and 19 year olds and ask them how they felt when they were younger

46. Conclusion • “Best interests of the child” are not always easy to determine and involve a multitude of competing issues • Complex interplay between public health, children’s rights, ethical principles and legal requirements • Since it is unlikely that clear guidance will be provided anytime soon, RECs will need to evaluate applications on a case-by-case basis • RECs to be encouraged to waiver requirement for parent/LG and/or care-giver consent where approprriate • Flexibility is currently under threat by section 71 of NHA

47. Questions?