Presentation on theme: "1 GROUPWORK (1) Ethical/ Behavioural Group Rotational brainstorming problem analysis Consultation on ethical-legal complexities in adolescent HIV vaccine."— Presentation transcript:
1 GROUPWORK (1) Ethical/ Behavioural Group Rotational brainstorming problem analysis Consultation on ethical-legal complexities in adolescent HIV vaccine & microbicide trials: Durban, South Africa 5 September 2007
2 1. What are the key issues? Is it necessary to enroll adolescents at all? Scientists need to defend this position. Regulatory vs ethics Consent: Ethics and law – legal: age of consent, who should consent. Contradictions in law Consent: Autonomy vs protection – extent of parental involvement; risk of polarising parents & adolescents – norm is some degree of interaction. Consent: How are seroconversions dealt with if there is not parental consent? Culture: Is adolescent enrollment insensitive in certain cultures? Input from science: Consent processes must be contextualized for each community where adolescents will be recruited Input from science: Assessment of understanding may have to be better. Input from community: Consent process: Can’t administer the process in the same way. We have to do better in the consent processes with adolescents! Innovation is needed Input from community: Informed consent testing of comprehension needs to happen consistently. Counsellors need to be better trained to assess understanding! How do they probe properly etc?
3 1. What are the key issues? Risk of therapeutic misconception: Lack of understanding of their protection during the trial; perception that they are receiving health care vs being research subjects. Risks of invasive procedures: Fear of needles, pelvic exams. Procedures are too risky for adolescents, cause for concern for adolescents Risk of disinhibition – concerns raised about the risk versus discomfort with the trials possibly? Addition from Science Group: be more precise about the term. Get data from other studies to counter this claim Addition from Community: Risk behaviour of adolescents: We don’t have a good understanding of who is doing what with who, when and how often (“sexual networking”). Especially for adolescents. Standard education campaigns are not really working; we need a better understanding. Input from science: We need to address this issue of increased risk behaviour, and perception that this happens? Ask Merck – can they share their data on whether adolescents risk behaviour increased? Merck didn’t collect this! Did Vaxgen do an analysis by age group?
4 1. What are the key issues? Benefits: Standard of care – where do we stop with each individual? Need to have guidelines for managing seroconversion/pregnancy. Issues raised in VCT need to be addressed in trials. Limits of responsibility for researchers? Not only specific to individual trial but also across trials (minimum standards) – needs to be consistent across trials Benefits: Adolescents should be offered a range of health services/benefits during participation – what are the known things we can give adolescents to help them with their health? Ethics review: Bodies in SA have different standards for parental consent
5 2. Is anything unique to, or plays out differently in, vaccine vs microbicide trials? Scientific justification: Why enrol adolescents in MTs? Are they not little adults? Dissent here. But the justification needs to be spelled out more clearly. Consent: For microbicides – men are also exposed to the product. So are partners to be informed/ involved? Safety concerns for men Confidentiality of microbicides – male partners can tell when women are using microbicides! Microbicide trial impacts on sexual behaviour where vaccines don’t – For adolescents – might not have relationships with their partners where they can discuss such issues like mc use
6 2. Is anything unique to, or plays out differently in, vaccine vs microbicide trials? Microbicide trials more complex behaviourally – must use the product when they gave sex etc MTs versus VTs: who has longer term risks?? Are vaccines more long term? Implications of ARV-based microbicides. Adolescents tend to have short-term focus. Dissent. Is disinhibition likely to be different between microbicide & vaccine trials? (dissent) Inputs from community: MTs may have another unique risk, e.g. impact on bone density with Tenovifir? Inputs from community: PREP trials may have a unique risk: That is, enrolling young women + seroconvert (and don’t test) that continue on product…this holds out risk of increased resistance
7 2. Is anything unique to, or plays out differently in, vaccine vs microbicide trials? Product sharing – specific to microbicides and not vaccines. Addition from Community Group: counter this with good education for adolescents Ethical review: Is there inequity in REC decision between vaccine and microbicide involvement of adolescents???? Has this happened??? Demandingness of interventions: are microbicide trials more demanding than vaccines? (dissent) Long-term antibody testing – unique to vaccine trials. In MTs, cultural practices more NB because the product can alter sexual experience, e.g. in some settings dry sex may be preferred. Addition from science group: not so in Zambia.
Adapted from E Emanuel (2005)8 3. Are any issues unique to, or exacerbated in, developing vs developed country setting? Benefit/ Health care issues: ability to treat adolescents on trial. Adolescents tend to fall through cracks. Consent: Parental consent operationally more difficult in developing countries – families are split, don’t have parents Different risk-benefit ratio: Younger age of infection so more benefit to enrolling young people – than compared to Western countries; Input from science: not all developing counties have same incidence rates in adolescents as SA. Different trial phases in developing (phase 3) vs. developed countries (phase I/II) due to incidence rates
Adapted from E Emanuel (2005)9 3. Are any issues unique to, or exacerbated in, developing vs developed country setting? Review capacity might be less in developing countries – less experienced/well-formed IRBs Less legal/ethical protection for adolescents in developing countries than developed countries Culture? Debate – is culture only relevant in developing countries? Addition from science group: Culture in developed world setting is critical Less resources in developing countries – can’t provide adolescent specific services. Addition from science: In inner city US care may not be great but sites would offer a higher standard to adolescents.
10 4. What are the priorities we should focus on? Consent Benefits Scientific justification – clearer materials for stakeholders
11 4. Additions from science group HIV antibody issue is critical; PAVE 100 and Merck – we don’t know how long antibody response will last…Networks are making a concerted effort to come up w consistent response to how this would be managed in the US. HVTN is working with countries to consider this. But this must be flagged in other settings. Adults may be better able to self-identify + access help for a FP test. Can adolescents advocate as well for themselves and access resources? Implications for military services entry or testing in the battlefield? for example. Are they limiting their options early in life? We need more advocacy with military for example. It is not insurmountable but needs major attention. A select test is being developed that could be more helpful than what we currently have. This risk may be more exacerbated in settings rolling out routine testing, rapid testing. LONG TERM ACCESS TO CONFIRMATORY TESTING IS A PRIORITY.
12 Clarifications + additions (science group) Community participation for adolescents will have to be more sophisticated than adults, e.g. more impact on protocols. Very complex in research-naive communities. Staff may need to be better matched to adolescent participants in terms of age; Adolescent friendly sites – after hours clinics for example. Can’t process samples after hours!
13 Additions (Community) For adolescent trials, we need to do better to integrate social and behavioral issues into the trial, e.g. assessment of understanding and adherence We can’t loose sight of the HIV infected persons, better coordination between prevention and care initiatives COMMUNITY PARTICIPATION IS A PRIORITY. WE NEED BETTER AWARENESS-RAISING; WE NEED MORE EDUCATORS, ESPOUSED POLICIES NEED TO BETTER IMPLEMENTED. E.g. In Cape Town focus group discussions have paired parents with adolescents that are not their children, to stimulate debate and exchange