South Africa is likely to be the first country in the world to host an adolescent HIV vaccine trial. Adolescents may be enrolled in late 2007. In the development and review of adolescent HIV vaccine trial protocols there are many complexities to consider, and much work to be done if these important trials are to become a reality.
This article sets out essential requirements for the lawful conduct of adolescent research in South Africa including compliance with consent requirements, child protection laws, and processes for the ethical and regulatory approval of research.
This article outlines likely complexities for researchers and research ethics committees, including determining that trial interventions meet current risk standards for child research. Explicit recommendations are made for role-players in other jurisdictions who may also be planning such trials. This article concludes with concrete steps for implementing these important trials in South Africa and other jurisdictions, including planning for consent processes; delineating privacy rights; compiling information necessary for ethics committees to assess risks to child participants; training trial site staff to recognize when disclosures trig mandatory reporting response; networking among relevant ethics commitees; and lobbying the National Regulatory Authority for guidance.
HealthWise South Africa: Life Skills for Adolescents (HW) is an evidence-based substance use and sexual risk prevention program that emphasizes the positive use of leisure time. Since 2000, this program has evolved from pilot testing through an efficacy trial involving over 7,000 youth in the Cape Town area. Beginning in 2011, through 2015, we are undertaking a new study that expands HW to all schools in the Metro South Education District.
This paper describes a research study designed in partnership with our South African collaborators that examines three factors hypothesized to affect the quality and fidelity of HW implementation: enhanced teacher training; teacher support, structure and supervision; and enhanced school environment.
Teachers and students from 56 schools in the Cape Town area will participate in this study. Teacher observations are the primary means of collecting data on factors affecting implementation quality. These factors address the practical concerns of teachers and schools related to likelihood of use and cost-effectiveness, and are hypothesized to be “active ingredients” related to high-quality program implementation in real-world settings. An innovative factorial experimental design was chosen to enable estimation of the individual effect of each of the three factors.
Because this paper describes the conceptualization of our study, results are not yet available.
The results of this study may have both substantive and methodological implications for advancing Type 2 translational research.
Factorial design; Implementation quality; Prevention; Translational research
Strategies to enforce underage drinking laws are aimed at reducing youth access to alcohol from commercial and social sources and deterring its possession and use. However, little is known about the processes through which enforcement strategies may affect underage drinking. The purpose of the current study is to present and test a conceptual model that specifies possible direct and indirect relationships among adolescents’ perception of community alcohol norms, enforcement of underage drinking laws, personal beliefs (perceived parental disapproval of alcohol use, perceived alcohol availability, perceived drinking by peers, perceived harm and personal disapproval of alcohol use), and their past-30-day alcohol use. This study used data from 17,830 middle and high school students who participated in the 2007 Oregon Health Teens Survey. Structural equations modeling indicated that perceived community disapproval of adolescents’ alcohol use was directly and positively related to perceived local police enforcement of underage drinking laws. In addition, adolescents’ personal beliefs appeared to mediate the relationship between perceived enforcement of underage drinking laws and past-30-day alcohol use. Enforcement of underage drinking laws appeared to partially mediate the relationship between perceived community disapproval and personal beliefs related to alcohol use. Results of this study suggests that environmental prevention efforts to reduce underage drinking should target adults’ attitudes and community norms about underage drinking as well as the beliefs of youth themselves.
Underage drinking; Community norms; Enforcement of minimum legal drinking age laws; Personal beliefs; Prevention
South Africa currently has a pluralistic health care system with separate public and private sectors. It is, however, moving towards a socialised model with the introduction of National Health Insurance. The South African legislative environment has changed recently with the promulgation of the Consumer Protection Act and proposed amendments to the National Health Act. Patients can now be viewed as consumers from a legal perspective. This has various implications for health care systems, health care providers and the doctor-patient relationship.
Calling a recipient of health care a ‘consumer’ as opposed to a ‘patient’ has distinct connotations and may result in differential behaviour. Labels reflect the ideals of the context in which they are used. Various models of the doctor-patient relationship exist and different metaphors have been used to describe it. Increasingly there are third parties involved within the doctor-patient relationship making it more difficult for the doctor to play the fiduciary role. In certain parts of the world, there has been a shift from a traditional paternalistic model to a consumerist model. The ethical implications of the commodification of health care are complex. As health care becomes a ‘product’ supplied by the health care ‘provider’, there is the risk that doctors will replace professional ethics with those of the marketplace. Health care is a universal human need and cannot be considered a mere commodity. In modern medical ethics, great emphasis is placed on the principle of respect for patient autonomy. Patients are now the ultimate decision-makers. The new Consumer Protection Act in South Africa applies to consumers and patients alike. It enforces strict liability for harm caused by goods and services. Everyone in the supply chain, including the doctor, can be held jointly and severally liable. This may lead to enormous challenges in health care delivery.
Viewing patients as consumers may be detrimental to the doctor-patient relationship. While it facilitates an emphasis on respect for patient autonomy, it inadvertently results in the commodification of health care. The new legislative environment in South Africa promotes the protection of patient rights. It may, however, contribute to increased medical litigation.
Patients; Consumers; Health care; Consumerism; Commodification; Autonomy; Rights; Ethical; Legal; South African
The conduct of biomedical research involving the participation of human beings implicates a variety of ethical concerns pertaining to such values as dignity, bodily integrity, autonomy, and privacy. These ethical concerns have been translated into a complex regulatory apparatus in the USA, containing specific legal provisions concerning such matters as participant safety, informed consent, and confidentiality. A topic of particular interest for pathologists is the handling of human tissue specimens that may be used for present, or stored for future, research purposes. This article examines the ethical and legal ramifications of obtaining and storing tissue samples for research purposes, with special attention to the issues of informed consent and confidentiality.
ethics; law; research; tissue
The legal requirements and justifications for collecting patient‐identifiable data without patient consent were examined. The impetus for this arose from legal and ethical issues raised during the development of a population‐based disease register. Numerous commentaries and case studies have been discussing the impact of the Data Protection Act 1998 (DPA1998) and Caldicott principles of good practice on the uses of personal data. But uncertainty still remains about the legal requirements for processing patient‐identifiable data without patient consent for research purposes. This is largely owing to ignorance, or misunderstandings of the implications of the common law duty of confidentiality and section 60 of the Health and Social Care Act 2001. The common law duty of confidentiality states that patient‐identifiable data should not be provided to third parties, regardless of compliance with the DPA1998. It is an obligation derived from case law, and is open to interpretation. Compliance with section 60 ensures that collection of patient‐identifiable data without patient consent is lawful despite the duty of confidentiality. Fears regarding the duty of confidentiality have resulted in a common misconception that section 60 must be complied with. Although this is not the case, section 60 support does provide the most secure basis in law for collecting such data. Using our own experience in developing a disease register as a backdrop, this article will clarify the procedures, risks and potential costs of applying for section 60 support.
In 1990 women’s rights activists in Uganda successfully lobbied to amend the Defilement Law, raising the age of sexual consent for adolescent females from fourteen to eighteen years old and increasing the maximum sentence to death by hanging. The amendment can be considered a macro-level intervention designed to address the social and health inequalities affecting young women and girls, particularly their disproportionately high rate of HIV as compared to their male counterparts. While the intention of the law and aggressive campaign was to prosecute “sugar daddies” and “pedophiles,” the average age of men charged with defilement was twenty-one years old and many were believe to be “boyfriends” in consensual sexual liaisons with the alleged victims. This article uses court records, case studies, and longitudinal ethnographic data gathered in central-eastern Uganda to examine the impact of the age of consent law at national and local levels, and specifically what the disjunctures between national intentions and local uses reveal about conflicting views about the sexual privilege and rights. I argue that existing class, gender, and age hierarchies have shaped how the Defilement Law has been applied locally, such that despite the stated aim of “protecting” young women, the law reinstates patriarchal privilege (especially against men of lower social class) while simultaneously increasing the regulation of adolescent female sexuality and undermining their autonomy. This paper demonstrates how ethnography and gender theory—which emphasizes the intersectionality of gender, age, and class in the (re)production of inequalities—can be used to examine consequences of macro-level interventions in ways that may be undetected in conventional public health evaluation techniques but that are crucial for designing and modifying effective interventions.
East Africa; gender; sexuality; HIV; macro-level structural intervention; evaluation; law; Uganda
Several decades of research have shown that lesbian, gay and bisexual (LGB) adults are at high risk for substance use and substance use disorders, and a recent meta-analysis shows that these disparities most probably begin in adolescence; however, no studies to date have examined longitudinal growth in substance use in LGB youth and heterosexual youth to determine if they follow different trajectories into young adulthood. The primary aims of this paper were to estimate individual trajectories of substance use in youth and examine differences between self-identified LGB and heterosexual subsamples.
A school-based, longitudinal study of health-related behaviors of adolescents and their outcomes in young adulthood was used to test our hypotheses (The National Longitudinal Study of Adolescent Health). Participants were included if they were interviewed at all three waves and were not missing information regarding self-identified sexual orientation (n = 10 670).
Latent curve models (LCMs) showed that LGB identity was associated significantly with individual variability in substance use intercepts and slopes, above and beyond age, race and gender. Self-identified LGB youth reported higher initial rates of substance use and on average their substance use increased over time more rapidly than did substance use by heterosexual youth. Two other indicators of sexual orientation (same-sex romantic attraction and same-sex sexual behavior) were also associated with substance use trajectories, and differential results were found for youth who identified as ‘mostly heterosexual’ and bisexual compared with youth who identified as completely heterosexual or homosexual.
Sexual orientation is an important risk marker for growth in adolescent substance use, and the disparity between LGB and heterosexual adolescents increases as they transition into young adulthood. More research is needed in order to examine: causal mechanisms, protective factors, important age-related trends (using a cohort-sequential design), the influence of gay-related developmental milestones, curvilinear effects over time and long-term health outcomes.
Bisexual; gay; lesbian; longitudinal; substance use; youth
This study examined the impact of state and school district-level policies on the prevalence of physical education (PE) and recess in a nationally representative sample of U.S. public elementary schools.
Analyses from annual, nationally representative, cross-sectional surveys of School Administrators in the US.
Data were collected through surveys conducted between February and June during the 2006-07, through 2008-09 school years. State laws and district policies were compiled annually by UIC researchers using established legal research techniques.
The sample size was 47 states, 690 districts, and 1761 schools.
State and District-level PE and recess-related laws
Twenty minutes of daily recess and 150 minutes of PE weekly
The odds of schools having 150 weekly minutes of PE increased if they were located in states (OR, 2.8; 95% CI, 1.3-5.7) or school districts (OR, 2.4; 95% CI, 1.3-4.3) having a law or policy, respectively, requiring 150 minutes of PE weekly. Schools located in states with laws encouraging daily recess were significantly more likely to have 20 minutes of recess daily (OR, 1.8; 95% CI, 1.2-2.8). District policies were not significantly associated with school-level recess practices. Adequate PE time was inversely associated with recess and vice versa suggesting that schools are substituting one form of physical activity for another rather than providing the recommended amount of both recess and PE.
By mandating PE or recess, policy makers can effectively increase school-based physical activity opportunities for youth.
Data protection laws offer such broad exemptions for research that research ethics boards and data custodians lack sufficient guidance as to when it may be acceptable to release data to researchers without consent. The result: idiosyncratic institutional policies that create major challenges for researchers conducting multi-centred studies. The 2005 CIHR Best Practices for Protecting Privacy in Health Research provide an important first step towards greater clarity. However, there is still a need to translate these Best Practices into harmonized policies. This should be seen as an opportunity rather than a threat. Clear rules for data protection will reinforce public trust, which is essential for continued access to personal information for research.
Suicide is a leading cause of death for adolescents. A number of problem behaviors associated with youth suicide fall into the purview of law enforcement personnel, and they are therefore in a position to detect risk and prevent suicidal behaviors. Eight hundred one youth identified as having school difficulty, a group at increased risk for both suicide and legal problems, participated in a paper and pencil survey followed by an interview focusing on suicide risk and protective factors. Linear regression was used to examine the ability of factors within each risk and protective factor dimension to predict current suicide risk. The study goal was to determine the most relevant factors influencing suicide risk in each domain examined. Findings are discussed in terms of implications for assessment and policy for law enforcement personnel.
adolescent; prevention; risk and protective factors; suicide
This study was designed to evaluate the efficacy of the HealthWise South Africa HIV and substance abuse prevention program at impacting adolescents’ polydrug use and sexual risk behaviors. HealthWise is a school-based intervention designed to promote social-emotional skills, increase knowledge and refusal skills relevant to substance use and sexual behaviors, and encourage healthy free time activities. Four intervention schools in one township near Cape Town, South Africa were matched to five comparison schools (N = 4040). The sample included equal numbers of male and female participants (Mean age = 14.0). Multiple regression was used to assess the impact of HealthWise on the outcomes of interest. Findings suggest that among virgins at baseline (beginning of eighth grade) who had sex by Wave 5 (beginning of 10th grade), HealthWise youth were less likely than comparison youth to engage in two or more risk behaviors at last sex. Additionally, HealthWise was effective at slowing the onset of frequent polydrug use among non-users at baseline and slowing the increase in this outcome among all participants. Program effects were not found for lifetime sexual activity, condomless sex refusal and past-month polydrug use. These findings suggest that HealthWise is a promising approach to HIV and substance abuse prevention.
This study investigated attendance at an HIV prevention randomized controlled trial for urban adolescent females. The intervention included four 2-hour sessions that were held at convenient community-based locations. Participants were recruited from reproductive and general health care clinics, as well as youth development programs. Of the 744 girls who consented to participate in the research study, 86% (n = 640) attended one or more of the risk reduction sessions but 14% (n = 104) did not attend any sessions. Data analyses indicated that girls who attended were more likely to be younger, African American, and non-Hispanic. They also reported earlier sexual debut and more recent sexual partners. Results indicate that sexual risk reduction interventions are attractive to many at-risk female adolescents. Strategies to improve attendance are described for this vulnerable population sub-group.
adolescent girls; HIV prevention; intervention attendance; sexual risk
A patient approaching a doctor expects medical treatment with all the knowledge and skill that the doctor possesses to bring relief to his medical problem. The relationship takes the shape of a contract retaining the essential elements of tort. A doctor owes certain duties to his patient and a breach of any of these duties gives a cause of action for negligence against the doctor. The doctor has a duty to obtain prior informed consent from the patient before carrying out diagnostic tests and therapeutic management. The services of the doctors are covered under the provisions of the Consumer Protection Act, 1986 and a patient can seek redressal of grievances from the Consumer Courts. Case laws are an important source of law in adjudicating various issues of negligence arising out of medical treatment.
Error of judgment; medical negligence; prior informed consent
An understanding of the association between adolescents’ sexual and reproductive health knowledge and their use of relevant services is needed to improve young people’s sexual and reproductive health.
Data from the National Survey of Family Growth were used to examine associations between sexual and reproductive health communication (parental and formal) and service use among 2,326 U.S. women aged 15–19 in 2002 and 2006–2008. Chi-square tests and multivariate logistic regression were used to assess relationships between adolescents’ receipt of sexual and reproductive health communication from parents and formal (school, church, community) sources and their use of sexual and reproductive health services.
The majority of adolescents had received parental (75%) and formal (92%) sexual and reproductive health communication; 43% reported recent service use. In unadjusted analyses, parental and formal communication were positively associated with service use. In regression models, overall parental communication remained positively associated with service use (odds ratio, 1.6); parental abstinence-only communication, which was not significant in 2002, was associated with reduced odds of service use for the pooled sample (0.4) and in 2006–2008 (0.3). Formal communication was not associated with service use.
Further research is needed to assess whether comprehensive sexual and reproductive health communication facilitates adolescents’ health care utilization. Examination of how communication sources, quality and content are related to service use is needed to understand adolescents’ sexual and reproductive health knowledge and needs.
Adolescent reproductive health has not continued to receive the attention it deserves since the start of the HIV epidemic. In South Africa, high numbers of adolescent women report pregnancies that are unwanted and yet few have accessed available termination of pregnancy services. Enabling contraception use is vital for meeting the goals of HIV prevention.
A nationally representative survey of South African 15–24 year olds was undertaken. Participants completed a questionnaire on sexual behaviour and provided an oral fluid sample for HIV testing. Analysis of the data was restricted to women (n = 6217), particularly those who reported being sexual active in the last 12 months (n = 3618) and was conducted using svy methods in the program STATA 8.0 to take account of sampling methods. Univariate and multivariate analyses were conducted to explore factors associated with contraceptive use.
Two thirds of all women reported having ever been sexually active and among these 87% were sexually active in the past 12 months. Among women who reported currently being sexually active, 52.2% reported using contraceptives. There was evidence of association between contraceptive use and being employed or a student (vs unemployed); fewer sex partners; type of last sex partner; having talked to last partner about condom use and having ever been pregnant.
Specific emphasis must be placed on encouraging young women to use contraceptive methods that offer protection against pregnancy and STIs/HIV. Our consistent finding of a relationship between discussing condom use with partners and condom use indicates the importance of involvement of male partners in women's contraceptive decisions.
To facilitate the design of effective policies that can address adolescent’s reproductive health problems, it is necessary to gain a thorough understanding of patterns of adolescents’ sexual behavior, and the factors that affect them. Using a unique set of data collected in 2004 from a nationally-representative survey of adolescents, this study examines adolescents’ risky and protective sexual behavior in Burkina Faso. Findings show that 11% of adolescent males had sexual intercourse in last twelve months with more than two partners but did not use condoms. Logistic regression analysis shows that the odds of using condoms increased with years of schooling and self-efficacy in use of condoms. Females who were very confident of getting a male partner to wear a condom were six times more likely to have used a condom at last sex than those who were not confident at all.
Burkina Faso; adolescents; risky sexual behaviors; condoms; HIV/AIDS
There is a need for effective prevention programmes aimed at reducing risk behaviour among South African adolescents. HealthWise South Africa is a school-based programme designed to reduce sexual and substance use risk behaviour, and promote positive use of leisure time among high-school learners (students). Based on successful programmes in the United States of America, HealthWise was developed for use in South Africa and pilot tested in four South African high schools. We carried out a process evaluation to establish the fidelity of implementation and make sure HealthWise was culturally relevant. Data sources comprised focus groups with educators and learners, lesson evaluations and observations, and interviews with school principals. Qualitative analysis of data highlighted pertinent cultural and contextual factors and identified areas for modifying HealthWise in order to promote better programme-consumer fit. These areas centred on time, language, and leisure. We noted a dynamic tension between the educators' desire to adhere to plan, and to make adaptations in accordance with learners' needs and the context. Ultimately, researchers need to find a balance between fidelity of implementation and programme adaptation to obtain effective programmes that are culturally acceptable to local consumers.
This article describes and analyses a research based engagement by a university school of public health in Bangladesh aimed at raising public debate on sexuality and rights and making issues such as discrimination more visible to policy makers and other key stakeholders in a challenging context. The impetus for this work came from participation in an international research programme with a particular interest in bridging international and local understandings of sexual and reproductive rights. The research team worked to create a platform to broaden discussions on sexuality and rights by building on a number of research activities on rural and urban men’s and women’s sexual health concerns, and on changing concepts of sexuality and understandings of sexual rights among specific population groups in Dhaka city, including sexual minorities. Linked to this on-going process of improving the evidence base, there has been a series of learning and capacity building activities over the last four years consisting of training workshops, meetings, conferences and dialogues. These brought together different configurations of stakeholders – members of sexual minorities, academics, service providers, advocacy organisations, media and policy makers. This process contributed to developing more effective advocacy strategies through challenging representations of sexuality and rights in the public domain. Gradually, these efforts brought visibility to hidden or stigmatised sexuality and rights issues through interim outcomes that have created important steps towards changing attitudes and policies. These included creating safe spaces for sexual minorities to meet and strategise, development of learning materials for university students and engagement with legal rights groups on sexual rights. Through this process, it was found to be possible to create a public space and dialogue on sexuality and rights in a conservative and challenging environment like Bangladesh by bringing together a diverse group of stakeholders to successfully challenge representations of sexuality in the public arena. A further challenge for BRAC University has been to assess its role as a teaching and research organisation, and find a balance between the two roles of research and activism in doing work on sexuality issues in a very sensitive political context.
Accessible sexual, reproductive, and mental healthcare services are crucial for adolescent health and wellbeing. It has been reported that school-based healthcare (SBHC) has the potential to improve the availability of services particularly for young people who are normally underserved. Locating health services in schools has the potential to reduce transport costs, increase accessibility and provide links between schools and communities.
A systematic review of the literature was undertaken. Pubmed, Psychinfo, Psychnet, Cochrane CENTRAL, and Web of Science were searched for English language papers published between January 1990 and March 2012
Twenty-seven studies were found which fitted the criteria, of which, all but one were from North America. Only three measured adolescent sexual, reproductive, or mental health outcomes related to SBHC and none of the studies were randomized controlled trials. The remaining studies explored accessibility of services and clinic utilization or described pertinent contextual factors.
There is a paucity of high quality research which evaluates SBHC and its effects on adolescent sexual, reproductive, and mental health. However, there is evidence that SBHC is popular with young people, and provides important mental and reproductive health services. Services also appear to have cost benefits in terms of adolescent health and society as a whole by reducing health disparities and attendance at secondary care facilities. However, clearer definitions of what constitutes SBHC and more high quality research is urgently needed.
School-based health care; School-based health clinics; Adolescent; Adolescent health services; School-based health centers; Sexual and reproductive health; Mental health; Systematic review
Interest in the reproductive health of adolescents continues to grow throughout the world. Few studies had explored the reproductive health knowledge, sexual behavior and experience of sexual coercion among secondary school students in North Eastern states of Nigeria. The objectives of this descriptive survey were to collect data to plan appropriate interventions that meet the reproductive health knowledge, service and skills needs of students in Bauchi, Borno and Gombe states.
Face-to-face interviews were conducted for 624 consenting students who were randomly selected from eighteen secondary schools using an 83-item structured questionnaire. Data were collected on demographic profile, reproductive health knowledge, sexual behavior and experience of sexual coercion.
The mean age of the respondents was 16.5 years. There were slightly more males (52%) than females (48%). Students' knowledge about reproductive health was generally low even though girls had better knowledge than boys. Thirteen percent of the entire students had had sexual experience; significantly more males (19%) than females (6%) had done so (p < 0.001).
Among boys the age at sexual debut ranged from 10–26 with a mean of 15.7 and median of 16. By contrast, the age at first sex among girls ranged from 10 to 18 years with a mean and median of 16.1 and 17 years respectively. Only 24% of those who were sexually active used a condom during their last sexual encounter. Overall 11% of the students reported that they had been tricked into having sex, 9% had experienced unwanted touch of breast and backside, and 5% reported rape.
Students low reproductive health knowledge and involvement in risky sexual activities predispose them to undesirable reproductive health outcomes.
In an ongoing effort of this Journal to develop and further the theories, models, and best practices around eHealth research, this paper argues for the need for a “science of attrition”, that is, a need to develop models for discontinuation of eHealth applications and the related phenomenon of participants dropping out of eHealth trials. What I call “law of attrition” here is the observation that in any eHealth trial a substantial proportion of users drop out before completion or stop using the appplication. This feature of eHealth trials is a distinct characteristic compared to, for example, drug trials. The traditional clinical trial and evidence-based medicine paradigm stipulates that high dropout rates make trials less believable. Consequently eHealth researchers tend to gloss over high dropout rates, or not to publish their study results at all, as they see their studies as failures. However, for many eHealth trials, in particular those conducted on the Internet and in particular with self-help applications, high dropout rates may be a natural and typical feature. Usage metrics and determinants of attrition should be highlighted, measured, analyzed, and discussed. This also includes analyzing and reporting the characteristics of the subpopulation for which the application eventually “works”, ie, those who stay in the trial and use it. For the question of what works and what does not, such attrition measures are as important to report as pure efficacy measures from intention-to-treat (ITT) analyses. In cases of high dropout rates efficacy measures underestimate the impact of an application on a population which continues to use it. Methods of analyzing attrition curves can be drawn from survival analysis methods, eg, the Kaplan-Meier analysis and proportional hazards regression analysis (Cox model). Measures to be reported include the relative risk of dropping out or of stopping the use of an application, as well as a “usage half-life”, and models reporting demographic and other factors predicting usage discontinuation in a population. Differential dropout or usage rates between two interventions could be a standard metric for the “usability efficacy” of a system. A “run-in and withdrawal” trial design is suggested as a methodological innovation for Internet-based trials with a high number of initial dropouts/nonusers and a stable group of hardcore users.
Internet; clinical trials; longitudinal studies; patient dropouts; survival analysis
In this paper, we examine the ways that early adolescents talked, interacted, and made references to events in their individual and collective lives during photography-based focus groups about sexuality and relationships. Twenty-three participants (10 boys and 13 girls) were recruited from three urban schools participating in a comprehensive sex education impact evaluation in the Northeast. We analyzed conversational narratives that were elicited in a group process while sharing photos of important people, contexts, and situations, showcasing participants’ exploration of sexuality and relationships. Our analysis revealed four main themes: (a) direct and indirect family communication about sexuality, (b) accidental and intentional Internet usage, (c) shared and contested peer knowledge, and (d) school as a direct and indirect learning context. Implications and future directions for practice, research, and policy are explored.
Qualitative focus groups; Photography; Sex education; Minority youth; Parent communication; Internet; School context
Clinical trials involving children previously considered unethical are now considered essential because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes that are interpreted in accordance with local laws and procedures raising the importance of contextualizing their implementation.
In Zimbabwe the parental informed consent document for children participating in clinical research is modeled along western laws of ethics and requires that the parent or legally authorized representative provide consent on behalf of a minor. This article highlights the experiences and lessons learnt by Zimbabwean researchers in obtaining informed consent from guardians of orphaned children participating in a collaborative HIV clinical trial involving the Medical Research Council, United Kingdom and four centers, three of which are in Uganda. Researchers were faced with a situation where caregivers of orphaned children were not permitted to provide informed consent for trial participation. The situation contrasted with general clinical practice where consent for procedures on orphans is obtained from their caregivers who are not legal guardians.
The challenges faced in obtaining informed consent for orphans in this clinical trial underscores the need for the Zimbabwe ethics committee to develop an ethical and legal framework for pediatric research that is based on international guidelines while taking into account the cultural context. The Medical Research Council of Zimbabwe has since started the process that is expected to involve critical stakeholders namely the community including children, ethicists, the legal fraternity and researchers.
This article addresses the unresolved conundrum of the legal status of consent forms used in research involving tissue samples or personal data. It identifies which rights participants might have by virtue of any consent form they have signed and which legal remedies might be available to them should the research depart from the terms of the original consent. The paper demonstrates that, although the legal status of consent forms is not clear in the UK, the landscape is evolving. We suggest that the growing legal protection afforded to autonomy and judicial recognition of individual property rights in tissues may offer opportunities for remedies in law where the regulatory regimes controlling uses of human tissue and personal data do not. However, we argue that in the governance of research relationships—which depend crucially on trust—resort to legal remedy may be undesirable. We suggest that treating consent as a one-off event that can be effectively captured in a written document—as the law tends to do—is an inappropriate and counter-productive approach. The aims of ethical research governance will be better served by seeing consent as continuing relational process, requiring on-going mutual respect, opportunity for communication, and accommodation of changing circumstances. The consent form is merely a framing instrument and only the starting point for a partnership that will evolve over time. Crucially, the limits of consent must be recognised in the design and governance of modern research practices. The article concludes with recommendations to reconceive consent in these terms.