Adolescent Participation In Research Research Articles

Evolving capacity of children and their best interests in the context of health research in South Africa: An ethico-legal position.

The existing ethico-legal regulation of adolescent children's participation in health research in South Africa is currently unclear. The article interrogates the existing framework governing children's consent to research participation, with specific emphasis on discrepancies in consent norms in law and ethical guidelines. Against the backdrop of the constitutional directive that requires that a child's best interests are of paramount importance in every matter concerning the child, the article assesses whether sufficient consideration is given to children's evolving maturity and capacities when consent to their participation in health research is sought. The article provides specific recommendations and proposes a legislative change to consent provisions in the National Health Act 61 of 2003 in order to address the existing lacunae and to align the framework with constitutional imperatives and international fundamental rights considerations.

Contrasting Comprehension of HIV Research by Adolescents, Young Adults, and Caregivers in Western Kenya: A Cross-sectional Analysis.

Adolescent participation in research is critical to inform interventions that improve outcomes for this group. Adolescents and young adults living with HIV often present to care without caregivers, yet caregiver permission is typically required for those younger than 18 years. We evaluated whether understanding of key consent information differed between adolescents ( n = 1,393) and caregiver adults ( n = 169). Compared with caregivers, adolescents aged 10-14 years showed significantly lower understanding, whereas understanding for older adults living with HIV did not differ significantly from caregivers. Risks were the least understood consent information for all age groups. Our findings suggest that for low-risk research, waiving caregiver permission requirements will not compromise the ethical need to ensure understanding of research before enrollment and may allow adolescents greater access to potential research benefits.

Evaluation of a youth-led participatory action research to address adolescent sexual and reproductive health and rights issues in Senegal

ABSTRACT Participatory approaches are increasingly popular in public health, but remain little used to address adolescent health issues. However, adolescent participation in research has enormous potential for identifying solutions to health issues that concern them. In Senegal, a youth-led participatory action research (YPAR) project was implemented in four communities where teams of adolescents were trained to conduct a research project and identify solutions to address adolescent sexual and reproductive health and rights (ASRHR) issues. This article presents the results of the project evaluation, which aimed to explore the potential of YPAR to address ASRHR issues and inform future YPAR projects. Observations and interviews were carried out during results dissemination meetings in each of the communities. The evaluation of the project demonstrated the potential of YPAR to identify relevant solutions, while promoting positive and meaningful adolescent participation. Despite some difficulties, such as community resistance, the youth researchers were able to successfully complete their research project, while developing their confidence and self-esteem. The adolescents were convinced that they could act as agents of positive social change. This project has shown that it is possible and relevant to involve adolescents in research projects, and that this approach has significant potential in global health.

Shifting From Tokenism to Meaningful Adolescent Participation in Research for Obesity Prevention: A Systematic Scoping Review.

Background: Traditionally, adolescent participation in research has been tokenistic. Adolescents are rarely afforded the opportunity to influence decision-making in research designed to prevent obesity. Engaging adolescents in meaningful decision-making may enhance research translation. This review aimed to analyze the current modes and nature of adolescent participation in obesity prevention research decision-making.Methods: A systematic scoping review was conducted using Arksey and O'Malley's six-stage framework. Six major databases were searched for peer-reviewed primary research studies with adolescent participation related to obesity, physical activity, and diet. Modes of adolescent participation were categorized based on the Lansdown-UNICEF conceptual framework for measuring outcomes of adolescent participation. The framework outlines three modes of meaningful participation: (i) consultative, which involves taking opinions and needs into consideration; (ii) collaborative, where adolescents are partners in the decision-making process; and (iii) adolescent-led participation where adolescents have the capacity to influence the process and outcomes. The degree of involvement in research cycles was classified based on the National Health and Medical Research Council consumer engagement framework. Five stages of the research cycle were determined: identify, design and develop, conduct, analyze and disseminate.Results: In total, 126 papers describing 71 unique studies were identified. Of these, 69% (49/71) took place in the USA, and 85% (52/61) were conducted in minority or underserved communities, while males were more likely to be under-represented. In 49% (35/71) of studies, participation was consultative and 9% (6/71) of studies involved an adolescent-led approach. Furthermore, 87% (62/71) of studies incorporated adolescent participation in one or more of the research cycle's formative phases, which involve eliciting views, opinions and idea generation. Only 11% of studies engaged adolescents in all five stages of the research cycle where adolescents could have more influence over the research process.Conclusion: Meaningful adolescent participation in the obesity prevention research cycle is limited. Empowering and mobilizing equal partnership with adolescents should be at the forefront of all adolescent-related obesity prevention research.

Ethical considerations for involving adolescents in biomedical HIV prevention research

BackgroundInvolvement of adolescent girls in biomedical HIV research is essential to better understand efficacy and safety of new prevention interventions in this key population at high risk of HIV infection. However, there are many ethical issues to consider prior to engaging them in pivotal biomedical research. In Uganda, 16–17-year-old adolescents can access sexual and reproductive health services including for HIV or other sexually transmitted infections, contraception, and antenatal care without parental consent. In contrast, participation in HIV prevention research involving investigational new drugs requires adolescents to have parental or guardian consent. Thus, privacy and confidentiality concerns may deter adolescent participation. We describe community perspectives on ethical considerations for involving adolescent girls in the MTN 034 study in Uganda.MethodsFrom August 2017 to March 2018, we held five stakeholder engagement meetings in preparation for the MTN 034 study in Kampala, Uganda (NCT03593655): two with 140 community representatives, two with 125 adolescents, and one with 50 adolescents and parents. Discussions were moderated by the study team. Proceedings were documented by notetakers. Summary notes described community perspectives of adolescent participation in HIV research including convergent, divergent or minority views, challenges, and proposed solutions.ResultsMost community members perceived parental or guardian consent as a principal barrier to study participation due to concerns about adolescent disclosure of pre-marital sex, which is a cultural taboo. Of 125 adolescent participants, 119 (95%) feared inadvertent disclosure of sexual activity to their parents. Community stakeholders identified the following critical considerations for ethical involvement of adolescents in HIV biomedical research: (1) involving key stakeholders in recruitment, (2) ensuring confidentiality of sensitive information about adolescent sexual activity, (3) informing adolescents about information to be disclosed to parents or guardians, (4) offering youth friendly services by appropriately trained staff, and (5) partnering with community youth organizations to maximize recruitment and retention.ConclusionsStakeholder engagement with diverse community representatives prior to conducting adolescent HIV prevention research is critical to collectively shaping the research agenda, successfully recruiting and retaining adolescents in HIV clinical trials and identifying practical strategies to ensure high ethical standards during trial implementation.

Adolescent Participation in Research, Policies and Guidelines for Chronic Disease Prevention: A Scoping Review Protocol.

Adolescents (10–24 years old) account for 23% of the global population. Physical inactivity, suboptimal dietary intake, overweight, and obesity during adolescence are risk factors associated with chronic disease development into adulthood. Research, policies, and guidelines that seek to prevent chronic disease risk factor development rarely engage adolescents in planning and decision-making processes. The aims of this review are to investigate (i) how adolescents currently participate in research, policy, and guidelines for reduction of chronic disease risk factors, and (ii) provide recommendations to optimize adolescent participation in future research, policy, and guideline decision making for chronic disease prevention. A systematic scoping review of the health peer-review research, policy, and guidelines, using Arksey and O’Malley’s six-stage framework, will be conducted. Participatory outcomes will be assessed based on the Lansdown-UNICEF conceptual framework for measuring adolescent participation. Classified as consultative, collaborative, or adolescent-led according to the degree of influence and power adolescents possess in the decision- making processes. Consultation with adolescents via digital surveys and focus groups will provide further information, perspective, and insight. Qualitative data will be analyzed by descriptive numerical summary and qualitative content analytical techniques. The title of this protocol is registered with Joanna Briggs Institute and Open Science Framework, doi:10.17605/OSF.IO/E3S64.

Research participation provides adolescents and parents a launching pad for conversations.

Little is known about whether adolescent participation in sexual health research prompts adolescents and parents to have conversations about sensitive topics. One year after being presented with a hypothetical microbicide safety study, 248 adolescent-parent dyads were asked about conversations they may have had after their initial study visit. Sixty-three per cent of adolescents and 82% of parents reported having a conversation about the study. A launching conversation about broader topics (e.g. risk behaviours) was reported by 8% of adolescents and 17% of parents. Because there is evidence that conversations are occurring, researchers could provide guidance to help facilitate potentially sensitive discussions.

“I think the parent should be there because no one was born alone”: Kenyan adolescents’ perspectives on parental involvement in HIV research

Despite a pressing need for adolescent HIV research in sub-Saharan Africa, ethical guidance for conducting research among minor adolescents is lacking. One ethical issue is the degree to which parents should be involved in the research process. The existing discourse is predominantly speculative and focuses on negative consequences of parental involvement. We use empirical data to describe the perspectives of Kenyan adolescents on parental involvement in consent and disclosure of HIV test results within a research study context. We conducted two rounds of focus group discussions with 40 adolescents in western Kenya to ask about minor adolescent participation in HIV research. We analysed data using codes and matrices. Kenyan adolescents were largely in favour of parental involvement during the research process. Half felt adolescent minors should solicit parental consent to participate, and nearly all said parents should learn the HIV test results of adolescent minors in order to provide necessary support. From their perspective, involvement of parents in research extends beyond obtaining their consent to providing essential support for youth, regardless of HIV status, both during and beyond the research study. Ethical guidelines that prioritise adolescent autonomy in research must consider reasons to involve parents considered important by adolescents themselves, particularly in low-resource settings.

Parent Perspectives About Sexual Minority Adolescent Participation in Research and Requirements of Parental Permission

PurposeLesbian, gay, bisexual, transgender, and other sexual and gender minority (LGBTQ) adolescents and young adults experience health inequities relative to heterosexuals but may be reluctant to participate in research that requires guardian permission. Institutional review boards are often reluctant to approve studies without parental permission because of concerns about parent reactions. There is little to no data from the parent's perspective on these issues. We aimed to understand parent perspectives on parental permission requirements for minimal risk studies of LGBTQ health inequities. MethodsWe conducted semistructured interviews with 31 parents of LGBTQ individuals. We presented a vignette describing an HIV behavioral surveillance protocol and assessed beliefs about whether parental permission should be required under various conditions (i.e., varying adolescent demographics, study procedures). ResultsMost parents (74.2%) believed that parental permission should not be required, and this percent increased when considering adolescent participants for whom permission would be less feasible or potentially more dangerous (e.g., homeless adolescents). Qualitative analyses revealed that many parents were concerned about research quality and negative consequences for adolescents if permission was required. Others wanted to help support their child in making decisions about research and health care. ConclusionsMost parents believed that parental permission should not be required for a minimal risk study, and the reasons for their beliefs fell squarely in line with federal regulations regarding adolescent self-consent to research. Studies of LGBTQ adolescent health inequities should receive waivers of parental permission to obtain representative samples and minimize risk of harm to the adolescent.

An Examination of Incentive Strategies to Increase Participation in Outcomes Research for an Adolescent Inpatient Unit.

Tracking adolescent outcomes after inpatient hospitalization is important in informing clinical care for this age group, as inpatient care is one of the most expensive treatment modalities. This study examined 4 incentive strategies used to maintain adolescent participation in follow-up research (at 6, 12, and 18 mo) after their discharge from the hospital (N=267). A generalized estimation equation approach was taken to investigate whether different incentive strategies predicted adolescent completion of the follow-up assessments at each time point. Findings demonstrate that implementation of social worker contact significantly differed from other incentive strategies in increasing adolescent completion of follow-up assessments (Z=2.51, P=0.012) over the 3 time points, even when controlling for age and sex. Although these findings ultimately need to be confirmed through a randomized controlled study of incentive strategies, they provide preliminary support for the notion that relational incentives, such as maintaining contact with a member of the clinical team at the hospital, may be particularly important in promoting adolescent participation in outcomes research.

Legal Barriers to Adolescent Participation in Research About HIV and Other Sexually Transmitted Infections.

Whether adolescents can participate in clinical trials of pharmacologic therapies for HIV prevention, such as preexposure prophylaxis, without parental permission hinges on state minor consent laws. Very few of these laws explicitly authorize adolescents to consent to preventive services for HIV and other sexually transmitted infections. Unclear state laws may lead to research cessation. We have summarized legal, ethical, and policy considerations related to adolescents' participation in HIV and sexually transmitted infection prevention research in the United States, and we have explored strategies for facilitating adolescents' access.

Attitudes and beliefs toward biobehavioural research participation: voices and concerns of urban adolescent females receiving outpatient mental health treatment

Background: Biobehavioural research methodology can be invasive and burdensome for participants – particularly adolescents with mental illnesses. Human biological researchers should consider how methodological impositions may hinder adolescent research participation. However, literature on adolescent’s voices and concerns toward biobehavioural research participation is virtually non-existent.Aim: This study was designed to determine adolescents’ perceptions of participation in research involving the collection of biomarkers via blood, saliva and/or urine samples.Subjects and methods: Urban adolescent females (aged 12–19) receiving outpatient mental health treatment (n = 37) participated in focus groups with concurrent survey administration to explore attitudes, beliefs and willingness/intentions toward biobehavioural research participation.Results: Participants had favourable attitudes toward biobehavioural research and were amenable to provide each specimen type. Mistrust for research emerged, however, and concerns related to privacy and confidentiality were expressed.Conclusion: Participant recruitment is a critical component in study design and implementation; this includes knowledge of population-specific recruitment barriers and facilitators. This innovative paper provides a context for the research participants’ decision-making process, strategies to allay fears and concerns and concrete areas to target in research-related interventions. Although the findings are from a specific, US-based sample, the implications warrant replication of the research in other geosocial settings.

Empirically Derived Knowledge on Adolescent Assent to Pediatric Biomedical Research

Background: There has been a recent growth in empirical research on assent with pediatric populations, due in part to the demand for increased participation of this population in biomedical research. Despite methodological limitations, studies of adolescent capacities to assent have advanced and identified a number of salient psychological and social variables that are key to understanding assent. Methods: The authors review a subsection of the empirical literature on adolescent assent focusing primarily on asthma and cancer therapeutic research; adolescent competencies to assent to these studies; perceptions of protocol risk and benefit; the effects of various social context variables on adolescent research participation decision making; and the interrelatedness of these psychological and social factors. Results: Contemporary studies of assent, using multivariate methods and updated approaches to statistical modeling, have revealed the importance of studying the intercorrelation between adolescents’ psychological capacities and their ability to employ these capacities in family and medical decision-making contexts. Understanding these dynamic relationships will enable researchers and ethicists to develop assent procedures that respect the authority of parents, while at the same time according adolescents appropriate decision-making autonomy. Conclusions: Reviews of empirical literature on the assent process reveal that adolescents possess varying capacities for biomedical research participation decision making depending on their maturity and the social context in which the decision is made. The relationship between adolescents and physician-investigators can be used to attenuate concerns about research protocols and clarify risk and benefit information so adolescents, in concert with their families, can make the most informed and ethical decisions. Future assent researchers will be better able to navigate the complicated interplay of contextual and developmental factors and develop the empirical bases for research enrollment protocols that will support increased involvement of adolescents in biomedical research.

Predicting Adolescent Asthma Research Participation Decisions From a Structural Equations Model of Protocol Factors

To examine similarities and differences in the process that parents and adolescents use to make decisions concerning participation in an asthma clinical trial. We hypothesized that a single conceptual model, tested through structural equations modeling, could explain adolescent assent and parent consent for adolescent research participation. One hundred nine adolescents enrolled with at least one parent and received an asthma evaluation from a pediatric asthma specialist and then evaluated a hypothetical asthma research protocol. Family members independently evaluated the protocol and made research participation decisions. Perceived risk, benefit, and compensation were direct predictors of participation decisions for parents and adolescents. Adolescents perceived direct study benefit from the relationship with the physician, however parents did not. Parent decisions were most strongly associated with perceived risk, and parents associated discomfort with risk more strongly than did adolescents. Protocol procedures contributed to perceptions of benefit and discomfort for parents and adolescents. Parent and adolescent research participation decisions are influenced by protocol variables in similar ways, although there are differences that account for disagreements within families. Findings may help investigators develop protocols that appeal to parents and adolescents and highlight issues of particular importance to address during the process of informed consent.

Include Them and They Will Tell You: Learnings From a Participatory Process With Youth

Encouraging youth voice, visibility, and active participation in adolescent-related research is strongly advocated in the literature. In this article, we describe how participatory approaches informed by arts-based methods (e.g., reflective writing, dramatization) were used with adolescents to enhance the research process in an exploratory study designed to develop and evaluate prevention resources for sexual risk-taking behaviors.Youth aged 15 to 17 years participated in iterative focus groups conducted over a 1-year period in school settings in Prince Edward Island, Canada. Descriptions of our experiences, strategies, and insights provide evidence for guiding practice to optimize adolescent participation in research.

Parental permission and perceived research benefits in adolescent STI research.

An understanding of why parents provide consent for adolescent participation in research on sensitive topics can inform and improve the ethical conduct and review of such research. As part of a longitudinal study of sexually transmitted infections (STIs) in lower-income adolescents, we asked 134 parents why they permitted their daughter to participate, analyzing responses using qualitative methods. Over half described participation benefits, providing reasons such as the study being generally good for their daughters, sex education, someone to talk to, and STI testing. Other reasons included positive interactions and familiarity with research and clinical staff, friend or family member participation, and adolescent autonomy in making the decision to participate. If parents perceived their daughter to be "at risk" in some way, such as for STI or pregnancy, they were more likely to cite participation benefits. These data can be used to make such research more sensitive to family and community needs.

Enrolling Adolescents in Asthma Research: Adolescent, Parent, and Physician Influence in the Decision-making Process

Background. The factors influencing family decisions to participate in adolescent asthma research are not well understood. Legal and ethical imperatives require adolescent research participation to be voluntary. While parents and adolescents often agree about research decisions, disagreements may also occur with relative frequency. Physician recommendations are also known to influence research participation decisions. Little attention has been given to how these dynamics may affect adolescents' involvement in decisions to participate in research. Objective. To examine the influence of family and physician-investigator relationships and recommendations on adolescent asthma clinical research participation decisions. Methods. A statewide community sample of 111 adolescents 11 to 17 years of age, with a diagnosis of asthma, and their parents participated in this study. Adolescents received a medical evaluation from an asthma specialist and then the family was offered participation in a hypothetical asthma clinical trial. By random assignment, the research study was presented by either the same or an unknown asthma specialist, and half the families in each group also received affirmative recommendations from the asthma specialist to participate in the hypothetical asthma clinical trial. Parents and adolescents made initial private decisions about participating in the trial. Then, following a family discussion of the clinical trial, a final research participation decision was made. Results. Thirty-three percent of parents and adolescents initially disagreed about the research participation decision. When disagreements occurred, final decisions followed the parents' initial views except when the physician-investigator was known and a recommendation was made. Families with initial disagreement about participating were less likely to enroll when the investigator was unknown or when no recommendation was made. Adolescents who initially disagreed with parents' views were less likely to concur with the final research participation decision, felt less comfortable, and were less likely to feel they influenced the decision. Conclusions. Parents' views on research decisions take precedence over adolescents' views in most circumstances. Physician-investigator relationships may reduce parental resistance to participation and enhance adolescent decision-making autonomy when research participation is desired by the adolescent.

Effectively Obtaining Informed Consent for Child and Adolescent Participation in Mental Health Research

With the recent expansion of child mental health research, more attention is being paid to the process of informed consent for research participation. For the consent to be truly informed, it is necessary that the relevant information be both disclosed and actually understood. Traditionally, much effort has gone to ensuring the comprehensiveness of consent/assent documents, which have progressively increased in length and complexity, whereas less attention has been paid to the comprehensibility of these documents. Available data indicate that many parent and children have difficulties appreciating the research nature of treatment studies and that a higher level of formal education among the parents is associated with a greater degree of understanding. Promising approaches to achieving truly informed research participation have emerged, such as additional time for parents to meet with the researchers and using postexplanation questionnaires for identifying issues in need of further clarification. Research is needed to develop and test strategies for improving the effectiveness of the informed consent process in child mental health.

Ethical Approaches to Adolescent Participation in Sexual Health Research

Purpose In this paper we make the case for the importance of adolescent sexual health research, and argue that requiring parental consent for adolescent participation may (a) be unwarranted, (b) be inconsistent with the principles of justice and inclusiveness, (c) be confusing, and (d) serve to silence young people who most need to have a voice in sexual health research. Methods Through a case study of the Toronto Teen Survey, we offer concrete suggestions and alternatives for protecting adolescent health research participants in community-based settings and promoting ethical research approaches. Results Strategies suggested include: (1) adopting a community-based participatory research approach, (2) careful attention to youth-friendly protocols and consent procedures, (3) proper training of all research staff and peer researchers, (4) partnering with experienced community based youth-serving agencies, (5) paying maximum attention to issues of confidentiality and anonymity, and (6) valuing participation appropriately. Conclusions Institutional review boards and researchers should be encouraged to adopt localized context-dependent strategies that attend to the unique vulnerabilities of their particular study populations. Attention to flexibility, vulnerability, and community-specific needs is necessary to ensure appropriate ethical research practices that attend to the health and well-being of young people.

Sensitive Research With Adolescents: Just How Upsetting Are Self-Report Surveys Anyway?

Distress related to answering personal survey questions about drug use, suicidal behavior, and physical and sexual abuse were examined in multiple convenience samples of adolescents. Samples varied in consent procedures utilized (active vs. passive parental consent), data collection setting (school vs. juvenile justice), developmental level (middle school vs. high school). Participation rates differed across consent procedures (e.g., 93% with passive vs. 62% with active parental consent). Results indicated that small percentages of adolescents in every sample reported frequently feeling upset while completing the survey (range 2.5% to 7.6%). Age, race, gender, and data collection strategy did not emerge as significant predictors of feeling upset. Instead, as hypothesized, adolescents reporting a history of suicidal ideation or attempt, illicit drug use, or experiences of physical or sexual victimization endorsed more frequent feelings of upset while completing the survey than peers without these experiences. Taken together, however, these sensitive event experiences explained only 6.6% of the variance in adolescents' upset ratings. The scientific and ethical implications of these findings are discussed with regard to adolescent participation in survey research about sensitive topics.