Assent Process Research Articles

Analyzing Empowerment Processes Among Cancer Patients in an Online Community: A Text Mining Approach.

BackgroundPeer-to-peer online support groups and the discussion forums in these groups can help patients by providing opportunities for increasing their empowerment. Most previous research on online empowerment and online social support uses qualitative methods or questionnaires to gain insight into the dynamics of online empowerment processes.ObjectiveThe overall goal of this study was to analyze the presence of the empowerment processes in the online peer-to-peer communication of people affected by cancer, using text mining techniques. Use of these relatively new methods enables us to study social processes such as empowerment on a large scale and with unsolicited data.MethodsThe sample consisted of 5534 messages in 1708 threads, written by 2071 users of a forum for cancer patients and their relatives. We labeled the posts in our sample with 2 types of labels: labels referring to empowerment processes and labels denoting psychological processes. The latter were identified using the Linguistic Inquiry and Word Count (LIWC) method. Both groups of labels were automatically assigned to posts. Automatic labeling of the empowerment processes was done by text classifiers trained on a manually labeled subsample. For the automatic labeling of the LIWC categories, we used the Dutch version of the LIWC consisting of a total of 66 word categories that are assigned to text based on occurrences of words in the text. After the automatic labeling with both types of labels, we investigated (1) the relationship between empowerment processes and the intensity of online participation, (2) the relationship between empowerment processes and the LIWC categories, and (3) the differences between patients with different types of cancer.ResultsThe precision of the automatic labeling was 85.6%, which we considered to be sufficient for automatically labeling the complete corpus and doing further analyses on the labeled data. Overall, 62.94% (3482/5532) of the messages contained a narrative, 23.83% (1318/5532) a question, and 27.49% (1521/5532) informational support. Emotional support and references to external sources were less frequent. Users with more posts more often referred to an external source and more often provided informational support and emotional support (Kendall τ>0.2; P<.001) and less often shared narratives (Kendall τ=−0.297; P<.001). A number of LIWC categories are significant predictors for the empowerment processes: words expressing assent (ok and yes) and emotional processes (expressions of feelings) are significant positive predictors for emotional support (P=.002). The differences between patients with different types of cancer are small.ConclusionsEmpowerment processes are associated with the intensity of online use. The relationship between linguistic analyses and empowerment processes indicates that empowerment processes can be identified from the occurrences of specific linguistic cues denoting psychological processes.

Industry and Patient Perspectives on Child Participation in Clinical Trials: The Pediatric Assent Initiative Survey Report

Obtaining assent from children participating in clinical trials acknowledges autonomy and developmental ability to contribute to the consent process. This critical step in pediatric drug development remains poorly understood, with significant room for improving the clarity, efficiency, and implementation of the assent process. Beyond ethical necessity of informing children about their treatment, the assent process provides the advantages of including children in discussions about their diagnosis and treatment-allowing greater understanding of interventions included in the study. A formalized assent process acknowledges the child as a volunteer and provides a forum for questions and feedback. Legal, cultural, and social differences have historically prevented the development of clear, concise, and accessible materials to ensure children understand the clinical trial design. Published guidelines on obtaining pediatric assent are vague, with many decisions left to local institutional review boards and ethics committees, underscoring the need for collaboratively designed standards. To address this need, 2 surveys were conducted to quantify perspectives on assent in pediatric clinical trials. Two digital surveys were circulated in the United States and internationally (October 2014 to January 2015). The first survey targeted children, parents, and/or caregivers. The second polled clinical trial professionals on their organizations' experience and policies regarding pediatric assent. Forty-five respondents completed the child and parent/caregiver survey; 57 respondents completed the industry survey. Respondents from both surveys detailed experiences with clinical trials and the impediments to securing assent, offering potential solutions to attaining assent in pediatric patients. An important opportunity exists for standardized practices and tools to ensure pediatric patients make well-informed decisions regarding their participation in clinical trials, using materials appropriate to their level of understanding. These tools would establish a baseline standard for the assent process and be made available to researchers, improving their ability to secure assent from young patients.

Multimedia Aided Consent for Alzheimer’s Disease Research

ABSTRACTObjectives: Optimizing the research consent process simultaneously fosters respect for autonomy and protection of those with diminished capacity for autonomy. This study evaluated the effectiveness of an enhanced research consent procedure, employing multimedia disclosure and corrective feedback, in improving decisional capacity among 114 people with mild-to-moderate Alzheimer’s disease (AD) and 134 non-psychiatric comparison (NC) subjects.Methods: Participants were randomized to consent type (routine versus enhanced) and protocol type (lower versus higher risk). Outcomes included a 5-item questionnaire assessing immediate comprehension, MacArthur Competence Assessment Tool for Clinical Research assessing four components of decision-making capacity, and categorical decisional capacity (based on a cut-score established in reference to expert judgments for a subset of participants).Results: There was no significant effect of the enhanced consent procedure, relative to routine consent, on immediate comprehension or decisional capacity.Conclusions: Multimedia tools do not appear to be the solution to better consent for AD research.Clinical Implications: Given the ethical primacy of informed consent and issues of justice for impaired populations who might be harmed by an absence of research-based treatment advances, continued search for ways to more meaningfully engage people with AD in the consent or assent process is warranted.

Development of a consensus operational definition of child assent for research

BackgroundThere is currently no consensus from the relevant stakeholders regarding the operational and construct definitions of child assent for research. As such, the requirements for assent are often construed in different ways, institutionally disparate, and often conflated with those of parental consent. Development of a standardized operational definition of assent would thus be important to ensure that investigators, institutional review boards, and policy makers consider the assent process in the same way. To this end, we describe a Delphi study that provided consensus from a panel of expert stakeholders regarding the definitions of child assent for research.MethodsBased on current guidelines, a preliminary definition of assent was generated and sent out for review to a Delphi panel including pediatric bioethicists and researchers, Institutional Review Board members, parents, and individuals with regulatory/legal expertise. For each subsequent review, the process of summarizing and revising responses was repeated until consensus was achieved. Panelists were also required to rank order elements of assent that they believed were most important in defining the underlying constructs of the assent process (e.g., capacity for assent, disclosure). In providing these rankings, panelists were asked to frame their responses in the contexts of younger (≤ 11 yrs) and adolescents/older children (12-17 yrs) in non-therapeutic and therapeutic trials. Summary rankings of the most important identified elements were then used to generate written construct definitions which were sent out for iterative reviews by the expert panel.ResultsConsensus regarding the operational definition was reached by 14/18 (78%) of the panel members. Seventeen (94%) panelists agreed with the definitions of capacity for assent, elements of disclosure for younger children, and the requirements for meaningful assent, respectively. Fifteen (83%) members agreed with the elements of disclosure for adolescents/older children.ConclusionsIt is hoped that this study will positively inform and effect change in the way investigators, regulators, and IRBs operationalize the assent process, respect children’s developing autonomy, and in concert with parental permission, ensure the protection of children who participate in research.

Perspectives of US and Australian Hand Therapists About Pediatric Hand Transplantation.

Pediatric hand transplantation (PHT), an investigational therapy, was recently performed in the United States. Perspectives of hand therapists about PHT patient selection (inclusion and exclusion criteria), team configuration, patient assent, and patient compliance were explored. Quantitative survey. We used a research ethics committee-approved 18-question e-link anonymous questionnaire to survey members of the American Society of Hand Therapists and the Australian (AU) Hand Therapy Association for their perspectives on PHT. All surveyed hand therapists work with children (n = 18 Australia [AU], n = 85 United States) and some had been involved in adult hand transplant rehabilitation (28% AU, 21% United States; P = .543, not significant (NS)). The US and AU therapists differ regarding their opinions on multidisciplinary team membership, smoking as an exclusion criterion, and risk of posttransplant rehabilitation noncompliance. This research opens a dialogue on the clinical and ethical complexity of PHT, including team configuration, inclusion/exclusion criteria, the assent process, and rehabilitation access/compliance. Furthermore, international perspectives are informative as they highlight funding and access issues and can potentially guide global professional society policy.

Rereading assent in critical literacy research with young children

Literacy researchers often include young children in the research process. Yet discussions about the complexities of gaining and keeping assent are often missing in research reports. In this paper, we report on our attempts to make the assent process, a typical requirement for Institutional Review Boards, an educative experience for children in a critical literacy Kindergarten classroom. We asked: When assent is treated as a text to be read, revisited, interpreted and negotiated, what meanings are made by young children? We designed research lessons and collected artefacts of students’ learning, including interviews. Our analysis traced children’s developing recognition and critical analysis of concepts such as voluntary participation, understanding of procedures, confidentiality, benefits and risks of the study, and the right to ask questions. We found that when assent is treated as an educative process, particularly in the context of critical literacy education, young children learn and make meaning about their rights and responsibilities as participants. We present evidence of meaning-making, transfer and voluntariness of each ethical concept. Implications for literacy research with young children are discussed.

Informed Assent Recall Among Adolescents in Substance Use Disorder Treatment Research

ABSTRACTEvidence suggests that vulnerable populations such as substance users, those involved in the criminal justice system, and those with cognitive deficits often fail to recall information regarding the informed assent process. This study investigated correlates of assent quiz errors (AQE) among adolescents enrolling in a substance use disorder treatment study. Method: Adolescents (ages 13 to 19) entering substance use treatment completed a standard informed consent procedure to participate in a longitudinal research study, followed by a brief six-item assent quiz. Results: Informed assent quiz errors were lower in this study relative to those observed in the adult literature. Being male and having lower treatment resistance was associated with making an AQE. Both days of marijuana use and days spent in the criminal justice system were associated with AQE. Hyperactivity-impulsivity approached significance (p = .057) but was not a correlate of AQE. Conclusion: Those collecting assent should be aware that heavily using males involved in the criminal justice system are prone to make more errors, and should use procedures such as assent quizzes to enhance their understanding of study procedures. Future research should investigate the impact of motivation and consider using experimental designs to test adolescent recall of study procedures under various assenting conditions.

Evaluation of Involvement of Children/Adolescents Diagnosed with Cancer in Their Own Assent Process and Treatment

Kanser gibi yasami tehdit eden hastalik durumunda hekimler arasinda tibbi gercegin hastaya soylenmesi egilimi her ulkenin kendi ahlaksal, sosyal ve kulturel yapisina gore farklilik gosterebildigi gibi, ulkelerin saglik politikalari ve geleneksellesmis hekim tutumlari da belirleyici olabilmektedir. Bunun yani sira hastanin kanser tanisi hakkinda bilgilendirilme yontemi, hastanin ozelliklerine ve kullandigi psikolojik uyum yontemlerine bagli olarak da degisebilmektedir. Hastanin, orselenebilir kabul ettigimiz cocuk ve ergen yas grubunda olmasi, durumu daha da karmasik hale getirebilmektedir. Hekimlerin ve ebeveynlerin; kanser ve olum konusundaki endiselerinin yansimasi, bu endiselerden cocugu koruma istekleri; yikici bilgiyle bas edebilecek kadar psikolojik guclerinin olmadigi yonundeki inanclari, cocugu ve cocuk kavrami icinde muamele goren ergenleri onay surecinin disinda birakabilmektedir. Oysaki cocuklarin ve ergenlerin tedavi karari surecine dahil edilmeleri; hekim-hasta iliskisinin en onemli sartlarindan biri olan karsilikli guveni, kanser tedavisine uyumu ve tedavi icin gerekli olan isbirligini saglama acisindan onemlidir. Bu makalede; oncelikle cocuklardan tedaviye yonelik onay almanin onemi vurgulanacak; sonrasinda kanser gerceginin soylenmesinde yetke ogesi olan ebeveynlerin ve hekimlerin tutumlarina bakilacak; ulkemiz acisindan konu ile ilgili kisa bir degerlendirme yapildiktan sonra, kanser surecinde iletisim konusunun onemi ve diger onerilerimizi dile getirerek yazin sonlandirilacaktir

Developing a new justification for assent.

BackgroundCurrent guidelines do not clearly outline when assent should be attained from paediatric research participants, nor do they detail the necessary elements of the assent process. This stems from the fact that the fundamental justification behind the concept of assent is misunderstood. In this paper, we critically assess three widespread ethical arguments used for assent: children’s rights, the best interests of the child, and respect for a child’s developing autonomy. We then outline a newly-developed two-fold justification for the assent process: respect for the parent’s pedagogical role in teaching their child to become an autonomous being and respect for the child’s moral worth.DiscussionWe argue that the ethical grounding for the involvement of young children in medical decision-making does not stem from children’s rights, the principle of best interests, or respect for developing autonomy. An alternative strategy is to examine the original motivation to engage with the child. In paediatric settings there are two obligations on the researcher: an obligation to the parents who are responsible for determining when and under what circumstances the child develops his capacity for autonomy and reasoning, and an obligation to the child himself. There is an important distinction between respecting a decision and encouraging a decision. This paper illustrates that the process of assent is an important way in which respect for the child as an individual can be demonstrated, however, the value lies not in the child’s response but the fact that his views were solicited in the first place.SummaryThis paper demonstrates that the common justifications for the process of assent are incomplete. Assent should be understood as playing a pedagogical role for the child, helping to teach him how specific decisions are made and therefore helping him to become a better decision-maker. How the researcher engages with the child supports his obligation to the child’s parents, yet why the researcher engages with the child stems from the child’s moral worth. Treating a child as having moral worth need not mean doing what they say but it may mean listening, considering, engaging or involving them in the decision.

Adapting ethical guidelines for adolescent health research to street-connected children and youth in low- and middle-income countries: a case study from western Kenya.

BackgroundStreet-connected children and youth (SCCY) in low- and middle-income countries (LMIC) have multiple vulnerabilities in relation to participation in research. These require additional considerations that are responsive to their needs and the social, cultural, and economic context, while upholding core ethical principles of respect for persons, beneficence, and justice. The objective of this paper is to describe processes and outcomes of adapting ethical guidelines for SCCY’s specific vulnerabilities in LMIC.MethodsAs part of three interrelated research projects in western Kenya, we created procedures to address SCCY’s vulnerabilities related to research participation within the local context. These consisted of identifying ethical considerations and solutions in relation to community engagement, equitable recruitment, informed consent, vulnerability to coercion, and responsibility to report.ResultsSubstantial community engagement provided input on SCCY’s participation in research, recruitment, and consent processes. We designed an assent process to support SCCY to make an informed decision regarding their participation in the research that respected their autonomy and their right to dissent, while safeguarding them in situations where their capacity to make an informed decision was diminished. To address issues related to coercion and access to care, we worked to reduce the unequal power dynamic through street outreach, and provided access to care regardless of research participation.ConclusionsAlthough a vulnerable population, the specific vulnerabilities of SCCY can to some extent be managed using innovative procedures. Engaging SCCY in ethical research is a matter of justice and will assist in reducing inequities and advancing their health and human dignity.

The Ethical Inclusion of Children With Psychotic Disorders in Research: Recommendations for an Educative, Multimodal Assent Process

This article addresses the issue of properly assenting children with psychotic disorders to participate in clinical research. Due to the protective concerns with such a vulnerable population, additional precautions are necessary to ensure that youth with psychotic disorders assent to research with an appropriate level of understanding regarding study procedures. Current literature suggests that positive/negative symptoms and minor cognitive deficits do not interfere with the ability to comprehend study-related information for adults with psychosis if the study information is presented through an educative process. Similarly, youth benefit from repeated presentation of procedures and periodic assessment of their comprehension. An integrated educative process is proposed that emphasizes the importance of an interactive consent through repetition and participant/investigator feedback.

Patient Involvement in Informed Consent for Pediatric Phase I Cancer Research

To examine children's and adolescents' involvement in the informed consent conference for phase I cancer trials and test associations with patient age, ease of understanding, and pressure to participate. Participants included 61 patients aged 7 through 21 years who were offered participation in a phase I trial. Consent conferences were audiotaped, transcribed, and coded for communication between patients and physicians and between patients and parents. On the basis of word counts, the mean proportion of the consent conference in which the physician was talking to the patient was 36%; the vast majority (73%) of this communication consisted of giving information. Physician-patient communication increased with age, but overall levels of patient-to-physician communication were low (3%). After controlling for patient age, greater physician-to-patient communication was associated with greater ease of understanding. The focus on providing information in the context of informed consent may come at the expense of other communication exchanges that are important to patients, especially in the context of end-of-life decisions. Children and adolescents may benefit from the assent process when physicians direct more of their communication to them. Future research should identify the reasons for low patient communication during the consent conference and strategies to enhance their participation in decision making about phase I trial enrollment.

Parent ratings of ability to consent for clinical trials in fragile X syndrome.

Advances in understanding neurobiology and intellectual disabilities have led to clinical trials testing new medications. This study assessed parents' perceptions of the ability of their son or daughter with fragile X syndrome (FXS), an inherited form of intellectual disability, to participate in the consent process for clinical trials. Four hundred twenty-two families participated in a survey that included six items assessing various aspects of the ability to provide consent. A rank ordering of decisional tasks was found. The easiest task was to understand that the medication was different from his or her medical treatment; the most difficult was the ability to understand and weigh the potential benefits and risks of study participation. Factor analysis suggested that despite the range in difficulty, the six items were best summarized by a single decisional ability score. Parents of 29% of males reported that their son was not at all capable of participating, but the remainder exhibited a range of decisional skills. Factors associated with this variability include age and parents' willingness to enroll their child in clinical trials. We conclude that many individuals with FXS appear to be able to participate at some level in the consent or assent process, but will likely need individualized support to maximize effective participation.

PAeDS-MoRe: A framework for the development and review of research assent protocols involving children and adolescents

We systematically reviewed contemporary literature to create an evidence-informed framework for research studies involving children and adolescents who can assent to participate. We searched seven citation indices to locate peer-reviewed research published in English language journals between 2000 and 2012. After screening 1,231 titles and abstracts for relevance, we assessed levels of evidence, extracted information, and analysed content from 87 articles. Most articles narrowly focused on paediatric assent barriers and facilitators for decision-making about research participation. No articles provided a single, comprehensive ethical framework to guide the development and review of research assent protocols. We developed a 6-step framework that provides guidance to: prepare the child for the assent process; assess the child’s readiness to engage in decision making; discuss the elements of informed consent to the greatest extent possible; seek an initial assent decision; monitor and affirm assent; and respect the child’s role as a research participant. The PAeDS-MoRe framework also supports the creation of process models that address the unique, developmental needs of paediatric sub-groups, and guides the operationalization of jurisdictional requirements for ethical research involving children who are unable to provide free, informed and ongoing consent.

Conversations With Children About DNA and Genes Using an Original Children's Book

IntroductionThe purpose of this evaluation was to compare parent and nurse use of an original children's book about deoxyribonucleic acid (DNA) function as a potential aid in the assent process in research. We also appraised parent's knowledge about DNA and the use of genetic testing results. MethodWe used mixed qualitative and quantitative methods. Parent-child dyads were recruited at an urban pediatric hospital. Knowledge of genetic concepts was assessed in adults with use of the Genetic Knowledge Index. Participants read the book What DNA Does with a nurse or alone and participated in interviews with investigators. The content of field notes from interviews was analyzed. ResultsParent and child knowledge of DNA and gene function was generally poor but improved in most cases, particularly after reading with the nurse. DiscussionThe evaluated book is appropriate as a teaching aid in the child assent process in research or prior to genetic testing but should be presented by clinicians in most cases.

Assent in Research: The Voices of Adolescents

Adolescents join clinical research after investigators obtain their positive agreement or "assent." Although intended to respect adolescents, little is known about the views of adolescents or their parents regarding assent or research enrollment decisions. This study aimed to better understand perspectives of adolescent research participants and their parents about assent and parental permission. Structured interviews were conducted with 13- through 17-year-old teens, enrolled in clinical research at the National Institutes of Health or Seattle Children's Hospital, and separately with one parent. One hundred and seventy-seven adolescent-parent pairs were interviewed. Teens were well distributed by age and gender, represented a wide variety of research and illnesses ranging in severity from mild to life threatening; 20% were healthy volunteers. Teens and parents were generally satisfied with the assent/permission process. Normally, they made the enrollment decision together and teens wanted parents' input and support. About 25% of teens reported pressure to enroll, not only from parents or relatives but also from doctors/nurses/research teams. Only 2% of teens preferred not to sign a consent form. Despite some differing views about how decisions should be made, the current assent/permission process is perceived as satisfactorily respectful by most teens in research. Many teens want to sign consent forms, and teens' signatures should generally be sought. Flexible guidance allows research teams and Institutional Review Boards to customize the assent process for teens in particular studies in order to facilitate an appropriate balance between giving teens a voice reflective of their emerging independence and enabling supportive collaboration with parents.

Teenagers and texting: use of a youth ecological momentary assessment system in trajectory health research with latina adolescents.

BackgroundAdolescent females send and receive more text messages than any others, with an average of 4050 texts a month. Despite this technological inroad among adolescents, few researchers are utilizing text messaging technology to collect real time, contextualized data. Temporal variables (ie, mood) collected regularly over a period of time could yield useful insights, particularly for evaluating health intervention outcomes. Use of text messaging technology has multiple benefits, including capacity of researchers to immediately act in response to texted information.ObjectiveThe objective of our study was to custom build a short messaging service (SMS) or text messaging assessment delivery system for use with adolescents. The Youth Ecological Momentary Assessment System (YEMAS) was developed to collect automated texted reports of daily activities, behaviors, and attitudes among adolescents, and to examine the feasibility of YEMAS. This system was created to collect and transfer real time data about individual- and social-level factors that influence physical, mental, emotional, and social well-being.MethodsYEMAS is a custom designed system that interfaces with a cloud-based communication system to automate scheduled delivery of survey questions via text messaging; we designed this university-based system to meet data security and management standards. This was a two-phase study that included development of YEMAS and a feasibility pilot with Latino adolescent females. Relative homogeneity of participants was desired for the feasibility pilot study; adolescent Latina youth were sought because they represent the largest and fastest growing ethnic minority group in the United States. Females were targeted because they demonstrate the highest rate of text messaging and were expected to be interested in participating. Phase I involved development of YEMAS and Phase II involved piloting of the system with Latina adolescents. Girls were eligible to participate if they were attending one of the participating high schools and self-identified as Latina. We contacted 96 adolescents; of these, 24 returned written parental consent forms, completed assent processes, and enrolled in the study.ResultsYEMAS was collaboratively developed and implemented. Feasibility was established with Latina adolescents (N=24), who responded to four surveys daily for two two-week periods (four weeks total). Each survey had between 12 and 17 questions, with responses including yes/no, Likert scale, and open-ended options. Retention and compliance rates were high, with nearly 18,000 texts provided by the girls over the course of the pilot period.ConclusionsPilot results support the feasibility and value of YEMAS, an automated SMS-based text messaging data collection system positioned within a secure university environment. This approach capitalizes on immediate data transfer protocols and enables the documentation of participants’ thoughts, feelings, and behaviors in real time. Data are collected using mobile devices that are familiar to participants and nearly ubiquitous in developed countries.

Ethical issues in pediatric pharmacogenomics.

Ethical issues in pediatric pharmacogenomics.

Pediatric Clinical Trials: Current Scenario in the Asia Pacific Region

Pediatric Clinical Trials: Current Scenario in the Asia Pacific Region Lisa Marie Saldanha,1 Saumya Nayak,1 Adeline Sng,1 Mei-Ling Long,1 Elisabeth Schrader,2 Amanur Rahman,3 Elvira Zenaida Lansang,1 Karen Wai,1 Ken Lee41Feasibility and Site Identification Asia, Quintiles East Asia Private Limited, Singapore; 2Quintiles Pediatric Center of Excellence, Durham, NC, USA; 3Faculty of Engineering, National University of Singapore, Singapore; 4Asia Site Services, Quintiles East Asia Private Limited, SingaporeObjective: This site survey was conducted to understand the current pediatric clinical trial landscape across countries in the Asia Pacific region, specifically in terms of interest, experience, capabilities, requirements of the ethics committee, patient availability, and overall challenges involved in conducting pediatric trials.Methods and materials: Between May and June 2012, an English language survey form was sent to sites (identified through Quintiles&rsquo; internal database) with pediatric capability and referrals from doctors during a preliminary outreach. In July 2012, the responses from the completed survey forms were entered into SurveyMethods, a web-based central repository. Data analysis was performed in August&ndash;September 2012 using SurveyMethods.Results: Seventy-seven sites were contacted for this survey across the Asia Pacific region. Sixty-four percent (49 sites) completed 63 surveys and confirmed interest to participate in clinical trials in the pediatric population. Seventy-one percent of the sites had prior experience. Eighty percent confirmed needing an assent from pediatric patients; 81%&ndash;95% confirmed acceptance of placebo-controlled and pharmacokinetic studies by ethics committees; and 37% cited challenges in conducting studies in this population.Conclusion: This survey indicates that there is a high level of interest among sites in the Asia Pacific region in conducting pediatric trials across various therapeutic indications. No major insurmountable challenges were identified in conducting pediatric trials. Complexity of the consent and assent process across the countries needs to be considered. Also to be considered are the sites&rsquo; needs as well as trial design adaptations for this population to ensure compliance (minimize invasive procedures, placebo control, visit schedules versus school timings, etc). There also appears to be an adequate patient pool in many indications, and the availability of a database of healthy subjects can assist in faster screening of subjects for vaccine trials.Keywords: Site survey, ethical, challenges, consent patients

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.