Informed Consent Procedures Research Articles

Russian Roulette with Rotterdam Convention

JOM, Vol. 67, No. 11, 2015 DOI: 10.1007/s11837-015-1651-x O 2015 The Minerals, Metals & Materials Society Russian Roulette with Rotterdam Convention Oladele A. Ogunseitan Opinion: For Your Consideration Always interested in hearing the thoughts of our readers, JOM offers For Your Consideration as a forum for individual opinions. On this page, we encourage thoughtful discourse on topics pertaining to JOM coverage areas. Opinions expressed are the author’s and not necessarily those of TMS or the editorial staff. We want to hear from you! Find out how to submit your opinion to JOM at http://www.tms .org/pubs/journals/JOM /authorTypesofPapers .aspx In his treatise on natural history, Pliny the Elder described the invention of a woven napkin material that is LQGHVWUXFWLEOHE\?UHZKLFKKHHQWLWOHG asbestinon. 1 The extraordinary qualities of DVEHVWRV?EHUVPDGHWKHPLQGLVSHQVDEOH for numerous domestic and industrial products and processes. However, evidence increasingly accumulated about adverse health effects of asbestos. Akin to compulsively pulling the trigger on a gun loaded with a single rare bullet aimed at the chest, 125 million people are regularly H[SRVHGWRDVEHVWRV?EHUVDQGHDFK\HDU luck runs out for 107,000 of these people. The outcome for the unlucky is death by mesothelioma among other asbestos- linked preventable diseases. 2 Eradication of asbestos-related chronic diseases may hinge on banning the mining and use of DVEHVWRV?EHUVLQFRQVXPHUSURGXFWV6XFK a ban will require complete cooperation of all nations to adopt binding regulatory policies and the compliance of private corporations with such international decisions. The United Nations’ Rotterdam Convention (RC) provides a nearly perfect framework for advancing toward a mesothelioma-free world. The RC was designed to “promote shared responsibility and cooperative efforts among Parties in the international trade of certain hazardous chemicals in order to protect human health and the environment from potential harm.” 3 To bridge some of the translational science gaps between countries with robust research programs and countries with great needs in disease prevention, the RC emphasizes informed consent, and aims to facilitate information exchange about hazardous chemicals and materials characteristics, thereby supporting national decision-making processes on their production, importation, and exportation (Figure 1). Parties to the RC make binding decisions through unanimous consent during biannual conferences. Although desirable for some types of international governance, the requirement for unanimous consent has proven to be a peculiar weakness of the RC. At 3:45 a.m. on 16 May 2015, the meetings of the Conference of Parties to the Basel, 5RWWHUGDPDQG6WRFNKROP&RQYHQWLRQV ended with much trumpeted successes toward protecting people all over the world from the adverse health impacts of toxic chemicals. But one major failure largely overshadowed the successes—seven countries, led by Russian Federation and including Cuba, India, Kazakhstan, Kyrgyzstan, Pakistan, and Zimbabwe voiced informal opposition to the adoption of a formal recommendation that chrysotile, the serpentine form of asbestos &$61RVKRXOGEHFRPH subject to the prior informed consent procedure by its inclusion in Annex-III of the RC. 5 Despite moving testimony from ailing victims of asbestosis and vocal support from most of the 154 Parties to the RC, Russian Federation, Kazakhstan, .\UJ\]VWDQDQG=LPEDEZHFRQ?UPHG WKHLURSSRVLWLRQDWWKH?QDOSOHQDU session to shoot down the chrysotile recommendation. The 2015 conference LVWKH?IWKWLPHWKDWDIHZFRXQWULHVZLOO have blocked the inclusion of chrysotile in Annex-III of the RC. Delegates of opposing countries usually give three reasons for their staunch position. First, that there are no cost-effective alternatives for chrysotile in the building, construction,

Participant selection for preventive Regenerative Medicine trials: ethical challenges of selecting individuals at risk

The innovative field of Regenerative Medicine (RM) is expected to extend the possibilities of prevention or early treatment in healthcare. Increasingly, clinical trials will be developed for people at risk...

CODEMamb – an observational communication behavior assessment tool for use in ambulatory dementia care

Introduction: Communication improves well-being and quality of life for both people with dementia and their professional and family caregivers. Individualized communication, as required in informed consent procedures and psychosocial interventions, can improve quality of life, especially in ambulatory settings. However, few valid and reliable instruments exist that enable communication to be assessed and communication and behavioral resources to be identified. We, therefore, extended and adapted the newly developed observational instrument CODEM for use in ambulatory settings (CODEMamb).Methods and results: Reliability and validity of the new instrument were studied in a total of 171 patients, whereby principal component analysis revealed three important factors: relationship aspects, verbal communication behavior and nonverbal communication behavior. CODEMambs internal consistency, interrater and retest reliability were satisfactory to excellent. Convergent validity indices, as shown by examining correlations with similar but not identical constructs (CERAD-NP verbal subscales), were medium–high, while the divergent validity index (constructional praxis) was relatively low. The relationship to peer-rating remained nonsignificant. Criterion validity was investigated in groups of patients in accordance with their cognitive status. As expected, verbal communication abilities deteriorate faster than the relationship aspects of communication as the disease progresses.Conclusions: In summary, CODEMamb is a reliable and valid instrument that can be used to collect important information with the ultimate aim of supporting communication with people with dementia.

002.1 Point-of-care testing and immediate treatment of curable sexually transmitted and genital infections among antenatal women in papua new guinea

Background Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) and bacterial vaginosis (BV), are associated with adverse maternal and neonatal health outcomes, particularly preterm birth and low birth weight. These infections are highly prevalent in many low-income settings but remain undiagnosed and therefore untreated in pregnancy because of a lack of suitable diagnostic technology. In 2014, we conducted the first feasibility study of newly-available, easy to use and highly-accurate point-of-care (POC) STI assays in a routine clinical setting in Papua New Guinea (PNG) in preparation for a large-scale field trial to evaluate the potential of this strategy to improve pregnancy outcomes. Methods Women aged 18–35 years attending their first antenatal visit were invited to participate. Following informed consent procedures, women completed a short interview, obstetric examination, and provided self-collected vaginal specimens for clinic-based STI testing, conducted by trained clinic staff: CT/NG and TV were tested using the Cepheid GeneXpert platform, and BV tested using the BVBlue Test. Participants were provided with same-day POC test results, and antibiotic treatment as indicated. Women were also provided routine onsite antenatal HIV and syphilis screening. Results A total of 125 women were enrolled. The prevalence of CT was 20.0%; NG, 11.2%; TV, 37.6%; BV 18.4%; and more than half (67/125) had one or more of these infections. Over 70% of those with a POC-confirmed STI would not have been detected on clinical grounds alone. The prevalence of HIV was 1.6% and active syphilis, 4.0% in this population. All women with an STI and their sexual partners were successfully treated. Conclusion Antenatal POC STI testing and treatment proved feasible in an antenatal setting in PNG. If this strategy is proven to be effective in our future field trial (2015–18), it has the potential to improve pregnancy outcomes in all high-burden, low-income countries worldwide. Disclosure of interest statement Nothing to Disclose

P10.02 Field evaluation of the xpert hpv test for the detection of human papillomavirus infection in women using self-collected vaginal compared to clinician-collected cervical specimens

Background The Cepheid Xpert® HPV Test has high sensitivity and specificity for the detection of HPV infection in women compared to the Roche cobas 4800 HPV assay using cervical specimens. In many high-burden, low-resource countries it will not be feasible to achieve high cervical screening coverage using HPV-DNA technologies that require clinician-collected samples. We are conducting the first evaluation of self-collected vaginal specimens compared to clinician-collected cervical specimens for the detection of HPV infection using the Xpert® HPV Test. This study is being conducted in Papua New Guinea, which has among the highest rates of cervical cancer globally, with an age-standardised incidence of 23.7/100,000 compared to 5.0/100,000 in Australia and New Zealand. Methods Women aged 30–54 years attending two Well Woman Clinics are invited to participate and following informed consent procedures, complete a short interview, clinical examination, and provide self-collected and clinician-collected cytobrush specimens for clinic-based HPV testing. Women are given their cervical test result the same day. Those with a positive HPV test and a positive examination on visual inspection of the cervix with acetic acid are offered same-day cervical cryotherapy. Results A total of 313 women were recruited to end-Feb 2015. There was 94.2% overall percentage agreement (OPA) between vaginal and cervical tests for all high-risk HPV (hrHPV) types; 100% OPA for HPV-16; and 99.7% OPA for HPV 18/45. Based on cervical test results, the prevalence of HPV-16 was 4.2% (13/313); HPV 18/45 was 1.6% (5/313); and other hrHPV, 11.8% (37/313). Overall, 15.7% (49/313) of participants had one or more hrHPV infection. Conclusion Preliminary results suggest that self-collected vaginal specimens compare favourably to clinician-collected cervical specimens for the detection of HPV infection using the Xpert® HPV Test. If confirmed, this finding is likely to have significant implications for future HPV-based cervical screening programs in high-burden, low-resource settings worldwide. Disclosure of interest statement Nothing to Disclose.

Ethical Considerations in the Application of the Scientist–Practitioner Model for Psychologists Conducting Intervention Research

This paper explores the scientist–practitioner model as a paradigm for psychologists involved in treatment research, as it has been instrumental in defining the field of clinical psychology as a science-driven profession. The principles and standards of the APA Ethics Code (Ethical Principles of Psychologists and Code of Conduct with the 2010 Amendments. Retrieved June 3, from, http://www.apa.org/ethics/code/index.aspx 2010) are used as the foundation to guide scientist–practitioners as they navigate unique ethical dilemmas and issues that arise when engaging in the simultaneous pursuit of research and clinical endeavors. Specific ethical issues will be discussed, including conflicts of interest, the process of informed consent, relationship boundaries, and boundaries of competence. Recommendations are made for optimizing outcomes for clients and professionals using this model, including adherence to established informed consent procedures and treatment research protocols, as well as collaboration with those not invested in the outcome of research and clinical endeavors. Solutions are proposed as a means of maintaining the principles of beneficence and nonmaleficence, fidelity and responsibility, and integrity in the ethical practice of treatment outcome research.

Exploring researchers' experiences of working with a researcher-driven, population-specific community advisory board in a South African schizophrenia genomics study.

BackgroundCommunity engagement within biomedical research is broadly defined as a collaborative relationship between a research team and a group of individuals targeted for research. A Community Advisory Board (CAB) is one mechanism of engaging the community. Within genomics research CABs may be particularly relevant due to the potential implications of research findings drawn from individual participants on the larger communities they represent. Within such research, CABs seek to meet instrumental goals such as protecting research participants and their community from research-related risks, as well as intrinsic goals such as promoting the respect of participants and their community. However, successful community engagement depends on the degree to which CABs legitimately represent and engage with communities targeted for research. Currently, there is little literature describing the use of CABs in genomics research taking place in developing countries, and even less in the field of genomics research relating to mental illness. The aim of this article is to describe and consider the contributions made by a researcher-driven, population-specific CAB in a genomics of schizophrenia research project taking place in South Africa, from the perspective of the research team.DiscussionFour broad discussion topics emerged during the CAB meetings namely: 1) informed consent procedures, 2) recruitment strategies, 3) patient illness beliefs and stigma experiences, and 4) specific ethical concerns relating to the project. The authors consider these discussions in terms of their contributions to instrumental and intrinsic goals of community engagement.SummaryThe CAB gave valuable input on the consent processes and materials, recruitment strategies and suggested ways of minimizing the potential for stigma and discrimination. All of these contributions were of an instrumental nature, and helped improve the way in which the research took place. In addition, and perhaps more importantly, the CAB made a unique and important contribution relating to intrinsic functions such as promoting the respect and dignity of research participants and their community. This was particularly evident in ensuring sensitivity and respect of the community’s traditional beliefs about schizophrenia and its treatment, and in this way promoting a respectful relationship between the research team and the participants.

Human health risk assessment of pesticide residues in snappers (Lutjanus) fish from the Navachiste Lagoon complex, Mexico

Organochlorine pesticides (OCPs) residues were determined in fillets of Lutjanus colorado, L. argentiventris, and L. novemfasciatus. Fillet samples were collected bimonthly from February 2012 to February 2013. OCPs average concentrations do not differ significantly according to size, weight, or season, nor do they relate with the physico-chemical parameters of the sea water. The highest concentration and most frequently encountered OCPs were endosulfan sulfate, δ-HCH, and heptachlor epoxide, which indicates their use in the recent past and confirms their persistence. Average concentrations of ∑HCHs, ∑chlordane, and ∑heptachlor in samples were above cancer MRLs according to data from monthly consumed portions. HCHs and heptachlor are listed in Appendix III of the Rotterdam Convention of chemicals placed on a prior informed consent procedure for import and export purposes; they are considered illegal in Mexico. The OCPs concentrations above cancer MRLs in Lutjanus spp. turn its frequent consumption into a human health risk.

Untangling research and practice: What Facebook’s “emotional contagion” study teaches us

Published in 2014, the Facebook “emotional contagion” study prompted widespread discussions about the ethics of manipulating social media content. By and large, researchers focused on the lack of corporate institutional review boards and informed consent procedures, missing the crux of what upset people about both the study and Facebook’s underlying practices. This essay examines the reactions that unfolded, arguing the public’s growing discomfort with “big data” fueled the anger. To address these concerns, we need to start imagining a socio-technical approach to ethics that does not differentiate between corporate and research practices.

Experiences of Women Who Underwent Predictive BRCA 1/2 Mutation Testing Before the Age of 30.

This qualitative interview study focuses on the experiences of a sample of British female BRCA 1/2 carriers who had predictive testing before the age of 30, which is the minimum age for breast screening in the UK. Following appropriate informed consent procedures participants were recruited through the Cancer Genetics Service for Wales. Semi-structured interviews were conducted face-to-face with seven participants, transcribed in full and analyzed using thematic analysis. The motives for testing and perceived advantages described by participants were similar to those identified in previous studies with older participants, such as increased awareness and knowledge and feeling more in control. However some of the perceived disadvantages were specific to younger women, including feeling pressured to make important life decisions earlier than they would have liked, such as about family planning and risk reducing surgery. Participants also reported feeling abandoned or forgotten because of lack of ongoing clinical contact, or feeling "stuck waiting" for screening to begin. However, none felt that these disadvantages were a reason to regret having testing. Findings in this small study suggest that having BRCA 1/2 predictive testing can have positive outcomes for young women even though they may be unable to access interventions such as breast screening. However it may be helpful to encourage young women during pre-test counseling to explore the decisions and choices they may face. These young women could benefit from ongoing support and follow up and increased interaction with healthcare professionals.

Intensive care unit research ethics and trials on unconscious patients.

There are widely acknowledged ethical issues in enrolling unconscious patients in research trials, particularly in intensive care unit (ICU) settings. An analysis of those issues shows that, by and large, patients are better served in units where research is actively taking place for several reasons: i) they do not fall prey to therapeutic prejudices without clear evidential support, ii) they get a chance of accessing new and potentially beneficial treatments, iii) a climate of careful monitoring of patients and their clinical progress is necessary for good clinical research and affects the care of all patients and iv) even those not in the treatment arm of a trial of a new intervention must receive best current standard care (according to international evidence-based treatment guidelines). Given that we have discovered a number of 'best practice' regimens of care that do not optimise outcomes in ICU settings, it is of great benefit to all patients (including those participating in research) that we are constantly updating and evaluating what we do. Therefore, the practice of ICU-based clinical research on patients, many of whom cannot give prospective informed consent, ticks all the ethical boxes and ought to be encouraged in our health system. It is very important that the evaluation of protocols for ICU research should not overlook obvious (albeit probabilistic) benefits to patients and the acceptability of responsible clinicians entering patients into well-designed trials, even though the ICU setting does not and cannot conform to typical informed consent procedures and requirements.

Can obtaining informed consent alter self-reported drinking behaviour? A methodological experiment.

BackgroundInformed consent is the foundation of the ethical conduct of health research. Obtaining informed consent may unwittingly interfere with the data collected in research studies, particularly if they concern sensitive behaviours that participants are requested to report on. To address gaps in evidence on such research participation effects, we conducted a methodological experiment evaluating the impact of the informed consent procedure on participants’ reporting behaviour, specifically on their self-report of drinking behaviour as measured by Alcohol Use Disorder Identification Test (AUDIT).MethodsA two arm double blinded randomised controlled trial was used. University students present in London student unions at the time of recruitment were contacted in two phases (an initial run-in phase followed by the main phase). Those providing positive responses to verbal questions: 1) “are you a student?”; 2) “do you drink alcohol?”; 3) “would you like to take part in a brief health survey, which will take around 5 minutes?” were recruited. Participants received one of the two envelopes by chance, with the sequence generated by an online random sequence generator. One contained the participant information sheet, informed consent form and the AUDIT questionnaire (the intervention group), while the other contained only the AUDIT questionnaire (the comparator group). The primary outcome was the mean AUDIT score, which ranges from 0 to 40. The secondary outcome was the proportion of participants in each group scoring 8 or more on the AUDIT, the threshold score for hazardous and harmful drinking warranting intervention.ResultsA total of 380 participants were successfully recruited, resulting in 190 participants in each group, of which 378 were included in the final analysis. There is no evidence of any statistically significant difference between groups in the primary outcome. A statistically significant difference in the secondary outcome was found in the run-in phase only, and not in the main phase, or overall. Moreover, between-group outcome differences between the two phases suggest an important influence of setting on reporting behaviour.ConclusionsThere is no strong evidence that completion of informed consent itself alters self-reporting behaviour with regards to alcohol, though the effect of settings needs to be further studied.Electronic supplementary materialThe online version of this article (doi:10.1186/s12874-015-0032-z) contains supplementary material, which is available to authorized users.

Talking more about talking cures: cognitive behavioural therapy and informed consent

Cognitive behavioural therapy (CBT) has risen to prominence as an orthodox treatment option which is commonly recommended to patients with anxiety and depressive disorders. Mainstream healthcare institutions (including the National...

Informed consent procedures with cognitively impaired patients: A review of ethics and best practices.

The objectives of this article are to discuss ethical issues of informed consent in cognitively impaired patients and review considerations for capacity determination. We will also discuss how to evaluate capacity, determine competence, and obtain informed consent when a patient is deemed incompetent. This review emphasizes how to carry out informed consent procedures when capacity is questionable and discusses measures supported for use when determining cognitively impaired patients' ability to consent. Information was gathered from medical and psychological codes of ethics, peer-reviewed journals, published guidelines from health-care organizations (e.g., American Medical Association), and scholarly books. Google Scholar and PsycINFO were searched for articles related to 'informed consent' and 'cognitive impairment' published in English between 1975 and 2014. Relevant sources referenced in retrieved publications were subsequently searched and reviewed. We selected 49 sources generated by our search. Sources were included in our review if they presented information related to at least one of our focus areas. These areas included: review of informed consent ethics and procedures, review of cognitive impairment evaluations, recommendations for measuring cognitive capacity, and alternative forms of informed consent. Patients' cognitive impairments can hinder the ability of patients to understand treatment options. Evaluating the capacity of patients with cognitive impairment to understand treatment options is vital for valid informed consent and should be guided by best practices. Thus, proper identification of patients with questionable capacity, capacity evaluation, and determination of competence, as well as reliance upon appropriate alternative consent procedures, are paramount.

Informed consent in the field of language and sexuality

In order to understand how sexual and romantic relations are established and negotiated in discourse, the field of language and sexuality is dependent upon empirical data from naturally occurring spontaneous interaction. However, detailed discussions of research methods are lacking in the field. In this article, I explore ways of accessing intimate spontaneous data in a heterosexual online dating context. Through interactional analysis of three types of online dating interaction, I examine the multi-faceted context for securing informed consent while at the same time preserving participants’ intimacy. I argue that institutionalized informed consent procedures may undercut participant agency and expose symbolic violence towards their carefully built interactional framework. The analysis demonstrates participants’ ability to negotiate ethical issues and to turn such issues into a contribution to the ongoing flirtatious interaction. As a result, I suggest a method that integrates participants’ interactional expertise in the consent-gaining process.

Customising informed consent procedures for people with schizophrenia in India.

There is little information on how the ethical and procedural challenges involved in the informed participation of people with schizophrenia in clinical trials are addressed in low- and middle-income countries (LMICs). The informed consent procedure used in the collaborative community care for people with schizophrenia in India (COPSI) RCT was developed keeping these challenges in mind. We describe the feasibility of conducting the procedure from the trial, researcher and participants perspectives and describe the reasons for people consenting to participate in the trial or refusing to do so. Three sources of information were used to describe the feasibility of the COPSI consent procedure: key process indicators for the trial perspective, data from a specially designed post-interview form for participant's observations and focus group discussion (FGD) with the research interviewers. Categorical data were analysed by calculating frequencies and proportions, while the qualitative data from the FGD, and the reasons for participation or refusal were analysed using a thematic content analysis approach. 434 people with schizophrenia and their primary caregiver(s) were approached for participation in the trial. Consent interviews were conducted with 332, of whom 303 (91%) agreed to participate in the trial. Expectation of improvement was the most common reason for agreeing to participate in the trial, while concerns related to the potential disclosure of the illness, especially for women, were an important reason for refusing consent. The COPSI consent procedure demonstrates preliminary, observational information about the feasibility of customising informed consent procedures for people with schizophrenia LMIC contexts. This and other similar innovations need to be refined and rigorously tested to develop evidence-based guidelines for informed consent procedures in such settings.

The asbestos paradox: global gaps in the translational science of disease prevention.

The asbestos paradox: global gaps in the translational science of disease prevention.

Next-generation sequencing-based genome diagnostics across clinical genetics centers: implementation choices and their effects.

Implementation of next-generation DNA sequencing (NGS) technology into routine diagnostic genome care requires strategic choices. Instead of theoretical discussions on the consequences of such choices, we compared NGS-based diagnostic practices in eight clinical genetic centers in the Netherlands, based on genetic testing of nine pre-selected patients with cardiomyopathy. We highlight critical implementation choices, including the specific contributions of laboratory and medical specialists, bioinformaticians and researchers to diagnostic genome care, and how these affect interpretation and reporting of variants. Reported pathogenic mutations were consistent for all but one patient. Of the two centers that were inconsistent in their diagnosis, one reported to have found ‘no causal variant', thereby underdiagnosing this patient. The other provided an alternative diagnosis, identifying another variant as causal than the other centers. Ethical and legal analysis showed that informed consent procedures in all centers were generally adequate for diagnostic NGS applications that target a limited set of genes, but not for exome- and genome-based diagnosis. We propose changes to further improve and align these procedures, taking into account the blurring boundary between diagnostics and research, and specific counseling options for exome- and genome-based diagnostics. We conclude that alternative diagnoses may infer a certain level of ‘greediness' to come to a positive diagnosis in interpreting sequencing results. Moreover, there is an increasing interdependence of clinic, diagnostics and research departments for comprehensive diagnostic genome care. Therefore, we invite clinical geneticists, physicians, researchers, bioinformatics experts and patients to reconsider their role and position in future diagnostic genome care.

Comic strips help children understand medical research: Targeting the informed consent procedure to children's needs

ObjectiveChildren involved in medical research often fail to comprehend essential research aspects. In order to improve information provision, a participatory approach was used to develop new information material explaining essential concepts of medical research. MethodsA draft of a comic strip was developed by a science communicator in collaboration with pediatricians. The draft was presented to children participating in a clinical trial and to two school classes. Children were consulted for further development in surveys and interviews. Subsequently, the material was revised and re-evaluated in four school classes with children of varying ages and educational levels. ResultsIn the first evaluation, children provided feedback on the storyline, wording and layout. Children thought the comic strip was ‘fun’ and ‘informative’. Understanding of 8 basic research aspects was on average 83% and all above 65%, illustrating that children understood and remembered key messages. ConclusionA comic strip was developed to support the informed consent process. Children were consulted and provided feedback. The resulting material was well understood and accepted. Practice implicationsInvolving children in the development of information material can substantially contribute to the quality of the material. Children were excited to participate and to ‘be a part of science’.

Establishing the feasibility of assessing the mental health of children displaced by the Syrian conflict.

In the humanitarian crisis context of conflict zones, collecting data is essential for identifying and addressing the mental health needs of refugee children to avoid mass suffering. This study tested the feasibility of recruiting refugees caring for children and using established and brief parent-report questionnaires in a challenging context to collect mental health data on refugee children displaced by Syria's conflict. Caregivers of 4-10-year olds attending primary schools run by non-governmental organisation (NGO) Generation Freedom in and near refugee camps on the Syrian-Turkish border were invited to complete the Pediatric Emotional Distress Scale (PEDS) and Strengths and Difficulties Questionnaire (SDQ). It was possible to reach 144 adult refugees caring for children with research participation information and use informed consent procedures. A total of 106 caregivers completed the questionnaires yielding a good return rate (74%). Eighty-two (77.4%) caregivers had complete data on the PEDS and 61 (57.5%) on the SDQ. Almost half (49%) of the children met the clinical cut-off for being anxious/withdrawn and 62% for being fearful rated using the PEDS and 45% for SDQ rated emotional symptoms. More than a third had clinical levels of behavioural problems on both scales. It proved feasible to collect child mental health data in challenging conditions in the context of the Syrian crisis with support from a local NGO providing humanitarian assistance. The PEDS performed better than the SDQ in this context. High levels of emotional distress and behavioural problems in children reiterate the urgent need for evidence-based psychosocial support.