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BACKGROUND: Dementia is assumed to alter mental capacity, which may necessitate legal guardianship. However, only limited research exists on how dementia affects mental capacity, and most studies have focused solely on a medical perspective and concentrate on memory functions. The aim of this qualitative study was to investigate physicians' and legal experts' perceptions on a broad range of cognitive and neuropsychiatric domains potentially affecting mental capacity and the need for guardianship in people with dementia. METHODS: Physicians (N = 30) and legal experts (N = 20) participated in semi-structured individual interviews. The data were analyzed by using content analysis and further semi-quantified according to the cognitive and neuropsychiatric domains. RESULTS: Physicians considered neuropsychiatric symptoms and executive dysfunction to be the most important deficits in the legal context, while legal experts highlighted episodic memory impairment and dyscalculia. Perceptions regarding the importance of several cognitive and neuropsychiatric symptoms varied between and within the professional groups. CONCLUSIONS: Physicians and legal experts diverged in their perceptions of cognitive and neuropsychiatric domains affecting mental capacity and the need for guardianship. The evaluation and influence of medical evidence among legal experts heavily rely on subjective opinions. Given the substantial potential impact on patients' equal access to their rights, developing standardized guidelines is essential.
Subject(s)
Dementia , Legal Guardians , Physicians , Qualitative Research , Humans , Legal Guardians/legislation & jurisprudence , Dementia/psychology , Male , Female , Middle Aged , Physicians/psychology , Mental Competency/legislation & jurisprudence , Adult , Attitude of Health PersonnelABSTRACT
Introduction: A family history is impacting the individual's risk perception. The objective of this systematic review was to describe inherited risk perceptions of type 2 diabetes from the citizen's viewpoint. The aim was to summarize and increase understanding so that the increased knowledge could be used effectively in type 2 diabetes risk communication in health care. Methods: We conducted a systematic review using CINAHL, Medline, and Scopus databases for hereditary, risk, perception, and diabetes related concepts, within the date range of 1.1.2017 to 2.8.2022. Eligible articles were English, peer-reviewed, and addressed the research question: how is hereditary risk of type 2 diabetes perceived? Returns were viewed independently by two authors, and evaluated using the appraisal criteria of the Joanna Briggs Institute. A thematic analysis was used for the synthesis of the data, yielding three themes describing perceptions of inherited risk in type 2 diabetes. Results: A total of 32 articles were included, of which 23 were quantitative, 5 qualitative, and 4 were mixed-methods studies. The extracted themes were (1) Identifying heredity as a risk factor, (2) Diversity of hereditary risk, and (3) Perception of the magnitude of personal risk. Discussion: The perception towards hereditary risk can vary from a desire to actively make a lifestyle change, to the view that diabetes is inevitable regardless of lifestyle. A positive family history increases the risk perception of type 2 diabetes, but the perceived magnitude of the risk may vary from person to person. The findings have the potential to be applied in healthcare's risk communication.
Subject(s)
Diabetes Mellitus, Type 2 , Humans , Communication , Diabetes Mellitus, Type 2/genetics , Life Style , Perception , Risk FactorsABSTRACT
AIM: To explore the instruments used in measuring genomic competence in nursing. The objective was to understand how ethical issues are reflected in the instruments. DESIGN: A scoping review. METHODS: A systematically conducted scoping review was conducted by using CINAHL Complete and Medline databases covering the years from January 2010 to January 2022. Two authors inspected potentially eligible papers and assessed their quality independently using the critical appraisal tools of Joanna Briggs Institute. Twenty-five articles were eligible including 19 different instruments. Included articles answered the research question: "How ethical issues are reflected in instruments measuring genomic competence in nursing?" The inductive thematic analysis was used in this review. RESULTS: Descriptions of ethical themes were unstructured in the scoped articles and instruments. Not all genomic competence instruments covered ethical aspects. Only three studies asked direct questions by using the word ethics or its derivates, including confidentiality in solving ethical problems, familiarity with the ethical aspects of genetic counselling and ability to identify ethical issues. Thirteen articles included ethics-related themes encompassing knowledge, skills, concerns, advantages and disadvantages.
Subject(s)
Ethics, Nursing , Students, Nursing , Humans , Confidentiality , GenomicsABSTRACT
Genetics and genomics have become one of the most important development areas in healthcare. For this reason, it is essential that nursing professionals take their role to offer their skills in implementing genomics in health promotion. The education of public health nurses is taking vital steps in training the health promoters who are able to take the genome-based knowledge into account in precision healthcare. Tampere University of Applied Sciences managed to integrate genomics into the studies of public health nursing. This article describes the process of development and lays emphasis on the importance of genomic education of public health nurses.
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BACKGROUND: Research on genomics has increased while the biobank activities are becoming more common in different countries. In the mental health field, the questions concerning the potential participants' vulnerability as well as capacity to give the informed consent can cause reluctancy in recruiting persons with mental health problems, although the knowledge and understanding of mental health problems has remarkable changed, and practice is guided with inclusive approaches, such as recovery approach. AIM: The aim of this study was to describe the current knowledge of informed consent practices in the context of genomic research on mental health from the nurses' viewpoint. METHODS: An integrative review was conducted with search from seven international databases. Data consist 14 publications which were analyzed with thematic analysis. ETHICAL CONSIDERATIONS: Ethical requirements were respected in every phase of the research process. FINDINGS: Most of the papers were published in USA and between 2000-2010. Eight reports were categorized as discussion papers, four qualitative studies and one quantitative study. The thematic analysis provided information on five themes: complexity with the capacity to consent, mixed emotions towards participation, factors influencing the decision to participate, nurses' informed consent process competence and variations between consent procedures. DISCUSSION: In the informed consent practices, there are various aspects which may affect both the willingness to participate in the study and the informed consent process itself. Implications for practice, education, research, and policies are discussed. CONCLUSION: There is a need for more updated international research on the topic in the context of different international and national guidelines, legislation, and directives. This study provided a viewpoint to the more collaborative research activities with people with lived experiences also in this field of research following the ideas of recovery approach.
Subject(s)
Informed Consent , Mental Health , Genomics , Humans , Morals , Qualitative ResearchABSTRACT
BACKGROUND: Availability of genetic testing in neurodegenerative disorders has developed rapidly. This growing ability is providing specific genetic information to individuals and, in turn, their families, raising ethical concerns. However, family members' perspective is a seldom-studied phenomenon. AIM: The aim of this systematic review was to describe the ethical aspect of genetic testing in neurodegenerative diseases from the perspective of at-risk family members. METHOD: A systematic review of data was performed in accordance with the PRISMA statement. The data search was conducted using the CINAHL, PubMed and Scopus databases to identify original peer-reviewed studies published between January 2009 and April 2019. A total of 24 articles were selected. The data were analysed using inductive content analysis. FINDINGS: On the basis of the analysis, four central ethical implications were identified: (i) decision-making in genetic testing as a dilemma: balance between autonomy and responsibility, (ii) the individual's right to make a voluntary and informed decision for genetic testing, (iii) conflicting emotions after knowing one's genetic status and (iv) privacy and confidentiality of genetic information: the fear of genetic discrimination and stigma. CONCLUSIONS: The findings of this review increase understanding about the central ethical implications of genetic testing in neurodegenerative diseases from the perspective of family members, and identify and underline outstanding needs for further research.
Subject(s)
Neurodegenerative Diseases , Confidentiality , Family , Genetic Testing , Humans , Morals , Neurodegenerative Diseases/geneticsABSTRACT
AIM: To describe diabetes nurses' perspectives on the impact of the COVID-19 pandemic on people with diabetes and diabetes services across Europe. METHODS: An online survey developed using a rapid Delphi method. The survey was translated into 17 different languages and disseminated electronically in 27 countries via national diabetes nurse networks. RESULTS: Survey responses from 1829 diabetes nurses were included in the analysis. The responses indicated that 28% (n = 504) and 48% (n = 873) of diabetes nurses felt the COVID-19 pandemic had impacted 'a lot' on the physical and psychological risks of people with diabetes, respectively. The following clinical problems were identified as having increased 'a lot': anxiety 82% (n = 1486); diabetes distress 65% (n = 1189); depression 49% (n = 893); acute hyperglycaemia 39% (n = 710) and foot complications 18% (n = 323). Forty-seven percent (n = 771) of respondents identified that the level of care provided to people with diabetes had declined either extremely or quite severely. Self-management support, diabetes education and psychological support were rated by diabetes nurse respondents as having declined extremely or quite severely during the COVID-19 pandemic by 31% (n = 499), 63% (n = 1,027) and 34% (n = 551), respectively. CONCLUSION: The findings show that diabetes nurses across Europe have seen significant increases in both physical and psychological problems in their patient populations during COVID-19. The data also show that clinical diabetes services have been significantly disrupted. As the COVID-19 situation continues, we need to adapt care systems with some urgency to minimise the impact of the pandemic on the diabetes population.
Subject(s)
COVID-19 , Delivery of Health Care , Diabetes Mellitus/physiopathology , Nurse Specialists , Psychological Distress , Anxiety/psychology , Attitude of Health Personnel , Depression/psychology , Diabetes Mellitus/metabolism , Diabetes Mellitus/nursing , Diabetes Mellitus/psychology , Diabetes Mellitus, Type 1/metabolism , Diabetes Mellitus, Type 1/nursing , Diabetes Mellitus, Type 1/physiopathology , Diabetes Mellitus, Type 1/psychology , Diabetes Mellitus, Type 2/metabolism , Diabetes Mellitus, Type 2/nursing , Diabetes Mellitus, Type 2/physiopathology , Diabetes Mellitus, Type 2/psychology , Diabetic Foot/physiopathology , Europe , Humans , Hyperglycemia/metabolism , SARS-CoV-2 , Self-Management , Surveys and QuestionnairesABSTRACT
Several frameworks assist research ethics committees (RECs) in risk assessment of medical studies. However, little is known about how researchers describe risks of the procedures in study protocols and participant information sheets. We examined 349 study protocols and participant information sheets submitted to an REC and evaluated the risk assessments performed for 1,510 study procedures. Risks had been assessed for 399 (26%) procedures in study protocols and for 425 (28%) procedures in participant information sheets. Physical risks were assessed six times more frequently than psychological risks. Risks of medical procedures are not always detailed in study protocols or participant information sheets. Risk descriptions of procedures believed to be familiar to potential participants may be omitted.
Subject(s)
Ethical Review , Ethics Committees, Research , Humans , Risk AssessmentABSTRACT
BACKGROUND: Intensive-care unit (ICU) nurses have an important role in the recruitment of patients for scientific research and in the performance of clinical research. AIM: A study was conducted to examine ICU nurses' perceptions of ethics-related aspects of ICU-based research. The study focused on nurse attitudes and knowledge related to clinical research, with special emphasis on perceptions of the informed-consent process in ICU research. METHOD: The study applied a descriptive qualitative approach, involving semi-structured group interviews and theme-based inductive content analysis. Subjects were ICU nurses (n = 28) at a university hospital ICU who had experience with research protocols applied in that unit. FINDINGS: The nurses had mainly positive perceptions of clinical studies. They found research beneficial for future patients and for society. The nurses considered the information given to them about the studies inadequate. They were concerned about the fact that the consent for research is almost always obtained at the beginning of the ICU care, when patients and relatives are still in the crisis period. This limits the possibility of understanding and assimilating the information provided on the study. CONCLUSIONS: The role of ICU nurses in clinical studies should be more prominent and taken into account in the planning of ICU studies.
Subject(s)
Attitude of Health Personnel , Clinical Nursing Research/ethics , Clinical Nursing Research/standards , Critical Care/ethics , Critical Care/psychology , Informed Consent/ethics , Nursing Staff, Hospital/ethics , Nursing Staff, Hospital/psychology , Adult , Female , Finland , Humans , Male , Middle Aged , Nursing Methodology Research , Qualitative Research , Surveys and QuestionnairesABSTRACT
With changes in clinical research practice, the importance of a study-subject's privacy and the confidentiality of their personal data is growing. However, the body of research is fragmented, and a synthesis of work in this area is lacking. Accordingly, an integrative review was performed, guided by Whittemore and Knafl's work. Data from PubMed, Scopus, and CINAHL searches from January 2012 to February 2017 were analyzed via the constant comparison method. From 16 empirical and theoretical studies, six topical aspects were identified: the evolving nature of health data in clinical research, sharing of health data, the challenges of anonymizing data, collaboration among stakeholders, the complexity of regulation, and ethics-related tension between social benefits and privacy. Study subjects' privacy is an increasingly important ethics principle for clinical research, and privacy protection is rendered even more challenging by changing research practice.
Subject(s)
Biomedical Research , Confidentiality , Research Subjects , Data Anonymization , HumansABSTRACT
Ongoing demographic changes are challenging health systems worldwide especially in relation to increasing longevity and the resultant rise of non-communicable diseases (NCDs). To meet these challenges, a paradigm shift to a more proactive approach to health promotion, and maintenance is needed. This new paradigm focuses on creating and implementing an ecological model of Culture of Health. The conceptualization of the Culture of Health is defined as one where good health and well-being flourish across geographic, demographic, and social sectors; fostering healthy equitable communities where citizens have the opportunity to make choices and be co-producers of healthy lifestyles. Based on Antonovsky's Salutogenesis model which asserts that the experience of health moves along a continuum across the lifespan, we will identify the key drivers for achieving a Culture of Health. These include mindset/expectations, sense of community, and civic engagement. The present article discusses these drivers and identifies areas where policy and research actions are needed to advance positive change on population health and well-being. We highlight empirical evidence of drivers within the EU guided by the activities within the thematic Action Groups of the European Innovation Partnership on Active and Healthy Aging (EIP on AHA), focusing on Lifespan Health Promotion and Prevention of Age-Related Frailty and Disease (A3 Action Group). We will specifically focus on the effect of Culture on Health, highlighting cross-cutting drivers across domains such as innovations at the individual and community level, and in synergies with business, policy, and research entities. We will present examples of drivers for creating a Culture of Health, the barriers, the remaining gaps, and areas of future research to achieve an inclusive and sustainable asset-based community.
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This study investigated the kinds of ethical challenges experienced by nurses in oncology and hematology when nursing care and research overlap in clinical trials, and how the nurses handle such challenges. Individual interviews with 39 nurses from Sweden, Denmark, and Finland indicated that all nurses were positive about research, considering it essential for developing the best care. Ethical challenges exist, however; the most difficult were associated with the end-of-life patients, no longer responsive to standard therapy, who eagerly volunteer for cutting-edge drug trials in the hope of gaining therapeutic benefit. Many nurses lacked systematic strategies for addressing such challenges but found support from their nursing colleagues and relied on the research protocols to guide them.
Subject(s)
Attitude of Health Personnel , Biomedical Research/ethics , Hematology/ethics , Medical Oncology/ethics , Nurses , Nursing Care/ethics , Adult , Aged , Denmark , Female , Finland , Humans , Male , Middle Aged , Qualitative Research , Sweden , Terminal Care , Work/ethics , Young AdultABSTRACT
PURPOSE: Study design, personal persuasions, and experiences can influence willingness to participate in clinical trials (CTs). A study assessed differences between Parkinson's disease (PD) or epilepsy patients having participated in CTs and non-participants in knowledge of and attitudes toward CTs. Also considered were factors in willingness to take part and how CT participants experienced the informed consent process. METHOD: Random samples of members of Finland's PD (nâ¯=â¯2000) and epilepsy (nâ¯=â¯1875) patient organisations were posted a questionnaire on their views about CTs. Of the 1050 questionnaires returned, 845 met inclusion criteria. In total, 126 had participated in CTs. RESULTS: While over 90% of respondents knew that participation is always voluntary, CT participants were more often aware that one can withdraw (p<0.001). In both groups, most did not recognise the possibility of randomisation, and 57% in both CT participants and non-participants indicated that CTs are aimed primarily at seeking the best medication for the participant. Nevertheless, 83% of CT participants indicated ability to understand the information provided. CONCLUSIONS: While most in our study agreed that patients should be asked to participate in CTs, only 15% of subjects had done so. The discrepancy between willingness to participate and recruitment figures could be minimised by improving knowledge of CTs and communication between patients and researchers. Additionally, the groups displayed comparable false CT-related assumptions, raising questions about whether these subjects fully understood the clinical research's ultimate goal and CT participants had given true informed consent. These issues have practical and ethics implications for clinical investigators.
Subject(s)
Clinical Trials as Topic/psychology , Epilepsy/psychology , Health Knowledge, Attitudes, Practice , Informed Consent/psychology , Parkinson Disease/psychology , Patient Participation/psychology , Aged , Educational Status , Epilepsy/therapy , Female , Finland , Humans , Male , Middle Aged , Parkinson Disease/therapy , Surveys and QuestionnairesABSTRACT
An informed consent is a prerequisite for participating in medical trials, whereby the person asked to take part in the trial shall understand what he is committing himself to, and that the consent is given voluntarily. Voluntariness can be undermined by so-called therapeutic optimism, i.e. belief in personal benefit brought about by the trial, as well as the difficulty of understanding how conventional treatment and the trial differ from each other, i.e. the so-called therapeutic misconception. The investigator, especially if he is also the attending physician, may influence the development of therapeutic misconception, because the participant may assume that the physician works as an investigator for the best benefit of the patients. It is important to recognize unrealistic optimism and therapeutic misconception of the trial, because for the participant they may result in disappointment and loss of confidence during the trial.
Subject(s)
Clinical Trials as Topic/ethics , Drug Therapy , Ethics, Research , Informed Consent , Therapeutic Misconception , HumansABSTRACT
BACKGROUND: Protecting human subjects from being exploited is one of the main ethical challenges for clinical research. However, there is also a responsibility to protect and respect the communities who are hosting the research. Recently, attention has focused on the most efficient way of carrying out clinical research, so that it benefits society by providing valuable research while simultaneously protecting and respecting the human subjects and the communities where the research is conducted. Collaboration between partners plays an important role and that is why we carried out a study to describe how collaborative partnership and social value are emerging in clinical research. METHODS: A supra-analysis design for qualitative descriptive secondary analysis was employed to consider a novel research question that pertained to nurse leaders' perceptions of ethical recruitment in clinical research and the ethics-related aspects of clinical research from the perspective of administrative staff. The data consisted of two separate pre-existing datasets, comprising 451 pages from 41 interviews, and we considered the research question by using deductive-inductive content analysis with NVivo software. A deductive analysis matrix was generated on the basis of two requirements, namely collaborative partnership and social value, as presented in An Ethical Framework for Biomedical Research by Emanuel et al. RESULTS: The findings showed that collaborative partnership was a cornerstone for ethical clinical research and ways to foster inter-partner collaboration were indicated, such as supporting mutual respect and equality, shared goals and clearly defined roles and responsibilities. In addition, the social value of clinical research was an important precondition for ethical clinical research and its realisation required the research partners to demonstrate collaboration and shared responsibility during the research process. However, concerns emerged that the multidimensional meaning of clinical research for society was not fully recognised. Achieving greater social value for clinical research required greater transparency, setting research priorities, shared responsibility for the dissemination and use of the findings and stronger community awareness of the ethics-related aspects of clinical research. CONCLUSIONS: Collaborative partnership and social values are essential for protecting the human subjects and communities involved in clinical research.
Subject(s)
Biomedical Research , Cooperative Behavior , Patient Selection/ethics , Attitude of Health Personnel , Biomedical Research/ethics , Humans , Nurse Administrators , Nurse's Role , Qualitative Research , Research Design , Social ValuesABSTRACT
BACKGROUND: Clinical trials (CTs) are the "gold standard" to ensure the development of new effective treatments in medicine. A study was conducted to assess knowledge of, and attitudes toward, clinical trials among patients with Parkinson's disease (PD), along with factors that motivate them to participate. METHODS: A 50-item questionnaire on the views of patients with PD about CTs was developed. It included statements that the respondents assessed on a Likert scale from 1 ("strongly disagree") to 5 ("strongly agree"). The questionnaire was mailed to a random sample (n = 2000) of members of the patient organization the Finnish Parkinson Association. In all, 708 response forms were returned, of which 681 were accepted after exclusion (a 34% response rate). RESULTS: In general, attitudes of patients with PD toward CTs were positive. Older subjects and patients with lower education levels had inadequate knowledge of general issues related to CTs. Older age, low level of education, and lower number of PD medications were significant predictors for failure to understand the nature and purpose of clinical research. Additionally, significant positive correlation was found between education level and willingness to participate in CTs. CONCLUSIONS: Patients with PD have important gaps in their knowledge of methodological issues associated with CTs. The oldest subjects and those with a low level of education have the greatest information needs. Investigators should pay more attention to ensuring the comprehensibility of the information provided to potential CT participants.
Subject(s)
Antiparkinson Agents/therapeutic use , Clinical Trials as Topic/methods , Health Knowledge, Attitudes, Practice , Parkinson Disease/drug therapy , Patient Selection , Research Subjects/psychology , Age Factors , Aged , Aged, 80 and over , Antiparkinson Agents/adverse effects , Comprehension , Consumer Health Information , Educational Status , Finland , Humans , Middle Aged , Motivation , Parkinson Disease/diagnosis , Parkinson Disease/physiopathology , Parkinson Disease/psychology , Research Design , Surveys and QuestionnairesABSTRACT
BACKGROUND: In order to protect the autonomy of human subjects, we need to take their culture into account when we are obtaining informed consent. OBJECTIVE AND RESEARCH DESIGN: This study describes the cultural aspects related to informed consent in health research and is based on electronic searches that were conducted using the Scopus, PubMed, CINAHL, and Cochrane databases published between 2000 and 2013. A total of 25 articles were selected. FINDINGS: Our findings indicate that cultural perspectives relating to the informed consent process are essential during the whole research process and particularly crucial in the planning phase of a study. Our study indicates that appropriate communication between different stakeholders plays a vital role in cultural understanding. DISCUSSION AND CONCLUSION: The researchers' awareness of cultural differences and their ability to work in a culturally sensitive way are key factors in improving study participation and retention in a multicultural context. Taking cultural aspects into account during the whole research process improves the quality of research.
Subject(s)
Biomedical Research/ethics , Cross-Cultural Comparison , Ethics, Research , Informed Consent/ethics , Research Design , Cultural Characteristics , Cultural Competency/ethics , Cultural Diversity , Humans , Patient Selection/ethics , Qualitative ResearchABSTRACT
OBJECTIVES: To ensure the development of new effective treatments in medicine, clinical trials (CTs) need to be conducted. The study was aimed at assessing knowledge of and attitudes toward clinical drug trials among patients with epilepsy, along with factors that motivate them to participate in CTs. Use of this information could improve recruitment for future trials and enhance their quality. METHODS: A 45-item questionnaire on the views of patients with epilepsy about CTs was developed. It included statements that the respondents assessed on a Likert scale from 1 ('strongly disagree') to 5 ('strongly agree'). The questionnaire was mailed to a random sample (n=1875) of members of the Finnish Epilepsy Association aged at least 18 years. In all, 342 questionnaires were returned, and 325 were accepted after exclusion. RESULTS: The analysis indicates that the general attitudes of patients with epilepsy toward CTs are positive. Most of the patients with epilepsy saw participation in clinical trials as indispensable to new treatments becoming available. Retired respondents and persons who had developed epilepsy when young had inadequate knowledge of general issues related to CTs. Level of education and number of antiepileptic medications (AEDs) were significant predictors for failure to understand the nature and purpose of clinical research - i.e., for therapeutic misconception (TM). Additionally, strong correlation was found between TM and respondents' willingness to participate in clinical trials. CONCLUSIONS: The new treatments are often studied in patients with a high risk of TM and impaired comprehension of general procedures associated with CTs. Clinically, it may be worthwhile for the investigators to be able to recognize vulnerable individuals and pay special attention to the information provided on the purposes and methods of the trial, to contribute to high-quality AED studies.
Subject(s)
Anticonvulsants/therapeutic use , Clinical Trials as Topic/psychology , Epilepsy/drug therapy , Health Knowledge, Attitudes, Practice , Motivation , Patient Participation/psychology , Therapeutic Misconception , Adolescent , Adult , Counseling , Drug Evaluation , Epilepsy/psychology , Female , Humans , Male , Qualitative Research , Risk , Surveys and Questionnaires , Treatment Outcome , Young AdultABSTRACT
BACKGROUND: Randomised clinical trials (RCTs) involve procedures such as randomisation, blinding, and placebo use, which are not part of standard medical care. Patients asked to participate in RCTs often experience difficulties in understanding the meaning of these and their justification. METHODS: We reviewed RCT protocols, statements of the principal investigator (PI), and participant-information materials, as submitted for opinion to a research ethics committee. We evaluated how the justification for the use of placebo was described in these documents and how the participants had been informed about randomisation, placebo use, and the possible risks of receiving placebo. RESULTS: In total, 52 RCTs were identified. Eighteen of the study protocols (35%) provided some rationale for the use of placebo. In 15 (29%) of the statements, the PI had provided justification for its use. Possible risks related to placebo use were described in nine (17%) of the statements. An explanation as to why placebo was necessary featured in only 12 (23%) of the sets of participant-information materials, and only six (12%) of the documents discussed the possible risks associated with placebo. CONCLUSIONS: The justification of placebo control was inadequately described in the RCT study protocols, by principal or national co-ordinating investigators, and in participant-information documents. Furthermore, possible health-related risks associated with the use of placebo were poorly explained in the participant-information documents. Ethics committes and study participants need to be better informed of the rationale for the use of placebo, along with the associated risks.