Informed consent procedures: responsibilities of researchers in developing countries

We describe the informed consent procedures in a research clinic in Santiago, Chile, and a qualitative study that evaluated these procedures. The recruitment process involves information, counseling and screening of volunteers, and three or four visits to the clinic. The study explored the decision-making process of women participating in contraceptive trials through 36 interviews. Women understood the research as experimentation or progress. The decision to participate was facilitated by the information provided; time to consider it and to discuss it with partners or relatives; and perceived benefits such as quality of care, non-cost provision of methods and medical care. For some women, participation was an opportunity to express altruism. The main obstacles for participation were perceived side effects or risks. The final risk-benefit balance was strongly influenced by women's needs. Women perceived that the consent form benefited the clinic, proving that participants had made a free decision, and benefited the volunteers by warranting their right to free medical care. The most important problem detected was occasional misunderstanding of the information given on the form. We concluded that a full decision-making process enhances women's ability to exercise their right to choose, and assures research institutions that trials are conducted without coercion and that the participants are committed to the study. Researchers have the responsibility of conducting this process.     

Parents’ Agendas in Paediatric Clinical Trial Recruitment Are Different from Researchers’ and Often Remain Unvoiced: A Qualitative Study

Ensuring parents make an informed decision about their child’s participation in a clinical trial is a challenge for practitioners as a parent’s comprehension of a trial may differ from that intended by the practitioners responsible for recruitment. We explored what issues parents consider important when making a decision about participation in a paediatric clinical trial and their comprehension of these issues to inform future recruitment practice. This qualitative interview and observational study examined recruitment in four placebo-controlled, double-blind randomised clinical trials of medicines for children. Audio-recorded trial recruitment discussions between practitioners and parents (N = 41) were matched with semi-structured interviews with parents (N = 41). When making a decision about trial entry parents considered clinical benefit, child safety, practicalities of participation, research for the common good, access to medication and randomisation. Within these prioritised issues parents had specific misunderstandings, which had the potential to influence their decisions. While parents had many questions and concerns about trial participation which influenced their decision-making, they rarely voiced these during discussions about the trials with practitioners. Those involved in the recruitment of children to clinical trials need to be aware of parents’ priorities and the sorts of misunderstandings that can arise with parents. Providing trial information that is tailored to what parents consider important in making a decision about a clinical trial may improve recruitment practice and ultimately benefit evidence-based paediatric medicine.     

How good is general practice developmental screening?

All developmental screening in Somerset is performed by general practitioners and health visitors. A retrospective review of a cohort of 1504 7 year old children living in semirural Somerset found that the development assessment by a health visitor at age 3 1/2 years had a sensitivity of 45% for identifying the 103 children with special educational needs, whereas the sensitivity of the preschool examination by a general practitioner was 56%. There was no relation between results of preschool developmental assessment and later reading ability. Of the 23 children in special schools, 22 had been identified independently of the developmental screening programme before starting school. Intervention was started at a mean age of 1 year 5 months (range 2 months to 3 years) for children with severe learning difficulties, and 3 years 9 months (2 years 3 months to 6 years 6 months) for children with moderate learning difficulties. The preschool medical examination revealed fairly minor medical problems: 29 of 81 children referred for specialist opinions were shown to be medically normal, and for only seven of the medically abnormal children was information about their conditions given to their teachers. In Somerset screening the development of all children at predetermined ages has not been very useful.     

Children's exposure to environmental pollutants and biomarkers of genetic damage. I. Overview and critical issues

In the last decade, molecular epidemiological studies have provided new perspectives on studying environmental risks in pediatric populations, based on the growing understanding that children may be more susceptible to toxicants than adults. Protecting children's health is a social priority, and specific research programs have been initiated with this purpose in the United States and Europe. These programs address the development of (i) less invasive methods for biological specimens collection, (ii) specific tools for interpretation and validation of biomarkers, (iii) methods for translating biomarker results into intervention strategies and for integrating them with environmental monitoring and health data, (iv) optimal ways to obtain consent and provide information to children and/or their parents participating in the studies and (v) techniques for the effective communication with policy makers and the public. Critical issues in children's environmental research discussed in this paper include specific needs of study design, exposure assessment, sample collection and ethics. Special consideration is given to the autonomy of the child in giving consent, the details and nature of the information provided, and the need to warrant controlled access to sensitive information. The use of incentives such as gifts and payment to ensure the participation of school-aged children is specifically discussed. Examples of field studies that are focused on the effects of pesticides, air pollution and formaldehyde are used to illustrate advantages and limitations of biomarker studies in children.     

Information that should be given to HIV cohort participants during ongoing research: the viewpoints of patient representatives and research professionals

While investigators have a duty to provide research participants with summary findings at the end of a study, providing general information during the course of research is rarely considered. However, this raises an important ethical issue in the context of long-term studies such as cohorts or biobanks. We investigated this issue in the context of two ANRS cohorts of HIV-infected patients, AQUITAINE and COPILOTE. Face-to-face interviews were conducted with HIV patient representatives and research professionals concerning the delivery of information in the course of the research. Respondents stated that participants wish to be informed of research results (both aggregate and individual) but also expect general information about the cohort itself, research progression, and what their participation may provide. It was concluded that information provided during the course of the research may help participants to distinguish between care and research. The essential role of clinicians-investigators in providing information was emphasized.     

Do recommended textbooks contain adequate information about bile salt transporters for medical students?

Several studies have recently highlighted a number of limitations in medical textbooks. The aims of this study were to 1) to assess whether available medical textbooks provided students with adequate information about bile salt transporters, 2) compare the level of detail and the amount of information provided in current textbooks on hepatic transport mechanisms with those available in the literature, and 3) compare the amount of information provided in medical textbooks on hepatocyte transport mechanisms with those involving other transporters e.g., those found in the nephron. Seventy medical textbooks from disciplines including physiology, pathology, cell biology, medicine, pediatrics, pharmacology, pathophysiology, and histology published during the past six years were examined. The literature on bile salt transport has been searched mainly from the Internet (MEDLINE and PubMed). Most textbooks failed to provide any information on transporters found in the basolateral and canalicular membranes of hepatocytes. There are also deficiencies in information on bile salt transporters in the terminal ileum. However, up to the end of 2002, 3,610 articles and reviews had been published on hepatobiliary and enterocyte transport of bile salts. During the same period (from 1965), 10,757 articles had been published on renal transport. Thus the contents of textbooks may reflect the overall volume of research knowledge on renal transport. However, despite our current understanding of hepatic and intestinal transport of bile salts and extensive research, particularly over the past 12 years, there are major deficiencies in textbooks in this area. These findings indicate that there is an imbalance in the contents of current textbooks and a lack of information about hepatobiliary physiology, bile salt transporters, bile formation, and mechanisms underlying cholestasis and drug-induced injury. Authors, editors, and publishers of medical textbooks should consider the need to update the information provided on bile salt transporters.     

What research participants want to know about genetic research results: the impact of "genetic exceptionalism"

The disclosure of individual genetic results has generated an ongoing debate about which rules should be followed. We aimed to identify factors related to research participants' preferences about learning the results of genomic studies using their donated tissue samples. We conducted a cross-sectional survey of 279 patients from the United States and Spain who had volunteered to donate a sample for genomic research. Our results show that 48% of research participants would like to be informed about all individual results from future genomic studies using their donated tissue, especially those from the U.S. (71.4%) and those believing that genetic information poses special risks (69.7%). In addition, 16% of research participants considered genetic information to be riskier than other types of personal medical data. In conclusion, our study demonstrates that a high proportion of participants prefer to be informed about their individual results and that there is a higher preference among those research subjects who perceive their genetic information as riskier than other types of personal medical data.     

Ethical issues in research on sensitive topics: participants' experiences of distress and benefit

While many studies ask participants to disclose sensitive information or to participate in emotionally arousing tasks, little is known about participants' subjective experiences of discomfort and benefit. Ethics review committees, therefore, have little information about participant experiences to guide their informed decision-making. We asked undergraduate females about their experiences in a study that included an experimental session, interviews, and self-report measures on sensitive topics. We examined results overall, and compared the responses of individuals with and without childhood abuse experiences. Participants who had experienced child abuse were more likely to report distress due to remembering the past, but also more likely to report that participation was helpful. Implications for future research, and recommendations for review boards, are discussed.     

Perceptions of reimbursement for clinical trial participation

A greater understanding of participant views regarding reimbursement will help investigators plan studies that have better potential for reaching target enrollment, maximize efficient recruitment, maintain scientific integrity, and enhance retention over time. As part of a clinical trial in the area of sexual health, healthy women's perceptions of reimbursement for research participation were investigated. Semi-structured, audio-recorded, qualitative interviews were conducted immediately upon women's completion of the clinical trial to enable a participant-driven understanding of perceptions about monetary reimbursement. Audio-recordings were transcribed and analyzed using framework analysis. Women (N = 30) had a mean age of 29.5 ± 5.7 years (range 22-45 years). Sixty-three percent of participants (n = 19) were non-Hispanic (white n = 13, black n = 4, and Asian n = 2), while the remaining were Hispanic (n = 11). Seventy-three percent (n = 22) reported previous participation in research. In general, women viewed reimbursement as a benefit to research participation, the amount of which should reflect time, the inconvenience to the research subject, and the potential for unknown risks in the short- and long-term. They believed reimbursement should take into account the degree of risk of the study, with investigations of experimental products offering greater reimbursement. Women believed that monetary reimbursement is unlikely to coerce an individual to volunteer for a study involving procedures or requirements that they found unacceptable. The results of this study can be used to provide guidance to those planning and evaluating reimbursement for research participation.     

Web-site-based recruitment for research studies on abdominal aortic and intracranial aneurysms

Our current understanding on the pathogenesis of abdominal aortic and intracranial aneurysms is limited, but genetic and environmental factors as well as their interactions are likely to play important roles in the development and rupture of aneurysms. To identify genetic factors contributing to these diseases, we are carrying out genome-wide screening studies, which require a large number of patients and family members. Current methods of finding patients who qualify for genetic studies are, however, often costly and ineffective. To improve patient recruitment, a Web site was developed (cmmg.biosci.wayne.edu/ags). The site gives general information about our study, solicits participation into the study, and provides links to relevant medical and educational sites. During the time period of July, 1999, to December, 2000, the site received 5, 108 visits (13 visits/day). Approximately 20 research study applications are received each month. A total of 49% (57/117) of the individuals responding to the aortic aneurysm and 63% (84/134) responding to the intracranial aneurysm study report at least two affected blood relatives in the family and, therefore, qualify for our genetic studies. In conclusion, Web-based patient recruitment is successful and provides an improved success rate due to the fact that the responders are more motivated to participate in research studies.     

Appealing to Altruism is Not Enough: Motivators for Participating in Health Services Research

this pilot study sought to identify motivators and barriers to participating in a longitudinal survey; we interviewed patients and practitioners at a multidisciplinary primary care clinic where the proposed project would be based. While altruism motivates participation in medical research, we found that for many potential participants, the opportunity to benefit directly was the primary, and sometimes the only motive to participate or encourage participation in the research project. Patients often wanted direct feedback from their individual results, and they expected to provide consent before the results were forwarded to other parties such as their practitioners. Similarly, some practitioners were more likely to support the project if participation benefited patients directly. Other factors were also identified that influenced the acceptability and perceived risks and benefits of participating. More work is needed to understand these motivators and how patients might benefit directly from participating in health services research, especially when direct medical benefit is not possible.     

Medical Student Research: An Integrated Mixed-Methods Systematic Review and Meta-Analysis

Importance

Despite the rapidly declining number of physician-investigators, there is no consistent structure within medical education so far for involving medical students in research.

Objective

To conduct an integrated mixed-methods systematic review and meta-analysis of published studies about medical students'' participation in research, and to evaluate the evidence in order to guide policy decision-making regarding this issue.

Evidence Review

We followed the PRISMA statement guidelines during the preparation of this review and meta-analysis. We searched various databases as well as the bibliographies of the included studies between March 2012 and September 2013. We identified all relevant quantitative and qualitative studies assessing the effect of medical student participation in research, without restrictions regarding study design or publication date. Prespecified outcome-specific quality criteria were used to judge the admission of each quantitative outcome into the meta-analysis. Initial screening of titles and abstracts resulted in the retrieval of 256 articles for full-text assessment. Eventually, 79 articles were included in our study, including eight qualitative studies. An integrated approach was used to combine quantitative and qualitative studies into a single synthesis. Once all included studies were identified, a data-driven thematic analysis was performed.

Findings and Conclusions

Medical student participation in research is associated with improved short- and long- term scientific productivity, more informed career choices and improved knowledge about-, interest in- and attitudes towards research. Financial worries, gender, having a higher degree (MSc or PhD) before matriculation and perceived competitiveness of the residency of choice are among the factors that affect the engagement of medical students in research and/or their scientific productivity. Intercalated BSc degrees, mandatory graduation theses and curricular research components may help in standardizing research education during medical school.     

Public Opinion about the Importance of Privacy in Biobank Research

Concerns about privacy may deter people from participating in genetic research. Recruitment and retention of biobank participants requires understanding the nature and magnitude of these concerns. Potential participants in a proposed biobank were asked about their willingness to participate, their privacy concerns, informed consent, and data sharing. A representative survey of 4659 U.S. adults was conducted. Ninety percent of respondents would be concerned about privacy, 56% would be concerned about researchers having their information, and 37% would worry that study data could be used against them. However, 60% would participate in the biobank if asked. Nearly half (48%) would prefer to provide consent once for all research approved by an oversight panel, whereas 42% would prefer to provide consent for each project separately. Although 92% would allow academic researchers to use study data, 80% and 75%, respectively, would grant access to government and industry researchers. Concern about privacy was related to lower willingness to participate only when respondents were told that they would receive $50 for participation and would not receive individual research results back. Among respondents who were told that they would receive $200 or individual research results, privacy concerns were not related to willingness. Survey respondents valued both privacy and participation in biomedical research. Despite pervasive privacy concerns, 60% would participate in a biobank. Assuring research participants that their privacy will be protected to the best of researchers'' abilities may increase participants'' acceptance of consent for broad research uses of biobank data by a wide range of researchers.     

Corvids can decide if a future exchange is worth waiting for

Evidence for time-dependent calculations about future rewards is scarce in non-human animals. In non-human primates, only great apes are comparable with humans. Still, some species wait for several minutes to obtain a better reward in delayed exchange tasks. Corvids have been shown to match with non-human primates in some time-related tasks. Here, we investigate a delay of gratification in two corvid species, the carrion crow (Corvus corone) and the common raven (Corvus corax), in an exchange task. Results show that corvids success decreases quickly as delay increases, with a maximal delay of up to 320 s (more than 5 min). The decision to wait rests both on the quality of the prospective reward and the time required to obtain it. Corvids also apply tactics (placing the reward on the ground or caching it) that probably alleviate costs of waiting and distract their attention during waiting. These findings contrast previous results on delayed gratification in birds and indicate that some species may perform comparably to primates.     

Assessing students’ knowledge of owls from their drawings and written responses

Many children learn about and experience animals in the everyday environment where they live and attend school. One way to obtain information about children’s understanding of concepts or phenomena is by using their drawings in combination with written responses or interviews. This study assesses how much Slovenian students 10–15 years old (in sixth to ninth grade) know about owls by analysing their drawings and written responses. The study included 473 students. From assessing students’ drawings and written responses, it can be concluded that the respondents had some knowledge of owls’ appearance, their behaviours, diet and habitats. The differences between students in different grades regarding the representations of owls was not statistically significant. Some students had misconceptions about owls, such as the idea that owls can turn their heads 360 degrees, or they confused the long ear-tufts with external parts of the ears. The students’ written responses provided additional information on their ideas about owls; particularly about owls’ specific behaviours, diet, and conservational status. However, some information, such as depicting owls’ body parts and body proportions or their habitats, was more clearly depicted with drawings. One third of the students drew owls in trees and forests, which makes owls good candidates for promoting forest conservation.     

Participation in a government-subsidised colorectal cancer screening programme for asymptomatic individuals in Hong Kong

BackgroundA Government-subsidised colorectal cancer screening programme (CRCSP) was launched in Hong Kong. This study aimed to assess the participation rate in CRCSP among Chinese individuals between the ages of 50 and 75 years and to survey individuals’ reasons for declining to participate in the CRCSP.MethodsA cross-sectional study was performed. Asymptomatic Chinese individuals aged 50–75 years in Hong Kong who did not have a history of colorectal cancer were recruited. A survey was used to collect information about individuals’ participation in the CRCSP.ResultsThe survey was completed by 1317 participants. Of these, 432 (32.8%) joined the CRCSP and the remaining 885 participants (67.2%) did not join the CRCSP. The most common reason that participants provided for not joining the CRCSP was thinking that the screening was not necessary because they had no health problems (29.3%). Some (14.4%) of the participants claimed to lack information about the CRCSP and screening procedures. Some (12.5%) of them completed the screening before the CRCSP was launched, and the cost was covered by other sources.ConclusionThe participation in CRCSP for a screening among the Hong Kong population has generally increased, but obstacles to participating in screening programme remain.     

Informed consent: study of quality of information given to participants in a clinical trial.

OBJECTIVE--To determine whether the participants in a clinical trial had perceived adequate information about the trial according to the guidelines of the Declaration of Helsinki. DESIGN--About 18 months after the end of a gynaecological clinical trial the participants received a questionnaire by post, which focused on the quality of the information given to them before entering the trial. Neither researchers nor participants were aware in advance that the trial would become the subject of this follow up investigation. SETTING--Eight different centres in Sweden. SUBJECTS--43 women out of the 53 who completed the trial (mean (range) age 23 (16 to 35) years) returned the questionnaire. MAIN OUTCOME MEASURES--Adequacy of the information (based on requirements of the Declaration of Helsinki) to enable the following: understanding of the aims of the study; awareness of what participation meant; and awareness of the possibility of withdrawing from participation at any time. Motives for agreeing to participate, and a subjective evaluation of the given information were also recorded. RESULTS--All but one of the participants had been aware that they were taking part in a research project. Five women stated that they had not been aware that a second laparoscopy was performed only for research reasons. Seven women reported that they had not been aware of the meaning of participating in the project and 17 that they had had no information about the possibility of withdrawing from the study whenever they wanted. In the subjective rating 22 women considered the information given as good or very good. There was a systematic variation in the quality of the given information among the eight centres. CONCLUSION--Although all but one of the participants had been aware that they were taking part in a clinical trial, the quality of the information understood and recalled by participants varied, and in many cases clearly did not meet the guidelines of the Declaration of Helsinki. Variations among centres in participants'' perception of information suggest that deficiencies in perception may be caused by informers rather than the participants.     

Preventive health care of Indian preschoolers in the Sioux Lookout Zone,northwestern Ontario.

The provision of preventive health care to native children in the Sioux Lookout Zone of northwestern Ontario was assessed by reviewing the medical charts of 568 randomly selected preschoolers in 1980. Data were collected on the method of infant feeding; immunization status, vaccination and testing for tuberculosis; development, vision and hearing screening; monitoring of growth; and nutritional status and vitamin supplementation. Most of the children had been breast-fed and had received primary diphtheria-pertussis-tetanus-polio immunization as well as measles-mumps-rubella and bacille Calmette-Guérin vaccination. However, less than 30% had undergone developmental screening, and only 10% and 8% respectively had had their vision and hearing screened. Growth monitoring was adequate in the first year of life but not thereafter. Only about 55% of the children had ever had a hemoglobin level determined. More emphasis on health promotion is needed if native children are to receive adequate preventive health care.     

Croatian children's views towards importance of health care information

The aim of research was to investigate: the need for health care information of Croatian adolescents aged from 13 to 18 years; the difference in evaluation of the frequency of receiving information between hospitalized and healthy children; if the hospitalized children expectations about the frequency of receiving health care information differed significantly from information they have actually received; whose information was most comprehensible to the hospitalized children (doctors, parents, other health care givers). The children were either hospitalized in the pediatrics departments or were high schools pupils (healthy children). The hospitalized children "Completely agreed" (92.7%) with the statement "When I am sick, I should receive information about my health" in comparison to the healthy children (85.1%). In comparison to healthy children, the hospitalized children assessed that doctors, other health care givers and parents should give them information more frequently. The experience of hospitalized children indicate that they received less information then they have actually excepted. The information received from doctors was mostly in correlation with the understanding of this information. We concluded that the children want to be informed about their health, especially hospitalized children. Health care professionals should offer understandable health care information according to the children's expectation.     

Screening for fetal alcohol syndrome in primary schools: a feasibility study

BACKGROUND: This project was undertaken as a feasibility study to determine the possibility of screening for fetal alcohol syndrome (FAS) in early school-age children for epidemiological and interventional purposes. METHODS: All elementary schools in two counties in Washington State were asked to screen first graders for possible FAS. A child was screen positive if found to be growth deficient, to have certain specific facial abnormalities, or have a known history of substantial alcohol exposure in gestation. All screen-positive children were invited to "special diagnostic clinics" for final diagnosis and treatment planning. RESULTS: In County A, virtually all students were screened. In County B only about 25% of children were screened. This difference was related to the number of schools that agreed to participate in the project and the methods employed by each county to obtain parental permission. In each county, only about one-half of the screen-positive children were seen in the special clinics for diagnostic considerations. Only one of the seven children found to have FAS had been diagnosed previously. The minimal prevalence of FAS in County A was 3.1 in 1,000 students. The minimal prevalence of FAS in County B could not be calculated. The most efficient component in the screening process leading to a diagnosis of FAS was finding the specific facial features of the disorder. The diagnosis of FAS was generally helpful in improving educational planning. CONCLUSIONS: This study demonstrated that population-based FAS screening within a school system may be possible, but participation is dependent on local trust and understanding of the project before its inception within the schools and the community at large.