Health literacy and consent forms: librarians support research on human subjects.
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ABSTRACT:
SUBMITTER: Raimondo PG
PROVIDER: S-EPMC3878936 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Obtaining a research participant's voluntary and informed consent is the bedrock of sound ethics practice. Greater inclusion of children in research has led to questions about how paediatric consent operates in practice to accord with current and emerging legal and socio-ethical issues, norms, and requirements.Employing a qualitative thematic content analysis, we examined paediatric consent forms from major academic centres and public organisations across Canada dated from 2008-2011, which were purposively selected to reflect different types of research ethics boards, participants, and studies. The studies included biobanking, longitudinal studies, and gene-environment studies. Our purpose was to explore the following six emerging issues: (1) whether the scope of parental consent allows for a child's assent, dissent, or future consent; (2) whether the concepts of risk and benefit incorporate the child's psychological and social perspective; (3) whether a child's ability to withdraw is respected and to what extent withdrawal is permitted; (4) whether the return of research results includes individual results and/or incidental findings and the processes involved therein; (5) whether privacy and confidentiality concerns adequately address the child's perspective and whether standard data and/or sample identifiability nomenclature is used; and (6) whether retention of and access to paediatric biological samples and associated medical data are addressed.The review suggests gaps and variability in the consent forms with respect to addressing each of the six issues. Many forms did not discuss the possibility of returning research results, be they individual or general/aggregate results. Forms were also divided in terms of the scope of parental consent (specific versus broad), and none discussed a process for resolving disputes that can arise when either the parents or the child wishes to withdraw from the study.The analysis provides valuable insight and evidence into how consent forms address current ethical issues. While we do not thoroughly explore the contexts and reasons behind consent form gaps and variability, we do advocate and formulate the development of best practices for drafting paediatric health research consent forms. This can greatly ameliorate current gaps and facilitate harmonised and yet contextualised approaches to paediatric health research ethics.
| S-EPMC3571865 | biostudies-other
Project description:Long informed consent forms (ICFs) remain commonplace, yet they can negatively affect potential participants' understanding of clinical research. We aimed to build consensus among six groups of key stakeholders on advancing the use of shorter ICFs in clinical research. Partnering with the HIV Prevention Trials Network (HPTN), we used a modified Delphi process with semistructured interviews and online surveys. Concerns about redundancy of information were common. Respondents supported three strategies for reducing ICF length: (a) 91% agreed or strongly agreed with grouping study procedures by frequency, (b) 91% were comfortable or very comfortable with placing supplemental information into appendices, and (c) 93% agreed or strongly agreed with listing duplicate side effects only once. Implementing these strategies will facilitate adoption of the proposed changes to U.S. regulations on ICF length, should they be enacted.
| S-EPMC5821132 | biostudies-literature
Project description:IntroductionThe extent to which health sciences librarians are engaged in research is a little-studied question. This study assesses the research activities and attitudes of Medical Library Association (MLA) members, including the influence of work affiliation.MethodsAn online survey was designed using a combination of multiple-choice and open-ended questions and distributed to MLA members. Responses were analyzed using descriptive statistics, content analysis, and significance testing. The authors used statistical tools and categorized open-ended question topics by the constant comparative method, also applying the broad subject categories used in a prior study. Pearson's chi-square analysis was performed on responses to determine significant differences among respondents employed in three different institutional environments.ResultsAnalysis showed that 79% of respondents read research articles at least once a month; 58% applied published research studies to practice; 44% had conducted research; 62% reported acting on research had enhanced their libraries; 38% had presented findings; and 34% had authored research articles. Hospital librarians were significantly less likely than academic librarians to have participated in research activities. Highly ranked research benefits, barriers, and competencies of health sciences librarians are described.ConclusionsFindings indicate that health sciences librarians are actively engaged in research activities. Practice implications for practitioners, publishers, and stakeholders are discussed. Results suggest that practitioners can use published research results and results from their own research to affect practice decisions and improve services. Future studies are needed to confirm and extend these findings, including the need for intervention studies to increase research and writing productivity.
| S-EPMC4816469 | biostudies-literature
Project description:ObjectivesThis research studied hospital administrators' and hospital-based health care providers' (collectively, the target group) perceived value of consumer health information resources and of librarians' roles in promoting health information literacy in their institutions.MethodsA web-based needs survey was developed and administered to hospital administrators and health care providers. Multiple health information literacy curricula were developed. One was pilot-tested by nine hospital libraries in the United States and Canada. Quantitative and qualitative methods were used to evaluate the curriculum and its impact on the target group.ResultsA majority of survey respondents believed that providing consumer health information resources was critically important to fulfilling their institutions' missions and that their hospitals could improve health information literacy by increasing awareness of its impact on patient care and by training staff to become more knowledgeable about health literacy barriers. The study showed that a librarian-taught health information literacy curriculum did raise awareness about the issue among the target group and increased both the use of National Library of Medicine consumer health resources and referrals to librarians for health information literacy support.ConclusionsIt is hoped that many hospital administrators and health care providers will take the health information literacy curricula and recognize that librarians can educate about the topic and that providers will use related consumer health services and resources.
| S-EPMC2759165 | biostudies-literature
Project description:BackgroundInternational guidelines recommend the use of appropriate informed consent procedures in low literacy research settings because written information is not known to guarantee comprehension of study information.ObjectivesThis study developed and evaluated a multimedia informed consent tool for people with low literacy in an area where a malaria treatment trial was being planned in The Gambia.MethodsWe developed the informed consent document of the malaria treatment trial into a multimedia tool integrating video, animations and audio narrations in three major Gambian languages. Acceptability and ease of use of the multimedia tool were assessed using quantitative and qualitative methods. In two separate visits, the participants' comprehension of the study information was measured by using a validated digitised audio questionnaire.ResultsThe majority of participants (70%) reported that the multimedia tool was clear and easy to understand. Participants had high scores on the domains of adverse events/risk, voluntary participation, study procedures while lowest scores were recorded on the question items on randomisation. The differences in mean scores for participants' 'recall' and 'understanding' between first and second visits were statistically significant (F (1,41)=25.38, p<0.00001 and (F (1, 41) = 31.61, p<0.00001 respectively.ConclusionsOur locally developed multimedia tool was acceptable and easy to administer among low literacy participants in The Gambia. It also proved to be effective in delivering and sustaining comprehension of study information across a diverse group of participants. Additional research is needed to compare the tool to the traditional consent interview, both in The Gambia and in other sub-Saharan settings.
| S-EPMC4133653 | biostudies-literature
Project description:The success of any biobank depends on a number of factors including public's view of research and the extent to which it is willing to participate in research. As a prototype of surrounding countries, public interest in research and biobanking in addition to the influence and type of informed consent for biobanking were investigated in Jordan. Data were collected as part of a national survey of 3196 individuals representing the Jordanian population. The majority of respondents (88.6%) had a positive perception of the level of research in Jordan and they overwhelmingly (98.2%) agreed to the concept of investing as a country in research. When respondents were asked if the presence of an informed consent would influence their decision to participate in biobanking, more individuals (19.8%) considered having an informed consent mechanism as a positive factor than those who considered it to have negative connotations (13.1%). However, a substantial portion (65%) did not feel it affected their decision. The majority of survey participants (64%) expressed willingness to participate in biobanking and over 90% of them preferred an opt-in consent form whether general (75.2%) or specific for disease or treatment (16.9%). These results indicate a promising ground for research and biobanking in Jordan. Educational programs or mass awareness campaigns to promote participation in biobanking and increase awareness about informed consent and individual rights in research will benefit both the scientific community as well as the public.
| S-EPMC3641386 | biostudies-literature
Project description:BackgroundImproving informed consent to participate in randomized clinical trials (RCTs) is a key challenge in cancer communication. The current study examines strategies for enhancing randomization comprehension among patients with diverse levels of health literacy and identifies cognitive and affective predictors of intentions to participate in cancer RCTs.MethodsUsing a post-test-only experimental design, cancer patients (n?=?500) were randomly assigned to receive one of three message conditions for explaining randomization (ie, plain language condition, gambling metaphor, benign metaphor) or a control message. All statistical tests were two-sided.ResultsHealth literacy was a statistically significant moderator of randomization comprehension (P = .03). Among participants with the lowest levels of health literacy, the benign metaphor resulted in greater comprehension of randomization as compared with plain language (P = .04) and control (P = .004) messages. Among participants with the highest levels of health literacy, the gambling metaphor resulted in greater randomization comprehension as compared with the benign metaphor (P = .04). A serial mediation model showed a statistically significant negative indirect effect of comprehension on behavioral intention through personal relevance of RCTs and anxiety associated with participation in RCTs (P < .001).ConclusionsThe effectiveness of metaphors for explaining randomization depends on health literacy, with a benign metaphor being particularly effective for patients at the lower end of the health literacy spectrum. The theoretical model demonstrates the cognitive and affective predictors of behavioral intention to participate in cancer RCTs and offers guidance on how future research should employ communication strategies to improve the informed consent processes.
| S-EPMC5441300 | biostudies-literature
Project description:BackgroundThis case study describes the South Central Chapter of the Medical Library Association (SCC/MLA) initiative to develop an academic writing retreat for members who sought the necessary time and support to advance their research projects toward publication.Case presentationSCC/MLA staged a dedicated writing retreat to coincide with the organization's 2012, 2013, and 2014 annual meetings. Each cohort met over two days to write and to workshop their peers' manuscripts. Organizers distributed an online survey one month after each retreat to evaluate attendees' perceptions.ConclusionsThree years' worth of writing retreats yielded fourteen peer-reviewed articles and one book chapter. Participants indicated that the retreat helped them meet or exceed their writing goals by offering protected time and a setting conducive to productivity. The format of the retreat is cost effective and easily adaptable for fellow professionals who wish to organize a formal event as a conference offering or simply support a writing group at their home institutions. In SCC/MLA, the retreat revitalized interest in writing and demystified the scholarly publication process.
| S-EPMC5624429 | biostudies-literature
Project description:Magnetic resonance imaging (MRI) of human subjects is widely performed for clinical and research purposes. Clinical MRI requires a physician order, while research MRI typically requires an approved protocol from a local Institutional Review Board, as well as informed consent. However, there are several circumstances in which it is appropriate to perform MRI in human subjects, that constitute neither clinical nor research activities. Examples include clinical protocol development, training and teaching, and quality assurance testing. We refer to such activities as nonclinical, nonresearch MRI. The purpose of this document is to provide principles and guidelines for appropriate and safe use of MRI in human subjects for nonclinical, nonresearch purposes. LEVEL OF EVIDENCE:1 J. Magn. Reson. Imaging 2017;45:36-41.
| S-EPMC5164877 | biostudies-literature
Project description:BACKGROUND:The use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in biomedical research. METHODS:This multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important). RESULTS:Of the 2484 questionnaires distributed, 2113 (85.1%) were returned. The majority of respondents considered most elements required in the ICF to be 'moderately important' to 'very important' for their decision making (mean score, ranging from 3.58 to 4.47). Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF (mean score?=?4.47, 4.47, and 4.45, respectively). CONCLUSIONS:Research participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF.
| S-EPMC6139128 | biostudies-literature