Health literacy and consent forms: librarians support research on human subjects.
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ABSTRACT:
SUBMITTER: Raimondo PG
PROVIDER: S-EPMC3878936 | biostudies-literature | 2014 Jan
REPOSITORIES: biostudies-literature
Publications
Health literacy and consent forms: librarians support research on human subjects.
Raimondo Paula G PG Harris Ryan L RL Nance Michele M Brown Everly D ED
Journal of the Medical Library Association : JMLA 20140101 1
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Project description:BackgroundObtaining 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.MethodsEmploying 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.ResultsThe 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.ConclusionsThe 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-literature
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:In view of recent discussions of diversity in library work, it would seem prudent to have a good understanding of basic facts and considered opinions of health sciences librarians of African heritage concerning their career experiences, opportunities for advancement, perceptions of negative behavior in the library, experiences of bias and discrimination in the library, existence of special information needs of patrons of African heritage, and interactions with non-African-heritage medical librarians and staff. Since there is a dearth of literature and research on these topics, this commentary will attempt to stimulate and encourage such work by providing a brief summary of currently available literature and research and providing some ideas for future academic endeavors.
| S-EPMC9014947 | biostudies-literature
Project description:BackgroundIn Europe, within the scope of the General Data Protection Regulation, more and more digital infrastructures are created to allow for large-scale access to patients' health data and their use for research. When the research is performed on the basis of patient consent, traditional study-specific consent appears too cumbersome for many researchers. Alternative models of consent are currently being discussed and introduced in different contexts.ObjectiveThis study explores stakeholder perspectives on ethical, legal, and practical concerns regarding models of consent for health data research at German university medical centers.MethodsSemistructured focus group interviews were conducted with medical researchers at German university medical centers, health IT specialists, data protection officers, and patient representatives. The interviews were analyzed using a software-supported structuring qualitative content analysis.ResultsStakeholders regarded broad consent to be only marginally less laborious to implement and manage than tiered consent. Patient representatives favored specific consent, with tiered consent as a possible alternative. All stakeholders lamented that information material was difficult to understand. Oral information and videos were mentioned as a means of improvement. Patient representatives doubted that researchers had a sufficient degree of data security expertise to act as sole information providers. They were afraid of undue pressure if obtaining health data research consent were part of medical appointments. IT specialists and other stakeholders regarded the withdrawal of consent to be a major challenge and called for digital consent management solutions. On the one hand, the transfer of health data to non-European countries and for-profit organizations is seen as a necessity for research. On the other hand, there are data security concerns with regard to these actors. Research without consent is legally possible under certain conditions but deemed problematic by all stakeholder groups, albeit for differing reasons and to different degrees.ConclusionsMore efforts should be made to determine which options of choice should be included in health data research consent. Digital tools could improve patient information and facilitate consent management. A unified and strict regulation for research without consent is required at the national and European Union level. Obtaining consent for health data research should be independent of medical appointments, and additional personnel should be trained in data security to provide information on health data research.
| S-EPMC11339564 | 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:BackgroundMedical informed consent stands as an ethical and legal requisite preceding any medical intervention. Hospitalized patients face functional health literacy (FHL) challenges when dealing with informed consent forms (ICFs). The legitimacy of ICFs and informed consent procedures in China remains substantially undisclosed. The study's aim was to investigate if Chinese patients have adequate FHL to be truly informed before providing medical consent.MethodsIn this cross-sectional, structured interview-based study, FHL was assessed within the context of the informed consent scenarios in two teaching hospitals (a 1500-bed general tertiary hospital and a 700-bed cancer hospital) affiliated with Shantou University Medical College. Twenty-seven patients admitted across clinical departments, along with their relatives (n = 59), were enrolled in the study after obtaining informed consent. The participants underwent a three-step assessment with two selected ICFs -teach-back skills, perceived understanding (perception), and informed knowledge (cognizance), with each component carrying a maximum score of 10. Data were analyzed with SPSS (version 22.0) for descriptive and inferential statistics, with consideration of significant P values as < 0.05.ResultsThe median age (IQR and range) of participants was 35.5 (28 - 49 and 13 - 74) years. Most participants had only high school education (24.4%, 21/86) or below high school education (47.7%, 41/86). The median score (IQR) of FHL assessments-teach-back, perception, and cognizance-was 4.0 (2.5, 5.8), 8.0 (6.8, 8.8), and 6.5 (5.5, 8.0) out of 10, respectively. A moderate correlation was observed between the scores of cognizance and teach-back (r = 0.359, P = 0.002) or perception (r = 0.437, P < 0.001). Multivariate linear regression analysis predicted being a patient and having lower education levels as independent risk factors of inadequate FHL (Ps = 0.001). Lack of patient-centeredness in ICFs, time constraints, and poor clinical communication were identified as barriers impeding informed consent.ConclusionsThis study demonstrates inadequacy in personal FHL and impaired organizational HL, resulting in compromised informed consent in Chinese teaching hospitals. As a remedy, we propose improving the quality of ICFs and institutionally mandated outcome-focused training on informed consent for all concerned clinicians to enhance medical ethics, ensure quality health care, address patient values, and mitigate potential medical conflicts.
| S-EPMC11342605 | 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:ObjectiveHealth sciences librarians frequently engage in scholarly publication, both with other librarians undertaking intradisciplinary scholarship, and increasingly as members of research teams centered in other disciplines. We sought to assess the emotional and institutional context of authorship among health sciences librarians, including emotions experienced during authorship negotiation, the frequency with which authorship is denied, and the correlation of perceived support from supervisors and the research community with the number of publications produced.Methods342 medical and health sciences librarians took an online survey of 47 questions regarding emotions experienced when asking for authorship, denial of authorship, if they have been given authorship without asking, and the extent to which they felt supported to conduct research in their current job.ResultsAuthorship negotiation creates varied and complex emotions among librarians. The emotions reported differed when negotiating authorship with librarian colleagues and when negotiating authorship with professionals in another field. Negative emotions were reported when asking either type of colleague for authorship. Respondents reported feeling mostly supported and encouraged by their supervisors, research communities, and workplaces. Nearly one quarter (24.4%) of respondents reported being denied authorship by colleagues outside of their departments. Perceived research appreciation and support by the research community is correlated with the total number of articles or publications produced by librarians.ConclusionAuthorship negotiation among health sciences librarians involves complex and frequently negative emotions. Denial of authorship is frequently reported. Institutional and professional support appear to be critical to publication among health sciences librarians.
| S-EPMC10124612 | biostudies-literature