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Graduate students reported practices regarding the issue of informed consent and maintaining of data confidentiality in a developing country.

ABSTRACT: Research involving human subjects requires strict adherence to ethical principles, including informed consent and assuring data confidentiality. Herein, a questionnaire was utilized to assess compliance of graduate students who conduct research involving human subjects in Jordan with proper practices related to informed consent and maintaining of data confidentiality. Among the 251 respondents, 55.4% were from health-related fields, 61.4% undertook research involving humans, and 48.6% did research requiring institutional review board approval. Only 37.1% of respondents reported exposure to research ethics education during their graduate study. Satisfactory adherence to informed consent practices was reported at rates of 56.0%-67.5%. Satisfactory adherence to practices related to data confidentiality and study participants' anonymity was reported at rates of 67.3%-74.7%. Sharing of data or samples with others was reported at a rate of 24.3%. The rates of adherence to proper informed consent practices and practices that maintain data confidentiality were less than ideal. Significant policy changes need to be implemented to address these issues.

SUBMITTER: Swedan S

PROVIDER: S-EPMC7505757 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Graduate students reported practices regarding the issue of informed consent and maintaining of data confidentiality in a developing country.

Swedan Samer S Khabour Omar F OF Alzoubi Karem H KH Aljabali Alaa A A AAA

Heliyon 20200919 9

Research involving human subjects requires strict adherence to ethical principles, including informed consent and assuring data confidentiality. Herein, a questionnaire was utilized to assess compliance of graduate students who conduct research involving human subjects in Jordan with proper practices related to informed consent and maintaining of data confidentiality. Among the 251 respondents, 55.4% were from health-related fields, 61.4% undertook research involving humans, and 48.6% did resear ...[more]

PMID: 32995624

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Project description:BackgroundOnly a few studies have been conducted to assess physicians' knowledge of legal standards. Nevertheless, prior research has demonstrated a dearth of medical law knowledge. Our study explored physicians' awareness of legal provisions concerning informed consent and confidentiality, which are essential components of the physician-patient relationship of trust.MethodsA cross-sectional study assessed attending physicians' legal knowledge of informed consent and confidentiality regulations. The study was conducted in nine hospitals in Dolj County, Romania. Physicians were given a questionnaire with ten scenarios and instructed to select the response that best reflected their practice. We assessed the responses of physicians who claimed their practice to be entirely legal. Their legal knowledge was evaluated by comparing their answers to applicable laws. We also calculated a score for the physicians who admitted to committing a legal breach.ResultsOf the 305 respondents, 275 declared they never committed any law violation. However, their median correct answer score was 5.35 ± 1.66 out of 10. The specialty was the strongest predictor of legal knowledge, with emergency physicians rating the lowest and non-surgical physicians scoring the highest. Physicians who worked in both private and public sectors were better knowledgeable about legal issues than those who worked exclusively in the public sector. Results indicate that physicians are aware of the patient's right to informed consent but lack comprehensive understanding. While most physicians correctly answered simple questions, only a tiny minority identified the correct solution when confronted with ethical dilemmas. The physicians who acknowledged breaching the law, on the other hand, had a slightly higher knowledge score at 5.45 ± 2.18.ConclusionLegal compliance remains relatively low due to insufficient legal awareness. Physicians display limited awareness of legal requirements governing patient autonomy, confidentiality, and access to health data. Law should be taught in all medical schools, including undergraduate programs, to increase physicians' legal knowledge and compliance.

Project description:BackgroundProper informed consent is essential for patients to have sound knowledge about the indication, risks, and benefits of a proposed surgical procedure. The study aim was to assess the perceptions of postoperative patients about the informed consent process and identify various influential factors in a tertiary care hospital.MethodsA cross-sectional study was conducted from February to August 2018 at a tertiary care hospital in Lahore, Pakistan. A validated questionnaire was used to conduct interviews of 101 patients planning to undergo elective surgery after fulfilling all ethical considerations. A purposive sampling technique was employed to enroll and the data analysis was performed by using SPSS version 23.ResultsOut of total 101 patients, 50 (49.5%) of them were males and the mean age of total sample was 36.98 ± 14.23 years. The majority 92 (91.1%) considered informed consent to be important and that it did not influence their surgical decision 85 (84.2%). Consent was obtained by the consulting surgeon from 41 (40.6%) patients and by the residents/house officer from 60 (59.4%) patients. Fifteen (14.8%) patients signed the consent form themselves, and 86 (85.1%) relatives of patients signed. Ninety-eight (97.0) patients were told about indications of the surgery, and 54 (53.5%) were told about possible complications. Seventy-five (74.3%) patients were informed about alternatives to surgery. Significant reasons for not signing were language (p = 0.03), educational status (p = 0.002), and not being informed by relatives before signing (p = 0.02).ConclusionThe patients had adequate knowledge about the process of informed consent and considered it important. Factors identified as barriers to signing the consent form by the patients themselves included language, better educational status, and not being asked by relatives. It is imperative to involve the patients in the process of consent, especially in signing by them or in their presence by their surrogate.

Project description:BackgroundThe requirement to obtain written informed consent may undermine the potential of pragmatic randomized clinical trials (pRCTs) to improve evidence-based care. This requirement could compromise trials statistical power or even force it to close them down prematurely. However, recent data from the U.S. and Spain suggest that a majority of the public endorses written consent for low-risk pRCTs. The present manuscript assesses whether this view is shared by patients.MethodsThis was a cross-sectional, probability-based survey, with a 2 × 2 factorial design, assessing support for written informed consent versus verbal consent or general notification for two low-risk pRCTs in hypertension, one comparing 2 drugs with similar risk/benefit profiles and the other comparing the same drug being taken in the morning or at night. This web-based survey was conducted in May 2016. Two-thousand and eight adults who were representative of the Spanish population participated in the survey (response rate: 61%). Of these 2008 respondents, 338 indicated that they had been diagnosed with hypertension and were being treated with prescription medicines for this condition at the time of responding to the survey. The primary outcome measures were respondents' personal preference and recommendation to a research ethics committee regarding the use of written informed consent versus verbal consent or general notification.ResultsOverall, 74% of the 338 patient respondents endorsed written consent. In both scenarios, general notification received significantly more support (30.6%-44.7%) than verbal consent (13.3%-17.6%). 43% of respondents preferred and/or recommended general notification rather than written consent.ConclusionsAs in the survey of the general public, more patients endorsed written consent than the alternative option. However, two factors suggest that a different approach to written consent should be investigated for low-risk pRCTs: a) a substantial minority of respondents supported general notification, b) data from the US have shown that most patients who prefer written consent are willing to forego it if obtaining written consent makes the trial too difficult to be conducted; and c) 2016 CIOMS guidelines endorse waivers of consent when the trial fulfills specific conditions. Surveys in other EU countries are needed to assess what patients believe towards pRCTs. If similar results to that reported in this study are found, it is foreseeable that with educational efforts, general notification could be an acceptable and widespread approach to the conduct of low-risk pRCTs.

Project description:BackgroundIncreased application of electronic health information systems led to the buildup of patient information and facilitated access to this data. Consequently, the confidentiality of this information became an ethical challenge to medical teams' members including pharmacists. However, no study has been conducted to assess pharmacists' knowledge or practices of data confidentiality. Thus, the aim of this study was to assess the current practices and knowledge of pharmacists concerning data confidentiality.MethodsThis was a cross sectional study that included clinical pharmacists in tertiary hospitals and health care centers in Jordan. Data was collected through phone or face to face interviews using a data collection sheet. All continuous data was presented as median ± interquartile range (IQR) and categorical data as frequency (%). One way Chi square was used to check significant differences among categorical groups. Predictors that may affect knowledge and behavior scores were screened using simple linear regression.ResultsA total of 388 pharmacists were interviewed with a mean age of 39.59 ± 8.32 years, with an average experience of 12.55 ± 7.30 years. Pharmacists relied on their personal experience to resolve ethical dilemmas (n = 274, 70.3%), and when they seek advice, their work colleagues (n = 180, 46.4%) %), followed by the head of departments (144 n; 37.1%), were the main source of advice on ethical issues. The overall median knowledge score of pharmacists about data confidentiality was 2.0 out of 5.0 (IQR = 2.0). A considerable percentage of the pharmacists was willing to share information with family members without asking for permission from the patient (n = 98, 25.3%). Pharmacists had a median behavior score of 3.5 out of 4.0 (IQR = 0.4) regarding practices related to data confidentiality, where the majority of them handled medical information from the patient with great confidentiality (304 n, 78.4%), and 85.8% of them (n = 333) gave patient's sexual diseases-related medical information the highest confidentiality. However, based on univariate and multivariate linear regression analysis, none of the examined sociodemographic variables significantly predicted pharmacists' knowledge or behaviors (P > 0.05).ConclusionPharmacists are aware of the importance of confidentiality issues of their patients. However, a number of gaps in their knowledge and practices of data confidentiality were identified. Training that targets these gaps in their knowledge, and rectifies incorrect practices is needed during university education and as part of their continuous medical education.

Project description:IntroductionThe subjective assessment of the adequacy of informed consent for clinical trials, and the potential difficulties associated with it, has led several studies to develop objective measures of informed consent for clinical trials. These objective measures of informed consent are often specific to a particular population or clinical condition and largely focus on understanding of (some or all of) the key elements of informed consent. Many of the developed tools are study-specific, but some validated measures exist. Of these validated measures, those which are reported by participants are of particular interest. Whether these objective tools conceptualize and measure informed consent in the same way is not known. As such, it is not clear whether meta-analyzing data from studies reporting different tools is worthwhile. The aim of this systematic review was to critically appraise the evidence on the overall conceptualisation and item content of validated patient reported measures of informed consent for clinical trials, and to identify core domains of potential importance for informed consent.MethodsA systematic search of the literature was conducted to identify relevant articles that described the development, and/or validation, of patient-reported measures of adequacy of informed consent for randomised controlled trials. Data was synthesised by classifying the items identified into domains and sub-domains which were determined by the nomenclature reported in included studies. Both for descriptions of included studies and of the instruments reported in those studies, descriptive statistics were used to describe general information and instrument detail. A narrative synthesis of the instruments and their inter-related domains and subdomains was conducted to identify areas of both convergence and divergence.ResultsThe search identified 8193 citations. After screening titles and abstracts, 29 full text articles were retrieved for further assessment. Of these 29, 14 complied with our pre-specified inclusion criteria with 15 not being eligible. Of the 14 instruments, three explicitly reported a theoretical or conceptual framework underpinning their development, a further three implicitly referred to the 'conceptual dimensions of informed consent' or 'principles of research ethics' as informing their development and eight reported no guiding theoretical framework. Only three of the 14 studies reported patient or public involvement in the development of the tool. One hundred and seventy nine items were included across the 14 instruments. The primary focus of the instruments was on understanding. Five core domains were identified which included: Autonomy; Consequences; Expectations; Purpose; and Individualisation. There was substantial variability in the coverage of different domains across measures.ConclusionsThis study demonstrated the variability in the theoretical underpinning, development and domain coverage of existing patient-reported measures of informed consent for clinical trials. The conceptualisation of informed consent could benefit from being extended from a narrow focus on understanding to include broader considerations of decision-making. Meaningful involvement of potential trial participants during development of measures critical for tool relevance is also lacking. The identification of the key domains relevant to all stakeholders which could be measured to assess the informed consent process for clinical trials is needed.

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Graduate students reported practices regarding the issue of informed consent and maintaining of data confidentiality in a developing country.

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Graduate students reported practices regarding the issue of informed consent and maintaining of data confidentiality in a developing country.

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