Informed consent: Issues and challenges

Nijhawan, Lokesh P; Janodia, M.; Muddukrishna, BS; Bhat, Krishnamurthy; Bairy, KL; Udupa, N.; Musmade, Prashant B

doi:10.4103/2231-4040.116779

Cited by 208 publications

(75 citation statements)

References 10 publications

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“…Furthermore, patients who are already using a form of CAM may have been more likely to consent for participation in this study than those who were not, hence the potential for a selection bias [67]. However, the 1964 Helsinki Declaration stipulated that, within the consent form, “research subjects must be informed fully about the purpose and methods…”; accordingly such a potential bias could not have been avoided [68]. In addition, the interviewer-based approach in data collection could have incurred a social desirability bias; however the interviewer underwent intensive training to maintain a nonjudgmental and neutral attitude and use standardized techniques and avoiding questions that could influence the subject's responses [36].…”

Section: Discussionmentioning

confidence: 99%

Prevalence and Characteristics of CAM Use among People Living with HIV and AIDS in Lebanon: Implications for Patient Care

Abou-Rizk

Alameddine

Naja

2016

Evidence-Based Complementary and Alternative Medicine

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This study aimed to assess the prevalence and determinants of Complementary and Alternative Medicine (CAM) use among People Living with HIV and AIDS (PLWHA) in Lebanon and to identify related issues that may affect patient care. A cross-sectional survey design was used to interview 116 PLWHA in Beirut. The questionnaire addressed sociodemographic and disease characteristics as well as CAM use. The main outcome of the study was CAM use since diagnosis. Data analysis included descriptive statistics and logistic regression analyses. Overall, 46.6% of participants reported using one or more CAM therapies, with herbs and herbal products being the most commonly used (63%). A higher education level was associated with a 3-fold increase in the odds of CAM use. Among users, 20% used CAM as alternative to conventional treatment, 48% were not aware of CAM-drug interactions, 89% relied on nonhealth care sources for their choice of CAM, and 44% did not disclose CAM use to their physician. CAM use is prevalent among Lebanese PLWHA. Findings of this study highlighted the need to educate health care practitioners to have an open communication and a patient-centered approach discussing CAM use during routine care and to enhance awareness of PLWHA on safe use of CAM.

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Section: Discussionmentioning

confidence: 99%

Prevalence and Characteristics of CAM Use among People Living with HIV and AIDS in Lebanon: Implications for Patient Care

Abou-Rizk

Alameddine

Naja

2016

Evidence-Based Complementary and Alternative Medicine

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“…The process leading to informed consent should provide potential participants – or their guardians – with sufficient information to make informed decisions about their voluntary participation in research projects [1]. This is one of the major principles stated in the Declaration of Helsinki, which is the basis of rules and regulations concerning informed consent [1–3]. …”

Section: Introductionmentioning

confidence: 99%

Recruiting to Clinical Trials on the Telephone – a randomized controlled trial

Foss

Kjærgaard

Stensballe

et al. 2016

Trials

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BackgroundInformed consent is an essential element of clinical research. Obtaining consent, however, may be challenging. The use of the telephone for giving information and obtaining consent may be practical but little formal research has been done.MethodsWe examined the use of the telephone for the purpose of informing expectant mothers about The Danish Calmette Study; a randomized clinical trial assessing neonatal Bacille Calmette-Guérin vaccination. Expectant mothers received an invitation letter with a Participant Information Sheet about The Danish Calmette Study, the present trial, and a Consent Form. Two to 4 weeks later we contacted the mothers to discuss potential participation in the present trial. At this initial telephone contact, and after consent from the mothers, we randomized expectant mothers to receive the verbal information about The Danish Calmette Study by telephone, or at a face-to-face consultation. The primary outcome was a communication score, consisting of comprehension of information about The Danish Calmette Study and satisfaction with the information process. The outcome was measured using a questionnaire 2 days after the information was provided, and 2.5 months after the birth of the child.ResultsThe communication score obtained 2 days after information was given was significantly reduced in the telephone group, effect size −0.74 (95% confidence interval (CI), −1.11 to −0.36). The effect sizes of the subscores were −0.87 (95% CI, −1.25 to −0.49) for satisfaction and −0.22 (95% CI, −0.58 to 0.14) for comprehension. The effect sizes were slightly reduced when assessed 2.5 months after the birth.ConclusionThe communication score was reduced in the telephone group. This was due to a reduction in satisfaction, while no difference in the comprehension could be found in comparison to the control group. This may be ethically acceptable as both groups had high satisfaction scores.Trial registrationClinicalTrials.gov, registered on 5 October 2015 with trial registration number NCT02570061.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1680-y) contains supplementary material, which is available to authorized users.

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“…Primary clinical research is extremely resourceintensive, in terms of time and money. The process of data acquisition can be lengthy in particular (Nijhawan, 2013). We argue in this paper that decentralized and secure management of consent data can help expand the application fields for individual clinical studies with multiple data uses.…”

Section: Research and Practice Questions And Approachmentioning

confidence: 99%

“…For participation in clinical trials, participants (patients or healthy subjects) nowadays must first give their written informed consent (Nijhawan, 2013). The study's protocols must therefore be approved in advance by an ethics committee, while the study's physician manages the operational steps:…”

Section: As-is-situation and To-be-situationmentioning

confidence: 99%