Legal and ethical issues in research

Yip, Camille; Han, Nian-Lin Reena; Sng, Ban Leong

doi:10.4103/0019-5049.190627

Cited by 54 publications

(22 citation statements)

References 10 publications

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“…The ethics committee for the Region of Southern Denmark reviewed the protocol and found that the Medical Research Involving Human Subjects Act does not apply to this study. 15 A formal approval was therefore not required for this study. We did obtain written consent nevertheless, due to the sensitivity of the subject matter.…”

Section: Methodsmentioning

confidence: 99%

Drivers for successful long-term lifestyle change, the role of e-health: a qualitative interview study

et al. 2018

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ObjectivesAssisting patients in lifestyle change using collaborative e-health tools can be an efficient treatment for non-communicable diseases like diabetes, cardiovascular disease and chronic obstructive lung disease that are caused or aggravated by unhealthy living in the form of unhealthy diet, physical inactivity or tobacco smoking. In a prospective pilot study, we tested an online collaborative e-health tool in general practice. The aim of this study was to identify drivers of importance for long-term personal lifestyle changes from a patient perspective when using a collaborative e-health tool, including the support of peers and healthcare professionals.SettingGeneral practice clinics in the Region of Southern Denmark.Participants10 overweight patients who had previously successfully used a hybrid online collaborative e-health tool with both face-to-face and online consultations to lose weight.ResultsThe main themes identified were facilitators, barriers and support from family and peers. Establishment of a trustworthy relationship with the healthcare professionals was of paramount importance. It was important for the patients to monitor the measurable outcomes with realistic goals and feedback from a trusted person. Often, significant life events were identified as catalysts for successful long-term lifestyle changes. Dominant barriers to change were perception of insurmountable obstacles, experience of lack of self-efficacy and excess eating of high-calorie food. Finally, experiencing of trustworthy person-to-person forums, need for acknowledgement from referent others and support from family and peers were important drivers for long-term lifestyle change.ConclusionThe most important driver in long-term weight loss was a strong relationship with a healthcare professional. Collaborative e-health tools can support the relationship and behavioural changes through monitoring and providing relevant feedback. The support from family and peers also matters, and long-term success depends on the ability to establish strong, positive support on a day-to-day basis.

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Section: Methodsmentioning

confidence: 99%

Drivers for successful long-term lifestyle change, the role of e-health: a qualitative interview study

et al. 2018

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“…Notably, WAME's publication ethics policies have been praised in the context of the fight against violations of research and publication ethics in countries of emerging scientific powers. 38 …”

Section: Global Editorial Associations and Their Updated Documentsmentioning

confidence: 99%

Updated Editorial Guidance for Quality and Reliability of Research Output

et al. 2018

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Over the past few years, updated editorial policy statements of several associations have provided a platform for improving the quality of scientific research and publishing. The updates have particularly pointed to the need for following research reporting standards, authorship and contributorship regulations, implementing digital tools for the identification and crediting academic contributors, and moving towards optimal ethical open-access models. This article overviews some of the recent editorial policy statements of global editorial associations and reflects on the role of the regional counterparts in advancing scholarly publishing. One of the globally promoted documents is the Recommendations of the International Committee of Medical Journal Editors (ICMJE). Its latest versions contain statements on proper research reporting, reviewing, editing, and publishing. Points on ethical target journals and ‘predatory’ sources are also available. This year, in a move to update its editorial policy, the Committee on Publication Ethics (COPE) released the Core Practices, comprehensively reflecting on the major issues in publication ethics. Updated joint statements of medical writers associations are also available to implement transparent policy on contributorship in sponsor-supported research projects and related reports. Several suggestions are put forward to improve global editorial statements on online profiling, crediting, and referencing. It is also highlighted that knowledge and implementation of updated editorial guidance is essential for editors' good standing.

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“…The product being investigated could be a drug molecule, vaccine, nutritional supplement or therapeutic or surgical procedure 1. The use of human subjects in these trials introduces specific challenges, particularly violations of ethical rights and health hazards 2. Consequently, regulations have been developed to protect human rights and the dignity of individuals participating in biomedical research 3…”

Section: Introductionmentioning

confidence: 99%

<p>Factors Influencing Participation Of Healthy Volunteers In Clinical Trials: Findings From A Cross-Sectional Study In Delhi, North India</p>

Ranjan¹,

Agarwal²,

Kapur³

et al. 2019

PPA

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PurposeTo identify the specific motivations that drive healthy volunteers to consent for their participation in clinical studies. Additionally, the study aimed to document the socio-demographic determinants of participation in the trial related solely to the intention of securing financial gains.Patients and methodsThis cross-sectional study was conducted among subjects who participated as healthy volunteers in clinical trials conducted by Contract Research Organizations (CROs) of Delhi. Pre-tested, validated semi-structured questionnaires were used to collect baseline socio-demographic data, information about factors motivating participation in clinical trials, and pattern of utilisation of money received against participation in the trial. Logistic regression analysis was done to determine the factors that influenced participation in the trial related purely to the motive of securing financial gains.ResultsA total of 400 participants were selected. The majority of the volunteers (77.5%) reported that their sole reason for participating in clinical trials was for monetary gain. Around a tenth of the volunteers participated with the intent to advance scientific knowledge and another 4.5% participated due to benefits of free medical check-ups. Participants in the age group of 29–38 years, those that were married, those residing in an urban slum, male participants, those with a high number of dependent family members (ie, 5 to 8), and those earning less than 5000 INR (71 USD) a month had higher odds of participating in a clinical trial purely for the financial benefits. Those educated till intermediate and above had lower odds of participation in the trial due to monetary benefits.ConclusionOur study shows that healthy volunteers in Delhi consider participation in clinical trials mainly because of the prospect of financial reward. More research is needed to inform judgments around the ethics of providing financial rewards and enrollment of healthy research volunteers.

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Legal and ethical issues in research

Cited by 54 publications

References 10 publications

Drivers for successful long-term lifestyle change, the role of e-health: a qualitative interview study

Drivers for successful long-term lifestyle change, the role of e-health: a qualitative interview study

Updated Editorial Guidance for Quality and Reliability of Research Output

<p>Factors Influencing Participation Of Healthy Volunteers In Clinical Trials: Findings From A Cross-Sectional Study In Delhi, North India</p>

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