BMC Medical Ethics 11 (1):9- (2010)

Abstract
BackgroundThere is a permanent need to evaluate and develop the ethical quality of scientific research and to widen knowledge about the effects of ethical issues. Therefore we evaluated whether informed consent is related to implementation and success in a lifestyle intervention study with older research participants. There is little empirical research into this topic.MethodsThe subjects (n = 597) are a subgroup of a random population sample of 1410 men and women aged 57-78 years who are participating in a 4-year randomized controlled intervention trial on the effects of physical exercise and diet on atherosclerosis, endothelial function and cognition. Data were collected in two steps: A questionnaire about informed consent was given to all willing participants (n = 1324) three months after the randomization. Data on implementation and success in the exercise and diet interventions were evaluated at 12 months by intervention-group personnel. The main purpose of the analysis procedure performed in this study was to identify and examine potential correlates for the chosen dependent variables and to generate future hypotheses for testing and confirming the independent determinants for implementation and success. The nature of the analysis protocol is exploratory at this stage.ResultsAbout half of the participants (54%) had achieved good results in the intervention. Nearly half of the participants (47%) had added to or improved their own activity in some sector of exercise or diet. Significant associations were found between performance in the interventions and participants' knowledge of the purpose of the study (p < 0.001), and between success in interventions and working status (p = 0.02), and the participants' knowledge of the purpose of the study (p = 0.04).ConclusionThe main finding of this study was that those participants who were most aware or had understood the purpose of the study at an early stage had also attained better results at their 12-month intervention evaluation. Therefore, implementation and success in intervention is related to whether subjects receive a sufficient amount and are able to comprehend the information provided i.e. the core principles of informed consent.Trial Registration(ISRCTN 45977199)
Keywords No keywords specified (fix it)
Categories (categorize this paper)
DOI 10.1186/1472-6939-11-9
Options
Edit this record
Mark as duplicate
Export citation
Find it on Scholar
Request removal from index
Revision history

Download options

PhilArchive copy


Upload a copy of this paper     Check publisher's policy     Papers currently archived: 71,410
Through your library

References found in this work BETA

No references found.

Add more references

Citations of this work BETA

No citations found.

Add more citations

Similar books and articles

Informed Consent and Relational Conceptions of Autonomy.N. Stoljar - 2011 - Journal of Medicine and Philosophy 36 (4):375-384.
Consent and Informational Responsibility.Shaun D. Pattinson - 2009 - Journal of Medical Ethics 35 (3):176-179.
Autonomy, Consent and the Law.Sheila McLean - 2009 - Routledge-Cavendish.

Analytics

Added to PP index
2010-08-24

Total views
16 ( #668,797 of 2,519,855 )

Recent downloads (6 months)
1 ( #406,012 of 2,519,855 )

How can I increase my downloads?

Downloads

My notes