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The article offers a practical advice for researchers on preparing an application for ethical review of research in health and social care in Great Britain. The implementation of relatively minor changes in the early stages of creating the application is recommended. The function of research ethics committees is discussed in relation to the purpose of ethical review. An overview of the research ethics process in Great Britain is presented. The processes involved in research ethics application include the creation of an account on the online integrated research application.

In this commentary we consider the validity of tobacco industry-funded research on the effects of standardised packaging in Australia. As the first country to introduce standardised packs, Australia is closely watched, and Philip Morris International has recently funded two studies into the impact of the measure on smoking prevalence. Both of these papers are flawed in conception as well as design but have nonetheless been widely publicised as cautionary tales against standardised pack legislation. Specifically, we focus on the low statistical significance of the analytical methods used and the assumption that standardised packaging should have an immediate large impact on smoking prevalence. [ABSTRACT FROM AUTHOR]

Objective To examine whether the association of inadequate or unclear allocation concealment and lack of blinding with biased estimates of intervention effects varies with the nature of the intervention or outcome. Design Combined analysis of data from three meta- epidemiological studies based on collections of meta- analyses. Data sources 146 meta-analyses including 1346 trials examining a wide range of interventions and outcomes. Main outcome measures Ratios of odds ratios quantifying the degree of bias associated with inadequate or unclear allocation concealment, and lack of blinding, for trials with different types of intervention and outcome. A ratio of odds ratios <1 implies that inadequately concealed or non- blinded trials exaggerate intervention effect estimates. Results In trials with subjective outcomes effect estimates were exaggerated when there was inadequate or unclear allocation concealment (ratio of odds ratios 0.69 (95% Cl 0.59 to 0.82)) or lack of blinding (0.75 (0.61 to 0.93)). In contrast, there was little evidence of bias in trials with objective outcomes: ratios of odds ratios 0.91 (0.80 to 1.03) for inadequate or unclear allocation concealment and 1.01 (0.92 to 1.10) for lackof blinding. There was little evidence for a difference between trials of drug and non- drug interventions. Except fortrials with all cause mortality as the outcome, the magnitude of bias varied between meta-analyses. Conclusions The average bias associated with defects in the conduct of randomised trials varies with the type of outcome. Systematic reviewers should routinely assess the risk of bias in the results of trials, and should report meta-analyses restricted to trials at low risk of bias either as the primary analysis or in conjunction with less restrictive analyses. INSET: WHAT IS ALREADY KNOWN ON THIS TOPIC. [ABSTRACT FROM AUTHOR]

The article focuses on obtaining a participant's consent for the use of confidential medical information in research. Requirements for obtaining consent in research are discussed. Types of research participant consent are described, including express consent, informed consent, and free choice. Costs of the consent process are examined in comparison with the benefits to research. Recommendations for simplifying the consent process are provided.

A study is presented on the issue of consent for research on biological samples and public support for one-time general consent. A search of studies on support of consent for such research from PubMed revealed that the majority of respondents support one-time general consent. Respondents came from a variety of ethnic and national groups, many different countries and were patients, research participants, family members, religious leaders and the public. The diverse nature of the sample suggests that one-time general consent would be an effect way of obtaining consent, especially is used universally. The author calls for a universal standard for obtaining consent.

Presents an article documenting efforts of this journal to investigate suspected research fraud. The 1992 study by Dr. Ram B. Singh that became a "citation classic", his Indian diet heart study, and a 1993 epidemiological study that led to "serious concerns" about his research methods; Dr. Singh's response to allegations of fraud; The reason this journal's Ethics Committee decided to go public; The views of Dr. Chittakkudam Raman Soman, chair of the non-governmental organization, Health Action by People, and the opinions of others about Dr. Singh. INSET: Who is Singh?.

Background: There is relatively little research concerning the processes whereby Local Research Ethics Committees discharge their responsibilities towards society, potential participants and investigators.Objectives: To examine the criteria used by LRECs in arriving at their decisions concerning approval of research protocols through an analysis of letters sent to investigators.Design: Four LRECs each provided copies of 50 letters sent to investigators after their submitted proposals had been considered by the committees. These letters were subjected to a content analysis, in which specific comments and requests for additional information and changes in the protocols were recorded and compared.Findings: Overall 24% of proposals were approved without request for changes or clarifications, but this varied by committee: one committee approved only 6% of proposals without change or clarification while the others ranged from 26% to 32%. The content analyses of responses indicated that they could be placed into four categories: (i) further information for the committee to aid in their deliberations; (ii) requests for changes to the design or justification for the design used; (iii) changes to the information sheets provided to potential participants; and (iv) changes to consent procedures. Of these, alterations to information sheets were the most common type of request. These four types of response could be seen as safeguarding the wellbeing of potential participants (the principle of non-maleficence), of promoting the scientific validity of the research (the principle of beneficence), and of enhancing the rights of potential participants (the principle of autonomy).Conclusions: The committees were consistent in the types of requests they made of investigators, which can be seen as attempts to protect participants' rights and ensure the scientific validity of studies. Without an analysis of the proposals sent to the committees, however, it is difficult to account for the variation in the requirements set by the committees before approval was given. [ABSTRACT FROM AUTHOR]

The article presents six questions which people in the medical community can use to assess and appraise qualitative research. A discussion of the importance of determining whether samples used in research were appropriate to the research question, whether data in the research were collected and analyzed appropriately, whether the results of the research can be transferred to a medical setting, and whether the research adequately addresses potential ethical issue, is presented. Suggestions for further reading are offered.

Critiques the validity and ethics of cohort studies. Benefits of cohort studies to medical research; Comparison between cohort studies and randomized trials; View that random allocation in randomized controlled trials enhances the validity of results; Risk for selection bias to influence the results of cohort studies; Creation of a valid comparison group in cohort studies; Methods for ensuring the validity of a cohort study's results.

The article reports on the results of research which evaluated past research on the treatment of type 2 diabetes and was reported in the "Archives of Internal Medicine". Researchers found that poor data from research studies hamper the safe and effective treatment of type 2 diabetes and that an inadequate amount of research has been conducted in an effort to determine how doctors should optimize treatment to prevent cardiovascular disease in diabetics. Researchers also found that most research trials on type 2 diabetes were too short, contained poor research standards and were too small to be conclusive.

The article presents an overview of the way authors, editors and systematic researchers should handle suspected medical research misconduct. Several groups including the committee on Publication Ethics which publish guidelines on how editors should react to suspected research misconduct are discussed. The case of Dr. Julio Cruz, whose research publications have been called into question two years after his 2005 death is presented as an example of why medical research needs to be monitored for misconduct.

The article reports on a decision from the periodical "Lancet" to retract a paper on stress incontinence that it had published which was written by researchers at the Medical University of Innsbruck in Austria. The periodical made the decision after it was informed by Austria's Agency for Health and Food Safety that the researchers who conducted the research featured in the paper failed to get proper ethical approval from research subjects and neglected to inform subjects about the experimental nature of their research