Informed Consent and the Research Process: Following Rules or Striking Balances?

Gaining informed consent from people being researched is central to ethical research practice. There are, however, several factors that make the issue of informed consent problematic, especially in research involving members of groups that are commonly characterised as \'vulnerable\' such as children and people with learning disabilities. This paper reports on a project funded by the UK Economic and Social Research Council (ESRC) which was concerned to identify and disseminate best practice in relation to informed consent in research with six such groups. The context for the study is the increased attention that is being paid to the issue of informed consent in research, not least because of the broad changes taking place in research governance and regulation in the UK. The project involved the analysis of researchers\' views and experiences of informed consent. The paper focuses on two particular difficulties inherent in the processes of gaining and maintaining informed consent. The first of these is that there is no consensus amongst researchers concerning what comprises \'informed consent\'. The second is that there is no consensus about whether the same sets of principles and procedures are equally applicable to research among different groups and to research conducted within different methodological frameworks. In exploring both these difficulties we draw on our findings to highlight the nature of these issues and some of our participants\' responses to them. These issues have relevance to wider debates about the role of guidelines and regulation for ethical practice. We found that study participants were generally less in favour of guidelines that regulate the way research is conducted and more in favour of guidelines that help researchers to strike balances between the conflicting pressures that inevitably occur in research.Informed Consent; Research Ethics; Regulation of Research; Research Governance; Professional Guidelines

Empirical relationships between health literacy and treatment decision making : A scoping review of the literature

Copyright © 2014 Elsevier Ireland Ltd. All rights reserved. Acknowledgements This research was supported by a Joseph Armand Bombardier Doctoral Scholarship awarded to Leslie J. Malloy-Weir by the Social Sciences and Humanities Research Council of Canada. The authors would like to thank Maureen Rice for her help with the literature search strategy and Dr. Malcolm Weir for his help with the relevance screening.Peer reviewedPostprin

Sequence diversity and molecular evolution of the merozoite surface antigen 2 of plasmodium falciparum

Eleven new alleles of the Plasmodium falciparum merozoite surface antigen 2 (MSA2) from Papua New Guinea were analyzed by direct sequencing of polymerase chain reaction (PCR) products. We have used the sequence information to trace the molecular evolution of MSA2. The repeats of ten alleles belonging to the 3D7 allelic family differed considerably in size, nucleotide sequence, and repeat copy number. In the repeat region of these new alleles, codon usage was extremely biased with an exclusive use of NNT codons. Another new allele sequenced belonged to the FC27 family and confirmed the family-specific conserved structure of 96 and 36 bp repeats. In order to assess sequence microheterogeneity within samples defined as the same genotype by restriction fragment length polymorphism (RFLP), we have analyzed single-strand conformation polymorphism (SSCP) of different samples of the most frequent allele (D10 of the FC27 family) in the study population. No sequence heterogeneity could be detected within the repeat region. Based on analysis of the repeat regions in both allelic families, we discuss the hypothesis of a different evolutionary strategy being represented by each of the allelic familie

The TRIO Framework : Conceptual insights into family caregiver involvement and influence throughout cancer treatment decision-making

This research was supported under Australian Research Council's Discovery Projects funding scheme (Project Number: DP140103838).Peer reviewedPostprin

NCRM Methods Review Papers NCRM/001 Informed Consent in Social Research: A Literature Review

This paper comprises a literature review outlining the current issues and debates relating to informed consent in social research. Given the rapidly changing nature of the field it draws primarily on literature published between 1998-2004. However, it includes some papers and books published prior to this where these are viewed as having made an important contribution to issues and debates around informed consent. The paper focuses primarily on consent in relation to qualitative research comprising ‘traditional’ methods of data collection, such as interviews and observation. It does not does not engage with the many complex ethical issues relating to research using visual methods and new digital technologies nor does it engage with the issues of consent in relation to quantitative research both of which, while important, are beyond the scope of this paper. The paper explores issues of informed consent in qualitative social research in general but focuses specifically on research conducted with so called ‘vulnerable’ groups (to include children, older people and people with a range of physical and mental health problems) in that issues of consent are perceived as being particularly pertinent when conducting research with these groups. This review outlines the regulatory, ethical and legal context for consent in social research and the operationalisation of informed consent in practice. This review was conducted as part of a project funded within the ESRC Research Methods Programme 2002-2004

Anonymity and Confidentiality

This paper focuses on confidentiality and anonymity and explores the ways in which these issues are managed by researchers. It draws primarily on data collected from a study funded as part of the ESRC Research Methods Programme focusing on researchers’ views and experiences relating to the issue of informed consent in research. The focus is on these issues in relation to qualitative research

Use of contingency management incentives to improve completion of hepatitis B vaccination in people undergoing treatment for heroin dependence: a cluster randomised trial

Background: Poor adherence to treatment diminishes its individual and public health benefit. Financial incentives, provided on the condition of treatment attendance, could address this problem. Injecting drug users are a high-risk group for hepatitis B virus (HBV) infection and transmission, but adherence to vaccination programmes is poor. We aimed to assess whether contingency management delivered in routine clinical practice increased the completion of HBV vaccination in individuals receiving opioid substitution therapy. Methods: In our cluster randomised controlled trial, we enrolled participants at 12 National Health Service drug treatment services in the UK that provided opioid substitution therapy and nurse-led HBV vaccination with a super-accelerated schedule (vaccination days 0, 7, and 21). Clusters were randomly allocated 1:1:1 to provide vaccination without incentive (treatment as usual), with fixed value contingency management (three £10 vouchers), or escalating value contingency management (£5, £10, and £15 vouchers). Both contingency management schedules rewarded on-time attendance at appointments. The primary outcome was completion of clinically appropriate HBV vaccination within 28 days. We also did sensitivity analyses that examined vaccination completion with full adherence to appointment times and within a 3 month window. The trial is registered with Current Controlled Trials, number ISRCTN72794493. Findings: Between March 16, 2011, and April 26, 2012, we enrolled 210 eligible participants. Compared with six (9%) of 67 participants treated as usual, 35 (45%) of 78 participants in the fixed value contingency management group met the primary outcome measure (odds ratio 12·1, 95% CI 3·7–39·9; p<0·0001), as did 32 (49%) of 65 participants in the escalating value contingency management group (14·0, 4·2–46·2; p<0·0001). These differences remained significant with sensitivity analyses. Interpretation: Modest financial incentives delivered in routine clinical practice significantly improve adherence to, and completion of, HBV vaccination programmes in patients receiving opioid substitution therapy. Achievement of this improvement in routine clinical practice should now prompt actual implementation. Drug treatment providers should employ contingency management to promote adherence to vaccination programmes. The effectiveness of routine use of contingency management to achieve long-term behaviour change remains unknown

Museums and the ‘new museology’ : theory, practice and organisational change

The widening of roles and expectations within cultural policy discourses has been a challenge to museum workers throughout Great Britain. There has been an expectation that museums are changing from an ‘old’ to a ‘new museology’ that has shaped museum functions and roles. This paper outlines the limitations of this perceived transition as museum services confront multiple exogenous and endogenous expectations, opportunities, pressures and threats. Findings from 23 publically funded museum services across England, Scotland and Wales are presented to explore the roles of professional and hierarchical differentiation, and how there were organisational and managerial limitations to the practical application of the ‘new museology’. The ambiguity surrounding policy, roles and practice also highlighted that museum workers were key agents in interpreting, using and understanding wide-ranging policy expectations. The practical implementation of the ‘new museology’ is linked to the values held by museum workers themselves and how they relate it to their activities at the ground level

Finishing the euchromatic sequence of the human genome

The sequence of the human genome encodes the genetic instructions for human physiology, as well as rich information about human evolution. In 2001, the International Human Genome Sequencing Consortium reported a draft sequence of the euchromatic portion of the human genome. Since then, the international collaboration has worked to convert this draft into a genome sequence with high accuracy and nearly complete coverage. Here, we report the result of this finishing process. The current genome sequence (Build 35) contains 2.85 billion nucleotides interrupted by only 341 gaps. It covers ∼99% of the euchromatic genome and is accurate to an error rate of ∼1 event per 100,000 bases. Many of the remaining euchromatic gaps are associated with segmental duplications and will require focused work with new methods. The near-complete sequence, the first for a vertebrate, greatly improves the precision of biological analyses of the human genome including studies of gene number, birth and death. Notably, the human enome seems to encode only 20,000-25,000 protein-coding genes. The genome sequence reported here should serve as a firm foundation for biomedical research in the decades ahead