Research Participants’ Preferences for Hypothetical Secondary Results from Genomic Research

Secondary or incidental results can be identified in genomic research that increasingly uses whole exome/genome sequencing. Understanding research participants’ preferences for secondary results and what influences these decisions is important for patient education, counseling, and consent, and for the development of policies regarding return of secondary results. Two hundred nineteen research participants enrolled in genomic studies were surveyed regarding hypothetical preferences for specific types of secondary results, and these preferences were correlated with demographic information and psychosocial data. The majority of research participants (73%) indicated a preference to learn about all results offered, with no clear pattern regarding which results were not desired by the remaining participants. Participants who reported greater interest in genetic privacy were less likely to indicate a preference to learn all results, as were individuals who self-identified as Jewish. Although most research participants preferred to receive all secondary results offered, a significant subset preferred to exclude some results, suggesting that an all-or-none policy would not be ideal for all participants. The correlations between preferences to receive secondary results, religious identification, and privacy concerns demonstrate the need for culturally sensitive counseling and educational materials accessible to all education levels to allow participants to make the best choices for themselves.     

Working with Research Integrity—Guidance for Research Performing Organisations: The Bonn PRINTEGER Statement

This document presents the Bonn PRINTEGER Consensus Statement: Working with Research Integrity—Guidance for research performing organisations. The aim of the statement is to complement existing instruments by focusing specifically on institutional responsibilities for strengthening integrity. It takes into account the daily challenges and organisational contexts of most researchers. The statement intends to make research integrity challenges recognisable from the work-floor perspective, providing concrete advice on organisational measures to strengthen integrity. The statement, which was concluded February 7th 2018, provides guidance on the following key issues:

1. § 1.
   Providing information about research integrity
    
2. § 2.
   Providing education, training and mentoring
    
3. § 3.
   Strengthening a research integrity culture
    
4. § 4.
   Facilitating open dialogue
    
5. § 5.
   Wise incentive management
    
6. § 6.
   Implementing quality assurance procedures
    
7. § 7.
   Improving the work environment and work satisfaction
    
8. § 8.
   Increasing transparency of misconduct cases
    
9. § 9.
   Opening up research
    
10. § 10.
    Implementing safe and effective whistle-blowing channels
     
11. § 11.
    Protecting the alleged perpetrators
     
12. § 12.
    Establishing a research integrity committee and appointing an ombudsperson
     
13. § 13.
    Making explicit the applicable standards for research integrity
     

     

Do we Need a Special Ethics for Research?

Research is subject to more stringent ethical requirements than most other human activities, and a procedure that is otherwise allowed may be forbidden in research. Hence, risk-taking is more restricted in scientific research than in most non-research contexts, and privacy is better protected in scientific questionnaires than in marketing surveys. Potential arguments for this difference are scrutinized. The case in its favour appears to be weak. A stronger case can be made in favour of a difference in the opposite direction: If perilous or otherwise problematic activities have to be performed it is usually better to perform them in a research context where they are properly evaluated so that guidance is obtained for the future. However, retreating from current ethical demands on research is not a desirable direction to go. Instead, research ethics can serve to inspire the introduction of more stringent ethical principles in other social sectors.     

Content Analysis��A Methodological Primer for Gender Research

This article is intended to serve as a primer on methodological standards for gender scholars pursuing content analytic research. The scientific underpinnings of the method are explored, including the roles of theory, past research, population definition, objectivity/intersubjectivity, reliability, validity, generalizability, and replicability. Both human coding and computer coding are considered. The typical process of human-coded content analysis is reviewed, including the steps of unitizing, sampling, measurement, coder training, reliability assessment, and reportage of methods. Numerous applications to research on gender roles and related issues are reviewed. Practical checklists are offered for content analysis preparation and methodological execution.     

Recommendations for Research Success: One Investigator’s Perspective

This article is a personal reflection by an investigator with over 25 years of funding from the National Institutes of Health (NIH). The article: (1) highlights research opportunities for psychologists at the NIH outside of the traditional mental health arena; (2) provides specific recommendations to individual investigators to enhance their likelihood of obtaining NIH funding; (3) specifies needed changes in psychology’s research education and training programs to prepare the next generation of psychologists for research success; and (4) asks the Association of Psychologists in Academic Health Centers to play a lead role in both research training and advocacy. This article is based on a presentation given at the 3rd national conference of the Association of Psychologists in Academic Health Centers in May of 2007 in Minneapolis, Minnesota.     

Research Ethics Board (REB) Members’ Preparation for,and Perceived Knowledge of Research Ethics

The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) was first developed to establish a standard of practice in research ethics by the three federal agencies responsible for funding institutional research in Canada: Canadian Institutes of Health Research (CIHR), Natural Sciences and Engineering Research Council (NSERC), and Social Sciences and Humanities Research Council (SSHRC). In 2010, a second edition of the policy, known as the TCPS 2, was released with updated information and expanded coverage of research ethics issues. According to the TCPS 2, the Agencies’ mandate is “to promote research that is conducted according to the highest ethical standards,” and the TCPS 2 serves as a benchmark for this with respect for human dignity as its underlying value. Research institutions receiving Agency funding are to comply with this policy statement by forming Research Ethics Boards (REBs) to review all research involving human participants. The intention behind this review requirement is to provide a proportionate assessment of the benefit-to-risk ratio of the research, and in that process, to safeguard “respect for persons”, express a “concern for welfare”, and uphold “justice” (CIHR, SSHRC, NSERC 2010, p. 8). Research may not proceed until ethics approval is granted by an institution’s REB. The current study evaluates REB members’ perspectives on their knowledge of research ethics, and juxtaposes these perceptions with those of researchers. Specifically, we are interested in the extent to which REB members with less experience read the TCPS 2, and whether those with less experience have decreased confidence in their ethics knowledge.     

Scientists’ Ethical Obligations and Social Responsibility for Nanotechnology Research

Scientists’ sense of social responsibility is particularly relevant for emerging technologies. Since a regulatory vacuum can sometimes occur in the early stages of these technologies, individual scientists’ social responsibility might be one of the most significant checks on the risks and negative consequences of this scientific research. In this article, we analyze data from a 2011 mail survey of leading U.S. nanoscientists to explore their perceptions the regarding social and ethical responsibilities for their nanotechnology research. Our analyses show that leading U.S. nanoscientists express a moderate level of social responsibility about their research. Yet, they have a strong sense of ethical obligation to protect laboratory workers (in both universities and industry) from unhealthy exposure to nanomaterials. We also find that there are significant differences in scientists’ sense of social and ethical responsibility depending on their demographic characteristics, job affiliation, attention to media content, risk perceptions and benefit perceptions. We conclude with some implications for future research.     

A Clinician’s Primer for Idiographic Research: Considerations and Recommendations

Theorists and clinicians have long noted the need for idiographic (i.e., individual-level) designs within clinical psychology. Results from idiographic work may provide a possible resolution of the therapist’s dilemma—the problem of treating an individual using information gathered via group-level research. Due to advances in data collection and time series methodology, there has been increasing interest in using idiographic designs to answer clinical questions. Although time series methods have been well-studied outside the field of clinical psychology, there is limited direction on how clinicians can use such models to inform their clinical practice. In this primer, we collate decades of published and word-of-mouth information on idiographic designs, measurement, and modeling. We aim to provide an initial guide on the theoretical and practical considerations that we urge interested clinicians to consider before conducting idiographic work of their own.     

Metrics-Based Assessments of Research: Incentives for ‘Institutional Plagiarism’?

The issue of plagiarism—claiming credit for work that is not one’s own, rightly, continues to cause concern in the academic community. An analysis is presented that shows the effects that may arise from metrics-based assessments of research, when credit for an author’s outputs (chiefly publications) is given to an institution that did not support the research but which subsequently employs the author. The incentives for what is termed here “institutional plagiarism” are demonstrated with reference to the UK Research Assessment Exercise in which submitting units of assessment are shown in some instances to derive around twice the credit for papers produced elsewhere by new recruits, compared to papers produced ‘in-house’.     

Participatory Research in Systems of Care for Children’s Mental Health

The children’s system of care initiative in the United States requires the participation of caregivers of children with emotional or behavioral problems in conducting research and evaluation. This entails a restructuring of traditional power dynamics among families served by the community mental health system and other system stakeholders, including researchers. However, evidence indicates that system of care research may not currently embrace the different types of knowledge possessed by caregivers and may be frustrated by traditional power hierarchies, resulting in research findings that are not useful for the community. In this paper I examine a framework for power and knowledge and examine how, when viewed through this framework, participatory research in the system of care initiative thus far may be less than authentic. I conclude with improvements suggested by the framework that are expected to shift power to caregivers and result in more useful, actionable research findings for the community.     

Issues Involving Informed Consent for Research Participants with Alzheimer’s Disease

Alzheimer’s disease is the most common form of dementia which is estimated to impact 350,000 people over 65 years of age in Canada. The lack of effective treatment and the growing number of people who are expected to be diagnosed with Alzheimer’s disease in the near future are compelling reasons why continued research is in this area is necessary. With additional research, there needs to be greater recognition of the complexity of seeking ongoing informed consent from those with Alzheimer’s disease. This complexity is because the impairment of memory and cognitive ability does not diminish in a linear manner, but rather fluctuates between periods of impairment and relatively normal cognitive lucidness. There is limited discussion in the guidelines of those progressing from early stages of Alzheimer’s disease who have intermittent cognitive function. Guidelines to research and Research Ethics Boards require further development to facilitate researcher including those with Alzheimer’s disease while protecting this growing pool of potential participants.     

What Role for Parental Attributions in Parenting Interventions for Child Conduct Problems? Advances from Research into Practice

The role of parental attributions in parenting interventions has been the subject of intense interest from clinicians and researchers attempting to optimise outcomes in treatments for children with conduct problems. Despite research articulating the many ways parental attributions can influence behavioural parent training (BPT) outcomes, and recognition that addressing parental attributions in treatment is one of the great challenges faced by BPT practitioners, parenting interventions generally do not provide components that explicitly target or focus on changing problematic parental attributions. In this paper, we ask ‘Should parental attributions be included into best practice interventions? If so, how can this be done in a way that improves outcomes without cluttering and complicating the parent training model?’ We review the theoretical and empirical status of our understanding of the role of parental attributions in BPT with reference to three questions: ‘do pre-treatment parental attributions uniquely predict treatment outcomes’; ‘do changes in parental attributions uniquely predict treatment outcomes’; and ‘does targeting parental attributions in BPT affect treatment outcomes’. Our review indicates that existing research supports the importance of focussing on parental attributions for some families in order to maximise treatment outcomes. However, clinical processes for doing this are yet to be identified and specified in a way that would allow for manualised replication and scrutiny in research designs. We finish with a discussion of how these clinical and research challenges could be approached.     

Large Scale Surveys for Policy Formation and Research–a Study in Inconsistency

In this paper we analyse the degree to which a distinction between social science and public health research and other non-research activities can account for differences between a number of large scale social surveys performed at the national and European level. The differences we will focus on are differences in how participation is elicited and how data are used for government, research and other purposes. We will argue that the research / non-research distinction does not account for the identified differences in recruitment or use and that there are no other convincing justifications. We argue that this entails that eliciting participation by coercion or manipulation becomes very difficult to justify.     

The Limitations of “Vulnerability” as a Protection for Human Research Participants

Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges.     

Finite Mixture Multilevel Multidimensional Ordinal IRT Models for Large Scale Cross-Cultural Research

We present a class of finite mixture multilevel multidimensional ordinal IRT models for large scale cross-cultural research. Our model is proposed for confirmatory research settings. Our prior for item parameters is a mixture distribution to accommodate situations where different groups of countries have different measurement operations, while countries within these groups are still allowed to be heterogeneous. A simulation study is conducted that shows that all parameters can be recovered. We also apply the model to real data on the two components of affective subjective well-being: positive affect and negative affect. The psychometric behavior of these two scales is studied in 28 countries across four continents.     

Does an Appeal to the Common Good Justify Individual Sacrifices for Genomic Research?

In genomic research the ideal standard of free, informed, prior, and explicit consent is believed to restrict important research studies. For certain types of genomic research other forms of consent are therefore proposed which are ethically justified by an appeal to the common good. This notion is often used in a general sense and this forms a weak basis for the use of weaker forms of consent. Here we examine how the notion of the common good can be related to individual health, health care, and genomic research and we use this analysis to propose more precise criteria to justify forms of consent which diverge from the ideal standard.