Search Results

Introduction

Robert Rosenthal and Ralph L. Rosnow

in Artifacts in Behavioral Research: Robert Rosenthal and Ralph L. Rosnow's Classic Books

This short chapter defines volunteer bias and provides empirical evidence of the reliability of volunteering for research participation.

Toward Human Research Protection That Is Evidence Based and Participant Centered

Michael McDonald, Susan Cox, and Anne Townsend

in Human Subjects Research Regulation: Perspectives on the Future

This chapter addresses a fundamental question of whether current research protection systems based on compliance with rules actually do what they purport to do – protect participants without ... More

This chapter addresses a fundamental question of whether current research protection systems based on compliance with rules actually do what they purport to do – protect participants without needlessly impeding socially beneficial research. Based on the authors’ prior research, this chapter contends that it is essential to understand 1) how subjects actually experience research participation and (2) how these experiences are interpreted by researchers and research ethics committee members. Using specific examples drawn from subjects' accounts of risk, motivations for research participation, personal responsibility, and benefits/burdens, the authors argue in favour of an evidence-based system based on careful assessment of the actual impacts of research participation on subjects' lives, as opposed to the current rule-compliance system. A key premise of this approach is that the experience of research participants is pivotal to meaningful human subjects’ research protection. In this domain, they are sociologically and ethically “key” informants.Less

Differing Understandings of Informed Consent Held by Research Institutions, People with Intellectual Disability, and Guardians: Implications for Inclusive, Ethical Research

Britteny M. Howell and Karrie A. Shogren

in Research Involving Participants with Cognitive Disability and Difference: Ethics, Autonomy, Inclusion, and Innovation

Increasing participation of people with intellectual disability (ID) is necessary for inclusive, ethical research that reduces persistent disparities in representation. However, many adults with ID ... More

Increasing participation of people with intellectual disability (ID) is necessary for inclusive, ethical research that reduces persistent disparities in representation. However, many adults with ID have guardians, who must consent to research involvement. Researchers have found that guardians are less likely to provide consent than the person with ID, often resulting in lower participation. Institutional Review Board (IRB) members also have been found to hold very cautious views regarding research participation compared to the views of people with ID or their guardians. This chapter reviews issues that emerge because of differing views of research participation held by IRB members, guardians, and people with ID that may unnecessarily limit the participation of people with ID in research. The research literature on these barriers is summarized along with the authors’ own experiences with alternative participatory strategies that have the potential to increase both self-determination and participation in research for people with ID.Less

Dealing with Uncertainty: Payment Policy for the Generation of Evidence as Part of Clinical Practice

Carol M. Ashton and Nelda P. Wray

in Comparative Effectiveness Research: Evidence, Medicine, and Policy

Linking practice with evidence through payment policy will increase the value we get for the dollars we expend on medical care. But vast uncertainties exist in medicine. How should we proceed when ... More

Linking practice with evidence through payment policy will increase the value we get for the dollars we expend on medical care. But vast uncertainties exist in medicine. How should we proceed when valid evidence about the benefits and harms of an intervention or course of action does not yet exist? Under conditions of uncertainty of the value of a health service, the best way to protect the interests of both payers as well as patients is to reduce the uncertainty. Payment models like Medicare’s coverage with evidence development incentivize the reduction of uncertainty in medicine through participation in research. These arrangements give the patient access to the item or service in return for contributing to an evidence base. Hearts, minds, and processes must be changed if we are to realize the vision of making evidence generation an inseparable part of the medical interactions that occur in routine clinical practice.Less

Children and Young People’s Participation in Research

Nigel Thomas

in International Perspectives and Empirical Findings on Child Participation: From Social Exclusion to Child-Inclusive Policies

Children and young people’s participation in research can mean anything from taking part in adults’ research projects, to working in research partnerships with adults, to conducting their own ... More

Children and young people’s participation in research can mean anything from taking part in adults’ research projects, to working in research partnerships with adults, to conducting their own research with adults’ support. This chapter focuses on the second and third of these. It presents two projects conducted by the author. The first was a university-based project to support children in local elementary schools to plan and carry out their own research projects. The second was initiated by young people in public care, who were supported by university researchers to conduct a research project together. Following the description of the projects, the chapter considers the factors contributing to their success and the shortfalls and disappointments in the two projects. It concludes with some thoughts about the centrality of the researcher as a gatekeeper for child participation, in particular in a wider context in which children’s participation rights are seen as problematic.Less

Connecting classes and communities with conservation

Susan K. Jacobson, Mallory D. McDuff, and Martha C. Monroe

in Conservation Education and Outreach Techniques

Effective conservation aims to integrate, rather than compete with, the needs of the human and biological communities that share landscapes. This chapter focuses on techniques to connect classrooms ... More

Effective conservation aims to integrate, rather than compete with, the needs of the human and biological communities that share landscapes. This chapter focuses on techniques to connect classrooms and communities with conservation. Conservation education techniques, such as service-learning, issue investigation, and project-based learning, can involve students, teachers, and community members in finding creative approaches to issues such as reducing carbon emissions and building community gardens. In addition, public participation in scientific research involves collaboration between members of the public and scientists, and includes both citizen science and community-based research as examples. Finally, this chapter describes mapping as a technique that allows individuals or groups to create visual representations of resources, a community, or a region. The techniques described in this chapter bring real conservation issues to the forefront of communities and classrooms and ultimately help achieve conservation goals.Less

Researching end of life in old age: ethical challenges

Ailsa Cameron, Liz Lloyd, Naomi Kent, and Pat Anderson

in Researchers and their 'subjects': Ethics, power, knowledge and consent

One of the ethical dilemmas facing researchers and social researchers is the most appropriate way of researching the relationship between old age and death. This chapter reviews the ethical issues ... More

One of the ethical dilemmas facing researchers and social researchers is the most appropriate way of researching the relationship between old age and death. This chapter reviews the ethical issues that arose when developing the methodology for a one-year pilot study exploring the lives of one hundred people over the age of eighty. These ethical issues included whether older people with dementia can or should consent to research participation; whether it was right to obtain proxy consent from carers; how the ethical issues that emerge were addressed and resolved through a Research Ethics Committee (REC); and how the researchers dealt with ethical issues as they arose within the research interaction. The research project discussed in this chapter aimed to explore the issues of old age and death from the perspective of older people. By listening to the accounts and narratives of older people, the chapter aims to gain a better understanding of their involvement in key decisions made about their lives by health and social care professionals. While older people were the focus of this study, they were also actively involved in the project advisory group, helping researchers to plan and fine-tune the research methodology.Less

Evaluating the therapeutic misconception

Steven Joffe

in The Ethical Challenges of Human Research: Selected Essays

This chapter focuses on the notion of therapeutic misconception and its implications for research ethics. Therapeutic misconception was coined by Paul Appelbaum, Loren Roth, and Charles Lidz (1982) ... More

This chapter focuses on the notion of therapeutic misconception and its implications for research ethics. Therapeutic misconception was coined by Paul Appelbaum, Loren Roth, and Charles Lidz (1982) to describe the observed tendency of individuals enrolled in clinical trials to confuse the scientific orientation of their research participation with the therapeutic orientation of medical care. The chapter first examines the way Appelbaum and colleagues characterize the therapeutic misconception before considering how the therapeutic misconception impairs informed consent. More specifically, it asks whether an understanding of clinical trial participation that is free from any therapeutic misconception is a necessary condition of valid informed consent, and what steps investigators should take to counteract therapeutic misconceptions among prospective subjects. It argues that ethicists who write about informed consent must avoid the so-called “disadvantage thesis,” which appears to have little empirical support.Less

Vulnerability, Empowerment, and Dissent: The Importance of Saying No: Commentary on All Chapters

M. Ariel Cascio

in Research Involving Participants with Cognitive Disability and Difference: Ethics, Autonomy, Inclusion, and Innovation

This is a commentary on Chapters 1–17. It focuses on the vulnerability of potential research participants to undue influence or coercion, empowerment to make decisions about taking part in research, ... More

This is a commentary on Chapters 1–17. It focuses on the vulnerability of potential research participants to undue influence or coercion, empowerment to make decisions about taking part in research, and the importance of creating a space for potential participants to say no.Less

A Tale of Three Cultures

Jill A. Fisher

in Adverse Events: Race, Inequality, and the Testing of New Pharmaceuticals

Despite similar financial goals among healthy volunteers, there are regional differences in the culture of Phase I participation. Chapter 3 focuses on this theme to further unpack variations in how ... More

Despite similar financial goals among healthy volunteers, there are regional differences in the culture of Phase I participation. Chapter 3 focuses on this theme to further unpack variations in how patterns of imbricated stigma influence healthy volunteers’ perceptions of Phase I trials, particularly with respect to the longevity of their study involvement. Specifically, East Coast participants tend to be well-networked as part of their long-term, active pursuit of clinical trials, but they often also express anti-capitalist critiques of the industry. In comparison, Midwesterners tend to be more passive about their trial participation, thinking of it as a short-term financial opportunity to counterbalance a temporary setback. West Coast participants occupy a hybrid culture between those of the East Coast and Midwest participants, actively seeking out new studies but expressing a distrust in the clinics and wanting to limit their study involvement. These regional cultures act as a prism for healthy volunteers’ perceptions of Phase I trials, shaping whether and how they adopt identities as research participants.Less

Repurposing Ethnography to Assess Consent Capacity: Commentary on Mehmood (Chapter 14)

Megan S. Wright

in Research Involving Participants with Cognitive Disability and Difference: Ethics, Autonomy, Inclusion, and Innovation

This chapter comments on the use of ethnographic methods to assess prospective research participants’ capacity to consent to research. While repurposing ethnography provides a valuable tool to assess ... More

This chapter comments on the use of ethnographic methods to assess prospective research participants’ capacity to consent to research. While repurposing ethnography provides a valuable tool to assess consent capacity for persons with chronic mental illness by observing such persons in different settings and over a period of time, which can provide a fuller picture of capacity, there are limitations to this use. First, in some jurisdictions, an ethics review board may not permit a researcher to engage in ethnography without the consent of those being observed, which means this method would not be of use. Second, a researcher may not have appropriate methodological training to employ this method of assessing consent capacity. Third, the method may be limited to institutional settings. Finally, this method may only be appropriate for low-risk research.Less

What about the Customer? The Patient’s Dilemma

Michael Tansey

in Intelligent Drug Development: Trials and Errors in Clinical Research

Apparently no one was listening to Sir William. In a study carried out 80 years after Osler’s exhortation, physicians interrupted patients, on average, ... More

Apparently no one was listening to Sir William. In a study carried out 80 years after Osler’s exhortation, physicians interrupted patients, on average, after 18 seconds (H. Beckman and R. Frankel, 1984). It is common to take for granted the very people who are essential for our continued paid employment and the success of our endeavors, namely our customers. For example, some airline staff refer to passengers as “self-loading freight” or SLF (www. pprune.org), which, though mildly amusing and certainly accurate, is hardly indicative of a warm and friendly service-focused attitude. Attitudes in the pharmaceutical business are no different. Throughout the development and marketing cycles, the emphasis is primarily on satisfying intermediaries such as regulators, opinion leaders, prescribers, and insurers. Important though these intermediaries may be, they are not the customers. Patients are the sole customers. Only patients pay for their drugs (whether directly or through insurance or taxation) and only patients consume pharmaceutical products and experience the benefits and adverse effects. Only patients decide whether or not to continue taking a drug. Put simply, if there were no patients, there would be no pharmaceutical industry. Sir William Osler was talking in the context of clinical history taking and examination, but his comment applies more broadly. Over the past 10 to 15 years, there has been slowly increasing recognition that there are virtually no aspects of development, registration, and commercialization of a drug in which listening to the patient does not improve the outcome. Guidance issued by the FDA (Guidance for Industry, Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, U.S. Department of Health and Human Services, Food and Drug Administration, December 2009) has gone a long way in helping to redirect and focus the industry. The implications are broad and go beyond the traditional areas of patient input such as quality of life measures and can significantly influence trial design, approval, labeling, and reimbursement. Less