The Participation of Underrepresented Minorities in Clinical Research

2003 ◽  
Vol 29 (2-3) ◽  
pp. 221-245
Author(s):  
Barbara A. Noah
Keyword(s):  
Clinical Trials ◽  
Medical Research ◽  
Equal Opportunity ◽  
Human Subjects ◽  
Medical Application ◽  
Underrepresented Minorities ◽  
Trial Participation ◽  
Potential Risks ◽  
New Treatments

The past decade witnessed unprecedented growth in medical research involving human subjects, promising the development of new treatments that extend and improve the quality of life, as well as prevent disease. Recent biomedical breakthroughs such as the mapping of the human genome, improved understanding of pharmacokinetics and molecular biology, and novel theories about the mechanisms of diseases such as cancer have led to a proliferation of clinical trials. Such research provides the necessary bridge from scientific theory to practical medical application, and it is essential that these efforts benefit all persons who suffer from the studied diseases.In addition to the potential long-term pay-offs, clinical trials may offer immediate dividends to enrolled subjects. The opportunity to participate in medical research carries with it a variety of potential risks and benefits. Because clinical trial participation potentially results in significant individual benefits, including access to state-of-the-art care and improved disease monitoring, fairness demands equal opportunity for inclusion whenever scientifically appropriate.

scholarly journals Intergenerational monitoring in clinical trials of germline gene editing

2019 ◽  
Vol 46 (3) ◽  
pp. 183-187 ◽  
Author(s):  
Bryan Cwik
Keyword(s):  
Clinical Trials ◽  
Gene Editing ◽  
Ethical Issues ◽  
Human Subjects ◽  
Germline Gene ◽  
Ethical Challenges ◽  
Human Subjects Research ◽  
Follow Up Study

Design of clinical trials for germline gene editing stretches current accepted standards for human subjects research. Among the challenges involved is a set of issues concerning intergenerational monitoring—long-term follow-up study of subjects and their descendants. Because changes made at the germline would be heritable, germline gene editing could have adverse effects on individuals’ health that can be passed on to future generations. Determining whether germline gene editing is safe and effective for clinical use thus may require intergenerational monitoring. The aim of this paper is to identify and argue for the significance of a set of ethical issues raised by intergenerational monitoring in future clinical trials of germline gene editing. Though long-term, multigenerational follow-up study of this kind is not without precedent, intergenerational monitoring in this context raises unique ethical challenges, challenges that go beyond existing protocols and standards for human subjects research. These challenges will need to be addressed if clinical trials of germline gene editing are ever pursued.

scholarly journals Parental perspectives long term after neonatal clinical trial participation: a survey

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Thomas Salaets ◽  
Emilie Lavrysen ◽  
Anne Smits ◽  
Sophie Vanhaesebrouck ◽  
Maissa Rayyan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Trial Participation ◽  
Drug Trials ◽  
Clinical Trial Participation ◽  
Parental Perspectives ◽  
Positive Experiences ◽  
Almost All

Abstract Background Although recruiting newborns is ethically challenging, clinical trials remain essential to improve neonatal care. There is a lack of empirical data on the parental perspectives following participation of their neonate in a clinical trial, especially at long term. The objective of this study is to assess experiences and emotions of parents, long term after trial participation in an interventional drug trial. Methods Parents of former participants of five neonatal interventional drug trials were surveyed at long term (3–13 years ago) after participation. The survey assessed parental contentment with trial participation, perceived influence of the trial on care and health, emotional consequences of participation, and awareness of typical clinical trial characteristics on 6-point Likert scales. Results Complete responses were received from 123 parents (52% of involved families). Twenty percent of parents did not remember participation. Those who remembered participation reported high contentment with overall trial participation (median 5.00), but not with follow-up (median 3.00). Most parents did not perceive any influence of the trial on care (median 2.00) and health (median 2.43). Almost all parents reported satisfaction and pride (median 4.40), while a minority of parents reported anxiety and stress (median 1.44) or guilt (median 1.33) related to trial participation. A relevant minority was unaware of typical trial characteristics (median 4.20; 27% being unaware). Conclusions Overall, parents reported positive experiences and little emotional distress long term after participation. Future efforts to improve the practice of neonatal clinical trials should focus on ensuring effective communication about the concept and characteristics of a clinical trial during consent discussions and on the follow-up after the trial.

A Tale of Three Cultures

2020 ◽  
pp. 75-99
Author(s):  
Jill A. Fisher
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Healthy Volunteers ◽  
West Coast ◽  
East Coast ◽  
Trial Participation ◽  
Phase I Trials ◽  
Hybrid Culture ◽  
Active Pursuit

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.

A World of Research Subjects: Informed Consent and Benefit Sharing*

2010 ◽  
Vol 9 (4) ◽  
pp. 208-213
Author(s):  
George J. Annas ◽  
Michael A. Grodin
Keyword(s):  
At Risk ◽  
Clinical Trials ◽  
Informed Consent ◽  
Medical Research ◽  
Benefit Sharing ◽  
Research Subjects ◽  
Short And Long Term ◽  
Ethical Norms ◽  
Term Benefit

The most important question for any research project is whether the research should be done at all. Only after this is answered do issues of how and where to do the research become relevant. When doing research in another country, however, the whether and where questions become intertwined. This is because the recent globalization of clinical trials is itself suspect. What is the motivation for the sudden upsurge in clinical trials in other countries? Who benefits from the globalization of research, and who is put at risk? Some advantages have been suggested, including reduced regulation, less oversight, decreased costs, and more rapid results, but none of these alone (or together) is sufficient to justify the expansion of medical research to an underserved, disenfranchised, and exploitable population. The only justification is that the proposed research addresses a question that can only be answered by this unique population and the results must bring short- and long-term benefit. The research remains suspect until ethical norms are met. The subjects must never be worse off from participating in the trials than if they had never participated.

scholarly journals Regulatory Framework for Conducting Clinical Research in Canada

2017 ◽  
Vol 44 (5) ◽  
pp. 469-474 ◽  
Author(s):  
Josmar K. Alas ◽  
Glenys Godlovitch ◽  
Connie M. Mohan ◽  
Shelly A. Jelinski ◽  
Aneal A. Khan
Keyword(s):  
Clinical Trials ◽  
Human Subjects ◽  
Policy Statement ◽  
Institutional Research ◽  
Public Health Agencies ◽  
Clinical Trial Research ◽  
Health Agencies ◽  
Drug Regulations

AbstractResearch in human subjects is at the core of achieving improvements in health outcomes. For clinical trials, in addition to the peer review of the results before publication, it is equally important to consider whether the trial will be conducted in a manner that generates data of the highest quality and provides a measure of safety for the participating subjects. In Canada, there is no definitive legislation that governs the conduct of research involving human subjects, but a network of regulations at different levels does provide a framework for both principal investigators and sponsors. In this paper, we provide an overview of the federal, provincial and institutional legislation, guidelines and policies that will inform readers about the requirements for clinical trial research. This includes a review of the role of the Food and Drug Regulations under the Food and Drugs Act and the Tri-Council Policy Statement (TCPS2), an overview of provincial legislation across the country, and a focus on selected policies from institutional research ethics boards and public health agencies. Many researchers may find navigation through regulations frustrating, and there is a paucity of information that explains the interrelationship between the different regulatory agencies in Canada. Better understanding the process, we feel, will facilitate investigators interested in clinical trials and also enhance the long-term health of Canadians.

scholarly journals Ethical Regulations of Medical Research Involving Human Subjects: Exploring the Perspective of Trial Participants

2019 ◽  
Vol 9 (1) ◽  
pp. 34-49
Author(s):  
Anna Kravets
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Medical Research ◽  
Broad Spectrum ◽  
Human Subjects ◽  
Well Being ◽  
Research Protocols ◽  
Ethnographic Data ◽  
Protection Of Human Subjects ◽  
Trial Participants

In this paper I address the question of whether the existing ethical regulations of clinical research ensure protection and well-being of human subjects. Drawing on ethnographic data gathered in Berlin, Germany, I show that German institutions which are meant to ensure the ethical validity of clinical research cannot address posed issues. It appears that these institutions (Berlin Ethik-Kommission in particular) only evaluate research protocols and do not consider the broad spectrum of processes and interactions involved in clinical research. The experience of professional human subjects, as well as the consideration of the every-day life in a clinic, shows that there is much more to clinical trials. The argument of this paper is that the inability of institutions to address protection of human subjects originates from the bureaucratic logic of their organization. Drawing on Bauman’s (1992) argument that the bureaucratic machine is characterized by separation between morality and purpose, with the example of Berlin Ethik-Kommission, I argue that the bureaucratic machine cannot be sensitive to morality and ethics, even if these are its main purposes.

scholarly journals Bioethics in crisis or the crisis of bioethics? : An Anthropology of Pandemic in the Medicalized Society

2021 ◽  
Author(s):  
Antonio Sandu
Keyword(s):  
European Union ◽  
Clinical Trials ◽  
Side Effects ◽  
Medical Research ◽  
Human Subjects ◽  
Standard Procedure ◽  
Herd Immunity ◽  
The European Union ◽  
Record Time ◽  
Research On Human Subjects

We will discuss (…) the need for ethics in times of crisis. Many people consider ethics and bioethics and the call for principles to be bureaucratic obstacles to obtaining a rapid response from the population, for example, to achieve vaccines in record time, to immunize the population, to establish unpopular but necessary measures, such as closing borders and non-compliance with fundamental principles of the European Union, establishing public policies aimed at herd immunity or, conversely, closing most activities considered essential in the economy, to ensure social distancing and self-isolation of the population. These measures are understood as derogations from ethics or bioethics when targeting medical research on human subjects performed faster than required by standard procedure, or the implementation of innovative therapeutic practices that have not previously been studied by clinical trials to certify that there are no known side effects.

Long-term Obligations to Human Subjects in Clinical Trials

JAMA ◽  
2000 ◽  
Vol 284 (8) ◽  
pp. 960-961 ◽  
Author(s):  
J. L. Valdespino-Gomez
Keyword(s):  
Clinical Trials ◽  
Human Subjects

scholarly journals Qualitative Analysis of Interviews with Patients on Facilitators and Barriers to Reducing Chemotherapy for Early Stage Breast Cancer

2021 ◽  
Author(s):  
Courtney Andrews ◽  
Timothy C. Childers ◽  
Kimberly D. Wiseman ◽  
Valerie Lawhon ◽  
Stacey Ingram ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Early Stage ◽  
Qualitative Content Analysis ◽  
Barriers And Facilitators ◽  
Early Stage Breast Cancer ◽  
Fear Of Recurrence ◽  
Trial Participation ◽  
Treatment Intensity

Abstract Background As the combination of systemic and targeted chemotherapies is associated with severe adverse side effects and long-term health complications, there is interest in reducing treatment intensity for patients with early stage breast cancer (EBC). Clinical trials are needed to determine if it is feasible to reduce treatment intensity while maintaining 3-year recurrence-free survival of greater than 92%. In order to recruit patients for de-implementation trials, it is important to understand patient perspectives on barriers and facilitators to reducing treatment intensity. Methods We collected qualitative interview data from patients with Stage II-III breast cancer (N=24) and patient advocates (N=16). Interviews explored interest in de-implementation trial participation and identified potential barriers and facilitators to participation. 17 participants were asked about the potential impact of COVID-19 on de-implementation efforts. Interviews were audio-recorded and transcribed, and researchers used qualitative content analysis (NVIVO and Atlas.ti) to code for dominant themes. Results 17 participants (42.5%) expressed interest in participating in a trial of reduced chemotherapy. Barriers to reducing chemotherapy included (1) fear of recurrence and inefficacy, (2) preference for aggressive treatment, (3) disinterest in clinical trials, (4) lack of information about expected outcomes, (5) fear of regret, and (6) having young children. Facilitators included (1) avoiding physical toxicity, (2) understanding the scientific rationale of reducing chemotherapy, (3) confidence in providers, (4) consistent monitoring and the option to increase dosage, (5) fewer financial and logistical challenges, and (6) contributing to scientific knowledge. Of those asked, nearly all participants said they would be more motivated to reduce treatment intensity in the context of Covid-19, primarily in order to avoid exposure to the virus while receiving treatment. Conclusions We recommend framing de-implementation strategies and recruitment to trials in terms of customizing treatment to the individual patient and added benefit—reduced toxicities, higher quality of life during treatment and lower risk of long-term complications—rather than in terms of taking treatments away or doing less than the standard of care. Doctor-patient rapport and provider support will be crucial in this process.

scholarly journals Picking and Choosing Among Phase I Trials

2019 ◽  
Vol 16 (4) ◽  
pp. 535-549 ◽  
Author(s):  
Jill A. Fisher ◽  
Torin Monahan ◽  
Rebecca L. Walker
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Healthy Volunteers ◽  
Qualitative Interviews ◽  
Consent Process ◽  
Trial Participation ◽  
Therapeutic Area ◽  
Long Term Effects ◽  
Ethical Implications

Abstract This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials.

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