‘Who is going to put their life on the line for a dollar? That’s crazy’: community perspectives of financial compensation in clinical research

2021 ◽  
pp. medethics-2020-106715
Author(s):  
Amie Devlin ◽  
Kirsten Brownstein ◽  
Jennifer Goodwin ◽  
Emily Gibeau ◽  
Mariana Pardes ◽  
...  
Keyword(s):  
Clinical Research ◽  
Low Income ◽  
Research Participation ◽  
Semistructured Interview ◽  
Financial Compensation ◽  
Black African ◽  
Research Participants ◽  
Study Results ◽  
Study Participants ◽  
Available Information

BackgroundFinancial compensation of research participants has been standard practice for centuries, however, there is an ongoing debate among researchers and ethicists regarding the ethical nature of this practice. While these debates develop ethical arguments and theories, they fail to incorporate input from those most affected by financial compensation: potential research participants.MethodsTo identify attitudes surrounding clinical research, participants of a long-standing cohort completed a one-time interview. Open-ended questions stimulated a participant-driven discussion surrounding medical research. Following a grounded theory methodology, 58 semistructured interview transcripts were coded, focusing on attitudes surrounding financial compensation of research participants.ResultsOf the interviews coded, the majority of participants identified as Black/African American (n=44) and were women (n=40). Five major themes emerged. In support of financial compensation, participants felt that study participants should be compensated for time, effort and risk. However, participants were concerned that compensation may differentially impact low-income populations and entice them to hide potentially harmful side effects. Participants also mentioned that financial compensation may invalidate study results if participants knowingly provide false information to subvert inclusion/exclusion criteria.ConclusionThe emergence of both positive and negative themes reiterates the complicated issue of providing financial compensation for study participation. While compensation as a motivator for research participation raises ethical concerns, participants discussed weighing the benefits with the risks in order to make an informed decision. To avoid paternalistic behaviours, research staff must allow potential research participants to review the available information and make the decision that best reflects their wishes.

scholarly journals Therapeutic appropriation: a new concept in the ethics of clinical research

2016 ◽  
Vol 42 (12) ◽  
pp. 805-808 ◽  
Author(s):  
Rosalind McDougall ◽  
Dominique Martin ◽  
Lynn Gillam ◽  
Nina Hallowell ◽  
Alison Brookes ◽  
...  
Keyword(s):  
Primary Care ◽  
Clinical Research ◽  
Clinical Care ◽  
Research Participation ◽  
Therapeutic Benefit ◽  
Therapeutic Misconception ◽  
Ethical Problems ◽  
Ethical Concerns ◽  
Research Participants ◽  
Therapeutic Needs

Ethical concerns about therapeutic misconception have been raised since the early 1980s. This concept was originally described as research participants' assumptions that decisions relating to research interventions are made on the basis of their individual therapeutic needs. The term has since been used to refer to a range of ‘misunderstandings’ that research participants may have. In this paper, we describe a new concept—therapeutic appropriation. Therapeutic appropriation occurs when patients, or clinicians, actively reframe research participation as an opportunity to enhance patients' clinical care, while simultaneously acknowledging the generalised research aims. To illustrate the concept of therapeutic appropriation, we draw on data from an interview study which we conducted to investigate the experiences of patients and general practitioners involved in clinical trials in primary care. We argue that therapeutic appropriation has two key elements: comprehension that the research project is not necessarily aiming to benefit participants and the deliberate use of incidental features of the research for personal therapeutic benefit of various kinds. We conclude that therapeutic appropriation is a useful concept that refines understanding of potential ethical problems in clinical research, and points to strategies to address them.

scholarly journals 2171

2017 ◽  
Vol 1 (S1) ◽  
pp. 53-54
Author(s):  
Jane A. Otado ◽  
John kwagyan ◽  
Debra Ordor ◽  
Sarah Vittone ◽  
Priscilla Adler
Keyword(s):  
Clinical Trials ◽  
African Americans ◽  
Clinical Research ◽  
Family Member ◽  
Blood Draw ◽  
Convenience Sample ◽  
Financial Compensation ◽  
Future Studies ◽  
Research Participants ◽  
First Time

OBJECTIVES/SPECIFIC AIMS: The objectives of this study were (1) to examine research participant levels of satisfaction, experiences, and perceptions; and (2) to determine best practices for researchers for engaging research volunteers in clinical trials, and thereby reducing barriers to participation. METHODS/STUDY POPULATION: A self-administered IRB approved survey on satisfaction and perceptions of research participants in clinical and translational studies was developed. The study questions were validated by 5 key informants from each of the 3 research centers who were asked to provide constructive feedback on the clarity and relevance of the questions. The final survey was a 25-item questionnaire that used a Likert scale and focused on 5 domains to reflect satisfaction with “Staff delivery of care,” “Environment,” “Center Operations,” “Study specific questions,” and “overall experiences.” Questions to reflect participant perceptions were open ended. A convenience sample of all participants currently enrolled in research studies at CTSA institutions (GU, HU, and MHRI) was obtained. In total, 131 participants completed the survey. Of these, 15 were “surrogate” partners. RESULTS/ANTICIPATED RESULTS: Eighty-two (60%) of the participants were African Americans, 40 (29%) were Whites; 94 (67%) were first time study participants. Over 90% of those surveyed strongly agreed that they were “treated well,” that their “privacy was respected,” and that they “felt comfortable asking questions of the staff.” Eighty-four percent indicated they would participate in future studies while over 91% indicated they would recommend a family member or a friend. Only 46% of participants coming for their first research visit strongly agreed that the “compensation received was satisfactory.” However, 74% of participants returning for follow-up or who had been enrolled in a previous study felt the compensation was appropriate. Seventy-four percent of those enrolled for the first time indicated “knowing the duration of this study” as compared with only 38% of repeat visitors. When asked what they liked most about participating in a research study their primary responses were “contribution to science” and “knowledge about their diseases.” Conversely, when asked what they liked least about the study they responded that the blood draws were uncomfortable and there were often barriers to transportation and parking. DISCUSSION/SIGNIFICANCE OF IMPACT: The results of this survey demonstrated that the majority of research participants rate their experience as highly favorable even among those who had never participated in clinical research previously. In some existing literature, it has been reported that financial compensation was a major motivation to participation in studies involving healthy volunteers. In this current study, however, financial compensation did not appear to be the primary motivation for participation. The participants’ at all 3 sites stated that the main reason for their participation was the increased knowledge about their disease and the contribution to science. Negative experiences cited were primarily discomfort with blood draw, transportation, and parking logistics. Most importantly, a majority of the participants stated they would participate in future studies and would recommend a family member or a friend for a clinical study. In our sample, there was no difference in the favorable ratings as determined by race/ethnicity. In conclusion, the findings of this study inform the community with regard to how the research participants rate their experiences, and thus motivate others to participate in clinical research. Reasons for participants to withdraw from trials may be associated to their dissatisfaction with a trial or with the study staff. Thus, the degree of satisfaction with the research staff and the trial itself is crucial to reducing drop-out rates and increasing compliance with study procedures. Hence participant satisfaction is key to increasing participation in clinical trials, particularly among African Americans and other racial and ethnic minorities.

“Everybody Knows Everybody”: Adolescents’ Perceptions of What Helps Them Succeed in a Rural Title I School

2021 ◽  
pp. 074355842110438
Author(s):  
Erin M. West ◽  
Staci M. Zolkoski ◽  
Justin R. Lockhart ◽  
Jessica M. Holm ◽  
Josh Tremont
Keyword(s):  
Title I ◽  
Low Income ◽  
Interpretative Phenomenological Analysis ◽  
School Size ◽  
School Administrators ◽  
Future Research ◽  
Parental Consent ◽  
Title I School ◽  
Black African ◽  
Study Participants

The current study explored adolescents’ perceptions of what contributes to their experiences of success in a rural Title I school through interpretative phenomenological analysis (IPA). Participants included adolescents who were enrolled at a rural Title I Middle/High School in the southern United States. The single campus school district serves approximately 185 students from Prekindergarten to grade 12. Approximately, 73% of the students are identified as At-Risk, 88% of the students are economically disadvantaged, and 100% of the students qualify for free or reduced lunch. Ten students from this school, with assent and parental consent, participated in the current study. Participants’ ages ranged from 13 to 18, and the students represented different genders (seven males, three females) and various racial and ethnic backgrounds (three Black/African American, four Latinx, two White, and one Biracial). Results from the current study suggest low-income adolescents in a rural Title I school perceived (a) school size, (b) family support, and (c) their own internal drive to succeed as contributing to their success at school. These themes, their corresponding subthemes, and representative participant statements are included. Implications for school administrators, teachers, and counselors along with directions for future research are discussed.

scholarly journals Researcher and study participants’ perspectives of consent in clinical studies in four referral hospitals in Vietnam

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Jennifer Ilo Van Nuil ◽  
Thi Thanh Thuy Nguyen ◽  
Thanh Nhan Le Nguyen ◽  
Van Vinh Chau Nguyen ◽  
Mary Chambers ◽  
...  
Keyword(s):  
Hospital Setting ◽  
Research Participation ◽  
Consent Process ◽  
Future Research ◽  
Structured Interviews ◽  
Essential Information ◽  
Research Participants ◽  
Valid Consent ◽  
Referral Hospitals ◽  
Study Participants

Abstract Background Within the research community, it is generally accepted that consent processes for research should be culturally appropriate and tailored to the context, yet researchers continue to grapple with what valid consent means within specific stakeholder groups. In this study, we explored the consent practices and attitudes regarding essential information required for the consent process within hospital-based trial communities from four referral hospitals in Vietnam. Methods We collected surveys from and conducted semi-structured interviews with study physicians, study nurses, ethics committee members, and study participants and family members regarding their experiences of participating in research, their perspectives toward research, and their views about various elements of the consent process. Results In our findings, we describe three interrelated themes related to the consent process: (1) words and regulation; (2) reimbursement, suspicions, and joining; and (3) responsibilities. In general, stakeholders had highly varied perspectives of nghiên cứu (Eng.: research) and researchers used varying levels of detail regarding all aspects of the study in the consent process to build trust with and/or promote potential research participants’ choices about taking part in research. Findings additionally highlight how researchers felt that offering financial reimbursements in a hospital setting, where payment for services was routine, would be unfamiliar to participants and could raise suspicions about the research. Participants, however, focused their discussions on reimbursement or alternative reasons for joining the study, such as health related benefits or altruism. Finally, participants often relied on their physician to help them decide about joining a study or not. Conclusion Further research is needed to understand how researchers and participants make sense of and practice consent, and how that impacts participants’ decision-making about research participation. To promote valid consent within this context, it is important to engage with hospital-based trial communities as a whole. The data from this study will inform future research on consent, guide the revisions of consent related policies within our research sites and point to several larger issues surrounding researcher-participant expectations, communication, and trust.

scholarly journals The ethics of uninsured participants accessing healthcare in biomedical research: A literature review

2018 ◽  
Vol 15 (5) ◽  
pp. 509-521 ◽  
Author(s):  
Hae Lin Cho ◽  
Marion Danis ◽  
Christine Grady
Keyword(s):  
Clinical Research ◽  
Scoping Review ◽  
Low Income ◽  
Research Agenda ◽  
Access To Healthcare ◽  
High Income ◽  
Ethical Considerations ◽  
Limited Access ◽  
Research Participants ◽  
Post Trial

Background/aims Sparse literature exists on the challenges and ethical considerations of including people with limited access to healthcare, such as the uninsured and low-income, in clinical research in high-income countries. However, many ethical issues should be considered with respect to working with uninsured and low-income participants in clinical research, including enrollment and retention, ancillary care, and post-trial responsibilities. Attention to the uninsured and low-income is particularly salient in the United States due to the high rates of uninsurance and underinsurance. Thus, we conducted a scoping review on the ethical considerations of biomedical clinical research with uninsured and low-income participants in high-income countries in order to describe what is known and to pinpoint areas of needed research on this issue. Methods MEDLINE/PubMed, Embase, and Scopus databases were searched using terms that described main concepts of interest (e.g., uninsured, underinsured, access to healthcare, poverty, ethics, compensation, clinical research). Articles were included if they met four inclusion criteria: (1) English, (2) high-income countries context, (3) about research participants who are uninsured or low-income, which limits their access to healthcare, and in biomedical clinical research that either had a prospect of direct medical benefit or was offered to them on the basis of their ill health, and (4) recognizes and/or addresses challenges or ethical considerations of uninsured or low-income participants in biomedical clinical research. Results The searches generated a total of 974 results. Ultimately, 23 papers were included in the scoping review. Of 23 articles, the majority (n = 19) discussed enrollment and retention of uninsured or low-income participants. Several barriers to enrolling uninsured and low-income groups were identified, including limited access to primary or preventive care; lack of access to institutions conducting trials or physicians with enough time or knowledge about trials; overall lack of trust in the government, research, or medical system; and logistical issues. Considerably fewer articles discussed treatment of these participants during the course of research (n = 5) or post-trial responsibilities owed to them (n = 4). Thus, we propose a research agenda that builds upon the existing literature by addressing three broad questions: (1) What is the current status of uninsured research participants in biomedical clinical research in high-income countries? (2) How should uninsured research participants be treated during and after clinical research? (3) How, if at all, should additional protections for uninsured research participants affect their enrollment? Conclusions This review reveals significant gaps in both data and thoughtful analysis on how to ethically involve uninsured research participants. To address these gaps, we propose a research agenda to gather needed data and theoretical analysis that addresses three broad research questions.

Effects of Research-Related Activities on Graduation at a Hispanic Serving Institution

2021 ◽  
pp. 152102512110650
Author(s):  
Winny Dong ◽  
Rebecca M. Eddy ◽  
David M. Mendelsohn ◽  
Courtney Koletar ◽  
Monique Matelski ◽  
...  
Keyword(s):  
Low Income ◽  
Liberal Arts ◽  
First Generation ◽  
Undergraduate Research ◽  
Research Participation ◽  
Underrepresented Minority ◽  
Hispanic Serving Institution ◽  
Study Results ◽  
Hispanic Serving ◽  
The Impact

This paper reports on the results of a study of 6,654 unique students on the type of research-related activities (e.g., undergraduate research and internships) they participated in while at California State Polytechnic University, Pomona (Cal Poly Pomona). Results indicate that the odds of graduating for students who participated in research-related activities were almost twice those of students who did not participate in research-related activities. These results differ from and complement studies on the impact of undergraduate research at liberal arts colleges and research-intensive universities. Study results indicate that non-first-generation students, non-low-income students, and non-underrepresented minority (non-URM) students were more likely to participate in research. Participation in internships with industry and with a professional were most predictive of graduation. Students who participated in multiple research-related activities were also more likely to graduate than those who participated in fewer activities; results indicate research participation is equally beneficial across groups with different demographic characteristics including major, sex, first generation and URM status.

scholarly journals 2530

2017 ◽  
Vol 1 (S1) ◽  
pp. 54-54
Author(s):  
Bernadette McKinney
Keyword(s):  
Clinical Research ◽  
Policy Analysis ◽  
Research Participation ◽  
Equal Access ◽  
Policy Issues ◽  
Research Participants ◽  
Science Discussion ◽  
Study Population ◽  
Equity Model

OBJECTIVES/SPECIFIC AIMS: Discuss ethical and policy issues that will impact clinical research. Raise awareness of the need to understand internal policies at home institutions Encourage further examination of ways to facilitate clinical research participation. METHODS/STUDY POPULATION: Ethical and policy analysis. RESULTS/ANTICIPATED RESULTS: Ideally, clinical research participants should not be required to pay to participate in research. However, if we go with an equity model, as opposed to an equality model, policies should be changed to allow equal access to research participation. This is a matter of justice and also will enhance the quality of the science. DISCUSSION/SIGNIFICANCE OF IMPACT: Unless steps are taken to make participation in clinical research less burdensome financially for participants, research may slow or results may be biased, because only those who can pay will be able to participate.

scholarly journals Recommendations for the Return of Research Results to Study Participants and Guardians: A Report From the Children's Oncology Group

2012 ◽  
Vol 30 (36) ◽  
pp. 4573-4579 ◽  
Author(s):  
Conrad V. Fernandez ◽  
Kathleen Ruccione ◽  
Robert J. Wells ◽  
Jay B. Long ◽  
Wendy Pelletier ◽  
...  
Keyword(s):  
Task Force ◽  
Return Of Results ◽  
Personal Contact ◽  
Oncology Group ◽  
Cooperative Research ◽  
Group Setting ◽  
Research Results ◽  
Research Participants ◽  
Study Results ◽  
Study Participants

Purpose The Children's Oncology Group (COG) strongly supports the widely recognized principle that research participants should be offered a summary of study results. The mechanism by which to do so in a cooperative research group setting has not been previously described. Methods On the basis of a review of the available empirical and theoretic literature and on iterative, multidisciplinary discussion, a COG Return of Results Task Force (RRTF) offered detailed recommendations for the return of results to research study participants. Results The RRTF established guidelines for the notification of research participants and/or their parents/guardians about the availability of research results, a mechanism for and timing of sharing results via registration on the COG public Web site, the scope of the research to be shared, the target audience, and a process for creating and vetting lay summaries of study results. The RRTF recognized the challenges in adequately conveying complex scientific results to audiences with varying levels of health literacy and recommended that particularly sensitive or complex results be returned using direct personal contact. The RRTF also recommended evaluation of the cost, effectiveness, and impact of sharing results. Conclusion These recommendations provide a framework for the offering and returning of results to participants. They can be used by individual investigators, multi-investigator research collaboratives, and large cooperative groups.

Differential payment to research participants in the same study: an ethical analysis

2019 ◽  
Vol 45 (5) ◽  
pp. 318-322 ◽  
Author(s):  
Govind Persad ◽  
Holly Fernandez Lynch ◽  
Emily Largent
Keyword(s):  
Clinical Research ◽  
Ethical Analysis ◽  
Institutional Review Boards ◽  
Research Participants ◽  
Institutional Review ◽  
Study Participants ◽  
Incentive Payments ◽  
Review Boards

Recognising that offers of payment to research participants can serve various purposes—reimbursement, compensation and incentive—helps uncover differences between participants, which can justify differential payment of participants within the same study. Participants with different study-related expenses will need different amounts of reimbursement to be restored to their preparticipation financial baseline. Differential compensation can be acceptable when some research participants commit more time or assume greater burdens than others, or if inter-site differences affect the value of compensation. Finally, it may be permissible to offer differential incentive payments if necessary to advance the goals of a study. We encourage investigators and Institutional Review Boards to think about whether to offer payment, in what amounts and for what purpose, and also to consider whether differential payment can help promote the scientific and ethical goals of clinical research.

scholarly journals Inadequate Reporting of Analytical Characteristics of Biomarkers Used in Clinical Research: A Threat to Interpretation and Replication of Study Findings

2019 ◽  
Vol 65 (12) ◽  
pp. 1554-1562 ◽  
Author(s):  
Qian Sun ◽  
Kerry J Welsh ◽  
David E Bruns ◽  
David B Sacks ◽  
Zhen Zhao
Keyword(s):  
Clinical Research ◽  
New England ◽  
Clinical Studies ◽  
Measurement Procedure ◽  
Test Results ◽  
Plos Medicine ◽  
Study Results ◽  
Analytical Accuracy ◽  
Assay Precision ◽  
Study Participants

Abstract BACKGROUND Analytical characteristics of methods to measure biomarkers determine how well the methods measure what they claim to measure. Transparent reporting of analytical characteristics allows readers to assess the validity and generalizability of clinical studies in which biomarkers are used. Our aims were to assess the reporting of analytical characteristics of biomarkers used in clinical research and to evaluate the extent of reported characterization procedures for assay precision. METHODS We searched 5 medical journals (Annals of Internal Medicine, JAMA: The Journal of the American Medical Association, The Lancet, The New England Journal of Medicine, and PLOS Medicine) over a 10-year period for the term “biomarker” in the full-text field. We included studies in which biomarkers were used for inclusion/exclusion of study participants, for patient classification, or as a study outcome. We tabulated the frequencies of reporting of 11 key analytical characteristics (such as analytical accuracy of test results) in the included studies. RESULTS A total of 544 studies and 1299 biomarker uses met the inclusion criteria. No information on analytical characteristics was reported for 67% of the biomarkers. For 65 biomarkers (3%), ≥4 characteristics were reported (range, 4–8). The manufacturer of the measurement procedure could not be determined for 688 (53%) of the 1299 biomarkers. The extent of assessments of assay imprecision, when reported, did not meet expectations for clinical use of biomarkers. CONCLUSIONS Reporting of the analytical performance of biomarker measurements is variable and often absent from published clinical studies. We suggest that readers need fuller reporting of analytical characteristics to interpret study results, assess generalizability of conclusions, and compare results among clinical studies.

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