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190 Enhancing Research Ethics, Equity and Protections for Uninsured Study Participants
- Assya Pascalev, Jane Otado, Priscilla N. Adler, Marc R. Blackman, Sarah Vittone
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- Journal:
- Journal of Clinical and Translational Science / Volume 6 / Issue s1 / April 2022
- Published online by Cambridge University Press:
- 19 April 2022, p. 26
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OBJECTIVES/GOALS: To increase diversity in clinical and translational research (CTR), to strengthen protections for uninsured and under-insured study participants from vulnerable groups by addressing their medical, ancillary care and psycho-social needs and to develop a systematic ethically sound approach to addressing such needs in the study protocol and budget. METHODS/STUDY POPULATION: We conducted) ethical analyses of: (1) the regulatory and ethics scholarship concerning protections and duty of care to research participants from vulnerable groups, and 2) arguments concerning the nature and scope of ancillary care obligations of researchers, as well as 3) a review of the applicable local, federal, and international regulations and practices concerning the duty of care to CTR participants and potential participants who are uninsured, under-insured and/or undocumented members of vulnerable groups. RESULTS/ANTICIPATED RESULTS: Uninsured and underinsured study participants pose major ethical challenges for CTR as medical needs arising during a study are usually covered by the participants own insurance. Lack of health insurance increases vulnerability and creates (1) a barrier to research participation for members of socially disenfranchised groups, (2) risk of discriminatory exclusion of such participants from clinical studies, and (3) inter-institutional inconsistencies in meeting their medical needs; thus limiting diversity in CTR. To address the challenges, we propose an inclusive, systematic, ethically sound approach, which deliberately plans for and provides resources within a study protocol to address the medical and psycho-social needs of uninsured participants during and beyond the study. DISCUSSION/SIGNIFICANCE: Including diverse participants in CTR ensures data quality and social justice. PIs and IRBs should adopt an inclusive approach to the medical needs of vulnerable uninsured participants, plan for their medical and ancillary care needs in the protocol and budget, list community resources, provide follow-up support and note assistance in their files.
4036 POSITIVE EXPERIENCE OF INFORMED CONSENT UNDERSTANDING AT A METROPOLITAN MULTI-INSTITUTIONS CTSA HUB
- Jane Anyasa Otado, Reyneir Magee, John Kwagyan, Sarah Vittone, Debra Ordor, Amy Loveland, MaryAnne Hinkson
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- Journal:
- Journal of Clinical and Translational Science / Volume 4 / Issue s1 / June 2020
- Published online by Cambridge University Press:
- 29 July 2020, pp. 33-34
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OBJECTIVES/GOALS: There is not much known on how to improve informed consent understanding and there are no effective interventions that have been identified to improve understanding rates of information. This study seeks to assess participants understanding of the informed consent. METHODS/STUDY POPULATION: We studied a non-probability sample of 245 participants, 57% female, with age range from 6 to 84, currently enrolled in clinical trials conducted at an urban city, multi CTSA institution. A self-administered questionnaire approved by IRB was utilized. Redcap database was utilized for data entry. The items in the questionnaire reflected understanding of the informed consent (e.g., purpose for the study, participants’ rights, risks, benefits). Participants completed the survey during their first visit to the research centers or on a follow-up visit. Data were collected from July 2018 to November 2019. Data were analyzed descriptively by summary statistics. RESULTS/ANTICIPATED RESULTS: African Americans were 44%, Non-Hispanic Whites were 36%, Hispanic 6%. Others 13%. 52% married, 12% completed High school, 74.8% completed College, 13% less High school. 91% read the form themselves. 99% knew the purpose of the study; 99% knew they could quit the study at any time. While (113) 47% indicated knowledge of the potential risk, only (12)10.6% could not list any associated risk. 98% stated they had information on who to call with questions regarding the study. (204)86% knew of a potential benefit, only (11)5% could not name some study benefit. 38% were unsure/did not know the total number of visits study required of them. 74% knew the duration of the study. DISCUSSION/SIGNIFICANCE OF IMPACT: Extended discussion and more time on one-one by the study teams in this CTSA tend to increase trust. This approach has been reported to be most effective in improving participant understanding of informed consent process and may result in the positive experience.
2171: Satisfaction and perceptions of research participants in Clinical and Translational Studies
- Jane A. Otado, John kwagyan, Debra Ordor, Sarah Vittone, Priscilla Adler
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- Journal:
- Journal of Clinical and Translational Science / Volume 1 / Issue S1 / September 2017
- Published online by Cambridge University Press:
- 10 May 2018, pp. 53-54
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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.