Lessons learned obtaining informed consent in research with vulnerable populations in community health center settings

Riden, Heather E.; Grooms, Kya N.; Clark, Cheryl R.; Cohen, Laura; Gagne, Joshua J.; Tovar, Dora; Ommerborn, Mark J.; Orton, Piper S; Johnson, Paula A.

doi:10.1186/1756-0500-5-624

Cited by 10 publications

(17 citation statements)

References 22 publications

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“…Barriers to recruitment arising from other sources, such as unclear or confusing language in consent forms or the lack of age or race concordant recruiters, were also similar to those described elsewhere, as were the solutions. 16,17 Although IRB's aim is to protect human subjects, patients and stakeholders found the required consent language confusing and therefore counter to IRB goals. Similarly, institutions disallowed contact by text and email when those were preferred modes of contact for participants.…”

Section: Institutional Levelmentioning

confidence: 99%

Enrolling African-American and Latino patients with asthma in comparative effectiveness research: Lessons learned from 8 patient-centered studies

Kramer

LeRoy

Donahue

et al. 2016

Journal of Allergy and Clinical Immunology

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Asthma researchers may have greater success with recruitment by addressing uncertainty among patients about asthma diagnosis, engaging stakeholders in all aspects of study design and implementation, and maximizing flexibility of study and intervention protocols. However, even with such efforts, engagement of African-American and Latino patients in asthma research may remain low. Greater investment in research on engaging these populations in asthma research may ultimately be needed to improve their asthma care and outcomes.

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Section: Institutional Levelmentioning

confidence: 99%

Enrolling African-American and Latino patients with asthma in comparative effectiveness research: Lessons learned from 8 patient-centered studies

Kramer

LeRoy

Donahue

et al. 2016

Journal of Allergy and Clinical Immunology

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“…4 Briefly, eligible participants were contacted by phone or during in-person health center visits between December 2008 and January 2010. Of the 2,903 WHN participants who met the eligibility criteria, 51% could not be reached, owing to inaccurate or unavailable contact information.…”

Section: Study Populationmentioning

confidence: 99%

Preventive Care for Low-Income Women in Massachusetts Post–Health Reform

Clark

Soukup²,

Riden³

et al. 2014

Journal of Women's Health

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Background: Before enacting health insurance reform in 2006, Massachusetts provided free breast, cervical cancer, and cardiovascular risk screening for low-income uninsured women through a federally subsidized program called the Women's Health Network (WHN). This article examines whether, as women transitioned to insurance to pay for screening tests after health reform legislation was passed, cancer and cardiovascular disease screening changed among WHN participants between 2004 and 2010. Methods: We examined claims data from the Massachusetts health insurance exchange and chart review data to measure utilization of mammography, Pap smear, and blood pressure screening among WHN participants in five community health centers in greater Boston. We conducted a longitudinal analysis, by insurance type, using generalized estimating equations to examine the likelihood of screening at recommended intervals in the postreform period compared to the prereform period. Results: Pre-and postreform, we found a high prevalence of recommended mammography (86% vs. 88%), Pap smear (88% vs. 89%), and blood pressure screening (87% vs. 91%) that was similar or improved for most women postreform. Screening use differed by insurance type. Recommended mammography screening was statistically significantly increased among women with state-subsidized private insurance (odds ratio [OR] 1.58, p < 0.05). Women with unsubsidized private insurance or Medicare had decreased Pap smear use postreform. Although screening prevalence was high, 31% of women required state safety-net funds to pay for screening tests. Conclusion: Our results suggest a continued need for safety-net programs to support preventive screening among low-income women after implementation of healthcare reform.

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“…Moreover, if explanation is added to the FCOI, it needs to be “brief and simple” with a plain language (6–8th grade reading) to help participants understand ( 31 ). The consent process also needs to be performed by the trained coordinators, with highlights if needed ( 13 ).…”

Section: Effectiveness and Methodologymentioning

confidence: 99%

Legislative Issues in Disclosing Financial Conflicts of Interest to Participants in Biomedical Research: Effectiveness and Methodology

Kim

2017

J Korean Med Sci

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This research focuses on the analysis regarding disclosure of financial conflicts of interest (FCOI) after Gelsinger v. University of Pennsylvania (Penn). The main legal issue was that the participants did not have enough opportunity to make an autonomous decision about participating in the research because he was not informed about the researchers' and the institution's substantial FCOI. The disclosure system was adopted by the Code of Federal Regulations. Under the regulation, researchers and institutions need to report FCOI over $5,000 to the institution, and the internal review boards have to report to the federal authority if needed. In case of human research, the disclosure to Food and Drug Administration is mandatory. FCOI disclosure system would help participants to make an autonomous decision, and increase trust to the research process and researchers. Moreover, the system would let researchers keep fiduciary duty while (possibly) lowering legal liability in case of a lawsuit. There were discussions about the disclosure methodology in the United States. However, there have not been a lot of discussions in Korea even after the "Humidifier Disinfectant" case. Therefore, new legislations need to be considered. First, the system requires disclosure funded by not only government but also private institutions. Second, like California Supreme Court, the subject would be reviewed under the reasonable person standard by participants, including patents, equity, and stock. Third, the disclosure needs to include simple or brief explanation to the FCOI to be better understood by the participants. Fourth, the disclosure should be in the informed consent process. https://doi.org/10. 3346/jkms.2017.32.12.1910 • J Korean Med Sci 2017 32: 1910-1916 Keywords INTRODUCTIONShould research participants be told about the financial conflicts of interest (FCOI) of researchers or institutions? Until 1999, legal issues in the human research disclosure process had been focused on the disclosure of the potential risks and its management (1). However, when Dr. James M. Wilson conducted research without disclosing important FCOI information and resulted in a young human subject's death, critical opinions had emerged regarding whether the FCOI should be disclosed, and if so, how the process needs to be established in detail (2,3). CASE STUDY: WILSON CASE (GELSINGER V. UNIVERSITY OF PENNSYLVANIA [Penn])An 18-year-old participant named Jesse Gelsinger, died in one "human gene transfer study" conducted at the Penn in 1999. His death occurred after 4 days of infusion with a geno-vector.After the Food and Drug Administration (FDA)'s investigation, the government concluded that the subject's death was caused by two improper research procedures (4).First, the risk of Jesse's participation should have been reviewed under strict procedure regulation before the research, and Jesse, because of his rare disease, should not have been involved in the research (5). Jesse had ornithine transcarbamylase deficiency (OTCD), which makes it difficult for ...

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Lessons learned obtaining informed consent in research with vulnerable populations in community health center settings

Cited by 10 publications

References 22 publications

Enrolling African-American and Latino patients with asthma in comparative effectiveness research: Lessons learned from 8 patient-centered studies

Enrolling African-American and Latino patients with asthma in comparative effectiveness research: Lessons learned from 8 patient-centered studies

Preventive Care for Low-Income Women in Massachusetts Post–Health Reform

Legislative Issues in Disclosing Financial Conflicts of Interest to Participants in Biomedical Research: Effectiveness and Methodology

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