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Bioethics Survey

  Link to Survey

 

 https://www.surveymonkey.com/s/nocemhdbioethicssurvey

 

Study Purpose and Rationale

 

This proposal is an application for a Bioethics Research, Training, and Translation Supplement for the Northern Manhattan Center of Excellence in Minority Health and Health Disparities (NOCEMHD P60 MD000206; PI.Luchsinger). NOCEMHD currently supports an administrative core, a research core, 2 clinical trials, a cohort study, and the Northern Manhattan Center of Excellence in Comparative Effectiveness Research to Eliminate Disparities

In addition to center supported projects, NOCEMHD investigators conduct minority health and health disparities research in collaboration with other investigators at Columbia University Medical Center (CUMC), New York Presbyterian Hospital (NYPH), and the New York State Psychiatric Institute (NYSPI).

We have found several areas with unresolved bioethical issues in the conduct of our research activities in NOCEMHD and NOCERED. These issues are common to minority heath research across CUMC. These specific issues are:

The use of the clinical data warehouse (DCW) information to recruit minority individuals for clinical studies, including observational studies and clinical trials. The DCW houses all inpatient and outpatient administrative data from NYPH/CUMC including demographics and clinical diagnoses. It is a powerful, efficient and inexpensive way to identify potential research participants that has been used effectively at CUMC and NYPH. However, recent privacy and bioethical concerns have limited its use for our research projects.

Recruitment of minority individuals for studies or interventions that target relatives or families of persons with an index condition. We have tried recruiting Hispanic spouses of persons with dementia by first identifying the dementia patients. This has raised privacy and bioethical concerns.

Obtaining consent from minority individuals in clinical and research settings to have clinical and research information and biospecimens, including DNA, used for registries for future research studies. Minorities in Northern Manhattan, particularly Caribbean Hispanics, have proven reluctant to provide consent for this purpose and institutional discussions on this issue have come to a standstill.

These issues affect CUMC researchers, NYPH, the Institutional Review Board (IRB), the Office of HIPAA (Health Insurance Portability and Accountability Act) Compliance, and the Center for Bioethics. However, there is no harmonization of efforts to clarify these issues. The major goal of this application is to study the 3 stated bioethical issues through a formal and systematic consultation process that will involves all pertinent parties, including NOCEMHD/NOCERED, NYPH, the IRB, the Office of HIPAA Compliance, and the Center for Bioethics.

In addition, we seek to establish a bioethics initiative that will be available for minority health research at CUMC beyond the funding period of this supplement award.

We are conducting a one year program led by Drs. Paul Appelbaum, a Bioethics expert, and Roberto LewisFernandez, an expert in Bioethics and minority participation in research. Dr. Luchsinger, the NOCEMHD PI, provides administrative, logistical, and scientific support for this initiative. Our specific aims are:

To assemble a committee comprised of experts in ethics, bioinformatics, minority health research, members of the IRB, Office of HIPAA Compliance, and NYPH, to address the 3 particular bioethical issues, the use of the clinical data warehouse for minority health research, the identification of families and relatives, and obtaining consent from minority individuals to provide clinical data and biospecimens for open future research. This committee meets monthly to address these issues.

In the first 6 months the committee is identifying the ethical and legal problems, in the last 6 months it will propose solutions.

Convene focus groups of lay minority persons in the community and collect information on attitudes towards the 3 bioethical issues.

Conduct surveys of investigators and clinicians at CUMC, NYPH, and the community of Northern Manhattan about attitudes towards the 3 bioethical issues.

With the information gathered, we will conduct seminars in the last 6 months of the initiative, and prepare and disseminate publications of the findings.

The goal of this project is to create a harmonized legal, regulatory, and bioethical framework to guide the proposed bioethical issues. This framework will directly affect the conduct of research in minority health in NOCEMHD, NOCERED, and CUMC/NYPH.

Contact information: If you have any further questions, please contact Dr. Jose Luchsinger at jal94@cumc.columbia.edu or 212.305.4730.

If you have any questions regarding your rights as a research subjects, you can call the Institutional Review Board at 212-305-5883.

Publications

Robert J. Lucero, Joan Kearney, Yamnia Cortes, Adriana Arcia, Paul Appelbaum, Roberto Lewis Fernández & Jose Luchsinger (2014): Benefits and Risks in Secondary Use of Digitized Clinical Data: Views of Community Members Living in a Predominantly Ethnic Minority Urban Neighborhood, AJOB Empirical Bioethics, DOI: 10.1080/23294515.2014.949906


To link to this article: http://dx.doi.org/10.1080/23294515.2014.949906

 

 

 
 
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