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AJOB Empir Bioeth. 2016;7(2):76-91. Epub 2015 Nov 16.

Patients' Views Concerning Research on Medical Practices: Implications for Consent.

Author information

1
Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC; Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC.
2
Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD.
3
Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
4
Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD; Department of Health Policy and Management, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.
5
Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC; Department of Medicine, Duke University School of Medicine, Durham, NC.
6
Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD; Department of Health Policy and Management, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD; Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.

Abstract

BACKGROUND:

Comparative effectiveness research (CER) and pragmatic clinical trials commonly test interventions that are in routine use and pose minimal incremental risk or burdens to patients who participate in this research. The objective of this study was to elicit the range of patients' views and opinions regarding a variety of different types of research on usual medical practices, especially notification and authorization for them.

METHODS:

We conducted twelve focus groups with adults in five U.S. cities-six focus groups addressing CER ("CER groups") and six groups addressing research involving hospital operations and clinician interventions ("Operations groups"). Participants discussed hypothetical research studies and potential methods of notifying patients and obtaining their authorization to participate. Group discussions were recorded, transcribed, and coded to identify patients' views related to research on standard medical practice.

RESULTS:

A total of ninety six people participated. Twelve key themes emerged from participants' discussions of the hypothetical research studies; these themes were then grouped into four general categories: clinical care; notification and authorization; communication; and conduct and design of research. The desire to be actively notified and asked was more prominent with regard to CER studies than with regard to Operations studies.

CONCLUSIONS:

Our data suggest that effective policy and guidance will involve balancing different patients' interests and potentially different sets of interests for different types of research studies on usual medical practices.

KEYWORDS:

comparative effectiveness research; ethics; focus groups; policy; pragmatic clinical trials; research ethics

PMID:
27800531
PMCID:
PMC5085261
DOI:
10.1080/23294515.2015.1117536
[Indexed for MEDLINE]
Free PMC Article

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