Browsing by Subject "Clinical research"

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    Engaging patients throughout the health system: A landscape analysis of cold-call policies and recommendations for future policy change.
    (Journal of clinical and translational science, 2018-12) McHugh, Kelly R; Swamy, Geeta K; Hernandez, Adrian F
    Healthcare institutions may often prohibit "cold-calling" or direct contact with a potential research participant when the person initiating contact is unknown to the patient. This policy aims to maintain patient privacy, but may have unintended consequences as a result of physician gatekeeping. In this review, we discuss recruitment policies at the top academic institutions. We propose an ethical framework for evaluating cold-call policies based on three principles of research ethics. In order to maximize engagement of potential research participants, while maintaining patient privacy and autonomy, we then propose several alternative solutions to restrictive cold-call policies, including opt-in or opt-out platforms, a team-based approach, electronic solutions, and best practices for recruitment. As healthcare has evolved with more collaborative, patient-centered, data-driven care, the engagement of potential research participants should similarly evolve.
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    Ethics Standards (HRPP) and Public Partnership (PARTAKE) to Address Clinical Research Concerns in India: Moving Toward Ethical, Responsible, Culturally Sensitive, and Community-Engaging Clinical Research.
    (J Clin Res Bioeth, 2014-09-07) Burt, Tal; Gupta, Yogendra K; Mehta, Nalin; Swamy, Nagendra; Vishwas; Speers, Marjorie A
    Like other emerging economies, India's quest for independent, evidence-based, and affordable healthcare has led to robust and promising growth in the clinical research sector, with a compound annual growth rate (CAGR) of 20.4% between 2005 and 2010. However, while the fundamental drivers and strengths are still strong, the past few years witnessed a declining trend (CAGR -16.7%) amid regulatory concerns, activist protests, and sponsor departure. And although India accounts for 17.5% of the world's population, it currently conducts only 1% of clinical trials. Indian and international experts and public stakeholders gathered for a 2-day conference in June 2013 in New Delhi to discuss the challenges facing clinical research in India and to explore solutions. The main themes discussed were ethical standards, regulatory oversight, and partnerships with public stakeholders. The meeting was a collaboration of AAHRPP (Association for the Accreditation of Human Research Protection Programs)-aimed at establishing responsible and ethical clinical research standards-and PARTAKE (Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment)-aimed at informing and engaging the public in clinical research. The present article covers recent clinical research developments in India as well as associated expectations, challenges, and suggestions for future directions. AAHRPP and PARTAKE provide etiologically based solutions to protect, inform, and engage the public and medical research sponsors.