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.

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.

An Ethical and Legal Framework for Physicians as Surrogate Decision-Makers for Their Patients.

In Western industrialized countries, it is well established that legally competent individuals may choose a surrogate healthcare decision-maker to represent their interests should they lose the capacity to do so themselves. There are few limitations on who they may select to fulfill this function. However, many jurisdictions place restrictions on or prohibit the patient's attending physician or other provider involved with an individual's care to serve in this role. Several authors have previously suggested that respect for the autonomy of patients requires that there be few (if any) constraints on whomever they may appoint as a proxy. In this essay we revisit this topic by first providing a survey of current state laws governing this activity. We then analyze the clinical and ethical circumstances in which potential difficulties could arise. We take a more nuanced and circumspect view of prior suggestions that patients should have virtually unfettered liberty to choose their healthcare proxies. We suggest a strategy to balance the freedom of patients' right to choose their surrogates with fiduciary duty of the state as regulator of medical practice. We identify six domains of possible concern with such relationships and suggest straightforward methods of mitigating their potential negative effects that could be plausibly be incorporated into physician practice.