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.

Selectivity of physiotherapist programs in the United States does not differ by institutional funding source or research activity level.

PURPOSE: This study aimed to compare selectivity characteristics among institution characteristics to determine differences by institutional funding source (public vs. private) or research activity level (research vs. non-research). METHODS: This study included information provided by the Commission on Accreditation in Physical Therapy Education (CAPTE) and the Federation of State Boards of Physical Therapy. Data were extracted from all students who graduated in 2011 from accredited physical therapy programs in the United States. The public and private designations of the institutions were extracted directly from the classifications from the 'CAPTE annual accreditation report,' and high and low research activity was determined based on Carnegie classifications. The institutions were classified into four groups: public/research intensive, public/non-research intensive, private/research intensive, and private/non-research intensive. Descriptive and comparison analyses with post hoc testing were performed to determine whether there were statistically significant differences among the four groups. RESULTS: Although there were statistically significant baseline grade point average differences among the four categorized groups, there were no significant differences in licensure pass rates or for any of the selectivity variables of interest. CONCLUSION: Selectivity characteristics did not differ by institutional funding source (public vs. private) or research activity level (research vs. non-research). This suggests that the concerns about reduced selectivity among physiotherapy programs, specifically the types that are experiencing the largest proliferation, appear less warranted.

A pilot study of orthopaedic resident self-assessment using a milestones' survey just prior to milestones implementation.

OBJECTIVE: To pilot test if Orthopaedic Surgery residents could self-assess their performance using newly created milestones, as defined by the Accreditation Council on Graduate Medical Education. METHODS: In June 2012, an email was sent to Program Directors and administrative coordinators of the 154 accredited Orthopaedic Surgery Programs, asking them to send their residents a link to an online survey. The survey was adapted from the Orthopaedic Surgery Milestone Project. Completed surveys were aggregated in an anonymous, confidential database. SAS 9.3 was used to perform the analyses. RESULTS: Responses from 71 residents were analyzed. First and second year residents indicated through self-assessment that they had substantially achieved Level 1 and Level 2 milestones. Third year residents reported they had substantially achieved 30/41, and fourth year residents, all Level 3 milestones. Fifth year, graduating residents, reported they had substantially achieved 17 Level 4 milestones, and were extremely close on another 15. No milestone was rated at Level 5, the maximum possible. Earlier in training, Patient Care and Medical Knowledge milestones were rated lower than the milestones reflecting the other four competencies of Practice Based Learning and Improvement, Systems Based Practice, Professionalism, and Interpersonal Communication. The gap was closed by the fourth year. CONCLUSIONS: Residents were able to successfully self-assess using the 41 Orthopaedic Surgery milestones. Respondents' rate improved proficiency over time. Graduating residents report they have substantially, or close to substantially, achieved all Level 4 milestones. Milestone self-assessment may be a useful tool as one component of a program's overall performance assessment strategy.