Example: Consent process, conflict of interest, contract and budgets, training and education required inputs, and feedback from different Dorsomorphin FDA organization stakeholders. Key areas where processes were re-defined and made more objective Organization conflict of interest Relevance to contracts and budgets Ethics committee inspection of the research activity New meaning to vulnerability [Economical, illiteracy] Understanding of ethics committee quorum Ethics committee review process and functioning. Example: Introducing new process of auditing EC and evaluating their functioning which was endorsed by the HRPP board. This lead to improvement in the many areas like approval timelines, Ethics Committee evaluations, documentation, monitoring, and training program.

Site visit??living the process The site visit is the acid test that determines whether the Hospital HRPP is robust enough to meet the stringent conditions and standards of accreditation. As this was the first time hospitals in India were going for the AAHRPP accreditation, the objective was to ensure that everyone was aware of the processes and there was uniformity in understanding across the organization. This involved many weeks of prior training, preparation, and awareness sessions for all individuals involved. Example: Based on the groups selected for the interview, team leaders were selected who was responsible for the group to understand the applicable process. Daily training sessions were conducted in order to internalize the process. Individuals were given questionnaires and assessed on their understanding.

Two site visitors visited the Hospitals and reviewed records and interviewed researchers, senior Dacomitinib management, and ethics committee members. The site visitors focused on assessing whether processes were consistently understood and followed by all individuals. Example: EC minutes, agendas, and documentation were reviewed to determine compliance and whether it accurately represented the processes outlined in the SOPs. Post site visit, a draft report was forwarded and a response was to be submitted within 30 days. Final accreditation determination The application, site visit result, and report responses were reviewed by the AAHRPP council and final application status determined in the December Council Meeting. The Hospitals were granted Full AAHRPP accreditation, making them the first in India and 6th in Asia.

Even after receiving accreditation, the hospitals are aware that this is a continuous process improvement and is an ongoing http://www.selleckchem.com/products/Trichostatin-A.html commitment to ethical standards and quality. HOW THE ACCREDITATION PROCESS HELPED THE HOSPITALS Revised processes: As a prerequisite for this application, the hospitals created nearly 26 standard operating procedures and documents, which focused on the process for protecting Human subjects.