Ethics Committees in India: Past, present and future

UM Thatte, PA Marathe - Perspectives in clinical research, 2017 - journals.lww.com
Following watershed amendments in Schedule Y India's star rose rather rapidly on the
clinical research (especially clinical trials) horizon. Just as dramatic was the fall of this …

[HTML][HTML] Impact of accreditation on registered ethics committees in terms of quality and governance in India: A cross-sectional study

GN Dakhale, MV Kalikar… - Perspectives in Clinical …, 2024 - journals.lww.com
Background: Ethics Committee accreditation is a process to assess the performance against
a set of standards. Very few studies have shown that process of accreditation results in the …

[HTML][HTML] Ethics committee accreditation: Journey from voluntariness to essentiality for quality sustenance

RK Tripathi - Perspectives in Clinical Research, 2024 - journals.lww.com
Accreditation is defined as a process of external evaluation performed by an independent
body (evaluator) assessing how well an organization meets its established standards.[1] The …

Role of accreditation in quality improvement of institutional review board

AV Desai, RW Hawaldar, JV Divatia - Perspectives in Clinical …, 2017 - journals.lww.com
Aim: The aim of this study was to evaluate the process of accreditation resulting in
improvement of the Institutional Review Board (IRB) functioning. Methodology: Randomly …

Problems and development strategies for research ethics committees in China's higher education institutions

J Zhou - Journal of medical ethics, 2021 - jme.bmj.com
The establishment of research ethics committees (REC) in China's higher education
institutions (HEI) is lagging far behind western developed countries. This has at least partly …

An audit of institutional ethics committee queries raised after initial project submission by a single research department at a tertiary referral center in India

JP Raj, U Saxena, NJ Gogtay… - … in Clinical Research, 2023 - journals.lww.com
Methods: Queries received after the initial review and replies sent by a single research
department were evaluated. A content analysis was done to identify the domains and …

Addressing challenges faced by trial sites and investigators

SB Bavdekar - Perspectives in Clinical Research, 2021 - journals.lww.com
116 Perspectives in Clinical Research| Volume 12| Issue 3| July-September 2021 the
“checklist,” 83% of investigators stated that they have adequate space for the conduct of …

Experiences on the path to achieving SIDCER recognition of an Ethics Committee

V Mourouguessine, N Anandabaskar… - … Journal of Bioethics, 2022 - bjbio.bioethics.org.bd
Abstract Ethics Committees (ECs) are endowed with the responsibility of ensuring ethical
conduct of biomedical research and human research participants' protection. Although …

Regulatory Requirements and Quality Standards in India's Clinical Trials Journey

B George, SK Kulkarni, NA Kshirsagar - Drug Discovery and Drug …, 2021 - Springer
With the harmonization of patent laws in the post-WTO scenario, like many other developing
countries India became one of the preferred destinations for carrying our clinical trials (CTs) …

[PDF][PDF] Strengthening Quality Research Ethics Review in a Developing Country

HM Aung, KT Wai, YTU Oo, HM Thu… - GLOBAL BIOETHICS …, 2020 - cveglab.cut.ac.cy
Background: The high volume of research proposals increases the workload of Institutional
Review Boards (IRBs). Above all, ethical oversight ensures the quality improvement of …