ArticlePerspectives in clinical research
Monitoring of approved studies: A difficult tightrope walk by Ethics Committees.
Article in Perspectives in clinical research. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed.
- Ethical Precision in Nanoscale Brain Interfacing.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- Ethical oversight of AI-driven paediatric trials: a proactive, risk-sensitive interim review model.Frontiers in digital health · 2026Article
- A Survey Study on Knowledge and Attitude Toward the Ethics Committee and Research Ethical Practices Among Researchers From Kuwait.Science and engineering ethics · 2023Article
- Protecting Participants in Genomic Research: Understanding the "Web of Protections" Afforded by Federal and State Law.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2020Article
- A crucial role of on-site clinical trial monitoring: Insights from the ethics committee.Perspectives in clinical researchArticle
- Continuous review for ethical conduct of clinical trial-are the ethics committees complying?Perspectives in clinical researchArticle
- Post-approval process: A challenge for ethics committees.Perspectives in clinical researchArticle
- Strengthening postapproval oversight in research ethics committees: Challenges and solutions.Perspectives in clinical researchArticle
- Audit of principal investigator's compliance for submission of continue review application and decisions taken on lapses in validity of approval by the Institutional Ethics Committee at tertiary oncology center in Navi Mumbai.Perspectives in clinical researchArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Continuing review of studies approved by the Ethics Committees (ECs) involves review of the progress of the study, annual reports, protocol deviations/violations, serious adverse event monitoring, and on-site monitoring. International and national regulations and guidelines for continuing review state that it is an opportunity for the EC to be assured that risks to subjects are minimized and is are reasonable in relation to anticipated benefits if any to the subjects and the knowledge it will generate. There are several barriers (e.g. lack of workforce, lack of training of members for conducting onsite review, and poor infrastructure) for ECs to do ongoing review of projects approved by them. Industry is an important stakeholder for the research enterprise in India and strongly advocates that ECs should at a minimum have pragmatic standard operating procedures for continuing review/monitoring of studies initially approved. ECs which deal with larger volume of studies with well-functioning secretariat, appropriately trained EC members and funding should definitely conduct onsite review/monitoring in addition to the ongoing review.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.