ArticleInternational journal of medical sciences2008
Principal investigator views of the IRB system.
Article in International journal of medical sciences, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.
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
24 citing papers in PubMed, 1 synthesis or guideline pooled it, 68 citations in OpenAlex.
- A systematic review of the empirical literature evaluating IRBs: what we know and what we still need to learn.Journal of empirical research on human research ethics : JERHRE · 2011Pooled it
- The use of delayed telephone informed consent for observational emergency medicine research is ethical and effective.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2013Trial
- Principal Investigator Responsibility for Flagging Research with Dual-Use or Pandemic Risk.Applied biosafety : journal of the American Biological Safety Association · 2025Article
- Genetic and Genomic Researchers' Perspectives on Biological Sample Sharing in Collaborative Research in Uganda: A Qualitative Study.Journal of empirical research on human research ethics : JERHRE · 2023Article
- Researchers' Perspectives on Informed Consent and Ethical Review of Biobank Research in South Africa: A Cross-Sectional Study.Journal of empirical research on human research ethics : JERHRE · 2019Article
- The Real-Time IRB: A Collaborative Innovation to Decrease IRB Review Time.Journal of empirical research on human research ethics : JERHRE · 2018Article
- IRB Process Improvements: A Machine Learning Analysis.Journal of clinical and translational science · 2017Article
- Barriers to Effective Deliberation in Clinical Research Oversight.HEC forum : an interdisciplinary journal on hospitals' ethical and legal issues · 2016Article
- A Study of Assessing Errors and Completeness of Research Application Forms Submitted to Instituitional Ethics Committee (IEC) of a Tertiary Care Hospital.Journal of clinical and diagnostic research : JCDR · 2016Article
- Can an ethics officer role reduce delays in research ethics approval? A mixed-method evaluation of an improvement project.BMJ open · 2016Article
- Review
- Awareness of Federal Regulatory Mechanisms Relevant to Community-Engaged Research: Survey of Health Disparities-Oriented NIH-Funded Investigators.Journal of empirical research on human research ethics : JERHRE · 2015Article
- A domain analysis model for eIRB systems: addressing the weak link in clinical research informatics.Journal of biomedical informatics · 2014Article
- Article
- A study to assess completeness of project application forms submitted to Institutional Ethics Committees (IEC) of a tertiary care hospital.Perspectives in clinical research · 2012Article
- Ethical aspects in tissue research: thematic analysis of ethical statements to the research ethics committee.BMC medical ethics · 2012Article
- From anonymity to "open doors": IRB responses to tensions with researchers.BMC research notes · 2012Article
- Education Research and Human Subject Protection: Crossing the IRB Quagmire.Journal of graduate medical education · 2011Article
- Attitudes toward genetic research review: results from a survey of human genetics researchers.Public health genomics · 2011Article
- Integrating a Federated Healthcare Data Query Platform With Electronic IRB Information Systems.AMIA ... Annual Symposium proceedings. AMIA Symposium · 2010Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 1 country.
Funding
Abstract
We undertook a qualitative e-mail survey of federally-funded principal investigators of their views of the US human subjects protection system, intended to identify the range of investigator attitudes. This was an exploratory study with a 14% response rate. Twenty-eight principal investigators responded; their comments were analyzed to show underlying themes, which are here presented along with supporting quotations.There was consensus that it is important to protect human subjects from research abuse, but disagreement over how well the IRB system is functioning. Some researchers felt that the system is effective and serves its purpose well. Of those who support the system, some endorse its methods, purpose, and daily functioning, as they experience it, without reservation. Others, while expressing some frustration, feel that the purpose is important and their local IRB does its best to make a difficult system work well.Those investigators who were more harshly critical commented on multiple flaws in the system, including (1) consent forms that are inappropriate and incomprehensible, (2) an emphasis on minutiae, and (3) concern with protecting the institution more than research subjects. Respondents told us that the IRB system is a particular burden for research in neurology, emergency medical conditions, repositories, and social sciences in general; a more comprehensive study might identify other problematic areas. Significant concern was expressed about the cost, inefficiency, and irrationality of IRB review. The IRB system works well for some researchers, but our results indicate that other investigators feel the costs outweigh the benefits.
Indexed as
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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.