Your Human Subjects Review Process: A Road Block or a Competitive Advantage? (original) (raw)

2012, Journal of Clinical Research & Bioethics

AI-generated Abstract

The paper discusses the competitive advantage of an efficient human subjects review process within academic and clinical research environments, contrasting this with the negative impacts of a poorly functioning Institutional Review Board (IRB). It highlights that while the IRB process is traditionally suited for large-scale research, it is inadequate for smaller studies, which can hinder innovation. Three recommendations are made to improve IRB processes: evaluating IRB performance, publicly sharing IRB quality statements, and creatively exploring alternative mechanisms for human subject protection. The authors argue that change will be driven by the preferences of the best candidates and the need for institutions to remain competitive.

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N-of-1 Trials: Evidence-Based Clinical Care or Medical Research that Requires IRB Approval? A Practical Flowchart Based on an Ethical Framework

Healthcare

N-of-1 trials can provide high-class evidence on drug treatment effectiveness at the individual patient level and have been given renewed interest over the past decade due to improvements of the initial single patient design. Despite these recent developments, there is still no consensus under what circumstances N-of-1 trials should be considered as part of evidence-based clinical care and when they represent medical research with need for institutional review board (IRB) approval. This lack of consensus forms an obstacle for a more widespread implementation of N-of-1 trials. Based upon the existing literature, we as a group of researchers involved in N-of-1 trials and members of the IRB of a tertiary academic referral center, designed a practical flowchart based on an ethical framework to help make this distinction. The ethical framework together with a practical flowchart are presented in this communication.

A Program to Provide Regulatory Support for Investigator-Initiated Clinical Research

Academic Medicine, 2006

Investigator-initiated clinical trials represent a small but extremely important portion of medical research. In the process of translating basic science discoveries to novel therapies, new drugs or devices may be developed and tested. In light of increased compliance scrutiny, the need to streamline research projects, and the growing complexity of the U.S. Food and Drug Administration's (FDA's) regulations, the research leadership at the University of Minnesota Academic Health Center (AHC) determined in 2002 that a service should be established to address these issues. The assumption was that providing a service to assist researchers with regulatory obligations would result in additional clinical research that might not have been pursued due to perceived regulatory hurdles. The authors present an overview of the FDA regulatory process as it applies to investigator-initiated research involving investigational new drugs and investigational medical devices. The rationale for creating a program designed specifically to assist faculty with investigational new drug (IND) applications and investigational device exemption (IDE) applications is discussed. The services provided by the IND/IDE Assistance Program (IAP) at the University of Minnesota Academic Health Center are described. The value of the IAP to the AHC is presented along with examples of successes attributable to the IAP and lessons learned so far.

Protect us from poor-quality medical research

Human Reproduction, 2018

Much of the published medical research is apparently flawed, cannot be replicated and/or has limited or no utility. This article presents an overview of the current landscape of biomedical research, identifies problems associated with common study designs and considers potential solutions. Randomized clinical trials, observational studies, systematic reviews and meta-analyses are discussed in terms of their inherent limitations and potential ways of improving their conduct, analysis and reporting. The current emphasis on statistical significance needs to be replaced by sound design, transparency and willingness to share data with a clear commitment towards improving the quality and utility of clinical research.

“Special Scrutiny”: A Targeted Form of Research Protocol Review

Annals of Internal Medicine, 2004

on behalf of the Consortium to Examine Clinical Research Ethics Research participants require ongoing protection of the kind already established in law and regulation. However, "special scrutiny" for certain types of research is also needed. Three criteria for special scrutiny are 1) research that involves initial experiences of translating new scientific advances into humans, especially when the intervention is novel, irreversible, or both; 2) research with a known or credible risk for significant harm (death or serious disability are the clearest examples) to research participants as a consequence of the experimental intervention and with no potential for offsetting direct medical benefit; or 3) research with a protocol that raises ethical questions about research design or implementation for which there is no consensus. Special scrutiny recognizes that not all research protocols are equally ethically challenging and aims to provide appropriate protection for all research participants.

Improving public health by improving clinical trial guidelines and their application

European heart journal, 2017

Evidence generated from randomized controlled trials forms the foundation of cardiovascular therapeutics and has led to the adoption of numerous drugs and devices that prolong survival and reduce morbidity, as well as the avoidance of interventions that have been shown to be ineffective or even unsafe. Many aspects of cardiovascular research have evolved considerably since the first randomized trials in cardiology were conducted. In order to be large enough to provide reliable evidence about effects on major outcomes, cardiovascular trials may now involve thousands of patients recruited from hundreds of clinical sites in many different countries. Costly infrastructure has developed to meet the increasingly complex organizational and operational requirements of these clinical trials. Concerns have been raised that this approach is unsustainable, inhibiting the reliable evaluation of new and existing treatments, to the detriment of patient care. These issues were considered by patient...

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