Articles Tagged With: IRB
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IRB Websites Are a Helpful Resource for Undergraduate Research Ethics
The way IRBs communicate about research ethics varies widely depending on the institution. This article will explore what this means for researchers.
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Does Current IRB System Ensure Ethical Research?
A consensus is needed for how to measure IRB quality or effectiveness, and more inspections are needed to ensure instances of IRB noncompliance are identified, according to the authors of a recent report.
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Highly Publicized Research Fraud Erodes Public Trust
There is not much IRBs can do to spot misconduct or fraud in clinical trials. IRBs do not typically review data. However, IRBs should promote compliance with legal and ethical requirements, and deal with suspected noncompliance in a fair, reasonable, and timely fashion.
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Community Members Help Train Research Staff
At Tufts Clinical and Translational Science Institute, research staff learn how to provide informed consent by working with community members acting as simulated prospective study participants in role-playing exercises. More than 40 community members, researchers, patients and families, and healthcare providers offer feedback and help develop training.
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Real-Life Experience Allows Researchers to Obtain Ethical Consent
Research staff may have secured a signed consent form from a study participant, but did they obtain that consent ethically? People considering whether to join a clinical trial may not fully understand the procedures involved, risks and benefits, confidentiality issues, or even that participation is voluntary, depending on how the research is presented.
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Lack of Transparency on Informed Consent Documents Complicates Oncology Trials
Researchers should describe the potential benefits and risks of participating in the trial compared with potential benefits and risks of receiving standard treatment outside the trial. Also, strive to write consent forms that highlight the key issues involved in the decision to join a trial.
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Did Study End Early? There Is an Ethical Obligation to Participants
Research participants consent to take on risk for the benefit of others, not for their own benefit. If a trial ends prematurely, researchers should tell participants. Investigators also must ensure any risks participants accepted are mitigated to the fullest extent possible.
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Emerging Ethical Issues to Consider When Conducting Community-Engaged Research
Does the community representative possibly have a conflict of interest? How will any monetary incentives to participate in the study be distributed? Is the incentive for individual patients or the whole community?
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Participant Protection Is IRB’s Mission, but Difficult to Measure
It is possible to examine if IRBs advise researchers appropriately regarding reducing risks. Consider the types of questions and requests the IRB has in response to the risks in a particular research protocol.
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Variation in Ethical Justification of Randomized Clinical Trials
Ideally, when a researcher presents a randomized clinical trial to an ethics board (and to study participants), the term “equipoise” is defined explicitly. This ensures both the study investigator and the IRB mean the same thing when they say the randomization of patients is ethically justified.