Revamping the US Federal Common Rule: Modernizing Human Participant Research Regulations

JAMA. 2017;317(15):1521-1522
Authors: James G. Hodge Jr; Lawrence O. Gostin
“On January 19, 2017, the Office for Human Research Protections (OHRP), Department of Health and Human Services, and 15 federal agencies published a final rule to modernize the Federal Policy for the Protection of Human Subjects (known as the “Common Rule”). Initially introduced more than a quarter century ago, the Common Rule predated modern scientific methods and findings, notably human genome research.”
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Independent board needed to promote research integrity, US panel says

BMJ 2017; 357:j1879
Author: Michael McCarthy
“A new US report calls for the creation of an independent advisory board to help scientists, scientific institutions, journals, and other participants tackle research misconduct and reduce questionable practices, which, while they might not represent misconduct, harm research enterprise.”
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Addressing Ethical Lapses in Research

JAMA Intern Med. 2017;177(4): 461-462.
Authors: Bernard Lo, Deborah Grady
“The study “Association of Testosterone Levels With Anemia in Older Men,” published in this week’s JAMA Internal Medicine, contains an ethical error. Hemoglobin levels were measured in all 788 participants at baseline, and every 3 months during the 1-year duration of the trial. Blood obtained at baseline was stored until the end of the trial, when tests for the cause of anemia were performed. Participants with hemoglobin levels less than 10.0 g/dL at baseline were excluded from the trial and “referred to their primary care providers for evaluation of anemia.” However, the 126 participants (16%) with mild anemia (hemoglobin levels between 10.0 and 12.7 g/dL) were not told of this condition.”
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A qualitative study of participants’ views on re-consent in a longitudinal biobank

BMC Medical Ethics 2017 18:22
Authors: Mary Dixon-Woods, David Kocman, Liz Brewster, Janet Willars, Graeme Laurie, Carolyn Tarrant
“Biomedical research increasingly relies on long-term studies involving use and re-use of biological samples and data stored in large repositories or ‘biobanks’ over lengthy periods, often raising questions about whether and when a re-consenting process should be activated. We sought to investigate the views on re-consent of participants in a longitudinal biobank.”
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Should research ethics committees police reporting bias?

BMJ 2017; 356: j1501
Authors: Simon E Kolstoe, Daniel R Shanahan, Janet Wisely
“Progress through the application of science cannot be achieved if the results of scientific studies are not communicated appropriately. This is particularly relevant in medical research, where experiments are often conducted on human volunteers. Expensive new innovations cannot be produced without returns for investigators, but the distortion of the evidence base by long term withholding of data, either for financial gain or simply through negligence, can do real harm to patients.”
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Diabetologist and former journal editor faces charges of data fabrication

BMJ 2017; 356: j1348
Author: Clare Dyer
“At a four week hearing of the Medical Practitioners Tribunal Service that opened on 13 March, the GMC accuses Grant of a catalogue of research misconduct, including forging the signatures of coauthors, listing doctors who had not significantly contributed to papers as coauthors, and fabricating data.”
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Informed Consent

N Engl J Med 2017; 376:856-867
Authors: Jeffrey M. Drazen, David P. Harrington, et al
“In the classic interaction in which informed consent is obtained for research, an investigator presents the potential participant with information regarding a new therapeutic, diagnostic, or prophylactic intervention and then asks the participant to read and sign a detailed written consent document. This traditional prototype is becoming outdated. Informed consent, which is ethically essential in most clinical research, respects persons’ rights to decide whether participation in the research is compatible with their interests, including their interests in protection from exploitation and harm. Required by ethical guidelines and regulations unless explicitly waived by institutional review boards, informed consent is thus a means of protecting the rights and welfare of participants while they contribute to the advancement of knowledge.”
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Tribunal reprimands medical researcher for professional misconduct

Medical Board of Australia, 22 February 2017
“The Medical Board of Australia referred Mr Nicholas Melhuish to the tribunal on the grounds that his multiple breaches of the Privacy Act 1988 and the Health Records (Privacy and Access) Act 1997 (ACT) as well as breaches of Good medical practice: a code of conduct for doctors in Australia (the Code of Conduct), the National Health and Medical Research Council’s Australian Code for Responsible Conduct of Research 2007 (the NHMRC Code) and the ACT Health Research Practice Policy amounted to professional misconduct.”
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