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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Vulnerable patients – easy targets for companies willing to sacrifice ethics for profits – The Hill (Jody Lyneé Madeira | May 2018)0

Posted by Admin in on August 5, 2018
 

A small medical device has just become embroiled in a large controversy, suggesting violations of fundamental ethical norms and settled principles of scientific research.

Stories like this highlight why people living with a chronic medical condition (and their families) need to be discerning and cautious when it comes to glowing media reports about amazing new treatments.

At first glance, the Bridge — a neuro-modulation device that attaches behind the ear — resembles a hearing aid with wires. The Bridge received Food and Drug Administration (FDA) clearance in November 2017 for easing opioid withdrawal symptoms during detoxification; before, it was approved only for acupuncture.
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This device is supposed to help patients get through the difficult opioid withdrawal process. It’s used in pilot programs in several states, available in at least one major Indiana hospital chain, and is starting to be covered by insurance.
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(US) FDA’s revolving door: Companies often hire agency staffers who managed their successful drug reviews – Science (Charles Piller | July 2018)0

Posted by Admin in on August 4, 2018
 

The Food and Drug Administration (FDA) says its rules, along with federal laws, stop employees from improperly cashing in on their government service. But how adequate are those revolving door controls? Science has found that much like outside advisers, regular employees at the agency, headquartered in Silver Spring, Maryland, often reap later rewards—jobs or consulting work—from the makers of the drugs they previously regulated.

FDA staffers play a pivotal role in drug approvals, presenting evidence to the agency’s advisory panels and influencing or making approval decisions. They are free to move to jobs in pharma, and many do; in a 2016 study in The BMJ, researchers examined the job histories of 55 FDA staff who had conducted drug reviews over a 9-year period in the hematologyoncology field. They found that 15 of the 26 employees who left the agency later worked or consulted for the biopharmaceutical industry.

FDA’s safeguards are supposed to keep the prospect of industry employment from affecting employees’ decisions while at the agency, and to discourage them from exploiting relationships with former colleagues after they depart. For example, former high-level employees can’t appear before the agency on the precise issues they regulated—sometimes permanently, in other cases for a year or two.

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National Statement on Ethical Conduct in Human Research (2007) – Updated July 20180

Posted by Admin in on July 12, 2018
 

National Statement 2018 coverThe National Statement is the Australian national reference for human research. It was issued by the NHMRC and has been endorsed by the ARC and UA. The document articulates the four core principles of merit and integrity, beneficence, justice and respect for persons. Specific advice is provided with regard to benefits and risk, informed consent, privacy, methodologies and potential participant populations. Guidance is also provided with regard to the appointment and operation of human research ethics committees, the conduct of ethical reviews, and the responsibilities of institutions. Even though the document has not been enacted compliance with the National Statement is a strict condition of NHMRC and ARC funding.

Since 2014 a joint working group (including appointees from AHEC, the ARC and UA) have been conducting a rolling review of the National Statement. Dr Allen is involved in this rolling review.

In 2015-17 a joint drafting committee (including appointees from AHEC, the ARC and UA) drafted changes and addition to the chapters in Section 3 of the National Statement, as well as corresponding changes to Section 5 and the glossary Dr Allen, Prof Israel and Prof Thomson are involved in this rolling review.

Access – the PDF copy | the NS page

National Health and Medical Research Council, Australia (2007, updated 2018) National Statement on Ethical Conduct in Human Research. Available at: https://www.nhmrc.gov.au/_files_nhmrc/file/publications/national-statement-2018.pdf

(Philippines) National Ethical Guidelines for Health and Health-Related Research (PHREB | 2017)0

Posted by Admin in on July 5, 2018
 

Prepared by the Philippine Health Research Ethics Board Ad Hoc Committee for Updating the National Ethical Guidelines

R E S O L U T I O N “RECOGNIZING DR. MARITA V.T. REYES AND THE MEMBERS OF THE AD HOC COMMITTEE FOR THEIR EFFORTS ON THE REVISION OF THE NATIONAL ETHICAL GUIDELINES”

WHEREAS, the Ad Hoc Committee for the Updating of the National Ethical Guidelines was created to update the existing ethical guidelines to ensure adherence to local, national, and international principles and values and respect for Filipino morals and culture;

WHEREAS, the Ad Hoc Committee for the Updating of the National Ethical Guidelines was created on 13 January 2015, with Dr. Marita V.T. Reyes as Chair and the following as members: Dr. Rosario Angeles T. Alora, Dr. Leonardo D. de Castro, Prof. Edlyn B. Jimenez, Dr. Ricardo M. Manalastas, Jr., Dr. Evangeline O. Santos, and Dr. Cecilia V. Tomas;

WHEREAS the Ad Hoc Committee has completed its draft and the Philippine Health Research Ethics Board (PHREB) has approved the National Ethical Guidelines for Health and Health-Related Research 2017 (NEGHHR 2017);

Access the Filippino health research guidelines

Philippine Health Research Ethics Board (2017) National Ethical Guidelines for Health and Health Related Research. Manila: Department of Science and Technology – Philippine Council for Health Research and Development. http://www.ethics.healthresearch.ph/index.php/phoca-downloads/category/4-neg

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