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02/21/2018

Insider Report: NIH Alters Pre-Award Human Subjects Concerns Reporting; IRBs Not Told

by Craig Klugman, Ph.D.

On February 16, 2018, bioethics.net received an NIH memo sent to program officers on the same day. The missive came from the NIH OER Communications Office and was signed by Michael S. Lauer, MD, the NIH Deputy Director for Extramural Research:

Effective Tuesday February 20, 2018, NIH is changing how we handle pre-award human subject concerns identified during peer review to streamline administrative processes associated with making grant and R&D contract awards. Responsibility for review and approval of finalized human subjects’ research protocols vests with the Institutional Review Board (IRB) of record. The NIH Office of Extramural Research (OER) will no longer be involved in the resolution of human subject concerns.

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This entry was posted in Clinical Trials & Studies, Featured Posts, Human Subjects Research & IRBs, Science and tagged . Posted by Craig Klugman. Bookmark the permalink.

02/20/2018

Bioethics Has a Silencer on Gun Violence

by Craig Klugman, Ph.D.

Where is the vibrant bioethics literature on gun control and firearm violence? In 1997, bioethicist Leigh Turner asked why bioethics “neglect[s] issues of public health, preventive medicine and social medicine…{such as] gun control and firearm-related violence.” In 2012, Art Caplan wrote that “We need to treat violence as a public health issue” and in 2015 that “guns are a medical issue.” John Kaplan in an Albany Medical College blog in 2013 was amazed by “how little bioethicists are saying about the need for gun control.” In 2017, Jenny Nguyen in Medium offered a deontological examination of the issue: “I consider violence to be an issue that should be addressed using bioethics.” In 2018, Jones et.

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This entry was posted in Cultural, Featured Posts, Politics and tagged , , . Posted by Craig Klugman. Bookmark the permalink.

02/20/2018

Going the Extra Mile: A Med Student’s Marathon

By Shoshana B. Weiner “4 ounces water every mile, half an electrolyte ‘gu’ pack over 2.5 miles, ¼ energy bar every 6 miles.”  AKA how did you manage training for a marathon while in medical school?  The simple truth: I decided to run a marathon so I did.  Longer story: months of rigorous training, more […]

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02/20/2018

Removing Obstacles to a Peaceful Death

My colleagues Kathy Cerminara and Barbara Noah have a new article in the Elder Law Journal: "Removing Obstacles to a Peaceful Death." "We all will die, but the American health care system often impedes a peaceful death. Instead of a quiet death at hom...

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This entry was posted in Health Care and tagged . Posted by Thaddeus Mason Pope, JD, PhD. Bookmark the permalink.

02/20/2018

DIY CRISPR Kits – Gene Editing for the Rest of Us

One might think with the amazing advance of technology and easy access to nearly infinite data via the Internet that we, as a society, would see a reduction in false claims of benefit for novel medical procedures and untested medications. Sadly, it seems to be just the opposite. I seem to be spending gradually more time with my patients reviewing the results of their internet... // Read More »

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02/19/2018

Seriously Ill Long Term Care Residents Should Have a POLST

This powerful story illustrates why seriously ill long-term care residents should have a POLST.

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This entry was posted in Health Care and tagged . Posted by Thaddeus Mason Pope, JD, PhD. Bookmark the permalink.

02/18/2018

Advance Directives for VSED

Later this year, Canada will consider extending medical aid in dying (MAID) to patients through advance directive. While some U.S. legislatures have introduced bills to do the same, it seems unlikely that any such bill will pass. In the meantime, some...

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This entry was posted in Health Care and tagged . Posted by Thaddeus Mason Pope, JD, PhD. Bookmark the permalink.

02/17/2018

Religious Exception to Brain Death

A Canadian court will soon decide whether those with a religious objection to brain death can avoid being declared dead on neurological criteria like everyone else. Only New Jersey affords that right in the United States.   Shalom Ouanounou ...

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This entry was posted in Health Care and tagged . Posted by Thaddeus Mason Pope, JD, PhD. Bookmark the permalink.

02/16/2018

Warehousing and Torturing Dying Patients? Conference Promises a Different Future

Final Exit Network, an organization dedicated to achieving a peaceful death, is sponsoring a hemisphere-wide conference to bring together bioethicists, doctors, nurses, other health care professionals, hospice chaplains, legal experts, and lay ind...

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This entry was posted in Health Care and tagged . Posted by Thaddeus Mason Pope, JD, PhD. Bookmark the permalink.

02/16/2018

Physician-Assisted Death: Scanning the Landscape and Potential Approaches – A Workshop

Here is a video of my talk from this week's workshop at the National Academy of Sciences, Engineering, and Medicine: "Physician-Assisted Death: Scanning the Landscape and Potential Approaches."

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This entry was posted in Health Care and tagged . Posted by Thaddeus Mason Pope, JD, PhD. Bookmark the permalink.