Tag: research ethics

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The 2017 Common Rule and the Clinical Ethics of Prolixity

Some bioethicists link the beginnings of our field to the Nazi Medical experiments and the Nuremberg Trial (Annas). Whether this is the beginning of bioethics is debatable, but without a doubt, research ethics has been a central topic in the field. In fact, the very first federal bioethics commission laid out the principles of research ethics in the Belmont Report. Later, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research recommended to the President and Congress that a uniform framework and set of regulations should govern human subjects research.  This effort reached fruition under The Federal Policy for the Protection of Human Subjects or the “Common Rule” that was issued in 1991.  Since then, there have been no major changes to the regulations – until now.  After a five-year process and thousands of comments, the new “final rule” was released on January 19th, 2017.  The July 2017 issue of the American Journal of Bioethics addresses these changes.  In addition to our usual open peer commentaries, we are posting a number of blog posts written in response to the AJOB target article.

The following is a re-post of Steven Mile’s original February 2017 post.


by Steven H. Miles, MD

The new Common Rule to protect human subjects has an extraordinarily large and diverse audience.[i] The new Rules defines the obligations of an enormous number of personnel at the National Institutes of Health as well as virtually any other government agency engaged in research with human subjects. The Rules define the requisite knowledge, training, and work of staff who oversee and conduct clinical research in the United States.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

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Participants’ Testimonials: GBI Summer School a Smashing Success, (June 19-30), 2017

The GBI Summer School proved to be even better than anticipated or described. As a newcomer to the discipline, I had expected the course to provide a broad overview of topics and speakers. Indeed, while broad, the degree of expertise and timely subject material provided an excellent and comprehensive survey of the discipline in global and local settings. Moreover, the students provided another dimension of diversity, both in nationalities and areas of expertise. The speakers made their presentation materials readily available, answered questions, and were willing to address topics of interest offline. I would strongly recommend the course to both novices and subject matter experts alike. The course especially demonstrated the need, relevance, and desirability for global bioethics to be better incorporated into public policy formulation.

Geoffrey Pack, Prevention and Protection Officer, Office of Homeland and Security, City of San Diego, M.A.L.D., Fletcher School of Law and Diplomacy, Tufts University in Cooperation with Harvard University

The GBI Summer School, in the heart of NYC’s Pace University Campus, is a fantastic opportunity! International scholars and professionals from all over the world attended the program, contributing their experiences and engaging with bioethics experts. The City of New York – with the nearby Pace University Campus, Brooklyn Bridge, City Hall, and 9/11 Memorial – provided the perfect setting to discuss the global ethical challenges in technology and medicine. Discussions ranged from law and politics to culture and psychology, encompassing the ethical dilemmas that define the 21st century. I have immensely enjoyed not just the internationally known faculty but also hearing from the learners who come from all over the world representing diverse fields.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

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Rethinking the Belmont Report?

Some bioethicists link the beginnings of our field to the Nazi Medical experiments and the Nuremberg Trial (Annas). Whether this is the beginning of bioethics is debatable, but without a doubt, research ethics has been a central topic in the field. In fact, the very first federal bioethics commission laid out the principles of research ethics in the Belmont Report. Later, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research recommended to the President and Congress that a uniform framework and set of regulations should govern human subjects research.  This effort reached fruition under The Federal Policy for the Protection of Human Subjects or the “Common Rule” that was issued in 1991.  Since then, there have been no major changes to the regulations – until now.  After a five-year process and thousands of comments, the new “final rule” was released on January 19th, 2017.  The July 2017 issue of the American Journal of Bioethics addresses these changes.  In addition to our usual open peer commentaries, we are posting a number of blog posts written in response to the AJOB target article.


by Ibrahim Garba, MA, JD, LLM, Elizabeth Hall-Lipsy, JD, MPH, Leila Barraza JD, MPH

Norms supporting ethical research have been part of international human rights law from the start. The Doctors Trial in 1947 convicting 23 Nazi physicians and officials accused of euthanasia and unethical medical experiments produced the Nuremburg Code. The Code became a blueprint for subsequent human subject protection frameworks, most notably the World Medical Association’s Ethical Principles for Medical Research Involving Human Subjects (i.e.,

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

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The Belmont Report: First Word or Last Word on the Foundations of Research Ethics?

Some bioethicists link the beginnings of our field to the Nazi Medical experiments and the Nuremberg Trial (Annas). Whether this is the beginning of bioethics is debatable, but without a doubt, research ethics has been a central topic in the field. In fact, the very first federal bioethics commission laid out the principles of research ethics in the Belmont Report. Later, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research recommended to the President and Congress that a uniform framework and set of regulations should govern human subjects research. 

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

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Tune Ups to Belmont & Common Rule Need to Consider Community-Engaged Research

Some bioethicists link the beginnings of our field to the Nazi Medical experiments and the Nuremberg Trial (Annas). Whether this is the beginning of bioethics is debatable, but without a doubt, research ethics has been a central topic in the field. In fact, the very first federal bioethics commission laid out the principles of research ethics in the Belmont Report. Later, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research recommended to the President and Congress that a uniform framework and set of regulations should govern human subjects research.  This effort reached fruition under The Federal Policy for the Protection of Human Subjects or the “Common Rule” that was issued in 1991.  Since then, there have been no major changes to the regulations – until now.  After a five-year process and thousands of comments, the new “final rule” was released on January 19th, 2017.  The July 2017 issue of the American Journal of Bioethics addresses these changes.  In addition to our usual open peer commentaries, we are posting a number of blog posts written in response to the AJOB target article.


by Eric Wat MA, Nancy Shore PhD, Sarena D Seifer MD, CCPH, Lola Sablan-Santos, Alice Park MPH, Mei-Ling Isaacs MPH, Ahahui Malama I Ka Lokahi, Kelly Edwards PhD, Elaine Drew PhD, John Cooks, Paige Castro-Reyes BS BA, CCPH

We concur with Friesen and colleagues’ (2017) assertion that the Belmont Report requires, at a minimum, a “tune-up” to better reflect the unique ethical values and demands of community-engaged research (CEnR).

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

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Rethinking the Belmont Report? Yes!

Some bioethicists link the beginnings of our field to the Nazi Medical experiments and the Nuremberg Trial (Annas). Whether this is the beginning of bioethics is debatable, but without a doubt, research ethics has been a central topic in the field. In fact, the very first federal bioethics commission laid out the principles of research ethics in the Belmont Report. Later, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research recommended to the President and Congress that a uniform framework and set of regulations should govern human subjects research.  This effort reached fruition under The Federal Policy for the Protection of Human Subjects or the “Common Rule” that was issued in 1991.  Since then, there have been no major changes to the regulations – until now.  After a five-year process and thousands of comments, the new “final rule” was released on January 19th, 2017.  The July 2017 issue of the American Journal of Bioethics addresses these changes.  In addition to our usual open peer commentaries, we are posting a number of blog posts written in response to the AJOB target article.


by Emily Caldes, MA, CIP and Jennifer B McCormick, Ph.D., MPP

As noted by Friesen, Kearns, Redman and Caplan in their review of the Belmont Report, the Belmont Commission tackled the difficult task of distinguishing research from practice. The report defines research activities as those intended to develop or contribute to generalizable knowledge, and it defines practice as activities intended to enhance the well-being of particular individuals or groups of individuals.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

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Research Ethics Roundup: Pitfalls of Studying Only Male Lab Mice, Retirement Issues for Lab Chimpanzees, New SUPPORT Trial Findings, Zika Vaccine Pricing Concerns

This week’s Research Ethics Roundup the ramifications of only using male lab mice in preclinical research, why so few lab chimpanzees have been sent to sanctuaries, Public Citizen’s letter to the Department of Health and Human Services (HHS) on new SUPPORT trial findings, and the ethics of pricing a Zika vaccine.

The post Research Ethics Roundup: Pitfalls of Studying Only Male Lab Mice, Retirement Issues for Lab Chimpanzees, New SUPPORT Trial Findings, Zika Vaccine Pricing Concerns appeared first on Ampersand.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

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North Texas IRB Working Group

PRIM&R’s Regional Connections Program is designed to encourage research ethics professionals in a given geographic area to connect and build relationships. To that end, we offer support to individuals and institutions who would like to organize and host a Regional Connections event for their community. In this post, Mary-Colette Lybrand, MS, CCRP, CIP, regulatory services manager of Research Administration at the University of Texas at Arlington shares more about an innovative Regional Connections event initiated by her institution.

The post North Texas IRB Working Group appeared first on Ampersand.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

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How a Company You’ve Never Heard of Sends You Letters about Your Medical Condition

June 20, 2017

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Franco did not have psoriasis. But the year before, she remembered, she had searched for information about it online, when a friend was dealing with the condition. And a few months prior to getting the letter, she had also turned to the internet with a question about a skin fungus. It was the sort of browsing anyone might do, on the assumption it was private and anonymous.

Now there was a letter, with her name and home address on it, targeting her as a potential skin-disease patient. Acurian is in the business of recruiting people to take part in clinical trials for drug companies. How had it identified her? She had done nothing that would publicly associate her with having a skin condition.

When she Googled the company, she found lots of people who shared her bewilderment, complaining that they had been contacted by Acurian about their various medical conditions. Particularly troubling was a parent who said her young son had received a letter from Acurian accurately identifying his medical condition and soliciting him for a drug trial—the first piece of mail he’d had addressed to him besides birthday cards from family members.

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Image: By EFF – Own work, CC BY 3.0 us, https://commons.wikimedia.org/w/index.php?curid=27598327

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The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

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Research Ethics Roundup: New USDA Numbers on Animals in Research Labs, Improving Diversity in Research, Collins to Stay at NIH, ICMJE’s New Policy on Data Sharing

This week’s Research Ethics Roundup looks at the latest US Department of Agriculture (USDA) numbers on animals living in research labs, how researchers are working to better engage diverse populations, President Trump’s decision to keep Dr. Francis Collins as director of the National Institutes of Health (NIH), and the International Committee of Medical Journal Editors (ICMJE)’s final policy on data sharing statements for clinical trials.

The post Research Ethics Roundup: New USDA Numbers on Animals in Research Labs, Improving Diversity in Research, Collins to Stay at NIH, ICMJE’s New Policy on Data Sharing appeared first on Ampersand.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.