Tag: clinical research

Bioethics Blogs

Will CRISPR fears fade with familiarity?

With all these ‘test tube’ babies grown up, how have our reactions to the technology evolved? AP Photo/Alastair Grant

The first “test-tube baby” made headlines around the world in 1978, setting off intense debate on the ethics of researching human embryos and reproductive technologies. Every breakthrough since then has raised the same questions about “designer babies” and “playing God” – but public response has grown more subdued rather than more engaged as assisted reproductive technologies have become increasingly sophisticated and powerful.

As the science has advanced, doctors are able to perform more complex procedures with better-than-ever success rates. This progress has made in vitro fertilization and associated assisted reproductive technologies relatively commonplace. Over one million babies have been born in the U.S. using IVF since 1985.

And Americans’ acceptance of these technologies has evolved alongside their increased usage, as we’ve gotten used to the idea of physicians manipulating embryos.

But the ethical challenges posed by these procedures remain – and in fact are increasing along with our capabilities. While still a long way from clinical use, the recent news that scientists in Oregon had successfully edited genes in a human embryo brings us one step closer to changing the DNA that we pass along to our descendants. As the state of the science continues to advance, ethical issues need to be addressed before the next big breakthrough.

Birth of the test-tube baby era

Louise Brown was born in the U.K. on July 25, 1978. Known as the first “test-tube baby,” she was a product of IVF, a process where an egg is fertilized by sperm outside of the body before being implanted into the womb.

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.

Bioethics Blogs

Clinical Research Question of the Month: August 2017

You are the director of human research protection at a community hospital. You have one IRB with seven members. Six of the members are physicians with staff privileges at your hospital. The seventh member, a representative from the community, just resigned from the IRB. Six qualified people have applied to fill the empty seat: a bioethicist, a minister, a former study participant, a community leader, a sociologist, and a member of a disadvantaged group served by the hospital. Because of a hospital policy that is set in stone, you can accept only one new IRB member.

The post Clinical Research Question of the Month: August 2017 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.

Bioethics Blogs

How Can You Take Part in Clinical Research? Looking Beyond “First in Human”

For a remarkable journey through the front lines of clinical research, I’d like to invite you to join me in viewing First in Human, which premieres tonight at 9 p.m. ET on the Discovery Channel. This three-part docuseries, to be aired August 10, 17, and 24, provides an unprecedented look inside the NIH Clinical Center here in Bethesda, MD, following four of the many brave patients who’ve volunteered to take part in the clinical trials that are so essential to medical breakthroughs.

You’ll learn about what it’s like to take part in an experimental trial of a new treatment, when all standard options have failed. You’ll see that the NIH Clinical Center and its staff are simply amazing. But keep in mind that you don’t have to travel all the way to Bethesda to be part of outstanding, NIH-funded clinical research. In fact, we support clinical trials all across the country, and it’s often possible to find one at a medical institution near your home. To search for a clinical trial that might be right for you or a loved one with a serious medical problem, try going to ClinicalTrials.gov, a web site run by NIH.

According to a national survey conducted a few years ago, 16 percent of respondents reported that they or a family member had participated in a clinical trial [1]. But among adults with cancer, participation in clinical trials is estimated to be only about 3 percent [2].

These numbers need to go up! Not only do clinical trials offer sick people who have no other options a chance to receive experimental treatments that may extend or save their lives, such work is essential for advancing scientific knowledge in ways that will benefit the health of future generations.

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.

Bioethics Blogs

The Neuroethics Blog Series on Black Mirror: The Entire History of You

By Somnath Das
Somnath Das recently graduated from Emory University where he majored in Neuroscience and Chemistry. He will be attending medical school at Thomas Jefferson University starting in the Fall of 2017. The son of two Indian immigrants, he developed an interest in healthcare after observing how his extended family sought help from India’s healthcare system to seek relief from chronic illnesses. Somnath’s interest in medicine currently focuses on understanding the social construction of health and healthcare delivery. Studying Neuroethics has allowed him to combine his love for neuroscience, his interest in medicine, and his wish to help others into a multidisciplinary, rewarding practice of scholarship which to this day enriches how he views both developing neurotechnologies and the world around him. 
Humans in the 21st century have an intimate relationship with technology. Much of our lives are spent being informed and entertained by screens. Technological advancements in science and medicine have helped and healed in ways we previously couldn’t dream of. But what unanticipated consequences may be lurking behind our rapid expansion into new technological territory? This question is continually being explored in the British sci-fi TV series Black Mirror, which provides a glimpse into the not-so-distant future and warns us to be mindful of how we treat our technology and how it can affect us in return. This piece is part of a series of posts that will discuss ethical issues surrounding neuro-technologies featured in the show and will compare how similar technologies are impacting us in the real world. 

*SPOILER ALERT* – The following contains plot spoilers for the Netflix television series Black Mirror.

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.

Bioethics Blogs

You’ll Want to See This! “First in Human” Debuts August 10

For over 60 years, the NIH Clinical Center—the world’s largest hospital dedicated to clinical research—has been at the forefront of developing treatments for our most deadly and damaging diseases. It’s here at our “House of Hope” in Bethesda, MD, where, among many other medical firsts, chemotherapy was first used to treat cancerous tumors, gene therapy underwent its first human tests, surgeons first successfully replaced the heart’s mitral valve, and the first anti-viral drug for HIV/AIDS met with early success.

Now, in a Discovery Channel documentary called First in Human, millions of people all around the globe will get a chance to see the doctors, nurses, and other staff of NIH’s remarkable research hospital in action. Narrated by Big Bang Theory star Jim Parsons, the three-part series debuts at 9 p.m.-11 p.m., ET, Thursday, August 10. The second and third segments will air at the same time on August 17 and 24. For a sneak peak, check out the video clip above!

Filmed in the Clinical Center between September 2015 and June 2016, First in Human follows four seriously ill patients—two with cancer and two with rare, inherited diseases—as they take part in clinical trials of experimental therapies. By volunteering for such research with no guarantee that they themselves would benefit, these four brave individuals helped to build the foundation for tomorrow’s breakthroughs. When you consider all of the medical “firsts” made possible by clinical research, it’s clear that we owe an enormous debt of gratitude not only to these patients, but to everyone who participates in clinical studies at the Clinical Center and across the nation.

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.

Bioethics News

Exclusion of Mothers-To-Be From Clinical Studies Unfair and Potentially Harmful

July 18, 2017

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In fact, pregnant women’s vulnerability boils down to the lack of research carried out in this group, and it’s a dilemma that can only be overcome by including mums-to-be in clinical studies, they say.

“Our study once and for all demonstrates that there is no indication that pregnant women are vulnerable because of informed consent, susceptibility to coercion, or vulnerability of the fetus,” they write.

“The only reason why pregnant women are potentially vulnerable in clinical research is to the extent that they are increasingly exposed to higher risks due to a lack of scientific knowledge which might render them vulnerable as research subjects,” they continue.

“Only a joint effort to promote fair inclusion by funding agencies, authorities, researchers, methodologists, pharmacologists, guideline committees and [research ethics committees] can successfully reduce pregnant women’s vulnerability,” they conclude.

In a linked Commentary, Drs Carleigh Krubiner and Ruth Faden, of the Berman Institute for Bioethics at Johns Hopkins University, Baltimore, argue that the designation of pregnant women as ‘vulnerable’ “is inappropriate and disrespectful.”

And rather than protecting them, it has had the opposite effect, and created a great deal of uncertainty and anxiety.

… Read More

Vulnerability of pregnant women in clinical research, Journal of Medical Ethics (2017). DOI: 10.1136/medethics-2016-103955

Commentary: Pregnant women should not be categorised as a ‘vulnerable population’ in biomedical research studies: ending a vicious cycle of ‘vulnerability’ Journal of Medical Ethics (2017). DOI: 10.1136/medethics-2017-104446

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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.

Bioethics Blogs

Research Ethics Roundup: Poor Enrollment of Seniors in Research, All of Us Research Program Pushes Transparency, FDA Announces 21st Century Cures Act Plans, EU Recommends Keeping Nonhuman Primate Research

This week’s Research Ethics Roundup looks at why the elderly continue to be underrepresented in clinical research, how a massive government study is working on community engagement efforts, the Food and Drug Administration (FDA)’s plan for new patient-focused drug development guidance, and a European Union committee’s opinion that nonhuman primate research should continue in its member countries.

The post Research Ethics Roundup: Poor Enrollment of Seniors in Research, All of Us Research Program Pushes Transparency, FDA Announces 21st Century Cures Act Plans, EU Recommends Keeping Nonhuman Primate Research 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.

Bioethics Blogs

PRIM&R Responds to NIH’s Request for Information on Inclusion in Clinical Research Across the Lifespan

Recently, PRIM&R submitted comments to the National Institutes of Health (NIH) in response to a Request for Information (RFI): Invitation to Comment on Inclusion in Clinical Research Across the Lifespan.

The post PRIM&R Responds to NIH’s Request for Information on Inclusion in Clinical Research Across the Lifespan 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.

Bioethics Blogs

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.

Bioethics Blogs

Not Just About Consent: The Ethical Dimensions of Research Methodology Knowledge in IRBs

Guest Post: Sarah Wieten

The recent article, “Some Social Scientists Are Tired of Asking for Permission” in the New York Times inspired a great deal of debate about the role of institutional research ethics board (IRB) oversight in social science, which some argue is in most cases unlikely to involve significant harm to participants.

While the role IRBs play in sociological research is being re-examined, the importance of IRB oversight for medical research was not similarly called into question. But what exactly does IRB oversight in medical research involve? Should these groups be content with assuring that patients and participants in medical research have provided informed consent? Or do they have wider duties? What is the relationship between methodologically rigorous science and ethical science?

The approval of research projects by IRBs is an integral part of the conduct of research in universities. IRBs ensure that all research follows key ethical guidelines and is pursued for good reason, and in doing so, they aim to keep patients and participants out of harm’s way. IRBs are important gatekeepers of institutional research, and serve as a check on the work of scientists, physicians, and others who are pursuing new knowledge.

We would assume then, that people serving on IRBs have a clear understanding of relevant research design. That way, they can check the research for ethical issues stemming from the methodology. They can also make sure that methodologically poor studies do not proceed, as this would be an unethical waste of resources (and would put participants at risk without a reasonable prospect of gaining reliable knowledge in exchange).

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.