Tag: behavioral research

Bioethics Blogs

“She Can’t Help The Choices She Makes”

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By Madeleine Cardona

I will never forget the day my mother got diagnosed. I could swear that just yesterday I was thirteen years old waiting anxiously to be called in from the waiting room of some fancy New York State doctor’s office. I was young, but I had some idea of what was going on. I knew my parents and I were there because they were going through a divorce and fighting for custody of me. What I did not know was that we were about to endure a court-ordered psychiatric evaluation and that the results were going to change my life forever.

“Madeleine, your mom is very sick,” the psychiatrist attempted to explain to me. I did not understand. I did not know a sick person could look perfectly healthy. “It’s not a physical sickness, it’s in her head. She has a mental disorder called Paranoid Schizophrenia.” She went on using big words to explain how my mother’s brain “wasn’t like other people’s brains.” I sat there listening closely, hanging on every word the woman was saying to me. “She can’t help the choices that she makes, it’s not her fault that she is the way that she is. She needs help.” Every day since that day in the doctor’s office, that remark replays in my head over and over. “She can’t help the choices she makes.”

That is what gave me the most trouble. I sat around for years and years watching the choices that my mother was making, unable to intervene.

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

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.

Bioethics Blogs

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.

Bioethics Blogs

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.

Bioethics Blogs

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.

Bioethics News

Brain death: experts divided on how death is defined

Pdf logoSome authors, as Bernat reports in his article, have come to classify brain death unscientifically, illogically, even treating it as a legal fiction

In the November 2014 issue of the American Journal of Bioethics, see HERE (1), Professor James L. Bernat reflects on where the concept of brain death is headed. The reason for this is the fact that there is still reticence as regards this concept in the public and academic spheres. Professor Bernat refers to two recent cases in which the diagnosis of brain death led to clinical-ethical-care problems that emerged in the media and public opinion.   One of these is the case of Jahi McMath, a child who suffered severe anoxic encephalopathy, as a result of which she developed symptoms consistent with a diagnosis of brain death. Jahi’s parents refused to accept the diagnosis of death and requested that the patient’s treatment is maintained, as they did not consider her dead. The second case is that of Marlise Muñoz, a pregnant patient, also declared brain dead and whose physicians decided to maintain life support measures (connection to a respirator, and maintenance of other treatments), based on the fact that the survival of the foetus was at stake. Marlise’s family asked that these support measures be withdrawn since Marlise was considered clinically and legally dead.

Persistence of controversy in brain death criterion

The persistence of controversies in relation to the concept of brain death is striking, although it is over 40 years since the birth of this concept of death of the person, published in the Journal of the American Medical Association (JAMA) in 1968 (2).

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

Dear Mr. President: It’s Time for Your Bioethics Commission

by Craig Klugman, Ph.D.

Last week, seven Democratic members of the U.S. House Representatives sent a letter to the White House asking President Trump to appoint a director to the Office of Science and Technology Policy (OSTP), position that normally serves as the presidential science advisor. The impetus for writing the letter was a communication from the Deputy National Science Advisor that two hoax reports, that tried to undermine climate change, were circulating through the West Wing as “science.” The Congresspersons state “Where scientific policy is concerned, the White House should make use of the latest, most broadly-supported science…Relying on factual technical and scientific data has helped make America the greatest nation in the world.” Among the signers are a PhD in math and a PhD in physics. They hold that the U.S. faces strong questions that revolve around science, both opportunities and threats, and the need for a scientist who can understand and explain the importance of objective fact to the chief executive is essential.

This article led me to think that the U.S. also faces a lot of issues regarding health and medicine and their impact on society. Consider the task of creating a new health plan, CRISPR/CAS-9, in vitro gametogenesis, the threat of Zika, extra uterine gestational systems, legalized marijuana, digital medicine—pharmaceutical computing for treating disease, head transplants, and DYI science are among the bioethical issues that will effect policy in the coming few years. Thus, it is time for President Trump to call for his Presidential Bioethics Commission.

The last bioethics advisory body ended in January 2017, although many of the staff are still winding down the office and archiving the many reports and papers produced.

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

A social scientist’s guide to the Final Rule

On 18 January 2017, sixteen federal agencies announced revisions to the Federal Policy for the Protection of Human Subjects. As I noted earlier, this marks a huge victory for historians, who have spent the last 20 years working to end the inappropriate interference of IRBs with oral history research.

In addition, the final rule includes several provisions of note to scholars in the humanities and social sciences. Here are some of them; I don’t claim it is a complete list.

No biospecimens overhaul; less controversy

The final rule “does not adopt the proposal to require that research involving nonidentified biospecimens be subject to the Common Rule, and that consent would need to be obtained in order to conduct such research.” This was the target of the greatest criticism from groups like the National Academies of Sciences, Engineering, and Medicine and SACHRP. So while this change has little direct bearing on the work of social scientists and scholars in the humanities, it will likely reduce the controversy surrounding the regulatory reform as a whole.

The abandonment of the biospecimens proposal could also reduce opposition to reform by conservatives. The House Freedom Caucus opposed a new Common Rule on the grounds that it would cost $13.334 billion over 10 years. This figure seems to have been drawn from the NPRM’s quantified costs of $13.342 billion (using a 3 percent discount rate), and ignored the NPRM’s quantified benefits of $2.6 billion. If all the Freedom Caucus cares about is money, it may like the final rule a lot more.

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

Reforms for “21st century science” would have been good for the 20th too

A group of 11 researchers and IRB professionals, most of them affiliated with the University of California, San Diego, report on a brainstorming session from early 2015. They argue that readable consent forms, expert review, a less punitive system, and more exemptions would better serve researchers and participants. While they present their ideas as “a human research protections system that is responsive to 21st century science,” the measures they propose are equally valid for research as it has been practiced for decades.

[Cinnamon Bloss et al., “Reimagining Human Research Protections for 21st Century Science,” Journal of Medical Internet Research 18, no. 12 (2016): e329, doi:10.2196/jmir.6634.]

Five recommendations

The team presents its proposals under five headings, but I see the second and fifth as similar in intent.

  • Redesigning the Consent Form and Process

There’s broad consensus that written consent forms often fail to give prospective research participants the information they need to make a good decision. The UCSD team proposes consent forms based on Creative Commons licenses (like the one used by this blog). “Research studies,” they explain, “could create three consent forms: one that contains all the legalese and scientific exposition; one in plain English that presents the facts; and a third that is simplified even further and presents risks in bullet point format.”

  • Empowering Researchers to Protect Participants

Though the authors call for “empowering researchers,” really they are calling for expert peer review:

Researchers intending to engage in human-participant research could produce a document that lays out plans and risks of the research. They could then offer those documents, along with an outline of the proposed consent process, for review by their peers.

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.