Informed-Consent Books

This is an excellent volume that should be read by anyone involved in clinical research. It is both scholarly and accessible. The arguments are well-developed and the rich case histories and examples are well-referenced. Menikoff brings into sharp relief the need to rethink the relationship between clinician and investigator and between patient and research subject. The volume should not be seen as a denial of the importance of clinical research but rather as a call for IRB members, investigators, and patients to think carefully about what clinical research is and what it is not.

Informed Consent tells the story about a doctor and researcher, Jeffrey Cramer, who has discovered a possible cure for AIDS. The media loves him. But guilt from accidents that wreak havoc on the lives of those he loves plaques him and spurs him toward work, taking him away from his family. When another accident? sabotage? brings about horrible results with his cure, the media and the hospital turns against him. Now his own son's life hangs in the balance. Dare he use the cure to save his son's life, even if it means unethical medical practices?

The writings propels you forward, forward, forward in the action, and deep into the character's psyche. Sandi doesn't waste a single word. Each scene spins with meaning.

Nothing is simple. Even when characters make decisions that you know are wrong, you don't question the character. Sandi doesn't give you predictable or easy answers. Flaws pepper the pages, yet these characters aren't pure evil. They are you and me trying out to figure out truth in this messy world.

REVIEW: WARNING: After reading "Informed Consent" you will NEVER look at Doctors and nurses the same way again. After all they are just humans like the rest of us right? I know there is office politics in whatever work environment but when you read about what goes on in the inner workings of a hospital it makes you a little sick to your stomach.

When Hospital personnel make mistakes on the job or don't follow procedure or don't get "INFORMED" consent patients are put at risk and some die. Sandra definitely explores how some doctors try to get around "Informed Consent" and what that means to the patients.

How is the cure for AIDS going to be found? Sandra reveals one way; thru that of a Dr./Researcher who is personally motivated by personal tragedy to find a cure for what killed his father but not himself. Could finding the cure for his fathers death lead to a break thru the whole world is looking for? It could happen!

Parts of this book were medically wordy. Some where stressful to read because it dealt with children and possible medical mishaps that put them in harms way. Then there were other parts of the book that were fast paced - thrilling and emotionally suspenseful!! Buckle up when you read this book.

Nora St.Laurent
Book Club Servant Leader
Novel Review www.novelreviews.blogspot.com

WARNING: After reading "Informed Consent" you will NEVER look at Doctors and nurses the same way again. After all they are just humans like the rest of us right? I know there is office politics in whatever work environment but when you read about what goes on in the inner workings of a hospital it makes you a little sick to your stomach.

When Hospital personnel make mistakes on the job or don't follow procedure or don't get "INFORMED" consent patients are put at risk and some die. Sandra definitely explores how some doctors try to get around "Informed Consent" and what that means to the patients.

How is the cure for AIDS going to be found? Sandra reveals one way; thru that of a Dr./Researcher who is personally motivated by personal tragedy to find a cure for what killed his father but not himself. Could finding the cure for his fathers death lead to a break thru the whole world is looking for? It could happen!

Parts of this book were medically wordy. Some where stressful to read because it dealt with children and possible medical mishaps that put them in harms way. Then there were other parts of the book that were fast paced - thrilling and emotionally suspenseful!! Buckle up when you read this book.

Nora St.Laurent
Life Way Book Club Leader

I almost didn't accept this book to review as I had SO many to read, but the subject matter intrigued me. Now I'm glad I took this book on. I'll tell you why...Informed Consent is one of the most emotional, suspenseful, intelligent, and exhilarating stories I've read in a long time. The up-close look into marriage issues, grief and loss, and biomedical/ethical subject matter makes me rank this amazing novel as one of the best I've read this year. It is SO obvious that the author did a lot of research and she addressed the subject with insight and compassion. This story moved me to tears numerous times.

In some ways Informed Consent--which is a perfect title for the story--reminded me of a movie I watched starring Denzel Washington. In the movie he was stuck in an impossible situation and yet found a way to fix the problem. His solution was totally insane, but it sure made you think about the desperation people feel when they long to save a loved one, but face seemingly impossible barriers along the way. Informed consent tackled some really tough issues with finesse.

I'm reluctant to share much detail regarding this awesome novel because it's very suspenseful and I don't want the reader to miss out on the anxiety-provoking twists and turns by tipping them off to some of the dilemmas and solutions. But I will say that this story not only provokes intelligent thinking, but it makes you ponder spiritual issues as well. I am thoroughly impressed by the quality of the plot, the author's incredible "voice", and the pull this story had on me. I can't say enough good things about it, but I will say that from this point forward I intend to read EVERY book Sandra Glahn writes.

Glahn is a superb researcher and it shows in this fine novel. The characters are real, the situations from today's headlines and readers will be thrown into the ethical debates and struggle with coming to their own conclusions on the matter. She is a great writer and one to watch. She gets better with each novel.

An intersting book that presents a lot of legal history in regards to health care decision-making. Chapter 13 is a real eye-opener!

American culture is unique in its emphasis on individual liberty and freedom of choice. In "Some Choice" George Annas brilliantly shows how these values have taken precedence over others as important, for example, equality, justice and solidarity, and how the liberty rhetoric has undermined the very essence of that which it intends to promote.

I am fortunate enough to actually have been taught by the writer of this book, Professor George Annas, who is also the chair of the Health Law Department at the School of Public Health at Boston University.

Besides being a prolific writer, the man is gifted with an incredible legal mind and the soul of a humanist. As such, he is well equipped (and well regarded in the fields of health law and medical ethics) to briefly discuss the challenges, ethical dilemmas, and basic problems in a number of contemporary topics that currently provide us with no clear answers. The book provides a good overview of some of these topics, like tobacco control, medical research involving human beings, the true extent of choices involving one's "right" to die, and AIDS and TB.

The true shock (which reads more like an "X Files" storyline than anything real--I hope) is Chapter 13: "Our Most Important Product." The book price is worth getting just this one chapter; I won't ruin the surprise for you, but let's just say that, if you're like me, after reading this chapter you'll be running periodic Internet searches to see if anything related to this story comes up. (And wondering if the FBI, CIA, or other governmental agency is watching my searches.) Read it for yourself and then decide: Truth? Fiction? Is the Truth stranger than Fiction?

As always, a thoughtful "kick in the butt" by Professor Annas, who consistently and skillfully forces us to face the difficult issues plaguing our medical research and technological advances.

I would recommend this book to anyone who is thinking about entering a clinical trial. Research Studies are valuable tools for learning about diseases, and sometimes the only way to find a cure for a disease. But you have to understand to risk and side affects associated with them. This is a must read book for the researcher, doctor, and patient alike.

This is a very good critique of the rationale for and present practice of using informed consent in research and clinical practice. To some extent, this book is a sequel to O'Neill's prior work on bioethics. In her Autonomy and Trust in Bioethics, O'Neill presented a very effective critique of the reliance on the concept of autonomy and the nature of the concept of autonomy used in clinical and research ethics. O'Neill argued well that the reliance on the principle of autonomy was poorly formulated and contributed to erosion of trust. In the present book, O'Neill and Manson provide an effective critique of the conventional informed consent approach and present a conceptual alternative. Manson and O'Neill argue that the present informed consent doctrine exhibits a misplaced emphasis on autonomy, is practically difficult, and leads to neglect of ethically necessary aspects of communication between physicians/researchers and patients/participants. They suggest that the present model is based on a "container" approach to delivering information that has major defects. Manson and O'Neill present a model of informed consent based on a "waiver" of specific obligations and rights and an "agency" model of the consent process which tries to stress the full spectrum of requirements for effective communication. This model is extended to some related issues like data privacy and genetic issues in a rigorous way that produces recommendations at variance with present practice. Manson's and O'Neill's critique is carefully developed and convincing. The major drawback of this book is that it is theoretically strong but the authors' suggestions for concrete changes are quite modest. Regardless, the arguments developed in this book are much more rigorous and well founded than those found in the great majority of the bioethics literature.

Undue Risk: Secret State Experiments on Humans by Jonathan D. Moreno

This very readable book faces the uncomfortable reality of using humans for medical experiments. Government secrecy is corrosive to democracy, and is a true threat to our way of life. The use of human guinea pigs shows something rotten at the heart of society's political rulers.

Chapter 5 tells about radiation experiments. There was a need to study the health risks from inhalation or ingestion to determine the toxic levels. Releasing radioactive products into the air was part of deliberate policy that occurred hundreds of times (pp.153-4). Chapter 6 tells how the Nuremberg Code was adopted for testing ABC weapons (p.166). This rule prevailed in the civilian hierarchy but lacked traction in the military medical culture (p.184); this reflected the political struggles (p.187). Chapter 7 tells of the experiments with hallucinogens as a military secret weapon during WW II (pp.190-1), and afterwards. The Blauer Case tells how state hospitals' experiments killed patients (pp.194-8)! Scanty record keeping on atomic bomb explosions was continued with Agent Orange in Vietnam (p.206). The known dangers from uranium mines were disregarded by the AEC (p.221). Uranium miners fate was to die in their forties for reasons of national security (p.226). After Nuremberg, only America among Western countries experimented on prisoners (p.230).

Chapter 8 tells of the attacks on the Nuremberg Code rules. Pages 252-3 tell why it is legal to experiment on members of the Armed Forces: the Supreme Court said so! Nerve gas experiments were suspended in 1969 (p.263). President Nixon asked for the ratification of the 1925 Geneva Accord to prohibit the first use of biological and chemical weapons. The1977 Senate hearings on the biological testing program resulted in new ethics of research for government agencies (p.265). Chapter 9 tells of the 1991 Gulf War aftermath: many veterans reported illnesses. One explanation was the drug alleged to protect our soldiers caused this problem. PB was never tested or approved, so its use was reckless and a poor experiment (p.269). Pyridostigmine bromide was never approved against chemical weapons (p.270). The FDA created an exceptional "Rule 23(d)". Did PB react with organophosphates to create harm (p.272)? The lack of records prevents any investigation. The last section on '91 Bravo' reads like a very optimistic and cheerful ending to this story.

Undue Risk is a clearly and meticulously constructed documentation of over 50 years of medical and military experiments world wide, with an emphasis on those done in the U.S. It is one of the most important books written on the subject, and it is a must read for anyone concerned about the ethics and interests of government.
Moreno limits himself to information that is documentable. He focuses on the medical community as handmaidens to the military establishment. For example, his thorough and horrific accounts of Dr. Ishii's murderous medical experiments on thousands of helpless captives during WWII in Japan, and his grim comment that despite his criminality, Dr. Ishii today enjoys high social status and wealth, partially due to intervention by the United States, are a testimony to Moreno's clear insight into the pervasive nature of intellectual greed and the grand cover-up of government when it wishes to acquire knowledge.
It is unfortunate that Moreno could not cover the misdeeds of the neuro-sciences. But with the neuro/psychopharmacological arsenal of amnesiacs, sedatives, ECT, and hypnosis it is difficult to find those survivors who can clearly articulate the tale of what was done to them in the name of science. To his credit, Moreno does refer to the CIA's MKULTRA experiments, and gives a nice insight into the LSD death of Fort Detrick's Dr. Frank Olsen, who specialized in airborne delivery of disease as a biological weapon. This book is a must read. It is aurhoritative, restrained in nature, but completely accurate.

I used to work at an ethical review board, and I read whatever books I could find on medical research ethics. This is the most memorable one I read. It was shocking but fascinating. I would recommend this book to anyone working in clinical research or medical ethics.

Undue Risk: Secret State Experiments on Humans by Jonathan D. Moreno

Calling chemical warfare "weapons of mass destruction" is misleading since they are more limited than atomic or biological weapons. Biological weapons can turn against their users. Only atomic weapons have enormous destructive capacity (p.xv). The Advisory Committee on Human Radiation documented secret experiments on humans from WW II to the present day. Biological warfare goes back to ancient times: placing decaying bodies into a water supply or launching them into a besieged fort. There is much more known about biological and chemical weapons today than before 1992. Government secrecy is corrosive to democracy, and is a true threat to our way of life. The use of human guinea pigs shows something rotten at the heart of society's political rulers. This very readable book faces the uncomfortable reality of using humans for medical experiments.

Bacteria and chemicals are hard to control and deliver effectively but relatively cheap to produce and transport. Testing on humans has a long international history, as is hiding these facts (p.4). The Nazi doctors trial at Nuremberg set a standard for military-medical human experiments. Hundreds of other doctors were never tried. A "crime against humanity" was defined as the reckless pursuit of scientific knowledge, or sheer sadism. Experiments on humans predated the Nazis; in 1931 the powerful chemical manufacturers were caught using patients in hospitals (p.64). Then there was America's own wartime research (pp. 65-6). But America was not riddled with a hate-mongering pathology that permitted the systematic injury of certain groups of humans (p.79).

Chapter 4 tells of Nazi scientists brought to America because of their expertise. They now used American soldiers rather than concentration camp victims (p.89)! Similar experiments were done by Japanese Unit 731 (pp.103-7). Their history was kept secret to protect Army biological weapon testing at Fort Detrick, whose budget was second to the Manhattan project (p.109). The US military wanted this information on crop destruction and human experiments. A Soviet war crimes trial documented these facts (p.111-4). Germ warfare charges in Korea and China are discussed on pages 115-6.

Mr. Moreno's stunning account of experiments done by the Nazis was very interesting. His great writing made the book a page turner and I applaud Mr. Moreno for writing it. I am looking forward to reading more of his books.

After reading Neil Ravin's Informed Consent, my first question is, where was the editor? Generic drugs are capitalized, trade names are not, medical slang is misspelled. This tale of a doctor in a research-oriented university hospital has many promising elements, but they just aren't developed well enough to make a good book. The subplot involving the investigative reporter could have been intriguing but instead is ho-hum; why tell us the contents of her well-stocked medicine cabinet without disclosing her need for the many heavy-duty psychotropics? Unlike the characters in Ravin's earlier M.D., these doctors are poorly defined and sort of blur into each other. The noncompliant, hospital-hating patient does get our sympathy, and the details of the medical detective work involved in identifying his disease are interesting, but I found the book to limp along without the spark and freshness of M.D.

A book which was written before ER, more than ten years ago, which seems very current in its unpretentious voice and its fast pace. It's a little like a precursor to ER, but it's set in a research hospital, and it follows a doctor in the last phase of his training as he struggles with the demands of producing new knowledge and the difficulties of extracting this knowledge from the suffering of real, individual, often very likeable patients. There is a detective story aspect to the central "case" in the book, and if the hero/doc doesn't solve it correctly, the patient will die. The hero makes mistakes, goes down blind alleys, but his relentlessness eventually brings him to the answers his patient often resists. There's a lot mixed in here: implied problems in medical ethics, the hunt for deep, explosive killer diagnosis, the politics of university hospitals and research grants. In the end, it comes down to finding the answer in a single patient, and what it means for him and for his family

Mr. Byrne's wife must not have gotten a decent settlement from the bankruptcy decision against Dow Corning, so he had to write this expose of the corruption that was rampant in the synthetic chemicals industry that produced the deadly silicone breast implant.

The problem is that, even though the plaintiffs' attorneys were successful in proving to the court that silicone breast implants caused every illness from fibromyalgia to lupus to lymphoma, NO CREDIBLE SCIENTIFIC STUDY ever successfully identified an increased incidence of any disease associated with breast implants.

Mr. Byrne doesn't have the luxury of recognizing this fact. Having blown the whistle against Dow Corning, and I suspect having received triple damages for doing so, he is committed by his past actions to believing until his dying day that there was a conspiracy in the satanic halls of corporate America to destroy the female half of our species (at least the utterly vain and vapid subpopulation of women) by implanting deadly time-release silicone bombs in their [...].

The above book by PJ Weindling was given a very favorable review in the Journal of the American Medical Association.
I bought the book several months ago and have read only 185 pages so far.
Very tedious reading. Author mentions lots of names and gives loads of info about the various MDs investigated for medical war crimes. However, he tells us very little about the actual experiments conducted by these physicians and other scientists. We are told that there were experiments in high altitude physiology, cold water tolerance, and infectious diseases.No details about the experiments are presented , at least in the first 185 pages. Some details about the actual experiments and results would be very interesting. Other than the fact that concentration camp inmates obviously did not give consent and most likely suffered greatly from these experiments, there are few other details.

The writing style often makes it difficult to read more than a few pages at a time. Often particular phrases and words are repeated unnecessarily.

A more interesting book about Nazi doctors is "The Nazi Doctors" by Psychiatrist Robert Lifton. He actually interviewed a number of German physicians who were assigned to the concentration camps and other killing centers such as the Psychiatric hospitals.