Bioethics Discussion Blog: July 2005





Sunday, July 31, 2005

“Better Dead Than Disabled”: Bad Date and Bad Balance

To be fair, I should give an opposing view to the entire PBS presentation on the suicide issue particularly with regard to the date and the philosophy of the initial broadcast. So here is a
press release by Steven Drake of Not Dead Yet on the eMediaWire. I must say, however, that my postings about the film was about the presentation of personal character of a man, how he rationalized his suicide decision to his family and not about political issues. ..Maurice

Disability Activists Blast PBS for ADA Anniversary Promotion of Better Dead than Disabled Film

Disability activists blast PBS for choosing to air a "better dead than disabled" documentary on the anniversary of the Americans with Disabilities Act.
For Immediate Release

(PRWEB) July 25, 2005 -- In an all-too-common feat of cultural insensitivity, PBS has chosen July 26th, the anniversary of the signing of the Americans with Disabilities Act (ADA), to air “POV: The Self-Made Man.” The documentary features the videotaped statements of Bob Stern, an elderly man deciding to commit suicide rather than face possible disability, medical uncertainly or complications.

“The choice of this particular air date is an affront to people with disabilities in this country,” says Diane Coleman, president of Not Dead Yet, a national disability rights group based in Forest Park, IL. “The 15th anniversary of the ADA is, for people with disabilities, the nation’s largest minority, what the Civil Rights Act of 1964 is for people of color. Not only is it being ignored by PBS, but the network is featuring and promoting a program about a person so terrified of aging and disability that he commits suicide. In terms of sensitivity to diversity issues, this puts PBS in the same league as the Fox News Channel. And, no, that is not a compliment.”

Stephen Drake, research analyst for Not Dead Yet, notes that the film is a slanted portrayal of the broader issues. “Normally, we don’t comment when a rich, privileged guy decides to take his own life. We didn’t comment when Hunter Thompson shot himself. After all, Thompson wasn’t asking for a change in the law, a permission slip, or help from anyone.”

Drake says the situation is different with “The Self-Made Man.” “It’s being promoted as a tool for adding to the public discourse in regard to assisted suicide, an issue confronting the U.S. Supreme Court and legislators in California," he said. "Whether society will treat some suicidal people differently than others is a public policy issue. The film, however, frames the issue as a dispute between religious conservatives and those who “believe in autonomy.”

Coleman and Drake say this ignores the fact that secular disability rights groups have been at the forefront of opposing legalization of assisted suicide. Twelve national disability groups filed an amicus brief supporting the Attorney General in the Gonzalez v. Oregon case currently before the Supreme Court.

Moreover, disability opposition is well known to the official “advisors” to the documentary. Three out of the four credited advisors to the program are long-time assisted suicide/euthanasia advocates: Paul Spiers, ex board Chair of “Compassion and Choices;” Margaret Battin, advisory board of the Death with Dignity National Center; and Dennis Kuby, ex-regional director (California) of the Hemlock Society. These “advisors” could have advised a truthful portrayal of the policy debate, including disability opposition. “Obviously, balance is one thing producer Susan Stern wasn’t looking for,” says Drake.

Stephen Drake 708 209 1500 ext 29
Diane Coleman 708 420 0539

Rational Suicide Considered: "Fire in the Belly" and Whose Quality of Life?

I watched last night the PBS “Point of View” presentation of the film produced by the daughter of Bob Stern. As you may recall from my July 25th posting, Mr. Stern videotaped his explanation to his family of his intended suicide. His son and wife were present to listen and argue. The suicide was completed by the next morning. The film was very interesting and enlightening since most people who commit suicide never openly discuss their rationale, in detail, to their family in advance of their act. The film provided a extensive look into the life a man who tried to be in control of his life throughout the years and insisted to be in control up to the end when he found he was losing control because of the medical problems of an earlier stroke and then cancer of the prostate and finally scheduled surgery for an abdominal aortic aneurism.

The question is whether his death represented a “rational suicide”, one based on a thought out decision considering the gains and losses, as he had always done in his business life, but without an underlying mental depression to sway that decision. After reviewing the film, I find it difficult to define Bob Stern’s act as fully thought out and free of depression. First, I truly doubt some clinical depression was not present despite his fairly upbeat appearance that he had made a clear thinking analytical decision. He talked about losing the “fire in [his] belly” which had provided the drive for many of his previous business and personal accomplishments. Couldn’t this comment suggest underlying depression?

Further, and this is a consideration I would like my visitors to discuss, should a “rational” decision for suicide be made only with regard to the individuals own “best interest” as he described it and not include the best interest of the caring family? It seems Mr. Stern had developed through his presence, attention, interaction and love over the years a concerned, loving and in a sense dependent family. Yet, their need for him seems to have been disregarded in his analytical balancing of his life account as he worked out his decision. Should his considerations of quality of life, as he called it, have been limited only to his own or should he have considered the quality of life of his family with him gone? It is because of these points that if there is such an act as rational suicide, I don’t believe that Bob Stern’s death qualifies. What do you think? ..Maurice.

Thursday, July 28, 2005

In the UK Physicians trump Patients: No Artificial Hydration/Nutrition

From today’s BBC News website: Patient loses right-to-food case

The General Medical Council has won its appeal against a ruling which gave a seriously-ill patient the right to stop doctors withdrawing food and drink.
Leslie Burke, 45, who has a degenerative brain condition, fears artificial nutrition could be stopped against his wishes when he cannot talk.
Mr Burke, from Lancaster, had won a landmark ruling, supporting his right to artificial nutrition and hydration.
But the GMC appealed, saying doctors could be put in an impossible position.

On the original May 24, 2005 posting on this blog describing Mr. Burke’s wishes, the previous ruling and the appeal by the General Medical Council, I expressed the following view:

My view is that unless the artificial nutrition and hydration is physiologically futile, which it rarely is, whether this specific treatment is started or removed should be the patient's own decision after comparing the risks vs the quality of life to be gained. I think food and fluid decisions should be that of the patient and in all cases requests should be followed by the healthcare providers. There may be medical resistance to starting other life-supporting treatments if the physician finds the medical benefit to be nil, such as beginning dialysis in a terminal cancer patient. There may be special circumstances, such as temporary prolongation of life, which would make starting them appropriate. All life-supportive treatments should also be stopped at the patient's request. Beyond life-supportive treatments, other treatments requested by the patient should be subject to medical standards of practice.

Wednesday, July 27, 2005

Suicide: "No Way to See What Your Last Sorrow Hid"

This poem which I found on Poems for Free puts into a poetic verse the very view that I commented on in my last posting. Those who know the suicide victim and even those who only hear about the suicide, usually feel a sense of guilt for someone not doing something to prevent the act. I suspect often, unlike the Bob Stern case decribed in the last post where Mr.Stern discussed openly his anticipated act with his family on a video, there is at times no unambiguous warning or explanation to those who know the victim or society itself. For more poems about suicide, go to the above link. ..Maurice.

"There's No Understanding What You Did" by
Nicholas Gordon

There's no understanding what you did,
Or why, or what we now should think or do:
No way to see what your last sorrow hid.

What unimaginable agony amid
Our ordinary lives unraveled you?
There's no understanding what you did,

No way for you to tell us why you rid
Yourself of us and family, and . . . who?
No way to see what your last sorrow hid.

Or was it you were just a spoiled kid,
Trying to make us all feel bad for you?
There's no understanding what you did,

Whether mere curiosity had bid
You to sneak ahead a lethal view;
No way to see what your last sorrow hid,

Nor penetrate that awful, granite lid
That lies between our thoughts and what is true.
There's no understanding what you did,
No way to see what your last sorrow hid.

Monday, July 25, 2005

“Rational Suicide” or Is It Depression?

“Bob Stern always was a fiercely logical thinker, and he made the decision to die with the same unflinching reason that had governed his life.
He explained the process to a video camera he set on a tripod in his living room.”

The comments above is from the story of Bob Stern and his family and his self-inflicted death in
“One man's defense of his own suicide
Documentary looks at his 'rational' act” by
Reyhan Harmanci, staff writer of the San Francisco Chronicle in today’s edition

I present this resource now as a followup to the July 16, 2005 posting here on assisted suicide in which commentator Bob Koep discusses the concept of “rational suicide”.

This issue is also discussed in the Chronicle article with comments by Hemlock Society founder Derek Humphrey who is quoted "Elderly suicidal people recognize that life has run its course and if that's what the person wants…" Whereas Wesley Smith, an opponent of assisted suicide, is quoted "If you end up with a public policy around rational suicide, you might as well throw suicide prevention in the trash…If a mental health professional gets in the business of stamping suicide, it's abandonment."

My question: Does the fact that a person requests “assisted suicide” makes the diagnosis of depression since the person is “asking for help” and if the person such as Bob Stern shoots himself in his head, this act makes a diagnosis of “rational suicide”? Or should we just forget about the term “rational suicide” since all suicide represent mental irrationality of one sort or another?. ...Maurice.

p.s.- Thanks to Alyssa Uphoff for referring me to this article.

Sunday, July 24, 2005

Is an Ideal Physician a Simple Physician?

Maybe to some patients the ideal physician is simple physician. At least that is the impression given by Wystan Hugh Auden in his poem below. ..Maurice.


Wystan Hugh Auden (1907-1973)

Give me a doctor partridge-plump,
Short in the leg and broad in the rump,
An endomorph with gentle hands
Who'll never make absurd demands
That I abandon all my vices
Nor pull a long face in a crisis,
But with a twinkle in his eye
Will tell me that I have to die.

(Resource for the poem is and noted “This poem is thought to be in the public domain”)

Saturday, July 23, 2005

Praying and Illness: The Jewish Attitude

Continuing on with the thread of the role of prayer in medicine, the following is an extract from a paper in the Mount Sinai School of Medicine Journal nr2,vol 66, p 102-105, March 1999 titled
"Complementary Therapies and Traditional Judaism" by Fred Rosner, M.D. Prayer appears to be considered as a complementary form of treatment since “the healing powers of God was never allowed to usurp the essential functions of the physician and of medical science.” Read the entire paper, which includes, in addition to prayer, discussion of the views in Judaism regarding amulets, astrology, medical charms an incantations, nostrums, quacks and quackery. ..Maurice.

At one time or another, most human beings offer prayers for the relief of their own illness
or that of others. These prayers may differ in content and in the manner in which they are offered,
by both religious and non-religious people (1). Recourse to prayer in Judaism during illness is not
necessarily an indication that the person lacks confidence in traditional medical therapy.
The patriarch Abraham prayed for the recovery of Abimelech (Genesis 20:17), and God
healed him. David prayed for the recovery of his son (II Samuel 12:16), but his son died. Elisha
prayed for the recovery of the Shunamite woman’s son (IIKings 4:33), and the boy recovered. King
Hezekiah prayed forhis own recovery (IIChronicles 32:24), and God added 15 years to his life. The
shortest healing prayer on record is the famous one uttered by Moses for the recovery of his sister
Miriam, who was afflicted with leprosy. Said Moses: El na r’fa na la [O God, heal her, I beseech
thee] (Numbers12:13),and she recovered. These incidents are anecdotal andhence donot constitute scientific, statistical evidence for the efficacy of prayer, but they are certainly worthy of mention.
One should never be discouraged from praying, even under the most difficult and
troublesome conditions. The Talmud says (2) that “even if a sharp sword rests upon a man’s neck,
he should not desist from prayer.” On the other hand, a person should never stand in a place of danger and say that a miracle will be wrought for him. One should not count on being cured by
direct intervention by God without first having sought out the advice and treatment offered by
conventional human medical practitioners. The Jewish attitude toward prayer is succinctly summarized by Jakobovits (3) as follows:
.while every encouragement was given for the sick to exploit their adversity for
moral and religious ends and to strengthen their faith in recovery by prayer,
confidence in the healing powers of God was never allowed to usurp the essential
functions of the physician and of medical science.

1. Rosner F. The efficacy of prayer: Scientific versus religious evidence. J Relig Health 1975;
2. Rosner F. Medicine in the Bible and Talmud. 2nd ed. Hoboken (NJ) and New York: Ktav and
Yeshiva University Press; 1995. pp. 204–210.
3. Jakobovits I. Jewish medical ethics. New York: Bloch Publishing Co.; 1975. pp. 15–

Friday, July 22, 2005

Science and Religion:Making a Good Medical Decision

Beyond the issue of physicians praying with their patients, either initiating or on request, there is the issue of the relationship between science and religion with respect to principles of patient autonomy and physician beneficence in patient care. In a survey of physicians on this matter, Farr A. Curlin, M.D. et al, writing in the Jan 10 2005 issue of the Archives of Internal Medicine come to this conclusion:

“There is no bright line that can be drawn between discussion of medicine and discussion of religion. Therefore, when conflict occurs, moral (ie, religious) counsel inheres in medical recommendations. Science tells patients what they can do, but physicians also tell patients what they should do, and the latter is always a moral exercise. If religious advocacy is a threat to patient autonomy, one must ask whether autonomy is not equally threatened by challenges to patients’ ideas of religious faithfulness, whether or not they conflict with medical evidence.

Our findings suggest that physicians always navigate a balance between respect for patient autonomy (remaining open-minded and flexible) and concern for the patient’s good (persuading the patient to adhere to recommendations). That navigation will always be guided by the physician’s sense of what "the good" is. Rather than striving for illusory neutrality, physicians should practice an ethic of candid, respectful dialogue in which they negotiate accommodations that allow them to respectfully work together with patients, despite their different ways of understanding the world.”

I would agree that the physician’s recommendations (what the patient should do) does carry a moral potential since should is not necessarily free of moral opinion. The practical issue in medical practice is unfortunately there doesn’t often appear to be enough time (or skill or motivation?) for physicians to “negotiate accommodations” and the patient is left with what seems as a paternalistic type of physician advice and the physician may be left with impression that the patient is being unrealistic and stubborn. What is the solution to the issue? Those patients who have significant decisions to make should be scheduled for more of the physician’s time. Physicians should also be aware of the potential conflict between religion or moral beliefs (physician’s and patient’s) and the science of medicine. If the physician feels insecure in the art of mediation, well.. this would be something to learn as part of continued medical education. ..Maurice.

Wednesday, July 20, 2005

Praying With the Patient: The Ethics of One Physician’s Action

Writing in “A Piece of My Mind” section of the Journal of the American Medical Association JAMA. 2001;286:1291-1292. Bruce D. Feldstein, MD told about his experience, while covering for a another doctor, with a patient Mrs. Martinez, who had metastatic lung cancer, previously treated, whom he now had to tell that a current CT scan showed metastases to the brain. She was overwhelmed by the news and described the information “a death sentence.” When it appeared that his statements of reassurance did not help, on seeing a crucifix around her neck, he considered that praying together would be best he could do for her at the time. When asked, the patient agreed. This was the first time in his career that he had considered praying with his patient. He was Jewish, she Catholic. He had concern what the words of the prayer should say. He finally led the simple prayer:

"Oh, God, You Who are the Great Healer."
"Who guides us through life,"
"In your wisdom . . . "
". . . may you guide [patient’s oncologist] and all the other doctors and nurses to provide the best care."
"Provide us all with Your comfort and guidance . . . "
"Thank you for hearing our prayer."

and it ended with her tearful “thank you.” Later, out of concern about the ethics of what he had done, Dr. Feldstein discussed his action with an ethicist and Dr. Feldstein writes:

[The ethicist] and I looked at it in terms of core ethical principles: to do good (beneficence), to do no harm (nonmaleficence), and to respect a patient's autonomy. We examined it in terms of the duties of truth telling (veracity), loyalty and putting the patient first (fidelity), of confidentiality and privacy. We contemplated the virtues of compassion and professionalism. We reflected on the goals of a physician to relieve pain and suffering and to provide comfort, as well as the value of the Golden Rule: "Do unto others as you would have them do unto you." A prayer that is supportive and comforting for the patient, that has his or her permission, and is mutually respectful is ethical. One that is proselytizing, coercive, and unrealistic is not.

As [the ethicist] discussed, the prayer was appropriate on all counts. "Your intentions were ethical," he said, "to tell the truth and to provide comfort, what physicians pledge to do. Mrs Martinez asked you specifically for the test results. You answered truthfully. You were aware how your pronouncement could provide harm and suffering and you followed the Hippocratic principle First, do no harm. Conventional medical, psychological, or philosophical explanations were insufficient or problematic, so you considered a spiritual approach. Prayer is a tremendous source of comfort for people who are prayerful. Although new for you, in the world of spiritual care, offering a prayer is as straightforward as recommending an antibiotic.

"A physician praying with a patient may not be standard practice," he went on, "but this does not make it unethical unless you do not have the permission of the patient or if you conducted your prayer in an unethical way. You identified a cue—the cross—that it would be appropriate to offer a prayer and trusted your deep intuition and judgment. You could have called a cleric if one was available, but then there is the question of timing, to make the right intervention in the right moment. You asked her first if she was a prayerful person. She said yes. Only then did you ask her if she wanted to have a prayer together. She could have said no. You found a common language. You did not tell her what faith to have and did not pray for a miracle."

I was satisfied that that as a physician, praying with Mrs Martinez was right.

Note: The above link to the full text may be available only to subscribers or those linking via a library computer. ..Maurice.

Tuesday, July 19, 2005

Should Physicians Pray with Their Patients?

My wife, who is a nurse at a local hospital, told me today about a internal medicine physician who is Christian asking his patient, an ill man who is Jewish, whether it would be acceptable to the patient for the doctor to pray for him and his recovery. The patient said it would be OK. My wife was surprised about the idea that a doctor would initiate an offer to the patient to pray rather than the other way around and particularly a patient of a different faith. I told her that I think it is a bit unusual because my understanding from my reading is that it would be the patients who might ask their physicians to join them in prayer. And then comes the moral decision for the physician whether to accept the invitation. What does praying with the patient really imply? And what might it apply if the physician initiates the request? Should more doctors do it as part of making an professional connection with the patient?

In an ethics address delivered to the 169th semi-annual scientific meeting of the Texas Surgical Society in April 2002 in Tyler, TX. by Michael D. Dent, Dmin, Tyler, Tx,the senior pastor of Marvin United Methodist Church and chair of the ethics committee of Trinity Mother Frances Hospital talked about ethical behavior of surgeons and you can find the whole talk recorded on the website of the American College of Surgeons. Here is the portion of the talk which is pertinent to physician offering prayers.

Two different people have asked me the same
question in the past month: “Have you ever heard
of a doctor praying with the patient before surgery?”
The inquirers were surprised that a surgeon
would do such a thing. There are some ethical
issues in that practice of prayer. Is it offered as
an option to the patient? Is it directed at persons
of no faith or a faith different than the physician’s?
Is it a person in power taking advantage of a person
who is vulnerable? Such prayer could be very
appropriate or tremendously inappropriate, depending
on the answers to these types of questions.
Nonetheless, there is something special, sacred,
and spiritual about the process of surgery, something
that is inexplicable—not magical, but certainly
In a chapter with the intriguing title, “The Snake
and the Saints,” Albert R. Jonsen, PhD, writes:
We frequently hear that physicians “play God”
when they make decisions about life and death.
The phrase is supposed to suggest arrogance. Yet
it is a dim echo of the ancient beliefs that in all
healing, God is active. The rabbis of ancient Judaism
justified the use of physicians by proposing
that they healed by the power of God. Ambroise
Paré, the father of modern surgery…adopted the
motto, “I treat, God heals.” In a more secular era,
the flippant phrase “playing God” is about all that
remains of that ancient belief. Yet with it we remind
ourselves of the mystery of medicine.4
Call it an awesome ambiguity or a miraculous
mystery, surgeons represent the source of beneficence,
healing, and hope in the eyes of many they
treat. Patients entrust their lives to finite and fallible
physicians with the expectation to be treated
with care, competence, and compassion.
Here is an example of how surgery is perceived
as a divine act, a sacred task. It was presented by
a member of the church that I pastor. This 72-yearold
man was recently hospitalized for seven
weeks—in and out of the surgical intensive care
unit following several delicate surgeries and two
weeks in rehab. These are the first words he
penned to his pastors on a thank you card: “People
pray for miracles and God sends his doctors to perform
Hands are holy. Surgery is sacramental. Medicine
is miraculous for many on the receiving end.
They see the good done as a gracious reflection of

Any thoughts? ..Maurice.

Graphic: Photo I took of a sign at a local church 6-11-2012.

Saturday, July 16, 2005

Assisted Suicide: Who Should Assist? Should It Be Done?

Should there be laws in the United States that permit assisted suicide? Well, in a recent posting elsewhere, I expressed my views against physician participation and wrote: "I think that assisted suicide, if it is to be accepted by all states be accomplished by trained and certified technicians with legal access to specific death drugs. No physician participation should be involved except for diagnosis and prognosis."

Bob Koepp read that comment and wrote me the following:

I think all we know about human nature suggests that "certified technicians" who specialize in killing will demonstrate considerably less reticence about exercising their "craft" than would ordinary citizens in intimate relationships with those seeking death. Most friends and family members who are asked for such assistance try very hard to dissuade the "seekers."

IF the "seeker" was motivated by concerns related to medical questions, consulting a physician would be appropriate. But I think that people might have sound reasons for seeking death that are not medical in nature, which would not be reflected in a physician's diagnosis and prognosis.

I responded with:

What if there were regulatory laws as currently in Oregon by which the two physicians would have to screen the patient for depression and also to provide the technician (and patient of course) with a dx and prognosis and suggest any approaches to the symptoms without need for suicide. Finally, if all the I's are dotted and T's crossed, it would be up to the technician to make the final decision as to whether to grant the patient's request for assisted suicide. The main point here is that the final decision for prescribing the patient the deadly pills would not be up to the physician but up to the tech who will know and obey the law. ..Maurice.

And Bob responded with:

Someone should conduct the following experiment (please excuse the deception -- it's necessary). Take two groups of randomly selected physicians. Those in Group A are approached by patients who say they want to kill themselves, but don't ask for any assistance. Those in Group B are approached by patients who also say they want to kill themselves, but do ask for assistance. How do the physicians respond to these different patients?

Quite apart from such an experiment, I don't think physicians are all that good at diagnosis and prognosis, and setting them up as gatekeepers to "legitimate" assisted suicide invites problems. Physicians no less than the rest of us are prone to letting their prejudices influence their judgments. A physician who believes strongly in the "rightness" or the "wrongness" of assisted suicide will be inclined to interpret signs and symptoms in a way that comports with his/her prior convictions. Word gets out about which physicians are more likely than others to support requests for assisted suicide, and it is to these physicians that people seeking such assistance will turn. Where's the objectivity in such a system?

I understand and share your concern with preventing suicides, the vast majority of which seem to me to reflect serious depression or desperation born of ignorance about viable alternative courses of action. Only a very few suicides seem to me to be likely candidates for classification as "rational suicide," and only a few of these few involve any sort of request for assistance. And then, as I mentioned in my previous message, even among these "few of the few," those approached for assistance are often unwilling to provide such assistance, even though the person making the request might have good reasons for wanting to die.

I would actually go further, and suggest that the mere fact that a would be suicide seeks material assistance should often be interpreted as a call for help of a different sort, since it is very rare indeed that such assistance is actually necessary to the performace of the deed. For how many of the suicides so far "assisted" in Oregon, the Netherlands, Belgium, Switzerland... was the person actually incapable of killing him/herself? How many people, whether or not they actually _needed_ assistance, when once supplied with effective means to end their lives have then not put them to their "intended" use? With respect to those who don't use the means provided, I think the natural conclusion is that they didn't want to kill themselves so much as they wanted to feel some sense of control. Did the physicians who screened them misdiagnose?

In short, I think there are very, very few cases where assisting in a suicide could withstand critical scrutiny. But in recognition of those very, very few cases, I think assisted suicide should be decriminalized.

Creating a new body of law to "legalize" and "regulate" the "practice" of assisted suicide, provides a patina of respectability to "following the rules" in an area that probably is beyond the reach of general rules. And I persist in my belief that when we explicitly recognize a separate class of "workers" with a special "expertise," those workers become _more_ inclined than the rest of us to engage in the activity in question, and _less_ reflective and _less_ critical of their own actions. Rather than regulating assisted suicide, I think every purported assisted suicide should be critically scrutinized for any evidence that those providing assistance have negligently endangered another's welfare, or worse, have intentionally acted contrary to the interests of another. We already have laws against such behavior, whether it involves suicide or other activities.

Bob Koepp

I would like to read what other visitors think about assisting a suicide attempt either in the context of a suffering patient or in any other situation. Specifically, should any assistance be necessary? As Bob noted: “I would actually go further, and suggest that the mere fact that a would be suicide seeks material assistance should often be interpreted as a call for help of a different sort, since it is very rare indeed that such assistance is actually necessary to the performance of the deed.” Well, except for a quadriplegic who wanted to die, I suppose that is true. Anyway, what do you think? ..Maurice.

Wednesday, July 13, 2005

Bioethics Discussion Blog: One Year Old

July 8 2005 was an important date for me. That date represented the one year anniversary of this blog. I wasn't really sure what I was getting into when I decided to start but I am not disappointed nor am I, so far, exasperated or overwhelmed. Since the beginning I have written about 200 posts. I have tried to cover many different aspects of bioethics (primarily medical bioethics), medical professionalism and medical education. Though discussion of most of bioethics, I think, should be devoid of a guiding political ideology but based on established and accepted ethical principles, some of my posts have clearly shown my political viewpoints when discussing governmental decisions. I have tried to keep the presentations, in my opinion, interesting using historical literature excerpts, poems and even jokes. Rather than posting a totally new issue every time, I have tried to keep the thread of the content going for several days on a number of the topics. I have appreciated all of the comments of my visitors and I want to thank each and every one of them for their participation, even those posting anonymously.

I hope my blog, as presented to my visitors, is a bit different than the other fine medical blogs available on the internet. I would like to continue the blog as a resource to provide understanding to my visitors about the applied discipline of bioethics and the issues, particularly in the medical field, it needs to cover. I will leave the daily news reporting and comment to the others.

But I do need the suggestions of topics by my visitors, particularly those topics which I have not as yet presented. So please feel free to write me. Well, that's all about me for now. And now back to bioethics blogging. ..Maurice.

Tuesday, July 12, 2005

UNESCO Draft Declaration: Towards a Declaration on Universal Norms on Bioethics

Below, you will find the entire UNESCO Universal Draft Declaration on Bioethics and Human Rights (24 June 2005)which is currently being made public. The initial text is the description of the history and background for the Declaration. I wanted to make this text promptly available to all who are interested (and really I think all citizens of the world should be interested wherever they are and under whatever conditions they live). I hope to bring up for discussion here elements of this Declaration in the future. ..Maurice.

Towards a Declaration on Universal Norms on Bioethics

Since the 1970s, the field of bioethics has grown considerably. While it
is true that bioethics today includes medical ethics issues, its
originality lies in the fact that it goes much further than the various
professional codes of ethics concerned. It entails reflection on
societal changes and even on global balances brought about by scientific
and technological developments. To the already difficult question posed
by life sciences - How far can we go? - other queries must be added
concerning the relationship between ethics, science and freedom.

The background

A growing number of scientific practices have extended beyond national
borders and the necessity of setting universal ethical guidelines
covering all issues raised in the field of bioethics and the need to
promote the emergence of shared values have increasingly been a feature
of the international debate. The need for standard-setting action in the
field of bioethics is felt throughout the world, often expressed by
scientists and practitioners themselves and by lawmakers and citizens.

States have a special responsibility not only with respect to bioethical
reflection but also in the drafting of any legislation that may follow.
In the field of bioethics, whilst many States have framed laws and
regulations aimed at protecting human dignity and human rights and
freedoms, many other countries wish to establish benchmarks and
sometimes lack the means to do so.

At its 31st session in 2001, the General Conference invited the
Director-General to submit "the technical and legal studies undertaken
regarding the possibility of elaborating universal norms on bioethics".

At the request of the Director-General, the International Bioethics
Committee (IBC) therefore drafted the Report of the IBC on the Report of
the IBC on the Possibility of Elaborating a Universal Instrument on
Bioethics finalized on 13 June 2003. The Report examines some issues in
bioethics that could be addressed in an international instrument and
illustrates how the elaboration of such an instrument could contribute
to and support international efforts being made to provide ethical
guidelines in matters related to recent scientific developments. The
Report explores the likely form and scope of an instrument as well as
its value in terms of education, information dissemination,
awareness-raising and public debate.

The mandate

At its 32nd session in October 2003, the General Conference considered
that it was "opportune and desirable to set universal standards in the
field of bioethics with due regard for human dignity and human rights
and freedoms, in the spirit of cultural pluralism inherent in bioethics"
(32 C/Res. 24).

The General Conference also invited "the Director-General to continue
preparatory work on a declaration on universal norms on bioethics, by
holding consultation with Member States, the other international
organizations concerned and relevant national bodies, and to submit a
draft declaration to it at its 33rd session" (32 C/Res. 24).

Which instrument?

As to the form of the instrument, IBC - supported by Member States
during the General Conference - came out clearly in favour of an
instrument of a declaratory nature, at least initially, which would be
best suited to a constantly changing context and would enable the
broadest possible consensus to be reached among Member States.

The form of the instrument does not prevent its content from
contributing to a code of universally recognized general principles of
bioethics (such as human dignity, solidarity, freedom of research,
respect for privacy, confidentiality, non-discrimination, informed
consent, integrity of research and intellectual honesty) insofar as
these principles pertain to bioethics. Lastly, an instrument on
bioethics must call strong attention to the importance of
awareness-raising, information, education, consultation and public


Over the years UNESCO has confirmed its standard-setting role in
bioethics. UNESCO has already contributed to the formulation of basic
principles in bioethics through in particular the Universal Declaration
on the Human Genome and Human Rights, adopted unanimously and by
acclamation by the General Conference in 1997 and endorsed by the United
Nations General Assembly in 1998, and the International Declaration on
Human Genetic Data, adopted unanimously and by acclamation by the
General Conference on 16 October 2003.

Apart from the fact that ethical issues related to the advances in life
sciences and their applications are highly topical, the depth and extent
of their roots in the cultural, philosophical and religious bedrocks of
various human communities are reason enough for UNESCO, the only
organization whose fields of competence include the social and human
sciences, true to its ethical vocation, to take the lead in this

Which procedure?

UNESCO will obviously not be able to embark alone on such an
undertaking. If the first steps of the elaboration of the declaration
are entrusted to IBC, in close consultation with the Intergovernmental
Bioethics Committee (IGBC), only the participation of all the actors
concerned could ensure that all the different perceptions of ethical and
legal issues are taken into account.

As explicitly requested by Member States, wide-ranging consultations and
hearings will therefore be held from the very beginning of the
elaboration of the declaration in order to involve in particular States,
the United Nations and the other specialized agencies of the United
Nations system, other intergovernmental and non-governmental
organizations and appropriate national bodies and specialists.


Universal Draft Declaration on Bioethics and Human Rights

The General Conference,

Conscious of the unique capacity of human beings to reflect upon their
own existence and on their environment; to perceive injustice; to avoid
danger; to assume responsibility; to seek cooperation and to exhibit the
moral sense that gives expression to ethical principles,

Reflecting on the rapid developments in science and technology, which
increasingly affect our understanding of life and life itself, resulting
in a strong demand for a global response to the ethical implications of
such developments,

Recognizing that ethical issues raised by the rapid advances in science
and their technological applications should be examined with due respect
to the dignity of the human person and universal respect for, and
observance of, human rights and fundamental freedoms,

Resolving that it is necessary and timely for the international
community to state universal principles that will provide a foundation
for humanity's response to the ever-increasing dilemmas and
controversies that science and technology present for humankind and for
the environment,

Recalling the Universal Declaration of Human Rights of 10 December 1948,
the Universal Declaration on the Human Genome and Human Rights adopted
by the General Conference of UNESCO on 11 November 1997 and the
International Declaration on Human Genetic Data adopted by the General
Conference of UNESCO on 16 October 2003,

Noting the two United Nations International Covenants on Economic,
Social and Cultural Rights and on Civil and Political Rights of 16
December 1966, the United Nations International Convention on the
Elimination of All Forms of Racial Discrimination of 21 December 1965,
the United Nations Convention on the Elimination of All Forms of
Discrimination against Women of 18 December 1979, the United Nations
Convention on the Rights of the Child of 20 November 1989, the United
Nations Convention on Biological Diversity of 5 June 1992, the Standard
Rules on the Equalization of Opportunities for Persons with Disabilities
adopted by the United Nations General Assembly in 1993, the ILO
Convention 169 concerning Indigenous and Tribal Peoples in Independent
Countries of 27 June 1989, the International Treaty on Plant Genetic
Resources for Food and Agriculture adopted by the FAO Conference on 3
November 2001 and entered into force on 29 June 2004, the Recommendation
of UNESCO on the Status of Scientific Researchers of 20 November 1974,
the UNESCO Declaration on Race and Racial Prejudice of 27 November 1978,
the UNESCO Declaration on the Responsibilities of the Present
Generations Towards Future Generations of 12 November 1997, the UNESCO
Universal Declaration on Cultural Diversity of 2 November 2001, the
Trade Related Aspects of Intellectual Property Rights Agrements (TRIPS)
annexed to the Marrakech Agreement establishing the World Trade
Organization, which entered into force on 1 January 1995, the Doha
Declaration on the TRIPS Agreement and Public Health of 14 November 2001
and other relevant international instruments adopted by the United
Nations and the specialized agencies of the United Nations system, in
particular the Food and Agriculture Organization of the United Nations
(FAO) and the World Health Organization (WHO),

Also noting international and regional instruments in the field of
bioethics, including the Convention for the Protection of Human Rights
and Dignity of the Human Being with regard to the Application of Biology
and Medicine: Convention on Human Rights and Biomedicine of the Council
of Europe, adopted in 1997 and entered into force in 1999, together with
its additional protocols, as well as national legislation and
regulations in the field of bioethics and the international and regional
codes of conduct and guidelines and other texts in the field of
bioethics, such as the Declaration of Helsinki of the World Medical
Association on Ethical Principles for Medical Research Involving Human
Subjects, adopted in 1964 and amended in 1975, 1989, 1993, 1996, 2000
and 2002 and the International Ethical Guidelines for Biomedical
Research Involving Human Subjects of the Council for International
Organizations of Medical Sciences adopted in 1982 and amended in 1993
and 2002,

Recognizing that this Declaration is to be understood in a manner
consistent with domestic and international law in conformity with human
rights law,

Recalling the Constitution of UNESCO adopted on 16 November 1945,

Considering UNESCO's role in identifying universal principles based on
shared ethical values to guide scientific and technological development
and social transformation, in order to identify emerging challenges in
science and technology taking into account the responsibility of the
present generation towards future generations, and that questions of
bioethics, which necessarily have an international dimension, should be
treated as a whole, drawing on the principles already stated in the
Universal Declaration on the Human Genome and Human Rights and the
International Declaration on Human Genetic Data, and taking account not
only of the current scientific context but also of future developments,

Aware that human beings are an integral part of the biosphere, with an
important role in protecting one another and other forms of life, in
particular animals,

Recognizing that, based on the freedom of science and research,
scientific and technological developments have been, and can be, of
great benefit to humankind in increasing inter alia life expectancy and
improving quality of life, and emphasizing that such developments should
always seek to promote the welfare of individuals, families, groups or
communities and humankind as a whole in the recognition of the dignity
of the human person and the universal respect for, and observance of,
human rights and fundamental freedoms,

Recognizing that health does not depend solely on scientific and
technological research developments but also on psycho-social and
cultural factors,

Also Recognizing that decisions regarding ethical issues in medicine,
life sciences and associated technologies may have an impact on
individuals, families, groups or communities and humankind as a whole,

Bearing in mind that cultural diversity, as a source of exchange,
innovation and creativity, is necessary for humankind and, in this
sense, is the common heritage of humanity, but emphasizing that it may
not be invoked at the expense of human rights and fundamental freedoms,

Also bearing in mind that a person's identity includes biological,
psychological, social, cultural and spiritual dimensions,

Recognizing that unethical scientific and technological conduct has had
particular impact on indigenous and local communities,

Convinced that moral sensitivity and ethical reflection should be an
integral part of the process of scientific and technological
developments and that bioethics should play a predominant role in the
choices that need to be made concerning issues arising from such

Considering the desirability of developing new approaches to social
responsibility to ensure that progress in science and technology
contributes to justice, equity and to the interest of humanity,

Recognizing that an important way to evaluate social realities and
achieve equity is to pay attention to the position of women,

Stressing the need to reinforce international cooperation in the field
of bioethics, taking into account in particular the special needs of
developing countries, indigenous communities and vulnerable populations,

Considering that all human beings, without distinction, should benefit
from the same high ethical standards in medicine and life science

Proclaims the principles that follow and adopts the present Declaration.


Article 1 - Scope

a) The Declaration addresses ethical issues related to medicine,
life sciences and associated technologies as applied to human beings,
taking into account their social, legal and environmental dimensions.

b) The Declaration is addressed to States. As appropriate and
relevant, it also provides guidance to decisions or practices of
individuals, groups, communities, institutions and corporations, public
and private.

Article 2 - Aims

The aims of this Declaration are:

(i) to provide a universal framework of principles and procedures to
guide States in the formulation of their legislation, policies or other
instruments in the field of bioethics;

(ii) to guide the actions of individuals, groups, communities,
institutions and corporations, public and private;

(iii) to promote respect for human dignity and protect human rights,
by ensuring respect for the life of human beings, and fundamental
freedoms, consistent with international human rights law;

(iv) to recognize the importance of freedom of scientific research
and the benefits derived from scientific and technological developments,
while stressing the need that such research and developments occur
within the framework of ethical principles set out in this Declaration
and that they respect human dignity, human rights and fundamental

(v) to foster multidisciplinary and pluralistic dialogue about
bioethical issues between all stakeholders and within society as a

(vi) to promote equitable access to medical, scientific and
technological developments as well as the greatest possible flow and the
rapid sharing of knowledge concerning those developments and the sharing
of benefits, with particular attention to the needs of developing

(vii) to safeguard and promote the interests of the present and future
generations; and

(viii) to underline the importance of biodiversity and its conservation
as a common concern of humankind.


Within the scope of this Declaration, in decisions or practices taken or
carried out by those to whom it is addressed, the following principles
are to be respected.

Article 3 - Human Dignity and Human Rights

a) Human dignity, human rights and fundamental freedoms are to be
fully respected.

b) The interests and welfare of the individual should have priority
over the sole interest of science or society.

Article 4 - Benefit and Harm

In applying and advancing scientific knowledge, medical practice and
associated techologies, direct and indirect benefits to patients,
research participants and other affected individuals should be maximized
and any possible harm to such individuals should be minimized.

Article 5 - Autonomy and Individual Responsibility

The autonomy of persons to make decisions, while taking responsibility
for those decisions and respecting the autonomy of others, is to be
respected. For persons who are not capable of exercising autonomy,
special measures are to be taken to protect their rights and interests.

Article 6 -Consent

a) Any preventive, diagnostic and therapeutic medical intervention
is only to be carried out with the prior, free and informed consent of
the person concerned, based on adequate information. The consent should,
where appropriate, be express and may be withdrawn by the person
concerned at any time and for any reason without disadvantage or

b) Scientific research should only be carried out with the prior,
free, express and informed consent of the person concerned. The
information should be adequate, provided in a comprehensible form and
should include the modalities for withdrawal of consent. The consent may
be withdrawn by the person concerned at any time and for any reason
without any disadvantage or prejudice. Exceptions to this principle
should be made only in accordance with ethical and legal standards
adopted by States, consistent with the principles and provisions set out
in this Declaration, in particular in Article 27, and international
human rights law.

c) In appropriate cases of research carried out on a group of
persons or a community, additional agreement of the legal
representatives of the group or community concerned may be sought. In
no case should a collective community agreement or the consent of a
community leader or other authority substitute for an individual's
informed consent.

Article 7 - Persons without the capacity to consent

In accordance with domestic law, special protection is to be given to
persons who do not have the capacity to consent:

a) authorization for research and medical practice should be
obtained in accordance with the best interest of the person concerned
and in accordance with domestic law. However, the person concerned
should be involved to the greatest extent possible in the
decision-making process of consent, as well as that of withdrawing

b) research should only be carried out for his or her direct health
benefit, subject to the authorization and the protective conditions
prescribed by law, and if there is no research alternative of comparable
effectiveness with research participants able to consent. Research
which does not have potential direct health benefit should only be
undertaken by way of exception, with the utmost restraint, exposing the
person only to a minimal risk and minimal burden and, if the research is
expected to contribute to the health benefit of other persons in the
same category, subject to the conditions prescribed by law and
compatible with the protection of the individual's human rights. Refusal
of such persons to take part in research should be respected.

Article 8 - Respect for Human Vulnerability and Personal Integrity

In applying and advancing scientific knowledge, medical practice and
associated technologies, human vulnerability should be taken into
account. Individuals and groups of special vulnerability should be
protected and the personal integrity of such individuals respected.

Article 9 - Privacy and Confidentiality

The privacy of the persons concerned and the confidentiality of their
personal information should be respected. To the greatest extent
possible, such information should not be used or disclosed for purposes
other than those for which it was collected or consented to, consistent
with international law, in particular international human rights law.

Article 10 - Equality, Justice and Equity

The fundamental equality of all human beings in dignity and rights is to
be respected so that they are treated justly and equitably.

Article 11 - Non-Discrimination and Non-Stigmatization

No individual or group should be discriminated against or stigmatized on
any grounds, in violation of human dignity, human rights and fundamental

Article 12 - Respect for Cultural Diversity and Pluralism

The importance of cultural diversity and pluralism should be given due
regard. However, such considerations are not to be invoked to infringe
upon human dignity, human rights and fundamental freedoms, nor upon the
principles set out in this Declaration, nor to limit their scope.

Article 13 - Solidarity and Cooperation

Solidarity among human beings and international cooperation towards that
end are to be encouraged.

Article 14 - Social Responsibility and Health

a) The promotion of health and social development for their people
is a central purpose of governments, that all sectors of society share.

b) Taking into account that the enjoyment of the highest attainable
standard of health is one of the fundamental rights of every human being
without distinction of race, religion, political belief, economic or
social condition, progress in science and technology should advance:

(i) access to quality health care and essential medicines, including
especially for the health of women and children, because health is
essential to life itself and must be considered as a social and human

(ii) access to adequate nutrition and water;

(iii) improvement of living conditions and the environment;

(iv) elimination of the marginalization and the exclusion of persons
on the basis of any grounds; and

(v) reduction of poverty and illiteracy.

Article 15 - Sharing of Benefits

a) Benefits resulting from any scientific research and its
applications should be shared with society as a whole and within the
international community, in particular with developing countries. In
giving effect to this principle, benefits may take any of the following

(i) special and sustainable assistance to, and acknowledgement of,
the persons and groups that have taken part in the research;

(ii) access to quality health care;

(iii) provision of new diagnostic and therapeutic modalities or
products stemming from research;

(iv) support for health services;

(v) access to scientific and technological knowledge;

(vi) capacity-building facilities for research purposes; and

(vii) other forms of benefit consistent with the principles set out
in this Declaration.

b) Benefits should not constitute improper inducements to
participate in research.

Article 16 - Protecting Future Generations

The impact of life sciences on future generations, including on their
genetic constitution, should be given due regard.

Article 17 - Protection of the Environment, the Biosphere and

Due regard is to be given to the interconnection between human beings
and other forms of life, to the importance of appropriate access and
utilization of biological and genetic resources, to the respect for
traditional knowledge and to the role of human beings in the protection
of the environment, the biosphere and biodiversity.


Article 18 - Decision-Making and Addressing Bioethical Issues

a) Professionalism, honesty, integrity and transparency in
decision-making should be promoted, in particular declarations of all
conflicts of interest and appropriate sharing of knowledge. Every
endeavour should be made to use the best available scientific knowledge
and methodology in addressing and periodically reviewing bioethical

b) Persons and professionals concerned and society as a whole
should be engaged in dialogue on a regular basis.

c) Opportunities for informed pluralistic public debate, seeking
the expression of all relevant opinions, should be promoted.

Article 19 - Ethics Committees

Independent, multidisciplinary and pluralist ethics committees should be
established, promoted and supported at the appropriate level in order

(i) assess the relevant ethical, legal, scientific and social issues
related to research projects involving human beings;

(ii) provide advice on ethical problems in clinical settings;

(iii) assess scientific and technological developments, formulate
recommendations and contribute to the preparation of guidelines on
issues within the scope of this Declaration; and

(iv) foster debate, education, and public awareness of, and
engagement in, bioethics.

Article 20 - Risk Assessment and Management

Appropriate assessment and adequate management of risk related to
medicine, life sciences and associated technologies should be promoted.

Article 21 - Transnational Practices

a) States, public and private institutions, and professionals
associated with transnational activities should endeavour to ensure that
any activity within the scope of this Declaration, which is undertaken,
funded or otherwise pursued in whole or in part in different States, is
consistent with the principles set out in this Declaration.

b) When research is undertaken or otherwise pursued in one or more
States (the host State(s)) and funded by a source in another State, such
research should be the object of an appropriate level of ethical review
in the host State(s) and the State in which the funder is located. This
review should be based on ethical and legal standards that are
consistent with the principles set out in this Declaration.

c) Transnational health research should be responsive to the needs
of host countries, and the importance of research to contribute to the
alleviation of urgent global health problems should be recognized.

d) When negotiating a research agreement, terms for collaboration
and agreement on benefits of research should be established with equal
participation by those party to the negotiation.

e) States should take appropriate measures, both at the national
and the international level, to combat bioterrorism, illicit traffic in
organs, tissues and samples, genetic resources and genetic-related


Article 22 - Role of States

a) States should take all appropriate measures, whether of a
legislative, administrative or other character, to give effect to the
principles set out in this Declaration in accordance with international
human rights law. Such measures should be supported by action in the
spheres of education, training and public information.

b) States should encourage the establishment of independent,
multidisciplinary and pluralist ethics committees, as set out in Article

Article 23 - Bioethics Education, Training and Information

a) In order to promote the principles set out in this Declaration
and to achieve a better understanding of the ethical implications of
scientific and technological developments, in particular for young
people, States should endeavour to foster bioethics education and
training at all levels as well as to encourage information and knowledge
dissemination programmes about bioethics.

b) States should encourage the participation of international and
regional intergovernmental organizations and international, regional and
national non-governmental organizations in this endeavour.

Article 24 - International Cooperation

a) States should foster international dissemination of scientific
information and encourage the free flow and sharing of scientific and
technological knowledge.

b) Within the framework of international cooperation, States should
promote cultural and scientific cooperation and enter into bilateral and
multilateral agreements enabling developing countries to build up their
capacity to participate in generating and sharing scientific knowledge,
the related know-how and the benefits thereof.

c) States should respect and promote solidarity between and among
States, as well as individuals, families, groups and communities, with
special regard for those rendered vulnerable by disease or disability or
other personal, societal or environmental conditions and those with the
most limited resources.

Article 25 - Follow-up action by UNESCO

a) UNESCO shall promote and disseminate the principles set out in
this Declaration. In doing so, UNESCO should seek the help and
assistance of the Intergovernmental Bioethics Committee (IGBC) and the
International Bioethics Committee (IBC).

b) UNESCO shall reaffirm its commitment to dealing with bioethics
and to promoting collaboration between IGBC and IBC.


Article 26 - Interrelation and Complementarity of the Principles

This Declaration is to be understood as a whole and the principles are
to be understood as complementary and interrelated. Each principle is
to be considered in the context of the other principles, as appropriate
and relevant in the circumstances.

Article 27 -Limitations on the Application of the Principles

If the application of the principles of this Declaration are to be
limited, it should be by law, including laws in the interests of public
safety, for the investigation, detection and prosecution of criminal
offences, for the protection of public health or for the protection of
the rights and freedoms of others. Any such law needs to be consistent
with international human rights law.

Article 28 - Denial of acts contrary to human rights, fundamental
freedoms and human dignity

Nothing in this Declaration may be interpreted as implying for any
State, group or person any claim to engage in any activity or to perform
any act contrary to human rights, fundamental freedoms and human

Monday, July 11, 2005

Fabrication, Falsifaction and Plagiarism in Research

A series of needs: not only is there need to assure ethical treatment of human subjects in medical studies, there is also the need to assure honesty in the reporting of the results of those studies. As I have noted previously, bad research is in part related to the researcher’s ego-needs rather than the need for scientific honesty.

A current news story by Martha Mendoza of the Associated Press and available on many newspapers including the Miami Herald titled “Fake research allegations reach new highs” details the statistics and some personal stories of researcher misconduct. Ms Mendoza writes “In a survey published June 9 in the journal Nature, about 1.5 percent of 3,247 researchers who responded admitted to falsification or plagiarism. (One in three admitted to some type of professional misbehavior.)”

It is clear that fabrication, falsification and plagiarism can,besides representing dishonesty on the part of the researcher, also represent abuse of any human subjects in the study by diminishing the benefit of the risks they took to participate. In addition, it might put patients at unneeded risk who later would be subjected to the results of the faulty study.

And is the academic/pharmaceutical system also at fault here? Would there be some pressures that institutions are applying to scientists, like “publish or perish” or drug companies who want to be sure their product gets FDA approval and sells? What do you think? ..Maurice.

The Nuremberg Code: Has The Code Been Observed?

Here, from the Health and Human Services website is the first major contribution to spell out the ethics of human research in the modern era, the Nuremberg Code. However, in reviewing the chronology of human research abuse in my last posting and looking at the research examples dated since 1947, one wonders whether the Code was even considered by their researchers. If so, I wonder how they rationalized what appears to be human subject abuse. ..Maurice.

[ "Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10", Vol. 2, pp. 181-182. Washington, D.C.: U.S. Government Printing Office, 1949.]


1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision. This latter element requires that, before the acceptance of an affirmative decision by the experimental subject, there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person, which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.

2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study, that the anticipated results will justify the performance of the experiment.

4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

5. No experiment should be conducted, where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.

6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.

9. During the course of the experiment, the human subject should be at liberty to bring the experiment to an end, if he has reached the physical or mental state, where continuation of the experiment seemed to him to be impossible.

10. During the course of the experiment, the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgement required of him, that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Wednesday, July 06, 2005

A Chronology of Human Research: The Sad and the Hope

Humans have been used as subjects for research of one kind and another for ages. The research may have been for practical or theoretical reasons but basically to learn something about human biology or humanity. Unfortunately, there has been some research on human subjects simply to boost the researcher’s ego or standing or for purely political or ideological reasons. Because of the Nazi experience and subsequent court trials, the Judgment of Nuremberg Code was written and since then there have been other codes and laws to attempt to make research using human subjects as rational, safe and ethical as possible. In more recent years withn the U.S., institutional research boards (IRB) have been set up to screen research on humans at the local level as well as an office for the protection of human subjects at a federal level. But there still are mistakes in research or worse and it takes organizations such as the Alliance for Human Research Protection (a national network promoting the protection of human subjects in medical research) and others to keep watch. Despite legal protection and institutional "review", there still are areas of human research which needs more attention including informed consent, conflict of interest, studies of children or mentally incompetent, study results not being published and issues of patent rights amongst many others.

To give my visitor a long view of the history of the human research; the bad and ethically sad research but also those activities which were designed to hope for human protection and good ethics, I have posted below a “Chronology of Human Research” with the permission of the author and Alliance for Human Research Protection on whose site the chronology was published.

Human Experiments: A Chronology of Human Research
by Vera Hassner Sharav

6th century B.C.: Meat and vegetable experiment on young Jewish prisoners in Book of Daniel.
5th century B.C: "Primum non nocere" ("First do no harm"), medical ethics standard attributed to Hippocrates. This Oath became obligatory for physicians prior to practicing medicine in the 4th century AD
1st century B.C. Cleopatra devised an experiment to test the accuracy of the theory that it takes 40 days to fashion a male fetus fully and 80 days to fashion a female fetus. When her handmaids were sentenced to death under government order, Cleopatra had them impregnated and subjected them to subsequent operations to open their wombs at specific times of gestation. []
12th century: Rabbi and physician Maimonides' Prayer: "May I never see in the patient anything but a fellow creature in pain."
1796 Edward Jenner injects healthy eight-year-old James Phillips first with cowpox then three months later with smallpox and is hailed as discoverer of smallpox vaccine.

1845-1849: J. Marion Sims, "the father of gynecology" performed multiple experimental surgeries on enslaved African women without the benefit of anesthesia. After suffering unimaginable pain, many lost their lives to infection. One woman was made to endure 34 experimental operations for a prolapsed uterus.
1865: French physiologist Claude Bernard publishes "Introduction to the Study of Human Experimentation," advising: "Never perform an experiment which might be harmful to the patient even though highly advantageous to science or the health of others."
1896: Dr. Arthur Wentworth performed spinal taps on 29 children at Children's Hospital, Boston, to determine if the procedure was harmful. Dr. John Roberts of Philadelphia, noting the non-therapeutic indication, labeled Wentworth's procedures "human vivisection."
1897: Italian bacteriologist Sanarelli injects five subjects with bacillus searching for a causative agent for yellow fever.
1900: Walter Reed injects 22 Spanish immigrant workers in Cuba with the agent for yellow fever paying them $100 if they survive and $200 if they contract the disease.
1900: Berlin Code of Ethics. Royal Prussian Minister of Religion, Education, and Medical Affairs guaranteed that: "all medical interventions for other than diagnostic, healing, and immunization purposes, regardless of other legal or moral authorization are excluded under all circumstances if (1) the human subject is a minor or not competent due to other reasons; (2) the human subject has not given his unambiguous consent; (3) the consent is not preceded by a proper explanation of the possible negative consequences of the intervention."
1906: Dr. Richard Strong, a professor of tropical medicine at Harvard, experiments with cholera on prisoners in the Philippines killing thirteen.
1913: Pennsylvania House of Representatives recorded that 146 children had been inoculated with syphilis, "through the courtesy of the various hospitals" and that 15 children in St. Vincent's House in Philadelphia had had their eyes tested with tuberculin. Several of these children became permanently blind. The experimenters were not punished.

1915: A doctor in Mississippi, working for the U.S. Public Health Office produces Pellagra in twelve Mississippi inmates in an attempt to discover a cure for the disease
1919-1922: Testicular transplant experiments on five hundred prisoners at San Quentin.
1927: Carrie Buck of Charlottesville is legally sterilized against her will at the Virginia Colony Home for the Mentally Infirm. Carrie Buck was the mentally normal daughter of a mentally retarded mother, but under the Virginia law, she was declared potentially capable of having a "less than normal child." By the 1930s, seventeen states in the U.S. have laws permitting forced sterilization
The settlement of Poe v. Lynchburg Training School and Hospital (same institution, different name) in 1981 brought to an end the Virginia law. It is estimated that as many as 10,000 perfectly normal women were forcibly sterilized for "legal" reasons including alcoholism, prostitution, and criminal behavior in general.
1931: Lubeck, Germany, 75 children die in from pediatrician's experiment with tuberculosis vaccine.
1931: Germany adopts "Regulation on New Therapy and Experimentation" requiring all human experiments to be preceded by animal experiments. This law remained in effect during the Nazi regime.

1931: Dr. Cornelius Rhoads, a pathologist, conducted a cancer experiment in Puerto Rico under the auspices of the Rockefeller Institute for Medical Investigations. Dr. Rhoads has been accused of purposely infecting his Puerto Rican subjects with cancer cells. Thirteen of the subjects died. A Puerto Rican physician uncovered the experiment an investigation covered-up the facts. Despite Rhoads' hand written statements that the Puerto Rican population should be eradicated, Rhoads went on to establish U.S. Army Biological Warfare facilities in Maryland, Utah, and Panama, and was later named to the U.S. Atomic Energy Commission. Rhoads was also responsible for the radiation experiments on prisoners, hospital patients, and soldiers. The American Association for Cancer Research honored him by naming its exemplary scientist award the Cornelius Rhoads Award.
1932-1972: U.S. Public Health Service study in Tuskegee, Alabama of more than 400 black sharecroppers observed for the natural course of untreated syphilis.
1932: Japanese troops invade Manchuria. Dr. Shiro Ishii, a prominent physician and army officer begins preliminary germ warfare experiments.
1936: Japan's Wartime Human Biowarfare Experimentation Program.
1938: Japan establishes Unit 731 in Pingfan, 25 km. from Harbin. Unit 731, a biological-warfare unit disguised as a water-purification unit, is formed outside the city of Harbin.
1939: Third Reich orders births of all twins be registered with Public Health Offices for purpose of genetic research.
1939: Twenty-two children living at the Iowa Soldiers' Orphans' Home in Davenport were the subjects of the "monster" experiment that used psychological pressure to induce children who spoke normally to stutter. It was designed by one of the nation's most prominent speech pathologists, Dr. Wendell Johnson, to test his theory on the cause of stuttering.
1940: Poisonous gas experiments at Unit 731. One experiment conducted September 7-10, 1940, on 16 Chinese prisoners who were exposed to mustard gas in a simulated battle situation.
1940-1941: Unit 731 used aircraft to spread cotton and rice husks contaminated with the black plague at Changde and Ningbo, in central China. About 100 people died from the black plague in Ningbo as a result.

1940's: In a crash program to develop new drugs to fight Malaria during World War II, doctors in the Chicago area infected nearly 400 prisoners with the disease. Although the Chicago inmates were given general information that they were helping with the war effort, they were not informed about the nature of the experiment. Nazi doctors on trial at Nuremberg cited the Chicago studies as precedents to defend their own research aimed at aiding the German war effort.
1941: Sterilization experiments at Auschwitz.
1941-1945: Typhus experiments at Buchenwald and Natzweiler concentration camps.
1941: Dr. William c. Black inoculated a twelve month old baby with herpes. He was criticized by Francis Payton Rous, editor of the Journal of Experimental Medicine, who called it "an abuse of power, an infringement of the rights of an individual, and not excusable because the illness which followed had implications for science." Dr. Rous rejected outright the fact that the child had been "offered as a volunteer."
1942 –1945: Unit 731. Ishii begins "field tests" of germ warfare and vivisection experiments on thousands of Chinese soldiers and civilians. Chinese people who rebelled against the Japanese occupation were arrested and sent to Pingfan where they became human guinea pigs; there is evidence that some Russian prisoners were also victims of medical atrocities. "I cut him open from the chest to the stomach and he screamed terribly and his face was all twisted in agony. He made this unimaginable sound, he was screaming so horribly. But then finally he stopped. This was all in a day's work for the surgeons, but it really left an impression on me because it was my first time." NYT
These prisoners were called 'maruta' (literally 'logs') by the Japanese. After succumbing to induced diseases - including bubonic plague, cholera, anthrax - the prisoners were usually dissected while still alive, their bodies then cremated within the compound. Tens of thousands died. The atrocities were committed by some of Japan's most distinguished doctors recruited by Dr. Ishii.

1942: High altitude or low pressure experiments at Dachau concentration camp.
1942: Harvard biochemist Edward Cohn injects sixty-four Massachusetts prisoners with beef blood in U.S. Navy-sponsored experiment.
1942: Japanese sprayed cholera, typhoid, plague, and dysentery pathogens in the Jinhua area of Zhejian province (China). A large number of Japanese soldiers also fell victim to the sprayed diseases.
1942-1943: Bone regeneration and transplantation experiments on female prisoners at Ravensbrueck concentration camp.
1942-1943: Freezing experiments at Dachau concentration camp.
1943 Refrigeration experiment conducted on sixteen mentally disabled patients who were placed in refrigerated cabinets at 30 degree Farenheit, for 120 hours, at University of Cincinnati Hospital., "to study the effect of frigid temperature on mental disorders."

1942-1943: Coagulation experiments on Catholic priests at Dachau concentration camp.
1942-1944: U.S. Chemical Warfare Service conducts mustard gas experiments on thousands of servicemen.
1942-1945: Malaria experiments at Dachau concentration camp on more than twelve hundred prisoners.
1943: Epidemic jaundice experiments at Natzweiler concentration camp.
1943-1944: Phosphorus burn experiments at Buchenwald concentration camp.
1944: Manhattan Project injection of 4.7 micrograms of plutonium into soldiers at Oak Ridge.
1944: Seawater experiment on sixty Gypsies who were given only saltwater to drink at Dachau concentration camp.
1944-1946: University of Chicago Medical School professor Dr. Alf Alving conducts malaria experiments on more than 400 Illinois prisoners.
1945: Manhattan Project injection of plutonium into three patients at Billings Hospital at University of Chicago.
1945: Malaria experiment on 800 prisoners in Atlanta.
1946: Opening of Nuremberg Doctors Trial by U.S. Military Tribunal.
1945: Japanese troops blow up the headquarters of Unit 731 in final days of Pacific war. Ishii orders 150 remaining ''logs'' (i.e., human beings) killed to cover up their experimentation. Gen. Douglas MacArthur is named commander of the Allied powers in Japan.

1946: U.S. secret deal with Ishii and Unit 731 leaders cover up of germ warfare data based on human experimentation in exchange for immunity from war-crimes prosecution.
1946-1953: Atomic Energy Commission sponsored study conducted at the Fernald school in Massachusetts. Residents were fed Quaker Oats breakfast cereal containing radioactive tracers.
1946: Patients in VA hospitals are used as guinea pigs for medical experiments. In order to allay suspicions, the order is given to change the word "experiments" to "investigations" or "observations" whenever reporting a medical study performed in one of the nation's veteran's hospitals.
1947: Colonel E.E. Kirkpatrick of the U.S. Atomic Energy Comission issues a secret document (Document 07075001, January 8, 1947) stating that the agency will begin administering intravenous doses of radioactive substances to human subjects.
1947: The CIA begins its study of LSD as a potential weapon for use by American intelligence. Human subjects (both civilian and military) are used with and without their knowledge.
1947: Judgment at Nuremberg Doctors Trial sets forth "Permissible Medical Experiments" – i.e., the Nuremberg Code, which begins: "The voluntary consent of the human subject is absolutely essential."
1949: Intentional release of radiodine 131 and xenon 133 over Hanford Washington in Atomic Energy Commission field study called "Green Run."
1949: Soviet Union's war crimes trial of Dr. Ishii's associates.
1949-1953: Atomic Energy Commission studies of mentally disabled school children fed radioactive isotopes at Fernald and Wrentham schools.

1940s-1950s: "psychic driving" and "mental departterning" experiments conducted by Dr. Ewen Cameron, depriving patients of sleep, using massive ECT combined with psychoactive drugs such as, LSD. After his "treatments" patients were unable to function. In the 1950's Dr.Cameron's experiments were sponsored by the CIA.
1950: Dr. Joseph Stokes of the University of Pennsylvania infects 200 women prisoners with viral hepatitis.
1950: U.S. Army secretly used a Navy ship outside the Golden Gate to spray supposedly harmless bacteria over San Francisco and its outskirts. Eleven people were sickened by the germs, and one of them died.
1951-1960: University of Pennsylvania under contract with U.S. Army conducts psychopharmacological experiments on hundreds of Pennsylvania prisoners.
1952-1974: University of Pennsylvania dermatologist Dr. Albert Kligman conducts skin product experiments by the hundreds at Holmesburg Prison; "All I saw before me," he has said about his first visit to the prison, "were acres of skin."
1952: Henry Blauer injected with a fatal dose of mescaline at New York State Psychiatric Institute of Columbia University. U.S. Department of Defense, the sponsor, conspired to conceal evidence for 23 years. I
1953 Newborn Daniel Burton rendered blind at Brooklyn Doctor's Hospital due to high oxygen study on RLF.

1953-1957: Oak Ridge-sponsored injection of uranium into eleven patients at Massachusetts General Hospital in Boston.
1953-1960: CIA brainwashing experiments with LSD at eighty institutions on hundreds of subjects in a project code named "MK-ULTRA."
1953-1970: U.S. Army experiments with LSD on soldiers at Fort Detrick, Md.
1954-1974: U.S. Army study of 2,300 Seventh-Day Adventist soldiers in 157 experiments code named "Operation Whitecoat."
1950s –1972: Mentally disabled children at Willowbrook School (NY) were deliberately infected with hepatitis in an attempt to find a vaccine. Participation in the study was a condition for admission to institution.
1956: Dr. Albert Sabin tests experimental polio vaccine on 133 prisoners in Ohio.
1958-1962: Spread of radioactive materials over Inupiat land in Point Hope, Alaska in Atomic Energy Commission field study code named "Project Chariot."
1962: Thalidomide withdrawn from the market after thousands of birth deformities blamed in part on misleading results of animal studies; the FDA thereafter requires three phases of human clinical trials before a drug can be approved for the market.
1962 to 1966, a total of 33 pharmaceutical companies tested 153 experimental drugs at Holmesburg prison (PA) alone.
1962-1980 Pharmaceutical companies conduct phase I safety testing of drugs almost exclusively on prisoners for small cash payments.
1962: Injection of live cancer cells into 22 elderly patients at Jewish Chronic Disease Hospital in Brooklyn. Administration covered up, NYS licensing board placed the principal investigator on probation for one year. Two years later, American Cancer Society elected him Vice President.
1962: Stanley Milgram conducts obedience research at Yale University.
1963: NIH supported researcher transplants chimpanzee kidney into human in failed experiment.

1963-1973: Dr. Carl Heller, a leading endocrinologist, conducts testicular irradiation experiments on prisoners in Oregon and Washington giving them $5 a month and $100 when they receive a vasectomy at the end of the trial.
1964: World Medical Association adopts Helsinki Declaration, asserting "The interests of science and society should never take precedence over the well being of the subject."
1965-1966: University of Pennsylvania under contract with Dow Chemical conducts dioxin experiments on prisoners at Holmesburg.
1966: Henry Beecher's article "Ethics and Clinical Research" in New England Journal of Medicine.
1966: U.S. Army introduces bacillus globigii into New York subway tunnels in field study.
1966: NIH Office for Protection of Research Subjects ("OPRR") created and issues Policies for the Protection of Human Subjects calling for establishment of independent review bodies later known as Institutional Review Boards.
1967: British physician M.H. Pappworth publishes "Human Guinea Pigs," advising "No doctor has the right to choose martyrs for science or for the general good."
1969: Judge Sam Steinfield's eloquent dissent in Strunk v. Strunk, 445 S.W.2d 145, the first judicial suggestion that the Nuremberg Code should influence American jurisprudence.
1969. Milledgeville Georgia, investigational drugs tested on mentally disabled children. No institutional approval.
1969: San Antonio Contraceptive Study conducted on 70 poor Mexican-American women. Half received oral contraceptives the other placebo. No informed consent.
1973 Ad Hoc Advisory Panel issues Final Report of Tuskegee Syphilis Study, concluding "Society can no longer afford to leave the balancing of individual rights against scientific progress to the scientific community."
1974: National Research Act establishes National Commission for the Protection of Human subjects and requires Public Health Service to promulgate regulations for the protection of human subjects.
1975: The Department of Health, Education and Welfare (DHEW) raised NIH's 1966 Policies for the Protection of Human subjects to regulatory status. Title 45 of the Code of Federal Regulations, known as "The Common Rule," requires the appointment and utilization of institutional review boards (IRBs).
1976: National Urban League holds National Conference on Human Experimentation, announcing "We don't want to kill science but we don't want science to kill, mangle and abuse us."
1978: Experimental Hepatitis B vaccine trials, conducted by the CDC, begin in New York, Los Angeles and San Francisco. Ads for research subjects specifically ask for promiscuous homosexual men.

1979: National Commission issues Belmont Report setting forth three basic ethical principles: respect for persons, beneficence, and justice.
1980: The FDA promulgates 21 CFR 50.44 prohibiting use of prisoners as subjects in clinical trials shifting phase I testing by pharmaceutical companies to non-prison population.
1981: Leonard Whitlock suffers permanent brain damage after deep diving experiment at Duke University.
1986: Congressional subcommittee holds one-day hearing in Washington, called by Rep. Pat Williams of Montana, aimed at determining whether U.S. prisoners of war in Manchuria were victims of germ-warfare experimentation. Hearing is inconclusive.
1981-1996: Protocol 126 at Fred Hutchinson Cancer Center in Seattle.
1987: Supreme Court decision in United States v. Stanley, 483 U.S. 669, holding soldier given LSD without his consent could not sue U.S. Army for damages.
1987:" L-dopa challenge and relapse" experiment conducted on 28 U.S. veterans who were subjected to psychotic relapse for study purposes at the Bronx VA.
1990: The FDA grants Department of Defense waiver of Nuremberg Code for use of unapproved drugs and vaccines in Desert Shield.
1991: World Health Organization announces CIOMS Guidelines which set forth four ethical principles: respect for persons, beneficence, nonmaleficence and justice.
1991: Tony LaMadrid commits suicide after participating in study on relapse of schizophrenics withdrawn from medication at UCLA.
1993: Kathryn Hamilton dies 44 days after participating in breast cancer experiment at Fred Hutchinson Cancer Center in Seattle.
1994. The Albuquerque Tribune publicizes 1940s experiments involving plutonium injection of human research subjects and secret radiation experiments. Indigent patients and mentally retarded children were deceived about the nature of their treatment.
1994. President Clinton appoints the Advisory Commission on Human Radiation Experiments (ACHRE) The ACHRE Report

1995. U.S. Department of Energy (DOE) published Human Radiation Experiments, listing 150 plus an additional 275 radiation experiments conducted by DOE and the Atomic Energy Commission, during the 1940s-1970s.
1995: 19-year-old University of Rochester student Nicole Wan dies after being paid $150 to participate in MIT-sponsored experiment to test airborne pollutant chemicals.
1995. President Clinton appoints the National Bioethics Advisory Commission.
1995: NYS Supreme Court rules (TD v NYS Office of Mental Health) against the state's policy of conducting nontherapeutic experiments on mentally incapacitated persons - including children - without informed consent. Justice Edward Greenfield ruled that parents have no authority to volunteer their children:
"Parents may be free to make martyrs of themselves, but it does not follow that they may make martyrs of their children."

1995: Thirty-four healthy, previously non-aggressive New York City minority children, boys aged 6 to 11 years old, were exposed to fenfluramine in a nontherapeutic experiment at the New York State Psychiatric Institute. The children were exposed to this neurotoxic drug to record their neurochemical response in an effort to prove a speculative theory linking aggression to a biological marker.
1996. Cleveland Plain Dealer investigative report series, 'Drug Trials: Do People Know the Truth About Experiments,' December 15 to 18, 1996. The Plain-Dealer found: of the "4,154 FDA inspections of researchers testing new drugs on people [since 1977] . . . more than half the researchers were cited by FDA inspectors for failing to clearly disclose the experimental nature of their work."
1996: Yale University researchers publish findings of experiment that subjected 18 stable schizophrenia patients to psychotic relapse in an amphetamine provocation experiment at West Haven VA.
1997. President Clinton issues a formal apology to the subjects of the Tuskegee syphilis experiments. NBAC continues investigation into genetics, consent, privacy, and research on persons with mental disorders.
1997. Researchers at the University of Cincinnati publish findings of experiment attempting to create a "psychosis model" on human beings at the Cincinnati VA. Sixteen patients, experiencing a first episode schizophrenia, were subjected to repeated provocation with amphetamine. The stated purpose was to produce "behavioral sensitization. This process serves as a model for the development of psychosis, but has been little studied in humans. Symptoms, such as severity of psychosis and eye-blink rates, were measured hourly for 5 hours."
1997. U.S. government sponsored placebo-controlled experiment withholds treatment from HIV infected, pregnant African women. NY Times, Sept. 18.
1997. Victims of unethical research at major U.S. medical centers - including the NIMH - testify before the National Bioethics Advisory Commission, Sept. 18.

1997. FDA Modernization Act gives pharmaceutical companies a huge financial incentive - a 6 month patent exclusivity extension - if they conduct drug tests on children. The incentive can yield $900 million.
1998. National Bioethics Advisory Commission (NBAC) Report. Research Involving Subjects with Mental Disorders That May Affect Decisionmaking Capacity. November 12, 1998
1998: The Japanese government has never formally apologized for Unit 731's activities, and did not even admit to its existence until August 1998, when the Supreme Court ruled that the existence of the unit was accepted in academic circles.
1998. Complaint filed with OPRR about experiments that exposed non-violent children in New York City to fenfluramine to find a predisposition to violence.
1998: Boston Globe (four part) series, "Doing Harm: Research on the Mentally Ill" shed light on the mistreatment and exploitation of schizophrenia patients who have been subjected to relapse producing procedures in unethical experiments.
1999: Nine month-old Gage Stevens dies at Children's Hospital in Pittsburgh during participation in Propulsid clinical trial for infant acid reflux.
1999: 18-year-old Jesse Gelsinger dies after being injected with 37 trillion particles of adenovirus in gene therapy experiment at University of Pennsylvania.
1999: Director of National Institute of Mental Health suspends 29 clinical trials that failed to meet either ethical or scientific standards.
2000: University of Oklahoma melanoma trial halted for failure to follow government regulations and protocol.
2000: OPRR becomes Office of Human Research Protection ("OHRP") and made part of the Department of Health and Human Services.
2000: President Clinton implement the Energy Employees Occupational Illness Compensation Act of 2000, which authorized compensation for thousands of Department of Energy workers who sacrificed their health in building the nation's nuclear defenses.
2000: The Washington Post (6 part) series, "Body Hunters" exposes unethical exploitation in experiments conducted by U.S. investigators in underdeveloped countries. Part 4 dealt with U.S. government funded, genetic experiments conducted by Harvard University in rural China.
2001: A biotech company in Pennsylvania asks the FDA for permission to conduct placebo trials on infants in Latin America born with serious lung disease though such tests would be illegal in U.S.
2001: Ellen Roche, a healthy 27-year old volunteer, dies in challenge study at Johns Hopkins University in Baltimore, Maryland.
2001: April 4, Elaine Holden-Able, a healthy retired nurse, consumed a glass of orange juice that had been mixed with a dietary supplement for the sake of medical research. This Case Western University Alzheimer's experiment, financed by the tobacco industry, wound up killing her in what was called a ''tragic human error.'' Federal Office of Human Research Protections did not interview hospital staff, mostly accepted hospital's internal report, imposed no penalty, and closed the case and did not mention the death in its letter of determination.
2001: Maryland Court of Appeals renders a landmark decision affirming "best interest of the individual child" as a standard for medical research involving children. The Court unequivocally prohibited nontherapeutic experimentation on children. (Higgins and Grimes v. Kennedy Krieger Institute).The case involved exposure of babies and small children to lead poisoning in EPA funded experiment. (

ADDENDUM: The author has e-mailed me that the chronology needs updating of more recent research projects. I hope she will be able to provide these updates later. ..Maurice.