Article

Why did OHRP SHRED informed consent documents?

Sat, 25 Oct 2003

China Daily’s premier medical correspondent, XIONG LEI, raises embarrassing questions that should trouble Americans, not just the bioethics and research community. She makes a plea for justice for some 200,000 Chinese farmers who were used in 12 genetic experiments without their informed consent. The experiments were conducted by Harvard researchers and funded by the US government and (in some cases) Millenium.

The federal Office of Human Research Protections (OHRP)is entrusted with ensuring that federal regulations for the protection of human research subjects are followed by all institutions that receive federal funding. OHRP is empowered to investigate when such institutions are accused of violating federal safeguards within the US. and offshore.

The Alliance for Human Research Protection (AHRP) has learned that OHRP, the agency charged with oversight and enforcement of federal research regulations, has SHREDDED original documents that had been sent to OHRP during its investigation into allegations that genetic experiments conducted in China by Harvard researchers failed to comply with federal and international informed consent requirements.

A Freedom of Information request by the ETC Group in North Carolina was submitted requesting copies of informed consent documents that Harvard researchers claimed were signed by Chinese farmers whose blood was drawn for genetic research purposes. Harvard submitted 2 boxes of documents on Jan 30, 2002 in response to OHRP’s May 21, 2001 request for consent forms pertaining to the genetic study of asthma conducted in the rural province of Anhui.

In a letter dated Sept. 26, 2003, the FOIA officer in the U.S. Public Health responded to the FOIA request by ETC stating: “I am advised that OHRP received 2 boxes of signed consent documents. However, OHRP shredded all but a few to save space and ensure privacy of the subjects.” See: http://www.ahrp.org/ethical/foiaBWH.php

Shredding documents that are likely to shed light on the validity of allegations of wrongdoing, and that may provide evidence in litigation, may be deemed an obstruction of justice. Such an action brought down a U.S. president.

OHRP’s rush to shred informed consent documents whose legitimacy was in doubt, gives rise to considerable doubt about the integrity of the agency’s investigations. This action calls for an investigation by Congress and the Department of Justice.

In 2002, OHRP issued 3 letters of findings–based on documents submitted by several Harvard teaching hospitals. The letters confirmed the allegations of gross federal violations of informed consent. See: http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/mar02a.pdf http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/mar02b.pdf http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/mar02c.pdf

But in its May 2,2003 letter of determination, OHRP essentially dropped the China investigation letting Harvard researchers off the hook without ever interviewing any of the Chinese human subjects, their families or local medics who have first-hand knowledge. So much for demonstrating “respect for persons” as required under federal regulations (45 CFR 46).

In her China Daily column (below), XIONG LEI raises serious concerns about the dangers posed by the insularity in which biomedical research stakeholders operate. Even the most egregious ethical violations are rationalized by a corps of institutional bioethicists who control public discussions:

“If ethical issues concerning human research must be discussed exclusively by professionals who consider themselves rule makers and have no interest in what other people think, this will only lead researchers into arrogance and violations of human rights. Silent and unnoticed, Chinese farmers have been making contributions to the life sciences, and they deserve a chance to air their views on issues concerning their rights and dignity to life.”

Indeed, research stakeholders represent an interlocking directorate of self-interest: the biotech / pharmaceutical industry, university and free-standing research centers, bioethicists, government oversight agencies, and medical journal publishers. This confluence of self-interest groups tightly controls the conduct of research and the oversight process as individuals within the enterprise move regularly from one to another position of authority. All of these players are financially and professionally interlocked. Independent public advocates are excluded from the process, thereby denying human subjects representation at any juncture.

Absent citizen representatives on advisory and policy making panels, the stakeholders are in the process of changing the Nuremberg Code terminology. They do so in order to obfuscate the distinctly different role of the players. Government bureaucrats and advisory panels are moving to change the universally understood term, “human subject” to the ambiguous term, “participant.” At the same time, they are resolutely turning a deaf ear and blind eye to concrete human rights violations of informed consent which constitutes the degradation of those subjects.

The government’s dismissal of the Chinese farmers case sends a resounding wrong message to Third World populations. It demonstrates utter disrespect for indigenous populations whose ignorance about their right to refuse. Their impoverished circumstances, naiveté, and a totalitarian regime, makes them easy targets for exploitation.

See: China Daily. A farming family’s recollection. 2003-09-25 Near-death experience after 55-year-old father of four inhales ‘fog-like’ spray http://www1.chinadaily.com.cn/en/doc/2003-09/25/content_267233.htm

AHRP’s website provides links to OHRP documents and criticism in the national and international press: http://www.ahrp.org/infomail/03/10/01.php
http://www.ahrp.org/infomail/0302/march312002.htm

and http://www.ahrp.org/infomail/0402/april10a2002.htm.

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http://www1.chinadaily.com.cn/en/doc/2003-10/22/content_274205.htm CHINA DAILY Research subjects’ right to know must be respected XIONG LEI Oct 22, 2003 08:02:38 page 4

Who profits? Who benefits? Who loses? Such questions were the theme of a panel at a working conference on bioethics held in the German capital Berlin earlier this month.

A determined gathering of nearly 100 biologists, philosophers, international law experts, journalists and human-rights advocates from over 30 countries in Africa, America, Asia, Europe and Oceania exchanged views and experiences on issues concerning ethics in the life sciences. They agreed that close attention should be paid to bioethics in all research involving human subjects.

It is essential to know who profits, who benefits and who loses in all research involving human subjects, since our basic rights as human beings are involved. Unfortunately, however, it is often the case that researchers intentionally evade this kind of questions, while many of those taking part as research subjects are not aware enough to ask them.

One example of such evasion is the Harvard-affiliated projects involving Chinese farmers in East China’s Anhui Province.

Harvard University in Massachusetts launched a series of genetic research projects in 1994 and has been publishing research papers since then. Starting in 1999, the US Government conducted a three-year investigation into the projects and found them to have been at fault. But, during the investigation period, the wrongdoers continued to publish research papers based on the genetic data illegally obtained. The US federal investigators effectively cleared Harvard in May this year by acknowledging all its “corrective actions.”

The faulty human genetic studies involved some 200,000 Chinese farmers, but the US federal investigators did not dispatch any of their own staff to the sites in China, interview a single farmer or consult any Chinese who were critical of the projects or who had evidence revealing possible fraud by the principal Harvard researchers.

We have fascinating principles of bio-ethics in human genetic research. There is the first part of the 1947 Nuremberg Code: “The voluntary consent of the human subject is absolutely essential.” The Helsinki Declaration, first adopted in 1964, contains the commitment: “The right of the research subject to safeguard his or her integrity must always be respected.” The 1997 Universal Declaration on the Human Genome and Human Rights advocates international co-operation with developing countries in a way that prevents abuse and benefits all.

Yet those researchers who come for our genes never bother to throw pennies to pay for cultivating our awareness of them. They are far more enthusiastic about collecting our DNA samples than honouring our rights. The ordinary people – the silent majority – are kept ignorant of these principles and this ignorance is often abused by some researchers.

If Harvard did take any “corrective actions,” they remain unknown to the Chinese public, not to mention the Anhui farmers whose right to know was ignored when their blood was taken away. Here can be felt the powerlessness of those fascinating bioethical principles – they only establish norms for what researchers should do but fail to discipline or punish anyone violating those norms.

When I learned that an international conference on bioethics was due to be held in Beijing in April this year, I proposed to the programme committee that they “add some Chinese farmers and grass-roots medical workers to the list of guests” to be invited to this very important meeting. I e-mailed my proposal to every committee member and told them the Chinese people who gave blood for those developed countries’ human genetic projects “have had little opportunity to exchange views with the investigators and researchers on an equal footing. And many of those who were so eager to take their blood samples have shown little interest in what they think and aspire to and would have to say.”

I held that the scheduled conference would “offer a good chance to correct this mistake.”

My proposal was turned down. The programme committee included famous scholars from England’s University of Oxford, Harvard and the Chinese Academy of Social Sciences and they decided that the conference “is an academic meeting which will focus on the ethical issues emerging in human research.” They added: “We don’t think it is appropriate to invite non-bioethical professionals to attend our conference.”

In the end, the conference was not convened because of SARS (severe acute respiratory syndrome). Nevertheless, I was appalled by its organizers’ outright denial of the right of so-called “non-bioethical professionals” to discuss with the academics on an equal basis an issue concerning their basic rights as human beings.

I think ethical principles should start with the involvement of all participants, not only the professionals. When it comes to ethics, we are no longer dealing with an exclusively academic issue.

If ethical issues concerning human research must be discussed exclusively by professionals who consider themselves rule makers and have no interest in what other people think, this will only lead researchers into arrogance and violations of human rights. Silent and unnoticed, Chinese farmers have been making contributions to the life sciences, and they deserve a chance to air their views on issues concerning their rights and dignity to life.

As a “non-bioethical professional,” I took part in the Berlin conference, entitled “Within and Beyond the Limits of Human Nature.” I left it with a stronger belief that those professionals must respect ordinary people’s right to know and must discard the arrogant approach that holds that the silent majority’s role is nothing more than to offer passively what the professionals want.

If we agree that bioethical principles must be honoured, we should take the issue of bioethics out of the grip of so-called “bioethical professionals.” It is an issue that concerns everyone, and nobody is privileged in the face of bioethics.

We in China should put our own house in order through better legislation and enforcement, while companies and institutions collecting gene specimens in our country must be urged to put resources into bioethics education and into promoting bioethical principles among the public so they know how to safeguard their rights. An international tribunal should be established to punish those who violate bioethical principles. An international coalition composed of both professionals and non-professionals should then be formed to make biological research really benefit the majority of the people, starting from honouring our right to know.

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