Updated Helsinki Guidelines for Clinical Research Get Mixed Reviews.

The World Medical Association‘s newly updated “Ethical Principles for Medical Research Involving Human Subjects” are drawing considerable praise, as well as some criticisms.

The guidelines were first penned nearly a half century ago, in 1964, at a meeting of the World Medical Association in Helsinki, Finland, and have since been updated 7 times. Before this most recent update, the last time the document saw revisions was 2008.

The newest update, published online October 19 in JAMA, covers a wide range of topics organized under several headings, including:

  • Risks, Burdens and Benefits

  • Vulnerable Groups and Individuals

  • Scientific Requirements and Research Protocols

  • Research Ethics Committees

  • Privacy and Confidentiality

  • Informed Consent

  • Use of Placebos

  • Post-trial Provisions

  • Research Registration and Publication and Dissemination Results

  • Unproven Interventions in Clinical Practice

Two Viewpoints, both published in the same issue of the journal, help put the revisions in context. In some cases, the editorialists point out perceived shortcomings.

he revised document includes several subsections that give added emphasis to specific issues as well as improve readability, notes Paul Ndebele, PhD, from the Medical Research Council of Zimbabwe, Causeway, Harare, in one perspective . “By so doing, the Declaration of Helsinki is a better and more important authority at what it is aimed at achieving — providing guidance on conducting medical research involving humans.”

Since the first declaration in 1964, research oversight has improved. However, Dr. Ndebele says, improved oversight has sometimes led to an underrepresentation of certain groups in research protocols. The new version of the declaration recommends that heretofore underrepresented groups need to be more involved in clinical trials so they have a chance, along with other groups, of benefiting from successful research. “Instead of excluding groups that have been ordinarily excluded from research, such as minority groups, women, and children, researchers need to clearly justify why these groups have been excluded from research,” he writes.

In addition, he notes that the newer version is more relevant for countries with limited resources as it includes clear language that specifically addresses issues of importance in poor countries. Dr. Ndebele points to one example: “The 2013 version of the Declaration of Helsinki recommends use of unproven interventions in cases for which proven interventions do not exist, after the physician has sought expert advice as well as the patient’s informed consent.”

The 2013 version also discusses issues related to dissemination of health research information. That includes making sure that trials are registered in publicly accessible databases and that those databases include not only trials with positive results but also those with findings that are negative or inconclusive.

Dr. Ndebele emphasizes that informed consent must be a cornerstone of ethical research. The new declaration acknowledges that in some closely knit societies, gaining consent needs to involve other people than the patient, such as community leaders and significant others. “By addressing this reality, the new version is emphasizing respect for culture and community norms as part of the research process,” he writes.

The new guidelines also encourage researchers to make use of videos, vignettes, and other innovative means to explain the rationale for their studies.

Once trials are complete, it is important to give participants feedback on the results, he adds. He believes that doing so demonstrates respect for research participants and also helps demystify research.

Dr. Ndebele concedes that in recent years there has been considerable debate regarding the ethics of conducting medical research in developing countries. However, he says the 2013 update of the guidelines makes progress in addressing the issues surrounding that debate.

In the second Viewpoint, Joseph Millum, PhD, from the Department of Bioethics, Clinical Center, and the Fogarty International Center, National Institutes of Health, Bethesda, Maryland, acknowledge that the 2013 update represents progress. However, they also see a number of challenges that still need to be addressed.

For one, they say, “While the document purports to be a statement of enduring ethical principles, the nearly continuous process of revision undermines its authority.”

In addition, the 2013 document, similar to previous versions, is aimed primarily toward physicians. That is a mistake, they say, as the document offers recommendations for other health professionals, research ethics committees, sponsors, and governments, as well as editors and publishers. “It is time for the [World Medical Association] to recognize that the Declaration of Helsinki should address physicians as well as other health professionals and personnel involved in research,” they write.

Dr. Millum and colleagues add that the 2013 version’s treatment of informed consent remains inadequate. “It fails to recognize the possibility of waiving consent for some research involving competent adults, even though such research is common and widely endorsed.”

Neither does the declaration provide guidance on when it is appropriate to ask participants in studies to give broad consent for donating biological samples that could be used for wide-ranging studies in the future.

Dr. Millum and colleagues also take issue with the way the declaration treats “nonbeneficial studies,” or studies that pose risks to patients without offering compensating benefits.

Research combined with medical care is an increasingly popular way of conducting studies, note Dr. Millum and colleagues, but the declaration only allows such studies if, in the words of the declaration, “this is justified by its potential prevention, diagnostic or therapeutic value.”

In the view of Dr. Millum and colleagues, “The declaration’s lack of clear and consistent guidance regarding when net risks are acceptable creates unnecessary confusion and fuels the unfounded concern that all medical research is inherently exploitative.”

The authors further take issue with the new declaration’s protection of research participants who are vulnerable to harm in 1 or more ways, saying that the document “is confused about what constitutes appropriate protections and the appropriate means to achieve those protections.”

They concede that creating an international document to guide global research is an enormously difficult and complicated task. Hence, they say, it is not surprising that the newest version contains flaws. In spite of those flaws, however, they see the update as a step forward.

Guantanamo Bay: A Medical Ethics–free Zone?.

American physicians have not widely criticized medical policies at the Guantanamo Bay detainment camp that violate medical ethics. We believe they should. Actions violating medical ethics, taken on behalf of the government, devalue medical ethics for all physicians. The ongoing hunger strike at Guantanamo by as many as 100 of the 166 remaining prisoners presents a stark challenge to the U.S. Department of Defense (DOD) to resist the temptation to use military physicians to “break” the strike through force-feeding.

President Barack Obama has publicly commented on the hunger strike twice. On April 26, he said, “I don’t want these individuals [on hunger strike] to die.” In a May 23 speech on terrorism, the President said, “Look at our current situation, where we are force-feeding detainees who are . . . on a hunger strike. . . . Is this who we are? . . . Is that the America we want to leave our children? Our sense of justice is stronger than that.” How should physicians respond? That force-feeding of mentally competent hunger strikers violates basic medical ethics principles is not in serious dispute. Similarly, the Constitution Project‘s bipartisan Task Force on Detainee Treatment concluded in April that “forced feeding of detainees [at Guantanamo] is a form of abuse that must end” and urged the government to “adopt standards of care, policies, and procedures regarding detainees engaged in hunger strikes that are in keeping with established medical professional ethical and care standards.”1 Nevertheless, the DOD has sent about 40 additional medical personnel to help force-feed the hunger strikers.

The ethics standard regarding physician involvement in hunger strikes was probably best articulated by the World Medical Association (WMA) in its Declaration of Malta on Hunger Strikers. Created after World War II, the WMA comprises medical societies from almost 100 countries. Despite its checkered history, its process, transparency, and composition give it credibility regarding international medical ethics, and its statement on hunger strikers is widely considered authoritative. The WMA’s most familiar document is the Declaration of Helsinki — ethical guidelines for human-subjects research. The Declaration of Malta states that “Forcible feeding [of mentally competent hunger strikers] is never ethically acceptable. Even if intended to benefit, feeding accompanied by threats, coercion, force or use of physical restraints is a form of inhuman and degrading treatment.” The Declaration of Malta aims to set the same type of ethical norm as the Helsinki document. Physicians can no more ethically force-feed mentally competent hunger strikers than they can ethically conduct research on competent humans without informed consent.2

It’s hardly revolutionary to state that physicians should act only in the best interests of their patients, with their patients’ consent. At Guantanamo, this principle is seriously threatened because constant physician turnover makes continuity of care impossible; physicians’ historical involvement in “enhanced interrogation” that has irrevocably damaged detainees’ trust in military physicians; and the use of restraint chairs to break a 2006 mass hunger strike.3 Physicians may not ethically force-feed any competent person, but they must continue to provide beneficial medical care to consenting hunger strikers. That care could include not only treating specific medical conditions but also determining the mental competence of the strikers, determining whether there has been any coercion involved, and even determining whether the strikers want to accept voluntary feedings to continue their protest without becoming malnourished or risking death.4

Hunger striking is a peaceful political activity to protest terms of detention or prison conditions; it is not a medical condition, and the fact that hunger strikers have medical problems that need attention and can worsen does not make hunger striking itself a medical problem. Nonetheless, Guantanamo officials have consistently sought to medicalize hunger strikes by asserting that protestors are “suicidal” and must be force-fed to prevent self-harm and “save lives.”2 The DOD’s 2006 medical “Instruction” on this subject states: “In the case of a hunger strike, attempted suicide, or other attempted serious self-harm, medical treatment or intervention may be directed without the consent of the detainee to prevent death or serious harm.” This policy mistakenly conflates hunger striking with suicide.

Hunger strikers are not attempting to commit suicide. Rather, they are willing to risk death if their demands are not met. Their goal is not to die but to have perceived injustices addressed. The motivation resembles that of a person who finds kidney dialysis intolerable and discontinues it, knowing that he will die. Refusal of treatment with the awareness that death will soon follow is not suicide, according to both the U.S. Supreme Court and international medical ethics.2 The March 2013 guard-force–centered Guantanamo policy on “Medical Management of Detainees on Hunger Strike” seems to concede this point, since it makes no references to suicide. (Available atwww.globallawyersandphysicians.org/storage/AgendaHungerStrikeMeeting.pdf is the text and a summary of a meeting on physician participation in hunger strikes.)

A more troubling argument is that military physicians adhere to different medical ethical standards than civilian physicians — that as military officers, they must obey military orders, even if those orders violate medical ethics. Unlike individual medical and psychiatric assessments made in the context of a doctor–patient relationship, the decision to force-feed prisoners is made by the base commander. It is a penological decision about how best to run the prison. Physicians who participate in this nonmedical process become weapons for maintaining prison order.

Physicians at Guantanamo cannot permit the military to use them and their medical skills for political purposes and still comply with their ethical obligations. Force-feeding a competent person is not the practice of medicine; it is aggravated assault. Using a physician to assault prisoners no more changes the nature of the act than using physicians to “monitor” torture makes torture a medical procedure. Military physicians are no more entitled to betray medical ethics than military lawyers are to betray the Constitution or military chaplains are to betray their religion.5

Guantanamo is not just going to fade away, and neither is the stain on medical ethics it represents. U.S. military physicians require help from their civilian counterparts to meet their ethical obligations and maintain professional ethics. In April the American Medical Association appropriately wrote the secretary of defense that “forced feeding of [competent] detainees violates core ethical values of the medical profession.” But more should be done. We believe that individual physicians and professional groups should use their political power to stop the force-feeding, primarily for the prisoners’ sake but also for that of their colleagues. They should approach congressional leaders, petition the DOD to rescind its 2006 instruction permitting force-feeding, and state clearly that no military physician should ever be required to violate medical ethics. We further believe that military physicians should refuse to participate in any act that unambiguously violates medical ethics.

Military physicians who refuse to follow orders that violate medical ethics should be actively and strongly supported. Professional organizations and medical licensing boards should make it clear that the military should not take disciplinary action against physicians for refusing to perform acts that violate medical ethics. If the military nonetheless disciplines physicians who refuse to violate ethical norms when ordered to do so, civilian physician organizations, future employers, and licensing boards should make it clear that military discipline action in this context will in no way prejudice the civilian standing of the affected physician.

Guantanamo has been described as a “legal black hole.”3 As it increasingly also becomes a medical ethics–free zone, we believe it’s time for the medical profession to take constructive political action to try to heal the damage and ensure that civilian and military physicians follow the same medical ethics principles.

Source: NEJM

Force-Feeding, Autonomy, and the Public Interest.

Hunger striking is a nonviolent act of political protest. It is not the expression of a wish to die, nor is it akin to the decision of a terminally ill patient to discontinue food and fluid intake. Rather, it is brinkmanship. Faced with hunger-striking detainees, prison authorities have three choices: force-feed the hunger strikers, let them die, or accede to their demands.

As the World Medical Association (WMA) suggests, most bioethicists unequivocally oppose force-feeding. Enteral feeding through a nasogastric tube while a detainee is strapped to a chair violates a mentally competent patient’s right to refuse treatment and is physically violent.1 The WMA is less categorical about artificially feeding unconscious or delirious hunger strikers through their abdominal wall. Under these circumstances, physicians may permissibly weigh their patient’s best interests and prior expressions of intent before deciding about continued treatment.

Physicians who care for hunger-striking detainees weigh autonomy and best interests; rarely must they consider security interests. Local authorities, however, do not have this prerogative. Whereas bioethicists are keen to uphold autonomy and avoid force-feeding, public officials are bound to maintain public order and prevent the deaths of detainees. Those responsibilities leave officials only two choices: forced or artificial feeding, or accommodation. Accommodation deserves first consideration because it may be a reasonable choice. Faced with hunger-striking Palestinian detainees in 2012–2013, for example, Israeli officials satisfied some prisoners by improving prison conditions or modifying their prison terms. Similarly, the Turkish government met some hunger strikers’ demands last year. In each case, the hunger strike ended. Strikers played their hands deftly, carefully choosing realistic aims and employing nonviolent protests to gain symbolic but important concessions. Local medical organizations also played a role: the Israeli Medical Association instructed its members to comply with WMA guidelines, thereby pushing public officials to earnestly explore accommodation.2

The situation at Guantanamo deserves similar creativity. The detainees’ demands are not monolithic. Prisoners who are cleared for release require expedited repatriation, whereas others may be satisfied with customary legal proceedings, better prison conditions, or both. Accommodating the protesters on some counts may not be impossible. But whereas the freed Palestinian hunger strikers were previously paroled prisoners, not public enemies, some Guantanamo detainees may be militants representing genuine security threats, and authorities may not be able to meet all their demands. Nor is it sensible to let prisoners die: widespread rioting, civil unrest, and attacks on military and civilian personnel often follow the deaths of hunger strikers. And if one cannot allow hunger strikers to die or accede to their demands, then force-feeding must be back on the table.

There is no doubt that when mentally competent people refuse to eat or be fed, force-feeding or artificially feeding them violates the principle of autonomy. But autonomy is not sacrosanct. Persuasive moral arguments appeal to the sanctity of life to permit caregivers to override respect for autonomy when necessary to avert an easily preventable death from starvation.3,4 Respect for autonomy, moreover, conflicts with other important, nonmedical principles. Among military personnel, for example, autonomy, privacy, and the right to refuse certain treatments are limited and subordinate to security interests and the conditions necessary to maintain a fighting force.5 Similarly, the imperative to respect a detainee’s right of informed consent is not obviously superior to the interests of public security. There are usually good reasons for keeping captured enemy combatants locked up and alive. In fact, that is the norm of military detention. A prisoner’s desire to go free or die trying cannot override this basic interest of the state. A democratic government cannot be so hamstrung that the possibility of viable incarceration evaporates.

Of course, this argument should not be construed as permission to violate a fundamental human right in the name of military necessity. But the right of informed consent is not such a fundamental right — it is subordinate to human rights that protect people from murder, servitude, torture, and cruelty. One might argue, then, that force-feeding assaults a person’s dignity, and surely that is true when the feeding is accompanied by physical violence. But that argument does not repudiate force-feeding; it only mandates a search for nonviolent and humane methods.

Two practical difficulties also plague any directive to prioritize autonomy. First, respecting autonomy requires firm knowledge of a striker’s intent, which caregivers and prison authorities are unlikely to have. Given the lack of continuity of care, along with cultural differences, language barriers, and instructions that detainees may have received from their leaders, it would be extraordinarily difficult for anyone to determine whether a detainee was acting autonomously or under duress. Under these circumstances, the case for autonomous decision making weakens sufficiently to allow physicians to weigh a patient’s best interest over his or her decision to refuse food. Second, clinicians face a crisis of confidentiality if hunger strikers agree to accept food and fluids once their condition deteriorates but demand that caregivers keep these instructions secret. In these instances, confidentiality maximizes a striker’s political leverage, draws doctors into the fight, and leaves medical workers to stand by helplessly if public officials make suboptimal decisions on the basis of erroneous information.

The moral and practical difficulties of dogmatically upholding respect for autonomy suggest that the WMA would not allow physicians to stand by and watch hunger strikers die. It is unimaginable that any decent society today would leave 10 Irish Republican Army hunger strikers to die of starvation as the British did in Northern Ireland in 1981. Accounts of their slow and anguished deaths are harrowing, and no rights-respecting government or medical association should ever permit a repetition of that event. Instead, we should think about how to feed hunger strikers humanely. Once respect for autonomy falls to best interests or public interests, it makes no difference whether the authorities turn to humane force-feeding or to artificial feeding. But artificial feeding is not ideal: though less aggressive than force-feeding, it is also less salubrious — surely it is healthier to prevent starvation than to treat it. Politically, hunger strikes only galvanize prisoners and enflame their supporters. Letting strikes drag out until detainees are at death’s door is not a solution.

Hunger strikes by security detainees pose an excruciating dilemma. Physicians who decry disrespect of autonomy are left to watch treatable patients die. Physicians who extol the sanctity of life are committed to feeding healthy inmates by force. Public officials can neither accede to inmates’ demands nor allow them to die when negotiations stall but instead require humane methods to keep inmates alive. In this environment, the medical community faces two challenges. First, health care professionals will be called on to develop and administer humane methods for feeding striking detainees while providing general medical care under trying prison conditions. Second, health care professionals must also continue to scrutinize the behavior of public officials, cognizant of the medical interests of their patients and the collective interests of their community. Force-feeding should be rare, the product of serious but ultimately unsuccessful negotiations with strikers.

These are not easy straits to navigate. Armed conflict and other public emergencies pit personal, professional, and public interests against one another. Medical professionals, like other citizens in a thriving democracy, must simultaneously sustain the efforts of war and contain them.


Source: NEJM