Who Will Speak for the Voiceless?

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As I reported in my piece, Ignoring Patient and Family Rights, a study has been approved by the United States government, under the auspices of the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), for over 20,000 unconscious patients to be experimented on without informed consent, with this research to be conducted by the Resuscitation Outcomes Consortium, described here in a news release provided by the National Institutes of Health (NIH).

This study will be done in medical centers in Seattle, Portland, San Diego, Dallas, Birmingham, Pittsburgh, Milwaukee, Toronto, Ottawa and around Iowa and British Columbia.

In a report entitled Waiver of Informed Consent for Emergency Room Research, published by the American Medical Association (AMA) in 1997, it states :

Research involving human subjects requires obtaining informed consent from patients or surrogate decision-makers prior to enrollment in any clinical trial. This is designed to safeguard patient autonomy and protect vulnerable populations from assuming undue research risks. Existing federal regulations had allowed an Institutional Review Board (IRB) to approve a waiver of informed consent only when research involved MINIMAL risk (My emphasis). Investigators, arguing that this limitation unduly hinders scientific advance, petitioned the federal regulatory agencies (i.e., the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) to revise their stance. The FDA released proposed rules in the fall of 1995 and final regulations on October 2, 1996.

As of that date, October 2, 1996, and included in the AMA report, these are the final regulations that have been created by the FDA as exceptions from the need for informed consent :

1. subjects are in a life-threatening situation, available treatments are unproven or unsatisfactory, and a controlled investigation is necessary;

2. obtaining informed consent is not feasible

3. research participation offers the possibility of direct therapeutic benefit to the subjects;

4. the investigation could not practicably be carried out without the waiver; and

5. additional protection of right and welfare of subjects are provided. (17)

   1. the subject must enter into the critical emergent state suddenly and unexpectedly (26) (Note: This criteria is meant to apply only if the condition were not anticipated by the physician and time prevented the ability to acquire informed consent.)

   1. the experimental treatment must have a realistic possibility of benefit at least equal to or greater than standard care. Only where equipose exists should individuals be deprived of potentially beneficial treatment or subjected to potential risk of harm

   1. the subject must lack the capacity to give consent

   1. the window of opportunity in which to apply the experimental treatment must be so narrow as to preclude obtaining proxy consent

   1. the risk associated with the research should be reasonable in light of what is known about the critical nature of the medical condition and possible alternative treatments

   1. the proposed treatment must be at a sufficient stage of investigation that it is appropriate for use in human trials

   1. the research in question must not have been able to be carried out without the informed consent waiver

In the AMA report, under Ethical Arguments, the question is asked:

To what risks is it permissible to expose an unknowing subject? As noted previously, the regulations referred to “minimal risk”. The new rules refer to “reasonable risk”, a concept which depends on what is known about the experimental treatment, the alternative treatments, and the medical condition. (24) Other commentators, including the Coalition Conference of Acute Resuscitation and Critical Care Researchers (hereafter “Coalition”) call for the use of a category of so termed “appropriate incremental risk”, which is defined as “any potential risk associated with participating in research protocol relative to the natural consequences of the medical condition, or any potential risk associated with receiving the experimental treatment relative to receiving the standard treatment for the medical condition.” (25)

The report explains that balancing the risks and benefits of any specific clinical trial is at the heart of justifying “.... more than minimal risk research without consent” and characterizes the decision to be made this way:

In essence, the patient's prognosis must be so unfavorable that the potential harms associated with the investigational agent are NOT MUCH GREATER (My emphasis) than the potential harms associated with standard treatment or no treatment (e.g. death or severe disability). Thus if the standard treatment involves high risk, or even if treatment there is a high risk of death or disability from the medical condition, then high-risk investigational treatment may be applied.

Under Requirements For Waiver (of informed consent), it is stated that among the most vulnerable populations in need of special protections are patients in emergency situations. Their eligibility for inclusion in research without consent, according to the Council on Ethical and Judicial Affairs, which maintains and updates the AMA's Code of Medical Ethics, requires the following conditions:

In summation of the waiver provisions, the report states that despite the informed consent waiver, the subject participants or their “.... legally authorized representatives, must be informed of their inclusion in the protocol and consent obtained for continued participation as soon as possible after intervention.” The patient or their representative, acting on their behalf, has the right to withdraw from participation in the study without concerns related to “.... repercussions for care”.

The provisions and criteria required, by the Council on Ethical and Judicial Affairs, are commendable and arguably may be the most reasonable guidelines that can be formulated for these purposes but, more is required.

Since 1996, the medical community has been allowed to experiment on patients using these guidelines under what would be considered emergency conditions with ethics boards arguing pro and con regarding what may or may not constitute unethical behavior.

The guidelines provided under the Department of Health and Human Services (HHS) are similar in nature and character to that of the AMA and would not conflict with any of the above stated provisions, with the NIH and FDA, those responsible for approving the study with uninformed consent, both being entities under the guidance of the HHS.

Yet, referring to the acknowledgment at the beginning of the discussion of Requirements For Waiver in the AMA report, that among the most vulnerable populations in need of special protections are patients in emergency situations, do these more than 20,000 test subjects scheduled to be experimented upon fall solely within these guidelines? Whether or not they do, an inevitable imbalance exists that must be addressed.

As set forth by the American Medical Association (AMA), assuming the inability of the patient or their representative to give consent prior to the administration of the experimental treatment, the check and balance for the patient or his or her proxy in this unfortunate set of circumstances and process seems to be the patient's right or that of her or his representative, for inclusion in the waiver of consent process after initiation of the experiment.

However, the process as outlined in this report, supported by FDA regulations, illuminates the reality that has always been. If the patient is unable to withdraw consent and there is no one acting on behalf of the patient's rights and he or she is without means, making it highly unlikely there would be any form of legal representation on his or her behalf, these patients, without family or proxy delegates or legal representation become doubly vulnerable, possibly being called upon, as has occurred in the past, to shoulder a disproportionate share of experimentation upon their persons.

www.ama-assn.org/ama1/pub/upload/mm/369/ceja_1a97.pdf