The Treating Physician as Researcher: Deficits in the Current Regulatory Scheme

PART IV: DEFICITS IN THE CURRENT REGULATORY SCHEME

The current system of regulation was made in response to specific episodes of patient’s rights violations. Regulation varies by federal institution and is not applied to all research. The NBAC draft policy refers to the current scheme as “cobbled.” The proposed changes to federal oversight of human subject research are a step in the right direction. Unfortunately, they only address some of the ethical violations in current medical and health care research. The majority of the regulations and proposed changes are aimed at the ethics of the research project itself and the understanding component of informed consent. The IRBs would be revamped under the proposal, which would help determine what projects were acceptable to society at large (or were even better to the proposed population of subjects). Scientific review for validity and value of the project would presumably continue. A new, independent federal office would oversee and enforce these new rules. Potential review of the process of informed consent would be helpful to insure disclosure and perhaps understanding by the subjects. The change in makeup of the IRBs membership would help insure this as well.

The federal regulations were revised on June 23, 2005, with unfortunately no significant change in the membership requirements for IRBs or in the requirements for informed consent. There were no substantive changes in the rules, including no change in the required elements of informed consent or in the method by which it is obtained. IRBs remain composed primarily of members of the parent institution with no change in the required spectrum of membership.

The current regulations, and those proposed by NBAC, only address the requirement that informed consent be voluntary, with respect to vulnerable populations. There is no discussion, nor are there any regulations, to insure that subjects in general are truly volunteers. Voluntary assent to participation is essential to informed consent. The issue of voluntariness comes to the surface when the treating physician is also the investigator. The patient-physician relationship impedes the ability of the patient to make a free choice.

Patients with illnesses are eager for treatment. Desperate hopes are easily manipulated. Patients trust in their physicians to act in their best interest. The suggestion of participation in a research project is often viewed as a recommendation for treatment. This conviction of benefit is not warranted. This distinction between treatment and research is hardest to make for those with the poorest prognosis. Every effort must be made to dispel this therapeutic misconception if we are to take informed consent seriously. The patient’s belief in the beneficence of their physician is the basis of the relationship. The belief that the doctor acts in their best interest cannot be removed merely by declaring that ‘this is an experiment and not treatment’.

The doctor-patient relationship can be viewed as a fiduciary relationship. The requirement of fidelity, candor and competence must be met or the duty of the doctor is violated. The tension between the roles of treating physician and investigator breaches the duty of fidelity. No longer is the patient’s best interest the sole concern or motivation for the physician/investigator’s recommended course of treatment or diagnostic scheme for the patient. This conflict of interest on the part of the physician cannot be obviated by disclosure. Candor will not fulfill the duty of fidelity. The tension between the interests of the investigator and the best interests of the patient (also presumably the physician’s interests) are too great to be compartmentalized. The risk of infringing on the patient’s autonomy and right to security of person are too great to leave to chance.

The Model Rules of Professional Conduct of Lawyers (MRPC) is another guide that may be helpful to apply to physicians/investigators. These rules can apply, with some modification, to the ethical conduct required of physicians. For example, MRPC 1.7 might be applicable to the case of informed consent obtained by treating physicians who assume the dual role of investigators. The physician’s duty is to act in the best interest of patients at all times, but the research interest brings interests adverse to the patient. The nature of the physician-patient relationship creates a conflict of interest in which the patient/subject cannot voluntarily consent, even if the physician offers full disclosure and the patient fully understands. MRPC 1.7 deals with the same issue regarding lawyers. Conflicts of interest between the lawyer and the client must overcome four hurdles before they are acceptable as delineated by MRPC 1.7.

The first requirement for an exception is that the lawyer must reasonably believe that the conflict will not adversely affect the client’s interest. The MRPC indicates that when lawyers have a conflict of interest with their clients, they must obtain informed consent if the conflict is “waivable.” This conflict strains and may breach the fiduciary duty of a lawyer to their client, specifically the duty of loyalty (fidelity). If the conflict is material, and if it is reasonable to believe the conflict will have an adverse affect on the client, then the conflict cannot be waived. Without a reasonable belief by the lawyer that there will be no adverse affect to the client, then clients cannot consent to continued representation by their lawyers. For treating physicians who assume the dual role of physicians/researchers, it will always be unreasonable to assume that a conflict will not adversely affect the patient’s interest. The general advancement of knowledge and other interest of the investigator are inherently adverse to the patient’s interests to be cured and to get the best medical care possible. Meanwhile, patients make the assumption that their doctor is also acting in their best interest to cure them.

MRPC Rule 1.8 prohibits lawyers from having pecuniary interests adverse to their clients, unless the following three requirements are met:

1. the transaction and terms on which the lawyer acquires the interest are fair and reasonable to the client and are fully disclosed and transmitted in writing in a manner that can be reasonably understood by the client;
2. the client is advised in writing of the desirability of seeking and is given are reasonable opportunity to seek the advice of independent legal counsel on the transaction; and
3. the client gives informed consent, in a writing signed by the client, to the essential terms of the transaction and the lawyer’s role in the transaction, including whether the lawyer is representing the client in the transaction.

For lawyers with adverse pecuniary interests to continue to represent clients requires meeting these stringent rules. In medicine, even if pressed, I do not think we can meet these requirements where doctors have pecuniary interests adverse to their patients.

Another analogy to the MRPC is that lawyers can only restrict relationships with clients if done so expressly. This decision is not solely the lawyers’. In the physician-patient relationship, it is the patient’s perspective that counts. The doctor-patient relationship exists when the patient believes it does, unless the physician expressly terminates the relationship. Thus, if a patient believes the doctor-patient relationship exists, then the physician should offer only standard treatments, and never experimental research.

Performing research on subjects in the same venue, and within the same relationship, as their treatment, poses a threat to the patients’ bodily integrity and autonomy. The protection of these rights should be vigorously guarded. The violation of this protection can result in devastating consequences to the patient/subject.

Applying the tenets of the Nuremberg Code helps clarify this problem. The first rule of the Nuremberg Code requires informed consent as an inviolate component of subject participation in research. Under rule one “the voluntary consent of the human subject is absolutely essential.” For voluntary consent, the patient must: 1) have legal capacity to give consent; 2) be so situated so as to be able to exercise free choice; 3) have sufficient knowledge and understanding. In order to exercise free choice, the subject must be free from: force, fraud, deceit, duress, overreaching, and other forms of constraint or coercion. The issue of free choice is particularly relevant to treating physicians obtaining consent for a research project from their patients. The existing physician-patient relationship is a “form of constraint or coercion” on the patient/subject. This relationship makes the free power of choice an unreasonable assumption in research participation. Voluntary assent becomes impossible.

The interests of the parties and the nature of their relationship cause this loss of truly free choice. The physician-patient relationship is a relationship of trust under which the interests/intent of physicians is to cure or treat their patients. The physician is beneficent and the code of do no harm prevails. Physicians act only in the patient’s best interest. Of course, this situation is the ideal, and there are exceptions. However, patients will act as if the relationship continues even as they become a subject. Their decision to participate will be made within this coercive physician-patient relationship and therefore cannot be truly voluntary.

The interest or intent of the investigator is quite different from that of the physician. The interest of the patient is no longer the only interest and often is not the preeminent interest of the physician/investigator. There are many interests of investigators, which include obtaining or renewing grants, advancing science, receiving financial gain, getting promotions and achieving prestige. At minimum, these interests dilute the motivations of treatment and create a conflict of interest.

The practice of medicine changes depending on the individual patient’s response to a particular intervention. If drug A does not have the desired effect, then the dose may be altered or a new treatment instituted. The timing of this change will vary from patient to patient, according to their specific condition and response. Scientific investigation is not so flexible. In most studies subjects are assigned to specific, predetermined protocols. These are set methods of treatment and diagnosis. If the trial is a randomized, controlled trial, there will be more than one arm or protocol of the study. Subjects will be assigned on a random basis. In many studies, one arm will be a control treatment or accepted practice. Often studies involve a placebo, which is no treatment. Placebo arms are thought by much of the scientific community to make it faster and easier to determine the efficacy of a new treatment, but this theory is debatable both scientifically and ethically.

Subjects in research protocols will not have the protocol altered for their benefit. The protocol is fixed, unless the subject withdraws from the study or if the study ends. The assignment of which arm of the study a subject is placed on is not a determination made in the subject’s best interest. The randomization is in the interest of science to further knowledge. The scientific method is not a mechanism to act in the best interest of the individual subject, but a means to advance scientific knowledge. The argument is made that the acquired knowledge will help future patients and society. I submit that the advancement of knowledge, or the benefit of future patients, is never a justification to use an individual as a means to an end.

Physicians/investigators often hold a personal belief of which treatment is the best. Even if the evidence is inadequate to make the treatment a proven or accepted practice, most investigators have a preference for one arm of the experimental protocol. A familiar way to conceptualize this is by inquiring which arm of the protocol they would use themselves or recommend to a family member. This belief is not communicated to their patients/subjects, nor can this preference be given to them because it would violate the scientific validity of the study. This example illustrates the tension between the role of physician and investigator. Investigators, by the nature of scientific experimentation, cannot always act in the best interest of their patient/subject. They cannot alter the protocol or preferentially assign the favored arm of the study to the patient. They cannot change the drug dose or the drug itself. Scientific protocols are rigid, but patient care is not.

In seeking care from a physician, patients’ interests and intentions seem clear. Patients go to the doctor to get well, to be treated, or to obtain information solely in their best interest. They trust in their physician. If they do not trust their physician, then patients go to another doctor or do not heed the doctor’s advice. Patients trust in their doctor’s professionalism, because doctors have knowledge that they do not have. Therefore, patients are on unequal footing with doctors. Patients assume that the doctor has no conflict that will affect their treatment; otherwise, they would not go to them. If patients and doctors were on equal footing concerning medical knowledge, the situation would be different. If it is assumed that patients would still go to the doctor, the relationship could be more of a partnership. No party would have the upper hand or undue influence on the other in their ability to make decisions. Disclosure and discussion with clear understanding by the patient would allow them to make a fee choice but most patients are not in this situation.

There is a clear conflict of interest between the patient and the investigator. Patients want to be treated in their best interest and investigators want to advance science and achieve their professional goals. Viewing this, in the context of the inferior footing of the patient in the relationship with the physician, it is not reasonable to believe that the interests of the physician/investigator would not materially affect the interests of the patient. This conflict reinforces the violation of the fiduciary relationship when treating physicians become investigators and their patients / subjects.

Nearly all patients have substantially less knowledge than the physician to whom they go for help. This unequal footing and the nature of the relationship make it unreasonable to assume that patients can exercise free choice, when their physician recommends participation in a research project. The therapeutic misconception, the belief that treatment is being administered when the intervention is for research, is common. Even when patients sign consent for a research project, they still believe that they will gain at least some benefit. The doctor-patient relationship colors how patients make their decision on whether or not to participate in a study. The source of the suggestion impacts how the patient makes their decision. If the source of the suggestion is the treating physician, the subject loses the required voluntariness of informed consent.

The situation of treatment differs in that the doctor does not have any conflict of interest and their suggested treatment is only in the patient’s best interest. There are exceptions to this case, including doctors with financial interests in pharmaceuticals or devices. The reliance of the patient on the physician’s beneficence and professionalism is not misplaced. It is unrealistic to believe that, by any reasonable amount of consultation, a patient can be brought up to the level of knowledge of the physician. In decision making patients always rely to some degree on their trust in physicians. It has been said that physicians can obtain consent from patients merely by how they present the alternatives, risks, and consequences.

Separating the role of physician and investigator and dispelling the therapeutic misconception has been suggested as a solution to the tension of this dual role of physician and investigator. Even with an express notification, that the intervention is experimental and that there will be no benefit, patients will still believe that they will have a possibility of benefit. Like lawyers, doctors cannot just take off their professional hat when it suits their interest. Professionals cannot unilaterally change their relationship with clients or patients. The doctor-patient relationship is based on the patient’s belief that the physician acts in their best interest and to dispel this belief is to dissolve the relationship. The dual role cannot be undertaken without violating the free will of the patient and violating the Nuremberg Code. Voluntary consent cannot be obtained.

Vulnerable populations have their participation limited or are excluded from participation in experimentation because it is believed that they do not have the ability to exercise free will. Patients go to the doctor because they have some illness, are afraid, are in pain or are dying. They are vulnerable. They are in a position of inferior knowledge and seeking help from a person with expertise. The sicker the patient, the more pain they feel, the more vulnerable they become. The less one understands and the less treatment available, the more vulnerable patients become to opportunistic physician-investigators. Desperate hopes are easily manipulated. I believe that patients, like the recognized vulnerable populations, cannot exercise free, voluntary choice due to their situation and relationship with their physician.

The interests of the subject are often different from those of the patient. There are a variety of possible motivations of subjects. Some are subjects unknowingly; they believe they are being treated. For some it is the only way to receive new or novel treatments. These treatments may not be available outside of research protocols or the subject may not be able to afford them. They may believe it is in their best interest. Some people become subjects for financial gain, for payment. Often they ‘volunteer’ even if it is not in their physical or mental best interest. These conflicts between the subject and the patient create interesting problems. The issue pertinent here is that the duty of the physician is to treat the patient in their best interest. They should be advising patients on the proven course of action in their best interest. They should not take advantage of potential subjects based on these motivations. The roles of investigator and treating physician must be separate and distinct. These roles must be performed by separate individuals. The physician must not have any interest in the study, nor should they be recommending participation or obtaining consent for studies. The line between suggesting studies to patients and informing them of their existence is a difficult one. Physicians should not cross the line to researcher with their patients. They should not refer patients to any study in which they have a financial interest or as a co-investigator or otherwise. The nature of the physician-patient relationship will have an undue influence on the patient. Patients believe that the research is in their interest and that there is a likelihood of benefit but investigation is to elucidate the unknown. If there were a known benefit the project would be treatment, not research.

• Introduction
• The Definition of Informed Consent and Its Legal Implications
• Abuses of Informed Consent and Responses to the Abuses
• Deficits in the Current Regulatory Scheme
• Summary

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