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The Nature of Consent

Gary Richard Schoener

"Psychiatric Researchers Under Fire" read the headline on page one of the New York Times Science Section of 19, May 1998. The story read in part (bold print mine):

Andrew BROWNSTEIN, a severe manic-depressive, was desperate. None of his medicines could keep the anxiety and depression of his illness at bay. So in the fall of 1994, he agreed to become a research subject at the national Institute of Mental Health in Bethesda, Md. It would put him, he recalls hoping at "the cutting edge of medicine", where he would learn much about his disorder and get superior treatment.

Instead, he said, he was taken off his medicines, subjected to painful tests and given a wide variety of chemical substances to test his reactions. Over the next year, he said, consent forms and explanations of experiments to be done on him were passed out casually, with little attempt to see that he understood. But then, he added,he was very ill and often could not follow what was said to him anyway.

"There were times when I was truly railroaded." Mr Browenstein, a 39-year-old resident of South Philadelphia said in an interview. (Hilts, 1998a,p.F-1)

The story goes on to quote Dr. John K. Hsiao, editor of the Schizophrenia Bulletin,"...that patients sometimes might not understand what they are getting into, because the consent forms and explanations can be legalistic and badly written, and doctors do not always make things clear to research subjects."(Hilts 1998a,p.F-5) Dr. Hsiao was further quoted:

"We shouldn't ever do anything that has a significant chance of permanent harm for the patients. But I think we can ask patients to put up with an exacerbation of symptoms. They should be given a chance to contribute to science." (Hilts 1998a,p.F-5)

The National Bioethics Advisory Commission, which is examining the consent issue in research, is reviewing a study being done at the Maryland Psychiatric Research Center at the University of Maryland. The study was done on nine inpatients with a schizophrenia diagnosis and involved taking them off their medications and giving them ketamine, an anesthetic in the same family as the hallucinogen called "angel dust" which would be expected to induce psychotic symptoms. Notwithstanding the question one might ask about how able such persons were to consent, the consent form being used in that study, while it did state that ketamine was not being tested as a therapy for their schizophrenia, also stated: "this medication, if effective, may not alter the underlying disease but merely offer symptomatic treatment." It apparently did not warn of the dangers of withdrawal from the therapeutic medications these patients were taking or that relapse was likely, with possibly devastating consequences. (Hilts, 1998b,p.F-5).

But one does not have to read the New York Times to find out about such problems. Our own Minneapolis Star-Tribune has provided us with a local situation in a story entitled " 'U Psychiatrist is Fined for Improperly Conducting Drug Trials" (Lerner, 1998). The story is based on information contained in a stipulation agreed to by Dr. James Halikas and the Board of Medical Practice. According to the story (bold print is mine):

Halikas, a professor of psychiatry, admitted that he failed to get signed consent forms before enrolling a group of Southeast Asian immigrants in the experimental treatment program, according to a signed agreement with the board

Halikas was the lead scientist on a study to test a drug called GHB, or gammahydroxybuyrate, as a possible treatment for opium addiction. He admitted that eight patients were started on the drug without signing consent forms, as required by federal law and university policy for human trials. Three patients signed for the forms after they started taking the medication.

The study was cut short in August 1993 after colleagues complained about how he was handling it. At the time, Halikas was a member of the university's human subjects committee, which polices all such research the university expelled him from the committee, reprimanded him and suspended his right to work on research using human subjects.

Although patients were told they could drop out at any time, several were turned down when they complained about GHB and asked for more methadone, the traditional treatment given in combination with GHB and two patients were given higher than approved dosages. (lerner, 1998)

While it would be easy to see these cases as applying to problems in research, something, alas, most of us are no longer involved in, they serve as an obvious reminder to clinicians concerning the question of informed consent. Furthermore, the Minnesota Board of psychology has been struggling long and hard, for several years, with the issue of informed consent and how to define it. I will leave it to Dr. Sam Albert or others on the Board to communicate with MPA members on what they come up with. The discussion -- and, in fact, debate -- has been a healthy one and involved multiple input.

While the cases cited earlier focus on consent forms -- their content and whether they were signed -- as is typical of the legal handling of such matters, such forms are not themselves the only issue in the obtaining of true informed consent.

In fact, I would contend, the nature of consent is such that no form or a signature upon it can ensure it. It is not that simple. After more than three decades f reading of the issue and participating in discussions and doing presentations on several continents on this issue, I have concluded that informed consent means simply (and not so simply) that:

the person authorizing the procedure knows what he or she needs to know to make the choice and give the consent.

While the use of client handouts and consent forms may have considerable value and/or be legally required, the common line is the communication with the client or person authorizing the assessment, treatment, or other procedure. It is inconceivable that a single printed form can accomplish this. There are numerous factors which may, and often do, play a role:

1. Reading level of the person giving/withholding consent.
2. Readability of the handout and/or form itself
3. Time allowed for the reading, and the set and setting. Are they actually conducive to reading and comprehending?
4. Cultural issues which may effect understanding.
5. Religious issues which may effect interpretation and/or ability to consent to certain things (see example below)
6. The intellectual functioning of the person -- presence or absence of intellectual limitations of deterioration due to developmental disability, impact of medications, intoxication, acute or chronic impact of brain injury, etc.
7. The emotional functioning of the person -- how upset or distracted are they?
8. Whether the person can actually read and comprehend the consent form.
9. Whether the person understands the potential consequences of the decision insofar as it is critical to their welfare.
10. Whether the original situation, issues and options are the ones which turned out to be the critical issues and choices

To illustrate this, let me use an example from pediatric surgery. Two parents are being asked to consent to a particular surgical procedure to be done on their child. The surgeon is trying to provide information and obtain consent. He inquires what the parents want to know to be able to give consent. Here are some responses:

Parents A: Doc, very frankly all we want is your recommendation. We know that all surgery is potentially dangerous, and very frankly don't care to hear about all the things that can go wrong in some small percentage of cases. Let's get on with it.

Parents B: Doc, can you just describe what you will be going and tell us about any serious dangers?

Parents C: Doc, can you tell us what other options, if any there are? And, we'd like you to review the hazards of not doing it, or of taking any one of those options. Can we take them one by one and review pluses and minuses, as you see it?

Parents D: Doc, nothing personal, but we'd like to get a second opinion. But first, can you run through what you're recommending, and let us take some notes. We'll do the same with the person who gives the second opinion.

Parents E: Doc, frankly, I'm a bit rattled. Can you write some of this down, or give us some sort of handout? I think it would be best if we went home to discuss it. And, I want to talk to my son, who's in medical school, and maybe my pastor

Parents F: As long as it is not urgent, I'd like to see some reports on this sort of operation, or maybe talk to some other parents whose kid has had it. Do you have any people who we might call Or, could you check with them?

Parents G: Well, as you know I'm a scientist, and my husband is a mathematician. We'd feel better about this decision if we could read some clinical or research reports, especially from peer-reviewed journals. Do you have any such items, or know of an Internet site we could check

What would be necessary to obtain consent varies dramatically with each situation. In some, providing a ton of information would not only be counterproductive, but potentially undermine the ability to give consent by overloading the person. Consider also the following case which is adapted from one handled by a biomedical ethics committee:

A child was born with a condition which required life support and would eventually be fatal. It had been determined that he would not live long and had no chance of survival. After long consideration, the health care team and parents had decided that the extraordinary measures being employed should be removed and that nature should be allowed to take its course. The parents were completely clear on their decision and authorized that this be done, and indicated that they would participate and actually hold the child as his life ebbed away. However, they balked at signing a consent form, making it clear that it was against their religion to actually write such a thing down. After due consideration, it was the committee's decision that it was unethical to require the written consent. That this was a legalism designed to protect the health care institution and that it was not necessary to ensure consent. The parents clarity of feelings and the fact that they would actually participate actively in what was to occur seemed clear enough. So, the extraordinary measures were withdrawn and the parents held the child as he passed away.

With the pluralism of American society and the endless stream of increasingly diverse peoples who come to our shores we will doubtless encounter cultural and religious systems of belief which will provide new challenges. Our approach to obtaining consent must take these into account. The parents in the case described above, by the way, had lived in this country for many years and were quite acculturated into American society.

With regard to consent for psychotherapy services, at a recent meeting Will Grove, Ph.D. explained that he had concerns about "bait and switch" situations. on other occasions I have heard this mentioned by other colleagues. This well-founded concern relates to point ten (10) in the list above. This has two facets to it:

1. Has the evaluation, the therapy, or the context of professional services changed to the degree that additional discussion and informed consent is needed. This may relate to the use of some measures that were not previously anticipated, a lengthening of the process, a change in the payment situation, etc.
2. Are there issues raided by what has come up, or by outside events, such as a custody battle, an allegation of child abuse, the possible need to make some mandated report, etc. For example, if the client begins talking about a bad experience with a former therapist but has not yet identified the person, it is a good idea to again review your reporting duties so that the client can decide whether he or she wants to specifically identify the professional by name. (If the name is not used, mandatory reporting may not be required, and yet one can still render help).

Informed consent is an ongoing duty. It is not limited to the first several sessions, and the need to provide information to the client and to obtain, or re-obtain consent, depends on many factors. Neither the professional nor the client is a fortune teller and able to see the future and foresee all circumstances. It is the professional's duty to do his or her best to try to anticipate reasonably foreseeable events and circumstances when first obtaining consent. But it is equally important to be alert to things which require further discussion. That is the reality of the situation -- and the nature of consent.