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I was going through some of my old papers and ran across this little bit on informed consent in research and figured I'd share it here.

Informed Consent is considered an essential part of modern research with human participants. O’Leary (2004) states that informed consent, “ensures that researchers do not violate people’s privacy and that prospective research participants are given enough information about the nature of a study to make a reasoned decision about whether they want to participate.

Three conditions must be met for informed consent: 1. The client must understand the information presented. 2. The consent must be given voluntarily. 3. Client must be competent to give consent.

Informed consent, as we understand it now, can really be seen as a major issue arising from many instances in history; however one which stands out were the Nuremburg Trials in the aftermath of WWII. Under the Nazi regime in Germany, many individuals were subjected to medical atrocities such as non-consensual x-ray sterilization, cold endurance, and experiments using people to test reactions to bombs, mustard gas, and other chemicals.

The subsequent Nuremberg Code (NIH, n.d.) set down the Directives for Human Experimentation. They are as follows:

  1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.

  2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

  3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.

  4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

  5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.

  6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

  7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

  8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.

  9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be

  10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

This is not to say that there was no such concept prior to the Nuremberg Code. One example would be Prussia around the turn of the century (1900). After a case involving research for a vaccine for syphyllis which utilized mostly prostitutes (without their knowledge, of course), a directive was made that any procedures outside of diagnosis, healing or immunization would require the patient’s “unambiguous consent after a proper explanation of the possible negative consequences of the intervention” (Vollmann, 1996). Even the Reich government (in 1931) under Adolf Hitler had a detailed code of the use of humans in research and therapy. As Vollmann notes of this code, “Some regulations were even stricter and more detailed than those contained in the Nuremberg code”.

However, these regulations were obviously overlooked and outright ignored by those individuals such as Josef Mengele, Horst Schumann and Carl Clauberg under the direction of Eduard Wirths for the SS under the command of Heinrich Himmler. It was seen as necessary to contribute to the security of the homeland.

Other examples of pre-Nuremberg Code consent disputes in the U.S. can be found in the legal literature from around the turn of the century – in 1906 “an Illinois woman sued her doctor contending she had never given permission for the removal of her uterus” (Evans & Meyer, 2004). However, as Evans and Meyer note, during this time, consent was much like a lightswitch in that it was either given or it wasn’t – a very simplistic dichotomy. A case in 1916, Schloendorff v. Society of New York Hospital, had in the court’s decision terminology closer to what we think of in regard to informed consent:

“Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent, commits an assault, for which he is liable in damage” (qtd. in Studdert, Mello, Levy, Gruen, Dunn, Orav et al., 2007).

It was not until 1957 that the idea of “informed” was paired with consent in the case of Salgo v. Leland Stanford, Jr. University Board of Trustees. In the decision of the court, the first appearance of “informed consent” was to be found when the decision stated, “In discussing the element of risk a certain amount of discretion must be employed consistent with the full disclosure of fact necessary to an informed consent” (Katz & Capron, 2002).

In 1964, the World Medical Association (1964) adopted the Declaration of Helsinki which laid down the ethical principles in dealing with human experimentation. The main principle within the document is respect for the individual:

“Medical research is subject to ethical standards that promote respect for all human beings and protect their health and rights. Some research populations are vulnerable and need special protection. The particular needs of the economically and medically disadvantaged must be recognized. Special attention is also required for those who cannot give or refuse consent for themselves, for those who may be subject to giving consent under duress, for those who will not benefit personally from the research and for those for whom the research is combined with care” (Article 8).

The individual’s right to self-determination as well as the right to make informed decisions are highlighted as well:

“The subjects must be volunteers and informed participants in the research project” (Article 20).

“The right of research subjects to safeguard their integrity must always be respected. Every precaution should be taken to respect the privacy of the subject, the confidentiality of the patient's information and to minimize the impact of the study on the subject's physical and mental integrity and on the personality of the subject” (Article 21).

“In any research on human beings, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail. The subject should be informed of the right to abstain from participation in the study or to withdraw consent to participate at any time without reprisal. After ensuring that the subject has understood the information, the physician should then obtain the subject's freely-given informed consent, preferably in writing. If the consent cannot be obtained in writing, the non-written consent must be formally documented and witnessed” (Article 22).

The declaration has since gone through five revisions, each adding important aspects to the outline as well as attempting to keep up with medical science as it progresses. Subsequent revisions dealt with the matters of consent from minors, independent committees, placebo use, and the application of ethical principles in international research.

In 1979, the Department of Health, Education and Welfare released the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This document outlined the details on Informed Consent:

Informed Consent. -- Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied.

While the importance of informed consent is unquestioned, controversy prevails over the nature and possibility of an informed consent. Nonetheless, there is widespread agreement that the consent process can be analyzed as containing three elements: information, comprehension and voluntariness.

Information. Most codes of research establish specific items for disclosure intended to assure that subjects are given sufficient information. These items generally include: the research procedure, their purposes, risks and anticipated benefits, alternative procedures (where therapy is involved), and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research. Additional items have been proposed, including how subjects are selected, the person responsible for the research, etc.

However, a simple listing of items does not answer the question of what the standard should be for judging how much and what sort of information should be provided. One standard frequently invoked in medical practice, namely the information commonly provided by practitioners in the field or in the locale, is inadequate since research takes place precisely when a common understanding does not exist. Another standard, currently popular in malpractice law, requires the practitioner to reveal the information that reasonable persons would wish to know in order to make a decision regarding their care. This, too, seems insufficient since the research subject, being in essence a volunteer, may wish to know considerably more about risks gratuitously undertaken than do patients who deliver themselves into the hand of a clinician for needed care. It may be that a standard of "the reasonable volunteer" should be proposed: the extent and nature of information should be such that persons, knowing that the procedure is neither necessary for their care nor perhaps fully understood, can decide whether they wish to participate in the furthering of knowledge. Even when some direct benefit to them is anticipated, the subjects should understand clearly the range of risk and the voluntary nature of participation.

A special problem of consent arises where informing subjects of some pertinent aspect of the research is likely to impair the validity of the research. In many cases, it is sufficient to indicate to subjects that they are being invited to participate in research of which some features will not be revealed until the research is concluded. In all cases of research involving incomplete disclosure, such research is justified only if it is clear that (1) incomplete disclosure is truly necessary to accomplish the goals of the research, (2) there are no undisclosed risks to subjects that are more than minimal, and (3) there is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them. Information about risks should never be withheld for the purpose of eliciting the cooperation of subjects, and truthful answers should always be given to direct questions about the research. Care should be taken to distinguish cases in which disclosure would destroy or invalidate the research from cases in which disclosure would simply inconvenience the investigator.

Comprehension. The manner and context in which information is conveyed is as important as the information itself. For example, presenting information in a disorganized and rapid fashion, allowing too little time for consideration or curtailing opportunities for questioning, all may adversely affect a subject's ability to make an informed choice.

Because the subject's ability to understand is a function of intelligence, rationality, maturity and language, it is necessary to adapt the presentation of the information to the subject's capacities. Investigators are responsible for ascertaining that the subject has comprehended the information. While there is always an obligation to ascertain that the information about risk to subjects is complete and adequately comprehended, when the risks are more serious, that obligation increases. On occasion, it may be suitable to give some oral or written tests of comprehension. Special provision may need to be made when comprehension is severely limited -- for example, by conditions of immaturity or mental disability. Each class of subjects that one might consider as incompetent (e.g., infants and young children,mentally disabled patients, the terminally ill and the comatose) should be considered on its own terms. Even for these persons, however, respect requires giving them the opportunity to choose to the extent they are able, whether or not to participate in research. The objections of these subjects to involvement should be honored, unless the research entails providing them a therapy unavailable elsewhere. Respect for persons also requires seeking the permission of other parties in order to protect the subjects from harm. Such persons are thus respected both by acknowledging their own wishes and by the use of third parties to protect them from harm.

The third parties chosen should be those who are most likely to understand the incompetent subject's situation and to act in that person's best interest. The person authorized to act on behalf of the subject should be given an opportunity to observe the research as it proceeds in order to be able to withdraw the subject from the research, if such action appears in the subject's best interest.

Voluntariness. An agreement to participate in research constitutes a valid consent only if voluntarily given. This element of informed consent requires conditions free of coercion and undue influence. Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence, by contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue influences if the subject is especially vulnerable. Unjustifiable pressures usually occur when persons in positions of authority or commanding influence -- especially where possible sanctions are involved – urge a course of action for a subject. A continuum of such influencing factors exists, however, and it is impossible to state precisely where justifiable persuasion ends and undue influence begins. But undue influence would include actions such as manipulating a person's choice through the controlling influence of a close relative and threatening to withdraw health services to which an individual would otherwise be entitled.

Texas Law and Informed Consent:

Texas law in this area is “grounded in an account of medical decision-making that gives accent to individual autonomy” (Cherry & Englehardt, 2004). Such is seen as a “common sense” view that people have a say in what is done to them. Under the Texas Health and Safety Code, Chapter 591.006:

Consent.

(a) Consent given by a person is legally adequate if the person:

(1) is not a minor and has not been adjudicated incompetent to manage the person's personal affairs by an appropriate court of law;

    (2) understands the information; and

    (3) consents voluntarily, free from coercion or undue influence.

(b) The person giving the consent must be informed of and understand:

(1) the nature, purpose, consequences, risks, and benefits of and alternatives to the procedure;

(2) that the withdrawal or refusal of consent will not prejudice the future provision of care and services; and

(3) the method used in the proposed procedure if the person is to receive unusual or hazardous treatment procedures, experimental research, organ transplantation, or nontherapeutic surgery.

While it is true that most of the cases involving informed consent have been found within the medical community, as Pope and Vasquez (2007) note, “the relevance (not always complete) of the principles to clinical assessment and psychotherapy can be inferred” (pp. 137).

Potential Problem Areas in Informed Consent:

Obtaining informed consent is not always a cut and dry process and as simple as making a nice looking form for an individual to sign. There are often circumstances when obtaining informed consent may be problematic. Four of these instances are discussed below.

Individual Comprehension:

Dunn and Jeste (2003) noted in an article published in Psychopharmacology that there can be problems in obtaining informed consent with individuals with severe mental illness. The examined 102 patients diagnosed with schizophrenia or schizoaffective disorder, mood disorder with psychotic features, or psychosis not otherwise specified. They found that, as compared to normal control subjects, these participants had trouble in comprehension about questions relating to the study procedures, time involved, as well as potential risks and benefits. Flory and Emanuel (2004) also noted many other studies in which comprehension by the participants was a problem for them to be fully informed of what they were agreeing to participate in. Through this examination, however, they did find that there were some solutions. Specifically they concluded that more time spent one-on-one with the participants by a researcher or outside educator aided in this task and had a higher success rate than other techniques such as the use of multimedia.

Minors:

With minors it is the general guideline that the consent will be obtained by the parent or guardian of the minor. It is assumed that the parent or guardian has the minor’s best interest in mind which is a core part of the informed consent in this area. There are exceptions, however, such as the case of minors who have been emancipated. In these cases the minors take the responsibility for consent as if they were adults. Also, some concessions are made for adolescents between 13 and 18 years in some states in the matter of contraceptives, STDs, pregnancy as well as alcohol and drug abuse.

In some instances mature minors may make their own decisions and provide consent which is sometimes determined by a court or left to the decision of the care provider such as a physician.

There is also minor assent which includes the minor is the decision-making process. This however is not considered as having the same depth as consent. There are some gray areas especially in the area of refusal of treatment as well as disagreement between adolescents and parents. Much of the onus falls upon the care provider in these situations. In such instances, in a medical setting for example, the physician is to act as a mediator between the adolescent and parents according to the Committee on Bioethics (Committee on Bioethics, 1995; Kuther, 2003).

Cognitively Impaired Individuals:

Those who are found to be cognitively impaired as to not let them comprehend or make rational decisions regarding their own care are most often treated similarly as minors with the guardian or some other legally authorized representative providing the consent in many cases. However, this may not always be the case and there is still much debate on exactly how to go about handling the situation. One particular area, for example, is in research done with adults with dementia. With this in mind the American Geriatrics Society has published a position on the matter and it has been proposed that their position be extended to other cognitively impaired individuals (AGS Ethics Committee, 2007). Other propositions involving more specific areas to be addressed have been proposed such as the use of surrogates to work on behalf of the individuals and to keep their best interests in mind (Berg, 1996).

Deception in Research:

Deception is a technique utilized in research which is important in many instances. How does one obtain an informed consent without undermining the purpose of the study? According to the APA Ethics Code Section 8.07, it is preferable to not use deception in research, however when deception is an integral part of the research the participants must explain any deception to the individuals, “as early as is feasible, preferably at the conclusion of their participation, but no later than at the conclusion of the data collection, and permit participants to withdraw their data”. Further, in Principle C: Integrity it states that, “psychologists have a serious obligation to consider the need for, the possible consequences of, and their responsibility to correct any resulting mistrust or other harmful effects that arise from the use of such techniques” (APA, 2003).

With all this being said, some may want a real world example of why informed consent for research is important aside from the actions of the Nazi party in Germany. Consider this scenario:

You have been told that you will be receiving free medical care provided by the United States government at a specific location near you. Sound good? Of course. When you arrive to be seen for flu-like symptoms, (headaches, general aches and pains, sickness, loss of appetite and a fever) you are ordered to have many different tests done including lumbar punctures and injections of some medication of which you aren’t made aware of what it is. How does that make you feel now?

Later on, you find out that you were being utilized in research to test what happens when syphilis goes untreated. Would you have accepted the “service” had you known what was involved?

This is what many African American males found during the infamous experiments carried out by the U.S. government for nearly 40 years on sharecroppers in Tuskegee, Alabama (Corbie-Smith, 1999).

References:

American Geriatrics Society (2007). Position Statement Informed Consent for Research on Human Subjects with Dementia AGS Ethics Committee. Retrieved October 14, 2008 from http://www.americangeriatrics.org/products/positionpapers/infconsent.shtml.

American Psychological Association (2003). Ethical principles of psychologists and code of conduct. Retrieved October 14, 2008 from http://www.apa.org/ethics/code2002.html#8_07.

Berg, J. (1996). Legal and ethical complexities of consent with cognitively impaired research subjects: Proposed guidelines. Journal of Law, Medicine & Ethics, 24, 18-35.

Cherry, M. & Englehardt, H. (2004). Informed consent in Texas: Theory and practice. Journal of Medicine and Philosopy, 29(2), 237-252.

Committee on Bioethics (1995). Informed consent, parental permission, and assent in pediatric practice. Pediatrics, 95, 314-317.

Corbie-Smith, G. (1999). The continuing legacy of the Tuskegee syphilis study: Considerations for clinical investigation. American Journal of the Medical Sciences, 317, 5-8.

Dunn, L. & Jeste, D. (2003). Problem areas in the understanding of informed consent for research: study of middle-aged and older patients with psychotic disorders. Psychopharmacology, 171, 81-85.

Evans, G. & Meyer, M. (2004). Informed Consent: The Third Generation. Austin: Texas Medical Liability Trust.

Flory, J. & Emanuel, E. (2004). Interventions to improve research participants’ understanding in informed consent for research. Journal of the American Medical Association, 292, 1593-1601.

Katz, J. & Capron, A. (2002). The Silent World of Doctor and Patient. Baltimore: Johns Hopkins University Press.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979). Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014. Washington, D.C.: U.S. Government Printing Office.

National Institutes of Health (n.d.). Nuremberg Code: Directives for Human Experimentation. Retrieved October 13, 2008 from http://ohsr.od.nih.gov/guidelines/nuremberg.html.

O’Leary, M. (2004). Introduction to Behavioral Research Methods. (4th ed.). Boston: Allyn and Bacon.

Pope, K & Vasquez, M. (2007). Ethics in Psychotherapy and Counseling. (3rd ed.). San Francisco: Jossey-Bass.

Studdert, D., Mello, M., Levy, M., Gruen, R., Dunn, E., Orav, J. et al. (2007). Geographic variation in informed consent law: Two standards for disclosure of treatment risks. Journal of Empirical Legal Studies, 4, 103-124.

Vollmann, J. (1996). Nuremberg Doctors’ Trial: Informed consent in human experimentation before the Nuremberg Code. British Medical Journal, 313, 1445-1447.

World Medical Association (2008). WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. Retrieved October 13, 2008 from http://www.wma.net/en/30publications/10policies/b3/index.html.