The informed consent , also informed consent and informed consent , a word creation based on the English model term informed consent , also consent after clarification , describes in connection with medical treatment the patient's consent to interventions and other medical measures based on information and clarification . Due to the patient's right to personality and self-determination, only those treatments may be carried out that are supported by the patient's will. Treatments that are carried out without effective consent can lead to claims for compensation by the patient against the treating person . The (prior) consent justifies the interference with the physical integrity of the patient in criminal and tort law and does not expose the doctor to criminal prosecution for bodily harm (Sections 223 and 230 StGB). The consent presupposes the ability to give consent , which - depending on the existing ability to understand - can also be given in the case of incapacitated persons . Under certain circumstances, the consent must be given by the legal representative (s) or by a legal guardian . According to German Civil Code (BGB), the approval of the supervisory court may be required. The power to give consent can be transferred to a proxy , for example by means of a health care proxy.
In the research on humans is only with the informed consent of a qualified approval , which will be given after the other side, so for example, the doctor, the therapist or experimenter , his duty to inform is fulfilled. The freely available publication by Margaret J. Neff provides an overview of individual questions of informed consent in the USA.
Civil and criminal meaning of consent
According toGerman Civil Code BGB), the treating is obliged to obtain the patient's consent before carrying out a medical measure, in particular an intervention in the body or health. After having properly informed the patient in an understandable way, the treating person must explicitly and unequivocally ask whether he or she consents to the measure.
For the treating person, the effective, i.e. informed consent is the justification for bodily harm associated with the treatment, so that the bodily harming treatment measures, insofar as they are covered by the consent, do not lead to criminal or tortious liability of the treating person.
Intervention clarification as a prerequisite for the effectiveness of the consent
The consent is only effective if the patient or the person entitled to consent has been informed competently in a language he can understand before the consent and before the medical intervention (so-called intervention explanation).
The Anglo-American literature developed the term informed consent for this. Already in 1914 Cardozo judged : "Every human being of adult years and sound mind has the right to determine what shall be done with his own body." (Quoted from Joseph H. King, the Law of Medical Malpractice in a Nutshell, St. Paul, Minn., 2nd edition 1986, p. 130)
Content and scope
The explanation of the intervention includes in particular the type, scope, implementation, expected consequences and risks of the measure as well as its necessity, urgency, suitability and prospects of success with regard to the diagnosis or therapy. When providing information, it is also necessary to point out alternatives to the measure if several medically equally indicated and common methods can lead to significantly different burdens, risks or chances of recovery (BGB) and to give the opportunity for questions and further advice in order to obtain informed consent.
The intervention explanation is separated from other information obligations of the treating person, for example from the obligation to inform the patient about essentials about his treatment, and from the safety explanation , which is supposed to ensure the success of the therapy (e.g. after sterilization the patient has to be informed that a Failure rate exists and further prevention is indicated). In contrast to intervention clarification, security information is not a prerequisite for the effectiveness of the consent.
The patient must be given the medical facts as part of the explanation of the intervention so that he can decide for or against the intended measure. He must be shown the essential risks associated with the intervention based on experience; the expected consequences of an omission should be set out in order to give him a choice. For this reason, real alternatives that come into question must be presented and explained after a medical examination.
- Typical intervention risks: General risk limits, such as listing all risks above 0.01%, do not make sense. In order for the patient to be able to recognize the severity and direction of the risk spectrum, the typical risks for the procedure must be described, even if they are very rare but can have serious effects. In the case of a cosmetic correction, a very detailed explanation is owed; in the case of an acute, vitally indicated treatment, the basics are sufficient. In the case of diagnostic interventions, there is a need for a more detailed discussion and risks less often than before urgent operations. Increased need for education concerns interventions whose chances of success are questionable.
- Risks of the specific intervention: It is controversial to what extent it is necessary to explain the risks inherent in the person of the doctor and the hospital equipment. Since the standard of a specialist must always be maintained anyway, the personal experience of the doctor is not a compulsory component, as well as possible deficiencies in equipment, as long as the standard of comparable hospitals is generally maintained. However, specific questions must be answered. Individual judgments by regional courts and higher regional courts are currently going in a different direction. Failure to refer to an older suction cup was seen as a failure to provide information.
- The risk of malpractice is not subject to disclosure.
- Alternative treatment methods: Only if the methods are similar in terms of opportunities and risks, i.e. if there is a real option, the doctor is obliged to provide further advice on which alternatives, with which opportunities and risks, are up for discussion. This obligation is unlimited if the patient asks himself. There is no obligation to provide information as long as alternative treatment methods are still in the experimental or trial stage.
Time and form
The information must be given verbally and in a personal conversation with the patient so that the patient has the opportunity to ask questions. The consenting party must give their express consent. A “formal consent” is not sufficient.
The information must also be given in good time before an intervention so that the patient has sufficient time to weigh up the reasons for and against the measure and to make a decision. In the case of surgical interventions, information must usually be given on the day before the operation. If the intervention is urgent, a shorter period may be sufficient. If the situation changes, the informed consent must be obtained again and the consent confirmed.
In practice, the Weissauer step-by-step explanation has established itself, which gives the patient basic information about the planned procedure and enables him to formulate questions or to forego further information. This is usually done in pre-printed information sheets. On the basis of this information, the special risks are addressed and the patient's questions are discussed in a personal consultation. This discussion can be delegated to subordinate doctors. In the case of foreign patients who do not speak German, family members are often available as translators with sufficient language skills. If this is not the case, a translator who knows the language must be called in.
- Children: Both parents are jointly represented; the child has the right to veto only relatively indicated interventions, provided they have sufficient insight. In the opinion of the Federal Court of Justice, the presence of the minor during an informational interview can be sufficient to satisfy the minor's right to self-determination even if the parents' consent has been given. The consent of both parents (if they have custody) is required; In the case of routine interventions of a lighter kind, without far-reaching risks, the doctor can rely on the parent appearing to inform him that he is authorized to give consent for the other. Otherwise, the consent is only effective if both parents have come to the information meeting and consented. The representation of the parents by third parties does not go as far as the self-determination of adult patients: religiously or ideologically motivated rejection of absolutely indicated treatments is irrelevant, as is the choice of an objectively failed therapy. In the event of contradicting statements by the parents or before an intervention that is refused by both parents, but which is essential for life, is initiated, the family court must apply for the replacement of the parental consent as far as possible; In an emergency, the doctor can, as an exception, be responsible for an unequivocally necessary measure.
- Inability to give consent: In the case of severe mental illness or intellectual disabilities , the patient may be incapable of giving consent . In this case, the consent of the respective legal representative is required. In the case of minors (see above), these are usually the parents (or the parent with sole custody) or a guardian or supplementary carer , in the case of adults a legal guardian or an authorized representative for health matters . In the case of dangerous treatment measures or life-prolonging measures, a supervisor or authorized representative also requires approval from the supervisory court ( BGB). This in turn does not apply if there is a consensus between the supervisor / authorized representative and the doctor on the interpretation of the patient's will.
According to the decision of the Federal Constitutional Court of March 23, 2011, there was no possibility in Germany of a representative consent to compulsory treatment, as a formally regulated law would be necessary for this, but the conditions defined by the court are currently not met by any regulation for "mentally ill" persons at the state level or at the federal level. This loophole in the law was closed for supervisors / authorized representatives with Section 1906 Paragraph 3 / 3a BGB in March 2013. In the meantime (as of spring 2017) most of the federal states have implemented corresponding regulations in the state laws for the mentally ill.
- Emergencies: The level of information required decreases with the urgency of the intervention and the decreasing ability of the patient to understand . As far as possible, family members or other confidants of the patient are to be involved in order to testify to the presumed will of the patient.
- Obstetrics: In all cases in which there is a serious possibility that the consent of the pregnant woman for further action is required, the doctor must provide information in good time; he cannot then plead that the progress of the birth prevented the informational discussion. In particular, the information on the alternative “cesarean section / vaginal delivery ” is to provide information on the operation for patient self-determination. The possible epidural anesthesia during childbirth is fraught with considerable risks and, as it is not indicated for vitality, is only permitted with the prior consent of the circle end. This can no longer be declared effective after an initial rejection during the birth process.
- Extension of a discussed operation: Even a carefully planning doctor often only recognizes the need to take further measures in the course of the operation. The doctor can only carry out the extended procedure without interruption if the extended procedure is vital; consent is deemed to be “presumed” if an “informed” patient would agree (which the doctor has to explain).
Burden of proof
In the event of a dispute, the treating person must provide evidence of his or her intervention .
The doctor can meet his burden of proof through his treatment documents. Above all, the Federal Court of Justice allows resident doctors to provide sufficient evidence if the fact that the information has been provided is recorded in the documentation and the doctor can provide evidence of regular clarification discussions, for example through his staff. The BGH is skeptical of formalized information, but accepts it if it is sufficiently specific and specific risks are mentioned. Corresponding service instructions are also sensible and required by case law in the clinical area.
The fully completed consent form signed by the patient first provides evidence of the correctness of the certificate; he justifies the assumption that the patient confirms correct facts in them, i.e. that an informative discussion was held, that the explicitly mentioned risks were mentioned and that the patient agrees to the treatment: he speaks against allegations of subsequent changes. However, the proof does not extend to the fact that the patient has read and understood an incomplete but signed sheet. Often there is a lack of a correct completion of the consent forms with regard to essential points (information about further risks, consent “with further questions” or “without” them, description of the operation). It promises the greatest success for the doctor's protection if it is recorded in a memo about the content and time of the conversation that every step of the explanation has taken place. The handing over of information sheets, their signature or the reason for their possible renewed handing out and late signing should also be recorded. In addition, the patient's written consent to essential information steps should be recorded, be it in consent forms or directly in the documentation.
In connection with Federal Court of Justice (BGH) has made it much easier for doctors to prove that their patients have been properly informed. According to , the court may base its formation of convictions on the information provided by the doctor about a completed risk assessment if its presentation is conclusive and “some” evidence for an informational interview is provided. This also applies if the doctor declares that he did not remember the disputed discussion. The signed consent form is - in both a positive and a negative sense - an indication of the content of the educational discussion.
The Hamm Higher Regional Court ruled on April 19, 2016 that a dentist can be liable for treatment using infiltration or conduction anesthesia if he has not informed the patient about the possible alternative treatment using intraligamentary anesthesia and that of the patient for the dental procedure given consent was therefore ineffective. It sentenced the dentist to pay € 4,000 in compensation for pain and suffering.
Informed consent in the sexual abuse debate
The term informed consent has been used by the American author David Finkelhor since 1979 as a justification for a general rejection of sex with children. Finkelhor formulated that children and sometimes adolescents can voluntarily consent to sexual acts, but do not understand the scope of such consent. Accordingly, they did not knowingly (informed) consent to the action , regardless of who they consent to. In his studies, Finkelhor demonstrated dramatic damage in the majority of abuse victims, but not in all of them. He found a developmental psychological argument against sexual acts with children, which is not necessarily based on evidence of damage and thus saves the victim from humiliating examinations.
Informed consent for sadomasochistic practices (BDSM)
From a legal point of view, there is a difference between criminal acts such as bodily harm, deprivation of liberty , insults or violations of the right to sexual self-determination (coercion) and the self-determined exercise of sexual preference ( BDSM ) in the voluntariness and consensuality of all adult partners who, according to the ethical principles of the SSC takes place. What is disputed, however, is the extent to which consent to (slight) bodily harm may be given at all, since the aspect of immorality is affected. According to StGB, consent to serious bodily harm is not possible.
Informed consent and debriefing after psychological experiments
“If a potential test person decides to participate in the investigation in question after taking note of all the relevant information, this is known as 'informed consent'. If people are interested in their own test results, it goes without saying that these will be communicated in writing, by telephone or in a small presentation after the test has been completed. "
“Occasionally, for an investigation to be successful, it is necessary that the investigation participants are not allowed to experience the actual purpose of the investigation [...]. If deceptions are unavoidable and the investigation promises important new findings, there is an obligation to explain the true relationships to the participants after the investigation has been completed ( debriefing ). Afterwards, attention should be drawn to the possibility of not allowing further analysis of your data. "
- Tom L. Beauchamp et al .: Art. Informed Consent , in: Stephen G. Post (ed.): Encyclopedia of Bioethics , Thomson Gale / Macmillan, New York 2004, ISBN 0-02-865774-8 , p. 1271– 1313. (With numerous other literature.)
- R. Faden, T. Beauchamp: A History and Theory of Informed Consent. Oxford 1986.
- Herbert Jäger: Criminal Law Policy and Science. In: Fritz Bauer (ed.): Sexuality and criminality. Fischer, Frankfurt a. M. 1963, pp. 273-298.
- Carrie Hill Kennedy: Assessing Compentency to Consent to Sexual Activity in the Cognitively Impaired Population. In: Journal of Forensic Neuropsychology. 1, 3 (1999): 17-33.
- Andreas-Holger Maehle: Medical intervention and bodily harm. On the historical and legal roots of informed consent in surgery, 1892–1940. In: Würzburger medical history reports 22, 2003, pp. 178–187.
- Janet Malek: Art. Informed Consent , in: Carl Mitcham (ed.): Encyclopedia of science, technology, and ethics , Thomson Gale / Macmillan, New York 2005, ISBN 0-02-865831-0 , Vol. 3, pp. 1016-1019. (With selected other literature.)
- Nir Eyal: Informed Consent. In: Edward N. Zalta (Ed.): Stanford Encyclopedia of Philosophy .
- Neff MJ: Informed consent: what is it? Who can give it? How do we improve it? , Respir Care. 2008 Oct; 53 (10): 1337-41. Review, PMID 18811997
- Argument: Abs. 2 BGB
- BGH, judgment of October 10, 2006 , Az. VI ZR 74/05, full text.
- BVerfG, decision of March 23, 2011 , Az. 2 BvR 882/09, full text.
- BGH, judgment of January 28, 2014, Az .: VI ZR 143/13
- Obligation to inform about treatment alternatives to infiltration or conduction anesthesia, intraligamentary anesthesia , Higher Regional Court Hamm, judgment of April 19, 2016, Az. 26 U 199/15.
- Ursula Enders (Ed.): I was tender, it was bitter . Manual Against Sexual Abuse. 3. Edition. Kiepenheuer & Witsch , Cologne 2003, ISBN 978-3-462-03328-1 , p. 22 : “Children [...] cannot knowingly refuse or consent to sexual contact with men (women) [...]. Consequently, every sexual contact between an adult and a child must be assessed as sexual abuse ([…] Finkelhor 1979 […]). "
- David Finkelhor et al. [Eds.]: A Sourcebook On Child Sexual Abuse , Newbury Park: Sage, 1986.
- Ursula Enders (Ed.): I was tender, it was bitter . Manual Against Sexual Abuse. 3. Edition. Kiepenheuer & Witsch, Cologne 2003, ISBN 978-3-462-03328-1 , p. 458 (on Bärsch: p. 457, on Lautmann: p. 462–463, on Bornemann: p. 457–458): “Borneman […] demands this in a documentation of the 'Interest and Protection Association of Dependent Fathers' (ISUV) Right of the child to his own undisturbed love life (from the age of 7), because children could - even with adults - lead a completely normal sex life (cf. ISUV 1992). "
- J. Bortz, N. Döring: Research methods and evaluation for human and social scientists . Springer, Heidelberg 2006, p. 44.