A 576 e

MEDICINE
cme: Patient Information and

Informed Consent before and after
Medical Intervention
Markus Parzeller, Maren Wenk, Barbara Zedler, Markus Rothschild
SUMMARY
Introduction: Numerous medical, medicolegal and ethical considerations surround medical
intervention, patient information and informed consent. Methods: The following discussion
focusses on the medicolegal viewpoint, based on decisions of the Federal Court of Justice,
medicolegal literature and the interpretation of some recent medicolegal cases. Results: Any
medical intervention fulfils the legal criteria for physical injury. This goes for diagnostic as well
as therapeutic procedures. Informed consent must therefore respect the patient's right to selfdetermination and freedom of decision making. These rights take clear precedence over and
above the doctor's medical opinion. Informed consent must always be carried out by a doctor; it
is unacceptable for it to be carried out by non medical personnel.
Dtsch Arztebl 2007; 104(9): A 57686.
Key words: patient autonomy, medical intervention, physical injury, patient information, informed
consent
n Germany today, the legal situation with respect to medical interventions, patient
information, and informed consent is extremely complex (125). On the basis of the
position espoused by the Imperial Court of Justice (Reichsgerichtshof) in 1894 (RGSt 25,
375), which has been consistently maintained by the Federal Court of Justice (Bundesgerichtshof) (BGHSt 35, 246), any medical intervention is considered to contain the
elements of the legal offense known as physical injury, as defined by 223 ff. StGB; 823
I BGB (table 1).
Interventions include not only therapeutic medical procedures, such as the performance
of operations or the administration of medications, but also diagnostic procedures over the
entire range of invasiveness, from endoscopy (for instance) to a simple venipuncture for
a blood sample. Physical injury is described in 223 StGB as physical maltreatment,
i.e., bad and inappropriate treatment that impairs physical well-being to a more than harmless
extent, or as personal injury / injury to the health through the creation or increase of a
pathological condition, even if this condition is only temporary.
The law considers it irrelevant whether the intervention was medically indicated and was
carried out according to accepted medical practice with the intent to heal (for other
interpretations, see table 1). Like any other physical injury, e.g., blows during an unlawful
assault, medical interventions can be sanctioned under criminal law with fines or imprisonment
unless there are special considerations that vitiate culpability.
In civil law, an unlawful medical intervention can give rise to either contractual ( 280 I
BGB) or tortious liability ( 823 I, II, 831 I, 839 I BGB) (table e1 [for all material marked
e please refer to the additional material at the end of this article]). Unlawful medical
Zentrum der Rechtsmedizin der Johann Wolfgang Goethe-Universitt, Frankfurt (RA Dr. med. Parzeller, Wenk, Zedler); Rechtsanwaltskanzlei Dr. med Parzeller, Obertshausen (RA Dr. med. Parzeller); Institut fr Rechtsmedizin der Universitt zu Kln (Prof. Dr.
med. Rothschild)
The legal status of medical procedures

Every medical intervention contains the elements
of physical injury as defined by law.
Medical interventions include not only therapeutic,
but also diagnostic procedures.
Dtsch Arztebl 2007; 104(9): A 57686 www.aerzteblatt.de
MEDICINE
Glossary
Note: The following German legal abbreviations will be used throughout this article:
AMG
Arzneimittelgesetz, Medical Preparations Act
ArztR
Arztrecht, Medical Law (a German-language legal journal)
Az
Aktenzeichen, reference number
Beschl
Beschluss, decision
BGB
Brgerliches Gesetzbuch, German Civil Code
BGH
Bundesgerichtshof, Federal Court of Justice
BGHSt
Bundesgerichtshof Strafsachen, Decisions of the Federal Court of Justice in

Criminal Matters (a German-language legal journal)
BVerfG
Bundesverfassungsgericht, Federal Constitutional Court
GG
Grundgesetz, Basic Constitutional Law of the Federal Republic of Germany
LG
Landgericht, Local Court
MBO
(Muster-)Berufsordnung, (Model) Professional Code of Conduct for the Chambers

of Physicians of the German states
NJW
Neue Juristische Wochenschrift (a German-language legal journal)
OLG
Oberlandesgericht, Higher Regional Court
RG
Reichsgerichtshof, Imperial Court of Justice (18791945)
RGSt
Reichsgerichtshof Strafsachen, Decisions of the Imperial Court of Justice in

Criminal Law (a German-language legal journal)
StGB
Strafgesetzbuch, Criminal Code
TPG
Transplantationsgesetz, Law on Transplantation
tvA
teilweise vertretene Auffassung, opinion expressed less than unanimously
Urt
Urteil, judgment
VersR
Versicherungsrecht, Insurance Law (a German-language legal journal)
interventions can also be punished by the Disciplinary Committee of the Chamber of Physicians
of one of the German states (Landesrztekammer), in accordance with the applicable rules
of professional conduct. It would clearly be inappropriate for physicians to be punished for
physical injury under both criminal and civil law after carrying out medically indicated
procedures according to accepted medical practice after proper and thorough information
of the patient and with his or her consent. The law, therefore, provides for the punishment only
of unlawfully and culpably committed physical injury. Interventions into the patient's legal
domain are unlawful if they lack a reason that makes them lawful. Acceptable reasons for the
lawfulness of a medical intervention are the patient's consent or presumed consent, and a
justifying emergency according to 34 StGB (table e1).
The patient's consent can be given explicitly or implicitly through behavior that implies
consent. Presumed consent comes into consideration when the patient's explicit or implicit
consent cannot be obtained in timely fashion before the intervention (e.g., because of
unconsciousness). The patient's presumed wishes are determined primarily from his or her
known personal interests, desires, needs, and values (BGHSt 35, 246). Criminal culpability
and civil liability can be absent even when massive interventions are performed on the
A medical intervention can be legally justified by:

The patient's presumed consent, e.g., if the patient is
unconscious.
A justifying state of emergency, when not enough time is
available to locate the guardian of the unconscious
patient, inform that person of the impending intervention,
and obtain consent.
Criterion for proper patient information

The patient's right to self-determination,
autonomy, and freedom of decision
unequivocally take precedence over the
physician's medical opinion.
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patient's body, as long as the patient has given valid consent to this medical treatment. Normally,
the patient is a medical layman and can give valid consent only after being informed about
the material circumstances, modalities, and risks of the impending medical intervention.
The treating physician bears the responsibility of informing the patient thoroughly about
the intervention beforehand, to enable the patient to make an autonomous decision and
thereby avoid legal difficulties.
Proper patient information

Basic constitutional principles give clear priority to the patient's self-determination, autonomy,
and freedom to choose over the physician's medical opinion. The right to self-determination
is derived from human dignity and the right to bodily integrity (table e1). It follows that the
patient may also decide in a medically unreasonable fashion and refuse any proposed medical
intervention. The patient's wishes are, in the end, determinative.
In the process of informing the patient, the physician, while giving due consideration to
the patient's point of view, provides him or her with all of the information needed to weigh
the reasons for and against the proposed intervention in the light of the specific circumstances
of the patient's illness and its course, and thereby to make a decision to undergo the intervention
or not. The patient must also be adequately informed, to a degree that meets his or her
personal expectations, about possible treatment failures and risks (BGH NJW 1981, 1320
[1320 ff.]). The physician's material duty is therefore not just to treat the patient with due
care, but also to preserve the patient's right to self-determination. The process of patient
information is not covered in general law, but only in special law and regulations (table e1).
The various German jurisdiction that have dealt with patient information have, however, resulted in the development of multiple, overlapping standards for patient information; the
differences between them are often subtle (table e2).
TABLE 1
Legal status of medical interventions as physical injury (12, 17, 24, 25)
Not considered physical injury
Considered physical injury
Repeated judicial decisions of the BGH

(BGHSt 35, 246) based on those of the
RG (RGSt 25, 375) dating back to 1894
Any medical intervention that impinges on

bodily integrity contains the elements of
a physical injury. Examples include:
The physician must be aware of these!
operations,
punctures,
diagnostic procedures,
preventive procedures,
treatment with medications,
cosmetic procedures,
shaving or cutting the hair of the head or
elsewhere on the body.
Other considerations based on the

outcome of the intervention (tvA)
when the intervention is successful

when the intervention is unsuccessful
but justified by the patient's consent
Other considerations based on danger

to the patient (tvA)
Prevailing view in the literature
When the intervention is unsuccessful and the

patient did not consent
When new dangers arise or the patient suffers
additional pain
When the procedure is medically indicated

and carried out according to accepted
medical practice, because its overall
result is an improvement of physical
well-being
Patient information is subdivided into

explanations of
the diagnosis,
the treatment,
the attendant risks,
and the further course after treatment.
The "Six W" Checklist

Who informs?
Whom does the physician inform?
When is the proper time for patient information?
What information should be provided, in what manner,
and to what degree of detail?
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The process of pre-treatment patient information serves the goal of self-determination by

giving the patient all of the relevant information that is necessary for him or her to decide
freely and responsibly about the performance of a medical treatment. The patient should be
informed in full detail about the nature of the treatment or intervention. The information received
ought to give him or her a clear idea of the type and course of the illness, its possible treatments
and treatment alternatives, and the spectrum and severity of the associated risks.
The provision of pre-treatment patient information is broken down into components
involving the diagnosis, treatment, risks, and further course of the illness (table e2). On the
basis of the information provided by the physician, the patient ought to understand the
probability of successful treatment, as well as the risks associated with the diagnostic
process and the intervention or treatment, in order to be able to make his or her own relative
assessment of the benefits and risks and then decide for or against the proposed treatment.
The physician is thus also required to mention all dangers associated with the proposed
treatment, even rare ones.
Generally known risks need not necessarily be explicitly mentioned (BGH NJW 1994,
2414 [2414]). Nevertheless, the most serious risks, i.e., the potential adverse events that
would impair the patient's well-being to the greatest extent, must be mentioned even if they
are very rare, as long as they are a typical complication of the proposed intervention.
Therapeutic patient information differs from pre-treatment patient information (the
"classic" type) in being a vital component of medical treatment during the further course of
the patient's illness. Errors relating to therapeutic patient information are considered to be
treatment errors, rather than informational errors (BGH NJW 1989, 2318 2319 f. ). Therapeutic
patient information, which is provided only after the intervention has taken place, is a means
of informing and counseling the patient about any possible medication intolerance, side
effects, or interactions, restrictions on driving, overdose prevention, and anything else the
patient needs to know about the further course of treatment. The patient should also be
instructed in how to promote his or her own recovery, e.g., by avoidance of sports if
mechanical stresses pose a danger (OLG Kln VersR 1992, 1231) or by taking prophylactic
measures against thrombosis (OLG Bremen VersR 1999, 1151). Therapeutic patient
information is also necessary if the patient's illness is contagious and thus poses a risk to
other individuals (BGH NJW 1994, 3012 [3013 f.] ).
The important juridical considerations in patient information are related to person, time,
and content, according to the "Six W Checklist" (5). With respect to person, the relevant
questions are who bears the responsibility for providing information (problem: delegation)
and whom he or she ought to inform (problem: minors). With respect to time, the question
is when it is appropriate for the physician to provide the required information (box 1). With
respect to content, the questions are what information should be provided, in what manner,
and to what degree of detail (table e3, table 2).
The basic requirement is that the task of informing the patient should be carried out by a
physician. Delegation to non-medical staff is not permissible (cf. BGH NJW 1974, 604
[605 f.]). It is best for the treating physician (for surgical interventions, the operating
surgeon) to inform the patient; another physician, such as a surgeon, may do so instead if he
or she possesses the required knowledge of the medical specialty and of the patient's
condition (cf. OLG Karlsruhe NJW-RR 1998, 459 [461]). The person who informs the
patient thereby provides part of the patient's medical treatment and shares responsibility for
the validity of the patient's consent. If the subsequent intervention is judged to have been
performed without valid consent, a physician who informed the patient but did not personally
perform the intervention is nonetheless liable for unlawful physical injury and any physical
injury that may result (BGH NJW 1980, 1905 [1906 f.]).
The proper time for patient information

The discussion for patient information should be held
at an appropriate interval before treatment.
The patient must be given enough time to consider
the pros and cons of the proposed intervention.
MEDICINE
BOX 1
Requirements for the first contact between the physician

and the patient (in some cases days or weeks before the
intervention) and for the timing of the discussion for patient
information*
First contact between the physician and the patient
(in some cases days or weeks before the intervention)
Comprehensive information about the diagnosis and the nature and risks of the proposed
intervention (for further details, see table e2).
The first contact may be the proper time for the definitive discussion for patient information if
an appointment for the intervention can be given at that time, as long as no test results are
still outstanding and no further tests must be performed.
If the patient has been informed at the first contact, another discussion for patient information
may have to be held later on, a short time before the intervention is carried out (so-called
double information).
24 hours before the intervention
Minor interventions with low risk (in- or outpatient)
Patient information is legally valid
Major interventions (in- or outpatient)
Patient information may not be legally valid
The evening before the intervention
Minor interventions with low risk (in- or outpatient)
Major interventions (in- or outpatient)
A discussion the evening before the intervention is inadequate if the patient hears then for the
first time about serious risks and possible detriments to his or her current quality of life
The day of the intervention
Minor interventions with low risk (outpatient, diagnostic)
as long as the patient comprehends the nature and extent of the intervention
and as long as the discussion for patient information is clearly separated from the operative
phase itself
Patient information may be legally invalid
if the discussion is held immediately before the intervention,
on the way to or in the operating room,
or after the administration of sedatives or other preoperative medications.
After the procedure has been performed
The patient can be informed about any necessary lifestyle adjustments (limitations, cautionary
measures, use of medication), if this has not already been done.
* Note: Individual circumstances are determinative in all cases. The requirements are less stringent in emergencies.
Precondition for valid consent

The patient must possess the necessary judgment and
free will to weigh the pros and cons of the proposed
intervention reasonably and to understand the
implications of his or her decision.
MEDICINE
The physician should inform the patient in a face-to-face conversation and in understandable
language. A personal conversation about the risks of a procedure can be dispensed with only
for very simple, routine procedures or emergencies. For routine procedures, an information
sheet may suffice as long as the patient has the opportunity to ask additional questions if
desired. Any language barrier that hinders communication with foreign patients must be
overcome with the aid of hospital personnel, relatives, or translators who speak the patient's
TABLE 2
Exceptions to the physician's duty of informing the patient*
Type of exception
Examples
Relevant case decisions
Extension
of operation
When the patient's life is in danger, the concept of presumed consent applies.
But cf. BGH decision of 20.5.2003

5 StR 592/02
Generally known
risks
e.g., hematoma after needle puncture (but cf. nerve injury in blood donation, BGH 14.3.2006
VI ZR 279/04), inadequate wound healing, risk of wound infection
BGH NJW 1991, 1541 (1542)
Informed patient
If the patient has already been informed by another physician (e.g., the general practitioner)
or is himself/herself a physician in possession of the necessary knowledge, the treating physician
may need to inform to a lesser extent, or not at all.
Cf. BGH NJW 1994, 2414 (2415)
Organizational error There is no duty to inform the patient about organizational errors, such as the fact that a physician
has inadequate malpractice insurance.
BGH decision of 7.12.2004 VI ZR

212/03
Patient requests
not to be informed
The physician cannot accede to a patient's request not to be informed at all about the proposed
procedure, as the patient must first know whether the procedure is necessary before he or she
can decline to be informed about it. The patient may, however, request not be informed
comprehensively about every detail.
Cf. also BGH NJW 1973, 556

(558); OLG Saarbrcken, VersR
1988, 95 (95)
Poor prognosis
The physician does not have a duty to inform the patient in full detail about a serious disease with
a poor prognosis for which there is no treatment (nevertheless, this information may be important
in prompting the patient to write a will).
Cf. (10)
Procedure performed There is no general duty to inform the patient of the physician's relative inexperience.
by inexperienced
The physician is expected to adhere to the accepted standards of medical care in all cases.
physician
Cf. BGH NJW 1984, 655ff.
Suspected
diagnoses
Suspected diagnoses and working hypotheses that might cause the patient considerable worry
BGH NJW 1983, 328 (329); OLG
need not be told to the patient, depending on the specific circumstances of the individual case (2936). Kln NJW 1987, 2936
Therapeutic
privilege
The law rejects the notion of therapeutic privilege. The highest court has ruled that the physician
must inform the patient of the diagnosis of an incurable illness, even if the prospect exists that
this information might itself worsen the patient's condition.
Cf. BGH NJW 1983, 328 ff.
Treatment
alternatives
The choice of method is up to the physician if the available methods do not differ in their risks and
chances of success.
Where a genuine alternative exists, e.g., conservative vs. invasive treatment, the patient must be
informed.
BGH NJW 19892, 2121 (2122 f.)
Treatment
conditions
The physician does not have a duty to inform the patient that better apparatus and infrastructure
are available in another institution (e.g., university hospital) as long as those that will be used
for the procedure are acceptable by medical standards.
BGH NJW 1988, 763; 1988, 2302
Treatment errors
The generally expressed opinion is that there is no duty to inform the patient of errors in treatment
as long as the lack of information does no further harm to the patient.
There is, however, a duty to inform the patient if the error creates a danger for the patient.
BHG NJW 1985, 2913
Vaccinations
Oral consent is not necessary in every case of vaccination according to standard government
recommendations, as long as the patient has been given an information sheet and has received
further information orally from the physician.
BGH NJW 1988, 765
OLG Koblenz NJW 2000, 3435

(3436 f.)
BGH NJW 2000, 1784 ff. but see
BGH MedR 1995, 25: Extent of
information about risks, e.g.,
1 in 15.5 million.
* The duty of informing the patient is only suspended in exceptional cases. If there is doubt, the current case law should be reviewed and a lawyer consulted, if necessary. (The types of
exception are listed in alphabetical order.)
Consent by a minor aged 14 to 18

A patient aged 14 to 18 is capable of giving valid consent if the
physician can justifiably assume that he or she possesses the
necessary degree of insight and judgment to do so, in view of
the nature and severity of the proposed intervention.
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language (OLG Dsseldorf NJW 1990, 771 [771]). The patient is nonetheless required to
inform the physician if there is difficulty in communication (OLG Hamm VersR 2002, 717).
Problems arise when the patient is unable to give valid consent and the responsibility
for consent therefore rests with third parties. Consent is valid only if it is given on the
basis of a correct understanding of the factual situation, and only if the consenting
person has an accurate conception of the probable course and possible consequences of
the proposed intervention. The consenting person must possess the necessary capacity
of judgment and emotional stability to appreciate the seriousness of his or her declaration
of consent and to weigh the pros and cons of the intervention against one another
rationally (BGHSt 4, 88, 90). Furthermore, the consenting person must be in full
possession of his or her faculties of reasoning and decision-making, which can be
impaired, for example, by severe pain (OLG Frankfurt MedR 1984, 194 [196]). A patient
who is a minor still possesses the right to dispose of personal legal interests, i.e., to make
autonomous decisions over interventions to be performed on his or her own body (box e1).
A minor patient's ability to consent to an intervention must be assessed according to the
concrete circumstances of the individual case. A minor's ability to make decisions
regarding his or her own bodily integrity is a function, not of legal contractual capacity,
but rather of the minor's natural faculties of understanding and judgment. For patients
under age 14, consent should usually be obtained from legally authorized guardians,
usually parents.
Minors from the age of 14 up to their 18th birthday can give legally valid consent if the
physician, taking the nature and seriousness of the proposed intervention into account, is
able to conclude that the patient possesses the necessary capacities of understanding and
judgment to make a well-reasoned decision.
In case of doubt whether a minor possesses the natural capacities of understanding and
judgment needed for valid consent, or if the proposed intervention exposes the minor patient
to special risks, it may be medically indicated for the patient's parents to be informed and
for consent to be obtained from them.
It is a fundamental principle that consent for medical interventions on children can only
be given by both parents jointly. This is especially so when both parents have participated
in discussions with the physician. When a decision is necessary, the physician is not entitled
to assume that one parent may decide alone. The only exceptions to this principle are in
cases where the intervention is not of a high degree of difficulty (BGH NJW 1988, 2946
[2947]). If medically indicated measures are rejected by the patient's parents and time is of
the essence, a medical intervention for the protection of a minor may be justified under 34
StGB. If, however, there is no medical reason that these measures cannot be deferred, a
decision in favor of the intervention must first be obtained from the guardianship court
(Vormundschaftsgericht).
Patient information must take place at an appropriate temporal interval before treatment.
The patient must be given enough time to weigh the pros and cons of the proposed
intervention against each other and thereby make use of his or her right to self-determination
and freedom of decision. Information about possible alternative treatments and their risks
may not be withheld (BGH NJW 2004, 3703; BGH NJW 2000, 1784 [1784 ff.]).
The extent of patient information can be correlated with the urgency of the intervention
(BGH NJW 1991, 2349 [2349]). The urgency of the intervention must not be falsely
dramatized (BGH NJW 1990, 2928). An elective intervention that can be deferred till later
requires more extensive patient information than an emergency intervention where time
must not be lost. Patient information is considered untimely if it occurs in the operating suite
when the patient has already been given preoperative medication, except in emergencies
Minors lacking sufficient insight

If the physician doubts whether the patient possesses the
necessary degree of insight and judgment to give valid consent,
then it is advisable to inform their parents and obtain their
consent.
MEDICINE
(cf. BGH NJW 1994, 3009 [3011]). The proper time for patient information may vary
depending on the seriousness of the intervention.
If major surgery is to be performed, the discussion for patient information should be held
at least 24 hours beforehand. According to court decisions, a discussion on the evening
before surgery is not timely. For smaller, ambulatory procedures, on the other hand, the
discussion may be held on the day of the procedure, but not in the operating suite itself
(BGH NJW 1998, 1784 [1785]) .
More than one discussion may be needed for major interventions with considerable
risks. If a long time elapses between the discussion for patient information and/or the
determination of a date for the operation and the operation itself, a second discussion may
be needed; this is known as "double information" (BGH NJW 1992, 2351).
The extent of patient information depends on a number of factors. One of these is the
indication for the procedure (e.g., elective, cosmetic, or emergency) and the associated
degree of temporal urgency. The frequency and severity of the risks specific to the procedure
also play a role. Moreover, the degree to which the proposed intervention is accepted by the
medical community at large is also very important. Therapeutic attempts that are not based
on standard, scientific medicine require more extensive patient information than those that
are. Finally, the patient's desire to be informed must also be taken into account. Patients
who ask not to be informed at all about the proposed intervention must still be given a
minimum amount of information.
Proper patient information (according to BGH NJW 1984, 1397):

1. The patient must be informed "broadly and generally" ("im Groen und Ganzen": BGH
VersR1992, 238; VersR 1990 1010 [1011], et alia) about probabilities, intervention-specific
risks, the goal of treatment, the benefit to the patient, and the alternatives, whenever it
can be presumed that a medical layperson would not or need not necessarily know these
things on the basis of general knowledge.
2. To the extent that the proposed intervention is associated with a lesser degree of medical
indication, necessity, or urgency, the information of the patient must be accordingly more
comprehensive. (A rule of thumb for the extent of preoperative patient information:
emergency surgery < medically necessary elective procedure < cosmetic surgery < human
experiment.)
3. The greater the risk of an intervention, the more comprehensively the patient must be
informed about less common risks.
4. The greater the risk of side effects or interactions of a given medication, the more
comprehensively the patient must be informed about this risk (e.g., patient
information about off-label use of a drug that has not been approved for the indication
for which it is to be used, or about the risk of fatal cerebral hemorrhage in
nephrological-angiological procedures).
"The patient must be informed about the use of a non-approved medication, because,
whatever the actual quality or safety of the medication, it lacks the sanction of official
approval, which may be essential for an individual patient's decision under the scope of
the Medical Preperations Act." BGH NStZ 1996, 34 (34).
5. Jurisdiction imply that it may be necessary to inform the patient of the risk of very
unlikely complications if these complications, should they occur, would weigh severely
on the patient's ability to live normally, and if, despite their rarity, they are specifically
associated with the intervention, though their occurrence would be surprising to a
layperson (BGH NJW 2006, 2108, BGH NJW 1984, 1395 probability threshold:
0.05% to 1% according to BGH NJW 1972, 335 [337], 0.7% according to OLG
Consent for elective procedures

An elective procedure that needs not be performed
right away requires more extensive information of
the patient than an emergency procedure
performed under time pressure.
Non-approved medications
The patient must be informed about the use of a non-approved
medication, because, whatever the actual quality or safety of
the medication, it lacks the sanction of official approval, which
may be essential for an individual patient's decision under the
scope of the Medical Prparations Act.
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TABLE 3
Recent decisions of the Federal Court of Justice (20042006)
Decision
Error committed in (Medical) consequences
Legal considerations
BGH decision of
Information about
14.3.2006,VI ZR 279/04 risks
Permanent nerve injury due to needle stick

for blood donation
Comprehensive information about possible permanent

deficits is required, particularly in view of the nature of
the intervention, which is performed not for the good of
the individual undergoing it, but for society at large.
BGH NJW 2005,

2072 f.
Information about
intervention
and risks
Bilateral vocal paralysis, respiratory symptoms
If possible extension of the operation can be envisioned

preoperatively, the patient must be informed about the
significantly higher risks of total as compared to partial
thyroidectomy. The burden of proof for hypothetical
consent rests with the treating physician.
BGH NJW 2005,

1716 ff.
Information about
intervention
and risks
Infarct of part of the middle cerebral a. territory

in a 29-year old female smoker as a complication
of oral contraceptive use
Consent to treatment with a medication with not

insignificant risks is invalid if the patient has not been
informed of the medication's dangerous side effects.
The patient must always be informed when the medical
intervention is associated with special risks that can
markedly impair the patient's ability to lead
a normal life.
BGH NJW 2005,

1718 ff.
Information about
risks, or patient
information in
general *
Progressive angulation of a fracture with

conservative treatment without repositioning,
or surgical fixation in abnormal position
The determination of the method of treatment is, in

principle, up to the physician, but the physician must
inform the patient if there is a genuine choice between
two or more methods that differ markedly in their risks
and chances of success.
BGH NJW 2005, 427 ff. Information about Visual impairment after retinal detachment, with
treatment or further failure to inform the patient of the need for further
necessary
follow-up in case symptoms should worsen
measures
A clear-cut breach of the physician's duty to provide

adequate therapeutic information shifts the burden of
proof of causation of the impairment by the treatment
error from the patient to the physician.
BGH decision of
16.11.2004,
VI ZR 28/04
Patient information Hemiparesis with visual field defect

in general *
The patient must be comprehensively informed about

the risks and benefits of an operation for the treatment
of epilepsy.
BGH NJW 2004,

3703 (3704)
Information about
intervention or risks
(available option of
twin delivery by
cesarean section)
The physician bears the burden of proof of having

fulfilled his or her duty to inform the patient.
Death of one twin and very severe injury of the

other (asphyxia, anemia, cerebral palsy, nearly
total blindness, epilepsy, abnormal mental
development)
Brandenburg NJW-RR 2000, 398 [399]; less than 0.1% according to OLG Stuttgart
NJW-RR 1999, 751 [752].
In civil proceedings, the physician bears the burden of proof of proper, complete, timely,
and correct information of the patient to enable an autonomous decision (BGH MedR 1990,
32931). Standardized patient information forms (pre-formulated informed consent declarations)
are therefore used to facilitate patient information by serving as a "comprehensive memory
aid" and to enable adequate documentation for medicolegal purposes. They should not,
however, be used uncritically or without a proper understanding of their legal status. A
patient can give consent orally or in writing, but it is best for documentary purposes that the
physician's discussion with the patient be documented in writing with a patient information
form, or that it be carried out in the presence of witnesses.
The mere handing of an information form to a patient for signature, without oral
explanation of its content, does not satisfy the requirement for proper patient information
(BGH NJW 1994, 793 [794]). A form can only be given to the patient for preliminary
Procedure for patient information

Written documentation of the discussion for patient
information is advisable if a prewritten consent form is
not used.
The mere handing of a consent form to the patient for
signature cannot replace the necessary face-to-face
discussion between the physician and the patient.
Consent forms
These may be used by physicians to provide
documentary proof of preoperative consent.
They should not be used uncritically or
without a proper understanding of their legal
status.
MEDICINE
information before the discussion takes place. The content of the form can then be discussed
(sequential patient information) and supplemented with written additions.
Nonetheless, for routine measures, such as vaccination, it may suffice for the patient to
read an information form, as long as the patient has an opportunity to ask the physician any
questions that might arise (BGH NJW 2000, 1784 ff.).
Consent
There are no concrete judicial provisions regarding consent for medical interventions.
Only 228 StGB indicates the possibility of consent for what would otherwise be unlawful
physical injury, as long as the act in question does not violate moral standards. As long as the
patient or legal guardian has been properly informed according to the criteria described
above, he or she can give valid consent for the intervention. The legal justification for the
patients consent requires that the conditions listed in box e1 be met. The fulfillment of these
conditions removes the illegality of the therapeutic action, which would otherwise constitute
unlawful physical injury.
The patient's explicit consent must be obtained before the procedure. Retrospective
approval of the patient after the procedure does not constitute valid consent. After consent
is given, the patient may revoke it at any time before the procedure and thereby nullify its
legal validity. A precondition for validity of consent is that the patient must possess the
necessary intellectual and moral maturity to understand the significance and implications
of the act of waiving his or her legal rights and to make a well-reasoned judgment about the
matter. Deception or compulsion by the physician compromises the voluntary nature of the
patient's "consent": for example, the physician may not falsely overstate his or her own
experience with the procedure or trivialize its substantial intra- and postoperative risks and
complications.
The physician must perform the procedure only after ascertaining that the patient has
consented to it and on the basis of this consent. If the patient is unable to consent, e.g.,
because of unconsciousness, a necessary procedure may be performed, within certain
restrictions, as long as this accords with the patient's presumed wishes and interests.
The latter form of consent is called presumed consent, as opposed to consent that has
been explicitly declared orally or in writing. If the patient has previously expressed opposition
to the contemplated intervention (e.g., known refusal of consent to an extension of a surgical
procedure, e.g., hysterectomy in a woman desiring to have children), then the will of the
patient must be respected and cannot be overruled by "reasonable medical practice" (BGH,
decision of 20 May 2003 5 StR 592/02).
Presumed consent should not be confused with so-called hypothetical consent.
The latter refers to situations in which the patient has consented only in part or not at all,
but the physician nevertheless states, in defense, that the patient would have consented
to the intervention if he or she had been aware of all relevant circumstances. Such claims
on the physician's part must be examined very critically when the procedure in
question is not urgently necessary (OLG Koblenz, NJW-RR 2002, 816 [818]), and
particularly when the patient expresses genuine difficulty arriving at a decision (BGH
MedR 1991, 200).
Summary
Patients generally trust their physicians and expect to be properly informed about impending
procedures so that they can make their own, individual decisions about them. Jurisdiction
in Germany over the last 3 years have placed stringent requirements on patient information
by a physician before medical procedures (table 3).
Patient consent
The patient's explicit consent must
be obtained before the intervention.
Summary
Patient information is an expression of respect for
the patient and the sole means of enabling him or
her to make a truly voluntary decision.
10
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One may question whether all of these judicial requirements can be practically met
within the bounds of the physician's normal clinical routine. One must remember, however,
that patient information is an important expression of respect for the patient, as it is the sole
means of enabling him or her to make a truly voluntary decision.
Conflict of Interest Statement
The authors declare that they have no conflict of interest as defined by the guidelines of the International Committee of
Medical Journal Editors.
Manuscript received on 24 May 2006; final version accepted on 27 December 2006.
Translated from the original German by Ethan Taub, M.D.
REFERENCES
1. Pflger F: Krankenhaushaftung und Organisationsverschulden. Berlin: Springer Verlag 2002.
2. Gotthardt H-J, Parzeller M: Die Rolle der Staatsanwaltschaft und der Gerichte bei Leichenschau und
Leichenffnung. In: Anders D, Bratzke H, Gotthardt H-J, Parzeller M (Hrsg.): Die Bearbeitung von
Ttungsdelikten. Stuttgart: Boorberg Verlag 2006; 6174.
3. Parzeller M, Schmidt P, Bratzke H: Die Funktion der Rechtsmedizin bei der Aufklrung von Kapitalverbrechen,
insbesondere Ttungsdelikten (medizinische und rechtliche Grundlagen). In: Anders D, Bratzke H, Gotthardt
H-J, Parzeller M (Hrsg.): Die Bearbeitung von Ttungsdelikten. Stuttgart: Boorberg Verlag 2006; 75122.
4. Andreas M, Debong B, Bruns W: Handbuch Arztrecht in der Praxis. Baden-Baden: Nomos Verlag 2001.
5. Bergmann K: Arzthaftung. 2. Aufl., Berlin, Heidelberg: Springer Verlag 2004.
6. Dettmeyer R: Medizin & Recht fr rzte. 2. Aufl., Berlin: Springer Verlag 2006.
7. Deutsch E, Spickhoff A: Medizinrecht. 5. Aufl., Berlin: Springer 2003.
8. Eickhoff U, Fenger H: Chirurgie und Recht. Springer Verlag. Berlin Heidelberg 2004.
9. Gei K, Greiner H-P: Arzthaftpflichtrecht. Mnchen: C.H. Beck Verlag 2001.
10. Hamann P, Fenger H: Allgemeinmedizin und Recht. Berlin, Heidelberg: Springer Verlag 2004; 3147.
11. Hardtung B: Einwilligung. In: Joecks W, Miebach K (Hrsg.): Mnchner Kommentar zum Strafgesetzbuch.
Mnchen: C.H. Beck Verlag 2003; 82445.
12. Joecks W: Straftaten gegen die krperliche Unversehrtheit Krperverletzung. In: Joecks W, Miebach K
(Hrsg.): Mnchner Kommentar zum Strafgesetzbuch. Mnchen: C.H. Beck Verlag 2003; 71560.
13. Knauer C: rztlicher Heileingriff, Einwilligung und Aufklrung berzogene Anforderungen an den Arzt? In:
Roxin C, Schroth U (Hrsg.): Medizinstrafrecht - Im Spannungsfeld von Medizin, Ethik und Strafrecht. Stuttgart:
Boorberg Verlag 2000; 927.
14. Krause DM, Caspary E: Arztstrafrecht. In: Cramer P, Cramer S (Hrsg.) Strafrecht Anwaltshandbuch. Kln:
Verlag Dr. Otto Schmidt 2002.
15. Laufs A: Die rztliche Aufklrung. In: Laufs A, Uhlenbruck W (Hrsg.): Handbuch des Arztrechts, 3. Aufl.
Mnchen: C.H. Beck Verlag 2002; 496536.
16. Martis R, Winkhart M: Arzthaftungsrecht aktuell. Kln: Verlag Dr. Otto Schmidt 2003.
17. Parzeller M: Ausgewhlte Rechtsfragen in der Sportmedizin. In Engelhardt M (Hrsg.): Sportverletzungen.
Mnchen: Elsevier, Urban & Fischer Verlag 2006; 78290.
18. Quaas M, Zuck R: Medizinrecht. Mnchen: C.H. Beck Verlag 2005.
19. Ratzel R, Lippert H-D: Kommentar zur Musterberufsordnung der deutschen rzte (MBO). 3. Aufl.: Berlin:
Springer Verlag 2002.
20. Rieger H-J: Lexikon des Arztrechts. Heidelberg: C.-F. Mller Verlag 2001.
21.Ries H, Schnieder K, Althaus J, Groblting R: Arztrecht - Praxishandbuch fr Mediziner. Berlin Heidelberg:
Springer Verlag 2004.
22. Steinbeck J, Fenger H: Orthopdie und Recht. Berlin Heidelberg: Springer Verlag 2004.
23. Sprau H: 823 BGB. In: Palandt: Brgerliches Gesetzbuch. 65. Aufl.: Mnchen: C.H. Beck Verlag 2006.
24. Trndle H, Fischer T: Strafgesetzbuch und Nebengesetze. 53. Aufl.: Mnchen: C.H. Beck Verlag 2006.
25. Ulsenheimer K: Arztstrafrecht in der Praxis. 3. Aufl.: Heidelberg: C. F. Mller Verlag 2003.
Corresponding authors
Dr. med. Markus Parzeller
Zentrum der Rechtsmedizin der
Johann Wolfgang Goethe-Universitt
Kennedyallee 104
60596 Frankfurt am Main, Germany
Rechtsanwaltskanzlei
Rechtsanwalt Dr. med. Markus Parzeller
Schnbornstr, 22
63179 Obertshausen, Germany
11
MEDICINE
Further Information
This article has been certified by the North Rhine Academy for Postgraduate and Continuing
Medical Education.
The Deutsches rzteblatt provides certified continuing medical education (CME) in accordance
with the requi-rements of the Chambers of Physicians of the German federal states (Lnder).
CME points of the Chambers of Physicians can be acquired only through the Internet by the use
of the German version of the CME question-naire within 6 weeks of publication of the article. See
the following website: www.aerzteblatt.de/cme .
Participants in the CME program can manage their CME points with their 15-digit "uniform CME
number" (einheitliche Fortbildungsnummer, EFN). The EFN must be entered in the appropriate
field in the www.aerzteblatt.de website under "meine Daten" ("my data"), or upon registration.
The EFN appears on each participant's CME certificate.
The solutions to the following questions will be published in Volume 17/2007. The CME unit
"Managing Nausea, Emesis and Consipation in Palliative Care" (Volume 5/2007) can be accessed
until the 16th March.
For Volume 13/2007 we plan to offer the topic "Asperger's Syndrome an Autism Spectrum Disorder"
Solutions to the CME questionnaire in volume 12/2007:
Sauer N, Eich W: "Somatoform and Functional Disorders": 1/b, 2/b, 3/b, 4/a, 5/d, 6/d, 7/a, 8/b,
9/d, 10/a.
Please answer the following questions to participate in our certified

Continuing Medical Education program. Only one answer is possible
per question. Please select the answer that is most appropriate.
Question 1
According to the highest court in Germany (BGH), a medical intervention
a)
b)
c)
d)
e)
contains the elements of a battery.

is always unlawful, even when there are considerations that justify it.
is not a battery.
is always lawful, as long as the physician has the desire to heal the patient.
is only unlawful in case of complications.
Question 2
Patient information is subdivided into information
a)
b)
c)
d)
e)
of the patient, his or her relatives, and third parties.

about the diagnosis, the treatment, the risks, and the further course.
about behavior, precautionary measures, and treatment.
about precautionary measures, risks, dangers, and side effects.
about alternatives, surgery, and anesthesia.
Question 3
Information about precautionary measures (therapeutic information) is of vital
importance for the further care of a patient after an intervention. Which of the
following is true of adequate therapeutic information?
a) The patient should be told how to avoid excessive physical activity if physical stress would
endanger his or her health.
b) This type of information is only necessary in a justifying emergency.
c) Information about the endangerment of others who might catch the patient's communicable
disease is not required.
d) The most important element of therapeutic information is telling the patient about treatment
errors that have no effect on his or her health.
e) The need for, and timing of, further follow-up should be left up to the patient.
12
MEDICINE
Question 4
A healthy 17-year-old female high-school student who does not smoke would like
a prescription for oral contraceptives because her boyfriend has a latex allergy.
She does not want her parents to be informed. What should you do?
a) The patient's right to sexual self-determination implies that she should be prescribed oral
contraceptives without her parents' consent.
b) The patient is a minor and can be prescribed contraceptives only with her parents' consent.
c) Because this is a gynecological issue, consent must be obtained from the patient's mother.
d) As long as there is no evidence to the contrary, a 17-year-old high-school student can be presumed
to have the necessary maturity of insight and understanding to receive a prescription for oral
contraceptives without the consent of her parents, as long as she has been completely informed
by a physician and has arrived at a firm decision to take this medication.
e) This patient must be prescribed "the pill" in any case, because her boyfriend is allergic to latex.
Question 5
The following is true of an elective procedure:
a)
b)
c)
d)
e)
The discussion for patient information must take place at the appropriate time.
The patient must decide immediately during the discussion.
The patient can be informed exclusively through a printed information sheet.
The patient can be informed by a nurse.
When an elective procedure is involved, the usual requirements for proper patient information
are not applicable.
Question 6
Which of the following is true of informed consent?
a) The less pressing the indications are, the more extensive the information must be.
b) The less dangerous a procedure is, the more extensive the information must be.
c) The more dangerous a medication is, and the more severe its side effects, the less extensive the
information must be.
d) The greater the risks and dangers in the postoperative period, the less is the duty on the part of
the treating physician to give the patient appointments for further follow-up.
e) The more elective a procedure is, the less the patient needs to be informed about it.
Question 7
What general considerations apply for the preservation of the patient's rights and the
medicolegal protection of the physician when a medication is used for an indication for
which it is not approved (off label)?
a) The patient should never be informed about off-label use, because the fact is irrelevant to his or
her right to self-determination and does not affect the autonomy of his or her decision to take
the medication.
b) The patient must be informed about off-label use, because, whatever the actual quality or safety
of the medication, it lacks the sanction of official approval, which may be essential for an individual
patient's decision under the scope of the Medical Preparations Act.
c) The patient should, in general, not be informed about the possibly serious side effects of
off-label use, as fear and anxiety can lessen the chance of successful treatment.
d) The main criterion for the propriety of off-label use is the physician's competence and desire to
heal, so that the patient's consent is, in principle, not necessary.
e) The physician, acting as an agent of the hospital, must assume personal responsibility for
assessing the risks of off-label use of medication, and must then act accordingly, even without
the patient's consent, if this is in the hospital's economic interest.
Question 8
According to applicable jurisdiction, what must the patient be informed of,
and how?
a)
b)
c)
d)
All possible medical treatment errors and their legal consequences.

The nature, extent, and technique of the treatment or procedure, broadly and generally.
Every suspected diagnosis and working hypothesis.
Better apparatus in the possession of another doctor, even if the treating physician's apparatus
meets medical standards.
e) All other treatment methods with greater risks and lower chances of success.
13
MEDICINE
Question 9
Which of the following is true of the requirements for informed consent, according to
applicable judicial decisions?
a) If there is a genuine choice between medically indicated and usual treatment methods that have
different risks or prospects of success, particularly if there is a genuine choice between surgery
and conservative treatment, the patient's right to self-determination implies the need for
complete information by the physician so that the patient can decide for himself or herself what
direction the treatment should take.
b) If a medication might have serious side effects, the prescribing physician needs to tell the
patient about this specifically (rather than just relying on the patient information in the package
insert) if the risk of side effects is greater than 3%.
c) Basic patient information requires only that the patient be informed about treatment errors that
have taken place in the past 2 years.
d) Currently applicable jurisdiction derive the need for patient consent from the German Health
Care Modernization Law.
e) A physician who requires a patient to decide whether an intervention is to be performed and
then schedules the procedure must inform the patient thoroughly just before the procedure is to
take place.
Question 10
Which of the following is true of the patient's informed consent?
a)
b)
c)
d)
e)
Patient consent is a legal justification for a medical intervention.

Patient consent, once given, cannot be revoked.
Presumed consent requires only that the physician desires to heal.
Because of time constraints, hypothetical consent is more usual than explicit consent.
If the patient is clearly opposed to a procedure and has explicitly stated this, the concept of
presumed consent can be applied by the physician against the patient's will if this is medically
reasonable to achieve the goal of treatment.
Additional Material see next page
14
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Additional Material
Case Study
Off-label use of medications
After the dilatation of a stenotic renal artery, a patient
was treated with a combination of medications
carrying a high risk of hemorrhage, even though
this combination was not recommended by the
manufacturers in this situation (off-label use).
The physician failed to inform the patient of the
medications' lack of approval. Under treatment with
these medications, the patient sustained a massive
intracerebral hemorrhage that was untreated for
several hours even though the patient was hospitalized
and comatose.
The responsible physician (chief of the department)
retrospectively denied the need for early diagnosis
of a brain hemorrhage, citing the poor prognosis of

this condition. The patient died the day after the
hemorrhage.
According to the general provisions of the decisions
of the highest German court, the Bundesgerichtshof
or Federal Court of Justice (NStZ 1996, 34 [34]), the
following considerations apply to the preservation of
patients' rights and the medicolegal protection of
physicians whenever a non-approved medication is
used (off-label use):
"The patient must be informed of the use of a
non-approved medication, because, regardless of its
actual quality or safety, the medication still lacks the
sanction of official approval, which may be essential
for an individual patient's decision under the scope
of the Medical Preparations Act."
(See also table e3, "Special cases concerning patient
information and informed consent.")
BOX e1
The essential elements of (presumed, hypothetical) consent to a medical

intervention (see, in particular, references 6, 1114, 16, 17, 24, 25)
1. Consent: "Volenti non fit injuria" (No wrong is done to a consenting person)
"Consent to a medical intervention implies that the patient waives the right to absolute protection against having a physical
injury committed upon himself or herself, within the scope of the proposed intervention. Furthermore, the patient assumes the
risk of the side effects and possible complications of treatment. If valid consent is lacking, the medical intervention is an
unlawful violation of the patient's bodily integrity."
(BGH VersR 1989, 851)
Disposable legal rights
Individual legal rights, such as bodily integrity, that are subject to the patient's disposal
The patient has no right to commit suicide with a physician's help (because of the unlawfulness of homicide by request, as
established by 216 StGB)
Consent must be by a duly authorized person
The person whose rights are in question (the patient)
The legal guardian of a minor (1626 BGB)
The custodian of a ward; for particularly serious interventions, additional approval must be obtained from the guardianship
court (1904 BGB)
The proper time for consent
After timely information before the intervention
Retrospectively obtained consent or approval is insufficient
The consent must still be applicable at the time of the intervention, without having been retracted in the meantime by the
patient
The patient's capacity to consent
Not the same as contractual capacity; rather, the possession of the necessary moral and intellectual maturity to understand the
significance and implications of consent and to act according to this understanding
15
MEDICINE
BOX e1 (continuation)
Preconditions for valid consent

No deficiency of intent
The patient decides autonomously
No compulsion, pressure, deception, or threat
Manner of expressing consent
Explicit (the usual requirement for medical interventions)
Implicit (through behavior that implies consent)
Tacit
228 StGB
The act in question must not violate moral standards (e.g., a mutilating operation)
The element of subjective justification
The physician must act in the knowledge that consent has been granted by the patient, the guardian of a minor patient, the
custodian of a ward, or the guardianship court.
2. Presumed consent
BGH NJW 1988, 2310 ff.: "Presumed consent is an independent legal justification of a medical intervention and is not merely
a subtype of a justifying emergency. When an intervention, particularly the extension of an operation in progress, is medically
indicated, the permissibility of the intervention on the basis of the patient's presumed consent is not limited to cases where a
vital indication is present." Continuation in BGH NJW 2000, 885 ff.
Legal basis
An independent legal justification recognized in customary law.
Examples of application
Cases where it is no longer possible to speak with the patient to obtain his or her consent (unconsciousness after an accident,
emergency surgery on a comatose patient, question of extension of operation when the patient is already under anesthesia)
Subsidiarity
Presumed consent cannot be valid when the opportunity exists to obtain the patient's consent in timely fashion before the
procedure, or, in applicable cases, to interrupt the operation before extending it, when there is no vital reason to do otherwise
and the contemplated extension of the operation is not insignificant.
The procedure is not manifestly performed against the patient's wishes
Presumed consent is invalid if the patient has previously expressed (explicitly or implicitly) a contrary wish; the requirement for
presumed consent is that the patient would have granted consent if it had been possible to inquire about his or her wishes.
The interest of the patient
The basis for presumed consent must not be an objective consideration of the patient's best interest, but rather an exclusively
subjective consideration of what the patient would have considered (even unreasonably) to be in his or her best interest.
The element of subjective justification
The physician must act in knowledge of the elements of an offense that are present.
3. Hypothetical consent
BGH 1991, 2342 (2343): "The contention that the patient would have consented to the operation if he or she had been
properly informed of its risks deserves consideration in principle, but the physician or hospital bears the burden of proving this
contention, and the standard of proof must be strict, so that a means will not be created whereby the patient's right to be
informed might be circumvented. . . . The conceptual starting point of so-called hypothetical consent is always the hypothesis
of proper, and therefore also complete, information of the patient."
Reason for application
The patient was informed incompletely, improperly, or not at all.
Conceptual basis
Consideration of the patient's right to self-determination, presumed wishes, and interests with regard to health (16).
A judgment whether the patient would have consented after being properly informed (BGH NStZ-RR 2004, 16).
Proof
Strict standard (OLG Koblenz NJW-RR 2002, 310 [311].
The intervention is not considered an unlawful battery
. . . as long as the patient would have consented after being properly informed (and this contention has been proven according
to a strict standard).
4. The burden of proof in criminal law
"In dubio pro reo""When in doubt, decide for the defendant" (i.e., there is a presumption of innocence). Nonetheless, the
16
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BOX e1 (continuation)
judges, when considering the evidence, must take into account the severity, indication, alternatives, etc., of the intervention, in
particular when a genuine conflict in decision-making is alleged (25).
5. The burden of proof in civil law
The burden of proof lies with the physician, who may, however, contend that the patient would have consented if he or she had
been informed. If the physician contends this, the patient may in return contend that, in such a case, he or she would have faced
a conflict in decision-making (BGH 1994, 2414 [2415]; OLG Koblenz NJW-RR 2002, 310 [311]. The burden of proof shifts back
to the physician if the patient gives plausible reasons in support of the claim that he or she would have decided against the
intervention, or against its being carried out at this particular time.
Abbreviations:
BGB
Brgerliches Gesetzbuch, Code of Civil Law
BGH
Bundesgerichtshof, Federal Court of Justice
NStZ-RR
Zeitschrift fr Strafrecht Rechtsprechungs-Report (a German-language journal of criminal law)
OLG
Oberlandesgericht, Superior State Court
StGB
Strafgesetzbuch, Code of Criminal Law
VersR
Versicherungsrecht, Insurance Law
TABLE e1
Legal principles of patient information and informed consent in Germany
Legal code
GG
StGB
BGB
Article No.
Text of law (translation from the original German)
Art. 1 I 1
Human dignity is inviolable. All government authorities are obligated to respect and protect it.
Art. 2 II 1
Every individual has a right to life and bodily integrity.
34
An individual who performs an otherwise unlawful act to avert a present and not otherwise preventable danger to
his or her own or another individual's life, person, liberty, good name, property, or other legally protected interest
has not acted unlawfully if, when the conflicting interests are compared, the legal interests that are thereby
protected from impending danger significantly outweigh the interests prejudiced by the act. This is the case,
however, only if the act is an appropriate means of averting the danger in question.
223
Premeditated
physical injury
(1) Whoever physically maltreats another individual or harms another individual's health is punished with up to
five years' imprisonment or a monetary fine.
(2) The attempt to do so is also a punishable offense.
228 Consent
Whoever commits a battery on another individual with that person's consent acts unlawfully only if the act,
despite consent, is a violation of good moral standards.
229 Negligent
physical injury
Whoever negligently commits battery on another individual is punished with up to three years' imprisonment or
a monetary fine.
107 Consent
by a legal
guardian
A minor can declare his or her consent only through the declaration of his or her legal guardian, unless the
consent in question redounds exclusively to the benefit of the minor's legal interests.
823 Duty of
compensation
for harm
(1) Whoever unlawfully and in premeditated or negligent fashion harms the life, person, health, liberty, property,
or other legally protected interest of another individual is required to compensate him or her for the harm done.
(2) The same requirement applies to whoever violates a law whose objective is to protect another individual.
If the law in question states that violation of the law is not always culpable, then a duty to compensate is present
only in case of culpable violation.
831 I Liability
for vicarious agents
An individual (principal) who uses a vicarious agent to perform an act must pay compensation for harm done
unlawfully by that agent to a third person in performance of the act. There is no duty to compensate if the
principal has exercised the usual and due care in choosing the agent and in overseeing the performance of the
act, insofar as his or her oversight is required for the acquisition and use of any apparatus or equipment, or when
the harm done would have resulted even if the principal had exercised this degree of care.
1626 Parental care: (1) The parents have both the duty and the right to care for their minor children (parental care). Parental care
basic principles
comprises care for the child's person and for the child's property. . . .
1631 Scope and
limits of care for
the child's person
(1) Parental care for the child's person encompasses, in particular, the duty and right to care for, educate,
and supervise the child and to determine the child's place of habitation.
1904 Approval of
medical interventions
by the guardianship
court
(1) A custodian's consent to a diagnostic test of the state of health of a ward or to a therapeutic intervention or
medical procedure on a ward requires the approval of the guardianship court if there is a well-grounded danger
that the ward might die or suffer a severe and long-lasting impairment to health as a result of the measure.
Without such approval, the measure may be undertaken only if a delay in its performance would be dangerous.
(2) Paragraph 1 applies also to consent by an authorized person. Such consent is valid only when it is given in
writing and when it explicitly applies to the measures listed in Paragraph 1, Sentence 1.
17
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TABLE e1 (continuation)
Legal principles of patient information and informed consent in Germany
Legal code
Article No.
1905 Sterilization
Text of law (translation from the original German)

(1) If the medical procedure involves sterilization of a ward who cannot give consent, the custodian can consent
to the procedure only if
1. sterilization is not against the ward's will and
2. the ward will permanently remain unable to consent, . . .
(2) Consent requires the approval of the guardianship court. Sterilization may be performed only after two weeks
have elapsed from the time of the court's approval.
AMG
40 General
requirements for
clinical testing
(1) . . . A pharmaceutical may be clinically tested on a human being only if

3. the person in question
(a) has attained legal majority and is able to understand the nature, significance, and implications of the clinical
test and to decide accordingly whether or not to undergo it,
(b) has been informed according to the provisions of Paragraph 2, Sentence 1, and has consented in writing,
except under the provisions of Paragraph 4 or 41, and
(c) has been informed according to the provisions of Paragraph 2a, Sections 1 and 2, and has consented in
writing; the consent must also explicitly refer to the acquisition and processing of health-related personal
information, . . .
41 I Special
requirements for
clinical testing
(in persons of full age)
40 paragraphs 13 apply to clinical testing on a person of full age suffering from a disease that is to be treated
with the pharmaceutical to be tested, with the following additional requirements: . . .
. . . If consent cannot be obtained because of an emergency situation, then a treatment that must be performed
without delay to save the life, restore the health, or alleviate the suffering of the affected person may be instated
right away. Consent for the further provision of the treatment must be obtained as soon as this is reasonably
possible.
TPG
3 Organ removal
with the consent
of the donor
(1) In the absence of any special considerations covered in 4, the removal of organs is permitted only when
1. the organ donor has consented to such removal, . . .
TFG
6 Information
and consent
(1) The removal of a blood specimen for donation may be performed only when the donor has been previously
informed, accurately and in a manner that he or she can understand, of the nature, significance, and mode of
performance of the removal of the specimen and the related testing, and has consented to the removal of the
specimen and the related testing. Informed consent must be declared in writing by the donor. In giving consent,
the donor must also declare that the donated specimen may be used, as long as the donor does not take
advantage of a provision for confidential self-exclusion. . . .
KastrG
3 Consent
(1) Consent is invalid if the affected person has not previously been informed concerning the reason, significance,
and aftereffects of castration, other treatment options that could be considered, and any further considerations
that he or she manifestly considers relevant to consent.
(2) The consent of the affected person is not invalidated by the fact that he or she, at the time of consent, was
confined to an institution by court order.
(3) If the affected person is not capable of fully understanding the reason and significance of castration and to
decide accordingly, then the castration is permissible only if
1. the affected person has agreed to it after being informed about it in a manner corresponding to his or her
own condition and has at least understood its immediate consequences, and
2. the affected person has been given a guardian, the scope of whose responsibilities includes the matter of
castration and who has consented to this treatment after being fully informed according to the provisions
of Paragraph 1.
MBO
Before performing any treatment, the physician must have the consent of the patient. Consent must be preceded
by the necessary information of the patient by the physician in a face-to-face discussion.
(Explanation: the (Model) Professional Code of Conduct [2004] has legal force for a physician only after it has
been accepted as an enactment of the Chamber of Physicians of the German federal state (Land) in which the
physician practices and has been approved by the overseeing government authority.)
Abbreviations:
AMG: Arzneimittelgesetz, Medical Preparations Act; BGB: Brgerliches Gesetzbuch, Code of Civil Law; GG: Grundgesetz, Basic Law (constitution of the Federal Republic of Germany);
KastrG: Kastrationsgesetz, Law on Castration; MBO: (Muster-)Berufsordnung, (Model) Professional Code of Conduct for the Chambers of Physicians of the German states;
StGB: Strafgesetzbuch, Code of Criminal Law; TFG: Transfusionsgesetz, Law on Transfusions; TPG: Transplantationsgesetz, Law on Transplantation
18
MEDICINE
TABLE e2
Types of Patient Information (cf. in particular references 5, 10, 15, 16, 17, 20, and 22 in the CME article)
A. Patient information for informed consent (also called basic information or information about an intervention)
Information of the patient so that he or she can make a free and autonomous decision
Determination of the extent to which the medical intervention corresponds to the wishes of the patient
Under civil law, the physician bears the burden of proof that the patient was properly informed
Applicable judicial decisions:
BGH decision of 15. 3. 2005 VI ZR 313/03; OLG Stuttgart decision of 2. 4. 2002 1 U 7/2002, 1 U 7/02
Type of patient
information
Subtypes
Diagnostic information:
OLG Frankfurt VersR 1996,
101f.;
OLG Stuttgart
VersR 1988, 695
Information about findings, medical diagnoses, and the goal of the treatment or intervention
Extent of information depending on the type of illness and in consideration of the patient's emotional state
Recommendation not to inform, or to inform less than fully, in case of very severe disease with poor prognosis and
no possibility of treatment
No information about merely suspected diagnoses
Therapeutic information:
BGH decision of
22.09.1987
Az.: VI ZR 238/86
Information about the proposed intervention:

Type of treatment (surgical, conservative, diagnostic, etc.)
Dose of medication
Methods (also degree of pain expected)
Consequences of the intervention
Implications of the intervention
Any further interventions that might be necessary afterward; treatment alternatives
Off-label use
Information about further

disease course: BGH VersR
1988, 493; OLG Koblenz
NJW-RR 2002 816 (817);
OLG Hamburg NJW 1975,
603 f.
Information about:
The nature, extent, and technique of the proposed treatment, "in broad and general terms" ("im Groen und Ganzen")
Probable course of illness after treatment
Failure rate
Treatment alternatives, particularly when not treating at all is a reasonable alternative
Consequences and side effects of treatment (e.g., surgical scars)
Course of illness without treatment
Information about risks

(information about
complications), BGH
decision of 5.4.2005,
Az.: VI ZR 216/03;
OLG Koblenz NJW-RR
2002, 816 (817); OLG
Hamm VersR 1990, 855
Patient information about risks, dangers, and complications (without trivialization or dramatization)
A general picture of the severity and purpose of the intervention
Necessary even for smaller procedures (which are otherwise unlawful)
Relative indication of the proposed procedure
Dangers
Possible complications
Possibly resulting harm (including transient harm)
Permanent damage (e.g., surgical scars)
Further deterioration of health if the intervention fails
Typical risks (e.g., risks that impair the patient's ability to lead a normal life) and atypical risks (limited; e.g., particularly
serious or unexpected risks, etc.)
Concrete spectrum of risks
The risk that the procedure will fail, estimated quantitatively
Treatment alternatives, if tested alternatives exist and have different levels of risk (the choice of technique is fundamentally
the doctor's decision)
Medication side effects and interactions
Off-label use
B. Therapeutic patient information (= treatment information, information for patient safety)

Not a discussion for informed consent in the technical legal sense
A part of medical treatment to ensure therapeutic success
Information given to the patient after a treatment is performed
The need for further follow-up is a function of the magnitude of the risks and dangers to the patient
Recommendations to the patient for behavior that will promote recovery (lifestyle, sporting activities, diet)
Description of medication side effects, interactions, allergies
Description of necessary follow-up tests and studies and of the possible risk of infecting others
Postoperative risks of outpatient surgery
Under civil law, the patient bears the burden of proof of a therapeutic error through faulty therapeutic patient information (OLG Kln NJW-RR 2001, 92;
OLG Hamm VersR 2002, 1562 [1563]). The burden of proof shifts to the physician, however, if the failure to deliver therapeutic patient information is considered a gross treatment error (BGH NJW 1987, 705). BGH decision of 14.6.2005 VI ZR 179/04; BGH decision of 27.4.2004 VI ZR 34/03; BGH NJW
1989, 2318
Abbreviations:
Az: Aktenzeichen, reference number; BGH: Bundesgerichtshof, Federal Court of Justice; NJW-RR: Neue Juristische Wochenschrift Rechtsprechungs-Report (a German-language legal
journal); OLG: Oberlandesgericht, Superior State Court; VersR: Versicherungsrecht, Insurance Law; VI ZR: Sixth Senate in Civil Law of the Federal Court of Justice
19
MEDICINE
Table e3
Special cases concerning patient information and informed consent (in alphabetical order) (see, in particular, references 5, 6, 10, 15,
16, and 17 of the CME article)
Type
Examples
Relevant case law
Choice of treatment "There is a basic requirement that the patient must be informed whenever there are several
(see also treatment medically indicated and usual treatment methods that differ in their risks or chances of success.
alternatives)
This requirement applies when an operation might be avoided by means of conservative treatment
or when it might be indicated only after conservative treatment fails. In such cases, the patient
possesses a real choice; thus, in the consistent view of the judicial decisions of the Senate, the
patient's right to self-determination implies that he or she must be fully informed by the physician
in order to become able to decide autonomously about the course of treatment and the time at
which he or she is to be exposed to any of the possible risks."
BGH decision of 22.2.2000

IV ZR 100/99; BGH NJW 1998,
2734; BGH NJW 1998, 1784
Contagion
The physician must inform the patient about the risk of infecting others and how this can be avoided.
BJH NJW 1994, 3012 ff.

(after vaccination)
Cosmetic surgery
The physician must inform the patient with uncompromising honesty and severity of all possible
complications, including disfiguring ones, with the use of color pictures depicting them (scarring,
deformity, wound necrosis, need for further surgery, etc.)
BGH NJW 1991, 2349 (2349);

Oldenburg VersR 2001, 1381
Deviation from
standard methods
The physician must inform the patient that the proposed treatment is an alternative or entirely
innovative therapy and thereby deviates from generally accepted methods of medical treatment.
OLG Oldenburg VersR 1997, 192
Diagnostic
interventions
The patient must be informed of all complications, including very unlikely ones, if the diagnostic
intervention is not vitally indicated.
BGH VersR 1979, 720 f.
Economic
circumstances
There is an increasing duty to inform the patient about costs, cheaper alternative treatments,
and lack of coverage of costs by insurance (e.g., in case of off-label use).
The patient must be comprehensively informed that an expensive treatment is to be used that
has not been scientifically proven effective and whose costs are not covered by insurance
(otherwise, the physician may have to compensate the patient for costs incurred).
BGH NJW 1983, 2360; KG Berlin
Emergency surgery
Depending on the circumstances of the individual case, it may be permissible for the patient
to be informed immediately before the operation.
NJW-RR 2000, 35 (36);

OLG Hamm NJW 2002,
307 (308)
OLG Saarbrcken VersR 1988, 95
Expectant treatment If further observation is a reasonable alternative form of treatment, the patient must be informed
(further observation) of this.
BGH NJW 1998, 1784 (1785)
Extension
of operation
The operation must be interrupted (if its continuation is not vitally indicated) so that the patient
can be informed and his or her consent can be obtained.
BGH decision of 20.5.2003

5 StR 592/02; BGH NJW 1977,
337 (338)
Follow-up
If a failure to deliver information about the need for follow-up is so serious as to constitute a gross OLG Kln VersR 2002, 1285
error of treatment, this may justify a reversal of the burden of proof from the patient to the physician
Further surgery
The patient must be informed of the necessity of further surgery.
BGH NJW 1987, 705 (706)
Innovative medicine, The more the proposed intervention serves the purposes of scientific advancement (clinical
OLG Oldenburg VersR 1997, 192
research
experimentation) rather than the interests of the patient, the more extensively and comprehensively
the physician must inform the patient about it, without limitation.
"The more innovative and less tested a procedure is, the more cautiously and meticulously the
(From ref. 25, translated)
physician must perform it, and the more incisively and comprehensively the physician must inform
the patient beforehand. . . Furthermore, the patient must be informed of the experimental nature
of the intervention if the new technique is still in an experimental phase, . . ."
Off-label use of
medications or use
of other, not yet
approved medical
products, etc.
Rare risks
The ordering of a medication contains the legal elements of a battery in the sense of 223ff. StGB
and is not unlawful only if the patient has consented after being properly informed by the physician.
In case of use of a non-approved medication, or of one not approved for the particular indication,
there must be a precise consideration of the benefits and risks and the patient must be informed
with special thoroughness. In particular, the patient must be informed that a non-approved
medication is to be used:
"An explanation of alternative modes of treatment is, in principle, also necessary when these
consist of the use of different types of prostheses and the particular prosthesis implanted by the
physician is, as in this case, a medical device that requires approval but has not been approved
(cf. also 40 Paragraph 1 No. 2 AMG). Under these circumstances, the prosthesis used, regardless
of its actual quality or safety and even if its use meets internationally accepted standards, still lacks
the sanction of official approval, which may be essential for an individual patient's decision under
the scope of the Law on Pharmaceuticals. The patient must therefore be informed of the lack
of approval."
According to generally accepted legal opinion, a violation of the duty to provide the patient with
basic information causes the intervention to be unlawful because of a lack of valid consent:
"Basic patient information includes the requirement that the patient has been informed of the most
serious risk with which the proposed intervention is specifically associated."
If there is a possibility of a disastrous outcome, no matter how unlikely it may be, the BGH requires
that the patient be informed about this risk fully and in timely fashion.
There is a duty to inform the patient of a rare complication if it would severely impair the patient's
ability to lead a normal life.
Generally accepted legal opinion

(see references 6, 12, 15, 17,
24, 25)
From BGH NStZ 1996, 34 (34)
BGH MedR 1996, 213 (214)

BGH NJW 1992, 743 ff.
BGH VersR 2000, 725 (726)
20
MEDICINE
Table e3 (continuation)
Special cases concerning patient information and informed consent (in alphabetical order) (see, in particular, references 5, 6, 10, 15,
16, and 17 of the CME article)
Type
Examples
Relevant case law
Refusal of treatment The physician must explain the risks and dangers of refusing treatment and document the
by the patient
explanation in the medical record.
BGH NJW 1998, 1782 (1783)
Relative indication
If the indication for an operation is merely relative, because conservative treatment might also lead
to therapeutic success, comprehensive patient information is required.
BHG NJW 2000, 1788 (1789)
Reproductive
medicine
The patient must be informed about the risk of failure of sterilization; otherwise, the physician can
be held liable for child support if a child is born after the patient has intercourse without preventive
measures under the assumption of sterility.
The physician must inform a male patient of the need for a spermiogram
after sterilization.
Failure to inform the patient of the possibility of therapeutic abortion in case of a defective embryo
("wrongful life" cases) may cause the physician to be liable for child support.
BVerfG NJW 1998, 519 (521)

BGH NJW 1992, 2961 (2961
254 BGB)
BGH NJW 1987, 2923 f.;
NJW 1984, 658 ff.
Risk of failure
The physician's duty to inform the patient about the risk of failure is particularly great when
the indication for treatment is doubtful and the chance of failure is high.
OLG Koblenz NJOZ 2004, 2655f.
Risky medications,
dangerous
substances
If the side effects of a medication are severe to the degree indicated above, then the information
contained in the package insert does not suffice, and the patient must also be personally informed
of the side effects by the physician ordering the medication.
"The act of prescribing medication obliges the physician to inform the patient about its dose,
interactions, and side effects. The more dangerous the substance, the greater the duty to inform."
BGH NJW 2005, 1716 ff.

(From ref. 15, translated)
Scientific studies
The patient must be informed that a medication is being prescribed in the setting of a study whose
purpose is the approval of the medication.
See AMG requirements
Standard treatment
Information is required when serious scientific concern has been raised about a treatment that is
currently considered standard treatment and its associated dangers.
BGH VersR 1978, 41 (42);

BGH VersR 1996, 233
Therapeutic privilege Only in very unusual (exceptional) cases may the physician choose not to inform the patient,
(harm done by patient if the physician believes that the act of informing the patient will itself do more harm than good.
information itself)
OLG Kln, MedR 1988, 184
Treatment
The physician is free to determine the technique of treatment, but may still have the duty to inform
alternatives (see also the patient about measures that, although their success in curing the patient is not certain,
choice of treatment) nonetheless may alleviate the patient's suffering or make it more bearable.
BGH NJW 1982, 2121

OLG Hamm, VersR 1990, 855.
Treatment outside
the scope of
scientifically based
medicine
The physician also has a duty to inform the patient of the economic significance of such a treatment OLG Frankfurt VersR 1988, 733
if it is not reimbursed by health insurance.
Trivialization
The physician may not trivialize a proposed intervention of doubtful indication and high risk.
BGH NJW 1997, 1637
Urgency
The physician must inform the patient properly about the true degree of urgency of the treatment.
False information can invalidate the patient's consent.
BGH NJW 1990, 2928 (2928)
Abbreviations:
AMG: Arzneimittelgesetz, Law on Pharmaceuticals; BGH: Bundesgerichtshof, Federal Court of Justice; IV ZR: Fourth Senate in Civil Law of the Federal Court of Justice;
KG Berlin: Kammergericht (Chamber Court), Berlin; MedR: Medizinrecht, Medical Law; NJOZ: Neue Juristische Online Zeitschrift (a German-language Internet legal journal);
NJW-RR: Neue Juristische Wochenschrift Rechtsprechungs-Report (a German-language legal journal); NStZ: Neue Zeitschrift fr Strafrecht (a German-language journal of criminal law);
OLG: Oberlandesgericht, Superior State Court
21
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MEDICINE

cme: Patient Information and

The legal status of medical procedures

Dtsch Arztebl 2007; 104(9): A 57686 www.aerzteblatt.de

Arzneimittelgesetz, Medical Preparations Act

Arztrecht, Medical Law (a German-language legal journal)

Aktenzeichen, reference number

Brgerliches Gesetzbuch, German Civil Code

Bundesgerichtshof, Federal Court of Justice

Bundesgerichtshof Strafsachen, Decisions of the Federal Court of Justice in

Bundesverfassungsgericht, Federal Constitutional Court

Grundgesetz, Basic Constitutional Law of the Federal Republic of Germany

Landgericht, Local Court

(Muster-)Berufsordnung, (Model) Professional Code of Conduct for the Chambers

Neue Juristische Wochenschrift (a German-language legal journal)

Oberlandesgericht, Higher Regional Court

Reichsgerichtshof, Imperial Court of Justice (18791945)

Reichsgerichtshof Strafsachen, Decisions of the Imperial Court of Justice in

Strafgesetzbuch, Criminal Code

Transplantationsgesetz, Law on Transplantation

teilweise vertretene Auffassung, opinion expressed less than unanimously

Versicherungsrecht, Insurance Law (a German-language legal journal)

A medical intervention can be legally justified by:

Criterion for proper patient information

Proper patient information

Not considered physical injury

Considered physical injury

Repeated judicial decisions of the BGH

Any medical intervention that impinges on

The physician must be aware of these!

Other considerations based on the

when the intervention is successful

Other considerations based on danger

When the intervention is unsuccessful and the

When the procedure is medically indicated

Patient information is subdivided into

The "Six W" Checklist

Dtsch Arztebl 2007; 104(9): A 57686 www.aerzteblatt.de

The process of pre-treatment patient information serves the goal of self-determination by

The proper time for patient information

Dtsch Arztebl 2007; 104(9): A 57686 www.aerzteblatt.de

Requirements for the first contact between the physician

Precondition for valid consent

Dtsch Arztebl 2007; 104(9): A 57686 www.aerzteblatt.de

Relevant case decisions

But cf. BGH decision of 20.5.2003

BGH NJW 1991, 1541 (1542)

Cf. BGH NJW 1994, 2414 (2415)

BGH decision of 7.12.2004 VI ZR

Cf. also BGH NJW 1973, 556

Cf. BGH NJW 1984, 655ff.

Cf. BGH NJW 1983, 328 ff.

BGH NJW 19892, 2121 (2122 f.)

BGH NJW 1988, 763; 1988, 2302

BHG NJW 1985, 2913

BGH NJW 1988, 765

OLG Koblenz NJW 2000, 3435

Consent by a minor aged 14 to 18

Dtsch Arztebl 2007; 104(9): A 57686 www.aerzteblatt.de

Minors lacking sufficient insight

Dtsch Arztebl 2007; 104(9): A 57686 www.aerzteblatt.de

Proper patient information (according to BGH NJW 1984, 1397):

Consent for elective procedures