Jou nal o Complemen a y The apies in Heal h
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Jou nal o Complemen a y The apies in Heal h 2026:4(1). doi:10.5281/zenodo.17660881 ins i u op c.com/jou nal-complemen a y- he apies
Re iew
The E hics o In o med Consen in T adi ional Chinese
Medicine P ac ice and Resea ch: A Na a i e Li e a u e Re iew.
Ema Simões Calçada1*, and Liliana Sampaio dos San os1,2 .
1 ABS – A lân ico Business School, Vila No a de Gaia, Po o, Po ugal;
2 IPB – Poly echnic Ins i u e o B agança, B agança, Po ugal.
* Co espondence: ema. [email protected]
Abs ac
Backg ound: T adi ional Chinese Medicine (TCM), a complemen a y/non-con en ional he apy, is
inc easingly being in eg a ed in o mode n heal hca e sys ems. Howe e , i s p ac ice and esea ch
aise e hical challenges, pa icula ly conce ning In o med Consen (IC), an essen ial elemen o en-
su ing pa ien au onomy, anspa ency, and p o ec ion.
Objec i e: This s udy aimed o conduc a Na a i e Li e a u e Re iew o iden i y he use o IC in
clinical p ac ice and esea ch wi hin TCM, highligh ing i s necessi y and impo ance o p o ec ing
pa ien igh s and p omo ing he adop ion o e hical s anda ds (including espec o au onomy,
cul u al sensi i i y, us , sa e y, and isk managemen ).
In o med Consen in TCM: IC is a undamen al e hical and legal equi emen , de ined as a olun a y
p ocess whe e an indi idual ag ees o a p ocedu e o ea men a e ully unde s anding he isks,
bene i s, al e na i es, and po en ial ou comes (disclosu e, comp ehension, and olun a iness).
TCM, as a non-con en ional he apy, is subjec o legal amewo ks equi ing pa ien choice and
in o med consen o all p o essional ac s. IC is especially c i ical in TCM o ensu e clea , cul u ally
adequa e communica ion ega ding holis ic concep s like Qi and Yin/Yang.
Conclusion and Recommenda ions: The e iew con i ms ha IC is a cen al e hical and legal p e-
equisi e o TCM. Despi e being widely ecognised, he s udy sugges s ha i s p ac ical applica ion
o en lacks quali y and anspa ency, some imes being ea ed in o mally. To add ess his, IC mus
e ol e om a me e o mali y in o an essen ial communica i e p ocess. The e o e, in es ing in spe-
ci ic e hical aining o TCM p o essionals and he s anda disa ion o pa ien in o ma ion ma e ials
is s ongly ecommended o s eng hen he clinical and social legi imacy o hese p ac ices.
Keywo ds: Consen , F ee and In o med; T adi ional Chinese Medicine; Complemen a y The apies.
1. In oduc ion
Unde s anding how TCM eme ged equi es going back in ime and his o y, as i is
p esen in ancien medical p ac ices. Howe e , TCM has come a long way and, gi en i s
ecogni ion as a medical p ac ice, albei non-con en ional, i is beginning o be in eg a ed
in o mode n heal hca e sys ems. And wi h i s expansion on a global scale, i s objec i e
and me iculous eadjus men o mode n imes is cu en ly based on p agma ic concep s,
aiming o be e guidance in diagnosis and unde s anding o he subjec 1. In his sense,
he e is a need, in ou opinion, u gen , o analyse he e hical issues ha guide i s p ac ice,
pa icula ly in ela ion o IC. I should be ecalled ha , despi e he inc easing ecogni ion
o TCM as a medical p ac ice, i is no ed ha , unlike con en ional Wes e n medicine,
whe e es ablished IC p o ocols exis , TCM aces some challenges, which a ise om di e -
ences in cul u al no ms, as well as diagnos ic app oaches and ea men me hods 2-4. How-
e e , like Wes e n medicine, whe he in TCM clinical p ac ice o i s esea ch, IC is a c ucial
Ci a ion: Calçada E.S., dos San os
L.S. The E hics o In o med Consen
in T adi ional Chinese Medicine
P ac ice and Resea ch: A Na a i e
Li e a u e Re iew. Jou nal o Com-
plemen a y The apies in Heal h.
2026;4(1) 10.5281/zenodo.17660881
Academic Edi o : Jo ge Rod igues
Recei ed: 22 Oc obe 2025
Re iewed: 12 No embe 2025
Re ised: 18 No embe 2025
Accep ed: 19 No embe 2025
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Jou nal o Complemen a y The apies in Heal h 2026: 4(1). 2 o 10
Calçada E.S., dos San os L.S.
The E hics o In o med Consen in T adi ional Chinese Medicine P ac ice and Resea ch: A Na a i e Li e a u e Re iew.
doi:10.5281/zenodo.17660881
elemen o e hical esponsibili y, ensu ing espec o pa ien au onomy, as well as ans-
pa ency be ween TCM p o essionals and hei pa ien s 5. In his line o hinking, i is im-
po an o highligh he impo ance o IC wi hin he scope o TCM p ac ice and esea ch
and, concomi an ly, iden i y he e hical challenges associa ed wi h IC. This is because, by
ecognising and p io i ising IC, p o essionals and esea che s ensu e ha hei p ac ices
uphold he igh s, sa e y, and au onomy o pa ien s and pa icipan s (in esea ch), con-
ibu ing o he assump ion o e hical in eg i y in TCM, as well as i s accep ance and in e-
g a ion in o mode n heal hca e sys ems 2,4,5. Thus, he aim is o ca y ou a na a i e li e -
a u e e iew ha iden i ies he use o IC in clinical p ac ice and esea ch in TCM and ha
highligh s he necessi y and impo ance o IC o gua an ee he p o ec ion o pa ien s'
igh s and, a he same ime, p omo e he adop ion o e hical s anda ds in TCM, bo h a
he le el o clinical p ac ice and esea ch in his heal h a ea, namely, in ela ion o espec
o au onomy, cul u al sensi i i y, building a he apeu ic ela ionship o us and based
on anspa ency, sa e y, and isk managemen , e hical esea ch p ac ices, and compliance
wi h e hical s anda ds es ablished by con empo a y heal hca e sys ems.
2. T adi ional Chinese Medicine
As Coimb a 6 explains, TCM is a sys em o diagnosis and heal hca e ha has de el-
oped o e mo e han 3000 yea s, wi h he oldes eco ds da ing back o 1000 BC (be o e
Ch is ), du ing he Shang dynas y, a ime when complex medical issues we e al eady be-
ing ea ed. I can be desc ibed as an ancien heal hca e sys em ha o igina ed in China,
based on a holis ic app oach o heal h and well-being wi h he aim o balancing he mind,
body, and en i onmen o p omo e healing and p e en disease. Acco ding o Williams
e al. 7, TCM wo ks on he p emise ha disease is c ea ed as a consequence o a dis u bance
ha occu s in he pe son's emo ional and men al body. Secondly, om a philosophical
poin o iew, ha healing is a p ocess ha mus in ol e he whole body, ha is, ega d-
less o he physical poin whe e he disease de eloped, i mus be unde s ood ha he
body is sick 7. This, which is one o se e al non-con en ional he apies (NCTs), encom-
passes a ious p ac ices and heo ies ha di e om so-called con en ional medicine,
Wes e n medicine, ocusing on es o ing he balance o he o ganism and no jus ea ing
speci ic symp oms, since TCM ansla es in o a se o e y sophis ica ed p ac ices, aimed
a cu ing disease and main aining heal h and well-being 7. Fo a be e unde s anding o
wha TCM is, i is impo an o in oduce wha a e conside ed i s undamen al concep s:
Qi o Chi (ene gy); Jing (essence o ances al ene gy); Xue (blood); Shen (spi i o con-
sciousness); and o ganic Fluids 8. In e ms o ad an ages, i is wo h men ioning ha TCM
is e ec i e in ea ing some ch onic diseases; i adop s a holis ic app oach, add essing all
aspec s o he indi idual's heal h; i ocuses on he undamen al cause o he disease and
no me ely on he isible symp oms 9. I can also be said ha in p ac ice, Chinese doc o s
di e en ia ed he " oo " o an illness, he pa e n o ene ge ic imbalance in he pa ien ,
om he "b anches" ha eached he appa en symp oms 9,10. This he apeu ic sys em does
no depend on d ug he apy, in some cases associa ed wi h unwan ed side e ec s; i p o-
mo es he pe son's gene al heal h, in addi ion o ea ing speci ic diseases; i ends o be
mo e economically accessible han con en ional allopa hic ea men ; i can be used in
conjunc ion wi h Wes e n medicine, including o alle ia e he ad e se e ec s o Wes e n
he apies 10,11.
2.1. Legal F amewo k
As p e iously men ioned, TCM is an NCT and is he e o e egula ed by Law No.
71/2013, o Sep embe 2nd 12,13, which egula es access o and he exe cise o p o essions
wi hin he scope o NCTs in he public o p i a e sec o , wi h o wi hou p o i , and which,
in i s A icle 2, ecognises TCM as an NCT. In his ma e , i is also necessa y o e e o
Law No. 45/2003, o Augus 22nd 12,14, which es ablishes he amewo k o he ac i i y and
exe cise o p o essionals who apply NCTs, as de ined by he Wo ld Heal h O ganiza ion
(WHO). Acco ding o his legal diploma, NCTs a e he apies ha a e based on a di e en
Jou nal o Complemen a y The apies in Heal h 2026: 4(1). 3 o 10
Calçada E.S., dos San os L.S.
The E hics o In o med Consen in T adi ional Chinese Medicine P ac ice and Resea ch: A Na a i e Li e a u e Re iew.
doi:10.5281/zenodo.17660881
philosophy om con en ional medicine and apply speci ic diagnos ic and he apeu ic
p ocesses (no. 1, a icle 3) 14. Conside ing he heme o he wo k, i is impo an o men ion
ha his diploma deno es a conce n wi h e hics in he p ac ice and esea ch o TCM as an
NCT and wi h IC. Le us conside i s A icle 4, whe e i s guiding p inciples a e se ou :
The indi idual igh o choose he he apeu ic me hod, based on an in o med choice,
abou he sa e y, quali y, e icacy, and possible isks; The de ence o public heal h, in e-
spec o he indi idual igh o heal h p o ec ion; The de ence o use s, which equi es ha
NCTs be p ac iced wi h a high deg ee o esponsibili y, diligence, and compe ence, based
on he p o essional quali ica ion o hose who p ac ice hem and hei espec i e ce i ica-
ion; The de ence o he use 's well-being, which includes complemen a i y wi h o he
heal h p o essions; The p omo ion o scien i ic esea ch in he di e en a eas o NCTs,
aiming o achie e high s anda ds o quali y, e icacy, and e ec i eness 14. A he same
ime, A icle 13 is highligh ed, which e e s o he igh o op ion and o in o ma ion and
consen , meaning ha "ci izens ha e he igh o eely choose he he apies hey deem
app op ia e" (no. 1) and ha "non-con en ional he apy p o essionals can only pe o m
ac s wi h he in o med consen o he use " (no. 2) 14. The e o e, he necessi y and im-
po ance o IC being used in he p ac ice and esea ch o TCM is immedia ely e iden .
Finally, we wan o highligh O dinance No. 45/2018 o Feb ua y 9 h 15, which emphasises
he need o a deg ee in TCM o include adequa e aining in all a eas, including e hics. In
i s A icle 9, di ec ed a he TCM p ac ice aining componen , i highligh s he need o
his aining o include espec o sa e p ac ice, e hical, and deon ological s anda ds, and
in complemen a i y, i s A icle 10 ( aining in o he a eas) emphasises he du y o he
s udy plan leading o a deg ee in TCM o ensu e, ac oss he di e en componen s, ade-
qua e aining in he a ea o e hics and deon ology, among o he a eas 15. Thus, TCM, e en
hough i is no a con en ional medicine, is also guided by e hical and deon ological p in-
ciples, simila o con en ional medicine, which allows us o unde line he necessi y o
using IC in i s p ac ice and esea ch, jus as in he p ac ice and esea ch o Wes e n medi-
cine. In addi ion o he a o emen ioned legal documen s, i is impo an o highligh o he s
ha es ablish he obliga ion o espec he pe son and hei igh s, as IC in ends o do: a
a na ional le el, he Cons i u ion o he Po uguese Republic, he Penal Code, he Ci il
Code, and he Basic Heal h Law a e also highligh ed; and on he in e na ional s age, he
Uni e sal Decla a ion on Bioe hics and Human Righ s, he Con en ion on Human Righ s
and Biomedicine, and he Cha e o Pa ien Righ s and Du ies 16.
3. In o med Consen
IC can be desc ibed as a p ocess h ough which an indi idual olun a ily ag ees o
pa icipa e in a medical p ocedu e, esea ch, o ea men , a e ully unde s anding he
isks, ad an ages, possible al e na i es, and he esul s ha can be ob ained 17. Tha is, IC
ansla es in o he p ocess ha equi es he indi idual o ecei e in o ma ion, possess he
men al capaci y o unde s and and e alua e i , and be ee om any o m o pe suasion
o coe cion. The e o e, he e a e wo basic elemen s o IC: comp ehension and ee cla i i-
ca ion. The i s conce ns he p o ision o co ec and clea in o ma ion abou he diagno-
sis and he apeu ic al e na i es, in a way ha is unde s andable o he indi idual; he sec-
ond e e s o he ac h ough which he indi idual, o hei own ee will, consen s and
au ho ises an in e en ion o hei pa icipa ion in esea ch 18. The e o e, i is unde s ood
ha IC se es he pu pose o disclosu e, ha is, p o iding all-impo an in o ma ion o
he pa ien such as he isks, ad an ages, al e na i es, and he objec i e o he in e en-
ion/ ea men / esea ch. Howe e , as ERS e e s 18, he in o ma ion o be p o ided mus
ake in o accoun h ee pa ame e s: he common p ac ice in he p o ession; he expec a-
ions o a speci ic pa ien ; and he needs o a speci ic indi idual. In addi ion, depending
on he men ioned pa ame e s, he in o ma ion p o ided in an IC mus espec :
Jou nal o Complemen a y The apies in Heal h 2026: 4(1). 4 o 10
Calçada E.S., dos San os L.S.
The E hics o In o med Consen in T adi ional Chinese Medicine P ac ice and Resea ch: A Na a i e Li e a u e Re iew.
doi:10.5281/zenodo.17660881
• he diagnosis and desc ip ion o he clinical condi ion;
• he desc ip ion o he p oposed ea men , i s na u e and objec i es;
• he isks and possible complica ions ha may esul om he ea men in ques ion;
• al e na i e ea men s;
• he isks o non- ea men ;
• he p obabili y o ea men success 18.
Comp ehension is equally impo an and se es o ensu e ha he indi idual unde -
s ands all he in o ma ion p o ided, which can be done h ough ques ioning. He e, he
impo ance o communica ion is highligh ed, as he ac ha he p ocess is based on good
communica ion makes IC a p ocedu e ha can be modi ied and e ol e h oughou he
ea men 18. Volun a iness is ano he inhe en cha ac e is ic o IC, allowing he indi idual
o make a olun a y decision, o hei own ee will and ee om manipula ion o in lu-
ence om hi d pa ies. This is because, ee consen is an in en ional and olun a y ac ,
which au ho ises someone, in his case, he heal hca e p o ide , ei he indi idually o in-
s i u ionally, o ac in a ce ain way du ing he he apeu ic ac 18. Finally, compe ence is
ano he impo an aspec o conside , as i is necessa y o con i m whe he he pe son has
he men al and legal capaci y o make he decision. The e o e, in u gen si ua ions, in si -
ua ions whe e pa ien s a e empo a ily o de ini i ely unable o decide (coma, men al dis-
abili y, child en), he IC will ha e o be ca ied ou by hei legal ep esen a i es 16. Ac-
co ding o ERS 18, one o he easons ha suppo s he exis ence o in o med consen is
ela ed o he ac ha i is admi ed o be a bene i o he pa ien o ac i ely pa icipa e
in decisions abou he medical ca e hey unde go. This bene i o pa ien in ol emen in
decisions abou hei heal h esul s, on he one hand, om being p oac i e, a oiding in-
e en ions ha he pa ien may conside po en ially dange ous o hei heal h, and, on
he o he hand, om con ibu ing o hei well-being. In ac , only ad an ages esul om
IC, and he e a e se e al easons ha jus i y i s impo ance, as i ensu es espec o he
pe son and hei undamen al igh s: 1) ensu es espec o he pa ien 's essen ial igh o
sel -de e mina ion; 2) p o ec s he pa ien agains possible physical and psychological
ha m ha may esul om he disease o ea men ; 3) p omo es he bene i o he pa ien 's
ac i e pa icipa ion in decisions ela ed o he medical ca e hey ecei e 19. The e o e, IC
is a c ucial e hical and legal equi emen , pa icula ly in he a ea o heal h and esea ch,
as is he case wi h TCM p ac ice and esea ch, because i ensu es espec o he au onomy
and igh o he indi idual o make hei own decisions ega ding hei body and heal h.
Fu he mo e, i os e s us , essen ial o any he apeu ic ela ionship 19, and he e o e IC
e lec s an exchange o ideas ha s eng hens he doc o -pa ien ela ionship 20. The IC
o m is he documen ha ma e ialises he IC i sel , being an e hical and legal documen
ha aims o in o m he pa ien abou he p ocedu e he pa ien is going o unde go, wi h
he pu pose o he la e exe cising hei igh o ee au onomy, and a he same ime,
p o ec ing he heal h p o essional 21, and he e o e, i canno be disc edi ed o igno ed,
no ea ed in o mally 22. Fo his e y eason, we ag ee wi h he idea ha assuming ha
in o med consen should be based on comp ehension and ee consen , i s co ec appli-
ca ion depends on he obse ance o hese p inciples in he pa ien 's decision-making p o-
cess. As i is a p ocess ha in ol es no only he pa ien 's au onomy and eedom, bu also
du y and esponsibili y, i s applica ion is no subjec o p ecise e alua ion, al hough s a -
egies can be de ined o implemen i s applica ion and e alua e he igo wi h which he
p ocess is app oached 18.
3.1. The Fou E hical P inciples
I has been a gued, ega ding IC, ha TCM p ac ice and esea ch, e en hough no
alling unde con en ional medicine, should be guided by IC p o ocols. In his line o
hinking, i is ecognised ha he ou e hical p inciples ha cu en ly p e ail in Wes e n
medical e hics can and should be applied in he con ex o NCTs, such as TCM. They a e:
non-male icence; bene icence; espec o au onomy; and jus ice 23. Thus, espec o he
Jou nal o Complemen a y The apies in Heal h 2026: 4(1). 5 o 10
Calçada E.S., dos San os L.S.
The E hics o In o med Consen in T adi ional Chinese Medicine P ac ice and Resea ch: A Na a i e Li e a u e Re iew.
doi:10.5281/zenodo.17660881
p inciple o non-male icence is based on he idea o doing no ha m 24-26. Tha is, i inhe -
en ly ca ies he idea ha he pa ien should no be ha med, ensu ing ha he heal h p o-
essional mus a oid causing ha m o he pa ien . Fo his e y eason, he e mus be p e-
en ion o di ec ha m, as well as a cau ious assessmen o he isks a ising om he in e -
en ion, in o de o a oid complica ions and minimise any nega i e consequences. Con-
e sely, he p inciple o bene icence is based on he idea o doing good 24-26, ensu ing ha
he heal h p o essional ac s in he bes in e es o he pa ien , in o de o p omo e hei
well-being and maximise he bene i s o hei heal h and quali y o li e. In u n, he p in-
ciple o espec o au onomy gua an ees he pa ien 's igh o make hei own decisions
ega ding hei body and heal h, based on hei belie s, alues, and p e e ences, ha is,
he pe son chooses 24,26. The e o e, i allows he pa ien he eedom o decision, wi h
knowledge o he ac s and wi hou coe cion, h ough co ec in o ma ion 25. To ensu e
his igh , i is he esponsibili y o he heal h p o essional o co ec ly in o m he pa ien
abou hei disease, hei s a e o heal h, exis ing ea men s, and he isks and ad an ages
associa ed wi h each o hem, so ha he pa ien can make an in o med and olun a y
decision. The p inciple o jus ice, in he con ex o medical e hics, ad oca es he ai and
egali a ian ea men o all pa ien s, ega dless o hei socioeconomic s a us, eligion, po-
li ical op ion, sexual o ien a ion, among o he s. This p inciple is based on he idea o "p i-
o i ising equi ably, using a ailable esou ces judiciously 24,26. In his ega d, Rosa e al. 25,
based on he con ibu ion o o he heo is s, say ha his p inciple e e s o he equi able
dis ibu ion o esou ces necessa y o assis ance, as well as gua an eeing access o
heal hca e o all ci izens. This p inciple is ex emely impo an , as i p io i ises a ai dis-
ibu ion and access o heal h esou ces, ha is, i gua an ees access o heal hca e and
ea men wi hou disc imina ion o any kind o a ou i ism. Al hough hese p inciples
apply o Wes e n medical e hics, hey can be ansposed o TCM, assis ing i s p o ession-
als, jus as happens in con en ional medicine, in hei decisions. Because he o mula ion
o an e hical decision is based on he unde s anding o hese undamen al p inciples o
bioe hics ha apply o common p oblems o clinical p ac ice and is acili a ed when ins i-
u ional and indi idual esponsibili y a e well de ined 25. These p inciples guide heal h
p o essionals, in he sense o seeking o ind a balance be ween he igh s and in e es s o
pa ien s and hei esponsibili y and du ies, and he limi a ions o he cu en heal h sys-
em which, al hough al eady beginning o ecognise and in eg a e NCTs, a e s ill no he
objec o he ecogni ion hey dese e.
3.2. The Impo ance o In o med Consen in TCM P ac ice and Resea ch
IC is an essen ial p ocess in he p ac ice and esea ch o TCM, due o e hical ac o s,
which a e he ocus o his wo k, as well as clinical and cul u al ac o s. Rega ding he
challenges o e hical e iew in TCM clinical esea ch, Zhang e al. 27 s a e ha in China his
is highly con e gen wi h ha o Wes e n medicine, howe e , i lacks he cha ac e is ics
and cul u e o TCM, which is pa icula ly impo an when we hink abou he Po uguese
eali y, whe e i is necessa y, in o de o achie e his con e gence be ween Wes e n med-
icine and Eas e n medicine, o ha e g ea e knowledge and egula ion o TCM. Fi s ly,
espec o pa ien au onomy has been widely e e ed o, and jus as in con en ional med-
icine, in he con ex o TCM oo, pa ien s ha e he igh o make hei own in o med deci-
sions abou hei heal h and body. A he same ime, simila o wha happens in Wes e n
medicine, whe e pa ien s do no ha e medical knowledge abou ea men s, in TCM hey
also do no ha e knowledge o i s p ac ices and ea men s. The e o e, IC ensu es ha
hey unde s and wha hey a e ag eeing o, and by being in o med, hey gain knowledge
o make hei in o med choices based on hei p e e ences, alues, and belie s. In his e-
ga d, i is wo h men ioning he a icle by Whi e e al. 28, which unde lines he igh o
pa ien s o be in o med abou he isks and bene i s o any examina ion o ea men and
he obliga ion o doc o s o ob ain p io IC. The same au ho s also men ion he impo ance
o in o ma ion abou he isks and ad an ages o his echnique being a ailable o heal h
p o essionals and pa ien s, ha ing designed an in o ma ion lea le ha no only iden i ies
Jou nal o Complemen a y The apies in Heal h 2026: 4(1). 6 o 10
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The E hics o In o med Consen in T adi ional Chinese Medicine P ac ice and Resea ch: A Na a i e Li e a u e Re iew.
doi:10.5281/zenodo.17660881
he isks bu can also be adap ed o he cons uc ion o an IC o m 28. TCM, as al eady
men ioned, app oaches heal h and disease holis ically, p io i ising he ela ionship be-
ween body, mind, and en i onmen , and he e o e i s philosophy includes concep s such
as Qi and he balance o Yin and Yang, concep s ha can be di icul o pa ien s un amilia
wi h hem o unde s and. In his sense, IC in TCM necessa ily equi es clea and cul u ally
adequa e communica ion, in o de o ensu e ha pa ien s unde s and he na u e, objec-
i es, and mechanisms o he ea men o ollow. Howe e , i is no ed ha IC o ea -
men such as acupunc u e, o example, is ea ed as an in o mal ma e , meaning ha
mos o i s p ac i ione s p obably only p o ide in o ma ion abou isks when asked, and
IC is assumed by he ac ha he pa ien appea ed a he clinic and und essed o p epa e
o ea men 29. On he o he hand, i is impo an ha pa ien s seeking TCM a e awa e o
he isks and bene i s inhe en in each ea men , and he e o e IC allows hem o be in-
o med abou he isks, ad an ages, and e ec i eness esul s o he ea men in ques ion.
As Whi e e al. 30 emphasise, " heo e ically, any heal h p o essional who does no espec
he p inciple o in o med consen may be he subjec o a lawsui by he pa ien and an
ac ion by hei p o essional body. Touching a pa ien wi hou alid consen , o example,
can cons i u e a ci il o c iminal o ense o assaul . Fu he mo e, i heal h p o essionals
ail o ob ain in o med consen and he pa ien subsequen ly su e s ha m as a esul o
he ea men , his ac may be a ac o in a negligence complain agains he p o essional."
A he same ime, e hical and legal esponsibili y is also p esen in TCM, and he e o e IC
es ablishes an e hical and legal basis ha holds he heal h p o essionals who p ac ice i
accoun able, ensu ing ha his in e en ion is p ac iced esponsibly, con ibu ing o
g ea e pa ien sa e y and us . Fo his e y eason, he key p inciples o in o med con-
sen a e ha consen mus be gi en by a pa ien a) olun a ily, b) who has he capaci y o
unde s and and c) who has been gi en app op ia e in o ma ion 30. Finally, in e ms o
esea ch, IC is impo an o p o ec ing pa icipan s. Tha is, h ough IC, pa icipan s in a
TCM s udy a e in o med abou whe he he ea men is expe imen al, wha he objec i e
o he s udy is, and wha he inhe en isks a e. Fu he mo e, in his con ex , he pa ien 's
iden i y is no mally p o ec ed, and IC se es p ecisely o gua an ee hei anonymi y and
he con iden iali y o he in o ma ion p o ided by hem. The e o e, he impo ance o IC
in p ac ice and esea ch wi hin TCM is a s ep o i o asse i sel a he le el o con en-
ional medicine and o egula ise i sel , being in une wi h he e hical s anda ds ha a e
equi ed in all o ms o medical p ac ice. IC is hus a c ucial p ocedu e o ensu e ha
pa ien s (clinical p ac ice) and hose in es iga ed ( esea ch) unde s and he ea men hey
will unde go o he s udy hey will pa icipa e in and wi h which hey ha e ag eed, ind-
ing ha he gene al e hical p inciples a e he basis o he e hical e iew o TCM, whe e IC
appea s as one o he aspec s o be conside ed due o he cha ac e is ics o TCM21.
3.3. Impo ance and Necessi y o In o med Consen in Non-Con en ional The apies
IC is a c ucial aspec in NCTs no only because o he unique challenges hey aise,
bu also because o he e hical conside a ions in ol ed in ea men s ha , o he mos
pa , a e no pa o con en ional medicine guidelines. Going somewha along he lines o
wha was p e iously men ioned ega ding IC in TCM, in NCTs, which include TCM, e-
spec o he pa ien 's igh o au onomy is also undamen al. In ac , NCTs co e a la ge
se o p ac ices (e.g., he bal medicine, homeopa hy, acupunc u e, TCM, e c.), and may in-
clude he apeu ic app oaches ha a e un amilia and unknown o many pa ien s. In his
way, IC gains pa icula ele ance, as p o essionals, a e clea ly in o ming hei pa ien s
abou he a ious ea men al e na i es (indica ing only hose ha a e app op ia e o
hei disease/condi ion), allow hem o make an in o med choice based on hei alues
and belie s, espec ing and ensu ing he igh o hei au onomy and sel -de e mina ion.
ERS 18 e e s ha one o he undamen al easons o he exis ence o in o med consen is
espec o he pe son. I is now an accep ed ac in ou socie ies ha each o us is he
holde o a se o p inciples and cha ac e is ics ha makes us a unique being, whose dig-
Jou nal o Complemen a y The apies in Heal h 2026: 4(1). 7 o 10
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The E hics o In o med Consen in T adi ional Chinese Medicine P ac ice and Resea ch: A Na a i e Li e a u e Re iew.
doi:10.5281/zenodo.17660881
ni y in ol es being able o assume hei own indi iduali y. The indi iduali y o he hu-
man being is associa ed wi h he concep o au onomy, which in his con ex canno be
dissocia ed om he capaci y o choice and sel -de e mina ion. Once he igh o au on-
omy is ecognised, unde s ood as he capaci y o e hically de e mine one's way o li e, i
would be an unaccep able e hical iola ion o condi ion hei eedom o choice, inducing
choices o e using hei ac i e pa icipa ion in making decisions ha may a ec hei u-
u e. On he o he hand, we wan o unde line he impo ance o IC in de ining ealis ic
expec a ions, in p o ec ion agains exploi a ion, and in encou aging anspa ency and
us . Rega ding expec a ions, i is no ed ha indi iduals may eso o NCTs as a esul
o he ine ec i eness o con en ional medicine ea men s. The e o e, IC se es o p o-
essionals o in o m abou he scien i ic e idence o hese he apies, hei e ec i eness in
he ace o he illness in ques ion, con ibu ing o pa ien s c ea ing ealis ic expec a ions
ega ding ea men h ough NCTs. In ela ion o p o ec ion agains exploi a ion, IC p o-
ec s pa ien s om une hical p ac ices, ensu ing ha hey unde s and he op ions a aila-
ble o hem, as well as he associa ed inancial cos s. Rega ding he encou agemen o
anspa ency and us , IC allows heal h p o essionals o explain how a he apy wo ks,
demons a ing he hones y o hei ac ions, as well as he openness o es ablishing a he -
apeu ic ela ionship based on us . A s udy ca ied ou by Ieong 29 discusses he s a e o
TCM in Po ugal compa ing i wi h he sys em in o ce in he coun y whe e i o igina ed
(China) and whe e i is ecognised in legisla i e, adminis a i e, educa ional, and p ac ice
e ms. The s udy's conclusions show ha , in na ional e i o y, he TCM egime is pa o
he inclusi e sys em acco ding o he WHO's de ini ion and desc ip ion o he in eg a-
i e, inclusi e, and ole an sys em. This same s udy highligh s he impo ance o IC in
TCM p ac ice in Po ugal, emphasising i s indispensable and special ole, la gely jus i ied
by he pa icula i y o he diagnosis, p esc ip ion, and ea men me hod. Ieong 29 hus
concludes ha he NCT sys em in Po ugal is s ill in a e y emo e phase, lacking de el-
opmen , wi h he pu pose o imp o ing and de eloping he ealisa ion o he IC doc ine
in his ecen ly legalised domain.
4. Final ema ks
I can be said ha he ou p inciples o IC a e usually p esen in s udies and in he
li e a u e ha esea ches TCM, whe e IC ope a ionalises espec o au onomy and con-
ibu es o bene icence and non-male icence by in o ming he pa ien abou isks/bene i s
and al e na i es 24-26. Howe e , as exp essed by Zhao e al. 5, al hough many s udies e e
o IC, his does no gua an ee ha consen is, e ec i ely, in o med and ha i complied
wi h all e hical equi emen s, namely, communica ion o isks, olun a iness, possibili y
o wi hd awal, among o he s. Tha is, al hough many ials men ion he applica ion o IC,
he e is no ce ain y abou he quali y o his p ocess and whe he i was documen ed in
acco dance wi h igo ous e hical s anda ds 5. In ac , se e al au ho s who commen on he
IC p ocess emphasise ha consen is a communica i e p ocess and no a simple o m, and
mus ensu e he comp ehension, olun a iness, and decision-making capaci y o each pa -
icipan 31,32. In his sense, Zhang e al. 2 de end he idea ha in o de o ob ain high-quali y
IC in TCM clinical ials, i is necessa y o imp o e anspa ency, language, ela ional ca e,
and ensu e ha pa icipan s unde s and all ele an and inhe en aspec s o he s udy/in-
e en ion hey a e pa icipa ing in. Empi ical esea ch 5 ound ha only a small ac ion
o he epo ed ials men ioned clinical ial egis a ion and ha e hical app o al was
e e ed o in less han a qua e o he pape s, which highligh s a gap in p ac ice and
epo ing. Thus, i is impo an he e o emphasise he s udy by Zhao e al. 5, which con-
empla ed IC in i s esea ch and ea ed i as an objec o in es iga ion, inso a as hey did
no assume ha IC was p o ided o pa icipan s, conce ning hemsel es wi h his aspec
by ques ioning hem abou how he p ocess was. In he same sense, i is unde s ood ha
Li e al. 33 de eloped a p o ocol ha conside s he necessa y e hical equi emen s o e-
sea ch on human beings, including speci ically in o ming pa icipan s abou he objec-
i es, p ocedu es, possible isks, and bene i s be o e signing he IC. TCM ial pa icipan s
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The E hics o In o med Consen in T adi ional Chinese Medicine P ac ice and Resea ch: A Na a i e Li e a u e Re iew.
doi:10.5281/zenodo.17660881
ask o clea explana ions abou he p oposed mechanisms, in e ac ions wi h Wes e n
ea men s, du a ion, isi s, ad e se e ec s, and al e na i es o non- ea men 2,5. This in-
dica es ha s anda d o ms/lea le s used in he clinic should include hese i ems in a sim-
ple and illus a i e way, and ools such as he model lea le by Whi e e al. 30 ( o acupunc-
u e) o he WHO models o he ICF can be adap ed o include speci ic sec ions on "wha
TCM is applied he e", "wha a e he di e ences in ela ion o Wes e n ea men ", "wha
a e he expec ed e ec s and po en ial ad e se e ec s" 30,32. Rega ding he s udy by Ba os
e al. 34, i allows o highligh ing gaps in concep ualisa ion among p o essionals/manag-
e s. Thus, o gua an ee quali y IC, i is necessa y o in es in he e hical aining o TCM
p o essionals, no leas because IC p o ec s agains p ac ices ha p omise ex ao dina y
cu es wi hou any scien i ic e idence. Fo his eason, IC should include an hones balance
be ween he e idence (wha is known and wha is no known) and ealis ic expec a ions,
p e en ing psychological and inancial ha m om alse expec a ions.
5. Conclusion
This e iew con i ms ha IC is a undamen al e hical and legal p e equisi e o he
p ac ice and esea ch o TCM. While IC is ecognised and commonly men ioned in p o o-
cols, signi ican de iciencies in i s quali y, anspa ency, and p ac ical implemen a ion
may occu . The co e inding is ha IC mus e ol e om a me e o mali y o an essen ial
communica i e p ocess o gua an ee pa ien au onomy and us . To s eng hen TCM's
e hical ounda ion, he s anda disa ion o in o ma ion ma e ials and dedica ed e hical
aining o p o essionals a e s ongly ecommended, ensu ing hese p ac ices align wi h
con empo a y heal hca e s anda ds.
C edi au ho s a emen : Concep ualiza ion: E.S.C. and L.S.S.; In es iga ion: E.S.C. and L.S.S.; W i -
ing, e iewing and edi ing: E.S.C. and L.S.S. All au ho s ha e ead and ag eed o he published
e sion o he manusc ip .
Funding: This esea ch did no ecei e any speci ic g an om unding agencies in he public,
comme cial, o no - o -p o i sec o s.
Con lic o In e es : The au ho s decla e ha he e a e no con lic s o in e es .
Ins i u ional Re iew Boa d S a emen : No applicable.
In o med Consen S a emen : No applicable.
Da a A ailabili y S a emen : The o iginal con ibu ions p esen ed in his s udy a e included in
he a icle. Fu he inqui ies can be di ec ed o he co esponding au ho .
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