CN111861807A

CN111861807A - Implementation method of informed consent, informed receiving end and system

Info

Publication number: CN111861807A
Application number: CN202010691096.6A
Authority: CN
Inventors: 张发宝; 李欣梅
Original assignee: Shanghai Medsci Medical Technology Co ltd
Current assignee: Shanghai Medsci Medical Technology Co ltd
Priority date: 2020-07-17
Filing date: 2020-07-17
Publication date: 2020-10-30

Abstract

The invention provides a realization method of informed consent, an informed receiving end and a system, wherein the method comprises the following steps: the informed receiving end divides the informed consent obtained from the informed initiating end to obtain a plurality of paragraph contents and obtains corresponding explanatory contents; the informed receiving end initiates an informed inquiry to the party after playing the paragraph contents and the corresponding explanatory contents thereof to the party from front to back in sequence according to the segmentation sequence; and the informed receiving end determines whether to enter the playing of the next paragraph content and the description content thereof according to the feedback result of the inquiry of the informed by the party, and repeats the content playing and feedback result obtaining process until the feedback of the party on the playing of all the paragraph contents and the description content thereof is obtained as the confirmed informed state. The invention can realize the explanation of the informed consent through the internet or the terminal equipment, thereby not only realizing the purpose of remotely signing the informed consent, but also avoiding the repeated communication interaction between the informing party and the party.

Description

Implementation method of informed consent, informed receiving end and system

Technical Field

The invention relates to the technical field of informed consent, in particular to an implementation method of informed consent, an informed receiving end and a system.

Background

The informed consent right refers to a right which can be chosen by a person and family members with independent judgment ability to understand the information informed by the person and family members and know the risks and consequences in the informed consent, and then decide the plan made by the informing party. The informed consent and notification of the party is a way to effectively solve the dispute between the party and the notifier, and the right obligation relationship between the two parties can be balanced.

Under the support of emerging information technologies such as cloud computing, big data and the Internet of things, the traditional service mode is gradually changed, and meanwhile, the traditional service mode and the traditional service mode are crossed and penetrated, so that the method is a product of fusion and innovation of the traditional service mode and the emerging service mode. Because a party may be puzzled or unknowingly informed of the content of the informed consent, how to intelligently realize the explanation of the informed consent so as to assist the informing party and the party to sign the informed consent is a problem which needs to be solved urgently.

Disclosure of Invention

The invention aims to provide a realization method of informed consent, an informed receiving end and a system, which can realize the explanation of an informed consent form through the Internet or terminal equipment, avoid repeated communication interaction between an informing party and a party and assist the informing party and the party to sign the informed consent form.

The technical scheme provided by the invention is as follows:

the invention provides a method for realizing informed consent, which comprises the following steps:

the informed receiving end divides the informed consent obtained from the informed initiating end to obtain a plurality of paragraph contents and obtains corresponding explanatory contents;

the informed receiving end initiates an informed inquiry to the party after playing the paragraph contents and the corresponding explanatory contents to the party from front to back in sequence according to the segmentation sequence;

and the informed receiving end determines whether to enter the playing of the next paragraph content and the description content thereof according to the feedback result of the principal on the informed inquiry, and repeats the content playing and feedback result obtaining process until the feedback of the principal on the playing of all the paragraph contents and the description content thereof is obtained as the confirmed informed state.

Further, the step of dividing the informed consent obtained from the informed originator by the informed receiving end to obtain a plurality of paragraph contents and obtaining corresponding explanatory contents includes:

the informed receiving end segments the acquired informed consent book through a preset punctuation mark or meaning group division rule to obtain a plurality of paragraph contents;

And the informed receiving terminal carries out word segmentation processing on the contents of each paragraph to obtain word segmentation results, and inquires according to the word segmentation results to obtain explanatory contents corresponding to the contents of each paragraph.

Further, the method for obtaining the explanatory content corresponding to each paragraph content by querying the word segmentation result includes the following steps:

the informed receiving end trains to obtain a word segmentation dictionary, and the word segmentation result is obtained by segmenting the current paragraph content through the word segmentation dictionary;

the informed receiving end screens out the words to be explained from the word segmentation result, and inquires the explanatory content of the words to be explained to obtain the explanatory content corresponding to the current paragraph content;

and the informed receiving end switches the next paragraph content to carry out word segmentation screening and query until explanatory contents corresponding to the paragraph contents are obtained.

Further, the sending an informed query to the principal after the paragraph content and the corresponding explanatory content are sequentially played to the principal from front to back according to the segmentation precedence order includes the steps of:

the informed receiving end plays the current paragraph content and the corresponding explanatory content thereof to the voice of the party from front to back according to the sequence of the segmentation sequence, and/or plays the current paragraph content and the corresponding explanatory content thereof by image-text rolling;

And the informed receiving end initiates an informed inquiry corresponding to the current paragraph content after finishing the voice playing and/or the image-text rolling playing of the current paragraph content and the explanatory content thereof.

the informed receiving end plays the current paragraph contents to the voice of the party from front to back according to the segmentation sequence and/or plays the current paragraph contents in a graph-text rolling way;

the informed receiving end initiates an explanation inquiry whether the explanation is needed or not to the party;

if the explanation is determined to be needed, the informed receiving end inquires and acquires the explanation content corresponding to the current paragraph content, and initiates an informed inquiry corresponding to the current paragraph content after the explanation content corresponding to the current paragraph content is played by a party in a voice way and/or in a picture and text rolling way;

and if the explanation is determined not to be needed, the informed receiving end initiates an informed inquiry corresponding to the current paragraph content.

Further, the step of determining whether to enter the playing of the next paragraph content and the description content thereof by the informed receiving end according to the feedback result of the party to the informed inquiry comprises;

The informed receiving end acquires a feedback result of the party on the informed inquiry;

if the feedback result is unclear or the party does not have the informed consent capability, the informed receiving end enters an informed assistance process;

if the feedback result is clear, the informed receiving end plays the next paragraph content and the corresponding explanatory content thereof from front to back to the party according to the segmentation sequence;

and the informed receiving end repeats the content playing and feedback result obtaining process until the playing feedback of the party on all paragraph contents and the description contents is determined to be informed.

Further, the step of obtaining the play feedback of the principal on all the paragraph contents and the description contents thereof until determining the informed state includes:

the informed receiving end prompts whether the party confirms agreement or not, and if yes, the biological characteristic signature input by the party is obtained;

and the informed receiving terminal generates an electronic edition informed consent according to the biological characteristic signature, encrypts and prevents modification of the electronic edition informed consent, stores the encrypted and prevented modification electronic edition informed consent, and sends the encrypted and prevented modification electronic edition informed consent to the corresponding informed initiating terminal.

Further, the step of the informed receiving end obtaining the feedback result of the party to the informed inquiry comprises the following steps:

the informed receiving end triggers and acquires the input information of the party, and stops playing the paragraph content and the corresponding explanatory content to the party when the triggering and acquiring of the input information is started;

and the informed receiving end analyzes and identifies the input information to obtain a feedback result aiming at the informed inquiry.

Further, if the feedback result is unclear or the party does not have the ability to agree with the knowledge, the entering of the flow of assistance with knowledge by the informed receiving end includes the steps of:

if the feedback result is that the party does not have the informed consent capability, the informed receiving end initiates a request to be assisted by the guardian to sign informed consent; or the like, or, alternatively,

and if the feedback result is unclear, the informed receiving end sends the paragraph contents which are fed back to be unclear to the informed starting end so as to obtain the explanation of the informing party from the informed starting end.

Further, the method for dividing the informed consent obtained from the informed originator by the informed receiving end to obtain a plurality of paragraph contents and obtaining the corresponding explanatory contents includes the following steps:

The informed consent template is obtained by the informed consent initiating terminal, and a corresponding informed consent is generated according to the informed consent template;

and the informed consent is sent to the corresponding informed receiving end by the informed initiating end.

The invention also provides an informed receiving end, which is applied to the implementation method of informed consent, and the communication module is used for acquiring an informed consent form from the informed initiating end;

the segmentation module is used for dividing the informed consent form to obtain a plurality of paragraph contents and acquiring corresponding explanatory contents;

the playing inquiry module is used for initiating an informed inquiry to the party after the paragraph contents and the corresponding explanatory contents are sequentially played to the party from front to back according to the segmentation sequence;

and the processing module is used for determining whether to enter the playing of the next paragraph content and the description content thereof according to the feedback result of the inquiry of the awareness by the party, and repeating the content playing and feedback result obtaining process until the feedback of the playing of all the paragraph contents and the description content thereof by the party is obtained as the confirmation awareness.

The invention also provides a system for realizing the informed consent, which is applied to the method for realizing the informed consent, and comprises the following steps: an informed-onset end and an informed-receiving end;

The informed consent terminal is used for sending an informed consent to the informed receiving terminal;

the informed receiving end is used for dividing the informed consent obtained from the informed initiating end to obtain a plurality of paragraph contents and obtaining corresponding explanatory contents;

the informed receiving end is also used for initiating an informed inquiry to the party after the paragraph contents and the corresponding explanatory contents are sequentially played to the party from front to back according to the segmentation sequence;

the informed receiving end is further configured to determine whether to enter playing of the next paragraph content and the description content thereof according to a feedback result of the principal on the informed inquiry, and repeat the content playing and feedback result obtaining process until obtaining that the feedback of the principal on playing of all the paragraph contents and the description content thereof is determined to be informed.

By the implementation method, the informed consent receiving end and the system for informed consent provided by the invention, the explanation of the informed consent can be realized through the internet or terminal equipment, and the repeated communication interaction between the informing party and the party is avoided, so as to assist the informing party and the party to sign the informed consent.

Drawings

The above features, technical features, advantages and implementations of a method, receiver and system for informed consent will be further described in the following detailed description of preferred embodiments with reference to the accompanying drawings.

FIG. 1 is a flow chart of one embodiment of a method of implementing informed consent of the present invention;

FIG. 2 is a flow chart of another embodiment of a method of implementing informed consent of the present invention;

fig. 3 is a flow chart of another embodiment of a method for implementing informed consent according to the present invention.

Detailed Description

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following description will be made with reference to the accompanying drawings. It is obvious that the drawings in the following description are only some examples of the invention, and that for a person skilled in the art, other drawings and embodiments can be derived from them without inventive effort.

The terms "system" and "network" are often used interchangeably herein. The term "and/or" herein is merely an association describing an associated object, meaning that three relationships may exist, e.g., a and/or B, may mean: a exists alone, A and B exist simultaneously, and B exists alone. In addition, the character "/" herein generally indicates that the former and latter related objects are in an "or" relationship.

For the sake of simplicity, the drawings only schematically show the parts relevant to the present invention, and they do not represent the actual structure as a product. In addition, in order to make the drawings concise and understandable, components having the same structure or function in some of the drawings are only schematically illustrated or only labeled. In this document, "one" means not only "only one" but also a case of "more than one".

One embodiment of the present invention, as shown in fig. 1, is a method for implementing informed consent, including:

s100, an informed receiving end divides an informed consent obtained from an informed initiating end to obtain a plurality of paragraph contents and obtains corresponding explanatory contents;

specifically, the informed receiving end is a terminal device used by the party, and of course, the informed receiving end may also be a self-service terminal placed in an office area where the informing party is located, such as a self-service terminal in an office area of a hospital, a court, a department office hall or a dispatch office. The estrus-aware terminal is a terminal device used by a notifying party (including, but not limited to, medical staff such as doctors and anesthetists, legal staff such as lawyers, and staff of a business entity such as a real estate administration). The informed receiving end and the informed starting end perform communication interaction in a wireless communication mode (including but not limited to Bluetooth, WIFI, 4G or 5G), so that the informing party uses the informed starting end to send the informed consent to the informed receiving end used by the party. The informed consent receiving end segments the informed consent according to the character arrangement sequence of the informed consent to obtain a plurality of paragraph contents with different sizes, namely the informed consent consists of a first paragraph content P1, a second paragraph content P2, … … and an nth paragraph content Pn according to the character arrangement sequence, wherein n is larger than 1 and n belongs to a positive integer. Then, the informed receiving end can sequentially acquire the corresponding explanatory contents according to the segmentation sequence of the contents of each paragraph, and can also synchronously acquire the explanatory contents corresponding to each paragraph at the same time.

S200, the informed receiving end initiates an informed inquiry to the party after sequentially playing the paragraph contents and the corresponding explanatory contents thereof from front to back according to the segmentation sequence;

s300, the informed receiving end determines whether to enter the playing of the next paragraph content and the description content thereof according to the feedback result of the inquiry of the informed by the party, and repeats the content playing and feedback result obtaining process until the feedback of the party on the playing of all the paragraph contents and the description content thereof is obtained as the confirmed informed.

Specifically, after the informed receiving end divides and obtains a plurality of paragraph contents, the first paragraph content P1 and the corresponding first explanatory content D1 are played to the principal in sequence from front to back according to the segmentation precedence order, and then a first informed query a1 for the first paragraph content P1 and the first explanatory content D1 is initiated to the principal so as to query whether the principal knows the contents of the first paragraph content P1 and the first explanatory content D1 clearly.

After acquiring the corresponding informed query, the party feeds back whether to clearly determine the paragraph content and the description content played before the informed query is initiated according to the subjective intention of the party and the understanding condition of the played content, and then receives the feedback result of the party on the informed query through the informed receiving end, and then the informed receiving end feels whether to enter the playing of the next paragraph content and the description content thereof according to the feedback result input by the party. Continuing with the above embodiment, if the feedback result is a deterministic conclusion, the receiving end plays the second session content P2 and its corresponding second explanatory content D2 to the principal in sequence from front to back according to the segment precedence order, and then initiates a second informed query for the second session content P2 and its corresponding second explanatory content D2 to the principal. The above steps are repeated until the party feeds back to the playing of all the paragraph contents and the description contents thereof as certain knowledge.

In this embodiment, after the content of the paragraph and the description content are played to the party each time according to the segmentation order, the informed query is initiated to the party, and after the party feeds back and determines the informed query in this round, the next round of playing and informed query is entered, so that the party can comprehensively and carefully know the content of the whole informed consent book, and can fully know the purpose, measure content, risk and benefit of the participation activity (for example, medical activities such as special inspection, special treatment and experimental clinical medical treatment, and legal activities such as civil complaint).

For example, the traditional paper edition informed consent has the problems of irregular filling, unqualified signature and blurred handwriting which can not be recognized in the long-term storage process. There is also the phenomenon that some researchers replace their hands with stamps. In addition, there are too many professional terms in the informed consent mode, and the traditional mode is to sign an informed consent form face to face, so that a lot of time is required for communication between doctors and patients, and whether the patients sign on the basis of understanding the content of the informed consent cannot be proved. In addition, due to serious inconsistency of medical professional knowledge between the two doctors and the patient, the patient or family members may consider worrying about acquaintance doctors under the psychological pressure, and the like, so that the problems of medical complaints and tense relationship between the doctors and the patient caused by the problem of the informed consent occur, and the remote (or non-face-to-face) informed consent mode can avoid the false 'informed consent' caused by the psychological pressure to a great extent, and is beneficial to guaranteeing the benefits of the two doctors and the patient.

The invention can avoid the phenomenon that the family members sign the paper informed consent books through the self-service terminal and the informed issuing end which are arranged in the office area where the informing party is positioned, and reduce the problem of after-deeding so as to provide effective legal evidence. Moreover, the problem that the traditional paper file is not beneficial to storage is avoided, the purpose of long-time storage is easily achieved, and the benefits of both the known party and the party are guaranteed. In addition, the work load of workers participating in activity signing of the informed consent book can be greatly reduced by signing the informed consent book through the Internet, the process of signing the informed consent book is simplified, and the signing efficiency of the informed consent book is improved. In addition, repeated communication interaction between the informing party and the party is avoided, and the understanding degree and the signing efficiency of the informed consent are further greatly improved. In addition, the invention can implement remote informed consent signing, and the parties can basically fill in the informed consent at any time, thereby further improving the efficiency of signing the informed consent. Due to the serious inequality of professional knowledge of both the informing party and the party, the remote mode can avoid the situation that the party signs an informed consent unwillingly caused by psychological pressure when facing the face to a great extent, and is beneficial to guaranteeing the benefits of both the informing party and the party.

In an embodiment of the present invention, a method for implementing informed consent includes:

s110, the informed receiving end segments the acquired informed consent book by presetting punctuation marks or meaning group division rules to obtain a plurality of paragraph contents;

specifically, the informed receiving end can perform sentence-breaking judgment through the preset punctuation marks to segment the informed consent book to obtain a plurality of paragraph contents. The predetermined punctuation marks used include, but are not limited to, commas, periods, pause signs, exclamation marks, question marks, spaces. And gradually dividing the preset punctuation informed consent into a plurality of paragraph contents, wherein punctuation follows the previous paragraph content. The continuity of the text semantics of the informed consent is considered by dividing the preset punctuation marks, so that the semantics are prevented from being broken by cutting, the paragraph contents are ensured to belong to a complete semantic segment as much as possible, and the generation of unusual words and sentences caused by cutting is avoided.

In addition, the informed receiving end can segment the informed consent book through the meaning group division rule to obtain a plurality of paragraph contents. The meaning group is each component divided according to meaning and structure in the sentence, each component is called a meaning group, and the words in the same meaning group are closely related to each other and cannot be randomly split, otherwise misunderstanding can be caused. The sense group division rule is a division rule that is split according to semantics and structure, for example, the sense group division rule is exemplified by division according to articles and nouns and division according to adjectives and names. The meaning group division rule is used for division, continuity of the text semantics of the informed consent is considered, the semantic breaking caused by cutting is avoided, the paragraph content is ensured to belong to a complete semantic segment as much as possible, and generation of unusual words and sentences caused by division is avoided.

S120, the informed receiving end carries out word segmentation processing on each paragraph content to obtain word segmentation results, and explanatory contents corresponding to each paragraph content are obtained through query according to the word segmentation results;

specifically, word segmentation models are set in advance according to word segmentation algorithms (including but not limited to a shortest path algorithm, a new word discovery algorithm, and a Chinese word segmentation method for constructing words from words), and words are segmented for contents of each paragraph through the word segmentation models. Illustratively, a rule of word segmentation (referred to as training) is learned by using a statistical machine learning model, so as to segment unknown texts. The main statistical machine learning models are: n-gram (N-gram), Hidden Markov Model (HMM), etc. It should be noted that the paragraph contents may include pure chinese characters, and may also include other characters such as numbers and english characters, which are not limited in this application.

Specifically, the same portions of this embodiment as those of the above embodiment are referred to the above embodiment, and are not described in detail here. In this embodiment, the informed consent is segmented, so that the informed consent can be segmented into a plurality of complete paragraph contents with a small number of words, then, the paragraph contents are segmented to obtain a segmentation result, and explanatory contents corresponding to the segmentation result are obtained by querying, so as to obtain explanatory contents corresponding to each paragraph content. Through the segmentation processing and the word segmentation processing, the method is convenient for carrying out informed inquiry after the paragraph contents and the description contents are played to the party in batches according to the segmentation sequence, so that the party does not need to memorize the whole paragraph of informed consent and description contents, and the use experience of the party is improved. In addition, the remote informed consent signing is realized through the Internet, the workload of signing and subscribing the informed consent can be reduced, the repeated communication interaction between the informing party and the party is avoided, the signing efficiency of the informed consent is improved, the phenomenon that the informed consent is not signed voluntarily is avoided, and the benefits of both the informing party and the party are guaranteed. Finally, the signing of the informed consent is realized through digitization, so that the purpose of long-time storage is easily achieved, and the problems that the informed consent is difficult to store and query and trace due to the traditional signing of paper are avoided.

An embodiment of the present invention, as shown in fig. 2, is a method for implementing informed consent, including:

s121, training a cognitive receiving end to obtain a word segmentation dictionary, and segmenting the current paragraph content through the word segmentation dictionary to obtain a word segmentation result;

specifically, the informed receiving end obtains a large amount of corpus, removes stop words collected manually from the corpus, and then cuts the corpus from which the stop words are removed into relatively small text segments. Stop words generally have no special meaning, and are often combined with other words to form words or phrases, which mainly comprise punctuation marks, pronouns, language-atmosphere words, auxiliary words, conjunctions and the like. Extracting candidate words from the text segments, counting the occurrence probability of the candidate words and each single word in all the text segments, if the occurrence probability is greater than a preset threshold value, retaining the candidate words, otherwise, deleting the candidate words, and then merging the screened candidate words to obtain a word segmentation dictionary. Then, the informed receiving end carries out word segmentation on the current paragraph content through the word segmentation dictionary to obtain a word segmentation result.

The word segmentation dictionary is constructed based on the statistical method, syntactic and semantic information is not needed, the word segmentation dictionary is not limited to a special field, any resource is not depended on, the universality is strong, and the word segmentation requirements of different fields can be effectively met by adopting the word segmentation dictionary for word segmentation.

S122, the informed receiving end screens out the words to be explained from the word segmentation result, and inquires the explanatory contents of the words to be explained to obtain the explanatory contents corresponding to the current paragraph contents;

s123, the informed receiving end switches the next paragraph content to carry out word segmentation screening query until explanatory contents corresponding to each paragraph content are obtained;

in particular, common words and uncommon words exist in the word segmentation result. Common words such as "pre-pregnancy", "bed rest", and the like are clear words, but very common words such as "coronary artery", "perinatal depression", and the like are unclear terms of expertise. Therefore, a professional dictionary (including a dictionary of professional terms or uncommon terms) and a general dictionary (including a dictionary of common terms) can be established in advance according to the manner of establishing the word segmentation dictionary according to the linguistic data in the professional field, the word segmentation result is matched with the professional dictionary, the word segmentation result which is the same as the professional term in the professional dictionary is screened out to obtain a first screening word set, the word segmentation result is matched with the general dictionary, the word segmentation result which is different from the common terms in the general dictionary is screened out to obtain a second screening word set, and the first screening word set and the second screening word set are combined to obtain a final word set, so that each word included in the final word set is a word to be explained.

The informed receiving end accesses to the Baidu literature and the professional literature website (corresponding to the medical literature website when the informed consent form for the medical activity is signed and corresponding to the legal literature website when the informed consent form for the legal activity is signed), and the informing party self uses the network interface of the knowledge sharing server to realize the retrieval of the professional terms and obtain the vocabulary explanation (including but not limited to the text description and the picture description) of the professional terms.

The informed receiving end carries out word segmentation on the current paragraph content through the word segmentation dictionary to obtain a word segmentation result, then selects words to be explained corresponding to the current paragraph content from the word segmentation result of the current paragraph content, then obtains explanatory contents corresponding to the current paragraph content based on the query mode, and carries out word segmentation, screening and query on the next paragraph content until explanatory contents corresponding to the paragraph contents are obtained.

S210, the informed receiving end plays the current paragraph content and the corresponding explanatory content thereof to the voice of the party from front to back according to the sequence of the segmentation, and/or plays the current paragraph content and the corresponding explanatory content thereof by image-text rolling;

s220, after finishing the voice playing and/or image-text rolling playing of the current paragraph content and the explanatory content thereof, the informed receiving end initiates an informed inquiry corresponding to the current paragraph content;

Specifically, there are various ways for the receiving end to play the paragraph content and the corresponding explanatory content to the party, one is text-text scrolling play, the other is voice play display, and the other is a combination of voice play and text-text scrolling play to play and inform the party. The informed receiving end performs segmentation to obtain a plurality of segmented contents with reference to the above embodiment, and after querying to obtain the explanatory contents corresponding to each segmented content, the informed receiving end performs voice playing of the first paragraph content P1 and the corresponding first explanatory content D1 to the party from front to back according to the segmentation order, and/or performs image-text scrolling playing of the first paragraph content P1 and the corresponding first explanatory content D1. Then, the informed receiver initiates a first informed query a1 for the first passage content P1 and the first explanatory content D1 to the party. And if the principal has determined the feedback of the first informed query A1, the principal is sent a second informed query A2 after the second story content P2 and the corresponding second explanatory content D2 are played in voice and/or the second story content P2 and the corresponding second explanatory content D2 are played in image and text in a rolling way. The above steps are repeated until the party feeds back to the playing of all the paragraph contents and the description contents thereof as certain knowledge.

Specifically, the same portions of this embodiment as those of the above embodiment are referred to the above embodiment, and are not described in detail here. According to the embodiment, the informed receiving end plays the paragraph content and the description content to the party by voice or rolling each time according to the segmentation sequence, the party does not need to manually read the informed consent, and the use experience of the party is further improved. Each time when the paragraph content and the description content thereof are played in a voice mode or in a rolling mode, an informed query is initiated to the party, and the playing and the informed query of the next round are entered after the party determines the feedback of the informed query of the round. In addition, the informed receiving end is provided with a crawler program to realize the retrieval of the words to be explained, so that the trouble of the parties in understanding the informed consent is avoided, the parties can comprehensively and carefully know the content of the whole informed consent, and the purposes, measures, risks and beneficial conditions of the participation activity are fully known. In addition, the description content is obtained through the inquiry of the informed receiving end, and the inquiry between the face of the party and the informing party is not needed, so that the repeated communication interaction between the informing party and the party is avoided, and the understanding degree and the signing efficiency of the informed consent are greatly improved.

Illustratively, the section of a certain informed consent form b at which a proxy contract is signed is as follows:

payment of imported contract payment, imported customs duty, value added tax and other fees: the first party pays the payment of the imported contract, the imported customs duty, the added value tax and other expenses (including booking, customs declaration, commodity inspection, quarantine inspection, port expenses, transportation, insurance, bank expenses and the like) required by the second party agency import according to the fifth rule of the agency contract in time, such as delayed payment or refusal payment of the first party for the money, and all losses caused by the delayed payment or refusal payment of the first party are borne by the first party; if the party B agrees to pay related money, the party A pays off the money information paid by the party B before taking the goods (the interest is calculated according to the interest rate of the contemporary bank loan), otherwise the party B has the right to reserve and process the imported goods by self, and all the loss caused by the loss is borne by the party A. (this is paragraph content Pn)

And (4) commodity inspection and quarantine: if the quality, quantity and the like of goods are found to be inconsistent with the import contract, the first party applies for the inspection of the inspection bureau immediately, issues an inspection certificate and a loss certificate, and directly puts a claim to the responsible party or the entrusted second party, wherein the first party is required to bear the judgment result and pay the arbitration or the loss of lawsuit cost (including lawyer cost) caused by the delay of the first party by the first party. (this is paragraph content Pn +1)

If the state declares that the goods under the contract item related to the agency import are subjected to inverse reimbursement plan investigation, inverse subsidy plan investigation or implementation of similar behaviors such as temporary guarantee terms of the domestic market, etc., the first party should add the deposit according to the requirements of the second party. For example, the state collects the behavior of inverse tax on the goods under the contract item, and all the cost and loss caused by the behavior are borne by the first party. (this is paragraph content Pn +2) "

The informed receiving end carries out paragraph segmentation on the partial paragraphs of the informed consent B to obtain paragraph contents Pn, Pn +1 and Pn +2, screens out all unrepeated words to be explained (including but not limited to booking, customs clearance, business inspection, anti-roll-off plan survey and anti-subsidy plan survey) according to the participles from the paragraph contents Pn, Pn +1 and Pn +2, then, after all the words to be explained are searched through a network or the corresponding explanatory contents are obtained from the informing party, the informed receiving end firstly plays the paragraph contents Pn according to the arrangement sequence of the paragraph contents Pn, Pn +1 and Pn +2, and initiates an informed inquiry after playing one paragraph content each time, after the party determines that the paragraph contents of the initiated informed inquiry are clear, the paragraph contents Pn +1 are switched to be played, and so on until the party determines that the informed consent is clear.

In an embodiment of the present invention, as shown in fig. 3, a method for implementing informed consent includes:

s230, the informed receiving end plays the current paragraph contents to the voice of the party from front to back according to the segmentation sequence and/or plays the current paragraph contents in a graph-text rolling way;

specifically, there are various ways for the receiving end to play the paragraph content and the corresponding explanatory content to the party, one is text-text scrolling play, the other is voice play display, and the other is a combination of voice play and text-text scrolling play to play and inform the party. The informed receiving end performs segmentation to obtain a plurality of segmented contents according to the above embodiment, and performs query to obtain the explanatory contents corresponding to each segmented content, and then performs voice playing and/or image-text rolling playing on the corresponding paragraph contents to the party from front to back according to the segmentation sequence.

S240, the informed receiving end initiates an explanation inquiry about whether the explanation is needed to the party;

specifically, after the informed receiving end plays the corresponding paragraph contents to the party in a voice playing mode and/or in a text rolling mode, the informed receiving end initiates an explanation inquiry to the party, and after the party obtains the explanation inquiry, the party determines whether to search and explain the contents of the paragraph contents played by the informed receiving end before according to the subjective will and the situation of understanding the played paragraph contents. After the party is determined, the informed receiving end acquires the input information of the party, and identifies the input information to judge whether the party has an explanation requirement on the played paragraph content.

The input information includes, but is not limited to, voice information, key input, and manually input text information, and it is determined that interpretation is required if a positive keyword such as "yes" or "certain" is parsed from the input information, and it is determined that interpretation is not required if a negative keyword such as "no" or "no" is parsed from the input information.

S250, if the explanation is determined to be needed, the informed receiving end inquires and acquires the explanation content corresponding to the current paragraph content, and initiates an informed inquiry corresponding to the current paragraph content after the explanation content corresponding to the current paragraph content is played by a voice and/or image-text rolling of a party;

S260, if the explanation is determined not to be needed, the informed receiving end initiates an informed inquiry corresponding to the current paragraph content;

specifically, if the principal determines that no explanation is needed, the informed receiver initiates an informed query corresponding to the content of the current paragraph. If the principal determines that the explanation is needed, the informed receiving end queries and obtains the explanation content corresponding to the current paragraph content according to the embodiment, and plays the explanation content corresponding to the current paragraph content to the principal by voice playing and/or image-text scrolling playing. Illustratively, the informed receiving end plays the first paragraph contents P1 to the principal in sequence from front to back according to the segment precedence order, and then initiates an explanation inquiry to the principal whether the explanation of the first paragraph contents P1 is needed or not through the display interface of the informed receiving end, and the display interface displays the control buttons of "yes" and "no". If the principal clicks 'yes', the first explanatory content D1 corresponding to the first paragraph content P1 is inquired, and then the first explanatory content D1 is played to the principal in a voice playing and/or picture and text scrolling mode. If the principal clicks "No," a corresponding first informed query A1 for the first paragraph of content P1 is initiated to the principal through the display interface of the informed receiving end. If the principal has determined the feedback of the first informed query A1, the second session content P2 is played to the principal by voice playing and/or image-text scrolling, and after the second session content P2 is played, an explanation query is initiated to determine whether the explanation of the second session content P2 is needed. The above steps are repeated until the party feeds back the playing of all the paragraph contents as certain knowledge.

Specifically, the same portions of this embodiment as those of the above embodiment are referred to the above embodiment, and are not described in detail here. According to the embodiment, the informed receiving end carries out voice playing or scrolling playing on the paragraph contents to the party every time according to the segmentation sequence, and when the party needs to explain the paragraph contents, the informed receiving end inquires and displays the corresponding explanatory contents, so that the party does not need to manually browse the informed consent, and the use experience of the party is further improved. Each time when the paragraph content and the description content are played in a voice mode or in a rolling mode, an informed query is sent to the party, and after the party feeds back and determines the informed query in the round, the next round of playing and the informed query are entered. In addition, the informed receiving end is provided with a crawler program to realize the retrieval of the words to be explained, so that the trouble of the parties in understanding the informed consent is avoided, the parties can comprehensively and carefully know the content of the whole informed consent, and the purposes, measures, risks and beneficial conditions of the participation activity are fully known. In addition, the description content is obtained through the inquiry of the informed receiving end, and the inquiry between the face of the party and the informing party is not needed, so that the repeated communication interaction between the informing party and the party is avoided, and the understanding degree and the signing efficiency of the informed consent are greatly improved.

s010 an informed consent template is obtained by an informed consent initiating terminal, and a corresponding informed consent is generated according to the informed consent template;

s020 an informed consent end sends an informed consent to a corresponding informed receiving end;

specifically, informed consent is an answer or consent of a party with complete knowledge of certain internal information. Three processes are actually involved: knowing the information; understanding; an informed consent is a certificate for the informed record and the party's decision process, either granted or denied. Informed consent included: usage information, descriptive information (including activity participant information, terms, control measures, and possible benefits, etc.), risk information (including foreseeable risks and possible adverse events, etc.), cost information, confidential information, party information (including party identity information, contact information, etc.), party signature completion location, activity participant signature completion location, and date completion location.

Illustratively, the informed consent form of a medical activity includes the knowledge of the basic situation of the medical institution, the knowledge of the basic situation of the treated medical staff, and then the selection and decision of the medical measures taken by the medical party, and generally, the content of the informed consent form includes. Informed consent is composed of both informed consent, in the form of a physician's notice, which typically includes sufficient and necessary instructions regarding the therapeutic (or diagnostic) method employed and its benefits or risks, the control measures to be employed and the risks that may arise,

And through calling the designed template, an informed consent meeting the specifications and requirements of the field to which the participation activity belongs is designed in an auxiliary way. The informed parties generate different types of informed consent templates according to the specifications, and the informed consent templates are selected by the informed initiation end according to the required intention of the parties. And the estrus initiating terminal automatically fills the corresponding informed consent templates according to the pre-stored use information, the description information, the risk information, the cost information and the confidential information, then the activity participants review the informed templates filled with the information, and sign the information after determining that no problem exists to generate the corresponding informed consent. And finally, sending the generated informed consent to an informed receiving end through a contact address reserved by the party through a server. For example, the informed consent templates for a medical activity include, but are not limited to, clinical treatment informed consent templates, clinical trial informed consent templates, and the informed consent templates corresponding to the patient's needs for a visit and the trial participation intent may be selected by the informed originating end.

s310, an informed receiving end acquires a feedback result of the party on the informed inquiry;

s320, if the feedback result is unclear or the party does not have the informed consent capability, the informed receiving end enters an informed assistance process;

s330, if the feedback result is clear, the informed receiving end plays the next paragraph content and the corresponding explanatory content from front to back to the party according to the segmentation sequence;

s340 the informed receiving end repeats the content playing and feedback result obtaining process until the playing feedback of all paragraph contents and the description contents of the paragraph contents of the party is determined to be informed;

specifically, after the informed receiving end plays the current paragraph content and the corresponding explanatory content to the party in a voice playing mode and/or in a picture and text rolling mode, the informed receiving end initiates an informed inquiry to the party, and after the party obtains the informed inquiry, the party determines whether to switch to play the next current paragraph content and the explanatory content according to the subjective intention of the party and the understanding of the played current paragraph content and the explanatory content thereof. And after the party determines the switching, the informed receiving end acquires the input information of the party and identifies whether the input information needs to be switched for playing.

The input information includes, but is not limited to, voice information, key input, and manually input text information, and the feedback result is determined to be clear if a positive keyword such as "yes" or "ok" is parsed from the input information, and is determined to be unclear if a negative keyword such as "no" or "no" is parsed from the input information.

If the feedback of the current paragraph content and the explanation content by the party is determined to be clear, the informed receiving end switches to play the next current paragraph content and the explanation content thereof. If the feedback of the current paragraph content and the explanation content of the party is determined to be unclear, the informed receiving end enters an informed assistance flow.

S400, prompting whether the party confirms the agreement or not by the informed receiving end, and acquiring the biological characteristic signature input by the party if the agreement is confirmed;

specifically, the informed receiving end completes the playing of all paragraph contents and description contents of the party according to the segmentation sequence, and when the feedback results of each round of initiated informed inquiry of the party are clear, the content of the whole informed consent book is clearly known by the party, the informed receiving end sends prompt information to prompt the party to enter the consent signing process, and if the party agrees to sign according to the subjective intention of the party, the party obtains the input biological characteristic signature of the party through the receiving end. If the party refuses to sign according to own subjective intention, the party feeds back a notification message of refusing to sign to the estrus initiating end through the receiving end.

The informed receiving end can intelligently analyze and record the voiceprint characteristics of the patient, the voiceprint characteristics serve as one of the biological identification characteristics of the person concerned, and a biological characteristic signature is generated. The informed receiver can also record the fingerprint of the party as one of the biological identification characteristics of the party by collecting and recording the fingerprint of the party and generate a biological characteristic signature. The informed receiver can also record the face information of the party as one of the biological identification characteristics of the party and generate a biological characteristic signature.

S400, the informed receiving end generates an electronic edition informed consent according to the biological characteristic signature, carries out encryption and modification prevention processing on the electronic edition informed consent, then stores the electronic edition informed consent, and sends the electronic edition informed consent after the encryption and modification prevention processing to a corresponding informed starting end.

Specifically, the preset encryption algorithm includes, but is not limited to, a SM2 algorithm, a hash algorithm, and other cryptographic algorithms. And the informed receiving end generates an electronic edition informed consent according to the biological characteristic signature, and encrypts the electronic edition informed consent to prevent modification, wherein the modification prevention processing mode is to switch the attribute of the electronic edition informed consent into read-only and encrypt the electronic edition informed consent with the read-only attribute by a preset encryption algorithm. And then, the informed receiving end stores the electronic edition informed consent subjected to the encryption and modification prevention processing into a local storage area. And sending the electronic edition informed consent subjected to encryption and modification prevention processing to a corresponding informed issuing end.

Specifically, the same portions of this embodiment as those of the above embodiment are referred to the above embodiment, and are not described in detail here. By using the biological characteristic signature, the informed consent can be stored for a long time without damage, and the rights and interests of the informed consent on the informing party and the party are protected. The electronic edition informed consent encrypting and modifying prevention processing can effectively realize 'what you see is what you sign', fully guarantee the informed right and the control right of the informing party and the party to the informed consent signed each time, prevent the content of the informed consent from being tampered, and once the information is updated, only one new informed consent can be signed again, thus greatly guaranteeing the benefits of the informing party and the party.

S311, the informed receiving end triggers to acquire the input information of the party and stops playing the paragraph content and the corresponding explanatory content to the party when the triggering of acquiring the input information is started;

s312, the informed receiving end analyzes and identifies the input information to obtain a feedback result aiming at the informed inquiry;

s321, if the feedback result is that the party does not have the informed consent capability, the informed receiving end initiates a request to be assisted by the guardian to sign informed consent;

specifically, after the informed receiving end plays the paragraph content and the corresponding explanatory content to the party, if the feedback result indicates that the party does not have the informed consent capability, the informed receiving end sends the informed consent and the authorization principal to the bound guardian terminal, and the guardian assists the party in signing the informed consent.

S322, if the feedback result is unclear, the informed receiving end sends the paragraph content which is fed back as unclear to the informed initiating end so as to obtain the explanation of the informing party from the informed initiating end;

specifically, after the explicit receiving end plays the paragraph content and the corresponding description content to the party, if the feedback result is that the party does not know the played paragraph content and the corresponding description content, the fed back unclear paragraph content is sent to the corresponding explicit initiating end, after the explicit initiating end receives the unclear paragraph content sent by the explicit receiving end, the explicit paragraph content is displayed in a popup window and the informing party is prompted to explain the unclear paragraph content, further explanation is performed by using understandable words according to professional knowledge and experience of the informing party, and then the explanation is fed back to the explicit receiving end, so that the party can know the unclear paragraph content conveniently.

s340 the informed receiving end repeats the content playing and feedback result obtaining process until the feedback of the party on the playing of all the paragraph contents and the description contents is determined to be informed.

s500, the informed receiving end generates an electronic edition informed consent according to the biological characteristic signature, carries out encryption and modification prevention processing on the electronic edition informed consent, then stores the electronic edition informed consent, and sends the electronic edition informed consent after the encryption and modification prevention processing to a corresponding informed starting end.

Specifically, the same portions of this embodiment as those of the above embodiment are referred to the above embodiment, and are not described in detail here. According to the embodiment, the guardian assists in signing informed consent by initiating the request, so that the method can effectively help the old or the disabled and other parties without informed consent, realize signing of the informed consent, and improve the application range of remote signed informed consent. In addition, only when the user feeds back that the played paragraph content is unclear, the informed receiving end sends the paragraph content fed back as unclear to the informed initiating end to obtain the explanation of the informing party, and the rest of the explanation content is automatically inquired and searched through the crawler program, so that the informing party does not need to respectively explain each unclear paragraph content, the workload of the staff participating in activity signing and deciding the informed consent is greatly reduced, the informed consent bookmark signing process is simplified, and the signing and signing efficiency of the informed consent is improved.

Preferably, the text content explained by the informing party for the unclear paragraph content is uploaded to the informing party self-use knowledge sharing server each time, so that the explanation information of the professional words by the informing party self-use knowledge sharing server can be greatly expanded, and the work load of the staff of the informing party for explaining each unclear paragraph content in person is reduced.

Illustratively, internet hospitals are a new medical model. The method relies on an internet platform, gradually changes the traditional medical service mode under the support of emerging information technologies such as cloud computing, big data and the internet of things, and is a product of integration and innovation of the traditional medical mode and the emerging medical mode by crossing the traditional medical mode. However, the internet diagnosis and treatment behavior is different from that of the entity hospital, and the party does not necessarily see a doctor on site. For example, clinical trials of drugs are a necessary verification link before the drugs are marketed, and researchers collect, collate and analyze data about the safety and effectiveness of new drugs during clinical trials on human subjects, thereby providing important judgment basis for approval and marketing of new drugs. With the continuous development of medical technology, the guarantee of the rights and interests of the subjects begins to become an international discussion topic, medical ethics becomes a prerequisite to be considered in clinical tests, and a clinical test of the drug which can be accepted by the society and benefits the society is not only scientifically reliable, but also ethically acceptable.

The implementation of a clinical trial of a drug requires the recruitment of eligible subjects, i.e., patients, and in order to ensure the benefit of the patients, it is necessary to inform the patients of various risks and rights during the period before the trial begins, which mainly includes: (1) studying the background; (2) (ii) project purpose; (3) testing process; (4) the test period; (5) possible benefit of the test; (6) testing grouping conditions; (7) the risk of possible trials; (8) test confidentiality and subject privacy protection; (9) testing insurance and compensation; (10) subject's rights were informed (voluntary, free participation and withdrawal).

The clinical trial recruits patients, the trial can be completed only by a designated organization, and the follow-up process can be performed after the patients are willing after the remote informed consent. So as to avoid the time waste of the patient and the doctor due to the fact that the patient does not receive informed consent after coming. Remote informed consent lacks specifications and thus remains controversial. With the development of internet technology and artificial intelligence technology, the functions of remotely implementing informed consent, reading the informed consent form, replacing a professional term part in a doctor explaining the informed consent form, intelligently identifying and storing the voice of a patient and converting the voice into a character record, storing the informed consent implementation record for a long time, recording a digital signature, recording biological identification characteristics of the patient and the like can be realized. The present embodiments may be implemented by software installed into a smartphone or wearable device.

The software functions as follows:

(1) the content of each paragraph can be read by voice or manually through TTS technology for the informed consent;

(2) the patient can be guided to carry out step-by-step confirmation, whether the patient understands or not is confirmed by software or manual work when the contents of each paragraph and the description end to read, and the patient confirms the understanding by voice response and then continues to read the contents of the next paragraph and the description;

(3) a biometric signature may be generated, which may be an acquired voice print, fingerprint, facial image, etc. of the patient.

(4) The information in the local database can be retrieved and utilized, the device for installing the software is connected with the Internet for searching, each term in the informed consent form is automatically marked, the attention of the patient is prompted, and the patient can click to view the corresponding explanation or know the term by completing reading by the device (such as a mobile phone) for installing the software.

The invention can greatly reduce the workload of staff in signing and approving the informed consent in clinical tests and also reduce the risk. In addition, remote informed consent can be implemented, and patients can basically fill in the informed consent at any time, so that the signing efficiency of the informed consent is improved. The invention can also be applied to other fields and scenes which need to be informed and agreed and need to sign contracts, such as the matters of court work, the work contract approval of enterprises and the like.

The doctor end (namely the informed consent initiating end) can design an informed consent in accordance with the specification according to different requirements, and patients with requirements download and install the informed consent software to the patient end (namely the informed consent receiving end) according to the requirements of doctors (patients participating in clinical tests or clinical treatments are according to the requirements of doctors) and register. The registration adopts a mobile phone number registration mode, a WeChat registration mode and the like, and can also be identified and registered by a face by opening a camera. The doctor uses the informed consent software installed at the doctor end to send the informed consent designed for the patient to the corresponding patient end in a single-sending mode or a group-sending mode. And starting and operating the informed consent software installed at the patient terminal by the patient, then opening the appointed informed consent, automatically reading the informed consent by voice after the informed consent is opened, and entering an informed consent process after the reading is finished. Specifically, software can automatically read the first paragraph content and the description content of an informed consent through a TTS speech synthesis technology, the software judges to read a paragraph or a group according to periods, spaces, word segmentation and other modes, then a pause is executed, a first informed query is inserted (for example, do you understand the above information. After the first paragraph content and the description content thereof are read and confirmed by the patient, the next paragraph content and the description content thereof are read and queried, and the specific process refers to the reading and querying process of the first paragraph content and the description content thereof.

When the patient inputs an answer aiming at the informed inquiry in a voice interaction mode, the software records a voice signal and transmits the voice signal to the server, and the server analyzes the voice signal, extracts and records voiceprint characteristics and generates a biological characteristic signature as one of biological identification characteristics. Of course, patients without the ability to consent to informed consent require family members or agents to assist in completing informed consent.

After repeating the steps to finish the reading of the whole content of the informed consent and the informed inquiry, the software plays the prompted information by voice and simultaneously displays the prompted information on a screen, so as to prompt the patient to determine whether to sign, wherein the signing mode is to collect any one or more of fingerprints, head images and voice, and if the patient agrees to sign the informed consent and signs in a voice mode, the patient needs to repeat the specified sentences by voice (for example, the patient confirms to understand and agrees the information, or the like). After the signing of the patient is finished, an electronic informed consent form of a biological characteristic signature version is generated, the electronic informed consent form comprises information content, term explanation, patient voiceprint characteristics, fingerprints, head portrait digital characteristics and the like, then software immediately encrypts the electronic informed consent form file, only can consult the electronic informed consent form file after the timestamp is effective, but cannot modify the electronic informed consent form file, and then the electronic informed consent form file and the electronic consent form file are respectively stored or stored by a proper third party.

After the informed receiving end obtains the informed consent, the informed consent is immediately divided, and the explanation sentences of the professional terms (namely the explanation contents of the words to be explained) in each paragraph content are inquired in advance to obtain the explanation contents corresponding to each paragraph content, then the informed receiving end can play the paragraph contents and the corresponding explanation contents to the party from front to back in sequence according to the segmentation precedence order and then initiate the informed inquiry to the party, or can selectively play the corresponding explanation contents to the party according to the explanation requirements of the party after playing the paragraph contents to the party from front to back in sequence according to the segmentation precedence order. The method and the device presets the mode of searching and obtaining the explanatory contents of the contents of each paragraph and storing the explanatory contents in the local, and calling and playing the explanatory contents from the local in real time when needed, can reduce the query waiting time of the party for searching the explanatory contents in real time, and improve the use experience of the party.

Illustratively, the non-face-to-face communication between the informing party and the non-face-to-face signing of the informed consent can be realized by the informed receiving end and the informed issuing end of the invention during the epidemic situation (such as new coronary pneumonia, SARS, plague and the like), so that the infection probability is greatly reduced, and the infection is prevented to a certain extent.

the segmentation module is used for dividing the informed consent to obtain a plurality of paragraph contents and acquiring corresponding explanatory contents;

the playing inquiry module is used for initiating an informed inquiry to the party after the paragraph contents and the corresponding explanatory contents thereof are sequentially played to the party from front to back according to the segmentation sequence;

Specifically, this embodiment is a device embodiment corresponding to the method embodiment, and specific effects are referred to the device embodiment, which is not described in detail herein.

The invention also provides a system for realizing informed consent, which comprises: an informed-onset end and an informed-receiving end;

the informed receiving end is also used for initiating an informed inquiry to the party after the paragraph contents and the corresponding explanatory contents thereof are sequentially played to the party from front to back according to the segmentation sequence;

the informed receiving end is also used for determining whether to enter the playing of the next paragraph content and the description content thereof according to the feedback result of the inquiry of the informed by the party, and repeating the content playing and feedback result obtaining process until the feedback of the party on the playing of all the paragraph contents and the description content thereof is obtained as the confirmed informed.

Specifically, this embodiment is a system embodiment corresponding to the above method embodiment, and specific effects refer to the above method embodiment, which is not described in detail herein.

It will be apparent to those skilled in the art that, for convenience and brevity of description, only the above-described division of program modules is illustrated, and in practical applications, the above-described distribution of functions may be performed by different program modules, that is, the internal structure of the apparatus may be divided into different program units or modules to perform all or part of the above-described functions. Each program module in the embodiments may be integrated in one processing unit, or each unit may exist alone physically, or two or more units are integrated in one processing unit, and the integrated unit may be implemented in a form of hardware, or may be implemented in a form of software program unit. In addition, the specific names of the program modules are only used for distinguishing the program modules from one another, and are not used for limiting the protection scope of the application.

The informed receiving end and the informed starting end can be a desktop computer, a notebook computer, a palm computer, a tablet computer, a mobile phone, a man-machine interaction screen and other equipment. It will be understood by those skilled in the art that the foregoing are merely examples of the informed receiving end and the informed initiating end, and are not intended to limit the informed receiving end, and may include more or less components than the foregoing embodiments, or may combine some components, or different components, for example: the informed receiving end may further include an input/output interface, a display device, a network access device, a communication bus, a communication interface, and the like. A communication interface and a communication bus, and may also include an input/output interface.

In the above embodiments, the descriptions of the respective embodiments have respective emphasis, and reference may be made to the related descriptions of other embodiments for parts that are not described or recited in detail in a certain embodiment.

Those of ordinary skill in the art will appreciate that the various illustrative elements and algorithm steps described in connection with the embodiments disclosed herein may be implemented as electronic hardware or combinations of computer software and electronic hardware. Whether such functionality is implemented as hardware or software depends upon the particular application and design constraints imposed on the implementation. Skilled artisans may implement the described functionality in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the present application.

In the embodiments provided in the present application, it should be understood that the disclosed apparatus/informed receiving end and method may be implemented in other ways. For example, the above-described apparatus/notification sink embodiments are merely illustrative, and for example, the division of the modules or units is only one logical division, and there may be other divisions when the actual implementation is performed, for example, multiple units or components may be combined or integrated into another system, or some features may be omitted, or not executed. In addition, the shown or discussed mutual coupling or direct coupling or communication connection may be an indirect coupling or communication connection of some interfaces, devices or units, and may be in an electrical, mechanical or other form.

The units described as separate parts may or may not be physically separate, and parts displayed as units may or may not be physical units, may be located in one place, or may be distributed on a plurality of network units. Some or all of the units can be selected according to actual needs to achieve the purpose of the solution of the embodiment.

In addition, functional units in the embodiments of the present application may be integrated into one processing unit, or each unit may exist alone physically, or two or more units are integrated into one unit. The integrated unit can be realized in a form of hardware, and can also be realized in a form of a software functional unit.

The integrated modules/units, if implemented in the form of software functional units and sold or used as separate products, may be stored in a computer readable storage medium. Based on such understanding, all or part of the flow of the method according to the embodiments of the present invention may also be implemented by sending instructions to relevant hardware through a computer program, where the computer program may be stored in a computer-readable storage medium, and when the computer program is executed by a processor, the steps of the method embodiments may be implemented. Wherein the computer program comprises: computer program code which may be in the form of source code, object code, an executable file or some intermediate form, etc. The computer-readable storage medium may include: any entity or device capable of carrying the computer program code, recording medium, usb disk, removable hard disk, magnetic disk, optical disk, computer Memory, Read-Only Memory (ROM), Random Access Memory (RAM), electrical carrier wave signals, telecommunications signals, software distribution medium, and the like. It should be noted that the content of the computer-readable storage medium can be increased or decreased according to the requirements of the legislation and patent practice in the jurisdiction, for example: in certain jurisdictions, in accordance with legislation and patent practice, the computer-readable medium does not include electrical carrier signals and telecommunications signals.

It should be noted that the above embodiments can be freely combined as necessary. The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.

Claims

1. A method for realizing informed consent is characterized by comprising the following steps:

2. The method for implementing informed consent according to claim 1, wherein the informed receiving end divides the informed consent obtained from the informed initiating end to obtain a plurality of paragraph contents, and obtains the corresponding explanatory contents comprises the steps of:

3. The method for implementing informed consent according to claim 2, wherein the informed receiving end performs word segmentation processing on each paragraph content to obtain a word segmentation result, and the step of obtaining explanatory content corresponding to each paragraph content according to the word segmentation result query comprises the steps of:

4. The method for implementing informed consent according to claim 1, wherein the step of initiating an informed query to the party each time the paragraph content and the corresponding explanatory content thereof are sequentially played to the party from front to back according to the segment precedence order comprises the steps of:

5. The method for implementing informed consent according to claim 1, wherein the step of initiating an informed query to the party each time the paragraph content and the corresponding explanatory content thereof are sequentially played to the party from front to back according to the segment precedence order comprises the steps of:

6. The method for implementing informed consent according to claim 1, wherein the informed receiving end determines whether to enter the playing of the next paragraph content and its description content according to the feedback result of the party to the informed inquiry;

and if the feedback result is clear, the informed receiving end plays the next paragraph content and the corresponding explanatory content thereof from front to back to the party according to the segmentation sequence.

7. The method for implementing informed consent according to claim 6, wherein the step of obtaining the feedback of the party on the playing of all paragraph contents and their explanatory contents comprises the following steps:

8. The method for implementing informed consent according to claim 6, wherein the informed receiving end obtaining feedback result of the party to the informed inquiry comprises the steps of:

9. The method for implementing informed consent according to claim 6, wherein if the feedback result is unclear or the party does not have the ability of informed consent, the informed receiving end enters an informed assistance flow comprising the steps of:

10. The method for implementing informed consent according to any one of claims 1-9, wherein the step of the informed receiving end dividing the informed consent obtained from the informed initiating end into a plurality of paragraph contents and obtaining the corresponding explanatory content comprises:

11. An informed receiving end, which is applied to the implementation method of informed consent according to any one of claims 1 to 9, and comprises:

the communication module is used for acquiring the informed consent form from the informed initiating terminal;

12. An implementation system of informed consent, which is applied to the implementation method of the informed consent of any one of claims 1-10, and comprises: an informed-onset end and an informed-receiving end;