HIV Replication 3D Medical Animation
Defend science and education to send 〔 2007 〕 17
Bureau of hall of sanitation of each province, municipality, municipality directly under the Central Government, xinjiang production builds corps health bureau, unit of ministry directly under, state
The courtyard concerns management department of scientific research of ministries and commissions:
Study to guide the biology medical that involves a person with normative our country ethics investigates the work, drive biology medicine to study healthy progress, remove for the mankind better ailment, promotional healthy service, my ministry organization was made " involve a person
Biology medicine research ethics examines way (try out) " , show print and distribute you, ask comply with to carry out.
27 years on January 11
Accessory:
The biology medicine that involves a person research ethics examines way (try out)
General principles of the first chapter
The application of the first biology medicine research that involves a person for the standard and relevant technology, tutelar life and health, uphold the person‘s dignity, esteem and protective mankind suffer the legitimate rights and interests of the person that try, according to " China people is republic
Country hold law of doctor of course of study " and " medical establishment regulation " concerned regulation, make this way.
The 2nd biology medicine that involves a person research ethics examines the job to all undertake according to this method organization.
The biology medicine research that this the 3rd method place weighs to involve a person and relevant technology application include the following activity:
(one) use modern physics, chemistry and biologic method to be opposite on human body the activity that the diagnosis of phenomenon of the person‘s physiology, pathology and disease, cure and preventive have study;
(2) the technology of medical treatment sanitation that research to form through biology medicine or the product is in human body is aspirant the activity of an experimental application. Already applied more than two years in clinical practice before this method applies, perhaps had obtained wholesome service to approve the technology of clinical application before this method applies, do not belong to what this method sets to examine limits.
The 4th ethics examines the regulation that ought to abide by state law, code and regulations and accepted life human relations
Manage principle, ethics examines a process to ought to become independent, objective, justice and transparent.
Committee of ethics of the 2nd chapter
The 5th Ministry of Public Health establishs medical ethics committee of experts. Provincial and wholesome service establishs the ethics of area of politics of one‘s own profession to examine direct advisory organization. The committee that Ministry of Public Health and provincial and wholesome service establish is advisory organization of medical ethics expert, basically undertake study to discuss in the light of great ethics problem, put forward policy to seek advice from an opinion, the ethics that can organize project of counterpoise old scientific research when necessary is examined; Examine the job to undertake guidance to the ethics of committee of ethics of the orgnaization inside area under administration, supervise. The ethical committee of experts that Ministry of Public Health and provincial and wholesome service establish " constitution "
Make separately.
The 6th begins the orgnaization of the biology medicine research that involves a person and activity of relevant technology application, include medical treatment sanitation control of precaution of place of courtyard of orgnaization, scientific research, disease and orgnaization of health care of women and children, establish orgnaization ethics committee. Orgnaization ethics committee basically assumes ethics to examine the task, to this orgnaization or the biology that belong to an orgnaization to involve a person medicine research and applied project undertakes relevant technology ethics is examined and be supervised; Also but according to social demand, accept entrust examine; At the same time the organization begins relevant ethics to groom.
The committee member of committee of ethics of the 7th orgnaization by the department that establishs this ethics committee or the orgnaization is on the base that seeks an opinion extensively, the choose in the expert that waits for social science domain from biology medicine domain and tubal a Confucian school of idealist philosophy of the Song and Ming Dynasties, ethnics, law, sociology arises, the number is not gotten little at 5 people, and ought to have the committee member of different sexual distinction. Minority area should consider minority committee member.
Tenure of office of committee member of committee of ethics of the 8th orgnaization 5 years, can be reappointed consecutively. Ethical committee sets one person of chairman committee member, vice director committee member a certain number of people, negotiate choose to arise by ethical committee committee member, can be reappointed consecutively. The department that establishs orgnaization ethics committee or the orgnaization ought to offer proper reward according to the working circumstance of ethical committee committee member.
The checkup of committee of ethics of the 9th orgnaization duty is: Examine research program, safeguard and protect the dignity that suffers the person that try and rights and interests; Ensure research won‘t will suffer the person that try to expose at unreasonable risk in; Undertake supervise and be checkinged to the research that already approved at the same time, handle those who suffer the person that try in time to complain with undesirable incident.
Committee of ethics of the 10th orgnaization is OK exercise is following attributive:
(one) requirement researcher offers know the inside story to agree with a book, or the request according to researcher, approval absolves know the inside story to agree with a program;
(2) requirement researcher amends research plan;
(3) requirement researcher break down or end research activity;
(4) the decision that makes the approval, reconsideration after be not approved or be being revised to studying plan.
Eleventh the research project that ethical committee committee member ought to examine to accept ethics is confidential.
Dozenth an ethical committee make a decision independently according to ethical principle, do not suffer any interference; Investigate a tie
Ought to be communicated in time if really or release.
Thirteenth ethical committee accepts area of politics of one‘s own profession and national sanitation service supervise and manage.
The 3rd chapter examines a program
The 14th biology medicine that involves a person research ethics examines a fundamental is:
(one) esteem and safeguard suffer the person that try to decide to agree with different perhaps idea to get trying right independently, fulfill know the inside story strictly to agree with a program, must not use deceit, lure by promise of gain, threatening wait for wrong step to make suffer the person that try to agree to suffer try, allow to suffer the person that try to be exited in any phase suffer try;
(2) the consideration of the safety of the person that try to sufferring, health and rights and interests must prep above is mixed to science the consideration of social interest, do one‘s best makes suffer the person that try to the oldest rate is benefited and avoid to harm as far as possible;
(3) reduce or absolve suffer the person that try to be in bear the economic responsibility that in trying a process, assumes because of be benefited;
(4) the privacy that esteem and protection suffer the person that try, will involve the data that gets privacy of the person that try to store according to the facts inform with use circumstance and confidential measure suffer the person that try, not the will involve data that gets privacy of the person that try and circumstance perhaps transmit media to divulge to a third party that have nothing to do;
(5) ensure suffer the person that try to try to seasonable and free treatment receives when be injured and receive corresponding compensation because of sufferring;
(6) the person that try to lose or lacking what ability maintains oneself right and interest to suffer (flimsy crowd) , include children, pregnant woman, intelligence low person, mental person, convict and economic condition are differred and literacy rate is very low person, ought to give special protection.
The research project that the 15th need has ethics examines should submit following data to ethical committee:
(one) ethics examines application form;
(2) study relevant perhaps technology uses program;
(3) suffer know the inside story of the person that try to agree with a book.
Applicant of the 16th project must get freewill written know the inside story agrees sufferring the person that try beforehand. Unavailable written know the inside story agrees, ought to obtain oral know the inside story to agree beforehand, submit the proof data that obtains oral know the inside story to agree. To incompetence, cannot oneself make a decision suffer the person that try to must get the written know the inside story with its procuratorial perhaps guardian agrees.
The seventeenth is in obtain when sufferring know the inside story of the person that try to agree, applicant must to suffer the person that try to offer complete the necessary news that knows easily, know the inside story agrees with a book to ought to be conveyed with straightaway character, minority area can use local character expression, understand to get place of the person that try, give at the same time suffer the time with the sufficient person that try to consider to whether agree to suffer try.
The 18th executive program when the project or when conditional happening changes, must recover the know the inside story that gets the person that try to agree, put forward ethics to examine application to ethical committee afresh.
Committee of the 19th ethics must not accept the ethics that the scientific research project that violates state law, statute puts forward to examine application. Ethical committee committee member and application project have an interest to conflict, ought to active and evasive. Cannot evasive, ought to publicize this kind of benefit to the applicant.
Committee of the 20th ethics is following to applying for the item that ethics examines to undertake examine:
(one) whether does the qualification of investigator, experience accord with experiment requirement;
(2) the demand that research whether plan accords with scientific sex and ethical principle;
(3) the venture rate that gets the person that try to may be sufferred is benefited to be compared with what research anticipates appropriate;
(4) in dealing with know the inside story to agree with a process, to suffer the person that try (or its family member, guardian, legal agent) offerred concerned information data is complete understand easily, the means that obtains know the inside story to agree is proper;
(5) to sufferring the data of the person that try to whether be adopted confidential measure;
(6) suffer the person that try selected with the level that eliminate appropriate with fairness;
(7) whether to the rights and interests that suffers the person that try to inform them clearly to should be enjoyed, in including to studying a process, can be exited at any time and need not offer reason and the right that does not get discrimination;
(8) suffer the person that try to whether consider and win reasonable compensation because of attending, when if consider and be damaged because of attending,dying even, the treatment that give and compensatory measure are appropriate;
(9) the problem that whether there is person specially assigned for a task to responsible processing know the inside story agrees and get security of the person that try in researcher;
(10) whether did susceptive risk take the likelihood in studying to sufferring the person that try safeguard;
(11) researcher and suffer between the person that try have conflict without the interest.
The checkup of committee of the 21st ethics is OK make approval, be not approved or make necessary the decision of the reconsideration after revising.
Made decision ought to get ethical committee 2/3 committee member agrees with ethical committee.
The decision of ethical committee ought to show reason.
Be damaged to anticipating or the project that unwell happening probability and degree do not get the probability that the person that try lives daily or groovy cure may produce and rate more than (the project that is less than lowermost risk namely) , perhaps can appoint by its by ethical committee chairman or a few committee members undertake checkup.
After committee of ethics of classics of project of the 22nd application examines approval, undertake modification in executive process, ought to sign up for ethical committee to examine approval. Serious and undesirable reaction produces in executive process of undesirable perhaps incident, ought to report in time to ethical committee.
Project of the 23rd application did not obtain ethical committee to examine approval, must not begin a project to study the work.
The 4th chapter controls government
The biology medicine that 24 supervisory management involve a person research ethics examines the job to ought to bring into scientific research of various and wholesome service to manage working category. Its content includes:
(one) whether does the orgnaization that begins the biology medicine research that involves a person establish ethical committee by the requirement;
(2) whether does the ethical committee of the orgnaization examine a principle to carry out ethics to examine according to ethics;
(3) ethics examines content and program to whether accord with a requirement;
(4) ethics examines a result to carry out a circumstance, have without controversy.
The 25th Ministry of Public Health executes macroscopical managing to ethical committee of the whole nation, build perfect ethics to examine regulations system, study formulate concerns policy. Provincial wholesome service is right the duty that the ethics of the ethical committee inside area of politics of one‘s own profession investigates the job to have supervisory government.
The orgnaization outside the 26th condition or individual undertake in Chinese churchyard medicine research involved the person‘s live thing, its study plan has passed place nation or the ethical committee of the area examines, still ought to the ethical committee that to our country according to this method establishs applies for examine and verify.
When the 27th biology medicine to involving a person research the project undertakes writtening guarantee inscribing checking and accept, ought to ask project controller the proof that issues the ethical committee with corresponding course to examine. The biology medicine that involves a person is published to study positive result in academic periodical when, researcher should issue this project to examine the proof that agree through ethical committee.
The 28th any individuals or the unit all has the right and obligation to inform against the biology medicine that involves a person violate in research compasses or the behavior of dishonourable.
The 29th researcher happening violates the act of ethical principle, study what project controller belongs to unit and wholesome service to all authority gives corresponding punishment, hand-in-hand travel publicizes criticism, cancel to gain promotive competence; Inspect item of scientific research of clue weight break down carry out, offend of state law, turn over judiciary processing.
Supplementary articles of the 5th chapter
Thirtieth this method applies since released day.
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