⑴ ICH-GCP 9.2 Research Misconct錛2錛
Part 4: Responding to Allegations of Research Misconct
Part 5: Safeguards for Informants and Accused Persons
Part 6: Possible Penalties for Research Misconct
Part 7: Summary of Key Points
Federal policy makes researchers and research institutions primarily responsible for reporting and investigating alleged research misconct. Research institutions鈥 expected tasks in dealing with such allegations are spelled out in 42 CFR Part 50 Subpart A .
鑱旈偊鏀跨瓥瑙勫畾鐮旂┒浜哄憳鍜岀爺絀舵満鏋 涓昏佽礋璐ｆ姤鍛婂拰璋冩煡琚鎸囨帶鐨勭爺絀朵笉褰撹屼負 銆傜爺絀舵満鏋勫勭悊姝ょ被鎸囨帶鐨勯勬湡浠誨姟鍦42 CFR絎50閮ㄥ垎A瀛愰儴鍒嗕腑鏈夎︾粏璇存槑銆
Generally, the response to an allegation of research misconct has three stages.
涓鑸鏉ヨ達紝瀵圭爺絀朵笉褰撹屼負鎸囨帶鐨勫洖搴斿垎涓轟笁涓闃舵點
The inquiry assesses the facts of the allegation and the need for an investigation. An inquiry must be completed within 60 calendar days of its start, unless circumstances clearly require a longer time.
鍒濇ヨ皟鏌ヨ瘎浼頒簡 鎸囨帶鐨勪簨瀹炲拰璋冩煡鐨勫繀瑕佹 銆傚垵姝ヨ皟鏌ュ繀欏誨湪寮濮嬪悗60涓鏃ュ巻鏃ュ唴瀹屾垚錛岄櫎闈炴儏鍐墊槑紜瑕佹眰鏇撮暱鐨勬椂闂淬
Those accused of misconct must be informed of the allegation and of the inquiry. A written report of the inquiry must be prepared, summarizing the evidence reviewed and conclusions reached. The accused person(s) must be given a of the inquiry report.
蹇呴』灝嗘寚鎺у拰璋冩煡 鍛婄煡琚鎸囨帶琛屼負涓嶅綋鐨勪漢 銆傚繀欏 鍑嗗囦功闈㈣皟鏌ユ姤鍛婏紝鎬葷粨瀹℃煡鐨勮瘉鎹鍜屽緱鍑虹殑緇撹 銆傚繀欏誨悜琚鍛婃彁渚涗竴浠借皟鏌ユ姤鍛婄殑 鍓鏈 銆
If the inquiry provides an adequate basis for an investigation, that investigation should begin within 30 days of completion of the inquiry. The decision to begin an investigation must be reported in writing to the Director, Office of Research Integrity (ORI), on or before the date the investigation begins.
濡傛灉璋冩煡涓鴻皟鏌ユ彁渚涗簡鍏呭垎鐨勫熀紜錛屽垯 錛堟ｅ紡錛夎皟鏌ュ簲鍦錛堝垵姝ワ級璋冩煡瀹屾垚鍚30澶╁唴寮濮 銆傚紑濮嬭皟鏌ョ殑鍐沖畾蹇呴』鍦 璋冩煡寮濮嬩箣鏃ユ垨涔嬪墠浠ヤ功闈㈠艦寮忔姤鍛婄粰鐮旂┒璇氫俊鍔炲叕瀹わ紙ORI錛変富浠 銆
The investigation normally will include:
鈪犮丒xamining all documents, including relevant research data, proposals, publications, correspondence, and records of telephone calls.
鈪°両nterviewing all informants and all those accused of misconct as well as others who may have information about key aspects of the allegation.
鈪銆丳reparing a report of the investigation鈥檚 findings and making the report available for comment by all informants and all those accused of misconct.
鈪ｃ丼ubmitting a final report to ORI, the PI, the sponsor, and NIH for NIH-funded or supported research.
姝ｅ紡璋冩煡閫氬父鍖呮嫭錛
1銆 媯鏌ユ墍鏈夋枃浠 錛屽寘鎷 鐩稿叧鐮旂┒鏁版嵁 銆 鎻愭 銆 鍑虹増鐗 銆 淇″嚱 鍜 鐢佃瘽璁板綍 銆
2銆 閲囪挎墍鏈変婦鎶ヤ漢 銆 鎵鏈夎鎸囨帶琛屼負涓嶇鑰 浠ュ強 鍙鑳芥帉鎻℃寚鎺у叧閿鏂歸潰淇℃伅鐨勫叾浠栦漢 銆
3銆佸噯澶囦竴浠 璋冩煡緇撴灉鎶ュ憡 錛屽苟灝嗚ユ姤鍛婃彁渚涚粰鎵鏈変婦鎶ヤ漢鍜屾墍鏈夎鎸囨帶涓嶅綋琛屼負鐨勪漢浠 渚涜瘎璁 銆
4銆 鍚慜RI銆丳I銆佽禐鍔╄呭拰NIH鎻愪氦鏈緇堟姤鍛 錛岀敤浜嶯IH璧勫姪鎴栨敮鎸佺殑鐮旂┒銆
In most cases, the investigation should be completed within 120 days of its start. If the institution decides it cannot complete the investigation within this time, it must submit to ORI a written request for an extension.
鍦ㄥぇ澶氭暟鎯呭喌涓嬶紝姝ｅ紡璋冩煡搴斿湪寮濮嬪悗120澶╁唴瀹屾垚銆傚傛灉鏈烘瀯鍐沖畾鏃犳硶鍦ㄦゆ椂闂村唴瀹屾垚璋冩煡錛屽垯蹇呴』 鍚慜RI鎻愪氦涔﹂潰寤舵湡璇鋒眰 銆
This request must explain the reason for the delay, report on the investigation鈥檚 progress so far, and estimate when the investigation will be completed and the final report submitted.
璇ヨ鋒眰蹇呴』瑙ｉ噴寤惰繜鐨勫師鍥狅紝 鎶ュ憡鍒扮洰鍓嶄負姝㈢殑璋冩煡榪涘睍 錛 騫朵及璁¤皟鏌ヤ綍鏃跺畬鎴愬拰鎻愪氦鏈緇堟姤鍛 銆
If the investigation concludes that the allegation has merit, the institution may impose suitable penalties. In addition, the ORI may impose penalties of its own on investigators or institutions.
濡傛灉璋冩煡緇撹鴻や負璇ユ寚鎺ф湁鏍規嵁錛岃ユ満鏋勫彲浠ユ柦鍔犻傚綋鐨勫勭綒 銆 姝ゅ栵紝ORI鍙瀵硅皟鏌ヤ漢鍛樻垨鏈烘瀯鏂藉姞鑷宸辯殑澶勭綒銆
Institutions must notify the Office of Research Integrity (ORI) immediately if certain circumstances are found ring an inquiry or investigation into an allegation of research misconct.
濡傛灉鍦ㄨ皟鏌ユ垨璋冩煡鐮旂┒涓嶅綋琛屼負鎸囨帶鏃跺彂鐜版煇浜涙儏鍐碉紝鍚勬満鏋勫繀欏葷珛鍗抽氱煡鐮旂┒璇氫俊鍔炲叕瀹わ紙ORI錛夈
Click to view Clinical Trial Network錛圕TN錛 related content
Every CTN member institution is expected to have an official responsible for investigating complaints of research misconct, also referred to as the Research Integrity Officer (RIO). When an allegation of scientific misconct is made in a CTN trial, the Research Integrity Officer of the research institution should be contacted immediately.
姣忎釜CTN鎴愬憳鏈烘瀯閮藉簲鏈変竴鍚嶅畼鍛樿礋璐ｈ皟鏌ョ爺絀朵笉褰撹屼負鎶曡瘔錛屼篃縐頒負鐮旂┒璇氫俊瀹橈紙RIO錛 銆傚綋鍦–TN瀹″垽涓鎻愬嚭縐戝︿笉絝琛屼負鎸囨帶鏃訛紝搴旂珛鍗寵仈緋葷爺絀舵満鏋勭殑鐮旂┒璇氫俊瀹樺憳銆
The Research Integrity Officer should promptly assess whether the allegation falls under the federal definition of research misconct and whether sufficient evidence exists to warrant an inquiry. He or she should alert the NIDA Center for the Clinical Trials Network office that an allegation of research misconct has been made at one or more CTN sites. Within NIDA, responsibility for oversight of inquiries and investigations into research misconct rests with the Office of Extramural Affairs.
鐮旂┒璇氫俊涓撳憳搴旂珛鍗 璇勪及璇ユ寚鎺ф槸鍚﹀睘浜庤仈閭﹀圭爺絀朵笉褰撹屼負鐨勫畾涔 錛屼互鍙 鏄鍚︽湁瓚沖熻瘉鎹鏀鎸佽皟鏌 銆備粬鎴栧ス搴旈氱煡NIDA涓村簥璇曢獙涓蹇冪綉緇滃姙鍏瀹わ紝鏈変漢鎸囨帶涓涓鎴栧氫釜CTN絝欑偣瀛樺湪鐮旂┒涓嶅綋琛屼負銆傚湪NIDA鍐呴儴錛屾牎澶栦簨鍔″姙鍏瀹よ礋璐ｇ洃鐫ｅ圭戠爺涓嶇琛屼負鐨勮皟鏌ュ拰璋冩煡銆
In addition, if NIDA is the sponsor of a study under an Investigational New Drug (IND), NIDA must promptly report to the FDA any information that any person involved in human subject trials committed research misconct. If the FDA receives a complaint of alleged trial misconct, the FDA will independently investigate, separate from the ORI investigation, and proceed with any necessary regulatory actions.
姝ゅ栵紝濡傛灉NIDA鏄鐮旂┒鏂拌嵂錛圛ND錛夐」涓嬬爺絀剁殑璧炲姪鑰咃紝 NIDA蹇呴』絝嬪嵆鍚慒DA鎶ュ憡鍙備笌浜轟綋璇曢獙鐨勪換浣曚漢鏈夌爺絀朵笉褰撹屼負鐨勪換浣曚俊鎮銆 濡傛灉FDA鏀跺埌鎸囨帶璇曢獙涓嶅綋琛屼負鐨勬姇璇夛紝FDA灝嗙嫭絝嬩簬ORI璋冩煡榪涜岃皟鏌ワ紝騫墮噰鍙栦換浣曞繀瑕佺殑鐩戠℃帾鏂姐
An allegation of research misconct can have a significant impact on the informant, the accused person(s), and the institution where the alleged misconct took place. Proceres must be in place to ensure the security of original documents, computers, biological specimens, laboratory notebooks, research and financial records, and other relevant items that might be altered, lost, or destroyed.
瀵圭爺絀朵笉褰撹屼負鐨勬寚鎺у彲鑳戒細瀵逛婦鎶ヤ漢銆佽鍛婁漢鍜屾秹瀚屼笉褰撹屼負鍙戠敓鐨勬満鏋勪駭鐢熼噸澶у獎鍝 銆傚繀欏誨埗瀹氱▼搴忥紝紜淇濆師濮嬫枃浠躲佽＄畻鏈恆佺敓鐗╂爣鏈銆佸疄楠屽ょ瑪璁版湰銆佺爺絀跺拰璐㈠姟璁板綍浠ュ強鍏朵粬鍙鑳借鏇存敼銆佷涪澶辨垨閿姣佺殑鐩稿叧鐗╁搧鐨勫畨鍏ㄣ
In addition, specific safeguards are necessary to assure the protection of all persons concerned with an allegation of research misconct.
姝ゅ栵紝鏈夊繀瑕侀噰鍙栧叿浣撶殑淇濋殰鎺鏂斤紝浠ョ『淇濅笌鐮旂┒涓嶅綋琛屼負鎸囨帶鏈夊叧鐨勬墍鏈変漢鍛樺緱鍒頒繚鎶ゃ
A whistleblower (informant) is any member of a research institution, including a non-employee, who alleges that the institution or one of its members has engaged in, or has failed to respond adequately to an allegation of, research misconct.
涓炬姤浜猴紙鍛婂瘑浜猴級鏄鎸囩爺絀舵満鏋勭殑浠諱綍鎴愬憳 錛 鍖呮嫭澹扮О璇ユ満鏋勬垨鍏舵垚鍛樹箣涓鍙備笌鎴栨湭鑳藉圭爺絀朵笉褰撹屼負鐨勬寚鎺т綔鍑哄厖鍒嗗洖搴旂殑闈為泧鍛樸
The role of the whistleblower is essential to the effort to protect the integrity of research. People who in good faith report apparent research misconct must be able to do so in confidence and without fear of retaliation or payback.
涓炬姤浜虹殑浣滅敤瀵逛簬淇濇姢鐮旂┒鐨勫畬鏁存ц嚦鍏抽噸瑕併傜湡璇氬湴鎶ュ憡鏄庢樉鐮旂┒涓嶅綋琛屼負鐨勪漢蹇呴』鑳藉熷湪涓嶆媴蹇冩姤澶嶆垨鍥炴姤鐨勬儏鍐典笅縐樺瘑鎶ュ憡銆
Federal policy requires institutions to offer informants the following safeguards:
鈪犮丳rotection of privacy to the extent possible. However, informants cannot remain anonymous.
鈪°丳rotection against retaliation.
鈪銆丗air and objective proceres for examining and resolving research misconct allegations.
鈪ｃ丏iligence in protecting the positions and reputations of informants.
鑱旈偊鏀跨瓥瑕佹眰鏈烘瀯鍚戜婦鎶ヤ漢鎻愪緵浠ヤ笅淇濋殰錛
1銆佸敖鍙鑳 淇濇姢闅愮 銆 浣嗘槸錛屽憡瀵嗚呬笉鑳戒繚鎸佸尶鍚 銆
2銆 闃叉㈡姤澶 銆
3銆 瀹℃煡鍜岃В鍐崇戠爺涓嶇琛屼負鎸囨帶鐨勫叕姝ｅ㈣傜▼搴 銆
4銆 鍔鍔涗繚鎶や婦鎶ヤ漢鐨勫湴浣嶅拰澹拌獕 銆
Neither research institutions nor indivial researchers may penalize persons who, in good faith, report alleged research misconct. Even if the allegations are not sustained, as long as they are made in good faith, informants must be protected because they play a vital role in professional self-regulation.
鏃犺烘槸鐮旂┒鏈烘瀯榪樻槸鐮旂┒浜哄憳涓浜猴紝閮 涓嶅緱澶勭綒鍠勬剰鎶ュ憡鐮旂┒涓嶅綋琛屼負鐨勪漢鍛 銆 鍗充嬌鎸囨帶涓嶆垚絝嬶紝鍙瑕佹寚鎺ф槸鍠勬剰鐨勶紝涓炬姤浜轟篃蹇呴』鍙楀埌淇濇姢 錛屽洜涓轟粬浠鍦 鑱屼笟鑷寰 涓鍙戞尌鐫鑷沖叧閲嶈佺殑浣滅敤銆
Most allegations of research misconct are not substantiated. Persons accused of research misconct must be assured that the mere filing of allegations will not bring their research to a halt or be the basis for other disciplinary action without compelling reasons. Other safeguards for accused persons include:
澶у氭暟鍏充簬縐戠爺涓嶇琛屼負鐨勬寚鎺ч兘娌℃湁寰楀埌璇佸疄銆 蹇呴』鍚戣鎸囨帶鐮旂┒涓嶇琛屼負鐨勪漢淇濊瘉錛屽傛灉娌℃湁浠や漢淇℃湇鐨勭悊鐢憋紝浠呬粎鎻愬嚭鎸囨帶涓嶄細浣誇粬浠鐨勭爺絀跺仠姝㈡垨鎴愪負鍏朵粬綰寰嬪勫垎鐨勫熀紜銆傚硅鍛婁漢鐨勫叾浠栦繚闅滄帾鏂藉寘鎷錛
鈪犮乀imely written notification of allegations made against them.
鈪°丄 description of all allegations.
鈪銆丷easonable access to the data and other evidence supporting the allegations.
鈪ｃ乀he opportunity to respond to allegations, supporting evidence, and any proposed findings of research misconct.
鈪ゃ丆onfidential treatment to the maximum extent possible.
1銆 鍙婃椂涔﹂潰 閫氱煡瀵瑰叾鎻愬嚭鐨勬寚鎺с
2銆 鎵鏈夋寚鎺х殑鎻忚堪 銆
3銆 鍚堢悊鑾峰彇鏀鎸佹寚鎺х殑鏁版嵁鍜屽叾浠栬瘉鎹 銆
4銆 瀵規寚鎺с佹敮鎸佹ц瘉鎹鍜屼換浣曠爺絀朵笉絝琛屼負鐨勫緩璁璋冩煡緇撴灉浣滃嚭鍥炲簲鐨勬満浼 銆
5銆佸敖鍙鑳 淇濆瘑 澶勭悊銆
The persons selected to investigate allegations of research misconct must have appropriate expertise and no unresolved conflicts of interest.
琚閫夊畾璋冩煡鐮旂┒涓嶅綋琛屼負鎸囨帶鐨勪漢鍛樺繀欏誨叿澶囬傚綋鐨 涓撲笟鐭ヨ瘑 錛屽苟涓 娌℃湁鏈瑙ｅ喅鐨勫埄鐩婂啿紿 銆
Reasonable time limits must be set for the response to an allegation of research misconct. Extensions of time may be allowed when necessary.
蹇呴』涓哄圭爺絀朵笉褰撹屼負鎸囨帶鐨勫洖搴 璁懼畾鍚堢悊鐨勬椂闂撮檺鍒 銆傚繀瑕佹椂鍙鍏佽稿歡闀挎椂闂淬
To the extent possible, knowledge of the identities of both subjects and informants involved in research misconct investigations should be closely held. However, the accused person is entitled to know the identity of the informant.
鍦ㄥ彲鑳界殑鎯呭喌涓嬶紝搴斿瘑鍒囦簡瑙ｅ弬涓庣爺絀朵笉褰撹屼負璋冩煡鐨勫彈璇曡呭拰綰誇漢鐨勮韓浠姐備絾鏄錛岃鍛婃湁鏉冪煡閬撲婦鎶ヤ漢鐨勮韓浠姐
Alleged misconct in a clinical trial that could threaten the health or safety of trial participants must be reported immediately to the trial principal investigator, the federal agency sponsoring the trial (NIDA in the case of CTN studies), and the Office of Research Integrity (ORI). The name(s) of the accused person(s) should remain confidential, but steps must be taken to ensure the safety of trial participants.
涓村簥璇曢獙涓鍙鑳藉▉鑳佽瘯楠屽弬涓庤呭仴搴鋒垨瀹夊叏鐨勬秹瀚屼笉褰撹屼負蹇呴』絝嬪嵆鎶ュ憡緇 璇曢獙棣栧腑鐮旂┒鍛 銆 璧炲姪璇曢獙鐨勮仈閭︽満鏋勶紙 灝盋TN鐮旂┒鑰岃█涓篘IDA錛夊拰 鐮旂┒璇氫俊鍔炲叕瀹 錛圤RI錛夈傝鍛婄殑濮撳悕搴斾繚瀵嗭紝浣嗗繀欏婚噰鍙栨帾鏂界『淇濆″垽鍙備笌鑰呯殑瀹夊叏銆
Research institutions may penalize researchers who are found to have committed research misconct by terminating their employment or by requiring supervision of future research activities.
鐮旂┒鏈烘瀯鍙浠ラ氳繃 緇堟浠栦滑鐨勫伐浣 鎴 瑕佹眰鐩戠潱鏈鏉ョ殑鐮旂┒媧誨姩 錛屾潵鎯╃綒閭ｄ簺琚鍙戠幇鏈夌爺絀朵笉絝琛屼負鐨勭爺絀朵漢鍛樸
When a grantee institution upholds a finding of research misconct by anyone working on a NIH-funded research project, the grantee must assess the effect of the finding on that person鈥檚 ability to continue working on the research project. In addition, the grantee must promptly obtain approval from the sponsor and NIH for any intended change of principal investigator or other key personnel involved in the research project.
褰撹璧勫姪鏈烘瀯鏀鎸佷換浣曞湪NIH璧勫姪鐨勭爺絀墮」鐩涓宸ヤ綔鐨勪漢鐨勭爺絀朵笉絝琛屼負鐨勫彂鐜版椂錛岃璧勫姪鏈烘瀯蹇呴』璇勪及璇ュ彂鐜板硅ヤ漢緇х畫浠庝簨璇ョ爺絀墮」鐩鐨勮兘鍔涚殑褰卞搷銆 姝ゅ栵紝琚璧勫姪浜哄繀欏葷珛鍗寵幏寰楄祫鍔╀漢鍜孨IH鐨勬壒鍑嗭紝浠ュ彉鏇翠換浣曟秹鍙婄爺絀墮」鐩鐨勪富瑕佺爺絀朵漢鍛樻垨鍏朵粬鍏抽敭浜哄憳銆
The Office of Research Integrity (ORI) may also impose penalties for research misconct. Penalties are determined by the severity of the misconct. Factors that ORI may consider in choosing a penalty may include the degree to which the misconct:
鐮旂┒璇氫俊鍔炲叕瀹わ紙ORI錛変篃鍙鑳藉圭爺絀朵笉絝琛屼負鏂藉姞澶勭綒銆傚勭綒鍙栧喅浜庝笉褰撹屼負鐨勪弗閲嶇▼搴︺傚湪閫夋嫨澶勭綒鏃訛紝ORI鍙鑳借冭檻鐨勫洜緔犲寘鎷涓嶅綋琛屼負鐨勭▼搴︼細
鈪犮乄as committed in a knowing, intentional, or reckless manner.
鈪°乄as an isolated event or part of a pattern.
鈪銆丠ad a significant impact on the research record, research subjects, other researchers, institutions, or the public welfare.
1銆佷互 鏄庣煡 銆 鏁呮剰 鎴 涓嶈″悗鏋 鐨勬柟寮忚繘琛屻
2銆佹槸涓涓 瀛ょ珛浜嬩歡鎴栨ā寮 鐨勪竴閮ㄥ垎銆
3銆佸 鐮旂┒璁板綍銆佺爺絀跺硅薄銆佸叾浠栫爺絀朵漢鍛樸佹満鏋 鎴 鍏鐩婁簨涓 鏈夐噸澶у獎鍝嶈呫
The Office of Research Integrity (ORI) may impose a variety of penalties when a finding of research misconct is upheld. These penalties may include:
鐮旂┒璇氫俊鍔炲叕瀹わ紙ORI錛夊彲鑳戒細鍦 緇存寔鐮旂┒涓嶇琛屼負鐨勮皟鏌ョ粨鏋 鏃 鏂藉姞鍚勭嶅勭綒 銆傝繖浜涘勭綒鍙鑳藉寘鎷錛
鈪犮丆orrection of the research record.
鈪°丩etters of reprimand.
鈪銆丼uspension or termination of a research grant.
鈪ｃ丼uspension or debarment from receiving federal funds.
1銆佺爺絀惰板綍鐨 鏇存 銆
2銆 鐢蟲枼淇 銆
3銆 涓姝㈡垨緇堟㈢爺絀惰祫鍔 銆
4銆 鏆傚仠鎴栫佹㈡帴鍙楄仈閭﹁祫閲 銆
When administrative actions are imposed by ORI (or the FDA, who has their own bulletin boards for debarred and disqualified investigators), the names of the indivials will be made public.
褰揙RI錛堟垨FDA錛屼粬浠鏈夎嚜宸辯殑鍏鍛婃爮渚涜紱佹㈠拰琚鍙栨秷璧勬牸鐨勮皟鏌ヤ漢鍛樹嬌鐢錛夐噰鍙 琛屾斂琛屽姩 鏃訛紝榪欎簺浜虹殑 濮撳悕灝嗚鍏甯 銆
If the ORI believes that research misconct may have involved criminal or civil fraud, it will refer the matter promptly to an investigative body such as the Department of Justice or the Office of the Inspector General, Department of Health and Human Services.
濡傛灉璋冩煡鏈烘瀯璁や負鐮旂┒涓嶇琛屼負 鍙鑳芥秹鍙婂垜浜嬫垨姘戜簨嬈鴻瘓 錛屽畠灝嗚繀閫熷皢姝や簨 鎻愪氦鍙告硶閮 鎴 鍗鐢熷拰鍏浼楁湇鍔￠儴鐩戝療闀垮姙鍏瀹 絳夎皟鏌ユ満鏋勩
ICH GCP was put together and became operational after public outcry of research misconct that had occurred over the years. Following the ICH GCP guideline assists in preventing fraud and misconct. So research misconct is also a form of non-compliance to ICH GCP
ICH GCP鏄鍦ㄥ叕浼楀瑰氬勾鏉ュ彂鐢熺殑鐮旂┒涓嶇琛屼負鎻愬嚭寮虹儓鎶楄鍚庢垚絝嬪苟寮濮嬭繍浣滅殑 銆傞伒寰狪CH GCP鎸囧崡鏈夊姪浜庨槻姝㈡鴻瘓鍜屼笉褰撹屼負銆傚洜姝わ紝鐮旂┒涓嶇琛屼負涔熸槸涓嶉伒瀹圛CH GCP鐨勪竴縐嶅艦寮忥紙錛燂級銆
鈪犮丗ederal policy defines research misconct as 鈥渇abrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.鈥 This definition does not include honest error or differences of opinion or authorship disputes unless they involve plagiarism.
1銆佽仈閭︽斂絳栧皢 鐮旂┒涓嶇琛屼負 瀹氫箟涓衡滃湪鎻愬嚭銆佹墽琛屾垨瀹℃煡鐮旂┒鎴栨姤鍛婄爺絀剁粨鏋滄椂鎹忛犮佷吉閫犳垨鍓界獌銆傗濊ュ畾涔変笉鍖呮嫭璇氬疄鐨勯敊璇銆佹剰瑙佸垎姝ф垨钁椾綔鏉冧簤璁錛岄櫎闈炴秹鍙婂壗紿冦
鈪°丗ederal policy on research misconct applies to all federally funded research and all proposals submitted to federal agencies for research funding.
2銆佸叧浜庣爺絀朵笉褰撹屼負鐨勮仈閭︽斂絳栭傜敤浜 鎵鏈夎仈閭﹁祫鍔╃殑鐮旂┒浠ュ強鍚戣仈閭︽満鏋勬彁浜ょ殑鎵鏈夌爺絀惰祫鍔╂彁妗 銆
鈪銆乀he Office of Research Integrity (ORI) in the Department of Health and Human Services oversees investigations of research misconct allegations and makes final determinations on findings of research misconct within the U.S. Public Health Service.
3銆佸崼鐢熶笌鍏鍏辨湇鍔￠儴鐨勭爺絀惰瘹淇″姙鍏瀹わ紙ORI錛 璐熻矗鐩戠潱瀵圭爺絀朵笉褰撹屼負鎸囨帶鐨勮皟鏌 錛屽苟 瀵圭編鍥藉叕鍏卞崼鐢熸湇鍔￠儴闂ㄧ殑鐮旂┒涓嶅綋琛屼負璋冩煡緇撴灉鍋氬嚭鏈緇堝喅瀹 銆
鈪ｃ丗ederal policy places the primary responsibility for reporting and investigating allegations of research misconct with researchers and research institutions.
4銆佽仈閭︽斂絳栧皢 鎶ュ憡鍜岃皟鏌ョ戠爺涓嶇琛屼負鎸囨帶鐨勪富瑕佽矗浠 浜ょ粰 鐮旂┒浜哄憳鍜岀爺絀舵満鏋 銆
鈪ゃ丟enerally, the response to an allegation of research misconct has three stages:
i銆両nquiry (to assess the facts of the allegation).
ii銆両nvestigation (if the inquiry provides adequate basis for one).
iii銆丄djudication (imposing of suitable penalties if the allegation is found to have merit).
5銆佷竴鑸鑰岃█錛屽圭爺絀朵笉褰撹屼負鎸囨帶鐨勫洖搴斿垎涓轟笁涓闃舵碉細
錛1錛 鍒濇ヨ皟鏌 錛堣瘎浼版寚鎺х殑浜嬪疄錛夈
錛2錛 姝ｅ紡璋冩煡 錛堝傛灉璋冩煡鎻愪緵浜嗗厖鍒嗙殑渚濇嵁錛夈
錛3錛 瑁佸喅 錛堝傛灉鍙戠幇鎸囨帶鏈変環鍊礆紝鍒欐柦鍔犻傚綋鐨勫勭綒錛夈
鈪ャ丳enalties for research misconct may include termination of employment, suspension or termination of a research grant, and suspension or debarment from receiving federal funds.
6銆佸圭爺絀朵笉絝琛屼負鐨勫勭綒鍙鑳藉寘鎷 緇堟㈤泧浣 銆 鏆傚仠鎴栫粓姝㈢爺絀惰祫鍔 錛屼互鍙 鏆傚仠鎴栫佹㈡帴鍙楄仈閭﹁祫閲 銆