⑴ ICH-GCP 9.2 Research Misconct锛2锛
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┒浜哄憳鍜岀爺绌舵満鏋 涓昏佽礋璐ｆ姤鍛婂拰璋冩煡琚鎸囨帶鐨勭爺绌朵笉褰撹屼负 銆傜爺绌舵満鏋勫勭悊姝ょ被鎸囨帶鐨勯勬湡浠诲姟鍦42 CFR绗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.
涓鑸鏉ヨ达紝瀵圭爺绌朵笉褰撹屼负鎸囨帶鐨勫洖搴斿垎涓轰笁涓闃舵点
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.
鍒濇ヨ皟鏌ヨ瘎浼颁簡 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椤诲湪寮濮嬪悗60涓鏃ュ巻鏃ュ唴瀹屾垚锛岄櫎闈炴儏鍐垫槑纭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』灏嗘寚鎺у拰璋冩煡 鍛婄煡琚鎸囨帶琛屼负涓嶅綋鐨勪汉 銆傚繀椤 鍑嗗囦功闈㈣皟鏌ユ姤鍛婏紝鎬荤粨瀹℃煡鐨勮瘉鎹鍜屽緱鍑虹殑缁撹 銆傚繀椤诲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.
濡傛灉璋冩煡涓鸿皟鏌ユ彁渚涗簡鍏呭垎鐨勫熀纭锛屽垯 锛堟ｅ紡锛夎皟鏌ュ簲鍦锛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冲畾蹇呴』鍦 璋冩煡寮濮嬩箣鏃ユ垨涔嬪墠浠ヤ功闈㈠舰寮忔姤鍛婄粰鐮旂┒璇氫俊鍔炲叕瀹わ紙ORI锛変富浠 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锛
1銆 妫鏌ユ墍鏈夋枃浠 锛屽寘鎷 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 閲囪挎墍鏈変妇鎶ヤ汉 銆 鎵鏈夎鎸囨帶琛屼负涓嶇鑰 浠ュ強 鍙鑳芥帉鎻℃寚鎺у叧閿鏂归潰淇℃伅鐨勫叾浠栦汉 銆
3銆佸噯澶囦竴浠 璋冩煡缁撴灉鎶ュ憡 锛屽苟灏嗚ユ姤鍛婃彁渚涚粰鎵鏈変妇鎶ヤ汉鍜屾墍鏈夎鎸囨帶涓嶅綋琛屼负鐨勪汉浠 渚涜瘎璁 銆
4銆 鍚慜RI銆丳I銆佽禐鍔╄呭拰NIH鎻愪氦鏈缁堟姤鍛 锛岀敤浜嶯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冲畾鏃犳硶鍦ㄦゆ椂闂村唴瀹屾垚璋冩煡锛屽垯蹇呴』 鍚慜RI鎻愪氦涔﹂潰寤舵湡璇锋眰 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.
璇ヨ锋眰蹇呴』瑙ｉ噴寤惰繜鐨勫師鍥狅紝 鎶ュ憡鍒扮洰鍓嶄负姝㈢殑璋冩煡杩涘睍 锛 骞朵及璁¤皟鏌ヤ綍鏃跺畬鎴愬拰鎻愪氦鏈缁堟姤鍛 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.
濡傛灉璋冩煡缁撹鸿や负璇ユ寚鎺ф湁鏍规嵁锛岃ユ満鏋勫彲浠ユ柦鍔犻傚綋鐨勫勭綒 銆 姝ゅ栵紝ORI鍙瀵硅皟鏌ヤ汉鍛樻垨鏈烘瀯鏂藉姞鑷宸辩殑澶勭綒銆
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┒涓嶅綋琛屼负鎸囨帶鏃跺彂鐜版煇浜涙儏鍐碉紝鍚勬満鏋勫繀椤荤珛鍗抽氱煡鐮旂┒璇氫俊鍔炲叕瀹わ紙ORI锛夈
Click to view Clinical Trial Network锛圕TN锛 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皟鏌ョ爺绌朵笉褰撹屼负鎶曡瘔锛屼篃绉颁负鐮旂┒璇氫俊瀹橈紙RIO锛 銆傚綋鍦–TN瀹″垽涓鎻愬嚭绉戝︿笉绔琛屼负鎸囨帶鏃讹紝搴旂珛鍗宠仈绯荤爺绌舵満鏋勭殑鐮旂┒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﹀圭爺绌朵笉褰撹屼负鐨勫畾涔 锛屼互鍙 鏄鍚︽湁瓒冲熻瘉鎹鏀鎸佽皟鏌 銆備粬鎴栧ス搴旈氱煡NIDA涓村簥璇曢獙涓蹇冪綉缁滃姙鍏瀹わ紝鏈変汉鎸囨帶涓涓鎴栧氫釜CTN绔欑偣瀛樺湪鐮旂┒涓嶅綋琛屼负銆傚湪NIDA鍐呴儴锛屾牎澶栦簨鍔″姙鍏瀹よ礋璐ｇ洃鐫ｅ圭戠爺涓嶇琛屼负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┒鏂拌嵂锛圛ND锛夐」涓嬬爺绌剁殑璧炲姪鑰咃紝 NIDA蹇呴』绔嬪嵆鍚慒DA鎶ュ憡鍙備笌浜轰綋璇曢獙鐨勪换浣曚汉鏈夌爺绌朵笉褰撹屼负鐨勪换浣曚俊鎭銆 濡傛灉FDA鏀跺埌鎸囨帶璇曢獙涓嶅綋琛屼负鐨勬姇璇夛紝FDA灏嗙嫭绔嬩簬ORI璋冩煡杩涜岃皟鏌ワ紝骞堕噰鍙栦换浣曞繀瑕佺殑鐩戠℃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.
瀵圭爺绌朵笉褰撹屼负鐨勬寚鎺у彲鑳戒細瀵逛妇鎶ヤ汉銆佽鍛婁汉鍜屾秹瀚屼笉褰撹屼负鍙戠敓鐨勬満鏋勪骇鐢熼噸澶у奖鍝 銆傚繀椤诲埗瀹氱▼搴忥紝纭淇濆師濮嬫枃浠躲佽＄畻鏈恒佺敓鐗╂爣鏈銆佸疄楠屽ょ瑪璁版湰銆佺爺绌跺拰璐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┒涓嶅綋琛屼负鎸囨帶鏈夊叧鐨勬墍鏈変汉鍛樺緱鍒颁繚鎶ゃ
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绌舵満鏋勭殑浠讳綍鎴愬憳 锛 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绌朵笉褰撹屼负鐨勬寚鎺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┒涓嶅綋琛屼负鐨勪汉蹇呴』鑳藉熷湪涓嶆媴蹇冩姤澶嶆垨鍥炴姤鐨勬儏鍐典笅绉樺瘑鎶ュ憡銆
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妇鎶ヤ汉鎻愪緵浠ヤ笅淇濋殰锛
1銆佸敖鍙鑳 淇濇姢闅愮 銆 浣嗘槸锛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鍐崇戠爺涓嶇琛屼负鎸囨帶鐨勫叕姝ｅ㈣傜▼搴 銆
4銆 鍔鍔涗繚鎶や妇鎶ヤ汉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┒鏈烘瀯杩樻槸鐮旂┒浜哄憳涓浜猴紝閮 涓嶅緱澶勭綒鍠勬剰鎶ュ憡鐮旂┒涓嶅綋琛屼负鐨勪汉鍛 銆 鍗充娇鎸囨帶涓嶆垚绔嬶紝鍙瑕佹寚鎺ф槸鍠勬剰鐨勶紝涓炬姤浜轰篃蹇呴』鍙楀埌淇濇姢 锛屽洜涓轰粬浠鍦 鑱屼笟鑷寰 涓鍙戞尌鐫鑷冲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氭暟鍏充簬绉戠爺涓嶇琛屼负鐨勬寚鎺ч兘娌℃湁寰楀埌璇佸疄銆 蹇呴』鍚戣鎸囨帶鐮旂┒涓嶇琛屼负鐨勪汉淇濊瘉锛屽傛灉娌℃湁浠や汉淇℃湇鐨勭悊鐢憋紝浠呬粎鎻愬嚭鎸囨帶涓嶄細浣夸粬浠鐨勭爺绌跺仠姝㈡垨鎴愪负鍏朵粬绾寰嬪勫垎鐨勫熀纭銆傚硅鍛婁汉鐨勫叾浠栦繚闅滄帾鏂藉寘鎷锛
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 瀵规寚鎺с佹敮鎸佹ц瘉鎹鍜屼换浣曠爺绌朵笉绔琛屼负鐨勫缓璁璋冩煡缁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┒涓嶅綋琛屼负鎸囨帶鐨勪汉鍛樺繀椤诲叿澶囬傚綋鐨 涓撲笟鐭ヨ瘑 锛屽苟涓 娌℃湁鏈瑙ｅ喅鐨勫埄鐩婂啿绐 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』涓哄圭爺绌朵笉褰撹屼负鎸囨帶鐨勫洖搴 璁惧畾鍚堢悊鐨勬椂闂撮檺鍒 銆傚繀瑕佹椂鍙鍏佽稿欢闀挎椂闂淬
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弬涓庣爺绌朵笉褰撹屼负璋冩煡鐨勫彈璇曡呭拰绾夸汉鐨勮韩浠姐備絾鏄锛岃鍛婃湁鏉冪煡閬撲妇鎶ヤ汉鐨勮韩浠姐
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锋垨瀹夊叏鐨勬秹瀚屼笉褰撹屼负蹇呴』绔嬪嵆鎶ュ憡缁 璇曢獙棣栧腑鐮旂┒鍛 銆 璧炲姪璇曢獙鐨勮仈閭︽満鏋勶紙 灏盋TN鐮旂┒鑰岃█涓篘IDA锛夊拰 鐮旂┒璇氫俊鍔炲叕瀹 锛圤RI锛夈傝鍛婄殑濮撳悕搴斾繚瀵嗭紝浣嗗繀椤婚噰鍙栨帾鏂界‘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 缁堟浠栦滑鐨勫伐浣 鎴 瑕佹眰鐩戠潱鏈鏉ョ殑鐮旂┒娲诲姩 锛屾潵鎯╃綒閭ｄ簺琚鍙戠幇鏈夌爺绌朵笉绔琛屼负鐨勭爺绌朵汉鍛樸
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换浣曞湪NIH璧勫姪鐨勭爺绌堕」鐩涓宸ヤ綔鐨勪汉鐨勭爺绌朵笉绔琛屼负鐨勫彂鐜版椂锛岃璧勫姪鏈烘瀯蹇呴』璇勪及璇ュ彂鐜板硅ヤ汉缁х画浠庝簨璇ョ爺绌堕」鐩鐨勮兘鍔涚殑褰卞搷銆 姝ゅ栵紝琚璧勫姪浜哄繀椤荤珛鍗宠幏寰楄祫鍔╀汉鍜孨IH鐨勬壒鍑嗭紝浠ュ彉鏇翠换浣曟秹鍙婄爺绌堕」鐩鐨勪富瑕佺爺绌朵汉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锛変篃鍙鑳藉圭爺绌朵笉绔琛屼负鏂藉姞澶勭綒銆傚勭綒鍙栧喅浜庝笉褰撹屼负鐨勪弗閲嶇▼搴︺傚湪閫夋嫨澶勭綒鏃讹紝ORI鍙鑳借冭檻鐨勫洜绱犲寘鎷涓嶅綋琛屼负鐨勭▼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 瀛ょ珛浜嬩欢鎴栨ā寮 鐨勪竴閮ㄥ垎銆
3銆佸 鐮旂┒璁板綍銆佺爺绌跺硅薄銆佸叾浠栫爺绌朵汉鍛樸佹満鏋 鎴 鍏鐩婁簨涓 鏈夐噸澶у奖鍝嶈呫
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锛夊彲鑳戒細鍦 缁存寔鐮旂┒涓嶇琛屼负鐨勮皟鏌ョ粨鏋 鏃 鏂藉姞鍚勭嶅勭綒 銆傝繖浜涘勭綒鍙鑳藉寘鎷锛
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銆佺爺绌惰板綍鐨 鏇存 銆
2銆 鐢虫枼淇 銆
3銆 涓姝㈡垨缁堟㈢爺绌惰祫鍔 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锛堟垨FDA锛屼粬浠鏈夎嚜宸辩殑鍏鍛婃爮渚涜绂佹㈠拰琚鍙栨秷璧勬牸鐨勮皟鏌ヤ汉鍛樹娇鐢锛夐噰鍙 琛屾斂琛屽姩 鏃讹紝杩欎簺浜虹殑 濮撳悕灏嗚鍏甯 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负鐮旂┒涓嶇琛屼负 鍙鑳芥秹鍙婂垜浜嬫垨姘戜簨娆鸿瘓 锛屽畠灏嗚繀閫熷皢姝や簨 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 绛夎皟鏌ユ満鏋勩
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┒涓嶇琛屼负鎻愬嚭寮虹儓鎶楄鍚庢垚绔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鸿瘓鍜屼笉褰撹屼负銆傚洜姝わ紝鐮旂┒涓嶇琛屼负涔熸槸涓嶉伒瀹圛CH GCP鐨勪竴绉嶅舰寮忥紙锛燂級銆
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︽斂绛栧皢 鐮旂┒涓嶇琛屼负 瀹氫箟涓衡滃湪鎻愬嚭銆佹墽琛屾垨瀹℃煡鐮旂┒鎴栨姤鍛婄爺绌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垨钁椾綔鏉冧簤璁锛岄櫎闈炴秹鍙婂壗绐冦
鈪°丗ederal policy on research misconct applies to all federally funded research and all proposals submitted to federal agencies for research funding.
2銆佸叧浜庣爺绌朵笉褰撹屼负鐨勮仈閭︽斂绛栭傜敤浜 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绌惰祫鍔╂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￠儴鐨勭爺绌惰瘹淇″姙鍏瀹わ紙ORI锛 璐熻矗鐩戠潱瀵圭爺绌朵笉褰撹屼负鎸囨帶鐨勮皟鏌 锛屽苟 瀵圭編鍥藉叕鍏卞崼鐢熸湇鍔￠儴闂ㄧ殑鐮旂┒涓嶅綋琛屼负璋冩煡缁撴灉鍋氬嚭鏈缁堝喅瀹 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︽斂绛栧皢 鎶ュ憡鍜岃皟鏌ョ戠爺涓嶇琛屼负鎸囨帶鐨勪富瑕佽矗浠 浜ょ粰 鐮旂┒浜哄憳鍜岀爺绌舵満鏋 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█锛屽圭爺绌朵笉褰撹屼负鎸囨帶鐨勫洖搴斿垎涓轰笁涓闃舵碉細
锛1锛 鍒濇ヨ皟鏌 锛堣瘎浼版寚鎺х殑浜嬪疄锛夈
锛2锛 姝ｅ紡璋冩煡 锛堝傛灉璋冩煡鎻愪緵浜嗗厖鍒嗙殑渚濇嵁锛夈
锛3锛 瑁佸喅 锛堝傛灉鍙戠幇鎸囨帶鏈変环鍊硷紝鍒欐柦鍔犻傚綋鐨勫勭綒锛夈
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銆佸圭爺绌朵笉绔琛屼负鐨勫勭綒鍙鑳藉寘鎷 缁堟㈤泧浣 銆 鏆傚仠鎴栫粓姝㈢爺绌惰祫鍔 锛屼互鍙 鏆傚仠鎴栫佹㈡帴鍙楄仈閭﹁祫閲 銆