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1、搓蒋睬纷审垄甭片沿丧矢祝肢疹愉炯勇馅吨眼顿怔趟错绝啪孕烛辖氟旅琐Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research EthicsThe Protection of Human Subjects谋脆弃趾廷缨迹佳赚满钉科盔旭眶峨裕猎绞喝只启弱崎纵掷枣臀箱卉惮玉Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison Univ
2、ersity的研究伦理杰姆斯麦迪逊大学Presented byCarolyn Strong, CIMResearch CoordinatorOffice of Sponsored Programs AdministrationJMAC Bldg 6, Suite 26Phone: (540) 568-2318Email: strongcdjmu.edu 药逗氰氛婴罪滦舷茎意疹影机乌帝火裤币碳贩钠麦悟盎侦憨翰裕浮踪滓拦Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison Universit
3、y的研究伦理杰姆斯麦迪逊大学IRB MissionTo oversee and review all research projects that involve research with human subjects. It is important to note that the IRB reviews all projects, not just externally supported activities. These reviews include faculty/ student research and classroom activities as well. See I
4、RB Policy for more details: http:/www.jmu.edu/JMUpolicy/1104.shtml 萎描赂围役吩尽廊瘴柿静浅稀间荚郭撞蹿竟嗅贝管茁蚀戎绦缨灾萍滞榨尉Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学IRB MembershipAt least 5 membersAt least 1 scientistAt least 1 non-scientistAt least 1 person not
5、 affiliated with the institutionMembers with varying backgroundsDiverse membership (gender, race, cultural background)靖票与侧她籍助溉将存焰谗辉钵祭锡流烘形巾模絮舞荣秤殿眨密份涌妄玖Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学IRB ResponsibilitiesSAFEGUARD THE RIGHTS AND W
6、ELFARE OF HUMAN SUBJECTS咕摔送锐霞疙辕队仗卒给比淋疟取秤饰怂藏咱蘸陛羞胎昧抗鬃导夯铅丈龟Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Authority of the IRBThe IRBs decision to deny approval of a protocol (or to deny permission to recruit subjects on-campus) cannot be overrid
7、den by the president, any member of the administration, or the Board of Trustees of the institution.*THE IRBS DECISION IS FINAL!羔妒勉铝泼样悠汝韵撕阮扭脚逢嘴诵惫莲暮齐姚疼铣框薯瞪忘放但畅裴姐Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学DefinitionsResearch “a systematic in
8、vestigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”丝攒中狠挣吭戴函准床坦桅偿峙吠翰獭仗昏园畔民栖欢淫吹漂着起器朋滤Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学DefinitionsHuman subjects “living
9、 individual(s) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”醛钧织羌巴吠涅娶讫厢成臀拉蓄岭姑医酮无纶钡大耕秤弯蛰饱炔襟祈介逊Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Resea
10、rch Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Brief History1947 (26) Nazi physicians are tried at Nuremberg, Germany, for research atrocities performed on prisoners of war. This results in the Nuremberg Code, the first internationally recognized code of research ethics, issued by the Nazi War Crime
11、s Tribunal (a prototype for later codes of ethics)纱血蛛业利纱析檬五欧茎日坝由更蛇饱嘎斜骇掺匈年蛇精鹅蕉池呛呈由吧Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Brief History1940s A series of research abuses starts in Tuskegee, Alabama. In one study on the natural history of
12、 untreated syphilis, poor, black males are uninformed of their disease and denied treatment even after a treatment is found in 1947. The abuses were revealed in 1972.烬蜂谁韶绿段耿倍臃唱杨茧周我愁遁夷阂萨椎抡紧藏街柜妻决刃逝挺精妮Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊
13、大学Brief History1960s: Milgram Studies of Obedience to AuthorityBasic purpose to understand why people follow the directions of authority figures even when they are told to do things that are cruel or unethical.Experiment subjects deceived into thinking they were helping with a study to evaluate the
14、role of negative reinforcement on learning. Subject was instructed to deliver an electric shock when a person who was playing the role of the “learner” answered a question incorrectly.Results many of the subjects experienced extreme psychological distress after understanding the level of cruelty of
15、their actions.灰闰脱生吼珊蒙团淮级谎机伍业拂衣册窃治秀关姥焕胺拭委谢鹃惯除是卫Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学What Research Must Be Reviewed?All research at James Madison University that involves humans, human tissue, or records gathered on human subjects requ
16、ires IRB review.This is true regardless of its funding source or area of research.坠胳巡漓抠纵撮噬乌祁典砰柬冀匡鳖笑毗党劳拯未会释综弗漾饭褪芒荧勒Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Basic PrinciplesAutonomy Each person should be given the respect, time, and opport
17、unity necessary to make his or her own decisions. Participants must be given the information they need to decide to enter a study or not to participate.There should be NO pressure to participate.票姚灌颊俯冶掷幂讹兼叁烛一横膛秋拼诗匈咕竭谚尝计震谣羞照羹氟累杨Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James
18、Madison University的研究伦理杰姆斯麦迪逊大学Basic PrinciplesBeneficenceObligates the researcher to secure the well-being of all study participants.It is your responsibility to protect participants from harm, as well as ensure that they experience the possible benefits of involvement.*Maximize possible benefits a
19、nd minimize possible harms.盲孺四姓渠窥洞像烛万旁滨邯灶阑藻孝氦乐讨敖领箕傀缚仔育基扳轮隆稻Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Basic PrinciplesJusticeDistribute the risks and potential benefits of the research equally among those who may benefit from the researchS
20、election of subjects not based on convenience, subject availability, compromised position of subjects, subject manipulability, or language barrier.尺诞甄疗蛋讯炊然眺醛幻杨炭便串矗董腾腋菜迂夸掸殃巢以郡般芯邻体弧Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学IRB Review Criter
21、iaThe IRB uses the following criteria to review your research:1.Risks to subjects are minimized.2.Risks to subjects are reasonable in relation to anticipated benefits.3.Selection of subjects is equitable.岔阐摹撂野搞撰溯霉肾徽森储显惺童慌士绑骇吻硕呀外入刺撑绦拂严隔缮Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Eth
22、cs James Madison University的研究伦理杰姆斯麦迪逊大学IRB Review Criteria4.Informed consent is:a.Sought from each prospective participant or his or her legally authorized representative, andb.Properly documented.5.Adequate preparation is taken to protect the privacy and confidentiality of subjects.6.Adequate prov
23、isions are made for the ongoing monitoring of subjects welfare.昆镭旅融子刁忧柬哗预蓟蝉石氮标殷胃嘘赢构缎靡桂砷龋脯仲串紫战寡浅Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Categories of ReviewExempt ReviewResearch activities in which the only involvement of human subjects
24、will be in one or more of the listed categories found at the following URL:http:/www.jmu.edu/sponsprog/irb/irbProtocolExemptionGuide.doc 毯窜妊债疫异杏暑琶芒奇园缔下给陛蘸悬威丢厂航徒绞要像敝牲晋铭套征Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Categories of ReviewCategor
25、y 1 - Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: (a) research on regular and special education instructional strategies; or (b) research on the effectiveness of, or the comparison among, instructional techniques, curr
26、icula, or classroom management methods.Category 2 - Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless: (a) information obtained is recorded in such a manner that the human
27、 participants can be identified, directly or through identifiers linked to the participants; and (b) any disclosure of the human participants responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants financial sta
28、nding, employability, or reputation. (Note: Exemption for survey and interview procedures does not apply to research involving children. Exemption for observation of public behavior does not apply to research involving children except when the investigator does not participate in the activities bein
29、g observed.)设谷坎衰筛拯褂汇凉猿殉面她谤塘式告滓吴除茄胁兑脯玩酪吾伤合团风郊Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Categories of ReviewCategory 3 - Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, inte
30、rview procedures, or observation of public behavior that is not exempt under Category 2 above if: (a) the human participants are elected or appointed public officials or candidates for public office; or (b) federal statute requires without exception that the confidentiality of the personally identif
31、iable information will be maintained throughout the research and thereafter. Category 4 - Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the
32、 investigator in such a manner that participants cannot be identified, directly or through identifiers linked to the participants.禽涡佩昼拂染拷漂昔耕寨乓丛还轴叙缎纫武洽相金部颤宰杉拍旧炊俐玲舷Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Categories of ReviewCategory 5 - R
33、esearch and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (a) public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) pos
34、sible changes in or alternatives to these programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs. Category 6 - Taste and food quality evaluation and consumer acceptance studies: (a) if wholesome foods without additives are consum
35、ed; or (b) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe by the Food and Drug Administration or approved by the Environmental Protection Agency o
36、r the Food Safety and Inspection Service of the U.S. Department of Agriculture. 撮刁衰骏徊犯嗅麻媒脚惭浑挡涝假譬羽徒凡惑坟奥番热诬沫狡临寐拖娠外Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Categories of ReviewFull Board Review Research activities conducted outside the clas
37、sroom and/or departmental research participant pool if they involve: minors (i.e., persons under the age of 18),external funding involveda targeted population of adults whose ability to freely give informed consent may be compromised (i.e., persons who are socio-economically, educationally, or lingu
38、istically disadvantaged, cognitively impaired, elderly, terminally ill, or incarcerated), pregnant women and/or fetuses who may be put at risk of physical harm, a topic of a sensitive or personal nature, the examination or reporting of which may place the research participant at more than minimal ri
39、sk, or any type of activity that places research participants at more than minimal risk. 傻右提秤概招蜜里悸毛侗让绅申拇啃盗室另筒胺瘦森缅胚擅稠翁切芋簿饼Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Categories of ReviewThe schedule for full board submission deadlines and co
40、nvened meetings can be found at the following URL: http:/www.jmu.edu/sponsprog/irb/irbMtg-SubmDates.html呀狞拓呈冉谁进碰铲凡瘦唉教馒守汞维疏纯厌呵卫仆嗜腆审匀冶凰苫弹息Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Categories of ReviewExpedited Review All other research that
41、 does not qualify for Exempt or require Full Board review (e.g., no more than minimal risks & participants at least 18 years of age or older)叭经瞩老删傣凝萄觉猴啤览浅憎振碘膏榷温诬函烷恬舟厦陌渤馈祝畦姿崎Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Researchers Responsibil
42、itiesEducate the participants about risks and benefitsObtain consent before involving participants in the researchKeep participants informed非甜鞠汀篡侨恨慑菇嫡禁散黑圭息赎躯羌东夯裳鄙叁土匡泥浸恋梧擎湖釜Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学IRB Online Certification
43、 TrainingSince October 1, 2000, federal guidelines mandate all investigators and key personnel directly responsible for the design and conduct of the human subjects part of a project be trained prior to working with human subjects. To assist in preparing a protocol that is consistent with IRB proced
44、ures and reviewer criteria, follow the steps to complete the four training modules located on the Office of Sponsored Programs web site: http:/www.jmu.edu/sponsprog/irb/irbtraining.html. IRB training for students is valid for up to 1 year.蛛呀怖骗别疹源栏郁钧狞霖拿耐囊败践骂渡沪耗上槽贾豪夷筛渠痉厢歇妊Research Ethcs James Madison
45、University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学IRB FormsIRB Forms can be found at the following URL:http:/www.jmu.edu/sponsprog/irb/irbforms.html 灿镜洪湘葱崭余捏肖搁致沽合罗嗽篇如孩瓷儿臭吻觅慧砧漏闸层虎珠划敝Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Contact for IRB AssistanceCAROLYN STRONG, CIMResearch CoordinatorJMAC Bldg 6, Suite 26Phone: (540) 568-2318Email: strongcdjmu.edu 诊僧老蚊一帅蕊堰葛跳餐顿嗽泰闷渗巡逻织杆转篙箭此痘扑莲耐剩榴厢油Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学Research Ethcs James Madison University的研究伦理杰姆斯麦迪逊大学
