北京磁共振脑成像中心人类被试研究申请书

1、北京磁共振脑成像中心人类被试研究申请书bmcbr human subjects research application1研究总负责人 overall / principal investigator姓名，职称name:门禁卡号guard system id#:first name, middle initial. last name, dcgrcc(s)单位institution: 北京磁共振脑成像中心bmcbr 其他，请写明other, specify系/室 dept/service:组 division/unit:地址 address:电话tel:传真fax:电子邮件e-mail:2.协

2、议题目 protocol titlei. 声明 certifications作为该研究负责人，我声明如下 as principal investigator, i certify the following:|1 我la经审阅过该协议并知道我将参与该研究 i have reviewed this protocol and acknowledge my participation. 我已阅读并熟知北京磁共振脑成像中心涉及该研究的相关规章制度i have read and am familiar with the bmcbr assurance governing this research.我己

3、经完成北京磁共振成像中心伦理与人体保护委员会所认可的与人体保护相关教育课程i have completed one of the human-subject protection education programs accepted by the irb of bmcbrll 我已经完成了进行该研究需耍的相应培训 i have completed the applicable institutional credentialing processes required to conduct this research.日期date研究负责人签字principal investigator(s

4、ign & date above)我/我们在下面签名，以表明我/我们同总遵守打保护被试和关的政府和中心的条例，并承担相应责任。i/we the undersigned accept responsibility for assuring adherence to government regulations, and institutional policies governing the protection of human subjects of research，including applicable institutional credentialing requireme

5、nts.i日期歸单位负责人(请填写姓名和单位并签名)department chair(type name & department and sign & date above)|日期date单位负责人(请填写姓名和单位并签名)department chair(type name & department and sign & date above)这些文件含有在北京磁共振脑成像屮心开展研究的研究者或其资助者的机密和&有的信息。这些文件的散发必须符合北 京磁共振脑成像中心的相应规定，其外传须得到北京磁共振脑成像中心的许可。these documents c

6、ontain information that is confidential and proprietary to the participating bmcbr or the study sponsor. its distribution is restricted in accordance with bmcbr policy and approval by the bmcbr is required for outside distribution.北京磁共振脑成像中心，人类被试研究屮请书文件：屮请书bmcbr human subjects research application f

7、ormfilename: application formversion 1 january，20043资助人/基金信息(每个资助填写一张表)sponsoivfunding information： (complete separate sheet for each sponsor)政府基金 government/foundation基金名称 government agency/foundation name:屮请者单位applicant institution: 北京磁共振脑成像中心其他，请写明other, explain below:bmcbr协议标题(如果与当前协议不同)tille of

8、 proposal (if different):研究负责人(如果与当前负责人不同)principal investigator (if different):基金编号(如果已知)sponsor grant # (if known):开展研究的地点performance sites:北京磁共振脑成像屮心 其他，诸写明0lher, specifybmcbrbelow:资助是否在本协议提交而就已获得？ has the project been awarded at the 是yes 否notime of this submission?内部/系所基金或其他基金来源internal/institut

9、ional funds or other source of funds基金名称及基金编号name of fund#（s）:项 u proj/grant:%:项 u proj/grant:%:其他來源，请场明 other sources of funds, specify:研究相关费用 research-related costs资助者是否提供经费（例如工资，研究费用等等）是否不清楚will the sponsor provide funding (i.c., salary support, study costs, etc.)?yesnona资助者是否承担设备使用费是否不清楚will the

10、 sponsor cover the cost of the device?yesnona资助者是否承担所有与研究相关的被试的费用（例如药剂、检测等等）是否不淸楚will the sponsor cover all subject research-related costs (c.g., drugs, tests)?yesnona如果对以上问题的凹答冇“否”，请解释其相关的研究费用的來源if no to any of above, explain how research-related costs will be covered:4.合作者/参与研究人员资料 co-investigator

11、s/study staff information在下面列出所有参与此项研究的合作者和研究人员，然后附上有每个人签名的个人申请书list below all co-investigators and study staff participating in the conduct of this study. attach individual specific co-investigator/study staff information pages with participating individuafs signature.姓名，职称 name (first, middle init

12、ial, last, degree(s)单位 institution5.协议信息 protocol information?a被试数目 number of subjects:在北京磁共振脑成像中心测试的被试数整个实验测试的被试数targettarget enrollment at bmcbr (#):enrollment study-wide (#)：(国内/国际 national/international)被试将在这些地方招募北京磁共振脑成像中心 其他，请说明other, specify:subjects will be enrolled at these sites: bmcbr 5b.

13、被试类型(在相应项冃上划钩)types of subjects: (check all that apply)成人adult未成年人pediatric脆弱人群 vulnerable populations 18-64 岁 adults(18-64)新生儿/婴儿 newborns/infants1 1 健康自愿者 healthy volunteers 65岁(禽)以 上 adults (65+)儿童(2-12岁)children (2-12)判断力受损者，如粘神状态不正常，脑损伤等等 decisionally impaired, e.g., mental abnormal state, brai

14、n injury, etc.青少年(13-18)adolescents (13-18)1 1 物理障碍,如脊髓受损 physically disabled, e.g., spinal cord injury注意：填写以儿童为被 试进行研究相关问题的 表格 complete separate form addressing issues related to the enrollment of children in research 怀孕妇女 pregnant womenll 其他，请说明 other, specify:5c被试来源(在相应项 li 上划钩)source of subjects

15、: (check all that apply)基层护理医牛/专科医* primaryphysiciaii/physician specialist1 1 报纸/电台/电视广告 newspaper/radio/television advertisingll 急救室 emergency roomi""1 医院内张贴 postings within hospital(s)住院病人inpatients 电子邮件声明 e-mail announcements人口调查/公共记录/商业邮件列表1 census/public records/conimercial mail lists

16、1 1 因特网站 internet sites 页疗记录/病人数据库medical records/patient databases其他，在协议小结中解释 0ther, explain in protocol summary注意：所有用于徵募被试的广告和信件文本应提交委员会审议note: the text of all advertisements and letters used to recruit subjects must be submitted for irb approval5d被试知情同愆书手续(在相应项h上划钩)consent procedures: (check all

17、that apply)符合国家规定的书面的被试知情同意书written consent waived in accordance with government regulations被试有至少12小时來决定是否参与(见下而的说明)subjects will have less than 12 hours to decide whether or not to participate (see note below)被试知惰同愆书来自consent to be obtained from:被试 subjectl 父母 parent(s)i"i 亲丿曲/近亲 family member

18、/next-of-kin法律授权的代表(法庭指定)legally authorized represeniaiive (court- appointed)注意：被试应该有充足的时间与亲属或医生商量。如果给予被试确定是否参与的时间少于12小时，请在协 议小结的被试徵募部分说明原因。note: subjects should be given sufficient time to consult with family members or their physician. if less than 12 hours is available in which to consider partic

19、ipation explain why in the recruitment section of the protocol summary.被试知悄同恿书收集者consent to be obtained by:有执照的医生(研究涉及药物/医疗设备)licensed physician investigator (studies involving drugs/devices) 其他，请在协议小结中说明other, explain in protocol summary5e.被试参加的时间长度 duration of subjects participation: 参与实验时 |hj (根据

20、研尤协议)active participation (as defined by protocol)：| 追踪h寸间 (长时程追踪) followp (long-term followup)：5h研究的关键词（列岀所研究的医学状态，疾病或生理状态）study keywords （provide keywords for5f报酬(在相应项冃上划钩)remuneration: (check all that apply)无no 有yes如果有，填写以下项目 if yes, complete below:现金cash停车费parkingi1 交通费 transportation ll 购物券 vouchers数额 amount: 数额 amount: 数额 amount: 数额 amount:1 其他，请解释 other, explain:5g-研究类型(在相应项 u 上划钩)study type: (check all that apply) 基础研究 basic research 诊断 diagnostic口 其他，请解释 0ther, explain:51约物：提供研究中用到的完整的药物/生物制剂列表，包括探索性的和经过fda认证的。右汗面列出经过 fda认证的，在研究中用于辅助性处理的药物，如乙酰甲胆碱耐受性测试，