华南师范大学脑成像中心人类被试研究申请书V10.doc

华南师范大学脑成像中心人类被试研究申请书V1.0SCNU-BIC HUMAN SUBJECTS RESEARCH APPLICATION FORM1. 研究总负责人PRINCIPAL INVESTIGATOR姓名，职称Name: First Name, Middle Initial, Last Name, Degree(s)单位Institution: 华南师范大学 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. 课题题目PROJECT TITLE声明CERTIFICATIONS作为该研究负责人，我声明如下As Principal Investigator, I certify the followings: 我已经审阅过该协议并知道我将参与该研究I have reviewed this protocol and acknowledged my participation. 我已阅读并熟知华南师范大学脑成像中心涉及该研究的相关规章制度I have read and familiared with the SCNU-BIC Assurance governing this research. 我已经完成华南师大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 SCNU-BIC. 我已经完成了进行该研究需要的相应培训 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(Sign & date above)我/我们在下面签名，以表明我/我们同意遵守与保护被试相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 requirements.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)这些文件含有在华南师范大学脑成像中心开展研究的研究者或其资助者的机密和专有的信息。这些文件的传播必须符合华南师范大学脑成像中心的相应规定，外传须得到华南师范大学脑成像中心的许可。These documents contain information that is confidential and proprietary to the participating SCNU-BIC or the study sponsor. Its distribution is restricted in accordance with SCNU-BIC policy and approval by the SCNU-BIC is required for outside distribution.3. 合作者/参与研究人员资料CO-INVESTIGATORS/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 all co-investigators and staff participating in the below about the conduct of this study. Attach individual-specific co-investigator/study staff information pages with participating individuals signature.姓名，职称NAME (First, Middle Initial, Last, Degree(s)单位INSTITUTION4. 协议信息PROTOCOL INFORMATION4A. 被试数目NUMBER OF SUBJECTS:在华南师范大学脑成像中心测试的被试数Target enrollment at SCNU-BIC (#): 整个实验测试的被试数Target enrollment study-wide (#): (国内/国际NATIONAL/INTERNATIONAL)被试将在这些地方招募Subjects will be enrolled at these sites: 华南师范大学SCNU 其他，请说明Other, specify: 4B. 被试类型（在相应项目上划钩）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/Infants 健康自愿者Healthy Volunteers 65岁（含）以上Adults (65+) 儿童（2-12岁）Children (2-12) 判断力受损者，如精神状态不正常，脑损伤等等Decisionally Impaired, e.g., mental abnormal state, brain injury, etc. 青少年（13-18岁）Adolescents (13-18) 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 Women 其他，请说明Other, specify: 4C. 被试来源（在相应项目上划钩）SOURCE OF SUBJECTS: (check all that apply) 基层护理医生/专科医生Primary Physician/Physician Specialist 报纸/电台/电视广告Newspaper/Radio/Television Advertising 急救室Emergency Room 学校内张贴Postings within School(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Census/Public Records/Commercial Mail Lists 因特网站Internet Sites 医疗记录/病人数据库Medical Records/Patient Databases 其他，在协议小结中解释Other, 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 approval. 4D. 被试知情同意书手续（在相应项目上划钩）CONSENT PROCEDURES: (check all 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小时来决定是否参与（见下面的说明）Subjects will have less than 12 hours to decide whether or not to participate (see note below)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 participation, explain why in the recruitment section of the protocol summary. 被试知情同意书来自Consent to be Obtained From:被试知情同意书收集者Consent to be Obtained by: 被试Subject 有执照的医生（研究涉及药物/医疗设备）Licensed Physician Investigator (studies involving drugs/devices) 父母Parent(s) 亲属/近亲Family Member/Next-of-Kin 其他，请在协议小结中说明Other, explain in protocol summary 法律授权的代表（法庭指定）Legally Authorized Representative (court-appointed)4E. 被试参加的时间长度DURATION OF SUBJECTS PARTICIPATION:参与实验时间（根据研究协议）Active Participation (as defined by protocol): 追踪时间（长时程追踪）Follow-up (long-term follow-up): 4F. 报酬（在相应项目上划钩）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数额Amount: 其他，请解释Others, explain: 停车费Parking数额Amount: 交通费Transportation数额Amount: 购物券Vouchers数额Amount:4G. 研究类型（在相应项目上划钩）STUDY TYPE: (check all that apply) 基础研究Basic Research 诊断Diagnostic 其他，请解释Other, explain: 4H. 研究的关键词（列出所研究的医学状态，疾病或生理状态）STUDY KEYWORDS (provide keywords for medical condition, disease/physiologic state being studied)4I. 药物：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。在下面列出经过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，用于研究相关的组织活体切片的利多卡因。DRUGS: Complete Drugs/Biologics Form for all investigational and FDA-approved drugs/biologics being tested or studied. List FDA-approved drugs in the below used for research-related ancillary/supportive care. For example, methacholine challenge tests, lidocaine for research-related biopsies, etc.4J. 病历/问卷/仪器（在相应项目上划钩）SUBJECT DIARIES/QUESTIONNAIRES/INSTRUMENTS: (check all that apply) 被试病历（例如症状，用药等等）Subject Diaries (e.g., symptoms, meds, etc.)病历号No. of diaries: 附上副本Include copies with submission 问卷/心理仪器Questionnaires/Psychological Instruments仪器号No. of instruments: 4K. 出于研究目的使用的下列设备 RESEARCH-RELATED USE OF ANY OF THE FOLLOWING 否NO 是YES高压注射器 hyperbaric injection 否NO 是YES刺激系统 （Stimulation System） 否NO 是YES 否NO 是YES 否NO 是YES 否NO 是YES 否NO 是YES 否NO 是YES5. 研究负责人的保证书 (Certification of Principal Investigator):本人声明所填写内容属实，并将严格按照申请书中有关内容从事实验和研究。严格遵守国家法律和中心有关规定，同时保护受试人的健康、权益和隐私。本人有责任将实验中出现的问题如实向中心汇报，并按照中心学术委员会的要求改正。My signature below certifies that the research described in this application and supporting materials will be conducted in full compliance with government regulations and MRI brain imaging centers policies, especially those governing human subject researches. I will promptly report any unanticipated problems or adverse events and make prompt corrections upon the recommendations of the scientific committee._ _研究负责人签名Signature of Principal Investigator (PI)日期Date8. 伦理与人体保护委员会意见及保证书Opinion and Certification of Institutional Review Board (IRB):以下为伦理与人体保护学术委员会评审专家意见（Opinion of the IRB）：对该研究申请人主持此人体研究工作的意见 (Opinion of the competency of the investigator(s) to conduct human subjects studies)：同意 Agree 不同意 Disagree 以下签名确认本委员会已经考察了研究申请课题的科研价值及人体保护相关的权益，并同意该研究申请人进行与人体相关的研究工作。 My signature below certifies that I have reviewed this research protocol and human subjects protection assurance that I attest to the scientific merit of this study and the competency of the investigator(s) to conduct human subjects studies._ _伦理与人体保护委员会主任签名Signature of Chair of the IRB 日期 Date8. 中心批准APPROVAL OF THE IMAGE CENTER:以下签名确认中心已经审核了研究申请人申请书并批准进行与人体相关的研究工作。My signature below certifies that I have reviewed this research protocol and that I approve the investigator(s) to conduct human subject studies._ _（中心盖章）脑成像中心负责人签字Signature of the Director 日期 Date合作者/参与研究人员（每个人员各填写一份）协议号：CO-INVESTIGATORS/STUDY STAFF PROTOCOL#: (Copy and complete for each study staff members). 姓名，职称Name: First Name, Middle Initial, Last Name, Degree(s)单位Institution: 华南师范大学 其他，请写明Other, specify 在项目中身份Indicate role on project: 合作者Co-Investigator 数据管理者Data Manager 协调者Research Coordinator 其他，请写明Other, specify: 系/室Dept