Human Research Protection Program Policy and Guidance
- Section 1: Mass General Brigham Human Research Protection Program Plan
- 第2节:机构审查委员会(IRB)治理和操作程序
- Section 3: Human-Subjects Research
- Section 4: Investigator and Study Staff Responsibilities, Training, and Documentation (Recordkeeping)
PI职责委托
也可以看看,QI计划人员签名/责任日志委托Human-Subjects Protection Education and Training Requirements for Investigators and Study Staff
Required GCP Training: New NIH Policy (effective 1/17/17 Memo # 2)
说明添加花旗GCP花旗集团有限公司urse List
也可以看看,Human Research Committee (HRC) Webpage, Education & Training (CITI Program - Internal Navigator Link)非英国妇女医院(BWH)/非马萨诸塞州综合医院(MGH)员工担任共同研究人员/学习人员
也可以看看,多站点研究者发起的合作研究Electronic Storage of Research Documents
Qi计划研究清单,研究日志,注释案例报告表格,工具和指导文件
PI Leave of Absence, Sabbatical, or Moving to Another Institution
- 第5节:利益冲突
- Section 6: Review of Human-Subjects Research Activities
Expedited Review (Initial, Continuing and Amendment)
HRC批准的持续审查和到期
也可以看看,QI Program, Study Close Out GuidanceProposed Changes in Approved Human-Subjects Research and Exceptions
Noncompliance in Human-Subjects Research
Suspension or Termination of Human-Subjects Research
Reporting to Institutional Officials, Regulatory Agencies and Accrediting Organizations
Requirements for Ancillary Committee Approval of Human-Subjects Research
See Human Research Committee (HRC) Webpage,Instructions & Forms for submission requirements
- 第7节:报告意外问题(包括不良事件)
- Section 8: Drug and Biologic Research
- 第9节:设备研究
- 第10节:脆弱人群
脆弱的人群,,,,包括儿童,州的病房,不确定生存能力的不可行的新生儿和新生儿,以及孕妇和/或胎儿。
- Section 11: Informed Consent
Individuals Who Can Obtain Consent in Human Subject Research
也可以看看,NIH机密证书政策(COC)
也可以看看,QI Program Informed Consent Compliance ChecklistConsent Form Reviewer Worksheet and Checklist
事实/信息表大纲和示例
Fact/Information Sheet Outline
Sample Fact/Information Sheet (1)
Sample Fact/Information Sheet (3)
Informed Consent in Online Research
- 第12节:招聘和报酬(研究主题的付款)
Recruitment of Research Subjects
Guidelines for Advertisements for Research Subjects
与研究Participan faq:电子邮件沟通ts and Potential Research Participants
招聘期间研究对象的预筛查
也可以看看,QI Program Pre-Screening LogRemuneration for Research Subjects
Bonus Payments in Clinical Trial Agreements
- 第13节:数据和安全监控计划
- Section 14: Off-Site Research and Multi-Site Research
- 第15节:组织库和存储库
- Section 16: Genetics/Genomics
- Section 17: Sponsored Research and Agreements
- 第18节:NIH支持研究
- Section 19: Additional Guidance