培训

All persons engaged in 人类被试 研究 at USA must complete adequate 培训 before becoming involved in either a new or existing study. 这适用于任何人 directly responsible for study management, data collection, data analysis, the consenting process, transcription, participant recruitment (or follow-up), etc. 美国IRB要求 根据您的职责,培训内容如下:

需要培训

  1. 所有学生都必须完成 受试者保护 为IRB提交而进行的培训. 的 合作院校培训计划 (CITI) online platform is utilized to meet this requirement. 这个培训不是 到期.

    For instructions on how to access and complete this 培训, click here. If you have completed an equivalent CITI module at a previous institution, this certificate 在美国就足够了.
    Note: If you have an existing CITI account but have not completed this particular 培训, please reference the above guidance document and begin at Step 5. 你可能 need to add an affiliation with USA if your account originated at an outside institution.

  2. Protected health information (PHI) obtained/maintained within a 美国健康 Systems Covered Entity must comply with HIPAA privacy and security 培训 requirements. USA Covered Entities include USA Hospitals, USA Physician’s Group Clinics, Mitchell Cancer Institute, the Speech Pathology and Audiology Clinic, Physical 的rapy Clinic 及心理诊所.

    Any student accessing, recording or maintaining protected health information (PHI) within one of these HIPAA Covered Entities for 研究 purposes must complete 美国HIPAA研究 培训. This 培训 can also be located in the USA IRB Documents for 研究ers IRBNet表单和模板中的库. 此培训不会过期.

    HIPAA PHI标识符的完整列表.

  1. 所有DNP学生都必须完成 受试者保护 为IRB提交而进行的培训. 的 合作院校培训计划 (CITI) online platform is utilized to meet this requirement. 这个培训不是 到期.
    For instructions on how to access and complete this 培训, click here.

  2. 所有DNP学生都必须完成 美国HIPAA研究 培训. This 培训 can also be located in the USA IRB Documents for 研究ers IRBNet表单和模板中的库. 此培训不会过期.
  1. 所有与人类受试者接触的人员(例如.g.,获得同意,与…互动 参与者等.)填写 受试者保护 为IRB提交而进行的培训. 的 合作院校培训计划 (CITI) online platform is utilized to meet this requirement. 这个培训不是 到期.

    For instructions on how to access and complete this 培训, click here. If you have completed an equivalent CITI module at a previous institution, this 在美国有证书就足够了.

    Note: If you have an existing CITI account but have not completed this particular 培训, please reference the above guidance document and begin at Step 5. 你可能 need to add an affiliation with USA if your account originated at an outside institution.

  2. Protected health information (PHI) obtained/maintained within a 美国健康 Systems Covered Entity must comply with HIPAA privacy and security 培训 requirements. USA Covered Entities include USA Hospitals, USA Physician’s Group Clinics, Mitchell Cancer Institute, the Speech Pathology and Audiology Clinic, Physical 的rapy Clinic 及心理诊所.

    Any personnel accessing, recording or maintaining protected health information (PHI) within one of these HIPAA Covered Entities for 研究 purposes must complete 美国HIPAA研究 培训. This 培训 can also be located in the USA IRB Documents for 研究ers IRBNet表单和模板中的库. 此培训不会过期.

    A HIPAA PHI标识符的完整列表 可以在这里看到.
  1. 所有与人类受试者接触的人员(例如.g.,获得同意,与…互动 参与者等.)填写 受试者保护 为IRB提交而进行的培训. 的 合作院校培训计划 (CITI) online platform is utilized to meet this requirement. 这个培训不是 到期.

    For instructions on how to access and complete this 培训, click here. If you have completed an equivalent CITI module at a previous institution, this 在美国有证书就足够了.

    Note: If you have an existing CITI account but have not completed this particular 培训, please reference the above guidance document and begin at Step 5. 你可能 need to add an affiliation with USA if your account originated at an outside institution.

  2. Protected health information (PHI) obtained/maintained within a 美国健康 Systems Covered Entity must comply with HIPAA privacy and security 培训 requirements. USA Covered Entities include USA Hospitals, USA Physician’s Group Clinics, Mitchell Cancer Institute, the Speech Pathology and Audiology Clinic, Physical 的rapy Clinic 及心理诊所.

    Any personnel accessing, recording or maintaining protected health information (PHI) within one of these HIPAA Covered Entities for 研究 purposes must complete 美国HIPAA研究 培训. This 培训 can also be located in the USA IRB Documents for 研究ers IRBNet表单和模板中的库. 此培训不会过期.

    A HIPAA PHI标识符的完整列表 可以在这里看到.

  3. 良好临床操作规范 (GCP) 培训 is required for all NIH-funded investigations/staff involved in the conduct, oversight, or management of clinical trials. FDA要求符合GCP for studies conducted under an investigational new drug application or investigational 设备免税.

    可接受的GCP在线课程包括:
  4. All study personnel responsible for the transport or shipping of biospecimens/biohazards 必须完成CITI Shipping and Transport of Regulated Biological Materials 培训. 要访问此培训,请点击这里.

    本培训有效期为2年.

    If you have completed an equivalent module from a reputable source, this will suffice 用于美国IRB目的. Please note that if no expiration date is listed on the current certificate one will be given in order to ensure annual 培训.

  5. 临床研究基础方向 sessions are periodically scheduled to provide instruction on the basic fundamentals 临床试验管理. 的se sessions are designed for the novice clinical 研究 coordinator and affiliated key 研究 personnel involved in the coordination 监督临床研究活动.

All unaffiliated personnel are required to provide proof of 受试者保护 他们所在机构的培训. 可能需要额外的培训,这取决于 正在进行的研究类型.

请参阅 研究、教育和学习矩阵 for additional information regarding 培训 that may be required according to your 研究领域和/或研究类型.

 

额外的培训和资源

研究合规办公室 & Assurance提供面对面和虚拟培训, lectures, demonstrations and educational sessions for faculty and students.

For information on educational sessions or classroom lectures conducted by the IRB Administrative Office, please contact Dusty Layton, Director of 研究 Compliance 及保证 dlayton@hzjly.net or 251-460-6625. 

For information on IRBNet presentations or demonstrations, please contact the IRB 管理员在 irb@hzjly.net or 251-460-6308.