数据管理 & 安全

活动项目

A human subjects research project is considered "active" from the time IRB approval is issued until the time personal identifiers linked to the research data no longer exist 和 the project is closed. Records for active IRB-approved research projects must be stored in some form (paper 和/or digital form) in secure locations on campus. 在校外进行的研究, the data should be secured 和 returned to campus as soon after collection as it is practical. Particular care should be taken to protect data on laptop computers, 外部硬盘驱动器和其他便携式设备. Study information containing personal identifiers stored on these devices should be encrypted to prevent unintentional breaches of confidentiality in the event the storage device is lost or stolen. 类似的, 确定研究参与者的书面记录, 包括同意表格, should be kept in a secure location with access restricted to key study personnel.

 

存储的基本级别

The level of protection for the data should be commensurate with the sensitivity of the data.

  • 纸质记录

    Paper files related to human subjects' participation in research must be securely stored on campus. Access to files should be restricted to key personnel 和 supervised by the principal investigator(s) of the study. Locked file cabinets ought to be used 和 preferably located in secured locations (i.e.，上锁的办公室或实验室). In the event that research activities are not carried on campus AND it is necessary to maintain the consent forms at the research site, copies of the signed consent form should also be stored in a secure University location (either as a paper copy or in digital form).

    Signed informed consents must not be used as the identifying link to the research data 和 must NOT contain participant ID numbers or be filed with other research data files.

  • 数字记录

    Digital files containing human subjects data must be stored in password protected files, 最好是在大学维护的服务器上(例如.g.， REDCap, One Drive)，定期和安全备份. Sensitive data should also be encrypted, stored, 和 securely erased when appropriate.

    Tapes 和 other media-supporting devices used for audio 和/or video recordings should be stored in the same secure manner as paper records 和 erased as soon as information has been transcribed or coded 和 is no longer needed for research.

关闭和保留

Approved human subject research projects should be closed at the time all data have been collected 和 identifying information is no longer needed. De-identified data for which no identifying key exists can be kept for further analysis 和 do not require continuing review 和 approval by an IRB.

A project closure report should be submitted to the IRB once data are no longer identifiable.

符合45 CFR 46.115(b) requires that all records relating to IRB-approved research be retained for three years after the closure of the project.

Records to be maintained include: copies of all research proposals reviewed, 科学评价(如有), 同意文件, 进度报告, 研究对象受伤和其他意外问题的报告. Electronic copies of correspondence between the IRB 和 the investigator(s) is preserved 和 stored in the IRBNet system 和 any other electronic records of a research project in hard copy, 电子或其他媒体形式, 是否必须保存以供审核使用. Records for the completed project should be stored in secure locations on campus with the same care used when the project was active.

如果是研究员(教员), 员工或学生)离开威尼斯人娱乐城, 研究记录的副本必须留在学校. Students should coordinate the storage of research records with their faculty sponsor 和/or department/college. In the event that the faculty sponsor or department/college are unable to retain the records, 他们应该被送到大学档案馆安全保管. Records sent to archives will be recalled only in the event of an audit requirement 和 will be destroyed at the end of the three-year retention period.

销毁记录

Destruction of human subjects research records should be performed in a fashion that protects the confidentiality of the research subjects. 建议将纸质记录撕碎, that physical tapes (audio 和 video) be erased 和 physically destroyed, 和 that electronic media used to store data be scrubbed after the fields are deleted.

Researchers may retain de-identified data for future analysis in the context of the project for which the data were collected. Data are considered to be completely de-identified when ALL links between individual identity 和 the data are destroyed. Research data are not considered de-identified simply because names have been removed if they still contain information that might identify the participants such as date of birth, address, 等.

威尼斯人娱乐城

For further guidance, please contact the 办公室 科研诚信 & 教育电话:303-871-2121或通过 IRBAdmin@bjtxtl.com.