已批准项目的修订 & 研究

The ACIRB must review and approve changes to previously approved projects or research to ensure the regulatory criteria for approval continues to be met and the risk/benefit ratio remains appropriate considering the proposed changes. 研究ers are responsible for proposing any changes for review and approval prior to implementation, except when the changes are necessary to avoid immediate hazards to subjects. 

Any change in study procedures or personnel must be submitted and approved by the ACIRB before being implemented. 研究ers notify the ACIRB of proposed changes by completing a modification submission in 小马. A modification submission opens the approved ACIRB submission for editing the application or other attachments. Exceptions to this process can only be made when there are concerns for subject safety. If there are subject safety concerns, immediately 联系ACIRB.

修改信息

Modifications may be categorized as a minor revision that involves no more than minimal risk to participants or a major revision that involves increased risk to subjects or significantly affects the design of the study. All changes to full board and expedited studies must be reviewed and approved by the ACIRB before the changes are implemented. Examples of proposed changes that require a modification submission include:

• Increased risk to subjects – a new risk is identified; serious adverse event has occurred
• Eligibility changes – inclusion or exclusion criteria is changed
• Recruitment of subjects – recruitment procedures are modified (number of subjects increased or decreased); recruitment materials are revised or new materials are used
• Scientific changes – study objectives are changed, statistical analyses are modified
• Data, 数据收集, and 数据收集 materials – Study diaries, 调查问卷, 或者对调查对象进行修改
• Editorial and administrative changes – changes made to contact information; changes to study staff; typographical revisions to recruitment materials

豁免课程, only certain changes must be reviewed and approved by the ACIRB prior to implementation:

• 所有人事变动
• 所有资金变化
• If protected health information is being collected, all changes to 数据收集 procedures
• 实质性的变化
• A change that results in the study no longer qualifying to be exempt
• Addition of participants from a vulnerable population (i.e., children, prisoners, cognitive impairment, etc.)
• Change in sensitivity level of study by adding sensitive questions or changing to identifiable 数据收集 procedures
• Addition of physical or biomedical procedures
• Addition of use of deception or incomplete disclosure
• 取消同意程序

Please note the examples provided are intended to be used for guidance only and are not all inclusive of changes that need to be approved prior to implementation. If you have questions about determining if a proposed change requires a modification submission, 联系ACIRB.

Modifications to any documents or communications (i.e., advertisements, introductory or reminder emails, 调查问卷, etc.) must include both a tracked changes and clean version as attachments to the modification submission. 

如何完成修改提交?

• 登录 小马
• On the 研究er Dashboard, select the Studies tab.
• Select the study requiring a modification submission (study must be approved before a modification submission may be completed).
• In the top right-hand corner of the Study Details page, 单击New Submission下拉菜单, 并选择修改.
• Follow the instructions in 小马 to complete the submission.

有关其他帮助，请访问 小马帮助中心 and search for “modification” to access detailed instructions.

续期或结案意见书

ACIRB approval of reviewed studies or projects is effective for one year beyond the approval date.

• If the study or project is not completed by the approval expiration date, the researcher must complete a renewal submission in 小马.
• If a study or project is completed prior to the approval expiration date, the researcher can indicate this by completing a closure submission. The ACIRB appreciates receiving closure submissions to maintain accurate record of study or project status.

If you have any questions about renewal or closure submissions, please contact the ACIRB.

How do I complete a renewal or closure submission?

• 登录 小马
• On the 研究er Dashboard, select the Studies tab.
• Select the study requiring a renewal or closure submission (study must be approved before a renewal or closure submission may be completed).
• In the top right-hand corner of the Study Details page, 单击New Submission下拉菜单, 并选择续订或关闭.
• Follow the instructions in 小马 to complete the submission.

有关其他帮助，请访问 小马帮助中心 and search for “renewal” or “closure” to access detailed instructions.