[FAQ on Project Withdrawal/Closure/Termination] If a Project Is Not Implemented for Any Reason, an Application for Project Withdrawal Shall Be Submitted Before the Approved Project Implementation Start Date. Please Submit an Application for Project Closure if the Implementation Period Approved by the Committee Has Expired.
Description: When new projects are submitted for ethics review, if the principal investigator encounters any of the following situations—such as not continuing the review during the review process for any reason, not implementing a new project after it passes review for any reasons, or terminating a new project that has passed review due to difficulties during the research implementation process—the principal investigator shall submit a report to the Committee based on the implementation status.
If a project has passed the research ethics review and the Committee is notified that the project was not implemented for any reason after the project implementation start date approved by the Committee, the principal investigator must still apply for [Closure] or [Termination]. The Committee will not accept applications for [Withdrawal] of the project.
說明:新案送倫理審查過程中,計畫主持人若遇下列情形,包含審查仍在進行中卻因故不續審、新案審查通過但因故不執行計畫,或新案審查通過,但研究執行中途因遭遇困難而須提出終止,請應依其執行狀況向本會送繳報告。
撤案:
針對已提出研究倫理審查申請之新案,若審查程序仍在進行中,因故不繼續送審,請向本會提出撤案申請。[屬尚未通過倫理審查即需要撤案者]
針對已通過研究倫理審查之新案,在未超過本會核准之計畫執行起日前,因故無法執行計畫,請向本會提出撤案申請。
[屬本會核可之計畫執行起日前(尚未開始執行計畫期間)即需撤案者]
終止:已通過研究倫理審查之新案,若於本會核可之執行起迄期間,因故不繼續執行,請向本會提出終止申請。[屬本會核可之計畫執行期限到期前(已經開始執行計畫期間),因故須終止者]
結案:針對已通過研究倫理審查之新案,若已超過本會核可之計畫執行期程,不論是否有實際執行計畫,仍應向本會提交結案報告,以告知計畫執行情形。[計畫核可執行期程到期後請辦理結案,如為多年期計畫請繳交持續報告]
若計畫已通過研究倫理審查、超過本會核可之計畫執行起日,才通知本會因故沒有執行計畫,仍須請計畫主持人採[結案]或[終止]之申請程序辦理,本會無法以[撤案]方式受理。。
(依據本會SOP-29撤案及終止審查程序V04.1版)