w*********8
发帖数: 132 | 1 最近收到NIH program official (PO) 要新grant的Just-in-Time (JIT) 的邮件，其中
有一项是要求提供IRB approval date (如下)，这个项目有一个美国以外的合作单位
，PO的JIT邮件里要求4个工作日提供IRB approval date，请教几个问题：
1）因为以前不知道这个grant能不能中，所以没有提前申请和准备IRB approval，显然
四天之内不可能提供IRB approval date，我的外国合作者直接跟我说他们那儿只有收
到funding以后才开始申请IRB，另外，NIH邮件里提到”Pending or out-of-date
approvals are not acceptable“，像这种情况怎么办，如何向NIH解释比较合理？
2）NIH邮件里提到” If IRB has not met, provide anticipated meeting date.“，
问题是IRB还没提交，也不知道哪天是anticipated meeting date，这个能提供一个大
概的时间吗？
3）这个项目可能涉及到两个不同的IRB approval，美国这边是用de-identified
archived samples，可能是IRB exemption (under Category 4)，合作单位需要收集
samples，可能不是IRB exemption (under Category 4)，像这种情况，美国这边的IRB
approval需要考虑合作单位的情况，把它作为不是IRB exemption (under Category 4
)的来处理吗？
4）如果delay提供IRB approval date或者anticipated meeting date，会不会影响这
个grant的最后funding？
”IRB approval date (NIH does not require a copy of the IRB certification/
approval). See NOT-OD-19-055. Pending or out-of-date approvals are not
acceptable. If IRB has not met, provide anticipated meeting date. “
非常感谢！ | F***Q
发帖数: 6599 | 2
just tell NIH you don't have it at this moment, but you and your
collaborators are working on it. it won't block your grant from getting
funded, but NIH, as well as your institute's grant admin, will set an IRB-
incomplete flag - with this flag, you can't commit any expense related to
human study, until you send your IRB approval letter to the NIH (along with
the human-study certificates of all IRB-listed investigators)
ask your post award people, they should know this.
【在 w*********8 的大作中提到】
: 最近收到NIH program official (PO) 要新grant的Just-in-Time (JIT) 的邮件，其中
: 有一项是要求提供IRB approval date (如下)，这个项目有一个美国以外的合作单位
: ，PO的JIT邮件里要求4个工作日提供IRB approval date，请教几个问题：
: 1）因为以前不知道这个grant能不能中，所以没有提前申请和准备IRB approval，显然
: 四天之内不可能提供IRB approval date，我的外国合作者直接跟我说他们那儿只有收
: 到funding以后才开始申请IRB，另外，NIH邮件里提到”Pending or out-of-date
: approvals are not acceptable“，像这种情况怎么办，如何向NIH解释比较合理？
: 2）NIH邮件里提到” If IRB has not met, provide anticipated meeting date.“，
: 问题是IRB还没提交，也不知道哪天是anticipated meeting date，这个能提供一个大
: 概的时间吗？
| w*********8
发帖数: 132 | 3 非常感谢！
with
【在 F***Q 的大作中提到】
:
: just tell NIH you don't have it at this moment, but you and your
: collaborators are working on it. it won't block your grant from getting
: funded, but NIH, as well as your institute's grant admin, will set an IRB-
: incomplete flag - with this flag, you can't commit any expense related to
: human study, until you send your IRB approval letter to the NIH (along with
: the human-study certificates of all IRB-listed investigators)
: ask your post award people, they should know this.
|
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