An IRB Authorization Agreement (IAA) is a special agreement between two institutions who are engaged in human subjects research to establish the IRB with primary oversight. An IAA allows an institution with a Federalwide Assurance (FWA) to extend the applicability of its FWA to cover research activities at another Institution. In practice, this means Montclair’s IRB will be the IRB of Record which reviews the study. IAAs can be requested by entering information within your 小马IRB submission. The program outlined below provides guidance on building allowable direct costs into your project budget that should be applied to all funded research activities where a reliance agreement is needed.
生效日期:2021年6月1日
适用性:
The fee schedule and program below applies to all non-exempt human subject research wherein the proposed activities associated with serving as an single IRB (sIRB) are the responsibility of Montclair IRB.
我如何在提案中计划sIRB请求?
与OSP的工作人员一起准备研究计划, researchers are responsible for notifying the OSP team that Montclair will be involved in multi-site non-exempt human subjects research. The OSP team will create an SP event notifying the IRB office that a researcher expects to be engaged in human subjects research involving an sIRB. The consultation process may take up to 10 business days to complete. Based on the consultation the researcher and OSP will be able to integrate the sIRB fee schedule into direct costs where applicable. If a letter of support is required the IRB will need up to 10 business days from initial request of consultation on sIRB.
sIRB fee schedule* (*the fee schedule is subject to change based and will be evaluated on an annual basis):
- 加快
- 起价1100美元/个，将依靠十大博彩推荐排名
- 修改$500/年(最多包括5次修改)
- 续借500美元/两年
- 董事会全体
- 最初1600美元/个，将依靠十大博彩推荐排名
- Modification $750/yr (Includes up to 5 modifications)
- 更新500美元/年
- Fees are charged to cover a number of tasks including but not limited to:
- 协调, 管理, and liaison activities with outside institutions for reliance documentation and negotiation of reliance agreements
- the costs associated with the IRB staff time spent screening and reviewing the IRB submission and the associated site materials
- 支持委员会进行sIRB审查
- educating outside researchers on sIRB process and procedures
- education and support of researchers to enable compliance specific to multi-site research
是的!
The single IRB (sIRB) mandate is a set of complementary federal policies that require certain types of federally-funded research that involve multiple institutions to use one IRB to accomplish IRB review and approval for all of the institutions conducting the study/trial. The Single IRB Model allows multiple institutions that conduct the same protocol to cede to a single IRB for review. The NIH Single IRB Policy and 普遍的规则 Cooperative 研究 Requirement are the two policies that require the use of a Single IRB.
自2018年1月25日起生效: 所有竞争NIH拨款申请(新, 更新, revision or re-submission) for multi-site studies with NIH receipt dates on or after January 25, 2018 must include a plan describing the use of a sIRB for the study.
Applies to: Domestic sites of NIH funded studies where each site will conduct the same protocol involving non-exempt human subjects research, 是否获资助, cooperative agreements contracts or the NIH Intramural 研究 Program.
- Exceptions: VA sites; international sites; sites involving tribal nations.
Effective January 20, 2020: Projects sponsored by signatories of the revised 普遍的规则, involving multiple research locations conducting human subjects research, IRB批准日期在1月20日或之后, 2020, 必须使用sIRB吗. This is mandated by the Cooperative 研究 provision which expands upon and supersedes the NIH’s Single IRB policy.
- Applies to: All sites in the United States participating in a federally funded cooperative research study (involves more than one site).
- Exceptions: Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or 研究 for which any Federal department of agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate.
No, at this time fees will only apply to projects initiating a reliance agreement plan after the effective date of 6/1/2021.
是的, at this time fees will only apply to projects where this cost is allowable by the funding agency and the project is initiating a reliance agreement plan after the effective date of 6/1/2021. 请发邮件至reviewboard@montclair.Edu确认豁免适用.