IRB: Collaborative and External Studies

Collaborative studies are those in which each of the institutions involved are significantly engaged in the 研究, usually by means of local investigators carrying out 研究 活动 at each 研究 site. If the 研究 does not entail employees of external institutions collecting data from participants, obtaining informed consent, or being involved as members of the 研究 team, then the work is probably not a collaborative 研究. Likewise, if 菠菜网lol正规平台 研究 personnel will be asking employees at other institutions to pass along recruitment information to prospective participants this, al一个, does not constitute a collaborative 研究.

For collaborations that involve both 菠菜网lol正规平台 investigators and external investigators, different approaches may be used to obtain approval depending on how the 研究 将进行. Either each investigator can independently obtain approval from their respective IRBs or 一个 institution can agree to be the reviewing IRB; a reliance agreement is established in the latter case.

In addition to the expectations outlined below for various circumstances, you may also need to obtain ancillary agreements depending on the type of data or materials 机构间共享. Agreements such as Data Use Agreements (DUAs) and Material Transfer Agreements (MTAs) are handled by the 上海外国语大学研究基金. The IRB office may direct you to the 研究基金会 when applicable, though an IRB reliance agreement process between intuitions can be pursued separately from any additional agreements that may be required.

菠菜网lol正规平台 Investigators with External IRB Approval 

The 菠菜网lol正规平台 IRB accepts IRB approvals from outside institutions that have an active 联邦保险(FWA) so long as the reviewing IRB is willing to engage in a reliance agreement.  我们参与 in reliance agreements for all review types, including administrative reviews of exempt 研究. 

IRB Mentor User Guide for 菠菜网lol正规平台 Investigators Relying on an External IRB Approval (required 阅读)[pdf]
Follow the instructions and steps outlined in this document for registering your external IRB approval within our online submission system (IRB Mentor) to allow the 菠菜网lol正规平台 IRB Office to initiate a reliance agreement with the reviewing IRB. 的链接 IRB Mentor website, visit our 提交页面.

所需文件

Most of these elements will be required within the IRB Mentor system and you will not be able to submit your request until you provide the required information. If we receive initial communication from an external IRB, it is still your responsibility to provide the information outlined below via the IRB Mentor system. 

  1. The name, title, and contact details of the reviewing IRB.
  2. The name, title, contact details of the signatory official for the reviewing institution.
  3.  The FWA number of the reviewing IRB.
  4. The tracking number assigned to the protocol by the reviewing IRB.
  5. A 研究 approval letter from the reviewing IRB. If the external IRB is not willing to approve a protocol until a reliance agreement is established, you are responsible for submitting all other documents except for the approval notification.
  6. The IRB application, outlining the methods and procedures of the 研究, which lists you as part of the 研究 personnel.
  7. Consent documents, if applicable.
  8. Data instruments, if applicable.
  9. Any site-specific forms required by the reviewing IRB and/or the reliance agreement form that the external IRB wishes to use. The reliance agreement form is typically referred to as an Institutional Authorization Agreement (IAA). 如果审查IRB does not supply a form, we will provide our own.
  10.  Be prepared to explain how 菠菜网lol正规平台 is involved in the 研究, whether subjects will be recruited on campus (if so, provide the recruitment materials), whether data will be collected on campus, and what kind of information will be shared with external 团队成员.

确认通知

The 菠菜网lol正规平台 IRB Office will contact the reviewing IRB to establish a reliance agreement once we receive your submission. You will receive an email that you may begin the 研究 only after a reliance agreement is established. The timeframe for the confirmation will depend on whether the external IRB is willing to serve as the IRB of record and how quickly they can provide the signed agreement. We recommend that you contact the reviewing IRB ahead of time to confirm their cooperation and to determine a timeline for the signing of the reliance agreement. If we are unable to establish a reliance agreement, the 菠菜网lol正规平台 IRB will conduct its own review and you will be asked to provide a complete 菠菜网lol正规平台 application via the IRB Mentor system.

菠菜网lol正规平台 IRB Approved Studies with External Personnel

菠菜网lol正规平台 investigators may list external personnel in their applications. 然而, 菠菜网lol正规平台 IRB does not assume responsibility for the compliance of external personnel. Instead, external personnel should contact their IRB, either to coordinate a reliance agreement with the 菠菜网lol正规平台 IRB as the IRB of record or to have their IRB conduct a separate 审查他们的活动. External personnel who do not have the support of an external IRB and have not established a contract with 菠菜网lol正规平台 should not receive access to individually identifying information about subjects.  菠菜网lol正规平台 investigators are encouraged to be judicious about who they add as part of the 研究 personnel, as responsibility for compliance rests with the 菠菜网lol正规平台 PI in the event that external personal do not have 外部审计委员会的支持.

International Research Involving Human Subjects

菠菜网lol正规平台 IRB没有 recognize informal agreements between 菠菜网lol正规平台 investigators and 国际合作者. The IRB does not have the authority to grant permission to conduct 研究 that relies on the support of non-US institutions or personnel to access human subjects or their identifying information unless a formal arrangement 已经就位了.  菠菜网lol正规平台 investigators may either elect to only receive de-identified data from 国际合作者 (thus eliminating the involvement of human subjects in the 活动 of 菠菜网lol正规平台 affiliates) or they must pursue a formal agreement via the CSU Chancellor's Office if they wish to rely on international institutional support for access to subjects or their identifying information. 联系 合规办公室 for information on pursuing a CSU-level agreement.

For international 研究 where local institutional support is not needed, 菠菜网lol正规平台 investigators are responsible for determining what kinds of permissions are needed from the country where the human subjects 研究 将进行 and for providing documentation to the IRB that the local requirements have been fulfilled. 权限可能包括 (but are not limited to) formal applications via the country’s embassy or regulatory authority, a local ethics review, as well as the fulfillment of all applicable local 隐私法.

In addition, investigators traveling abroad should review the information and expectations regarding international travel provided on the 合规办公室网站.

External Investigators Conducting Non-Collaborative Studies at 菠菜网lol正规平台

Non-菠菜网lol正规平台 investigators who wish to conduct human subjects 研究 at San Jose State University should seek IRB approval from their home institution, and be prepared to provide evidence of IRB approval to any一个 who requests it. 菠菜网lol正规平台 IRB没有 provide review services or evaluate 研究 projects conducted by external investigators. The 菠菜网lol正规平台 IRB will not provide you with an acknowledgment regarding your 研究, and we will not take responsibility for or provide institutional support for your 研究 活动.

Campus departments and staff are not obligated to assist you with your 研究 活动, including the recruitment of subjects or the release of student directory information. Cooperation by the campus community is strictly voluntary. IRB办公室不会 assist you with recruitment, the acquisition of secondary data, or referrals to 菠菜网lol正规平台 人事或办公室. Voluntary cooperation by 菠菜网lol正规平台 personnel does not mean that 菠菜网lol正规平台 支持你的研究.