2019 News

The Compliance Unit of the Northwestern Institutional Review Board (IRB) has made significant changes to the post approval monitoring checklists. Changes include the revision of current checklists and the release of three new supplemental checklists. MORE

As a requirement of conducting human subjects research, the Northwestern University IRB requires all individuals to complete human subjects protection training and to re-certify every 3 years. In an effort to improve compliance with training requirements, we are implementing a change to “study team member” only personnel changes that receive automatic approval upon submission. MORE

The social behavioral protocol template for new studies (HRP-583) has been revised and the revised version is now posted on the IRB website. This revised version of the protocol for new social behavioral studies does NOT need to be used for studies that have already been reviewed by the IRB and for studies currently in the IRB review process. MORE

To encourage best practices, the Northwestern University Institutional Review Board (IRB) has created a variety of study support resources and templates to provide investigators with the resources needed to conduct human participant research. The tools were created to support investigators and their study teams in properly organizing paper or electronically maintained regulatory documentation and research data. MORE

The Social-Behavioral consent template (HRP-582) has been significantly revised to better fit social-behavioral research. The revised version of HRP-582 contains instructions at the end on how to modify the final portion of the consent to fit verbal or online consent. MORE

The IRB has new guidance on when a study may be closed (that is, no longer requires IRB oversight). Although many minimal risk studies no longer require continuing review (unless the study is FDA-regulated), all non-exempt human research studies must still be closed in the eIRB+ system when they no longer require IRB oversight. MORE

The IRB office has significantly revised HRP-1704, the protocol template for analysis of data and/or specimens, to make the template more user-friendly and collect more of the information that the IRB needs to process these types of studies efficiently. MORE

The following documents have been updated: Per AAHRPP reaccreditation: - HRP-001 – SOP – Definitions - HRP-060 – SOP – Annual HRPP Evaluations MORE

The following templates have been updated: - HRP-593 Biomedical Protocol Template - HRP-508 Local Protocol Addendum Template - HRP-592 Biomedical Consent Document MORE

The Human Research Determination Form (HRP-503) has been updated per the revised Common Rule. MORE

The post approval monitoring (PAM) checklists have been updated. Updates include: Addition of HRP-427 – PAM Checklist – Clinical Trial MORE

As of January 21st, 2019, the revised Common Rule has taken effect. The changes to the regulations do not require immediate researcher action ––researchers should continue to follow their IRB approved protocols and the determinations made by the IRB as communicated in the determinations letters (i.e. related to submitting CRs, Mods, and RNIs), etc. MORE

Revised Memo re: New requirements for identifying funding source for IRB studies in eIRB+ What is changing? Effective January 19, 2019, the funding page in the eIRB+ application has been updated to require the submission preparer to select the InfoEd number (e.g., SP0054321) that corresponds to the grant or contract funding sponsored IRB studies. There will be no change to non-sponsored, or internally-funded studies. MORE

HRP-052 – SOP Post-Review has been updated. Section 5.2 in Procedures was updated to add, “If a study is closed to enrollment, the consent form will not be stamped at the time of continuing review unless determined by the IRB Analyst that it is necessary”. MORE

The IRB Office recently updated all public HRP documents in an effort remain compliant with the current regulations and to add new documents providing guidance to the research community. MORE