2022 News

The IRB Office updated numerous protocol templates and Liberty (“Libby”) Stouffer and Mila DeMarte, IRB Analysts, joined the Biomedical Team this month. The IRB Bulletin is sent monthly via the IRB listserv and IRB News & Announcements webpage.

The IRB Office has updated its Ongoing HRPP Evaluations (HRP-061). We are pleased to share the following IRB Office staff announcement: Christina Spicer has joined the team as IRB Reliance Analyst.

As a part of the Northwestern University IRB Office’s initiative to share timely resources and information with the research community, we are excited to welcome you to the new IRB Bulletin! The IRB Bulletin is released at the beginning of each month and contains relevant updates from the IRB office. The IRB Bulletin is sent via the IRB listserv and also posted monthly on the IRB News & Announcements webpage. Please keep reading for this month’s updates.

New IRB Office Guidance on Suicidality in Human Research Protocols (HRP-1915) was published this month, as well as substantial changes made to the Human Research Determination Form (HRP-503). Additionally, updates were made to the Supplemental Consent Language (HRP-1722), and Informed Consent and HIPAA Pages.

We are pleased to announce the following IRB Office staff announcement: Andres Gascon has joined the IRB Office as an Associate IRB Analyst.

The IRB Office has updated the COVID-19 Pre-Screener for pre-screening human research participants and any individual who must accompany the participant before they come on campus for in-person research study visits. Researchers who are not conducting study visits at a clinical facility may use this pre-screening tool when necessary. Researchers conducting study visits at a clinical facility should use the hospital/clinic’s screening protocol.

A new Biomedical Consent Form was published this month, in addition to other documents.

We are pleased to announce the following IRB Office staff announcements: Yasmeen Khan as IRB Compliance Analyst, Compliance and Education Team; John Munoz as IRB Analyst, Biomedical Team; Monica Kane as IRB Reliance Analyst Lead, Reliance Team; and Edeth Engel as Senior IRB Analyst, Social and Behavioral Team.

We are excited to announce the following IRB Office staff announcements: Elizabeth (Liz) Barajas as IRB Analyst, Biomedical Team, Alec Henderson as IRB Compliance Manager, Compliance and Education Team, and Lucas Sikorski as IRB Manager, Biomedical Team.

The Incident Assessment Tool is a new IRB Office guidance tool that assists the Principal Investigator in determining if an incident that occurs meets the IRB reporting criteria and how to robustly document the incident and any corrective/preventive measures.

The IRB Office updated Standard Operating Procedures (SOPs).

We are pleased to announce the following IRB Office staff announcements: Angela May Baumgartner as Lead IRB Compliance Analyst, Compliance and Education Team; Katie Wright as IRB Analyst, Social and Behavioral Team; and Candy Melara as IRB Analyst, Biomedical Team.

Research Document Retention Requirements for Principal Investigators (HRP-1914) was published this month.

Guidance for Determining Engagement in Human Research at Northwestern University and Affiliated Institutions and Use of Northwestern University IRB Services Policies were published this month.

We are pleased to announce that Nazneen Ali will assume the role of HRPP (Human Research Protection Program) Education and Communication Specialist, a new position within Northwestern University's IRB Office. 

We are pleased to announce that Marcella Cooks will assume the role of IRB Reliance Manager, which is a new leadership position within Northwestern University’s IRB Office. 

After a 3-month long nationwide search with a diverse candidate slate of high-caliber applicants, we are pleased to announce that effective Monday March 14th, 2022 that Lisa Linn will assume the inaugural role of Associate Director, IRB Operations for Northwestern University’s IRB Office.

After a 3-month long nationwide search and with a diverse candidate slate of high-caliber applicants, we are pleased to announce that Piper Hawkins-Green will assume the inaugural role of Associate Director, IRB Compliance and Reliance for Northwestern University’s IRB Office.

Post-Approval Monitoring Checklists were updated in February 2022 and a new Minors Acting as Research Study Team Members Policy is now available.

COVID-19 Resources and various other documents were updated in January 2022.

Researchers proposing to list COVID-19 vaccination and/or testing as part of eligibility criteria must provide scientific justification in order to add this requirement to any research study.

The IRB Office updated the COVID-19 Pre-Screener.