November 2023 IRB Bulletin: News from the IRB Office

ANNOUNCEMENTS

The IRB Office transitions from “cognitively impaired adults” to “adults with impaired decision-making capacity” across documents to reflect the use of people first language

The People First Movement started in the mid 1970’s as a desire by people with disabilities to be seen as a person, rather than as the disability that one has. One of the revisions to the Common Rule (45 CFR 46) in 2018 included the use of people first language. Using people first language puts the person before the disability, describing a condition that a person has, rather than describing the person as the condition. 

The change from “cognitive impairment” to “impaired decision-making” captures a broader group of potential research participants that may need additional safeguards and/or be vulnerable to coercion or undue influence (perceived or real). A person’s decision-making capacity can be impacted by a condition or substance for a permanent, fluctuating, or temporary duration, as can the severity of the impairment. For example, potential research participants who are in severe pain, intoxicated, have Down’s Syndrome, or have Alzheimer Disease may have the potential for impaired decision-making capacity such as making an informed, voluntary decision to participate in research. In general, all adults, regardless of their condition, should be presumed competent to consent to participate in research unless there is evidence of impaired capacity. Individuals with impaired decision-making capacity can participate in research when their inclusion in the study has a study-specific justification, when capacity to consent is assessed and documented, and when there are provisions for a legally authorized representative’s surrogate consent for participants who are determined to not have the capacity to consent. When a participant’s decision-making capacity may fluctuate, the protocol must include methods to monitor the participant’s capacity and re-obtain consent. The ethical principles of respect of persons and equitable selection of participants can be met by using people first language and a balance between protecting vulnerable participants and including these participants in research.

Additional Reviews from our Human Research Participant Partners

In addition to securing IRB approval for Human Research (or IRB Office approval for exempt Human Research), you may need to secure other approvals or notifications prior to initiating your research. The IRB Office has listed two new units, Nuclear Medicine and the Northwestern IT Research Computing and Data Services, where additional approvals or notifications may be relevant depending on the particulars of your research.  

Visit the IRB’s Additional Reviews page for a list of units and their contact information. 

Reportable New Information (RNI) Webpage Updates

The Reportable New Information (RNI) Webpage has significant updates which include: 

• Clarified RNI Considerations when relying on an External IRB per SOP External IRBs (HRP-092), and if the Northwestern University IRB is the IRB of record for one or more external sites per SOP Northwestern University serving as the IRB Of Record (HRP-093). 
• Clarified Institutional Reporting Obligations per SOP External Reporting (HRP-094). 
• Linked the Root Cause Analysis and Corrective and Preventative Action Plan (CAPA) pages. 
• Clarified RNI categories, RNI Pre-review, and the process for the researcher to respond when additional information is needed before the IRB can make a determination. The PI should consult the RNI letter and eIRB+, follow the directives of the IRB to complete any required action, provide the requested information, and submit the RNI back to the IRB for a final determination. 

Contact the IRB Office at IRBCompliance@northwestern.edu with any questions or feedback. 

RELIANCE RECAP

The Reliance team has developed a new resource for studies where Northwestern is serving as the IRB of Record for external sites.

The Reliance Welcome Packet is now available on the Northwestern Serving as the IRB of Record webpage. Check out these extremely useful resources!

• HRP-1832 Reliance Process Overview
• HRP-1833 Reliance Process Flowchart
• HRP-1834 Cover Letter
• HRP-1835 Reliance Welcome Email Template

UPDATED DOCUMENTS

The following updated protocol templates are now available on the Protocol Templates Page:

• Social Behavioral Protocol Template HRP-583
• Information updated throughout to support study teams when completing protocol (ie: adding checkboxes for FERPA/HIPAA, clarifying waiver of documentation of consent procedures, information about DEI practices) 
• Biomedical Protocol Template (HRP-593) 
• Added sharing results DEI section and small instructional text for providing PHI in cases of HIPAA use 

The following updated checklists are now available on the Checklists and Worksheets Page:

• Devices (HRP-307) 
• Mobile Apps and Mobile Medical Apps (HRP-336) 

The following updated SOPs are now available on the SOPs Page:

• Post-Review (HRP-052) 
• IRB Records (HRP-070)
• Written Documentation of Consent (HRP-091) 

STAFF SPOTLIGHT

Meet Edeth Engel, Lead IRB Analyst!

Before joining this awesome team, I spent 6 years working in all sorts of research, from studies about prisoners and children to exploring the world of people with spinal cord injuries and Parkinson's Disease. I joined the IRB’s Biomedical Department and later joined the Social-Behavioral Department. Beyond the office, you'll catch me swinging through the air doing trapeze, because life's all about balance, right? What drives me is my belief in collaborating with researchers to ensure that research is as safe and accessible as possible for everyone. I want all people to have the opportunity to participate in research because knowledge should know no boundaries.