If you have questions regarding the newsletter and/or ideas for content, please contact the IRB Education and Outreach Program at irb-outreach@uiowa.edu (link sends e-mail)

2024

June

• Herky Hint for HawkIRB: Reducing Workflow Regarding Data Collection Materials
• Sponsor Monitor Access to Epic
• AAHRPP Accreditation Review – Domain III. Researchers
• 50th Anniversary of the National Research Act
• 2024-25 Grant Proposals Seminar and Workshop
• LGBTQIA+ Inclusive Language for Research Participants
• In the News
• Updates for the UI Research Community
• IRB Educational Resources for July

May

• Non-UI Team Members Human Subjects Protection Training Requirements  
• Herky Hint: Before a PI Leaves the UI  
• AAHRPP Accreditation Review – Domain II. IRB 
• Reminder: Complete the Pre-Grant Submission Survey for Single IRB Model 
• New Glossary provides Lay Language for Clinical Trials 
• For Researchers Traveling Abroad 
• In the News

April

• IRB Efficiency Initiative – April 2024 Roll Out
• AAHRPP Accreditation Review – Organization, Part Two
• Research Data Security Review
• Consent Tools available for Clinical Research Professionals
• In the News

March

• IRB Efficiency Initiative: Recordings, Supplemental Documents and FAQs
• AAHRPP Accreditation Review – Organization, Part One
• Annual Disclosure of Outside Activities Due April 30
• New! Template Recruitment Message
• Herky Hint: UIHC Clinical Trials website: After close of enrollment
• Draft Guidance on Key Information in Informed Consent
• In the News

February

• How does the University of Iowa prepare for AAHRPP Accreditation?
• Recordings Available for IRB Efficiency Initiative, January 2024 Roll Out
• UI IRB SOP and Researcher Guide and Policy Changes
• Short Form Consent Process: Witness Signature is Required
• Optimizing Registration and Results Reporting on ClinicalTrials.gov
• FDA Guidance Updates
• Promoting Global Clinical Research in Children
• In the News

January

• What is AAHRPP Accreditation?
• Certificates of Confidentiality: What are They and Why do They Matter?
• Two Recent FDA Guidance Documents
• Student PI Training Requirement: Reminder to Faculty Advisors and Student PIs
• Learning Opportunity: Human Subjects Research, IRB Review Process, and HawkIRB
• Reminder: Complete the Pre-Grant Submission Survey for Single IRB Model
• Division of Sponsored Programs Rebroadcast: NDA Winter Data Submission Cycle
• Division of Sponsored Programs Rebroadcast: NIH Policy for Data Management and Sharing
• Recent IRB Presentation Recording Available
• In the News

2023

December

• Holiday Wishes
• OVPR Research Recruitment Survey
• Transparency In Clinical Trials and The Role of FDA Oversight
• Human Subjects Research in the UIHC: Not Just IRB Compliance
• HawkIRB User Interface
• Recent IRB Presentation Recordings Available
• In the News

November

• Best Practices for Research Collaboration and Data Sharing
• Herky Hint: Data Sharing and Security
• Informed Consent Tips
• eConsent Process and Checklists
• Tabling a Form Submission
• Medical Ethics Advisor Newsletter, October 2023
• In the News

October

• Herky Hint: HawkIRB Automatically Assigns Delegates to all New Projects
• Presentation Recap: Unlocking the Mystery of IRB Compliance Monitoring
• Recent Presentation Recordings
• Medical Ethics Advisor Newsletter, September 2023
• In the News

September

• Research Navigation Tool – for faculty and research scientists
• Learning Opportunity: Human Subjects Research, IRB Review Process, and HawkIRB
• CITI Training at Previous Institution
• External IRB Q&A: Non-UI Team Members
• General Data Protection Regulation (GDPR) May Affect Your Research Plan
• ClinicalTrials.gov Webinar Series (hosted by the Food and Drug Administration)
• Reminder: Complete the Pre-Grant Submission Survey for Single IRB Model
• An Invitation - UI Research Services Fair (October 12, 2023)
• Medical Ethics Advisor Newsletter, August 2023
• In the News

August

• Course-Related Student Projects: The Exception to the Rule
• Student PI Training Requirement: Reminder to Faculty Advisors and Student PIs
• Best practices: Studies Involving LGBTQIA+ Persons
• Informed Consent – New Food and Drug Administration (FDA) Guidance
• Medical Ethics Advisor Newsletter, July 2023
• In the News

July

• IRB Member Recruitment: Seeking Help from the UI Research Community
• DSP Rebroadcast: UI Research Data Policy and American Heart Association Open Data Policy
• Herky Hint: Acceptable Justifications for Waiver of Documentation of Consent
• Gathering Identifiers for Research Subject Compensation
• Give It to ‘Em Straight: Health Literacy in Clinical Research
• Recap: Hot Topics Lecture from July 12, 2023
• Medical Ethics Advisor Newsletter, June 2023
• In the News

June

• Best Practices: Responding to IRB Meeting Minutes
• Herky Hint: Protocol Amendments
• Do You Want to Build a Snow(ball sample)?
• Opening the Door: Accessibility and the IRB
• NIH Rebroadcast: NIH Campus Interactive Virtual Tour
• Medical Ethics Advisor Newsletter, May 2023
• In the News

May

• Good Application Initiative
• Summer Student Research Internships
• Project Closure Memo Now Available in HawkIRB
• Herky Hint: Deception Requires a Waiver of Consent
• Reminder: Complete the Pre-Grant Submission Survey for Single IRB Model
• Recap of “The Single IRB Process: Navigating the Waters”
• Recap of Casting the Net: Research Ethics in the Age of Social Media
• Medical Ethics Advisor Newsletter, April 2023
• In the News

April

• Before a PI Leaves the UI: Transfer/Departure/Change of Status Forms and Procedures
• Extra! Extra!: Offering Extra Credit as Compensation
• HawkIRB Updates: Expanded Character Limits (ROC.5 and ROC.6)
• Herky Hint: Assessing Capacity to Consent
• Recap: March 2023 Hot Topics Lecture
• Recap: ClinicalTrials.gov Reporting Requirements and Consequences of Noncompliance
• Medical Ethics Advisor Newsletter, March 2023
• In the News

March

• Annual Disclosure of Outside Activities Due April 30
• Herky Hint: Conflict of Interest—Don’t Guess!
• Human Subjects Office Staffing
• Trauma-informed Research Practices
• Presentation Recap: FDA Site Inspection Guide—Your Best Tool for Preparing
• The Top 10 Reasons Researchers Come to Office Hours and the Guidance We Give
• Medical Ethics Advisor Newsletter, February 2023
• In the News

February

• Policy Reminder: Mass Email for Research Recruitment
• Making it Plain: Meaningful Attachment Names in HawkIRB
• Herky Hint: Editing and Stacking Attachments & Mac Instructions
• NIH Grant Conference 2022 Presentation Recordings Now Available
• Medical Ethics Advisor Newsletter, January 2023
• In the News

January

• Changes to HawkIRB Are Coming Soon!
• Retrospective Record Reviews with Less Regulatory Burden
• Make Effective Recruitment Plans – December 2022 Lecture Recap
• Student PI Training Requirement: Reminder to Faculty Advisors and Student PIs
• Learning Opportunity: Human Subjects Research, IRB Review Process, and HawkIRB
• Reminder: Complete the Pre-Grant Submission Survey for Single IRB Model
• DSP Rebroadcast: Preparing for 2023 Data Management and Sharing Policy
• Medical Ethics Advisor Newsletter, December 2022
• In the News

2022

December

• Holiday Wishes
• Hot Topics and Updates from the IRB and Human Research Protection Program
• Herky Hint: How to get Clean, IRB-approved Documents
• Medical Ethics Advisor Newsletter, October 2022
• In the News

November

• IRB Presentation Recap: Checklists and Guidance Documents Galore!
• NIH-Funded Clinical Trials: Compliance with Reporting Results
• From WIRB to WCG, Website Updates, and More
• Food and Drug Administration Proposed Rule Change and Draft Guidance
• Medical Ethics Advisor Newsletter, October 2022
• In the News

October 

• The New Faculty/Staff Research Navigation Tool is here to help you!
• What is your plan to reconsent subjects?
• A Deeper Dive into the Research Process: Recordings of IRB/ICTS Lecture Series
• Herky Hints: Watermark on Pregnancy Consent Documents
• New FDA Draft Guidance: Ethical Considerations for Clinical Investigations of Medical Products Involving Children
• Medical Ethics Advisor Newsletter, September 2022
• In the News

September

• Student PI Training Requirement
• Herky Hints: Need documentation of what changed in a Modification form? No problem! Here is how to generate a copy of a form and an approval memo
• Announcement: Faster Access to Federally Funded Research Results
• Reminder: Complete the Pre-Grant Submission Survey for Single IRB Model
• Medical Ethics Advisor Newsletter, August 2022
• In the News

August

• Course-Related Student Projects: The Exception to the Rule
• Learning Opportunity: Human Subjects Research, IRB Review Process, and HawkIRB
• Increased Civil Monetary Penalties for ClinicalTrials.gov Record Noncompliance
• Herky Hints: HawkIRB Filters: A Handy Tool for Research Team Members
• Hot Topics and Updates from the IRB and Human Research Protection Program
• Division of Sponsored Programs Rebroadcast: Implementation Details for NIH Data Management and Sharing Policy
• Write Winning Grant Proposals Seminar and Workshop (2022-2023) – Registration open!
• Medical Ethics Advisor Newsletter, July 2022
• In the News

July

• Continuing Medical Education Credit for Compliance Monitoring
• The IRB Review Process: IRB/HSO/HRPP Improvements and Enhancements to Reduce Review Times
• ClinicalTrials.gov - Educational Points and Best Practices
• IRB ICON Course for Researchers – What’s in there, anyway?
• View Recorded IRB presentations - IRB ICON Course for Researchers
• NIH Webinars: Implementing the New Data Management and Sharing Policy
• Medical Ethics Advisor Newsletter, June 2022
• In the News

June

• New Guidelines for Posting Informed Consent Documents for Federally Funded Research
• HawkIRB Carousel Index: A Wealth of Information at Your Fingertips
• Division of Sponsored Programs Rebroadcast: Revised Workflow Form for PI Departure, Grant Transfers, and VPR Request for Approval to serve as Adjunct, Visiting or Emeritus PI
• Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD)
• Medical Ethics Advisor Newsletter, May 2022
• In the News

May

• Hot Topics and Updates from the IRB and Human Research Protection Program
• Good Cause Extension Submission Deadlines for Applicable Clinical Trials
• NIH Releases New Policy – Data Management and Sharing
• Exempt Research Application: Recorded HawkIRB Training
• Write Winning Grant Proposals Seminar and Workshop (2022-2023) – Registration open!
• Draft FDA Guidance: Diversity Plans to Improve Enrollment from Underrepresented Racial and Ethnic Populations
• Upcoming Conference - Achieving Research Equity and Inclusion: Name It! Act On It! Change It!
• Medical Ethics Advisor Newsletter, March and April 2022
• In the News

April

• Reminder: Pre-Grant Submission Survey for Single IRB Model
• Annual Disclosure of Outside Activities Due Apr 30
• The IRB Review Process—How Long is This Going to Take?
• Going Abroad? Plan Ahead to Conduct Research Outside the U.S.
• ClinicalTrials.gov Guidelines for Reporting Results – A Presentation to Simplify the Process
• Presentation Overview: Single IRB of Record Review Model for Federally Funded, Multi-Site Research
• Medical Ethics Advisor Newsletter, February 2022
• In the News

March 

• University of Iowa Purchases System to Facilitate Clinical Trials Management
• NIH FORMS-G Changes to be Reflected on Human Subjects Clinical Trials Form
• Medical Ethics Advisor Newsletter, January 2022
• In the News

January

• Reminder: Pre-Grant Submission Survey for Single IRB Model
• FAUCI & the Importance of Representation in Research: A Film Screening and Discussion
• New Exempt Application Rollout
• Protocol Outline Template
• Medical Ethics Advisor Newsletter, December 2021
• In the News