IRB Connection HSO Newsletter [1]

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 [3]

2023

September [4]

• 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 [5]

• 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 [6]

• 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 [7]

• 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 [8]

• 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 [9]

• 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 [10]

• 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 [11]

• 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 [12]

• 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 [13]

• 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 [14]

• 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 [15]

• 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 [16]

• 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 [17]

• 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 [18]

• 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 [19]

• 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 [20]

• 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 [21]

• 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 Announcements [22]

• 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 [23]

• 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

2021

December BONUS [24]

• Corporate Funded Clinical Trial F&A Rate Increase (***Rebroadcast***)
• Holiday wishes from the HSO
• Is there a recording of that IRB presentation I missed?
• Herky Hints: HawkIRB Workflow
• Medical Ethics Advisor Newsletter, October and November 2021
• In the News

Early December [25]

• eRA Enhancements (***Rebroadcast from RAD: Research Administration Dispatch***)
• WIRB / WCG Online Submission Platform Training December 8th
• Recent Updates Made to the UI’s CITI Program
• IRB Member Recruitment: Seeking IRB Community Members
• ClinicalTrials.gov Late Results Reporting – Serious Noncompliance Resulted in FDA Warning Letters
• In the News

October [26]

• Announcing Human Subjects Office (HSO) Education and Compliance Openings
• Reverting to Virtual Presentations Only Beginning November 1
• WIRB / WCG Online Submission Platform Training November 15th
• Hot Topics & IRB/HRPP Updates
• Research Billing Compliance: Ensuring a smooth road to success for your study
• An Overview of the IRB Review Process
• Locating Support and Training Materials for CT.gov
• In the News

September [27]

• Four-part HawkIRB Training Series Recordings Now in ICON
• The Student PI Training Requirement is Now in Effect
• HawkIRB Enhancements
• Reminder: Pre-Grant Submission Survey for Single IRB Model
• Hot Topics & IRB/HRPP Updates
• Social, Behavioral and Education Researchers: There is an IRB tool just for you!
• Locating Support and Training Materials for CT.gov
• IRB Advisor Newsletter, July 2021
• In the News

July [28]

• HSO/IRB Return-to-Campus Notification
• Incomplete HawkIRB Applications Will Now be Returned Without Review
• Individual Research Results: To Share or Not to Share
• HawkIRB Automated Feature: Creating a ClinicalTrials.gov record (Push to PRS)
• IRB Advisor Newsletter, May and June 2021
• In the News

June [29]

• Message from OVPR: Mask and Social Distancing Requirements Updated
• New Training Requirement for Student Principal Investigators
• Reminder: Pre-Grant Submission Survey for Single IRB Model
• IRB Advisor Newsletter, April 2021
• In the News

April [30]

• OVPR Announces Updated IRB Fee Information for FY2022
• Getting on the Same Page: A Three-Part Presentation Series
• Get to Know ClinicalTrials.gov (CT.Gov) Protocol Registration and Result System (PRS)
• A New HSO/IRB Educational Resource
• IRB Advisor Newsletter, March 2021
• In the News

March [31]

• OHRP Announces Release of Research With Children Video
• Annual Disclosure of Outside Activities Due April 30
• Herky Hints: How to Edit and Attach Revised Documents to HawkIRB
• IRB Advisor Newsletter, February 2021
• In the News

February [32]

• IRB Membership: Regulatory Requirements and Rosters
• What’s the Difference Between Human Subjects Protection and Good Clinical Practice Trainings?
• External and Commercial IRB Q & A: What is the order of workflow for other committees when using a commercial external IRB?
• Herky Hints: Selecting the Status of Your Funding in Section III
• IRB Advisor Newsletter, January 2021
• In the News

January [33]

• FDA Guidance on Complex Innovative Trial Design for Drugs and Biological Products
• Announcement: Upcoming Lecture, “The Immortal Life of Henrietta Lacks”: A Discussion of Race and Medical Ethics
• IRB Fees: The Cost of IRB Review
• External and Commercial IRB Q&A – What is the Submission and Review Process for Commercial IRB Applications (WCG/WIRB, Advarra, etc.)?
• Herky Hints: Linking an External Funding Source in Section III
• IRB Advisor Newsletter, November 2020
• In the News

2020

December [34]

• From the Editor: The Informed Consent Issue, Part 2 (Plus the 10-year Anniversary of the HSRD Form)
• Happy Holidays from the HSO!
• FDA Issues Guidance for Enhancing Diversity in Clinical Trial Populations
• Short Form Document and Process
• External and Commercial IRB Q&A: How do study teams make/edit an Informed Consent Document for an external commercial IRB?
• In the News

November [35]

• From the Editor: The Informed Consent Issue, Part 1
• Western IRB (WIRB) Online Submission Platform Training, 11/12/20
• Diversity, Equity and Inclusion in Research/Clinical Trials
• Creating Informed Consent Documents: Best Practices
• Exceptions to the Rule: Waivers of Consent (45 CFR 46.116(f)(3))
• The Consent Summary: A Concise and Focused Description of Key Information
• Herky Hint: Describing the Consent Process
• In the News

Late September [36]

• Invite the Human Subjects Office into Your Classroom for an IRB Overview Presentation
• The IRB Welcomes New Faculty and Staff Researchers!
• Conducting a Virtual or Electronic Consent (eConsent) Process for Human Subjects Research
• Course-Related Student Project Policy and Checklist
• Getting to Know the Delegate Permission System
• IRB Advisor, August
• In the News

Early September [37]

• Science Thursday with VPR Compliance Units!
• New CITI Program Course – COVID-19: Back to Campus
• External and Commercial IRB Q & A: What are the Differences Between Commercial and External Single IRBs?
• Herky Hint: Closing Time
• IRB Advisor, June and July
• In the News

July [38]

• Two-Step Login Required for Research Administration Services
• HawkIRB Enhancements & Initiating a Clinical Trials.Gov record on a UI PI’s behalf
• FDA Updates Clinical Trial Guidance
• OHRP Updates Decision Charts
• What Is Not Considered Human Subjects Research?
• External IRB Q & A: What Terminology Do I Need to Know?
• Herky Hints: Subject Compensation
• IRB Advisor, April and May
• In the News

June [39]

• From the Director: University of Iowa Human Research Protection Program Achieves Reaccreditation!
• HawkIRB Application Updates
• IRB Educational Opportunities Now Available Over Zoom
• Updated Data Security Guidance
• Saying Goodbye: Researchers Leaving the UI
• Resources for Potential Participants
• IRB Advisor, March 2020

April [40]

• Changes to the eResearch (HawkIRB) Application
• Pharmacy and Therapeutics (P&T) Investigational Drug Service (IDS) Upgrades
• Changes to the VA Privacy Officer and VA Information Security Officer Checklists
• COVID-19 Related Updates

February [41]

• From the Director: Removal of Delegates in HawkIRB
• Getting Started: Do I Need IRB Approval?
• Informed Consent Document Checklist
• IRB Advisor, January 2018: Right to Try in Oncology: Gatekeepers or Mercenaries?
• In the News

January [42]

• Last of the Revised Common Rule Changes Effective January 20^th
• Annual Disclosure of Outside Activities Due April 30^th
• The IRB is Blooming with Educational Opportunities, Spring 2020
• Invite the Human Subjects Office into Your Classroom for an IRB Overview Presentation
• Conducting Research with Prisoners
• IRB Advisor, December 2019: SACHRP Recommendations on Pay-to-Participate Research
• In the News

 

2019

December [43]

• Seasons Greetings from HSO
• Tracking HCCC Research
• New Postings on HSO Website
• HawkIRB Changes: Clarifying NRC Review (Section V.26)
• IRB Advisor: Is "Informed Consent" an Oxymoron?
• In the News 

November Regulatory Newsletter [44]

• National Cancer Institute (NCI) funded research occurring at the Iowa City VAHCS
• Announcing New Policies Regarding IBC Review
• Other Committee Review Tool

October Regulatory Newsletter [45]

• From the Director and IRB Education Outreach Manager
• What Does It Mean to be AAHRPP Accredited?
• Investigator Guide Changes – Oct 2019 Regulatory Newsletter
• New Educational Tool – Data Security
• Coming Soon! A Change in the Assignment of HawkIRB ID Numbers

May [46]

• Welcome, New Faculty/Staff Researchers
• Request a Presentation Now for your Research-Oriented Class or Group
• Course-Related Student Projects
• External IRB Review Process
• Before You Go: PI Transfer/Departure Checklist

 

2018

IRB Regulatory and Policy Updates [47]

• Changes to the timing of IRB approval and Pharmacy & Therapeutics Investigational Drug Service approval
• Changes to question V.22 that may impact research submissions
• New Automated UI Health Care Clinical (UIHC) Trials and Research Website recruitment tool

October [48]

• Exploratory Workshop- Informed Consent
• Research Ethics Reading List
• Biorights: Subjects' Rights in Future Research

August [49]

• New Faculty/Staff Orientation to the IRB
• Mass Email for Research Recruitment
• IRB Member Recruitment: Seeking IRB Community Members
• Protocol Changes or New Information: Remember to Re-Consent Subjects
• The Role of Risk Management in Reviewing Human Subjects Research

June [50]

• Congratulations to Lori Dolan and Dixie Ecklund
• 2018 Common Rule: Another 6-Month Delay for Compliance
• Spanish Resources for the Protection of Research Participants
• Deception Research: Withholding Information from Subjects

April [51]

• ClinicalTrials.gov Office Hours
• Conflict of Interest Disclosure Deadline
• Revised Common Rule Delay
• Determining Capacity to Consent
• Data Use Agreements
• Research in the Early Modern Era
• Herky Hints: HawkIRB Workflow and You
• IRB Advisor, April 2018: The Search for Justice in the Human Genome

March [52]

• ClinicalTrials.gov Registration Tool
• Hardin Library Exhibit about Human Subjects Research
• New International Listing of Social/Behavioral Research Standards
• Using UI Mass Email for Study Recruitment: The Top 5 Things Researchers Should Know
• Expressing Appreciation and Reporting Concerns
• Genetics and Research: New Frontiers, New Challenges
• Herky Hints: How to Get Your HawkIRB Applications Approved Quicker

Regulatory/Policy Update [53]

• New Policy and Procedures: Documenting Research Participation in the UIHC Medical Record
• Revised UI Health Care Policy and the Research Billing Compliance Process
• Training Requirements Associated with the UI Health Care Policy Change

February [54]

• Updates to Federal Regulations/Guidance
• HawkIRB Trainings, IRB Presentations, and Office Hours
• Resources for New Researchers
• IRB Education
• HH: HawkIRB Delegate Permission System

2017

December [55]

• Feedback about IRB Educational Resources
• Subversive Subjects in Clinical Trials
• Clinical Trials.gov

November [56]

• Update to GCP Training Certificates
• Mail-out Consent
• Expanding Vulnerable Populations

October [57]

• ITS Update of Mass Email Policy
• SBIR/STTR
• Patient Advocacy Groups in Research
• External/Commercial IRB Q&A 

September  [58]

• Summer Article Recap
• CITI Training
• PRIM&R: Informed Consent and the Revised Common Rule
• Resources for Researchers

August [59]

• FDA Draft Guidance for Electronic Records and Signatures
• Other Human Research Protection Program Committees & Units
• Risk Communication and Consent

July [60]

• Enrolling Children in Research
• Documentation of Informed Consent- Best Practices
• International Research
• Quality Assurance/Quality Improvement
• External/Commercial IRB Q&A
• HH: Accessing Medical Records for Recruitment Purposes

May [61]

• ClinicalTrials.gov Final Rule Updates
• Changes in the HawkIRB Approval Tab
• Changing PIs and RTMs in HawkIRB
• External/Commercial IRB Q&A
• HH: Funding Source Modifications

March [62]

• The New HawkIRB Carousel Index
• External/Commercial IRB Q&A
• VA/UI Research & Multiple Applications
• Top Monitoring Findings of 2016

February [63]

• Feedback and Suggestions
• IRB Presentations
• Documenting Subject Agreement for Optional Research Activities

2016

December [64]

• Looking Back and Looking Forward
• Ethical Principles Series- Justice
• Umbrella Projects

November [65]

• Updates from the Director
• Multisite Research with sIRB
• Essentials of Central/External IRB
• Commercial IRB
• Navigating sIRB Reliance
• External IRB Q & A
• Herky Hints: HawkIRB with UI as Lead OR Relying IRB
• IRB Advisor November 2016

October [66]

• Regulatory Updates from the Director
• Ethical Principles Series -- Beneficence
• Anonymity in Qualitative Research
• Reportable Events
• IRB Advisor Newsletter

September [67]

• Summer Article Recap
• IRB Member Recruitment
• Diversity in Online Research
• Herky Hints: Contact People
• Classroom Presentations
• IRB Advisor Newsletter

August [68]

• Ethical Principles in Research - Respect for Persons
• Course-Related Student Project Updates
• Herky Hints: What to Review for your Continuing Review
• A Measure of Our Performance: 2015 IRB Review Metrics
• The IRB Advisor Newsletter, August 2016: NIH Clinical Center Riddled With Research Problems 

July [69]

• Updates from the Director
• VII.B.1 Enhancements
• Clinical Trials.gov registration and reporting
• Research in Online Environments
• Research Subject compensation Reminder
• The IRB Advisor Newsletter, July 2016

June [70]

• The Central and External IRB Model of Oversight
• Changes to the Continuing Review reminder
• The IRB Advisor Newsletter, June 2016

May [71]

• Updates from the Director
• Health Literacy and Therapeutic Misconception: Barriers to Informed Consent
• Using Mobile Technologies to Address Barriers to Participation in Clinical Trials
• IRB-04 Department of Defense: Announcing the UI’s Newest IRB
• The IRB Advisor Newsletter, May 2016

March [72]

• Updates from the Director
• Sex Bias and Clinical Trial - An Ongoing Concern
• The IRB Advisor Newsletter: An educational resource
• Got a Minute to Talk About IRB Meeting Minutes?

February [73]

• UI’s Institutional Conflict of Interest in Human Subjects Research
• New FDA Site Inspection Guidance
• Promises, Promise: I Assure You...What Exactly?
• Using Social Media for Research Recruitment 

2015

December [74]

• HawkIRB Phase II Changes: Central and External IRB Models
• Developing Your Data Management Plan
• HawkIRB Hints: Breaking Down the Details of Risks

October [75]

• Changes to the HawkIRB Application: Phase 1
• Underrepsentation in Clinical Trials: The Black Experience
• HawkIRB Hints: YOU Can Prevent Reportable Events!

August [76]

• Back to School Special: Faculty Advisor Responsibilities
• Attention Biomedical Researchers: New Type of PRMC Notice
• HawkIRB Hints: Finding Your Way in HawkIRB

June [77]

• It’s OK to Delegate, but Remember… It’s Still Your Study!
• How Do I…?  FAQ Page Links
• HawkIRB Hints: How Do You Attach a Revised Document?

April [78]

• The Tattletale IRB
• IRB Compliance Staff to attend FDA Audits
• HawkIRB Hints: Best Kept Secret

February [79]

• "I didn't think it was Human Subjects Research because..."
• UI policy on Mandatory Reporting of Physical and Sexual Abuse of Children: The Research Perspective
• Conflict of Interest in Research-Implications for Investigators

2014

December [80]

• External IRBs incorporated into HawkIRB
• Financial Interest Disclosure Reporting
• News Flash

October [81]

• Financial Conflict of Interest in Research
• Upcoming AAHRPP Site Visit
• Subjects Who Are Lost to Follow-up
• News Flash: HSO Interim Director appointment and staff departures

September [82]

• Keeping Current on International Research Regulations
• Tips to Improve your Informed Consent Document
• Mainline Questions: HawkIRB Workflow

August [83]

• Facebook's Controversial Sociological Study
• A personal Note from the HSO director
• Need help with HawkIRB? Herky Hints: Oops, I Made this Draft... Now What?
• New Positions filled in the Human Subjects Office!

July [84]

• Research Misconduct, Prevention Strategies and More
• Changes in IRB Determinations for Studies that Access PHI for Recruitment
• Did You Know? – HSO Presentations
• Who Should Be a Research Team Member?
• Try Your Hand at Being an IRB Chair

June [85]

• A More Flexible IRB on the Horizon
• Tips to Protect and Secure Information When Using Mobile Devices
• News Flash: Relocation of the Conflict of Interest in Research Program
• Need help with HawkIRB?  Herky Hints: Assurance Document

May [86]

• IRB Review of Qualitative Research – Just Jumping Through the Hoops?
• A Change in Your Summer Plans? - Let us Know!
• News Flash: HSO Staff Farewell
• Need help with HawkIRB? Herky Hints: Dealing with HawkIRB email notifications

April - Research with Children Special Edition [87]

• Risk and IRB Review
• Assent
• Parental Permission  
• Applicable Regulatory Definitions
•  HawkIRB: Procedures for Obtaining Consent and Assent
• Pregnancy in a Minor Subject Population

April [88]

• Describing Risk to Research Participants
• Disclosing the Probability and Magnitude of Physical Risk
• What We Did Last Month...Submitted an application for AAHRPP Re-Accreditation
•  News Flash: Changes with HawkIRB and the CRU
• This month in Human Subjects Protection History: The Belmont Report

March [89]

• Additional Requirements for DoD Research
• Where is this CITI of which you speak, and what does it have to do with me?
• Spring Break Reminder (submit your HawkIRB application/HSRD)
• IRB Policy Revision: Revised Guidelines Regarding Payment and Compensation
• What’s that Mean?: Certified IRB Professional

February [90]

January - Reportable Events Special Edition (IRB-01/03) [91] 
January - Reportable Events Special Edition (IRB-02) [92] 

• What are Reportable Events?
• Serious Adverse Drug Events (IRB-01/03)
•  Serious Adverse Device Effect (IRB-01/03)
•  Reportable Events Q&A: Why do I need to submit REFs?
• Receipt of New Information
• Unanticipated Problems Involving Risks to Subjects or Others
• Noncompliance
• Preventing Reportable Events

January [93]

• Letter from the Editor
•  Should I Submit a New Project Application or a Modification?
• News Flash: Andy Bertolatus' retirement announcement
• Back to School Reminder: Submit your HawkIRB Application

2013

December [94]

• Why is My Study Going to the Full Board?
• Come to the Dark Side, we have cookies! (Working for the HSO)
• What's that Mean?: Human Subjects Research Acronyms
•  HawkIRB: How Do I Use the Inbox Filter?

November [95]

• The Informed Consent Process
• Mainline Questions: Flavors of Waivers
• Use of Short Form Consent Document for Non-English Speaking Subjects
• Obtaining Required Signatures on the Informed Consent Document

October [96]

September [97]

• Mainline Questions: What does Exempt mean?
• The Mailed Consent Process: What to do if there are errors?
• Back to School: Human subjects research in the classroom
• News Flash: Course-Related Student Project Policy Revision
• IRB Policy Reminder: UI Students as Research Subjects

August [98]

• Enrolling Minors: What Happens When They Age Up?
• HIPPA/HITECH Act Omnibus Final Rule
• Human Subjects Research Data and Sample Identification Terms
• IRB Policy Reminder: Case Report Forms (CRFs) Should not be attached to the HawkIRB Application
• Have an idea for IRB Connection?

July- Genetic Research Special Edition [99]

• Federal Regulations and Guidance
• Genetic Information Nondiscrimination Act (GINA)
• Is it Genetic Research?
• Incidental Findings

July [100]

• Top 5 Monitoring Findings of 2012
• Mainline Questions: Do I have to fill out an IRB application?
• HawkIRB: How do I find my Approval Memo?
• Get to Know: The HSO Exec. Director and UI Institutional Official
• News Flash: My Research Portal

June [101]

• Greetings from the HSO: Mainline Questions
• New FDA Rule: Children in Clinical Investigations
• IRB Policy: Compensation in Recruitment Materials
• Get to Know: The Education and Compliance Staff

May [102]

• Plain Language Facilitating Subjects Understanding
• Revisions to the Declaration of Helsinki
• IRB Policy Reminder: Recording Additional Information on the Informed Consent Document
• Issues to Consider when a PI leaves the UI
• Get to Know: The IRB-02 Staff