IRB Connection HSO Newsletter

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 

2020

April

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

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

August

• 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

• 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

• 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

• 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

• 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

• 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

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

November

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

October

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

September 

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

August

• FDA Draft Guidance for Electronic Records and Signatures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

July

• 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

• 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

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

February

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

2016

December

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

November

• 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

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

September

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

August

• 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

• 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

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

May

• 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

• 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

• 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

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

October

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

August

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

June

• 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

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

February

• "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

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

October

• 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

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

August

• 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

• 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

• 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

• 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

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

April

• 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

• 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

January - Reportable Events Special Edition (IRB-01/03) 
January - Reportable Events Special Edition (IRB-02) 

• 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

• 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

• 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

• 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

September

• 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

• 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

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

July

• 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

• 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

• 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