IRB Connection HSO Newsletter—Archive

The archives are listed below.  For more current newsletters please click here.

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If you have questions regarding the newsletter and/or ideas for content, please contact the IRB Compliance Program at irb-monitors@uiowa.edu 

Archives

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

New Compliance Monitoring Programs Coming to a Study Near You​
News Flash: HSO New Hours of Operation
IRB Policy Revision: Inclusion of Compensation Amount in Recruitment Materials
IRB Policy Reminder: Cold-Calling of Potential Subjects as a Recruitment Method​

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

Coercion and Undue Influence: What is the difference?
Mainline Questions: Alphabet Soup (HSO vs. IRB)
HawkIRB: How Do I Use the Delegate Permission System?
IRB Policy Reminder: Requirements for Completion of Optional Agreements

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