IRB Survival: Part 1. Karen Blackwell, MS, CIP Director, Human Research Protection Program Fall 2008. Today’s Topics. Obtaining approval to conduct research Operations of the KUMC IRB Basic review criteria What, where, and how Special laws about research in Kansas Finding assistance.
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Karen Blackwell, MS, CIP
Director, Human Research Protection Program
To partner with investigators to ensure safe and ethical research
*Accredited by AAHRPP September 2007
- Complete Human Subjects Training
- File Conflicts of Interest Disclosure
- Choose one of three application forms
*Scientific Merit Review is required
Protection against unnecessary risk for subjects and researchers
Ability to answer the research question
Potentially important results
- Other external peer review
- PRMC: for cancer studies
- GAC: for studies at GCRC
- Departmental ReviewScientific Merit Review
Submit paper and electronic copies of:
*Special Application for Retrospective Chart Reviews
Not exempt from…
Projects that do not meet exempt
or expedited criteria
- Legal guardian or Durable Power of Attorney for Healthcare Decisions
- Adult or emancipated minor’s spouse (unless legally separated)
- Adult child
- Adult relative by blood or marriage
Mondays 11 a.m. – 1 p.m.
Wednesdays 11 a.m. – 1 p.m.
Fridays 2 p.m. – 3 p.m.
Other times, as requested
- Help in evaluating feasibility and regulatory implications of a proposal
- Pre-review of your draft HSC application, protocol and consent form
- Assistance with answering provisos
- General questions about HSC and other regulatory requirements
HSC Office x1240
Dan Voss (IRB Administrator) x1240
Tom Field (HIPAA Manager) x0940
Karen Blackwell x0942