Transcript Protecting Human Subjects at KUMC

IRB Survival: Part 1
Karen Blackwell, MS, CIP
Director, Human Research Protection Program
Fall 2008
Today’s Topics
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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
What is an HRPP?
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Human Research Protection Program
Integrates all aspects of ethical and
safety review for human studies
Ensures compliance with federal
regulations
Educates investigators
The Mission of the HRPP
To partner with investigators
to ensure safe and ethical
research
Components of the HRPP*
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IRB - Human Subjects Committee
HIPAA
Conflict of Interest Committee
Data and Safety Monitoring Board
Radiation Safety and Biosafety
*Accredited by AAHRPP September 2007
The HSC Office
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G006 Sudler
Monday – Friday 8:00 a.m. – 4:30 p.m.
913-588-1240
[email protected]
When do these rules apply?
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Research – a systematic investigation,
including research development, testing
and evaluation, designed to develop or
contribute to generalizable knowledge.
Human Subject - living individual about
whom an investigator obtains (a) data
through an intervention or an interaction
with the individual, or (b) identifiable
private information.
Examples of Human Research Activities
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Retrospective chart reviews
Database queries
Registries of data from clinical care
Surveys, focus groups, interviews
Observational studies
Pilot studies
Biomedical or behavioral interventions
Generalizable QA/QI projects
Basic Requirements
- Complete Human Subjects Training
- File Conflicts of Interest Disclosure
- Choose one of three application forms
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Exempt
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Expedited*
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Full-Committee*
*Scientific Merit Review is required
Scientific Merit Review
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Procedures
consistent with sound
research
Protection against
unnecessary risk for
subjects and
researchers
Ability to answer the
research question
Potentially important
results
Options include:
- NIH
- Other external peer review
- PRMC: for cancer studies
- GAC: for studies at GCRC
- Departmental Review
Training and COI Disclosure
How to apply
Submit paper and electronic copies of:
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Application form
Protocol (study plan)
Investigator’s Brochure
Consent form
Complete grant (if applicable)
Data sheets, surveys, tests, ads,
Categories of Research
Exempt
Expedited
Full Committee
“Exempt”
Research That Meets One of Six Federal
Categories
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Research on normal educational practices
Anonymous surveys, low-risk interviews
Research on public officials or candidates
Existing, anonymous specimens or data*
Federal public service programs
Taste and food evaluations
*Special Application for Retrospective Chart Reviews
“Exempt”
Exempt from...
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Committee review
Annual re-review
Not exempt from…
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Submission to IRB for determination of status
Ethical conduct
Prior approval for protocol changes
Reports of unanticipated problems
Expedited Review
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Review by chairman or designee
Minimal Risk studies that fit at least one of
seven federal categories:
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Certain studies on approved drugs or devices
Blood draws
Non-invasive collection of specimens
Non-invasive procedures
Research using clinical data
Voice, video, digital, image recordings
Research on characteristics or behavior
Exempt and Expedited Projects
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No deadlines
Submit materials to the HSC office
Questions/conditions will be sent by
email to the PI, in about five days
Full-Committee Review
Projects that do not meet exempt
or expedited criteria
KUMC Processes
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Human Subjects Committees meets four
times per month:
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1st and 3rd Tuesdays
2nd and 4th Tuesdays
Deadline dates are eight business days in
advance (generally Friday at noon)
Subsequent reviews will go back to the
original committee
What does the HSC do?
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Rights and welfare of participants
8 federal criteria for approval
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Risks are minimized
Risk/benefit ratio is acceptable
Selection is equitable
Informed consent is sought
Informed consent is documented
Data is monitored to ensure safety
Maintain Privacy and confidentiality
Vulnerable subjects protection +
Scientific Merit Review
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Required for all expedited and fullcommittee projects
Options:
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NIH or other peer review process
GCRC Advisory Committee
PRMC – for cancer related studies
Departmental review (if none of the above)
Other Compliance Requirements
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HIPAA
Conflict of Interest
Data and Safety Monitoring
Radiation Safety Committee
Institutional Research Safety Committee
IRB requirements for collaborating sites
Requirements for IND/IDE sponsors
Special Rules in Kansas
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Children: < 18 years
Limits on research with foster children
Hierarchy for Legally Authorized Representatives
- Legal guardian or Durable Power of Attorney for Healthcare Decisions
- Adult or emancipated minor’s spouse (unless legally separated)
- Adult child
- Parent
- Adult relative by blood or marriage
Review Process
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Conditions of approval are called “provisos”
Provisos are emailed within 3 – 4 working days
Outcome of review will be:
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Tabled
Deferred
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Conditional approval
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Pending issues relate to federal approval criteria
Investigator’s response must go back to the committee
Minor changes or clarifications
Chair review only
Approval
Common Provisos
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Lack of congruence between the HSC
application, protocol, and consent form
Unclear plans for safety monitoring
Missing elements in the consent
document (please use our templates)
Complex language, high reading level
Radiation Safety review
When you get your provisos…
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Submit a written response
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Cover letter to address each proviso
Revised protocol, if applicable
Revised consent form, if applicable
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Other information, as requested
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Call the HSC office with questions
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Approval will be sent either to the Principal
Investigator or the Research Institute
After you get your approval:
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Keep accurate records
Obtain prior approval for study changes
Obtain prior approval for new personnel
Report problems
Submit continuing review on time
Come to us with questions
Special Issues related to
Collaborations
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Bringing your former research to KUMC
Collaborating with external investigators
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Do your activities constitute human subjects
research? (If yes, KUMC must review)
What agreements are in place to protect you
and the institution?
NEW
Use of Western IRB
Available for Phase III or Phase IV multicenter, industry-sponsored drug or biologic
trials
The KUMC Research Institute will submit on
behalf of investigators
HRPP Consultation Service
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
Services offered
- 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
Navigating the HRPP Website
HRPP Contacts…
HSC Office
x1240
Dan Voss (IRB Administrator)
x1240
Tom Field (HIPAA Manager)
x0940
Karen Blackwell
x0942
http://www2.kumc.edu/researchcompliance/human.htm