irb survival: part 1 karen blackwell, ms, cip director, human research protection program fall 2008
TRANSCRIPT
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
What is an HRPP?
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*
IRB - Human Subjects Committee HIPAA Conflict of Interest Committee Data and Safety Monitoring Board Radiation Safety and Biosafety
*Accredited by AAHRPP September 2007
When do these rules apply? 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
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 Exempt
Expedited*
Full-Committee*
*Scientific Merit Review is required
Scientific Merit Review 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: 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
1. Research on normal educational practices
2. Anonymous surveys, low-risk interviews
3. Research on public officials or candidates
4. Existing, anonymous specimens or data*
5. Federal public service programs
6. Taste and food evaluations
*Special Application for Retrospective Chart Reviews
“Exempt”Research That Meets One of Six Federal
Categories
Exempt from... Committee review Annual re-review
Not exempt from… Submission to IRB for determination of status Ethical conduct Prior approval for protocol changes Reports of unanticipated problems
“Exempt”
Expedited Review Review by chairman or designee Minimal Risk studies that fit at least one of
seven federal categories: 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 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
Human Subjects Committees meets four times per month: 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? Rights and welfare of participants 8 federal criteria for approval
1. Risks are minimized2. Risk/benefit ratio is acceptable3. Selection is equitable4. Informed consent is sought5. Informed consent is documented6. Data is monitored to ensure safety7. Maintain Privacy and confidentiality8. Vulnerable subjects protection +
Scientific Merit Review
Required for all expedited and full-committee projects
Options: NIH or other peer review process GCRC Advisory Committee PRMC – for cancer related studies Departmental review (if none of the above)
Other Compliance Requirements 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 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 Conditions of approval are called “provisos” Provisos are emailed within 3 – 4 working days Outcome of review will be:
Tabled Deferred
Pending issues relate to federal approval criteria Investigator’s response must go back to the committee
Conditional approval Minor changes or clarifications Chair review only
Approval
Common Provisos
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…
Submit a written response Cover letter to address each proviso Revised protocol, if applicable Revised consent form, if applicable
Other information, as requested
Call the HSC office with questions Approval will be sent either to the Principal
Investigator or the Research Institute
After you get your approval:
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 Bringing your former research to KUMC Collaborating with external investigators
Do your activities constitute human subjects research? (If yes, KUMC must review)
What agreements are in place to protect you and the institution?
Use of Western IRBAvailable for Phase III or Phase IV multi-center, industry-sponsored drug or biologictrials
The KUMC Research Institute will submit onbehalf of investigators
NEW
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