IRB Survival: Part 1
description
Transcript of IRB Survival: Part 1
![Page 1: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/1.jpg)
IRB Survival: Part 1
Karen Blackwell, MS, CIPDirector, Human Research Protection Program
Fall 2008
![Page 2: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/2.jpg)
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
![Page 3: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/3.jpg)
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
![Page 4: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/4.jpg)
The Mission of the HRPP
To partner with investigators to ensure safe and ethical
research
![Page 5: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/5.jpg)
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
![Page 6: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/6.jpg)
The HSC Office G006 Sudler Monday – Friday 8:00 a.m. – 4:30 p.m. 913-588-1240 [email protected]
![Page 7: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/7.jpg)
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.
![Page 8: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/8.jpg)
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
![Page 9: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/9.jpg)
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
![Page 10: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/10.jpg)
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
![Page 11: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/11.jpg)
Training and COI Disclosure
![Page 12: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/12.jpg)
How to applySubmit paper and electronic copies of:
Application form Protocol (study plan) Investigator’s Brochure Consent form Complete grant (if applicable) Data sheets, surveys, tests, ads,
![Page 13: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/13.jpg)
![Page 14: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/14.jpg)
Categories of ResearchExempt
Expedited
Full Committee
![Page 15: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/15.jpg)
1. Research on normal educational practices2. Anonymous surveys, low-risk interviews3. Research on public officials or candidates4. Existing, anonymous specimens or data*5. Federal public service programs6. Taste and food evaluations
*Special Application for Retrospective Chart Reviews
“Exempt”Research That Meets One of Six Federal
Categories
![Page 16: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/16.jpg)
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”
![Page 17: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/17.jpg)
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
![Page 18: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/18.jpg)
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
![Page 19: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/19.jpg)
Full-Committee Review
Projects that do not meet exempt
or expedited criteria
![Page 20: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/20.jpg)
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
![Page 21: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/21.jpg)
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 +
![Page 22: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/22.jpg)
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)
![Page 23: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/23.jpg)
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
![Page 24: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/24.jpg)
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
![Page 25: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/25.jpg)
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
![Page 26: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/26.jpg)
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
![Page 27: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/27.jpg)
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
![Page 28: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/28.jpg)
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
![Page 29: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/29.jpg)
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?
![Page 30: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/30.jpg)
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
![Page 31: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/31.jpg)
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
![Page 32: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/32.jpg)
Navigating the HRPP Website
![Page 33: IRB Survival: Part 1](https://reader033.fdocuments.in/reader033/viewer/2022061617/56815bcd550346895dc9c33f/html5/thumbnails/33.jpg)
HRPP Contacts…
HSC Office x1240Dan Voss (IRB Administrator) x1240Tom Field (HIPAA Manager) x0940Karen Blackwell x0942
http://www2.kumc.edu/researchcompliance/human.htm