IRB Survival: Part 1

IRB Survival: Part 1

Karen Blackwell, MS, CIPDirector, 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

The HSC Office G006 Sudler Monday – Friday 8:00 a.m. – 4:30 p.m. 913-588-1240 humansubjects@kumc.edu

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 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,

Categories of ResearchExempt

Expedited

Full Committee

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

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 x1240Dan Voss (IRB Administrator) x1240Tom Field (HIPAA Manager) x0940Karen Blackwell x0942

http://www2.kumc.edu/researchcompliance/human.htm