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

The HSC Office G006 Sudler Monday – Friday 8:00 a.m. – 4:30 p.m

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 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: 1 st and 3 rd Tuesdays 2 nd and 4 th 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 minimized 2. Risk/benefit ratio is acceptable 3. Selection is equitable 4. Informed consent is sought 5. Informed consent is documented 6. Data is monitored to ensure safety 7. Maintain Privacy and confidentiality 8. 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 ed 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 IRB Available for Phase III or Phase IV multi- center, industry-sponsored drug or biologic trials The KUMC Research Institute will submit on behalf of investigators NEW

HRPP Consultation Service Mondays 11 a.m. – 1 p.m. Wednesdays11 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