Conducting Research at LincolnConducting Research at Lincoln

IRB/HRPP Policies, ProceduresIRB/HRPP Policies, Procedures

& Good Clinical Practices& Good Clinical Practices B Kanna MD, MPH, FACPB Kanna MD, MPH, FACP

Associate Program Director of Internal MedicineAssociate Program Director of Internal MedicineIRB Chairman IRB Chairman

Associate GME Director for ResearchAssociate GME Director for ResearchLincoln Medical & Mental Health Center, New YorkLincoln Medical & Mental Health Center, New York

IRB / HRPPIRB / HRPP

• IRB – Institutional Research Review Board

• HRPP – Human Research participants protection

Guiding Ethical PrinciplesGuiding Ethical Principles

• Nuremberg Code of 1947

• Declaration of Helsinki, 1964 (last updated in 2004)

• Belmont Report 1979

Belmont PrinciplesBelmont Principles

1) Respect for persons: Individuals should be treated as autonomous agents (such as

providing informed consent); Persons with diminished autonomy may need additional

protections.

2) Beneficence: Researchers should do all they can to maximize possible

benefits and minimize possible harm to their research subjects.

3) Justice: Researchers must treat participants fairly and equitably

Including the equitable selection of subjects (in terms of who may bear the risks and who may receive the benefits of the research)

Historical factsHistorical facts

• Second World War camps – Nuremberg Code

• Hepatitis study

• Tuskegee study

IRB RegulationsIRB Regulations

• 45 CFR* 46

• 21 CFR 50; 56; 312; 812

*CODE OF FEDERAL REGULATIONS

• IRBs are required by federal law to review human research that is either federally funded or subject to FDA oversight.

Functions of the IRB Functions of the IRB

• The IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.

• The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy.

• Research that has been reviewed and approved by an IRB may be subject to review and disapproval by officials of the institution.

• However, officials may not approve research if it has been disapproved by the IRB

IRB CommitteeIRB Committee

• Scientific members

• Non-scientific members

• Community members

• Meets monthly in Lincoln

• Conducts voting on new studies before approval

IRB review of studiesIRB review of studies

• All human research must be reviewed and approved by IRB

• e.g. Clinical trials; observational studies; chart review studies

• What do you do if you are not sure ?

• Contact IRB before you plan any study

• X 5339 (Nikol Celestine,IRB Administrator)

Initial stepsInitial steps

• You have an idea for a research study• Discuss this with your mentor or research

director• Prepare a draft protocol• Contact IRB • Prepare a full protocol and other documents• Know what is an IRB review and what happens

at the IRB meeting

IRB pre-reviewIRB pre-review

• Occurs before IRB review

• Principal investigator and IRB administrator review the protocol and document requirements

• Type of review is determined

• Date for IRB review is planned

IRB initial reviewIRB initial review

• Types of review: Full; Expedited and exempt

• Full reviews must be reviewed at IRB meeting

• Expedited review will be reviewed by the IRB Chair or IRB member

• Exempt review is determined by IRB – not by the investigator

IRB initial reviewIRB initial review

• Full review

• More than minimal risk

• Reviewed by an IRB member ( primary reviewer)

• Submit all documents 2 weeks prior to next meeting

• Investigator required to present briefly the protocol at the IRB meeting

Documents for Initial reviewDocuments for Initial review

• Full protocol• Lay summary• Consent/Waiver• HIPAA/waiver• Conflict of Interest• CV/HIPAA training & HPPER certificate• Contracts/Budgets for funded studies• Fliers/brochures, etc

Initial ReviewInitial Review

• Submit all documents to IRB

• Fill out Application for initial review

• REASON application system for administrative review and approval

Administrative Review Administrative Review

• Separate from IRB review

• Is a LMMHC/HHC requirement

• REASON application system

• Review occurs in parallel with IRB review

DeadlinesDeadlines

• Full review submission: 2 weeks before IRB meeting

• Expedited review: 1 week before IRB meeting

• Other reports: As per IRB operating procedures

• IRB meeting: 2nd Tuesday of every month

• Approval time: 2-4 weeks

Expedited initial reviewExpedited initial review

• 45 CFR 46 provides guidelines • 9 categories under expedited review• Need not be discussed in IRB meetings• Approved by IRB Chair or member• Still needs administrative review• Deadline for submission: 1 week before

IRB meeting• Approval time: 2- 4 weeks

Initial ApprovalInitial Approval

• No study can be started unless final HHC Central Office approval is obtained in written

• IRB approval is a part of final approval• Approval is maximum for 1 year period• PI must remember this and submit

continued review in 1 year• PI will be reminded 1-2 months before end

of initial approval period

Continued reviewContinued review

• All studies that have been reviewed and approved by IRB must be re-reviewed within 1 year

• Dates are very important• A summary of the study must be available• If no subjects enrolled – justification to

continue study must be made clear• CR approval for additional 1 year

maximum until study is closed

Additional IRB reviewAdditional IRB review

• An adverse event; unanticipated event must be reported to IRB immediately

• Document requirements specific for each event

• Time lines are very important in reporting

• e.g – loss of data; side effects of rx

Study ClosureStudy Closure

• Must be reported to IRB

• Study summary and required documents must be submitted

• Reason for study closure

• If PI is leaving institution, must be cleared by IRB on the seperation form

IRB GuidelinesIRB Guidelines

• IRB standard operating procedures

• OHRP website

• 45 CFR 46

• IRB website

• IRB Office

• Research Director /IRB member

IRB templatesIRB templates

• Initial review:– Application for initial review– COI– HIPAA/Waivers– Consent/Waivers

• Continued review:– CR application

• Study closure:– Closure form

• Adverse events:– AE form– Safety updates form

IRB templatesIRB templates

• IRB reviewer– Initial review ( Full & expedited)– CR ( Full & Expedited)– Consent review template

• IRB administrator– Determination of type of review– OHRP tool for audits

IRB informationIRB information

• IRB website

• IRB representative from department

• IRB Office:– X 5339– Nikol Celestine, IRB administrator

Old model

Institution

IRB

New model

Director

Patient Advocates

Biosafety

Research compliance

Radiation Safety

Education

AO

DSMB

QA/QI

Pharmacy

Sponsors

Grants & Contracts

Chief of Staff

Medical Records

Public Affairs IRB

Investigators

Study Coordinators Conflict of Interest

Committee

Finance Office

Clinical managers

Subjects

Subjects

Questions Questions ??