SOPSOP

Melody Lin, Ph.D.Melody Lin, Ph.D.Deputy Director, Office for Human Research ProtectionsDeputy Director, Office for Human Research Protections

Director, International ActivitiesDirector, International ActivitiesMelody.Lin@hhs.govMelody.Lin@hhs.gov

Santiago, ChileSantiago, Chile

August 2006August 2006

SOP SOP (This Conference)(This Conference)

Value of the implementation Value of the implementation Role of SOP in preparing forRole of SOP in preparing for

- AuditsAudits

- InspectionsInspections

- RegistrationsRegistrations

- AccreditationsAccreditationsRelations to participant’s rights and Relations to participant’s rights and

protectionsprotections

ObjectivesObjectives

What is SOPWhat is SOPSOP for Ethics Review CommitteeSOP for Ethics Review CommitteeContribution to International Contribution to International

StandardsStandards

What is SOPWhat is SOP

A set of instructions or steps A set of instructions or steps someone follows to complete a jobsomeone follows to complete a job

Maximizes operational requirementsMaximizes operational requirementsMakes process, results, consistent, Makes process, results, consistent,

predictable, reproduciblepredictable, reproducible

The Benefits of SOPsThe Benefits of SOPs

StaffStaff

-Know how things are doneKnow how things are done

-Know who is competent to carry out Know who is competent to carry out what taskswhat tasks

-Clarify the roles of support staffClarify the roles of support staffManagersManagers

-Have confidence the same standard will Have confidence the same standard will be carried out during their absencebe carried out during their absence

The Benefits of SOPsThe Benefits of SOPs(2)(2)

Useful as a training tool for new staffUseful as a training tool for new staffAssure the quality and consistency of Assure the quality and consistency of

the operationthe operationServe as a compliance guide Serve as a compliance guide First line of defense in litigationFirst line of defense in litigation

Human Subject ProtectionsHuman Subject Protections

SOP = Written IRB policies and SOP = Written IRB policies and proceduresprocedures

Guidance on Written IRB Guidance on Written IRB ProceduresProcedures

“…“…provide sufficient step-by-provide sufficient step-by-step operational details so that step operational details so that an independent observer can an independent observer can understand how an IRB understand how an IRB operates and conducts its major operates and conducts its major functions”functions”

OHRP Guidance July 11, 2002OHRP Guidance July 11, 2002

Regulatory Requirements Regulatory Requirements

IRB must have and follow written IRB must have and follow written policies and procedures to describepolicies and procedures to describe

-what it doeswhat it does

-how it performshow it performs the necessary functions the necessary functions and and

-where it reports the findings where it reports the findings

Regulatory RequirementsRegulatory Requirements(2)(2)

The procedures which the IRBs will follow The procedures which the IRBs will follow toto

-Conduct its initial review of researchConduct its initial review of research

-Conduct its continuing review of researchConduct its continuing review of research

-Report its findings and actions to investigators Report its findings and actions to investigators and the institutionand the institution

-Determine which projects require review more Determine which projects require review more often than annuallyoften than annually

The procedures which the IRBs will The procedures which the IRBs will follow tofollow to

-Determine which projects need Determine which projects need verification from sources other than the verification from sources other than the investigators that no material changes investigators that no material changes have occurred since previous IRB have occurred since previous IRB reviewreview

Regulatory RequirementsRegulatory Requirements(3)(3)

The procedures which the IRBs will The procedures which the IRBs will follow to ensurefollow to ensure

-Prompt reporting to the IRB of proposed Prompt reporting to the IRB of proposed changes in a research activitychanges in a research activity

-Such changes may not be initiated Such changes may not be initiated without IRB review and approval except without IRB review and approval except when necessary to eliminate apparent when necessary to eliminate apparent immediate hazards to the subject.immediate hazards to the subject.

Regulatory RequirementsRegulatory Requirements(4)(4)

Regulatory RequirementsRegulatory Requirements(5)(5)

The procedures which the IRBs will The procedures which the IRBs will follow tofollow to

-Ensure prompt Ensure prompt reportingreporting to the IRB, to the IRB, appropriate institutional officials, any appropriate institutional officials, any Department or Agency head, and OHRP Department or Agency head, and OHRP

ReportingReporting

Any unanticipated problems involving Any unanticipated problems involving risks to subjects or others; risks to subjects or others;

Any serious or continuing Any serious or continuing noncompliance with regulation or the noncompliance with regulation or the requirements or determinations of the requirements or determinations of the IRB; and IRB; and

Any suspension or termination of IRB Any suspension or termination of IRB approvalapproval

FDA requirements:FDA requirements:21 CFR 56.115 IRB records21 CFR 56.115 IRB records

Minutes of IRB meetings … Minutes of IRB meetings … Records of continuing review Records of continuing review

activitiesactivitiesCopies of all correspondence Copies of all correspondence

between the IRB and the between the IRB and the investigatorsinvestigators

FDA requirements:FDA requirements:21 CFR 56.115 IRB records21 CFR 56.115 IRB records

A list of IRB members identified by A list of IRB members identified by -NameName-ExpertiseExpertise-AffiliationAffiliation

-Written procedures for the IRB Written procedures for the IRB

-Statements of significant new findings Statements of significant new findings provided to subjectsprovided to subjects

-The records shall be retained for at least The records shall be retained for at least 3 years after completion of the research, 3 years after completion of the research,

-The records shall be accessible for The records shall be accessible for inspection and copying by authorized inspection and copying by authorized representatives of the FDArepresentatives of the FDA

FDA requirements:FDA requirements:21 CFR 56.115 IRB records21 CFR 56.115 IRB records

Possible SanctionsPossible Sanctions

““The Food and Drug Administration The Food and Drug Administration may refuse to consider a clinical may refuse to consider a clinical investigation in support of an investigation in support of an application for a research or application for a research or marketing permit if the institution marketing permit if the institution or the IRB that reviewed the or the IRB that reviewed the investigation refuses to allow an investigation refuses to allow an inspection under this section.”inspection under this section.”

Top Ten Reasons for SOP Top Ten Reasons for SOP ContributionContribution

1.1. Make review predictable for Make review predictable for investigators, so they know what to investigators, so they know what to submitsubmit

2.2. When they submit complete When they submit complete packages, organized the same way packages, organized the same way reviews can be done more quickly, reviews can be done more quickly, and everyone is happyand everyone is happy

To ensure that:To ensure that:3.3. IRB operations are performed IRB operations are performed

consistently to maintain quality control consistently to maintain quality control of processes and products of processes and products

4.4. processes continue uninterrupted and processes continue uninterrupted and are completed on a prescribed are completed on a prescribed scheduleschedule

Top Ten Reasons for SOP Top Ten Reasons for SOP ContributionContribution

To ensure that:To ensure that:5.5. no failures occur in processes that no failures occur in processes that

would harm anyonewould harm anyone

6.6. approved procedures are followed in approved procedures are followed in compliance with company and compliance with company and government regulations government regulations

Top Ten Reasons for SOP Top Ten Reasons for SOP ContributionContribution

To serve as:To serve as:7.7. a training document for teaching new a training document for teaching new

IRB members and investigators IRB members and investigators

8.8. a checklist for co-workers who observe a checklist for co-workers who observe job performance to reinforce proper job performance to reinforce proper performance performance

Top Ten Reasons for SOP Top Ten Reasons for SOP ContributionContribution

To serve as:To serve as:9.9. an explanation of steps in a process so they an explanation of steps in a process so they

can be reviewed in noncompliance can be reviewed in noncompliance investigations investigations

10.10. international standardsinternational standards- If procedures are known, it can be compared If procedures are known, it can be compared

across borders, harmonized with each otheracross borders, harmonized with each other- Also if process is known, it can be evaluated and Also if process is known, it can be evaluated and

improvedimproved

Top Ten Reasons for SOP Top Ten Reasons for SOP ContributionContribution