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Human Subjects Research Human Subjects Research at Johns Hopkins Medicineat Johns Hopkins Medicine

Introduction to Clinical Research - Introduction to Clinical Research - 20102010

Human Subject Protection and Human Subject Protection and

IRBsIRBs

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Government Regulations Followed by Government Regulations Followed by the IRBs and JHM Administrationthe IRBs and JHM Administration

Department of Health and Human Services Department of Health and Human Services regulations - requires submission of a regulations - requires submission of a Federal Wide AssuranceFederal Wide Assurance

Food and Drug Administration regulationsFood and Drug Administration regulations Both groups require that JHU constitute an Both groups require that JHU constitute an

Institutional Review BoardInstitutional Review Board State of Maryland statutesState of Maryland statutes AAHRPP (Association for the Accreditation AAHRPP (Association for the Accreditation

of Human Research Protection Programs)of Human Research Protection Programs)

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Ellen Roche: Colleague and Research Subject Volunteer

04/18/2304/18/23

Director - Office of Human Subjects

Research Operations

Judith Carrithers

Dean /CEO

Dr. Edward Miller

Vice Dean for Clinical

Investigation

Dr. Daniel Ford

Assistant Dean for Human Subjects

Research Compliance

Barbara L. Starklauf

VP and General Counsel,

JHU

VP and General Counsel,

JHM

Office of Human Subjects Research

Advisory Committee

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Institutional Review Board - Institutional Review Board - IRBIRB

IRB is located within the School of IRB is located within the School of Medicine Office Of Human Subjects Medicine Office Of Human Subjects ResearchResearch

An IRB can approve, approve with An IRB can approve, approve with required modifications, or disapprove an required modifications, or disapprove an applicationapplication

Review and completion of the approval Review and completion of the approval process is required before a project may process is required before a project may begin. Written approval document begin. Written approval document should be in hand.should be in hand.

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Administrative ActionsAdministrative Actions

Research approved by an IRB may be Research approved by an IRB may be subject to further review by officials of subject to further review by officials of the institutionthe institution

Institutional officials Institutional officials maymay decide that an decide that an IRB approved study may not be doneIRB approved study may not be done

Institutional officials may not approve Institutional officials may not approve the research if the IRB has disapproved the research if the IRB has disapproved itit

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IRB must determineIRB must determine

Risks to participant are minimized, no Risks to participant are minimized, no better alternativebetter alternative

Risks are reasonable in relation to Risks are reasonable in relation to anticipated benefits and the importance of anticipated benefits and the importance of the knowledge that is expected to resultthe knowledge that is expected to result

Selection of participants is equitableSelection of participants is equitable Informed consent will be sought from Informed consent will be sought from

participants or their legally authorized participants or their legally authorized representativesrepresentatives

Confidentiality is adequately maintainedConfidentiality is adequately maintained

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Who is responsibleWho is responsible

Faculty and Faculty and research team research team have the have the responsibility to responsibility to understand policies understand policies and procedures and procedures and comply with and comply with themthem

IRBs and IRBs and institutions have institutions have responsibility to responsibility to comply with state comply with state laws and federal laws and federal regulations regulations

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Who may obtain consent from Who may obtain consent from potential research subjects?potential research subjects?

Principal investigatorPrincipal investigator

Co-investigators listed on the Co-investigators listed on the applicationapplication

Consent designees:Consent designees: Only if: trained by PI & approved by IRBOnly if: trained by PI & approved by IRB

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What are human subjects?What are human subjects?

Living individuals about whom an Living individuals about whom an investigator obtains either “data investigator obtains either “data through intervention or interaction through intervention or interaction with the individual or “identifiable with the individual or “identifiable private information.”private information.”

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Private informationPrivate information

Information that a person can Information that a person can reasonably expect is not being reasonably expect is not being observed or recordedobserved or recorded

Information that has been provided Information that has been provided for specific purposes and that “the for specific purposes and that “the individual can reasonably expect will individual can reasonably expect will not be made public (a medical not be made public (a medical record)”record)”

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What is the definition of What is the definition of research?research?

DHHS and FDA regulations contain DHHS and FDA regulations contain different definitions:different definitions: DHHS: The systematic collection of data DHHS: The systematic collection of data

designed to contribute to generalizable designed to contribute to generalizable knowledgeknowledge

FDA: Clinical investigation: Any FDA: Clinical investigation: Any experiment that involves a test article experiment that involves a test article and one or more human subjects must and one or more human subjects must be submitted to the FDA.be submitted to the FDA.

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What isn’t research?What isn’t research?

Clinical practice activitiesClinical practice activities QA/QI activitiesQA/QI activities Research materials/information from Research materials/information from

only deceased persons - HIPAA issueonly deceased persons - HIPAA issue Purchased, de-identified biospecimens Purchased, de-identified biospecimens

from a national repository from a national repository A single case studyA single case study

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Types of ReviewTypes of Review

ExemptExempt ExpeditedExpedited ConvenedConvened

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Who can be the principal Who can be the principal investigator?investigator?

SOM and SON facultySOM and SON faculty Senior staff - JHH Nursing, APLSenior staff - JHH Nursing, APL Senior staff – Howard County General Senior staff – Howard County General

HospitalHospital Physicians on the medical staff at one Physicians on the medical staff at one

of the Johns Hopkins Hospitalsof the Johns Hopkins Hospitals Fellows cannot be principal Fellows cannot be principal

investigatorinvestigator

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What must be submitted for What must be submitted for IRB review?IRB review?

ResearchResearch

Regardless of Regardless of funding or lack of funding or lack of fundingfunding

Regardless of site Regardless of site where conductedwhere conducted

Examples are :Examples are : Clinical trialsClinical trials Retrospective chart Retrospective chart

reviewsreviews Lab research with Lab research with

existing specimensexisting specimens Prospective Prospective

collection of collection of specimensspecimens

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How to handle case studies?How to handle case studies?

A single case study does not meet A single case study does not meet the definition of researchthe definition of research

IRB will not review and approveIRB will not review and approve IRB will acknowledge and provide letter IRB will acknowledge and provide letter

to the journalto the journal IRB policy posted on the web site at IRB policy posted on the web site at

http://irb.jhmi.eduhttp://irb.jhmi.edu

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JHM IRBs that review JHM IRBs that review research proposalsresearch proposals

East Baltimore campus: JHM IRBs 1, East Baltimore campus: JHM IRBs 1, 2, 3 & X2, 3 & X

JHMBC campus - JHM IRB 5JHMBC campus - JHM IRB 5 Western Institutional Review Board Western Institutional Review Board

(WIRB) - Olympia, Washington(WIRB) - Olympia, Washington

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Assignment of Applications Assignment of Applications to IRB X to IRB X

IRB X reviews the IRB X reviews the majority of projects majority of projects that qualify for an that qualify for an expedited review expedited review process and process and requests for requests for exemption, exemption, regardless of topic regardless of topic or department of or department of originorigin

IRB X does not IRB X does not review projects review projects submitted by their submitted by their members or members or projects submitted projects submitted from KKIfrom KKI

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General Assignment of General Assignment of Applications Applications

Applications may be assigned to any JHM IRBApplications may be assigned to any JHM IRB May be transferred to another JHM IRB after May be transferred to another JHM IRB after

original assignment at the request of the IRB or original assignment at the request of the IRB or the Vice Dean for Clinical Investigationthe Vice Dean for Clinical Investigation

Convened versus expedited reviewConvened versus expedited review

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How to start the IRB review How to start the IRB review process – E-IRBprocess – E-IRB

Obtain training in e-IRB procedures – Obtain training in e-IRB procedures – call 5-3008 to schedulecall 5-3008 to schedule

On line submission required as of On line submission required as of 9/1/2005 for new applications.9/1/2005 for new applications.

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What are the presubmission What are the presubmission requirements for JHM IRBs requirements for JHM IRBs

Completion of JHUSOM on-line human subjects Completion of JHUSOM on-line human subjects training course at https://secure.lwservers.net training course at https://secure.lwservers.net (revised July 2005)(revised July 2005)

Department chair signatures, when applicableDepartment chair signatures, when applicable Cancer treatment trialsCancer treatment trials

review by the Oncology Center Clinical Research Office - review by the Oncology Center Clinical Research Office - regardless of Dept of originregardless of Dept of origin

Review by the Kennedy Krieger Institute (KKI) Review by the Kennedy Krieger Institute (KKI) when subjects are recruited from the KKI, KKI when subjects are recruited from the KKI, KKI facilities usedfacilities used

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How to obtain answers to How to obtain answers to IRB process questionsIRB process questions

Generic questions may Generic questions may be sent to the office e-be sent to the office e-mail site at mail site at ohsceb@jhmi.eduohsceb@jhmi.edu

Contact the Director of Contact the Director of the Office of Human the Office of Human Subjects Research - Subjects Research - Judith Carrithers (5-Judith Carrithers (5-3008)3008)

Contact the IRB Contact the IRB Associate Managers via Associate Managers via e-mail or phone (5-3008)e-mail or phone (5-3008)

IRB Chairs/Co-Chairs IRB Chairs/Co-Chairs may be contacted with may be contacted with specific questions specific questions about issues raised in about issues raised in the review process - the review process - membership lists are membership lists are on the IRB websiteon the IRB website

Consent specialistsConsent specialists Guidance documents Guidance documents

available on the IRB available on the IRB web site at: web site at: http://irb.jhmi.eduhttp://irb.jhmi.edu

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Answers to HIPAA QuestionsAnswers to HIPAA Questions

Research related questions - OHSR Research related questions - OHSR regulatory specialists and Assistant regulatory specialists and Assistant Dean for Human Subjects Research Dean for Human Subjects Research Compliance (5-3008)Compliance (5-3008)

General questions - HIPAA Privacy General questions - HIPAA Privacy Officer - Carol Richardson (410-735-Officer - Carol Richardson (410-735-6509)6509)

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Who is in the middle?Who is in the middle?

SUBJECT

INSTITUTIONIRB

GOV’T

SOCIETY

INDUSTRY

INVESTIGATOR

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Impact of Non-complianceImpact of Non-compliance

InstitutionalInstitutional ProtocolProtocol Investigator – warning letters Investigator – warning letters

published on FDA Websitepublished on FDA Website

Responsibilities of PIResponsibilities of PI

Human subjects protection is more than Human subjects protection is more than creating an acceptable consent formcreating an acceptable consent form

Train and manage the study teamTrain and manage the study team Treat each research participant with Treat each research participant with

respectrespect Report adverse events in a timely mannerReport adverse events in a timely manner Ask for help if you have questionsAsk for help if you have questions Think beyond the regulationsThink beyond the regulations

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New Initiatives IRBNew Initiatives IRB

Data Safety Monitoring BoardsData Safety Monitoring Boards Payment of services in clinical trialsPayment of services in clinical trials Quality improvement activities as Quality improvement activities as

researchresearch Policy on Incidental FindingsPolicy on Incidental Findings