human subjects research at johns hopkins medicine
DESCRIPTION
Human Subjects Research at Johns Hopkins Medicine. Introduction to Clinical Research - 2010 Human Subject Protection and IRBs. Government Regulations Followed by the IRBs and JHM Administration. - PowerPoint PPT PresentationTRANSCRIPT
11
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
22
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)
33
Ellen Roche: Colleague and Research Subject Volunteer
04/20/2304/20/23
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
55
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.
66
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
77
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
88
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
99
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
1010
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.”
1111
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)”
1212
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.
1313
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
1414
Types of ReviewTypes of Review
ExemptExempt ExpeditedExpedited ConvenedConvened
1515
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
1616
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
1717
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
1818
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
1919
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
2020
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
2121
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.
2222
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
2323
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 [email protected]@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
2424
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)
2525
Who is in the middle?Who is in the middle?
SUBJECT
INSTITUTIONIRB
GOV’T
SOCIETY
INDUSTRY
INVESTIGATOR
2626
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
2727
2828
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