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Presentation: Overview for Medical, Behavioral and Educational ...

  1. 1. Institutional Review Board (IRB) Overview for Medical, Behavioral and Educational Research Jack Medendorp M.S., B.S.N., CIP. Office of Regulatory Research Compliance Drexel University
  2. 2. DISCUSSION POINTSDISCUSSION POINTS Regulatory OversightRegulatory Oversight What is Research?What is Research? Levels of IRB ReviewLevels of IRB Review Qualifications and TrainingQualifications and Training Application ProcessApplication Process Investigator ResponsibilitiesInvestigator Responsibilities 22
  3. 3. Regulatory Research Environment The last few years have witnessed increased public and governmental scrutiny of research involving human subjects resulting in a move towards significant enhancement in regulatory and ethical standards to ensure that researchers, sponsors and funding agencies operate in accordance with all applicable regulations Therefore, in this enterprise, researchers, institutions and funding agencies have the heavy responsibility to keep research subjects out of harms way. An important consideration in this environment is: Grasp of regulatory issues Compliance by researchers and others involved in this enterprise Gain public acceptance and confidence 33
  4. 4. Reputational damage to: – Research focus and advancing research – Researcher and his/her institution = financial hardship (loss of funding, etc.) Litigation Regulatory sanctions Fundamentally unethical All of the above force us to reexamine concepts of: - Personal responsibility - Ethical or legal culpability Consequences of Improper Conduct 44
  5. 5. Operate in accordance to all Federal, State, local regulationsOperate in accordance to all Federal, State, local regulations  Office for Human Research Protections (OHRP) guidelinesOffice for Human Research Protections (OHRP) guidelines CFR 45.46CFR 45.46 HHS/NIH supported clinical and non-clinical researchHHS/NIH supported clinical and non-clinical research  Food and Drug Administration (FDA) Code of Federal RegulationsFood and Drug Administration (FDA) Code of Federal Regulations (21 CFR Part 50, 54, 56, and 312)(21 CFR Part 50, 54, 56, and 312) Drug, Devices, Biologicals, RadiologicalDrug, Devices, Biologicals, Radiological  Health Insurance Portability and Accountability Act (HIPAA)Health Insurance Portability and Accountability Act (HIPAA) Protection of personal, identifiable health informationProtection of personal, identifiable health information  Drexel University policies and IRB guidelinesDrexel University policies and IRB guidelines Encompass all areas of research Office of Regulatory Research Compliance (ORRC) Objectives 55
  6. 6. Oversight of all Investigator research activities: – Provide assistance and guidance to investigators – Ensure ethical conduct and compliance in performance of research in the following areas: Human subject protection – Adults, Children and Vulnerable Populations Promote responsible conduct of research – Consideration for subject safety, ethics, and integrity Oversight of Behavioral, Educational and Medical research Conflict of Interest (determination and avoidance) ORRC Objectives 66
  7. 7. What Is Research?What Is Research? ResearchResearch means ameans a systematic investigationsystematic investigation,, includingincluding research developmentresearch development,, testingtesting andand evaluationevaluation, designed to, designed to developdevelop oror contribute tocontribute to generalizable knowledgegeneralizable knowledge. Activities which meet. Activities which meet this definition constitute research for purposes ofthis definition constitute research for purposes of this policy, whether or not they are conducted orthis policy, whether or not they are conducted or supported under a program which is consideredsupported under a program which is considered research for other purposes. For example, someresearch for other purposes. For example, some demonstration and service programs maydemonstration and service programs may include research activities.include research activities. HHS regulations defineHHS regulations define researchresearch at 45 CFR 46.102(d)at 45 CFR 46.102(d) 77
  8. 8. Types of ResearchTypes of Research Requiring IRB ReviewRequiring IRB Review STUDIES INVOLVING:STUDIES INVOLVING: Human subjects or information derived from human subjects that isHuman subjects or information derived from human subjects that is about that subject (sensitive surveys and questionnaires)about that subject (sensitive surveys and questionnaires) Human tissues and specimens specifically, and prospectivelyHuman tissues and specimens specifically, and prospectively collected for purposes of researchcollected for purposes of research Data and confidential information from human subjects which isData and confidential information from human subjects which is identifiableidentifiable Any type of research that may place the subject at minimal to moreAny type of research that may place the subject at minimal to more than minimal riskthan minimal risk Studies involving vulnerable populationsStudies involving vulnerable populations – Prisoners, pregnant women and fetuses, children, emotionallyPrisoners, pregnant women and fetuses, children, emotionally challenged or deficient.challenged or deficient. 88
  9. 9. Who decides whether an IRB review and approval is required?  OHRP has recommended that investigators not be given the authority to make an independent determination that research does not involve human subjects  Therefore, all investigators irrespective of whether their study involves human subjects or not, must submit their application to the ORRC for a determination to be made whether the proposed study is research and whether it involves humans subjects  The individuals who are authorized to make this decision at Drexel University and Drexel University College of Medicine are: IRB Chairs or Chair’s designees Vice Provost for Research Compliance Assistant Director for Research Compliance 99
  10. 10. What is an IRB?What is an IRB? Usually, a voluntary administrative board which has the authorityUsually, a voluntary administrative board which has the authority to approve, request modifications to, or disapprove researchto approve, request modifications to, or disapprove research involving human subjects or information derived from humaninvolving human subjects or information derived from human subjects.subjects. IRBs are federally mandated to ensure that human subjectIRBs are federally mandated to ensure that human subject research is conducted in accordance with federal regulationsresearch is conducted in accordance with federal regulations (Common Rule) and rights of subjects are protected.(Common Rule) and rights of subjects are protected. Federal regulations require that all research involving humanFederal regulations require that all research involving human subjects or analysis of data gathered from human subjectssubjects or analysis of data gathered from human subjects including data mining, surveys, clinical records and charts,including data mining, surveys, clinical records and charts, regardless of funding source/status be reviewed by the IRBregardless of funding source/status be reviewed by the IRB PRIOR to the implementation of any research activity.PRIOR to the implementation of any research activity. 1010
  11. 11. Drexel University College ofDrexel University College of Medicine IRB CommitteesMedicine IRB Committees DUCOM research oversight is registered withDUCOM research oversight is registered with DHHS under the Assurance for Drexel UniversityDHHS under the Assurance for Drexel University College of Medicine.College of Medicine. Four separate IRBs:Four separate IRBs: IRB #1- Adult Medical/Psychological TrialsIRB #1- Adult Medical/Psychological Trials IRB #3- Adult Behavioral/Educational/SocialIRB #3- Adult Behavioral/Educational/Social IRB #4- Children Medical/Psychological TrialsIRB #4- Children Medical/Psychological Trials Western IRB (WIRB)- Multicenter SponsoredWestern IRB (WIRB)- Multicenter Sponsored Clinical TrialsClinical Trials 1111
  12. 12. Meeting DatesMeeting Dates DUCOM IRB’sDUCOM IRB’s IRB #1 meets every 1IRB #1 meets every 1stst and 3and 3rdrd Wednesday of each month,Wednesday of each month, alternating between 1601 Cherry St. and Hahnemannalternating between 1601 Cherry St. and Hahnemann University Hospital/NCB.University Hospital/NCB. IRB# 3 meets every 3IRB# 3 meets every 3rdrd Thursday of each monthThursday of each month scheduled at Drexel University and 1601 Cherry St.scheduled at Drexel University and 1601 Cherry St. IRB#4 meets every 3IRB#4 meets every 3rdrd Wednesday of each month at St.Wednesday of each month at St. Christopher’s Hospital for Children.Christopher’s Hospital for Children. WIRB has 14 committees and meets weeklyWIRB has 14 committees and meets weekly 1212
  13. 13. IRB MEETING DEADLINESIRB MEETING DEADLINES Meeting dates and deadlines for submission for fullMeeting dates and deadlines for submission for full board meetings are posted on the Office of Regulatoryboard meetings are posted on the Office of Regulatory Research Compliance WebsiteResearch Compliance Website www.research.drexel.edu/compliancewww.research.drexel.edu/compliance There are NO deadlines for Exempt and ExpeditedThere are NO deadlines for Exempt and Expedited review applications.review applications. WIRB deadlines: Contact WIRB directly atWIRB deadlines: Contact WIRB directly at www.WIRB.comwww.WIRB.com 1313
  14. 14. Study may fall within the guidelines of one of the following levels of review: Case study or case review Exempt from IRB review (less than minimal risk) Expedited review (minimal risk) Full review (more than minimal risk) requiring rigorous review of risks and benefits by convened IRB IRB Levels of Review 1414
  15. 15. IRB Levels of Review Case study and Case reportsCase study and Case reports – Three or fewer patients, are prepared for the purposeThree or fewer patients, are prepared for the purpose of illustrating some points in the care of a patient, toof illustrating some points in the care of a patient, to educate and formulate new research questions whicheducate and formulate new research questions which may eventually lead to generalizable knowledge.may eventually lead to generalizable knowledge. Examples:Examples: – Uncommon observationsUncommon observations – Report of a new condition, treatment and follow upReport of a new condition, treatment and follow up – Report of a familial condition with a proposed mode of inheritanceReport of a familial condition with a proposed mode of inheritance – Questions regarding a new theoryQuestions regarding a new theory – Unusual combination of conditions or events that cause confusionUnusual combination of conditions or events that cause confusion – Adverse responses to therapiesAdverse responses to therapies 1515
  16. 16. IRB Levels of Review Exempt:Exempt: Categories 1-6Categories 1-6 – Category 1: Research involving normal educational practicesCategory 1: Research involving normal educational practices – Category 2: Educational tests, surveys, questionnairesCategory 2: Educational tests, surveys, questionnaires – Category 3: Survey and interview of public officialsCategory 3: Survey and interview of public officials – Category 4: Use of existing records/data/biological samplesCategory 4: Use of existing records/data/biological samples – Category 6: Taste and food quality evaluationsCategory 6: Taste and food quality evaluations – Rarely will involve consent of subject, may require use of HIPAARarely will involve consent of subject, may require use of HIPAA waiver of authorization (biologic samples/specimens)waiver of authorization (biologic samples/specimens) 1616
  17. 17. IRB Levels of Review Expedited ReviewExpedited Review – No more than minimal risk to the humanNo more than minimal risk to the human subjects,subjects, – According to Health and Human Services, 45 Code of FederalAccording to Health and Human Services, 45 Code of Federal Regulations, Part 46.102i, "minimal risk" means that the probability andRegulations, Part 46.102i, "minimal risk" means that the probability and magnitude of harm or discomfort anticipated in the proposed researchmagnitude of harm or discomfort anticipated in the proposed research are not greater in and of themselves from those ordinarily encounteredare not greater in and of themselves from those ordinarily encountered in daily life or during the performance of routine physical orin daily life or during the performance of routine physical or psychological examinations or tests. "Minimal Risk" does not includepsychological examinations or tests. "Minimal Risk" does not include administration of medication or use of any device placed inside theadministration of medication or use of any device placed inside the body.body. 1717
  18. 18. IRB Levels of Review Types of Expedited Review:Types of Expedited Review: – Retrospective chart review with waiver ofRetrospective chart review with waiver of consent and HIPAA waiverconsent and HIPAA waiver – Prospective collection of health informationProspective collection of health information with informed consent inclusive of HIPAAwith informed consent inclusive of HIPAA – Minimally invasive collection of humanMinimally invasive collection of human specimens (venipuncture, prospectivespecimens (venipuncture, prospective collections of discardable tissue)collections of discardable tissue) – Questionnaires and surveys of a sensitiveQuestionnaires and surveys of a sensitive nature or with identifiers (may qualify for full)nature or with identifiers (may qualify for full) 1818
  19. 19. IRB Levels of Review Full IRB review:Full IRB review: Projects for which the level ofProjects for which the level of riskrisk is determined by the principalis determined by the principal investigator or Chair of the IRB to beinvestigator or Chair of the IRB to be greater than minimalgreater than minimal . (Minimal risk. (Minimal risk means that the probability and magnitude of harm or discomfort anticipatedmeans that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarilyin the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical orencountered in daily life or during the performance of routine physical or psychological examination(s) or test(s).psychological examination(s) or test(s). Examples: projects which involve deception, sensitive or protectedExamples: projects which involve deception, sensitive or protected populations; e.g. minors, prisoners, fetuses, mentally disabled, test subjectspopulations; e.g. minors, prisoners, fetuses, mentally disabled, test subjects for new drugs or clinical devices, pregnant women, illegal behavior, orfor new drugs or clinical devices, pregnant women, illegal behavior, or legally incompetent personslegally incompetent persons Investigational New DrugsInvestigational New Drugs Investigational DevicesInvestigational Devices 1919
  20. 20. QUALIFICATIONS AND TRAININGQUALIFICATIONS AND TRAINING Who can be a PI?Who can be a PI? – Policy at DU/DUCOM requires a PI to bePolicy at DU/DUCOM requires a PI to be Attending PhysicianAttending Physician FacultyFaculty StaffStaff Who can be a sub-investigator?Who can be a sub-investigator? FellowsFellows ResidentsResidents StudentsStudents Research assistantsResearch assistants 2020
  21. 21. Mandatory TrainingMandatory Training Every Investigator, faculty member, staff or student directlyEvery Investigator, faculty member, staff or student directly involved in the proposed research activity must complete theinvolved in the proposed research activity must complete the appropriate Collaborative Institutional Training Initiative (CITI)appropriate Collaborative Institutional Training Initiative (CITI) training modules before a research protocol is approved.training modules before a research protocol is approved. Beginning July 1Beginning July 1stst 2010, CITI training specific to your type of2010, CITI training specific to your type of protocol is required regardless of the type or level of IRB reviewprotocol is required regardless of the type or level of IRB review and approval.and approval. Approval letters for new applications to the IRB, Periodic renewalsApproval letters for new applications to the IRB, Periodic renewals for continued enrollment or data analysis, and amendments tofor continued enrollment or data analysis, and amendments to protocol to add new personnel will not be released until theprotocol to add new personnel will not be released until the necessary CITI training modules are complete.necessary CITI training modules are complete. 2121
  22. 22. CITI Training CoursesCITI Training Courses DUCOM offers four (4) CITI training coursesDUCOM offers four (4) CITI training courses 1.1. CITI Human Subject Research (HSR) TrainingCITI Human Subject Research (HSR) Training • (All Investigators/Key Personnel)(All Investigators/Key Personnel) 1.1. CITI Good Clinical Practice (GCP)CITI Good Clinical Practice (GCP) • (drug, device or conducting clinical trials)(drug, device or conducting clinical trials) 1.1. CITI Responsible Conduct of Research (RCR)CITI Responsible Conduct of Research (RCR) • (required for applicants to National Science(required for applicants to National Science Foundation)Foundation) 1.1. CITI Health Information Privacy and Security (HIPS)CITI Health Information Privacy and Security (HIPS) • (All personnel accessing PHI)(All personnel accessing PHI) All applicable CITI training courses requireAll applicable CITI training courses require recertification everyrecertification every two (2) years.two (2) years. 2222
  23. 23. Training RequirementsTraining Requirements The required CITI training courses may be found at:The required CITI training courses may be found at: – www.research.drexel.edu/compliance orwww.research.drexel.edu/compliance or – www.citiprogram.orgwww.citiprogram.org DUCoM specific guidance and FAQs may be found atDUCoM specific guidance and FAQs may be found at http://drexel.edu/research/compliance/traininghttp://drexel.edu/research/compliance/training Personnel with CITI training certificates completed atPersonnel with CITI training certificates completed at non-DU/DUCOM institutions will be honored, thoughnon-DU/DUCOM institutions will be honored, though additional modules may be required, and be renewedadditional modules may be required, and be renewed every 2 years.every 2 years. 2323
  24. 24. Drexel Core Training ModulesDrexel Core Training Modules Additional training courses may be required dependingAdditional training courses may be required depending upon:upon: – Use or access to Protected Health Information (HIPAA I & II)Use or access to Protected Health Information (HIPAA I & II) – Use of surrogate, substitute or proxy consent processUse of surrogate, substitute or proxy consent process DUCOM Core HIPAA and Surrogate consent training do not requireDUCOM Core HIPAA and Surrogate consent training do not require recertificationrecertification – Collection and processing of human specimens/tissues, (blood borneCollection and processing of human specimens/tissues, (blood borne pathogen, laboratory safety training)pathogen, laboratory safety training) – Shipping of human or animal specimens/tissues off campus,Shipping of human or animal specimens/tissues off campus, Blood borne pathogen, Lab safety, and Shipping courses requireBlood borne pathogen, Lab safety, and Shipping courses require annual recertificationannual recertification These Drexel Core training modules may be found atThese Drexel Core training modules may be found at www.research.drexel.edu/compliance ORwww.research.drexel.edu/compliance OR http://drexel.edu/research/compliance/training/http://drexel.edu/research/compliance/training/ 2424
  25. 25. The ProcessThe Process Who can Assist you?Who can Assist you? – Each committee has a specifically assignedEach committee has a specifically assigned IRB CoordinatorIRB Coordinator Office of Regulatory Research ComplianceOffice of Regulatory Research Compliance www.research.drexel.edu/compliancewww.research.drexel.edu/compliance Phone: 215 255-7857Phone: 215 255-7857 Address:Address: 1601 Cherry Street,1601 Cherry Street, 3 Parkway Bldg., Suite 10-4443 Parkway Bldg., Suite 10-444 Philadelphia, Pa 19102Philadelphia, Pa 19102 2525
  26. 26. Pre-submission questions Set up an appointment with ORRC Attend monthly “lunch and learn” workshops, 2nd Tuesday of every month with Jack Medendorp at 12 noon Request for departmental meeting Ask questions Obtain information on how to complete forms Obtain information on levels of review Review status and follow up assistance for assistance with your IRB Coordinator Working with the IRBWorking with the IRB 2626
  27. 27. What does an IRB expect ofWhat does an IRB expect of an application?an application? Consideration of how the substantive issues & methods fit with ethical guidelines & IRB requirements Clarity in statement of problem, Research Questions & Methods of data collection Consistency in content of all documents Completeness of all materials 2727
  28. 28. What Forms Do I Submit?What Forms Do I Submit? Case Study: (Original)Case Study: (Original) – CS application, HIPAA waiver, copy of the CaseCS application, HIPAA waiver, copy of the Case StudyStudy Exempt: (Original and 1 copy)Exempt: (Original and 1 copy) – ChecklistChecklist – Category 1-6 applicationCategory 1-6 application – Written proposalWritten proposal – Data collection tool/survey/questionnaireData collection tool/survey/questionnaire – Any advertisement/announcementAny advertisement/announcement – Letter of approval from the “Owner” of data/materialLetter of approval from the “Owner” of data/material when the data is owned by an individual or entitywhen the data is owned by an individual or entity other than DU/DUCOM/Tenet 2828
  29. 29. What Forms Do I Submit?What Forms Do I Submit? Expedited Review: All applications must includeExpedited Review: All applications must include the following (Original and 3 copies)the following (Original and 3 copies) – ChecklistChecklist – Transmittal form (ONLY IF FUNDED)Transmittal form (ONLY IF FUNDED) – Written proposalWritten proposal – Full review/Expedited review formFull review/Expedited review form – Expedited certification formExpedited certification form – Data collection tool/survey/questionnaireData collection tool/survey/questionnaire – Any advertisement or announcementAny advertisement or announcement – Internal indemnification formInternal indemnification form SPECIAL NOTE:SPECIAL NOTE: – If your application is for pathologic samples, or chart review, useIf your application is for pathologic samples, or chart review, use their specific application form and NOT the combined formtheir specific application form and NOT the combined form 2929
  30. 30. What Forms Do I Submit?What Forms Do I Submit? Expedited special circumstances:Expedited special circumstances: – If your interaction and/or data collection is inIf your interaction and/or data collection is in any way prospective you MUST consent theany way prospective you MUST consent the subject by use of a consent form inclusive ofsubject by use of a consent form inclusive of HIPAA authorizationHIPAA authorization – If your data collection is ONLY retrospectiveIf your data collection is ONLY retrospective then you MUST include a consent waiver andthen you MUST include a consent waiver and HIPAA waiver of authorizationHIPAA waiver of authorization – Minors? Consent/Permission form and AssentMinors? Consent/Permission form and Assent formform 3030
  31. 31. What Forms Do I Submit?What Forms Do I Submit? Full Review: (Original and 3 copies)Full Review: (Original and 3 copies) – ChecklistChecklist – Transmittal form (ONLY IF FUNDED)Transmittal form (ONLY IF FUNDED) – Written proposalWritten proposal – Investigator BrochureInvestigator Brochure – Full review/Expedited review combined formFull review/Expedited review combined form – Consent for with HIPAA authorizationConsent for with HIPAA authorization Minors? Consent/Permission form and Assent FormMinors? Consent/Permission form and Assent Form – Data collection tool/survey/questionnaireData collection tool/survey/questionnaire – Any advertisement or announcementAny advertisement or announcement – Internal indemnification formInternal indemnification form 3131
  32. 32. Investigator Initiated ClinicalInvestigator Initiated Clinical Trials and ResearchTrials and Research New Committee: Investigator Initiated Study AdvisoryNew Committee: Investigator Initiated Study Advisory (IISA) Committee(IISA) Committee IISA reviews Investigator Initiated Clinical Trials andIISA reviews Investigator Initiated Clinical Trials and Research proposals independently in advance of an IRBResearch proposals independently in advance of an IRB applicationapplication – Committee evaluates investigator initiated protocols andCommittee evaluates investigator initiated protocols and provides guidance to the investigator and university related to:provides guidance to the investigator and university related to: Risk and or need for university indemnificationRisk and or need for university indemnification Conflict of InterestConflict of Interest Funding and Cost AnalysisFunding and Cost Analysis Need for infrastructure or manpowerNeed for infrastructure or manpower Identify possible need for FDA/OHRP registrations (IND, IDE, Certificate ofIdentify possible need for FDA/OHRP registrations (IND, IDE, Certificate of Confidentiality)Confidentiality) May recommend Drexel IRB vs. WIRB reviewMay recommend Drexel IRB vs. WIRB review Contact Jack Medendorp at 215-255-7859 for additional clarity.Contact Jack Medendorp at 215-255-7859 for additional clarity. 3232
  33. 33. Investigator Initiated ClinicalInvestigator Initiated Clinical Trials and ResearchTrials and Research IISA guidelines and application instructions/forms mayIISA guidelines and application instructions/forms may be found atbe found at http://www.research.drexel.edu/compliance/IRB/iisa.aspxhttp://www.research.drexel.edu/compliance/IRB/iisa.aspx The IISA membership:The IISA membership: – Clinical Research Group (CRG)Clinical Research Group (CRG) – Office of General CounselOffice of General Counsel – Office of Regulatory Research ComplianceOffice of Regulatory Research Compliance – Additional experts/consultants as necessaryAdditional experts/consultants as necessary This process:This process: – Should be done in advance of an IRB application,Should be done in advance of an IRB application, – The PI is invited to take part in the review,The PI is invited to take part in the review, – The IISA is not an editorial review, andThe IISA is not an editorial review, and – IISA is independent of the IRB review process.IISA is independent of the IRB review process. 3333
  34. 34. How Long Does IRB Approval Take? IT DEPENDS upon the level of review and the investigator’s responses to IRB conditions. Exempt and Expedited reviews generally take less time than full board reviews. In general, the turn around time may be improved if investigators respond to IRB/ORRC questions. Need assistance in responding to questions or clarifications on questions, contact ORRC so the office can help you resolve those questions 3434
  35. 35. WHEN CAN I BEGIN MYWHEN CAN I BEGIN MY RESEARCH?RESEARCH? NO RESEARCH ACTIVITIES MAYNO RESEARCH ACTIVITIES MAY COMMENCE UNTIL:COMMENCE UNTIL:  YOU HAVE RECEIVED YOUR IRBYOU HAVE RECEIVED YOUR IRB LETTER OF APPROVAL, AND IFLETTER OF APPROVAL, AND IF APPLICABLE,APPLICABLE,  YOUR APPROVED AND STAMPEDYOUR APPROVED AND STAMPED CONSENT FORMCONSENT FORM 3535
  36. 36. WHO CAN ASSIST WITH MY RESEARCHWHO CAN ASSIST WITH MY RESEARCH ACTIVITIES AND CONSENTING OFACTIVITIES AND CONSENTING OF SUBJECTS?SUBJECTS? Only investigators, sub-investigators andOnly investigators, sub-investigators and research coordinators or assistants whoresearch coordinators or assistants who have been approved by the IRB for thehave been approved by the IRB for the study, and have completed all relevantstudy, and have completed all relevant training requirements.training requirements. 3636
  37. 37. WHO IS PERMITTED TO OBTAIN AWHO IS PERMITTED TO OBTAIN A RESEARCH SUBJECT’S CONSENT?RESEARCH SUBJECT’S CONSENT? ONLY THOSE QUALIFIED INDIVIDUALSONLY THOSE QUALIFIED INDIVIDUALS WHO:WHO: – HAVE COMPLETED THEIR HUMANHAVE COMPLETED THEIR HUMAN SUBJECTSSUBJECTS RESEARCH TRAINING,RESEARCH TRAINING, – HAVE SIGNED A CONFLICT OF INTERESTHAVE SIGNED A CONFLICT OF INTEREST STATEMENT,STATEMENT, – HAVE BEEN APPROVED BY THE IRB, ANDHAVE BEEN APPROVED BY THE IRB, AND – WHOSE NAMES APPEAR IN THE SIGNATUREWHOSE NAMES APPEAR IN THE SIGNATURE SECTION OF THE CONSENT FORM.SECTION OF THE CONSENT FORM. 3737
  38. 38. WHO IS RESPONSIBLE OF FOR THEWHO IS RESPONSIBLE OF FOR THE RESEARCH ACTIVITIES ANDRESEARCH ACTIVITIES AND OUTCOMES?OUTCOMES? THE PRINCIPAL INVESTIGATOR ISTHE PRINCIPAL INVESTIGATOR IS RESPONSIBLE FORRESPONSIBLE FOR ALLALL ACTIONS ANDACTIONS AND ACTIVITIES OFACTIVITIES OF ALLALL INDIVIDUALS WHOINDIVIDUALS WHO CONTRIBUTE TO THE STUDY.CONTRIBUTE TO THE STUDY. ANY MISCONDUCT, FAILURE TO FOLLOWANY MISCONDUCT, FAILURE TO FOLLOW THE APPROVED PROTOCOL OR FAILURE INTHE APPROVED PROTOCOL OR FAILURE IN COMPLIANCE AND REPORTING IS THECOMPLIANCE AND REPORTING IS THE PI’sPI’s RESPONSIBILITY!RESPONSIBILITY! 3838
  39. 39. What happens after initial Approval? How can I change the protocol after it is approved? – Researcher submits for review all modifications or amendments (if any and however trivial they may be) Every project is approved for the duration of one year; Yearly (at least) continuing review and approval is required for the continuation of the research Protocol Expiration: 364 Days after date of approval If continuing review is not done, the project expires on the expiration date, no new subjects should be enrolled into the study, (reporting obligations to the ORRC remain). Expired protocols for reactivation requires brand new review. 3939
  40. 40. Reports, Records andReports, Records and Continuing ReviewsContinuing Reviews Activation notice sent by the PI to the IRB once theActivation notice sent by the PI to the IRB once the study begins enrollmentstudy begins enrollment Continuing Reviews are done as often as necessary,Continuing Reviews are done as often as necessary, but not less than once per yearbut not less than once per year Adverse Event reportingAdverse Event reporting Reporting non-compliance and suspensions toReporting non-compliance and suspensions to regulatory authorities, Institutional Officer and fundingregulatory authorities, Institutional Officer and funding agenciesagencies Accurate record keeping is critical (all documentsAccurate record keeping is critical (all documents related to the study must be kept in the regulatoryrelated to the study must be kept in the regulatory binder)binder) Final reportsFinal reports 4040
  41. 41. Non-complianceNon-compliance ConsequencesConsequences Serious Noncompliance Human subject research being carried out without IRB review and approval by institution’s IRB. Serious noncompliance also includes substantive modifications to IRB-approved research without IRB approval. Continuous Noncompliance This involves a principal investigator making the same mistake several times repeatedly, particularly after an IRB has informed him or her and his/her team member(s) of the problem. Continuous noncompliance also includes if the principal investigator has multiple problems with noncompliance over a long period of time or has a problem with multiple projects. Suspension or Termination The IRB and the Signatory Official and the Humans Subject Protection Administrator have the authority to suspend or terminate approval of human subject research that is not being conducted in accordance with the IRB’s requirements 4141
  42. 42. In SummaryIn Summary When in doubt, ask questions; seek help Remember: consideration for clarity, consistency, completeness On-going process – keep dialogue open All committees use “reasonable person” standard to ensure high standards of ethical research These committees help facilitate responsible of conduct of research 4242
  43. 43. Questions?Questions? Contact the Office of RegulatoryContact the Office of Regulatory Research Compliance atResearch Compliance at 215-255-7857215-255-7857 4343

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