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

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

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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 regulationsTherefore, 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 issuesCompliance by researchers and others involved in this enterpriseGain public acceptance and confidence

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Reputational damage to:– Research focus and advancing research– Researcher and his/her institution = financial

hardship (loss of funding, etc.)LitigationRegulatory sanctionsFundamentally unethical

All of the above force us to reexamine concepts of:- Personal responsibility - Ethical or legal culpability

Consequences of Improper Conduct

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Operate in accordance to all Federal, State, local regulationsOperate in accordance to all Federal, State, local regulations

Office for Human Research Protections (OHRP) guidelines Office for Human Research Protections (OHRP) guidelines CFR 45.46 CFR 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 Food and Drug Administration (FDA) Code of Federal Regulations (21 CFR Part 50, 54, 56, and 312)Regulations (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 guidelines Drexel University policies and IRB guidelines Encompass all areas of research

Office of Regulatory Research Compliance

(ORRC) Objectives

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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

integrityOversight of Behavioral, Educational and Medical researchConflict of Interest (determination and avoidance)

ORRC Objectives

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What Is Research?What Is Research?

ResearchResearch means a means a systematic investigationsystematic investigation, , including including research developmentresearch development, , testingtesting and and evaluationevaluation, designed to , designed to developdevelop or or contribute contribute to generalizable knowledgeto generalizable knowledge. Activities which . Activities which meet this definition constitute research for meet this definition constitute research for purposes of this policy, whether or not they purposes of this policy, whether or not they are conducted or supported under a program are conducted or supported under a program which is considered research for other which is considered research for other purposes. For example, some demonstration purposes. For example, some demonstration and service programs may include research and service programs may include research activities. activities.

HHS regulations define HHS regulations define researchresearch at 45 CFR 46.102(d) at 45 CFR 46.102(d)

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Types of Research Types of Research Requiring IRB ReviewRequiring IRB Review

STUDIES INVOLVING:STUDIES INVOLVING:Human subjects or information derived from human subjects Human subjects or information derived from human subjects that is about that subject (sensitive surveys and questionnaires)that is about that subject (sensitive surveys and questionnaires)

Human tissues and specimens specifically, and prospectively Human tissues and specimens specifically, and prospectively collected for purposes of researchcollected for purposes of research

Data and confidential information from human subjects which is Data and confidential information from human subjects which is identifiableidentifiable

Any type of research that may place the subject at minimal to Any type of research that may place the subject at minimal to more than minimal riskmore than minimal risk

Studies involving vulnerable populationsStudies involving vulnerable populations– Prisoners, pregnant women and fetuses, children, Prisoners, pregnant women and fetuses, children,

emotionally challenged or deficient.emotionally challenged or deficient.

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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 designeesVice Provost for Research ComplianceAssistant Director for Research Compliance 99

What is an IRB?What is an IRB?Usually, a voluntary administrative board which has the Usually, a voluntary administrative board which has the authority to approve, request modifications to, or authority to approve, request modifications to, or disapprove research involving human subjects or disapprove research involving human subjects or information derived from human subjects.information derived from human subjects.

IRBs are federally mandated to ensure that human IRBs are federally mandated to ensure that human subject research is conducted in accordance with federal subject research is conducted in accordance with federal regulations (Common Rule) and rights of subjects are regulations (Common Rule) and rights of subjects are protected. protected.

Federal regulations require that all research involving Federal regulations require that all research involving human subjects or analysis of data gathered from human human subjects or analysis of data gathered from human subjects including data mining, surveys, clinical records subjects including data mining, surveys, clinical records and charts, regardless of funding source/status be and charts, regardless of funding source/status be reviewed by the IRB PRIOR to the implementation of any reviewed by the IRB PRIOR to the implementation of any research activity.research activity.

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Drexel University College of Drexel University College of Medicine IRB CommitteesMedicine IRB Committees

DUCOM research oversight is registered with DUCOM research oversight is registered with DHHS under the Assurance for Drexel DHHS under the Assurance for Drexel University College of Medicine.University 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 Sponsored Western IRB (WIRB)- Multicenter Sponsored Clinical TrialsClinical Trials

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Meeting DatesMeeting Dates DUCOM IRB’sDUCOM IRB’s

IRB #1 meets every 1IRB #1 meets every 1stst and 3 and 3rdrd Wednesday of each Wednesday of each month, alternating between 1601 Cherry St. and month, alternating between 1601 Cherry St. and Hahnemann University Hospital/NCB.Hahnemann University Hospital/NCB.

IRB# 3 meets every 3IRB# 3 meets every 3rdrd Thursday of each month Thursday 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 Wednesday of each month at St. Christopher’s Hospital for Children.St. Christopher’s Hospital for Children.

WIRB has 14 committees and meets weeklyWIRB has 14 committees and meets weekly

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IRB MEETING DEADLINESIRB MEETING DEADLINES

Meeting dates and deadlines for submission for Meeting dates and deadlines for submission for full board meetings are posted on the Office of full board meetings are posted on the Office of Regulatory Research Compliance Website Regulatory Research Compliance Website www.research.drexel.edu/compliance www.research.drexel.edu/compliance

There are NO deadlines for Exempt and Expedited There are NO deadlines for Exempt and Expedited review applications. review applications.

WIRB deadlines: Contact WIRB directly at WIRB deadlines: Contact WIRB directly at www.WIRB.com www.WIRB.com

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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

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IRB Levels of Review

Case study and Case reportsCase study and Case reports– Three or fewer patients, are prepared for the Three or fewer patients, are prepared for the

purpose of illustrating some points in the care of purpose of illustrating some points in the care of a patient, to educate and formulate new research a patient, to educate and formulate new research questions which may eventually lead to questions which may eventually lead to generalizable knowledge. 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 theory Questions regarding a new theory – Unusual combination of conditions or events that cause confusion Unusual combination of conditions or events that cause confusion – Adverse responses to therapies Adverse responses to therapies

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IRB Levels of Review

Exempt:Exempt: Categories 1-6Categories 1-6

– Category 1: Research involving normal educational Category 1: Research involving normal educational practicespractices

– 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 Rarely will involve consent of subject, may require use of HIPAA waiver of authorization (biologic samples/specimens)HIPAA waiver of authorization (biologic samples/specimens)

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IRB Levels of Review

Expedited ReviewExpedited Review– No more than minimal risk to the human No more than minimal risk to the human

subjects, subjects,

– According to Health and Human Services, 45 Code of Federal According to Health and Human Services, 45 Code of Federal Regulations, Part 46.102i, "minimal risk" means that the Regulations, Part 46.102i, "minimal risk" means that the probability and magnitude of harm or discomfort anticipated in probability and magnitude of harm or discomfort anticipated in the proposed research are not greater in and of themselves the proposed research are not greater in and of themselves from those ordinarily encountered in daily life or during the from those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations performance of routine physical or psychological examinations or tests. "Minimal Risk" does not include administration of or tests. "Minimal Risk" does not include administration of medication or use of any device placed inside the body.medication or use of any device placed inside the body.

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IRB Levels of Review

Types of Expedited Review:Types of Expedited Review:– Retrospective chart review with waiver of Retrospective chart review with waiver of

consent and HIPAA waiverconsent and HIPAA waiver– Prospective collection of health information Prospective collection of health information

with informed consent inclusive of HIPAAwith informed consent inclusive of HIPAA– Minimally invasive collection of human Minimally invasive collection of human

specimens (venipuncture, prospective specimens (venipuncture, prospective collections of discardable tissue)collections of discardable tissue)

– Questionnaires and surveys of a sensitive Questionnaires and surveys of a sensitive nature or with identifiers (may qualify for full)nature or with identifiers (may qualify for full)

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IRB Levels of Review

Full IRB review:Full IRB review:Projects for which the level of Projects for which the level of riskrisk is determined by the principal is determined by the principal investigator or Chair of the IRB to be investigator or Chair of the IRB to be greater than minimalgreater than minimal. . (Minimal risk means that the probability and magnitude of harm or (Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological during the performance of routine physical or psychological examination(s) or test(s).examination(s) or test(s).

Examples: projects which involve deception, sensitive or protected Examples: projects which involve deception, sensitive or protected populations; e.g. minors, prisoners, fetuses, mentally disabled, populations; e.g. minors, prisoners, fetuses, mentally disabled, test subjects for new drugs or clinical devices, pregnant women, test subjects for new drugs or clinical devices, pregnant women, illegal behavior, or legally incompetent personsillegal behavior, or legally incompetent persons

Investigational New DrugsInvestigational New Drugs

Investigational DevicesInvestigational Devices

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QUALIFICATIONS AND QUALIFICATIONS AND TRAININGTRAINING

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 assistants Research assistants

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Mandatory TrainingMandatory Training

Every Investigator, faculty member, staff or student Every Investigator, faculty member, staff or student directly involved in the proposed research activity must directly involved in the proposed research activity must complete the appropriate Collaborative Institutional complete the appropriate Collaborative Institutional Training Initiative (CITI) training modules before a Training Initiative (CITI) training modules before a research protocol is approved. research protocol is approved.

Beginning July 1Beginning July 1stst 2010, CITI training specific to your type 2010, CITI training specific to your type of protocol is required regardless of the type or level of of protocol is required regardless of the type or level of IRB review and approval.IRB review and approval.

Approval letters for new applications to the IRB, Periodic Approval letters for new applications to the IRB, Periodic renewals for continued enrollment or data analysis, and renewals for continued enrollment or data analysis, and amendments to protocol to add new personnel will not be amendments to protocol to add new personnel will not be released until the necessary CITI training modules are released until the necessary CITI training modules are complete.complete.

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CITI Training CoursesCITI Training Courses

DUCOM offers four (4) CITI training courses DUCOM offers four (4) CITI training courses 1.1.CITI Human Subject Research (HSR) Training CITI Human Subject Research (HSR) Training

• (All Investigators/Key Personnel)(All Investigators/Key Personnel)

2.2.CITI Good Clinical Practice (GCP)CITI Good Clinical Practice (GCP)• (drug, device or conducting clinical trials)(drug, device or conducting clinical trials)

3.3.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)

4.4.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 require All applicable CITI training courses require recertification every recertification every two (2) years.two (2) years.

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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.org www.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 at Personnel with CITI training certificates completed at non-DU/DUCOM institutions will be honored, though non-DU/DUCOM institutions will be honored, though additional modules may be required, and be renewed additional modules may be required, and be renewed every 2 years.every 2 years.

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Drexel Core Training Drexel Core Training ModulesModules

Additional training courses may be required Additional training courses may be required depending upon:depending 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 DUCOM Core HIPAA and Surrogate consent training do not require recertificationrequire recertification

– Collection and processing of human specimens/tissues, (blood Collection and processing of human specimens/tissues, (blood borne pathogen, laboratory safety training)borne 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 require Blood 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/

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The ProcessThe Process

Who can Assist you?Who can Assist you?– Each committee has a specifically assigned IRB Each committee has a specifically assigned IRB

CoordinatorCoordinator

Office of Regulatory Research ComplianceOffice of Regulatory Research Compliance

www.research.drexel.edu/compliance www.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

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Pre-submission questions Set up an appointment with ORRCAttend monthly “lunch and learn” workshops, 2nd Tuesday of every month with Jack Medendorp at 12 noonRequest for departmental meetingAsk questionsObtain 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 IRB Working with the IRB

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What does an IRB expect What does an IRB expect of an application?of an application?

Consideration of how the substantive issues & methods fit with ethical guidelines & IRB requirementsClarity in statement of problem, Research Questions & Methods of data collectionConsistency in content of all documents Completeness of all materials

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What Forms Do I Submit?What Forms Do I Submit?

Case Study: (Original) Case Study: (Original) – CS application, HIPAA waiver, copy of the Case StudyCS application, HIPAA waiver, copy of the Case Study

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/material Letter of approval from the “Owner” of data/material

when the data is owned by an individual or entity when the data is owned by an individual or entity other than DU/DUCOM/Tenetother than DU/DUCOM/Tenet

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What Forms Do I Submit?What Forms Do I Submit?

Expedited Review: All applications must include Expedited 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, If your application is for pathologic samples, or chart review,

use their specific application form and NOT the combined formuse their specific application form and NOT the combined form

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What Forms Do I Submit?What Forms Do I Submit?

Expedited special circumstances:Expedited special circumstances:– If your interaction and/or data collection is If your interaction and/or data collection is

in any way prospective you MUST consent in any way prospective you MUST consent the subject by use of a consent form the subject by use of a consent form inclusive of HIPAA authorizationinclusive of HIPAA authorization

– If your data collection is ONLY retrospective If your data collection is ONLY retrospective then you MUST include a consent waiver then you MUST include a consent waiver and HIPAA waiver of authorizationand HIPAA waiver of authorization

– Minors? Consent/Permission form and Minors? Consent/Permission form and Assent form Assent form

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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 Form Minors? 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

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Investigator Initiated Clinical Investigator Initiated Clinical Trials and ResearchTrials and Research

New Committee: Investigator Initiated Study Advisory New Committee: Investigator Initiated Study Advisory (IISA) Committee(IISA) Committee

IISA reviews Investigator Initiated Clinical Trials and IISA reviews Investigator Initiated Clinical Trials and Research proposals independently in advance of an IRB Research proposals independently in advance of an IRB applicationapplication– Committee evaluates investigator initiated protocols and Committee 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 of Identify 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

Investigator Initiated Clinical Investigator Initiated Clinical Trials and ResearchTrials and Research

IISA guidelines and application instructions/forms may IISA guidelines and application instructions/forms may be found at be found at http://www.research.drexel.edu/compliance/IRB/iisa.aspx http://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 Counsel Office 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, and The IISA is not an editorial review, and – IISA is independent of the IRB review process.IISA is independent of the IRB review process.

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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

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WHEN CAN I BEGIN MY WHEN CAN I BEGIN MY RESEARCH?RESEARCH?

NO RESEARCH ACTIVITIES MAY NO RESEARCH ACTIVITIES MAY COMMENCE UNTIL:COMMENCE UNTIL:

YOU HAVE RECEIVED YOUR IRB YOU HAVE RECEIVED YOUR IRB LETTER OF APPROVAL, AND IF LETTER OF APPROVAL, AND IF APPLICABLE, APPLICABLE,

YOUR APPROVED AND STAMPED YOUR APPROVED AND STAMPED CONSENT FORMCONSENT FORM

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WHO CAN ASSIST WITH MY RESEARCH WHO CAN ASSIST WITH MY RESEARCH ACTIVITIES AND CONSENTING OF ACTIVITIES AND CONSENTING OF

SUBJECTS?SUBJECTS?

Only investigators, sub-investigators Only investigators, sub-investigators and research coordinators or and research coordinators or

assistants who have been approved assistants who have been approved by the IRB for the study, and have by the IRB for the study, and have

completed all relevant training completed all relevant training requirements.requirements.

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WHO IS PERMITTED TO OBTAIN A WHO IS PERMITTED TO OBTAIN A RESEARCH SUBJECT’S CONSENT?RESEARCH SUBJECT’S CONSENT?

ONLY THOSE QUALIFIED INDIVIDUALS ONLY THOSE QUALIFIED INDIVIDUALS WHO:WHO:– HAVE COMPLETED THEIR HUMAN HAVE COMPLETED THEIR HUMAN SUBJECTS SUBJECTS

RESEARCH TRAINING, RESEARCH TRAINING, – HAVE SIGNED A CONFLICT OF INTEREST HAVE 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 SIGNATURE WHOSE NAMES APPEAR IN THE SIGNATURE

SECTION OF THE CONSENT FORM.SECTION OF THE CONSENT FORM.

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WHO IS RESPONSIBLE OF FOR THE WHO IS RESPONSIBLE OF FOR THE RESEARCH ACTIVITIES AND RESEARCH ACTIVITIES AND

OUTCOMES?OUTCOMES?

THE PRINCIPAL INVESTIGATOR IS THE PRINCIPAL INVESTIGATOR IS RESPONSIBLE FOR RESPONSIBLE FOR ALLALL ACTIONS AND ACTIONS AND ACTIVITIES OF ACTIVITIES OF ALLALL INDIVIDUALS WHO INDIVIDUALS WHO

CONTRIBUTE TO THE STUDY.CONTRIBUTE TO THE STUDY.

ANY MISCONDUCT, FAILURE TO FOLLOW ANY MISCONDUCT, FAILURE TO FOLLOW THE APPROVED PROTOCOL OR FAILURE IN THE APPROVED PROTOCOL OR FAILURE IN

COMPLIANCE AND REPORTING IS THE COMPLIANCE AND REPORTING IS THE

PI’sPI’s RESPONSIBILITY! RESPONSIBILITY!3838

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 approvalIf 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

Reports, Records and Reports, Records and Continuing ReviewsContinuing Reviews

Activation notice sent by the PI to the IRB once Activation notice sent by the PI to the IRB once the study begins enrollmentthe study begins enrollmentContinuing Reviews are done as often as Continuing Reviews are done as often as necessary, but not less than once per yearnecessary, but not less than once per yearAdverse Event reporting Adverse Event reporting Reporting non-compliance and suspensions to Reporting non-compliance and suspensions to regulatory authorities, Institutional Officer and regulatory authorities, Institutional Officer and funding agenciesfunding agenciesAccurate record keeping is critical (all documents Accurate record keeping is critical (all documents related to the study must be kept in the related to the study must be kept in the regulatory binder)regulatory binder)Final reportsFinal reports

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Non-complianceNon-complianceConsequencesConsequences

Serious NoncomplianceHuman 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 NoncomplianceThis 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

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In SummaryIn Summary

When in doubt, ask questions; seek helpRemember: consideration for clarity, consistency, completenessOn-going process – keep dialogue openAll committees use “reasonable person” standard to ensure high standards of ethical research These committees help facilitate responsible of conduct of research

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Questions?Questions?

Contact the Office of Regulatory Contact the Office of Regulatory

Research Compliance at Research Compliance at

215-255-7857215-255-7857

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