research involving human subjects institutional review board (irb) judette haddad, phd, cip
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Research Involving Human SubjectsInstitutional Review Board (IRB)
Judette Haddad, PhD, CIP
History and Ethical principlesNuremberg Code 1947Declaration of Helsinki 1964 National Research Act 1974Belmont Report 1979Respect for person- Informed consentBeneficence- Favorable benefit-risk ratioJustice- Selection of subjectsPublic Heath Services Act 1985
Human Subject Protection RegulationsDHHS Regulations45 CFR part 46- Subparts A, B, C, D, & EFDA Regulations21 CFR part 50, Protection of Human Subjects21 CFR part 56, Institutional Review Boards21 CFR part 312, Investigational New Drug Application21 CFR part 812, Investigational Device Exemptions
OU Federal Wide AssuranceAll research involving the participation of human subjects must be submitted for review by the IRB (Institutional Review Board for the Protection of Human Subjects).
DHHS Definition45 CFR 46.102(d)Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
DHHS Definition (cntd)45 CFR 46.102(f)Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains(1) Data through intervention or interaction with the individual, or (2) Identifiable private information.
DHHS Definition (cntd)Private Information:Information about behavior that occurs in a setting in which the individual can reasonably expect that no observation or recording is taking place information that has been provided for specific purposes, other than research, where the individual can reasonably expect that it will not be made public (e.g., a medical record.) [45 CFR 46.102(f)]. Protected Health Identifiers (PHI)
DHHS Definition (cntd)Coded Private Information or Biological SpecimensDHHS Office of Human Research Protection (OHRP) policy considers private information or specimens to be individually identifiable when they can be linked to specific individuals either directly or indirectly through coding systems. DHHS OHRP guidance states that only a knowledgeable person or entity is authorized to determine if coded specimen or data constitute research. An investigator cannot make that determination.
Institutional Review BoardIRB is a review committee established to help protect the rights and welfare of human research subjects.Authority of the IRB:Approve, disapprove, or modify researchConduct continuing reviews Observe and verify changesSuspend or terminate approvalObserve the consent process and research procedures
Review CategoriesExemptExpedited ReviewFull board ReviewDepends on the Risk Level (physical, psychological, social and economic risk)
What is minimal risk?Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Review Categories (cntd)May be ExemptProjects that present no more than minimal risk to the participants and do not compromise the privacy of the participants or confidentiality of the dataFits 1 of 6 categoriesReviewed by IRB Chair or a designated memberCommon in Educational Research- No identifiers
Review Categories (cntd)May be ExpeditedProjects that present no more than minimal risk to the participants, and for minor changes in approved research Has to fit 1 of 7 categoriesReviewed and approved by 1 or 2 IRB Committee MembersCommon in Educational Research for data collection methods that use audio/visual data collection- Retain identifiers
Review Categories (cntd)Full Board ReviewProjects involving more than minimal riskFull Committee meets once per month (Applications must be received at least 10 days before the next meeting date)Researcher are invited to present the researchCommittee members ask the researcher questions regarding the research and participation of human subjectsVote is taken (in the absence of the researcher) and recommendations are made
Review Categories (cntd)Continuing ReviewAnnually for Expedited or Full Board approved applications.Email notifications sent two month prior to approval expiration date.Must complete the Continuing Review Form and attach a copy of the consent form.Same type of review as the original application with some exceptions.
Review by InstitutionResearch that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, institutional officials may not approve the research if it has not been approved by an IRB.
Criteria for IRB Approval of Research 1. Risks to subjects are minimizedsound research design which do not unnecessarily expose subjects to risk, using procedures already being performed on the subjects for diagnostic or treatment purposes. 2. Risks to subjects are reasonable in relation to anticipated benefits, and the importance of the knowledge that may result. 3. Selection of subjects is equitable.
Criteria for IRB Approval of Research (cntd)4. Informed consent is sought. 5. Informed consent is appropriately documented.6. Plans for monitoring the data collected to ensure the safety of subjects.7. adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.8. additional safeguards to protect vulnerable population (children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons).
IRB RequirementsIRB must review: Qualification of the PI and collaboratorsFull description about conflicts of interestA complete description of the proposed researchProvisions for the adequate protection of rights and welfare of subjectsCompliance with pertinent federal and state laws/regulations and institutional policies
HIPAA RequirementsHealth Insurance Portability and Accountability Act Mandated standards for storage and transmission of healthcare informationHHS- The Privacy Rule & Security RuleThe research must be HIPAA compliantHIPAA language requirement in consent formPHI- Protected Health Information- 18 identifiersAuthorization, Limited Data Set (16 ids) and Data Use Agreement De-identified Health Information- No restrictions
Informed Consent ProcessIt is a process and not just a form. It includes:Recruitment materialsVerbal instructions (in person or via video, DVD)Written materialsQ & A session(s)Documentation of consent by signature
Informed Consent Process (cntd)Participants must understand the nature of the research.Participants must be able to knowledgeably and voluntarily decide whether or not to participate.Participants must understand the risks and benefits of participation.The IRB must determine that informed consent will be properly obtained.
Elements of Informed ConsentEight Basic ElementsResearch, Purpose, Procedures (experimental), Expected durationRisks and discomfortBenefitAlternatives procedures (Treatments)Confidentiality of recordsMedical treatment in case of research related injuryContact Info: Research Qs, Rights Qs, Injury QsParticipation is Voluntary
Elements of Informed Consent (cntd)Additional elements, as appropriateUnforeseeable Risk (embryo or fetus)Participation may be terminated by researcherAdditional cost to subjectsConsequences of early withdrawal by subjectsSignificant new findings that may affect wiliness to continue participationApproximate number of participants
Elements of Informed Consent (cntd)VoluntaryConsent if voluntary, free of coercive elementsRight to refuse or withdraw with no penaltyUnjustifiable pressures occur when persons in authority urge a course of action for a subjectCoercion is likely whenever possible sanctions are involved (implied or actual)Undue influence occurs through an offer of an excessive, unwarranted, inappropriate or improper rewardConsent process may not involve the use of exculpatory language
Elements of Informed Consent (cntd)ComprehensionOrganizedAmple time for considerationOpportunities for questionsLay language appropriate for subject
Waiver or Alteration of ConsentThe IRB may approve a waiver or alteration of the consent process provided:The research involves no more than minimal risk to the subjects;The waiver or alteration will not adversely affect the rights and welfare of the subjects;The research could not practicably be carried out without the waiver or alteration; andWhenever appropriate, the subjects will be provided with additional pertinent information after participation.
Important Components of ProtectionMinimizing RiskMaintaining ConfidentialityMaintaining and Destroying RecordsMaintained for at least 3 years after the completion of the study and then destroyed in a manner that will protect the identity of human subjects.Reporting Adverse Events Related to Research
Approved ResearchResearch must be conducted as approved by the IRB.Any changes to original application must also be approved before implementation.Report changes to the IRB via modification form found in the document library of IRBNetIRB approval is valid for a maximum of one year a Continuing Review Form must be submitted to extend the research beyond one year.
How to ApplySubmit an application via IRBNet accessible through the Human Subjects (IRB) link on the ORA website.All sections of the forms must be completed.The application must include conflict of interest disclosures and CITI training completion reports for all key personnel, as well as the PI Assurance Form.Al