human subjects research and the irb
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DESCRIPTIONHuman Subjects Research and the IRB. Course Objectives. Review the basic ethical principles of research involving human subjects Review the basic regulatory framework for human subjects research Understand the differences in exempt, expedited and full board review. Belmont Principles. - PowerPoint PPT Presentation
Human Subjects Research and the IRB
Course ObjectivesReview the basic ethical principles of research involving human subjects
Review the basic regulatory framework for human subjects research
Understand the differences in exempt, expedited and full board review
Belmont PrinciplesRespect for Persons
Respect for PersonsTreat individuals as autonomous agents
Do not use people as a means to an end
Allow people to choose for themselves
Give extra protection to those with limited autonomy
BeneficenceActs of kindness or charity that go beyond duty
Obligations derived from beneficenceDo no harmPrevent harmPrevent evilPromote good
JusticeTreat people fairly
Fair sharing of burdens and benefits of research
Distinguish procedural justice from distributive justice
Responsibilities of IRBSafeguard rights & welfare of human subjects
Ensure subjects are adequately informed
Ensure voluntary participation
Ensure risk/benefit ratio is acceptable
Suspend & report studies that violate regulations
Responsibilities of InvestigatorObtain prospective IRB approval
Adverse events & protocol violations must be reported to IRB
Investigator can be held liable if willfully violates scope of research or does not obtain prospective IRB approval
Obtain MentorIf the PI is a student/trainee, a Mentor is required.
Mentor must be full time Faculty.
This person is listed on the IRB Application as a Mentor.
Educational MandateCITI / Univ. of Miami Tutorial Required
Definition of ResearchResearch is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge
45 CFR 46.102(d)
Definition of Human SubjectLiving individual
About whom an investigator obtainsData through intervention or interaction with the individualORIdentifiable private information
45 CFR 46.102(f)
Types of IRB Review
Exempt, Expedited and Full Board
Type of review depends on level of risks to subjects and federal regulations. Risk due to breach of confidentiality is always considered.
Minimal RiskA risk is minimal when the probability and magnitude of harm or discomfort anticipated in the research is no greater than that ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests
Exempt Research ActivitiesLess than minimal risk to subjects
Does not mean exempt from IRB reviewRequires determination from IRB Chair or his/her designee
ExamplesRetrospective chart reviewdata collection with no identifiersSurveys, questionnaires if the information is recorded without identifiers
Minimal risk to subjects
Does not mean review light or Fast ApprovalReview by Chair or designee
ExamplesStudies involving venipuncture only- volume of collection is limited.Prospective non-invasive collection of data/specimens (i.e., hair, nail clippings, saliva, etc.)Retrospective chart review in which identifiers must be documented
Full BoardGreater than minimal risk to subjects Investigational drugs/devicesSensitive issues (i.e., substance abuse, domestic violence)Protected Populations (i.e. children, cognitively impaired, pregnant women, fetuses, neonates, etc.)
Reviewed by Full Board at a convened meeting
IRB PROCESS(New Study)
PLAN AHEAD TO AVOID DELAYS
Determine which IRB to submit to Will depend on Dept and SponsorOff Site ResearchConsider ancillary committees (i.e. VA R&D, PRC, GCRC)
Review meeting dates & deadlines on IRB web siteIRB I & IRB II meet once a monthIRB III meets twice a month
Decide the type of study Exempt (review categories)Expedited (review categories)Full Board
IRB PROCESS (Cont)Electronic applicationCurrent System- ERMA http://erma.musc.edu/New System- eIRB http://hssc.scra.org/HSSCSTAGING
Determine items to submit with application. For example:Protocol (Use template on IRB website) http://research.musc.edu/ori/index.htmlInformed Consent (use guide on IRB website) or Consent WaiverHIPAA Authorization / HIPAA WaiverAdvertisements (include the word research; cannot be coercive, need contact information, etc.)Drug / Device Information Sheet if applicableSurveys and questionnairesBudget / IIT
IRB FORMS PAGEhttp://research.musc.edu/ori/irb/forms.html
PI Statement of AssuranceSignatures may only be obtained after submission of electronic application to the IRB
Signatures needed:PIMentor (If PI is a Student/Trainee)Department ChairAssociate Provost for Research (If research is Non-Sponsored or internally sponsored)
INFORMED CONSENT3 Key Elements:InformedUnderstoodVoluntary
MUSC Standard Consent Guide: http://research.musc.edu/ori/irb/Guidecon.html
HIPAAProtected Health information is defined as individually identifiable health information transmitted or maintained in any form (electronic, paper, or oral communication) that relates to the past, present or future physical or mental health or conditions of an individual.
HIPAA contains 18 identifiers (name, SSN, MRN, etc)
HIPAA cont.HIPAA Authorization FormThe subject has signed a written Authorization containing all the elements specified in the Privacy Rule that will be used in the study.
HIPAA Waiver of Authorization Form Used when it is impracticable to obtain written authorization from research participants.
IRB PROCESS (Cont)IRB checks for completenessExempt applications are reviewed by IRB Chair or his/her designeeExpedited and Full Board applications are reviewed by IRB Administrator and Primary ReviewersComments/questions sent to PI (via electronic database)PI provides response (via electronic database upload revised documents)
IRB PROCESS (Cont)Once the IRB is satisfied, approval is granted
Exempt & Expedited - IRB Chair (or the Chairs designee) gives approval
Full Board the board can approve, table or disapprove
Sponsored research requires release from ORSP verifying successful contract completion.
AmendmentsChange in Personnel
Change in Recruitment Process
Full Board AmendmentsChanges to approved studies that are greater than minimal risk will be reviewed by the Full Board at a convened meeting and must be submitted in accordance with deadlines. Increased riskIncreased dose range or increased number of subjectsAdding minors or other protected populationsChanges to an IND/IDE study other than administrative in nature.
If changes are not tracked on informed consents and/or protocols, they will be returned to the PI without review.
Continuing ReviewsRegulations require review no less than once a year or at intervals appropriate to the level of risk as determined by the Board.
Allow IRB to continue to assess the risk/benefit ratio of the study
Due one month prior to expiration; reminder sent two months prior to expiration
If a study is not renewed by the IRB, it will expire and be out of compliance. Enrollment will be suspended and/or research will be stopped. Once expired, re-instatement will require full board review and approval.
Status of study, enrollment numbers, problems or complications
Self Audit Checklist: http://academicdepartments.musc.edu/uco/documents/Audit%20Checklist%20MUSC%20and%20VA.doc
The University Compliance Office will initiate audits based on the following criteria: Priority 1: For-Cause-Audit: HR Study where allegations of human subjects violations have been lodged against a Principal Investigator. Priority 2: Administrative Audit: HR study where the IRB chair has identified a potential administrative problem with study documentation.Priority 3: Random Audit: HR study selected by chance using a random number generator. Each study has an equal likelihood of selection. This is the most common type of audit.
Where to Find AssistanceThe IRB
Research Support Serviceshttp://research.musc.edu/researchresourses.html
SUCCESS CenterProvides assistance with research navigation and development
IRB KEY CONTACTS
IRB Main Number- 792-4148IRB Program ManagerStacey Goretzka, CIP 792-6527 (firstname.lastname@example.org)
IRB ILinda Bunch, CIP- IRB I-Administrator 792-2525 (email@example.com)Katherine Duncan- IRB I- Coordinator 792-4843 (firstname.lastname@example.org)
IRB IILisa Johnson, MBA-IRB II- Administrator 792-4144 (email@example.com)Alanna Herman-IRB II-Coordinator 792-6710 (firstname.lastname@example.org)
IRB IIIJackie Shedrow, CIP-IRB III Administrator 792-3071 (email@example.com)Yashmin Karten, PhD, MBA-IRB III Administrator 792-6521 (firstname.lastname@example.org)Kenneth Thomas-IRB III Coordinator 792-9128 (email@example.com)Cheryl Green-IRB III Coordinator 792-3093 (firstname.lastname@example.org)
EXPEDITED and EXEMPT STUDIESSummer Young, JD, MPH Administrator 792-6534 (email@example.com)