Presentation on theme: "IRB Review and Approval of Community Based Research"— Presentation transcript:
1IRB Review and Approval of Community Based Research University of AlabamaOffice for Research Compliance (ORC)
2I’m convinced the IRB is CRAZY I’m convinced the IRB is CRAZY! OR Has anyone ever received approval for a CBR project?
3Overview Definition and Purpose of the IRB CBR IRB Challenges Steps Before Submitting the IRB ApplicationApplication GuidanceWays to Submit the Application to the ORCThe Application Review ProcessContinuing ReviewTips for Easing the Review ProcessCRB IRB OpportunitiesQuestion and Answer
4What is the “IRB” “IRB” is short for “Institutional Review Board” The IRB is a University Committee that reviews, approves, and monitors human subjects researchThe existence of the IRB is required by the federal government because UA receives federal research money
5Purposes of the IRBTo protect the health, welfare and rights of HUMAN research participantsTo review and approve all UA research with human participantsTo monitor ethical conduct of researchTo educate the UA community as well as the outside community about ethical research and research rights
6Community Based Research and the IRB ChallengesLack of understanding of CBR.Accessibility of IRB.Current Regulations do not fully address CBR.More likely that ethical considerations will evolve during projectRequires the ability to deal with unexpected issues as they arise.Researchers conducting CBR may be unfamiliar with how to meet IRB requirements.Ethical issues in CBR are active and on going as research continues.Current IRB reviews are not set up to deal with ongoing ethical issues.Risk and Benefits of CBR project needs to be weighed by the entire community. Typical IRB review includes risk/benefit ratio assessment.
7Steps Before Submitting the IRB Application Develop an Idea about the ResearchConsider:The topic to researchWill this involve human subjects as participantsTime from conception of the idea to a written draft
8Steps Before Submission continued Visit the IRB web site for guidance on what information you need to provide the ORCBasic Information Needed Includes:Study Description & Background InformationHuman Subjects Training CertificateCopies of Study Stimulus (survey instruments, video stimulus, interview guides, etc.)Consent form/Assent form or waiver requestPlan for carrying out the researchThe document should be in layman's terminology such that individuals outside of your field can understand the research.
9Application GuidanceIRB applications should be arranged in the following orderRequest for Approval Form (face sheet)Personnel listResearch DescriptionAppendices (which can include Consent and Assent forms or waivers, advertising/recruitment materials, and any supplementary forms, as for vulnerable populations)If announcements are being made in class regarding a research project, the IRB will need to review a copy of the recruitment script. If you are utilizing a subject pool such as the Psychology 101 subject pool you will need to include a copy of the announcement that will be posted to the subject pool website.
10Consent Form Required Elements Statement that the study involves researchStatement of PurposeWhat participation will involve (what will participants be asked to do)Time Required for ParticipationDescription of RisksDescription of BenefitsDisclosure of Alternatives to taking part in the researchConfidentialityCompensation / ReimbursementParticipation is voluntaryWhom to ContactPrivacy vs. Confidentiality – add notes
11Consenting in CBRCrucial to realize that consent is a process NOT a document.Issues of literacy and language are primary consideration.Potential participants may have crucial information but must understand that they have the right to choose not to participate.CBR more likely to use methods like face to face interviews making privacy an issue.Participants in CBR studies often live in small communities and can be easily identified by quotes.CBR researcher need to be aware of laws and mandated reporting requirements. Consideration should be given to whether this information needs to be a part of the consent.Privacy vs. Confidentiality – add notes
12Vulnerable Populations ChildrenCognitively ImpairedPrisonersPregnant Women, Fetuses, and NeonatesProjects involving these groups require supplemental forms which can be found on the IRB website
13Minors as Research Subjects A minor is defined in Alabama as a person less than 19 years old and not emancipated by the court, not legally married.Minors cannot legally grant consent.Must provide assent (active agreement - lack of a no does not mean yes).The assent process must be appropriate to the study as well as to:the age (recommended for ages 7 and older)maturityand psychological state of the child
14Ways to Submit the Application Our office receives protocol submissions via the following methodsTraditional MaileProtocol Submission (online submission system)Please note: In order to use the eProtocol system you will need to request a user ID and password from
15The Review ProcessApplications for Human Subjects Research fall into three categories:Exempt ReviewExpedited ReviewFull Board ReviewPlease note: The type of review that an application receives is determined within the Office for Research Compliance, but researchers may request a particular type of review.
16The Review Process continued General Steps include the following:1) The Human Subjects Application is reviewed by a Research Compliance Specialist for completeness.2) Feedback is provided to the Principal Investigator (PI) via3) Responses from the PI are reviewed
17The Review Process continued For Exempt review- Applications are reviewed by the Research Compliance Officer (RCO) to verify exempt status, if determined exempt, then the RCO approve the project and the IRB approval is grantedFor Expedited review- Applications are sent to one or two members of the IRB to verify expedited status; if determined that the application can be given an expedited review, then the reviewer may ask additional questions or approve the project . Please note in some instances, the reviewer will refer the protocol for review by the convened IRBFor Full Board Review-Applications are reviewed by a subcommittee of the IRB in which additional information may be requested; Applications are then reviewed at the convened IRB meeting, in which the board may make any of the following determinations:approve,approve with modifications,disapprove,table,or ask the PI to revise the application and resubmit to the board
20ClosureContinuing review is not required for studies in which data collection from human participants has ended, if the dataset no longer contains participant identifiers and there are no means of re-establishing the link.If data will remain identifiable, investigators must keep the IRB approval active.Investigators are urged to state in their applications how long they will retain the data and whether data will remain identifiable.
21Tips for Easing the IRB Review Process Ask Questions-Office for Research Compliance staff are available Monday through Friday from 8 AM to 4:45 PM358 Rose Administration BuildingPhoneFaxgeneral questions to
22Tips for Easing the IRB Review Process continued Allow yourself enough time to complete the processSubmit to 358 Rose AdministrationPrior to IRB submission, complete your human subjects training; if you are not sure whether or not your training is current, you may call our office to verifytraining website:
23Community Based Research and the IRB Opportunities & SolutionsRelationship building with IRB –currently 3 community members on the Non-Medical IRB and one on the Medical IRB.Provide better education for researchers on the IRB process.Add additional CB researchers to the IRB to expand expertise.Continuing education for IRB members regarding CBR.Community based researchers and the IRB need to develop closer relationships than usually required of standard research.
24Contact InformationOffice for Research Compliance – (205)Tanta Myles – Director of Research ComplianceJeanelle Graham – Research Compliance SpecialistEd Shirley – Research Compliance SpecialistTyler Uzzell – Research Compliance SpecialistMukesha Voltz – Research Compliance Specialist