How to Submit an IRB Application

IRB Review and Approval of Community Based ResearchUniversity of Alabama Office for Research Compliance (ORC)

Im convinced the IRB is CRAZY!ORHas anyone ever received approval for a CBR project?

OverviewDefinition and Purpose of the IRBCBR IRB ChallengesSteps 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 AnswerWhat is the IRBIRB is short for Institutional Review Board

The IRB is a University Committee that reviews, approves, and monitors human subjects research

The existence of the IRB is required by the federal government because UA receives federal research moneyPurposes 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 rightsCommunity Based Research and the IRBChallenges Lack 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. Steps Before Submitting the IRB ApplicationDevelop an Idea about the ResearchConsider:The topic to researchWill this involve human subjects as participantsTime from conception of the idea to a written draft

Steps Before Submission continuedVisit the IRB web site for guidance on what information you need to provide the ORC http://osp.ua.edu/site/irb.html

Basic 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 research

The document should be in layman's terminology such that individuals outside of your field can understand the research.8Application 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)http://osp.ua.edu/site/irb.htmlhttp://osp.ua.edu/site/irb_guidance_documents.html

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.9Consent Form Required ElementsStatement 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 Contact http://osp.ua.edu/site/irb_guidance_documents.html

Privacy vs. Confidentiality add notes10Consenting 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 notes11Vulnerable PopulationsChildrenCognitively ImpairedPrisonersPregnant Women, Fetuses, and Neonates

Projects involving these groups require supplemental forms which can be found on the IRB website http://osp.ua.edu/site/irb_forms.html

Minors as Research SubjectsA 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 childWays to Submit the ApplicationOur office receives protocol submissions via the following methodsEmailTraditional MaileProtocol Submission (online submission system) http://eprotocol.ua.edu:8080/hs/?sa=Online+Protocol+Submission Please note: In order to use the eProtocol system you will need to request a user ID and password from rscompliance@fa.ua.edu.

The Review ProcessApplications for Human Subjects Research fall into three categories:

Exempt ReviewExpedited ReviewFull Board Review

Please 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.The Review Process continuedGeneral 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) via email

3) Responses from the PI are reviewed The Review Process continuedFor 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 granted

For 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 IRB

For 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

ClosureContinuing 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. http://osp.ua.edu/site/irb_forms.html

Tips for Easing the IRB Review ProcessAsk Questions-Office for Research Compliance staff are available Monday through Friday from 8 AM to 4:45 PM358 Rose Administration BuildingPhone 205-348-8461Fax 205-348-8882Email general questions to rscompliance@fa.ua.edu

Tips for Easing the IRB Review Process continuedAllow yourself enough time to complete the processSubmit to 358 Rose AdministrationEmail : rscompliance@fa.ua.edu

Prior 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 verify training website: http://osp.ua.edu/site/irb_training.html

Continuing education for IRB members regarding CBR.Community based researchers and the IRB need to develop closer relationships than usually required of standard research.

Opportunities & Solutions Relationship 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.Community Based Research and the IRBContact InformationOffice for Research Compliance (205) 348-8461

Tanta Myles Director of Research Compliancecmyles@fa.ua.edu

Jeanelle Graham Research Compliance Specialistjgraham@fa.ua.edu

Ed Shirley Research Compliance SpecialistEShirley@fa.ua.edu

Tyler Uzzell Research Compliance Specialisttuzzell@fa.ua.edu

Mukesha Voltz Research Compliance Specialistmvoltz@fa.ua.edu

Questions???