IRB Review and Approval of Community Based Research

1. IRB Review and Approval of Community Based Research University of Alabama Office for Research Compliance (ORC)

2. I’m convinced the IRB is CRAZY!ORHas anyone ever received approval for a CBR project?

3. Overview • Definition and Purpose of the IRB • CBR IRB Challenges • Steps Before Submitting the IRB Application • Application Guidance • Ways to Submit the Application to the ORC • The Application Review Process • Continuing Review • Tips for Easing the Review Process • CRB IRB Opportunities • Question and Answer

4. What is the “IRB” • “IRB” 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 money

5. Purposes of the IRB • To protect the health, welfare and rights of HUMAN research participants • To review and approve all UA research with human participants • To monitor ethical conduct of research • To educate the UA community as well as the outside community about ethical research and research rights

6. Community Based Research and the IRB • Challenges • Lack of understanding of CBR. • Accessibility of IRB. • Current Regulations do not fully address CBR. • More likely that ethical considerations will evolve during project • Requires 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.

7. Steps Before Submitting the IRB Application • Develop an Idea about the Research • Consider: • The topic to research • Will this involve human subjects as participants • Time from conception of the idea to a written draft

8. Steps Before Submission continued • Visit 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 Information • Human Subjects Training Certificate • Copies of Study Stimulus (survey instruments, video stimulus, interview guides, etc.) • Consent form/Assent form or waiver request • Plan for carrying out the research

9. Application Guidance IRB applications should be arranged in the following order • Request for Approval Form (face sheet) • Personnel list • Research Description • Appendices (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.html http://osp.ua.edu/site/irb_guidance_documents.html

10. Consent Form Required Elements • Statement that the study involves research • Statement of Purpose • What participation will involve (what will participants be asked to do) • Time Required for Participation • Description of Risks • Description of Benefits • Disclosure of Alternatives to taking part in the research • Confidentiality • Compensation / Reimbursement • Participation is voluntary • Whom to Contact http://osp.ua.edu/site/irb_guidance_documents.html

11. Consenting in CBR • Crucial 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.

12. Vulnerable Populations • Children • Cognitively Impaired • Prisoners • Pregnant 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

13. Minors 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) • maturity • and psychological state of the child

14. Ways to Submit the Application • Our office receives protocol submissions via the following methods • Email • Traditional Mail • eProtocol 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.

15. The Review Process • Applications for Human Subjects Research fall into three categories: • Exempt Review • Expedited Review • Full 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.

16. The 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) via email 3) Responses from the PI are reviewed

17. The 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 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

20. Closure • Continuing 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

21. Tips for Easing the IRB Review Process • Ask Questions- • Office for Research Compliance staff are available Monday through Friday from 8 AM to 4:45 PM • 358 Rose Administration Building • Phone 205-348-8461 • Fax 205-348-8882 • Email general questions to rscompliance@fa.ua.edu

22. Tips for Easing the IRB Review Process continued • Allow yourself enough time to complete the process • Submit to 358 Rose Administration • Email : 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

23. Community Based Research and the IRB • Opportunities & Solutions • Relationship building with IRB –currently 3community 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.

24. Contact Information Office for Research Compliance – (205) 348-8461 Tanta Myles – Director of Research Compliance cmyles@fa.ua.edu Jeanelle Graham – Research Compliance Specialist jgraham@fa.ua.edu Ed Shirley – Research Compliance Specialist EShirley@fa.ua.edu Tyler Uzzell – Research Compliance Specialist tuzzell@fa.ua.edu Mukesha Voltz – Research Compliance Specialist mvoltz@fa.ua.edu

25. Questions???