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IRB Primary Purpose

Navigating the Institutional Review Board (IRB) Process at Texas Woman’s University Dr. Rhonda Buckley, Chair Dr. Vicki Zeigler, Co-Chair Ms. Bonnie King, IRB Senior Secretary, ORSP Ms. Tracy Lindsay, Director of Operation, ORSP (940) 898-3378 ACT 7th floor IRB@TWU.EDU. IRB Primary Purpose.

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IRB Primary Purpose

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  1. Navigating the Institutional Review Board (IRB) Processat Texas Woman’s UniversityDr. Rhonda Buckley, ChairDr. Vicki Zeigler, Co-ChairMs. Bonnie King, IRB Senior Secretary, ORSPMs. Tracy Lindsay, Director of Operation, ORSP(940) 898-3378ACT 7th floorIRB@TWU.EDU

  2. IRB Primary Purpose To protect human participants by insuring they are treated appropriately and to protect investigators by having an independent process verify that they are dealing properly with the human participants in their research.

  3. Governing Policies & Procedures • FederalwideProject Assurance # FWA00000178 • TWU University Policy 1.15 Human Subjects in Research • TWU IRB Procedures – January 2012 (revised copy to be released within 1-2 weeks) • Guidance for Course-related Activities/Class Projects • Guidance for Oral Histories • Guidance for Studies Involving the Use of Drawings for Prizes as Incentives for Participation in Research • Review of Research for Sponsored Projects • Closeout of Protocols for Faculty Leaving University

  4. 2013-2014 Denton IRB Membership Dr. Rhonda Buckley, Family Sciences, ChairDr. Vicki Zeigler, Nursing, Co-chairDr. Kathy DeOrnellas, Psychology & PhilosophyDr. Nancy DiMarco, Institute for Women’s HealthMs. Sherrill Harnish, Occupational TherapyDr. Pat McGregor, Citizen MemberDr. David Nichols, KinesiologyMr. Robert Placido, Office of TechnologyDr. Nila Ricks, Sociology & Social Work Dr. Lisa Rosen, Psychology & PhilosophyDr. Ludovic Sourdot, Teacher EducationMr. Andy Tucker, LibraryConsultants:Dr. James Williams, Sociology & Social WorkDr. Linda Ladd, Family Sciences Medical Consultant:Connie Menard, M.D., Student Health Services

  5. Website Application materials and other forms are available on our website at http://www.twu.edu/research/irb.aspin Microsoft Word format

  6. Training Requirement • All research team members (including principal investigators, research assistants, major advisors, and staff) are required to successfully complete an IRB (human subjects) training course. A current certification (less than 3 years old) must be submitted with all levels (exempt, expedited, and full reviews) of new IRB applications and with any request for extension. • The TWU IRB accepts training certificates from the National Institutes of Health (NIH) and through the Collaborative Institutional Training Initiative (CITI). Researchers should verify with the IRB prior to protocol submission whether training certificates from other sources will be approved. NOTE: only ONE training course is required (CITI OR NIH, not both). • The human subjects training should not be confused with the Responsible Conduct of Research (RCR) training which is a Graduate School requirement. • http://www.twu.edu/research/irb-training.asp

  7. Different Categories of Review • Exempt • Expedited • Full Review

  8. Exempt Studies • Involve little or no risk. Usually these are anonymous questionnaires (on non-sensitive topics) or studies evaluating normal school curriculum. • Are reviewed by one IRB member (usually the IRB chair or co-chair). • Usually receive a response within 1-2 weeks.

  9. Expedited Studies • Involve minimal risks and do not utilize vulnerable populations. These are often surveys or interviews which are not anonymous (although confidential) and do not contain extremely sensitive materials. • Are sent to 3 reviewers (through email). These reviewers then send their comments back to the IRB office where they are compiled into a letter. • Usually receive a response within 2-3 weeks.

  10. Full Review Studies • Studies which involve more than minimal risks, extremely sensitive topics, or vulnerable populations. • Must be reviewed by the full committee at a convened meeting. The application will be reviewed at the next meeting for which it meets the deadline. See website for specific deadlines. • Usually receive a response the week after the meeting date.

  11. Dual Review Studies Studies conducted at offsite institutions may require approval by the offsite institution’s IRB. TWU requires that studies also be reviewed and approved by the TWU IRB (dual review) at the same level as the original review. Regardless of the approval method, consent documents must meet TWU requirements

  12. Completing the ApplicationFrequently Asked Questions/Issues Advice on the best way to get your IRB application approved!

  13. Read the Instructions • The instructions for each type of application can be found @: • TWU WebsiteResearchInstitutional Review Board / IRB • Exempt Application Form and Instructions • Expedited / Full Review Application Form and Instructions

  14. Vulnerable Populations • Research with vulnerable populations includes the following: AIDS research Children Pregnant Women Prisoners Fetuses/Neonates If you think you may have a vulnerable population, complete the full review application rather than the expedited application. For example, victims of intimate partner violence would be considered a vulnerable population even though it is not included as such in the OHRP guidelines. If you are not sure, contact your IRB Chair or Co-Chair

  15. Provide detailed, pertinent information • Purpose of the study: provide the purpose, research questions/hypotheses instead of extraneous information. • Participants: provide exactly who will be participating in your study – who are these participants? • Recruitment: provide exactly what you will be doing to get people to participate in your study – who, what, when, where, how? • Procedures: provide exactly what you will be doing with people who are participating – who, what, when, where, how?

  16. Confidentiality and/or Anonymity • Confidentiality • 1. Identifiable information is collected • 2. Research Team members know the identities of participants or have access to the identities of participants • Ex: Observational research, focus groups, qualitative studies utilizing interviews, case study research, survey research with identifiable information • Anonymity • 1. No identifiable information is collected • 2. No one knows the identities of any of the participants or has access to the identities of participants • Ex: Survey research in which no identifiable information is collected and no participant identities are known

  17. Identifiable Data/HIPAA • The Health Insurance Portability and Accountability Act (HIPAA) of 1996 categorized 18 pieces of information as personally identifiable information. This is important because once you collect one of these pieces of data, regardless if your study is health oriented or not, your data is no longer anonymously collected. • If you are collecting this information in your research study, you’ll want to consider: (1) how the data will be kept confidential and (2) if public disclosure of the data will potentially harm participants as collecting this data can potentially increase this participant risk in your study.

  18. HIPAA 18 Pieces of Identifiable Data • Names • Address information (except state of address) • All dates related to an individual (e.g., birth date, date of marriage) • Phone numbers • Fax numbers • Email addresses • Social Security numbers • Medical record numbers • Health plan beneficiary numbers • Account numbers • Certificate/license numbers • Any vehicle identifiers, serial numbers, or license plate numbers • Device identifiers and serial numbers • Web Universal Resource Locators (URLs) • Internet protocol (IP) address numbers • Biometric identifiers (finger and voice prints) • Full face photographic images or comparable images • Any other unique identifying number, characteristic, or code (excludes study ID code)

  19. Risks • All studies have risks, there is no such thing as a study with no risks • Some risks are minimal and others are serious • Be sure to include all potential risks in your application • Include the steps to minimize those risks • The steps to minimize the risks must be logical – e.g., paying participants is not a way to minimize loss of time • All risks and steps to minimize those risks must be exactly the same in the application and the consent formor you will be asked to resubmit accordingly after making requested changes

  20. Consent Forms/Consent Information • If you have to obtain written consent, please use our sample consent form (Guide to Writing a Consent Form and Sample Consent Forms: Denton) • If you are using an online survey, include the consent information prior to participants answering survey items in the same format as delineated above. • Written consent forms MUST include multiple pieces of information before they can be approved, therefore it is very important to read and follow the instructions and use the sample.

  21. Consent Forms • If you are using written consent, make sure the pages are numbered in the following way: Page 1 of 2, Page 2 of 2 • Place a line for initials on all pages that do not have the signature line for consent • Written consent forms are considered identifiable information and should be kept in a locked file drawer in the PI’s office • Written consent forms should not be destroyed (like other identifiable data), but should be turned in to the IRB at completion of the study

  22. Consent Forms • Regardless of whether your consent form will be on paper or online, use the template on the IRB website as your guide • Make sure to include the required elements regarding confidentiality, especially if you will be using email, the Internet, or any form of electronic communication

  23. Recruitment Flyers • Recruitment flyers should be written in simple language • Provide specific information regarding how the flyers will be used. For example, “they will be placed in hospital break rooms on all medical surgical units.” • The flyer/script must contain the following elements: • The study is considered research • Participation is voluntary • Inclusion criteria • Contact information • If you will be using email, the Internet, or any form of electronic communication, include the TWU email statement

  24. Recruitment Scripts • Whether recruiting via telephone or email, a recruitment script must be included with the IRB application • It must contain the same elements as a recruitment flyer • When composing your script, think about what you will say to the potential participant when you email or speak with him/her and write that information down • At the end, participants should be given the opportunity to agree to participate or not agree to participate

  25. What is Agency Approval and when do I need it? • You may choose to recruit your participants or collect your data from a certain venue (hospital, website, school, etc.) • These venues are called agencies by the IRB • In order to recruit or collect data at these venues, you need permission from the venue or agency • This approval should state what it is the venue is giving you permission to do and it should be on letterhead accompanying your application • Some agencies require IRB approval first, so make this note on your application if this is the case

  26. How do I know if I need a Dual Review? • If you are collecting data at a certain institution, you may need to get dual IRB approval • For example, if you work at a hospital, they may require that you go through the hospital’s IRB, but because you are a student or faculty member at TWU, you must also get TWU IRB approval • Some institutions require that you obtain TWU IRB approval first and some want you to get institutional approval first • Check with the institution’s IRB to find out which one to do first • The level of review will be the same for both, i.e., if the hospital review was expedited, the TWU review will be expedited

  27. Using a Transcriptionist • If you will use a transcriptionist for your study, you need not include them as a research member in your application • You should have the transcriptionist complete the TWU IRB confidentiality agreement and include it with your application

  28. Be Consistent • All information in the application, recruitment materials and consent information must match • Most common errors: • Mismatched risks and steps to minimize those risks • Mismatched time allotments for participation • Mismatched procedures

  29. Spelling, Grammar, Sentence Structure • All materials that will be used for recruitment and participation in your study (e.g., emails, consent forms) must use proper spelling, grammar and sentence structure • Spelling, grammar and sentence structure are crucial in making sure that all information presented to potential participants and actual participants is clear. • Recruitment, procedural information and consent forms need to be written at a very low reading level (5th or 6th grade level for laypersons). • Any and all field-specific vernacular needs to be defined so that anyone outside of your field can understand exactly what you are doing.

  30. Provide the Board with All Materials • All recruitment materials (e.g., emails, flyers, phone scripts, Facebook posts, newspaper ads) • All procedural materials (e.g., surveys, observational coding sheets, body marker guides, time sheets, research questions, food diaries, recipes) • NIH certificates for all members of the research team – must be updated every three years

  31. IMPORTANT: PROOF, PROOF, PROOF! • PLEASE • READ • OVER • ORGANIZE • FINALIZE

  32. Requested Revisions • If you are required to submit revisions, please follow the instructions for submission; this makes it much easier (and faster) for committee members to review and approve the revisions. • Specifically: • Address each and every item by number in the application and/or supporting documents including the consent form • Highlight all changes with corresponding numbers • Submit a clean copy of the consent form with requested changes • If changes were not made, clarify the rationale for this in a cover letter to the IRB

  33. Process After Submission

  34. Exemption Letter

  35. More Info Letter

  36. ApprovalLetter

  37. Modifications Complete a modification request form when changes must be made to an approved study. This change could be a change in the research team, data collection sites, protocol (e.g., compensation, study procedures, etc.), and/or the informed consent. IMPORTANT: You may not implement any changes to an IRB-approved study until your Modification Request has been approved.

  38. Incident Reports TWU investigators conducting research with human participants are responsible for reporting all incidents that may be considered adverse events, unanticipated problems, or serious or continuing noncompliance. Incidents must be reported verbally to the IRB Office (940-898-3375) within two (2) working days of the occurrence. A completed IRB Incident Report Form must be submitted to the IRB within five (5) working days of the occurrence. An adverse event is any untoward or unfavorable occurrence in a human subject, including any abnormal sign, symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research. The IRB will notify department administrator(s) or other entities as necessary following review of incident reports.

  39. Notification of Expiration

  40. Extending a Study

  41. ExtensionLetter

  42. Closing a Study

  43. File Close Notification

  44. Forced Closure

  45. Contact Information Mailing Address: TWU’s Office of Research & Sponsored Programs Institutional Review Board PO Box 425619 Denton, TX 76204-5619 Phone: (940) 898-3378Fax: (940) 898-4416 Physical Location: ACT 7th floorEmail: IRB@TWU.EDU URL: http://www.twu.edu/research/irb.asp

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