10 STEPS TO IRB APPROVAL

Transcription

1 10 STEPS TO IRB APPROVAL

2 STEP 1: OBTAIN CITI TRAINING CERTIFICATE ALL STUDY PERSONNEL MUST TAKE AN ONLINE HUMAN SUBJECTS TRAINING EDUCATION PROGRAM. THE CERTIFICATES OF COMPLETION ARE NEEDED FOR ALL STUDY PERSONNEL IN ORDER TO SUBMIT A RESEARCH PROJECT. GO TO TO COMPLETE THIS COURSE FOR PRINCIPAL INVESTIGATORS AND KEY PERSONNEL.

3 STEP 2: FAMILIARIZE YOURSELF WITH THE TULANE HRPO WEBSITE CONTAINS USEFUL AND HELPFUL INFORMATION. SEE THE INVESTIGATORS GUIDANCE TAB TO DETERMINE THE TYPE OF REVIEW. THERE ARE LINKS FOR: -TYPES OF IRB REVIEW -CRITERIA FOR EXEMPT DETERMINATION -CRITERIA FOR EXPEDITED DETERMINATION -CRITERIA FOR IRB APPROVAL

4 STEP 3: CREATE AN IRBNET ACCOUNT THE TULANE HRPO ONLY ACCEPTS SUBMISSION VIA OUR ELECTRONIC DATABASE, IRBNET. GO TO AND CREATE AN ACCOUNT. THERE IS AN IRBNET USERS GUIDE AND A SHORT INSTRUCTIONAL VIDEO LOCATED ON THE HRPO WEBSITE. ALL OF THE FORMS/CHECKLISTS/TEMPLATES ARE FOUND UNDER THE FORMS & TEMPLATES LINK IN IRBNET.

5 STEP 4: REVIEW THE INITIAL SUBMISSION CHECKLIST REVIEWING THIS CHECKLIST WILL ASSIST YOU WHEN PUTTING TOGETHER A COMPLETE SUBMISSION. THERE ARE REQUIREMENTS FOR ALL STUDIES AND DEPENDING UPON YOUR RESEARCH, OTHER FORMS AND INFORMATION MAY BE NEEDED. THE CHECKLIST CAN BE FOUND ON THE HRPO WEBSITE UNDER INVESTIGATOR GUIDANCE AND ALSO IN IRBNET.

6 STEP 5: CREATE/REVIEW THE STUDY PROTOCOL A PROTOCOL IS REQUIRED FOR ALL RESEARCH STUDIES. IF THE RESEARCH IS SPONSORED AND A PROTOCOL HAS BEEN PROVIDED, REVIEW THE PROTOCOL. IF NO PROTOCOL WAS PROVIDED BY A SPONSOR, THE PI MUST CREATE A STUDY PROTOCOL. THERE IS A DOCUMENT ENTITLED, PROTOCOL TEMPLATE, WITHIN IRBNET AND FOUND ON THE HRPO WEB SITE UNDER INVESTIGATOR GUIDANCE THAT CAN BE USED AS A GUIDE WHEN DEVISING A STUDY PROTOCOL.

7 STEP 6: FILL OUT THE APPROPRIATE APPLICATION FORMS FOR THE STUDY GO TO THE FORMS & TEMPLATES LINK IN IRBNET TO DOWNLOAD AND FILL OUT THE APPROPRIATE FORMS. APPLICATION PART 1 IS A REQUIREMENT FOR ALL STUDIES (FILLED OUT ONLINE ON IRBNET); ALSO, DEPENDING ON THE TYPE OF REVIEW EITHER THE EXEMPT APPLICATION OR THE EXPEDITED/FULL BOARD APPLICATION IS NEEDED. ALL OF THE APPLICATIONS (EXCEPT APPLICATION PART 1) ARE DOWNLOADED, COMPLETED, SAVED, AND UPLOADED WITHIN THE SUBMISSION PACKAGE.

8 STEP 7: CREATE AN APPROPRIATE CONSENT PROCESS AND FORM A SOCIAL/BEHAVIORAL CONSENT TEMPLATE, A BIOMEDICAL CONSENT TEMPLATE, AN ASSENT TEMPLATE, AND A HIPAA TEMPLATE CAN ALL BE FOUND IN IRBNET AND ON THE HRPO WEB SITE. THESE TEMPLATES SHOULD BE USED WHEN CREATING AN APPROPRIATE CONSENT FORM. THE CONSENT PROCESS AND THE DOCUMENTATION OF CONSENT CAN BE WAIVED UNDER CERTAIN CIRCUMSTANCES. SEE THE GUIDANCE ON INFORMED CONSENT PROCESS DOCUMENT ON THE HRPO WEBSITE. THESE TEMPLATES ARE TO BE DOWNLOADED, COMPLETED, SAVED, AND UPLOADED WITHIN THE SUBMISSION PACKAGE.

9 STEP 8: UPLOAD ANY OTHER NEEDED DOCUMENTS INTO THE SUBMISSION USE THE CHECKLIST AND CONTINUE TO UPLOAD ANY OTHER STUDY DOCUMENTS. QUESTIONNAIRES, SURVEYS, FOCUS GROUP GUIDES, SITE APPROVALS, ADVERTISEMENTS, FLYERS, CITI TRAINING CERTIFICATES, TRANSLATED DOCUMENTS, ETC ALL NEED TO BE ADDED TO THE SUBMISSION. NOTE: A COVER LETTER IS REQUIRED FOR ALL SUBMISSIONS

10 STEP 9: ELECTRONICALLY SIGN OFF ON THE SUBMISSION THE TULANE HRPO POLICY REGARDING SIGNATURES: THE PI MUST ELECTRONICALLY SIGN OFF ON ALL SUBMISSIONS. EACH INITIAL SUBMISSION THAT IS SUBMITTED TO THE IRB MUST BE EVALUATED FOR SCIENTIFIC OR SCHOLARY VALIDITY. THE DEPARTMENT HEAD IS TYPICALLY RESPONSIBLE FOR ELECTRONICALLY SIGNING OFF ON THE VALIDITY OF THE RESEARCH VIA IRBNET. NOTE: IF THE PI IS THE DEPARTMENT HEAD, THEN THE DEAN OF THE SCHOOL IS TO PROVIDE THIS REVIEW AND ELECTRONIC SIGNATURE. NOTE: IF THE PI IS A STUDENT, A FACULTY ADVISOR MUST BE APPOINTED AND HE/SHE MUST PROVIDE THIS REVIEW AND ELECTRONIC SIGNATURE IN LIEU OF THE DEPARTMENT HEAD. *SIGNATURE INSTRUCTIONS CAN BE FOUND IN THE IRBNET USERS GUIDE

11 STEP 10: SUBMIT TO THE IRB FOR REVIEW ONCE YOU SUBMIT YOUR RESEARCH STUDY FOR REVIEW TO THE APPROPRIATE IRB (SOCIAL/BEHAVIORAL OR BIOMEDICAL), YOU WILL RECEIVE S IF ANY REVISIONS/FURTHER INFORMATION IS NEEDED. AN NOTIFICATION WILL BE SENT VIA IRBNET OF ANY CHANGE IN THE STATUS OF THE PROJECT.

12 REVIEW TIMELINE: NOTE: THE TIMELINE OF ANY REVIEW BEGINS AFTER A SUBMISSION HAS BEEN DEEMED COMPLETE BY THE HRPO AND IS FORWARDED OR REFERRED TO THE FULL BOARD. A NOTIFICATION WILL BE SENT TO ALL SHARED ON A PROJECT NOTIFYING OF ANY CHANGE IN STATUS.

13 ADDITIONAL SUBMISSIONS: CONTINUING REVIEWS: YOUR RESEARCH PROJECT WILL HAVE AN EXPIRATION DATE AND YOU WILL RECEIVE AUTOMATIC S FROM IRBNET NOTIFYING YOU WHEN THIS DATE IS NEARING. IF YOU WISH TO CONTINUE YOUR RESEARCH, A CONTINUING REVIEW MUST BE SUBMITTED, REVIEWED, AND APPROVED BEFORE THE EXPIRATION DATE. PLEASE SEE THE SECONDARY SUBMISSION CHECKLIST FOR THE ITEMS NEEDED AND THE IRBNET USERS GUIDE, WHICH EXPLAINS HOW TO SUBMIT A CONTINUING REVIEW.

14 ADDITIONAL SUBMISSIONS: AMENDMENTS: ANY AND ALL REVISIONS TO YOUR RESEARCH PROTOCOL MUST BE SUBMITTED, REVIEWED, AND APPROVED BEFORE IMPLEMENTATION. PLEASE SEE THE SECONDARY SUBMISSION CHECKLIST FOR THE ITEMS NEEDED AND THE IRBNET USERS GUIDE, WHICH EXPLAINS HOW TO SUBMIT AN AMENDMENT.

15 ADDITIONAL SUBMISSIONS: UNANTICIPATED PROBLEMS/PROTOCOL DEVIATIONS: ANY UNANTICIPATED PROBLEM INVOLVING RISK TO PARTICIPANTS OR OTHERS OR ANY DEVIATION FROM THE IRB APPROVED PROTOCOL MUST BE SUBMITTED, REVIEWED AND ACKNOWLEDGED BY THE IRB. PLEASE SEE THE SECONDARY SUBMISSION CHECKLIST FOR THE ITEMS NEEDED AND THE IRBNET USERS GUIDE, WHICH EXPLAINS HOW TO SUBMIT UNANTICIPATED PROBLEMS/PROTOCOL DEVIATIONS

16 CONTACT INFO: TULANE UNIVERSITY HRPO DOWNTOWN CAMPUS TIDEWATER BUILDING SUITE 1705 PHONE: