eirb Training Georgia Washington Anne DiSorbo

Transcription

1 eirb Training Georgia Washington Anne DiSorbo 1

2 Agenda IRB Overview Navigator Overview Insight Overview Navigating Insight Reading Workflow History 2

3 Agenda Case #1: Submitting a New Application Case #2: Linking to a Sponsor Case #3: Versioning Documents in an Amendment Case #4: Responding to a Review Case #5: Continuing Review 3

4 What is the IRB? (Institutional Review Board) Established to protect the rights and welfare of human subjects of research. Federal regulations give IRBs the authority to approve, require modifications in (to secure approval), or disapprove all human subjects research activities covered by DHHS policy and FDA or other applicable federal regulations. The Partners IRB is authorized to review and oversee human subjects research conducted by employees or agents of BWH, MGH, FH, McLean and NSMC regardless of where the research is conducted. Note: The BWH and MGH rely on the DFCI IRB for review of certain cancer-related human subjects research. 4

5 Partners IRBs 7 IRB panels About 200 committee members members are unpaid volunteers 12 meetings a month Regulations require the IRB to have at least 5 individuals: one scientist, one nonscientist, one individual who is not affiliated with the institution A quorum (more than one half ) of the IRB membership must be present to conduct business at a convened meeting NOTE: For more information on the operations of the Partners IRBs see: ating_procedures.pdf 5

6 Research Navigator Research Navigator is a consolidation of Partners research websites, intranets and online resources into a streamlined web-based portal. Members of the research community are encouraged to log into Research Navigator each day, where you will find an abundance of resources related to research administration: A consolidated view of pending tasks in InfoEd and Insight Information, tools, forms, contacts, and resources for the entire grant lifecycle organized by business process The latest news and announcements from across the research community and Partners Research Management 6

7 Research Navigator: Logging In Navigate to the public site at and click on Employee Login. Then Log in with your PHS Credentials: You can log into the Navigator from any web browser in any location. All you ll need is your primary address and Partners username and password. On the Office 365 Login page, enter your primary address. If the first address you enter doesn t work, try your alternate one (example: jdoe@mgh.harvard.edu instead of jdoe@partners.org) You will be directed to a Partners login page, and asked first for your user ID, followed by a page for your password 7

8 Research Navigator: Logging In On the Office 365 Login page, enter your primary address. If the first address you enter doesn t work, try your alternate one (example: jdoe@mgh.harvard.edu instead of jdoe@partners.org) You will be directed to a Partners login page, and asked first for your user ID, followed by a page for your password 8

9 9 Research Navigator: Toolbar

10 10 Research Navigator: Applying for a New Study

11 11 Research Navigator: Submitting CR, Amendment, Exception, Etc.

12 Insight Research Portal The Insight Research Portal is a web application that allows investigators to manage their research portfolio. It contains 7+ modules for IRB, Grants & Contracts, Effort Reporting, Building Budgets, etc. The module for IRB processes is called Humans/eIRB 12

13 What eirb Includes. FORMS Initial Review: New protocol Amendment: Changing/updating the protocol or related documents Continuing Review: Progress to date, documents for re-approval Other Event: Adverse Event, Unanticipated Problem, Protocol Exception. Additional eforms: Investigator Disclosure/Conflicts of Interest Templates: Consent Forms Protocol Summary Note: Protocols submitted prior to eirb implementation will have less information/history than those submitted from day one. 13

14 What eirb does Functionality Online preparation and submission of PHRC/IRB forms and studyrelated documents Review letters posted electronically Electronic routing/tracking of submissions Online review and electronic sign-off All are expected to sign electronically ecoi forms will be included if applicable Principal Investigators may delegate sign off authority temporarily on most transactions to a co-investigator contact your protocol administrator 14

15 15 Navigating Insight

16 16 Create New Process

17 17 Protocol Details

18 18 Submission Details

19 19 Staff & Access

20 20 Staff & Access

21 21 Checking Routing & Signoffs

22 22 Reading Submission History

23 23 Reading Submission History

24 24 Electronic Sign-Off

25 Workflow History Find a submitted application and figure out where it is in the submission process. 25

26 Starting an IRB submission 1. Complete any applicable Partners templates, e.g., protocol summary, consent forms, etc irb 2. Gather all study related documents, e.g., detailed protocol, protocol summary, consent forms, recruitment materials, phone scripts, questionnaires, diaries, etc. irb/pages/irb-forms.aspx 3. Go to Insight>>Humans/eIRB>>Create New Protocol to begin the submission to the IRB. 26

27 Case #1 Submit a New Application Create your own protocol 27

28 Case #2 Linking to a Sponsor/Funding Source You are told you need to create a link to your sponsor. What type of submission would you initiate? 28

29 29 Searching for a Sponsor/Funding Source

30 Case #3 - Versioning documents in an amendment Your PI tells you to submit a protocol amendment to change the consent form and add an advertisement. How do you begin? Find the last approved consent form WITHOUT the IRB stamp. Hint: It will be in Word format. Make your changes using red strikethrough for deleting and highlighting for additions. 30

31 31 Versioning Attachments

32 Case #4 Responding to an IRB review The PHS IRB sends the PI an with the review determination of the most recently submitted amendment. The determination is Requires Modifications or Req Mod. The letter states two points that need to be answered/addressed. 32

33 33 Responding to a Review

34 34 Responding to a Review

35 Case #5 Continuing Review You receive your 90 day continuing review notice from the IRB. You complete the intervention/interaction continuing review form. Next, you need to submit your consent form and questionnaire for reapproval. You click on the attachments page and the attachments from the last submission are there. Note: Any documents being changed must be submitted via an amendment. You are not allowed to version documents 35

36 36 Continuing Review Attachments

37 Partners Human Research Office Contacts IRB HelpLine Tel: Insight/eIRB Georgia Washington Tel: Anne DiSorbo Tel: Reliance Agreement/Cede Review Requests Maria Sundquist Tel: PHRC/IRB Policy/Guidance Rosalyn Gray Tel: Quality Improvement Sarah White Tel: Human Subjects Protection Training/CITI Linda Ryans Tel: P New Submissions Maribel Melendez Tel: Continuing Review Josephine O Driscoll-Davis Tel: jodriscolldavis@partners.org Partners Human Research Committee Website Insight Research Portal 37 Partners QI Program