IRAP Refresher Responsible Personnel OSP Lunch and Learn January 6, 2014

New Federal Regulations and New UAB Policy – August For all Responsible Personnel named on a grant or contract Must have a current financial interest disclosure on file with the CIRB Office prior to OSP submitting the application to the sponsor Must have completed Conflict of Interest Training prior to engaging in the research Must have any identified financial conflicts reviewed and managed if necessary prior to receiving the award

Who is Responsible? UAB defines Responsible personnel as anyone involved in the Design, Conduct or Reporting of Research. Design - The planning of the scientific strategy to test a research proposal. Conduct - The supervision or management of a study’s execution. This is typically done by the principal investigator (PI), subinvestigators (as defined by FDA) and co- investigators, but also may be performed by postdoctoral fellows and graduate students who have significant supervisory roles for junior researchers or technicians who are part of the study. Reporting - The authorship of publications or reports related to the research. This includes anyone who will likely present the data at national/international meetings. Research - For the purposes of reporting financial conflicts of interest on this form, the term research includes any grant/contract application processed by the Office of Sponsored Programs (OSP) and all work involving human subjects regardless of funding source.

Who is Responsible? PI is ALWAYS Responsible Other research team members are Responsible as determined by the PI Things to think about – Although not named on the grant, are they involved in an associated IRB protocol (1572, consenting patients, etc.) Will they be named on publications or make presentations about this research

Responsible Personnel List Notify CIRB of the Responsible Personnel on your project by submitting a Responsible Personnel List (RPL) to OSP

When is a RPL required? Original New Competing Continuation Transfer In Change in PI Resubmission And any time there is a change in Responsible personnel (These RPL submissions are revisions and should only include the names of responsible personnel that you are adding or removing and check the add or remove box as appropriate)

Who should be listed on the RPL? All Responsible personnel For Example: UAB Faculty/Staff/Postdocs/Students Children’s/HSF/Eye Foundation/Southern Research Personnel Outside consultants except for Responsible personnel associated with a subcontract. Subcontract* personnel should not be listed on the RPL – at the time that the subcontract is negotiated UAB will learn if their institution/organization will monitor their Conflicts of Interest. If their institution/organization will not we have a process in place to collect disclosures and ensure training. * If the award to UAB will have outgoing subcontracts, do not list those personnel on the RPL. If the award to UAB is a subcontract from another institution, list only the personnel considered Responsible at the UAB site

How to Fill out an Original RPL Original RPLs are submitted with a checklist for Original New, Competing Continuation, Change in PI, Transfer In and Resubmissions Make sure to list all Responsible personnel Make sure to have correct Blazer ID (if you are unsure of someone’s Blazer ID you can look it up by authenticating yourself in the UAB Directory) Make sure that you have the person’s name as it is listed in Oracle Make sure that you do not include any personnel associated with a subcontract Make sure that you remember to add the PI to section III Make sure that you do NOT click on any of the add/remove boxes

To find Blazer ID’s Authenticate your Directory search How to find a Blazer ID

How to Fill out a Revised RPL All other RPL submissions are considered Revisions Make sure that you know who is currently listed as Responsible on your grant/contract (instructions to follow) Make sure that you mark the RPL as Revised, update the date and include the OSP Assigned Number Make sure to only list the personnel that you would like to add or remove from the project Make sure to check the box next to add/remove as appropriate Make sure that you have the correct name and Blazer ID Make sure that you do not list any subcontract Personnel

How to fill out an RPL for a Program Project Grant Make sure to follow the guidelines for how to fill out an original or revised RPL Make sure that each subproject of the program project grant has its own RPL Make sure to completely fill out the subproject section of the RPL There is no need to list the PI of the Program Project under the personnel section, unless the person is PI of that particular subproject or is specifically involved as a responsible person with that subproject An RPL for the parent is NOT required These same instructions apply to federal contracts that are awarded as separate task orders (i.e. IDIQ)

What if I need help filling out an RPL If you need any help in determining who should be considered Responsible on your project please contact the CIRB for Guidance at or If you need help in filling out the RPL please contact or If we have any questions with the RPL that was submitted we will contact you and help get it all straightened out.

Other important things to remember The PI is responsible for determining who is responsible on a grant/contract For most fellowship grant/contracts the fellow and the mentor will both be considered responsible. Occasionally IRB will request that someone listed on your IRB WIRB protocol or the 1572 form be added as Responsible Once someone is listed as Responsible the only way to remove them is by a Revised RPL

How to determine who is listed as Responsible on a Grant? Log into IRAP and review COI project case Log into eReports and review Responsible Personnel Report

How to determine who is listed as Responsible on a grant in IRAP? Log into IRAP – Click on My Proposals and Show/List (this will give you all proposals which you are the PI of) Click on Search for Enter in OSP Assigned Number or other search criteria and click on Locate (this will give you the proposals that meet your search criteria) Enter in NO search criteria and click on Locate (this will give you all proposals that you are named on or that you have security access for) Hover over the yellow folder next to the proposal that you’d like to open and click on the eyeglasses

When the proposal opens you will see a group of folders in the left navigation bar Then click on the yellow folder to open up the COI Project case Click on the one that says COI projects

COI Project Case From the COI Project case you can view the Case Status. External Interest Project-Case Status Status Explanation Can OSP submit to sponsor? Can OSP process award? Can IRB submit to WIRB? No DisclosureThere is no disclosure on file. This is the default status when a case is initially established. NO Awaiting Disclosure One or more Responsible personnel do not have a current disclosure on file.NO OK to SubmitAll Responsible personnel have a current disclosure on file. The status is only used on initial OSP submissions. If a person is subsequently added who has not disclosed, the project-case status is not changed. YESNO Awaiting Training All Responsible personnel have a current disclosure on file and any disclosed financial conflicts have been managed; however, one or more listed people do not have current Financial Interest training. YESNOYES OK to AwardAny disclosed financial conflicts have been managed. The status is used only on new OSP submissions. If a person is added before the award, the status can be changed to OK to Submit or Awaiting Training as appropriate, but if added after the award, the case status is not changed unless the added person does not have current training. In this case, the status is changed to Awaiting Training even if the listed person has not yet disclosed. YES Not Active The project is not in a pending/negotiating or funded status.NO Project Case Statues

Related Personnel = Responsible Personnel Click on Related Personnel to see all Responsible personnel on your project.

No Disclosure – No financial interest disclosure information on file (Initial status for all UAB employees.) Expired - The most recent disclosure was submitted over one year ago. AAN – The responses to the screening questions are no (All Answers No.) No SFI - No significant financial interests have been disclosed. Transactional Review - Significant financial interests have been disclosed. Review will be required for potential conflicts with research activities. [Anyone with an active management plan will be in this category, although not everyone in this category will have an active management plan] Person-Case Status

Reviews and history of who has been responsible on project.

How to see who is Responsible on a Grant by using eReports?

make sure that you check who is currently listed as responsible before you submit a revised RPL to OSP call us ( ) before you submit to OSP if you have any questions To help us process your RPLs quickly and correctly please

What do I do if I can’t see anything in IRAP or I need training? Contact Molly at or Help to determine why you are not seeing anything in IRAP and walk you through the steps to get access Schedule to come to your office to walk you through how to use IRAP – this can be done individually or for small groups

Questions If you have Conflict of Interest related questions please contact the Office of the Conflict of Interest Review Board (CIRB) at or If you have questions about IRAP please contact Molly Moran Lerew at or 934- FAQs about the RPL are located at s/Responsible-Personnel-Lists-FAQ.aspx s/Responsible-Personnel-Lists-FAQ.aspx