OAIR Project: Integration with GMAS and Impact on Pre-Award Processes

GMAS/OAIR Pre-award Training January 2021

Agenda Provide an overview of the OAIR project What is it? Who is involved? Who does it impact? When is it happening? Overview of the GMAS / OAIR integration How will it work? How does this impact pre-award processes? What does the cutover period look like? Q+A Resources and Links 2

Outside Activity and Interest Reporting (OAIR) The OAIR project entails: Implementing a new, University-wide* system Integration with GMAS, which will be similar to fCOI and OAR De-commissioning of HMS s OAR system De-commissioning of fCOI Data migration Archiving Reporting Including new data + GMAS data available for OSP, and grant managers *excluding HBS, HLS 3

Outside Activity and Interest Reporting (OAIR) Awards Equities Advising Royalties External Committees Harvard Committees Intellectual Property Rights Paid External Work Fiduciary Roles Publications Fellowships Sponsored Travel Teaching Conflict of Interest/ Conflict of Commitment Performance and Academic Engagement Outside Activity Reporting Research Compliance Faculty Affairs 4

Types of OAIR Certifications There are two types of OAIR activities for faculty (and investigators ): Annual Project- or research-based For investigators on sponsored projects (added at any point during a grant life cycle initial, competing renewals, or any research team change) At proposal: a certification must be on file (but need not be reviewed by OAIR Review Contact) At award: a research-specific certification must be completed and reviewed by OAIR Review Contact For individuals with teaching appointments and other school- designated individuals Each schools runs an annual cycle OAIR Review Contact reviews certifications Report provided to OVPR annually per school Disclosers are also required to make any updates in OAIR within 30 days of acquiring new interests 5

Types of OAIR Certifications There are two types of OAIR activities for faculty (and investigators ): Annual Project- or research-based For investigators on sponsored projects At proposal: a certification must be on file (but need not be reviewed by OAIR Review Contact) At award: a research-specific certification must be completed and reviewed by OAIR Review Contact For individuals with teaching appointments and other school- designated individuals Each schools runs an annual cycle OAIR Review Contact reviews certifications Report provided to OVPR annually per school Disclosers are also required to make any updates in OAIR within 30 days of acquiring new interests 6

Outside Activity and Interest Reporting (OAIR) New system (OAIR) for: Individuals with faculty appointments and investigators Designated Institutional Officials (DIO), OAIR Review Contacts, and other administrators New integration with GMAS: Central sponsored office staff Department grant managers 7

Outside Activity and Interest Reporting (OAIR) 8

OAIR Review Contacts If you have questions about OAIR certifications, contact the OAIR reviewer: FAS/SEAS: Kristen Harding Graduate School of Design: Anne Mathew Graduate School of Education: Tiffany Blackman Harvard Divinity School: Karin Grundler-Whitacre Harvard Kennedy School: Carrie Kachoria HMS/HSDM: Cindi-Ann Hirst Chan School of Public Health: Angela Brazeau Wyss Institute: Katrin Duevel 9

GMAS / OAIR Integration

GMAS integration with OAIR GMAS is responsible for sharing information about investigators on sponsored projects with the OAIR system All investigators will have OAIR approvals in GMAS OAIR is responsible for: Determining whether a research certification is needed Sending out email notifications, as needed Tracking details of status If a research certification is not needed, OAIR will send GMAS back a "Done" status. The decisions of when a research certification is required is in OAIR, not in GMAS!

GMAS Integration GMAS and OAIR will send information back and forth several times during weekdays* GMAS sends information about new investigator approvals to OAIR every hour ten times a day Mon-Fri from 8AM to 6PM at quarter past the hour GMAS receives status updates/indication that certification is not required from OAIR every hour ten times a day Mon Fri from 8AM to 6PM at half past the hour GMAS sends updated project information (segment status changes, title changes, etc.) to OAIR four times a day Mon Fri at 9AM, 12PM, 3PM, and 6PM GMAS sends the list of removed investigators to OAIR four times a day Mon Fri at 9:45AM, 12:45PM, 3:45PM and 6:45PM Status updates can be requested anytime by selecting the <Update OAIR status> button available on the approval list screen for a particular projects OAIR approvals 12 *The connections will not be turned on until Monday, January 25th. See cutover slides.

Investigators The investigator question will be asked for all research team members on GMAS projects going forward* This is not a change for HMS For HSPH and University Area, non-PHS+ sponsored projects will now ask the investigator question An addition of an investigator at any stage of a sponsored project (initial, continuation, supplement, confirm research team, etc.) will generate an OAIR approval Subagreement PIs do not default on GMAS research teams Add sub PIs to the research team as an investigator if the individual is associated with a non-FDP organization that does not have a COI policy/system PHS definition of investigator Investigator is the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of proposed or funded research by PHS+, which may include, for example, collaborators or consultants. Note that in GMAS, only the PI is automatically an investigator. You can be a key person on the project but not be an investigator. The PI should determine who is an investigator. *The investigator question will continue to not be asked on pre-existing projects prior to cutover that didn't ask the investigator question. See cutover slides. 13

OAIR approval statuses in GMAS Status Description OK to submit proposal? OK to set up award? Pending The approval is being sent to the OAIR system Processing in OAIR The approval is not yet done (either waiting for the researcher or reviewer) Done All appropriate actions in OAIR are complete and any sponsored research activity can move forward Pending update An action in GMAS has triggered the need for a new review (notice logged or authorized at-risk request) and we are waiting for an updated status Withdrawn or Withdrawn from OAIR The approval no longer applies (for example, if the investigator flag is changed from yes to no ) 14

GMAS approval list screen enhancements The approval list screen has been organized by "Needed", "Done", and "Legacy" approvals to better highlight the state of approvals associated to the proposal/segment The <Update OAIR status> button is available from the approval list screen to get an update on OAIR approval statuses that are in process outside of the normal run times *The OAIR approval will not be a link to an approval screen until the next release (late January/early February). See cutover slides. 15

GMAS OAIR approval workflow Triggers that generate the new OAIR approval in GMAS Answering "Yes" to the investigator question for a new research team member (at any point in a GMAS project) Changing a research team members investigator flag from "No" to "Yes" (at any point in a GMAS project) Processing a Continuation or Supplement request that includes investigators on the research team that do not currently have an OAIR approval Confirming a research team with investigators that do not currently have and OAIR approval Also adding new research team members as investigators while confirming the research team Triggers that update OAIR approvals to Pending Update for an additional review by OAIR The first notice is logged against the project 16 An at-risk request is fully authorized on a Pending project

GMAS OAIR approval workflow 1. Investigator identified on proposal generates an OAIR approval 2. GMAS sends data to OAIR 3. OAIR sends data back to GMAS Approval status in GMAS will translate to reflect that the approval is processing in OAIR or Done 4. When an "At-award" event occurs, existing OAIR approvals will update to "Pending update" to be re-reviewed on the OAIR side At-award is defined as the initial notice being logged in GMAS, or an at-risk request on a pending segment being fully authorized (these are events that occur prior to account set-up)* 5. OAIR sends data back to GMAS Approval status in GMAS will translate to reflect that the approval is processing in OAIR or Done *GMAS has two new segment statuses to indicate that this event has occurred. See segment status enhancements slide. 17

Demo of workflow Initial Fellowship proposal created in GMAS at 9:57AM New approvals 18

Demo of workflow Approvals sent to OAIR at 10:15AM New approvals 19

Demo of workflow Approvals status update received by OAIR at 10:30AM On demand button New approvals 20

Demo of workflow On Demand button selected at 12:57PM for an update shows that the certification was completed for Tara but has not been completed yet for Allan On demand button Approval moves 21

Demo of workflow Approvals status update received by OAIR at 3:30PM shows that the certification was completed for Allan Needed section empty 22

Demo of workflow First notice logged on the segment, OAIR approvals re-send to OAIR Approvals update 23

GMAS segment status enhancements There are two changes to segment statuses to help support events that need to occur just-in-time New status Pending: Notice logged Indicates that a notice has been logged for the first time on the project Updated logic for existing status Pending: At-risk This is not a new status, but now occurs when the at-risk request is fully authorized (all required parties have signed off on the request) instead of when the at-risk revision has been committed These status updates help to facilitate the review that needs to occur prior to award set-up Segments will now show data related to the request version that is going to be awarded (today it only shows data from the most recent request version when there are multiple regardless of which version the notice has been associated to until after the segment revision has been committed) OAIR approvals will update to indicate another review is needed prior to account set up when the segment updates to either of these statuses 24

Cutover All sponsored projects created prior to the January 18th release that did not require investigator questions to be answered will continue to not ask the investigator question. Investigators on projects created prior to the January 18th release that did require investigator questions to be answered will generate OAIR approvals on continuations, supplements, and when confirming the research team. 25

Cutover There are three waves of GMAS enhancements planned to support OAIR: Wave 1 GMAS release is scheduled to be available on January 18th New OAIR approvals will generate on projects with new investigators New approval will not have a link to approval homepage GMAS and OAIR connections will not be turned on FCOI and OAR approvals are retired and no longer update If a proposal or award must move forward during the weekend of January 18 25, OSP and SPA should contact their OAIR Reviewer Contact for status updates Wave 2 GMAS and OAIR connections are turned on January 25th at 8AM All OAIR approvals that generated after the January 18th release will be sent to OAIR and OAIR will send notifications to investigators Wave 3 A GMAS release is scheduled to be available by early February (date tbd) New OAIR approval screen will be available Ability to update OAIR approval status to Done for non-HUID records Generated by information will be available from the approval list screen 26

Resources and Links General eNews (to be published 1/14/21): https://admin-enews.eureka.harvard.edu/ GMAS GMAS Job Aid: https://gmas.fss.harvard.edu/outside-activity-and-interest-reporting-oair-and-gmas-integration GMAS Release Overview: https://gmas.fss.harvard.edu/news/gmas-release-156 GMAS blog: https://gmas.fss.harvard.edu/blog GMAS Help: contactgmas@harvard.edu OVPR: Policy and definitions: https://vpr.harvard.edu/OAIR OAIR OAIR Fact Sheet: https://ras.fss.harvard.edu/files/ras/files/oair_project_-_fact_sheet.pdf Investigators without HUID: https://ras.fss.harvard.edu/files/ras/files/oair_guidance_- _investigators_without_a_harvardkey.pdf OAIR Support Staff Basics: https://ras.fss.harvard.edu/files/ras/files/oair_guidance_-_support_staff_basics.pdf OAIR Job Aids: https://ras.fss.harvard.edu/oair-job-aids OAIR Info Sessions (for OAIR users): https://ras.fss.harvard.edu/calendar OAIR Help: oairhelp@harvard.edu 27

Q+A

Appendix

OAIR Workgroup Membership OAIR (Compliance) OAR (Faculty Affairs) Tiffany Blackman (GSE) Karin Grundler-Whitacre (HDS) Angela Brazeau (HSPH) Philip Kret (HSPH) Katrin Duevel (Wyss) Jessica Pesce (GSE) Kristen Harding (FAS/SEAS) Kwok Yu (FAS) Carrie Kachoria (HKS) Project Team Kim Lincoln (HMS) Simone Alpen (HUIT) Anne Mathew (GSD) Matt Fox (OVPR) Megan Moore (FAS/SEAS) Dave Grosso (HUIT) Alisa Jahns (HUIT) Marilyn Rackley (HUIT) David Propen (Huron) 30