RAD 201a Negotiating the Twists and Turns of Research Set Up: Ethics; Environment, Health and Safety; and Access to Funds Julaine Herst, Assistant Director, Contracts & Agreements, RSO Kim Kordov, Research Ethics Officer, REO Michelle Rooker, Operations Team Lead, EHS

Ethics and Access to Funding Did You Know…. that the requirements for ethics certifications for all research projects at the University of Alberta flow from the Tri‑ Agency Agreement on the Administration of Agency Grants and Awards by Research Institutions? that the Agreement stipulates that the University must “allow access to Grant funds only after the Institution's research ethics board (REB or ACUC), or a board designated by the Institution, has approved the research project”? that the Agreement further states that the University must “ensure that funds are available to the Recipient only while ethics approval is maintained”?

The Basics Effectively access to funds is being used to enforce/reinforce ethics compliance and ethics approval is being used as a financial control. Research Services Office (RSO) required to verify that the appropriate certification approvals (human, animal, biohazards, and stem cells), prior to release of funding. It is the responsibility of the Principal Investigator (PI) to determine which approvals (if any) are applicable to his or her research projects, to communicate this information to the RSO and to apply for ethics approval.

The Basics cont’d Some awards should never require ethics approval, such as: Salary or Stipend awards: These funds may support people who might do work that requires ethics approval but those dollars will not be spent on those research activities. Note: Research Allowances that support stipends may require approval. Conference and Equipment grants: These funds might create capacity for work that requires ethics approval but those dollars will not be spent on research activities that require approval.

The Basics cont’d Duration of approval: Biohazard – lasts for duration of project; Animal Care Approval – maximum duration of 12 months; Human Ethics Approval – maximum duration of 12 months. Period of ethics approval rarely matches Year 1 of the award, but file is processed as long as approval has one month remaining. If a project does not require ethics approval or certification, the RSO needs to keep confirmation (written declaration) of this on file.

University of Alberta Research Services Office 4/19/2018 The Basics cont’d No ethics fosters late prosperity. www.rso.ualberta.ca

Release of Funds Sometimes the first months/years of a grant don’t involve human participant research or animal use, then what? Release of funds process – confirmation by PI that his/her funds will not be used for reviewable activities. Visit the REO website to obtain more information on a “Release of Funds Agreement”.

Tracking Approvals We operate using a “paperless” system between RSO and the REO – each has access to the other’s system. The approvals are tracked and the file numbers are cross- referenced in both systems: Research Services Office – “Grants 3.0” Research Ethics Office – “REMO”

Our Systems at a Glance … REMO: Data entry fields, note PI enters this information:

Our Systems at a Glance … cont’d Grants 3.0: Data entry fields:

Continuous Monitoring The Tri-Council requires that ethics approval must then be validated for the duration of the activities requiring ethics approval (human participant research or animal use) which may or may not be the duration of the award. The requirement is that funds are only to be accessible while REB and ACUC approvals are in place for the duration those activities requiring ethics approval.

Continuous Monitoring cont’d Money flows, time passes…. If ethics approval changes throughout the life of the protocol - it is REO’s responsibility to tell RSO. Usually ethics approval is renewed by the PI in REMO – note, PI receives three system reminders of pending expiration. In other words … in most instances, the PI renews the protocols online in REMO and RSO involvement is not required. Access to funding continues, but what happens if the protocol expires….

Continuous Monitoring cont’d REMO provides automatic notification of expiration to the “RSO Admin In-Box”. The Tracking pays off...

Continuous Monitoring cont’d Sometimes approval expires because PIs forget to renew or they may become ill. Under these circumstances, follow up is required. Often a REO/RSO tag team approach. Please be responsive to RSO inquiries, we do not want to inactivate your project!!! Under extraordinary circumstances, project may be inactivated and access to funding is denied.

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