Pre-Award Issues Related to Human Research and Animal Use March 15, 2013

Welcome and Introductions

Agenda – Review Of Requirements – Special Situations – How Do We Do It? Purdue University Washington University

Quick Review of Requirements – Does this project include research involving human or non-human vertebrate animal subjects? Question often asked through a proposal development or routing form PIs don’t always answer correctly – If yes to either, would activity be conducted at prime institution or by a subrecipient? – If at prime institution, is there an active, approved protocol? If yes, verify congruence through grant to protocol review – Not required prior to proposal submission, but must be verified before funds from award are expended. If no, remind PI of need for approved protocol before award funds are expended. – If by a subrecipient, does the subrecipient have an active assurance for the research (human or non-human vertebrate animal)? If yes, verify! If no, an appropriate assurance or authorization agreement will need to be in place before subrecipient can expend project funds.

Special Situations – Initial research may be required before the human or animal protocol can be written/finalized: human/animal research does not begin until year 2 or later. – Training Grants or Large Center/Program Project Grants: specific projects may not be known at time proposal is submitted. Trainees must be recruited/selected Seed Grant competitions must be completed to select specific projects – Sponsor requires review/approval by both grantee IRB/IACUC and sponsor’s IRB/IACUC (e.g. Defense agencies)

How Do We Do It? -- Purdue University – Staff reporting to Purdue’s Director of Research Regulatory Compliance (Sponsored Program Regulatory Administrator) work with Sponsored Program Services’ Pre-Award staff to review every proposal to identify research involving human or non-human vertebrate animal subjects. Sponsored Program Regulatory Administrator (SPRA) is a voting member of a Purdue IRB and of the Purdue Animal Care and Use Committee – Research involving human or non-human vertebrate animal research by prime institution. When identified, after submission to sponsor, the SPRA works with the PI and appropriate committee staff to identify existing protocols and conduct grant- to-protocol review for congruence. – If congruent, document review so that award will not be delayed. – If no protocol or not congruent, the PI is reminded of need to remedy before sponsor funds can be expended for either human or non-human vertebrate animal research.

How Do We Do It? -- Purdue University (cont’d) – Research involving human or non-human vertebrate animal research by subrecipient institution. Before proposal is submitted, SPRA determines whether proposed subrecipient has an appropriate, active assurance – If appropriate, active assurance, SPS Pre-Award proceeds with preparation and submission of proposal. – If no appropriate, active assurance, SPS Pre-Award contacts proposed subrecipient to learn how subrecipient wishes to remedy » Obtain/reinstate assurance » Execute appropriate Authorization Agreement – Once remedy determined, SPS Pre-Award proceeds to prepare and submit proposal.

How Do We Do It? -- Purdue University (cont’d) – Special situations If award is received and no appropriate, active protocol is in place, SPRA prepares and executes an internal Memorandum Of Understanding with the PI to confirm commitment that no human or non-human vertebrate animal research will be initiated until an appropriate, active protocol has been approved. – Some sponsors require approval of initial core protocol not identifying specific details of project before expending sponsor funds. – Once MOU or core protocol is in place, sponsor funds can be released. If dual review by grantee and sponsor IRB/IACUC is required and project includes research not involving human/non-human vertebrate animal research, execute MOU and allow sufficient funds for research NOT involving human/non-human vertebrate animal research to begin.

How We Do It -- Washington University More Decentralized Model – IRB Committee – IACUC Committee – Conflict of Interest Committee – Center for Clinical Studies – Office of Sponsored Research Services (OSRS) is coordinator of compliance to assure projects have appropriate compliance at the time of the proposal Protocol reviews mirror the Purdue model Just in Time Responses – Compliance Committees approval prior to spending funds IRB, IACUC, FCOI – OSRS validates active approvals for either human or animal research Like Purdue, PI MOU signed if approvals are not in place prior to expenditure of funds Subreciepents required to attest in subaward compliance with required approvals Like Purdue, WU seeks an MOU from PI committing that no human or animal research will be initiated if the award is received and no appropriate, active protocol is in place

Special Situation – Clinical Research At Washington University Clinical Research may have many faces – Research involving human subjects Therapeutic trials (cancer, devices) Healthy Volunteers – Tissue or Samples National Repositories (e.g.NIH, dbGap) – Genetics – Medical Record Reviews – Outcomes – Translational Pre-clinical to Clinical

Special Situation – Clinical Research At Washington University Clinical Research has some unique issues that impact the Pre-Award Process – Patient Care Costs – Overhead Determinations – Billing Compliance – Charging for IRB review Often clinical research is conducted with multiple sites – frequent use of subwards

Special Situation – Clinical Research At Washington University Clinical Research has some unique issues that impact the Award Negotiation Process – Industry Sponsors – clinical trial agreements (CTAs) Indemnification Insurance Patient Injury Intellectual Property Conflict of Interest Residual Balances Product Liability Transfer of Industry product e.g. drug, biologic, etc. – MOU – IRB review of contract language for: Informed consent Subject injury Payment of costs incurred Regulatory oversight, e.g. FDA – data - used in review

Special Situation – Clinical Research At Washington University Clinical Research has some unique issues that impact the Award Negotiation Process – Foundations Grant Proposal – RFA terms may have language very similar to those of Industry – NOA reads like a contract – Federal agencies Prior approval of HS protocol often required - NIH Some projects may require federal involvement of development of protocol

How We Do It -- Washington University – Human Subjects Oversight Organizations Proposal Stage – IRB – Cancer Center Proposal Review Committee and Auditing Group – Contract Language coordination – Conflicts of Interest – Sponsor Once all these entities are approved, award may be established and funds released Project Conduct Stage – IRB Compliance Review Committee – Cancer Center Proposal Auditing Group – Human Subjects Monitoring Committee – FDA reviews – Sponsor site visits Problems with Award or conduct of project may result in suspension of funds

Discussion of Hot Topics

Questions

– Peter E. Dunn, Ph.D. Associate Vice President for Research Purdue University – Denise McCartney Associate Vice Chancellor for Research Administration Washington University in St. Louis