An Orientation to Health Research Services Faculty of Health Sciences January 30 , 2012

1. An Orientation to Health Research Services Faculty of Health Sciences January 30, 2012 Location: HSC 1B7 Phone: Ext. 22465 Email: hsresadm@mcmaster.ca

2. Health Research Services • The Health Research Services (HRS) provides advice and administrative support to process operating and personnel grants, manages research resources and administers the ethics review process for medical research involving human and animal subjects.

3. McMaster University VP Res & Int’l Affairs FACULTY OF HEALTH SCIENCES St. Joseph’s Healthcare FSORC Office of Research Services McMaster Industry Liaison Office Hamilton Health Sciences Office of Integrated Research Services Health Research Services Research Finance Clinical Trials And Contracts SJH Research Ethics Board Research Services And Finance Major Projects Industry Liaison/ Tech Transfer Clinical Trials And Contracts Joint HHS/FHS Research Ethics Board Research Services And Finance Major Projects Major Projects Grants Contracts Grants Research Accounts Ethics Ethics Agreements City-wide research administration

4. More Specifically… • HRS oversees matters relating to research admin. in FHS: • Assists in identifying funding opportunities • Reviews and obtains institutional signatures for all research applications • Ensure applications follow both University & Sponsor guidelines • Assists in determining allowable budgetary items • Reviews requests for research accounts • Support of the ethics review processes • Manages equipment and space (in HSC)

5. Who Are We?

6. Where to find Funding Opportunities • Visit the HRS website: www.fhs.mcmaster.ca/healthresearch Contact HRS directly at Ph: Ext. 22465 Email: hsresadm@mcmaster.ca • Visit Sponsor websites, e.g. • CIHR (www.cihr-irsc.gc.ca/e/193.html ) • HSFC (www.hsf.ca/research) • Search the Community of Science Database www.cos.com

7. COS Funding Opportunities • Includes lesser-known funding sources, such as new or highly specialized sources, as well a conventional sources • Covers all disciplines: humanities and arts as well as the sciences • You can send opportunities to colleagues, download your results to review later, and save your searches. • Opportunities for many professional levels: faculty, post-docs, graduate students • Search tools help you target funding that is relevant to you, filtering out irrelevant records • Tools to help you manage your search effort and to communicate valuable information to other COS searchers

8. How To Get A Grant Application Signed • What Does HRS Need? • Please Submit Original + 1 Copy Of Everything • Completed HRS Checklist (with Department Chair’s Signature) • Summary of research proposal or working/draft copy of proposal/copy of application • Budget and budget justification (if applicable) • Ethics/Biohazard approval letters (if applicable) • Grant signature page (signed by P.I. and Department Chair) NOTE: GRANT APPLICATIONS SHOULD BE SUBMITTED TO OUR OFFICE, HSC 1B7, AT LEAST TWO WEEKS PRIOR TO THE AGENCY DEADLINE TO OBTAIN THE APPROPRIATE INSTITUTIONAL SIGNATURE(S).

9. HRS Checklist / Request for a Research Account • Internal, dual purpose form required with EVERY Grant Submission

10. How To Get A Research Account Opened All grants awarded require the following to open a new account: • Completed “HRS Checklist/Request for Research Account” form (signed by Dept Chair) • For NEW account holders, signed “Research Account Holders’ Accountabilities” form • Copy of proposal/copy of application • Budget and budget justification • Current Human or Animal Ethics, Biohazard and Health Physics approval letters (if applicable) • Notification of award (NOA) / funding agreement • For Internally Sponsored Research – we require McMaster Account# funds will come from

12. Once HRS receives all documents We review to ensure everything is in good order, eg. ethics approvals are current We update our Research Funding database Send the paperwork to FHS Research Finance for Processing Research Finance will email PI and Dept. Manager the “NEW RESEARCH ACCOUNT AWARD NOTICE”

13. Associate Dean, Research • Associate Dean (Research) - Dr. Stephen Collins • Dr. Collins has the authority to bind the institution in all matters related to research • Therefore, in most cases Dr. Collins is the signing authority on grant applications and agreements

14. INTRODUCTION • Lisa Hodge, Sr. Grants Advisor, CIHR • hodgel@mcmaster.ca ext 26367 • Highlights of Materials to be presented: • Zero Tolerance – eligibility, completeness • Research NET • e-Approval-on Research NET • What do you need to do? • -INTERNAL review • What HRS needs from applicants

15. Zero Tolerance What we know so far: • Incomplete applications will be withdrawn • Eligible institutions—HHSC has no signing authority • Eligible Applicants and CO-PI’s-staff/trainees • Missing signatures—sig’s still required; not sent in paper form by mail to CIHR—must upload pdf file • Updated “validated” Common CV required Call Lisa Hodge ext 26367 for clarification

16. CIHR UPDATES- Administrative Changes • ADMIN Changes: • ALL Research NET -application are ALL now submitted online • Many new programs on e-Approval – Catalyst, POP, PHSI,… • Signature pages -eliminated signatures for NPI • (electronic signature is your consent) • -no institutional signatures for co-app' s • -signatures pages no longer sent to CIHR • (must be uploaded as pdf to application) • NEW 2011! Online Deadline change • -ALL Research NET submissions DUE online by 8:00 PM EST

17. CIHR UPDATED POLICIES – Since 2008 • POLICY Changes: • Equipment-definition; not funded through Operating Grants • http://www.cihr-irsc.gc.ca/e/39922.html • Acceptable Attachment Format • -dictates format of ALL uploaded pdf documents • http://www.cihr-irsc.gc.ca/e/29300.html • Research Outputs Policy http://www.cihr-irsc.gc.ca/e/32005.html • Open access via Pub Med Canada McMaster repository • http://www.cihr-irsc.gc.ca/e/41770.html Neera Bhatnagar, Librarian • bhatnag@mcmaster.ca • Grad Pay rates (NEW!) ---no longer max/min amounts for graduate student pay rates on grants • Privacy Policy (NEW!)-integrated into new signature pages • http://www.nserc-crsng.gc.ca/_doc/NSERC-CRSNG/governance-gouvernance/consent-consentement_eng.pdf

18. CIHR Acceptable Attachment Format • Attachment format for all pdf files http://www.cihr-irsc.gc.ca/e/29300.html • The following apply to all attachments (including those for the Common CV): • Indicate your name, the project title and the section title (e.g., Summary of Research Proposal) at the top of each page. Indicate the page number clearly at the bottom of each page. For CV attachments, only your name (i.e., does not have to be nominated principal applicant name) and the section title (e.g., Patents and Intellectual Property Rights) are required in the header. • Insert a margin of 2 cm (3/4 inch) - minimum - around the page. • Observe page limitations, additional pages may NOT be added unless specified. • Use only letter size (21.25 X 27.5 cm / 8.5" X 11") white paper/background for all attachments. • Photo-reduce the supporting documents if the originals are larger than (21.25 X 27.5 cm / 8.5" X 11"). • Use a font size of 12 point, black type. Six lines per inch. No condensed type or spacing. • Attachments must be uploaded in PDF format. • The size of the attached document(s) cannot exceed 30 MB per document. • For more information about converting documents to PDF, please refer to Help with Accessibility page. • For all documents that need to be attached, please follow the instructions provided within Research NET on how to upload your document. • For further information, please direct your inquiries to info@cihr-irsc.gc.ca or telephone 1-888-603-4178.

19. Privacy Policy • As of November 17, 2011 Tri-council funding agencies have implemented a privacy policy http://www.nserc-crsng.gc.ca/_doc/NSERC-CRSNG/governance-gouvernance/consent-consentement_eng.pdf • slight change to informed consent and the look of signature pages • big change to what it means

20. e-Approval and Research NET ALL institutions are on e-Approval since Fall 2009 Operating grants competition • What it is • How it works • Who you are “submitting” to • INTERNAL review deadlines • Changes to signature process via HRS

21. Registration/Application on Research NET starts the e-Approval process Yellow highlighting indicates where action or attention is required

22. E-mail confirmation sent to applicant when they Hit “SUBMIT” online

23. Step-by Step e-Approval: Registration to Application stage Registration on Research NET: http://www.cihr-irsc.gc.ca/e/39633.html • Research NET requires a CIHR PIN • -new applicants must request a PIN • For two stage LOI/Registration and Applications submissions: • All information provided to CIHR at registration can be revised in the full application • Except: • Name of Nominated Principal Applicant • Project Title • Chosen Peer Review Committee

24. NEW! CIHR Deadline time change Effective January 2011 for ALL Research NET submissions • 20:00 (8:00) PM EST is the NEW GLOBAL CIHR submission deadline • Midnight is NO LONGER the FINAL deadline for CIHR online submissions • If you miss the CIHR 8:00 PM EST deadline, your application WILL NOT be submitted to the CIHR competition • 16:00 (4:00) PM EST is the HRS deadline time for administrative processing on Feb 21 INTERNAL deadline and March 1 FINAL deadline dates

25. INTERNAL Review: Common Issues (to Avoid) • Format • Budget • Eligibility: Common CV descriptions • Signature pages-missing signature page • Missing the INTERNAL review deadline

26. SAMPLE: Format required for all attachments • Header has NPI name, section title, and grant title (yr 1 $ amt is optional) • Footer has successive numbering by pdf attachment, starting at 1 and • ending at last page of each pdf file

27. REQUIRED PAPERWORK:What HRS needs from ALL applicants by the INTERNAL DEADLINE • Hit “SUBMIT” on Research NET to submit your online application for INTERNAL review (not the same as Mandatory Peer Review-for Operating grants only) • AND • Paperwork required for HRS institutional sign off: • Signed HRS Checklist http://fhs.mcmaster.ca/healthresearch/administration_forms.html • signed PRF Form (FHS Faculty only) • Routing Slip • BLANK Institutional Signature page – to be signed by Authorized Official (HRS) • --upload blank at INTERNAL review submission deadline • Biohazard or any other ethics clearances ready at time of application • Once all of these materials are received, e-Approval is possible

28. WHAT Paperwork HRS Needs from FHS Applicants by the INTERNAL deadline

29. Helpful Links Current funding opportunities http://www.researchnet-recherchenet.ca/rnr16/search.do?fodAgency=CIHR&fodLanguage=E&all=1&search=true&org=CIHR&sort=program&masterList=true&view=currentOpps Grants and Awards Guide http://www.irsc.gc.ca/e/805.html For further assistance contact Lisa Hodge hodgel@mcmaster.ca at ext. 26367

30. Agreements McMaster University Faculty of Health Sciences Health Research Services

31. When Do You Need an Agreement? • You need an agreement when: • When you are engaging an investigator at another institution (includes HHS and St. Joes) to be part of your project. (even if there are no $$ involved) • When you are being engaged by an investigator at another institution to work on their project • When you receive funds from a granting agency or industry to perform a specific project

32. How Do I Get an Agreement? Contact the Appropriate Office: • Health Research Services • McMaster Industry Liaison Office • Office of Integrated Research Services – Hamilton Health Sciences • Research Administration - St. Joseph’s Healthcare • McMaster Office of Research Services • McMaster Purchasing

33. Health Research Services Working Specifically for the Faculty of Health Sciences • grant agreements, • subgrant agreements • Inter-institutional agreements • McMaster co-ordinated Clinical Trial agreements, • Letters of Intent • MOU’s for the Faculty of Health Sciences • Amendments to any of these agreements

34. McMaster Industry Liaison Office (MILO) MILO working for all McMaster Faculties • research contracts, • industry sponsored agreements, • service agreements, • confidentiality agreements, • non-disclosure agreements, • data transfer agreements • material transfer agreements • intellectual property related issues

35. McMaster Office of Research Services • ORS handles all research agreements for all other McMaster Faculties McMaster Purchasing • Purchasing handles any service agreement or contract not related to research that involves the purchase of an item or service from an outside provider.

36. What are the steps for Mac? • If you have been provided a template send it for review to Caroline Woods in Health Research Services or contact Caroline Woods to arrange a draft agreement to send to your party for their review. • Health Research Services (HRS) will assist you with negotiation with the other parties to the agreement. • After negotiations are complete obtain authorized institutional signatures of McMaster and the other parties through HRS. • Complete the signature process before beginning the work. A fully executed original will be kept for HRS’s files.

37. What am I doing? • Ensuring compliance with University / Hospital policy • Looking at potential liability and conflict of interest issues • Making sure that the agreement accurately reflects the obligations and the intentions of everyone involved in the research

38. Why? • Not all agreements are created equal.

39. Important Clauses Clauses that determine roles and responsibilities of the Parties to an Agreement

40. Main Areas You Should be Aware of • Confidentiality • Publication • Indemnity and Insurance • Intellectual Property Rights and Ownership • Budget • Description of Work and Reporting • Term and Termination • Governing Law

41. Contracts and Consulting Non-Research related for provision of specific services

42. What makes an Agreement a Contract? • Differences between contracts and collaborative agreements • In contracts • the study plan is prepared by the sponsor • the data and intellectual property is owned by the sponsor • Reporting and oversight by the sponsor is extensive • Publication may be controlled or restricted by the sponsor • All deliverables are transferred to the sponsor • Future use of any deliverable by the university is not allowed or restricted to a specific license

43. Contract and Consulting Policies http://www.mcmaster.ca/policy/ • Research contracts are handled through MILO • Non- Research contracts handling is determined by required expertise on a contract by contract basis • Handling of consulting agreements is determined by McMaster policies • Staff Policy on Consulting and Freelancing • Statement on Consulting Policy and Procedures • Policy on Payments to Individual versus Employees

44. How Long Does it Take? Currently, 2-3 weeks on average

45. Who Can Sign for McMaster? • All Agreements are required to be signed by an individual with Institutional Signing Authority as designated in McMaster’s Execution of Instruments Policy: (Associate Dean, Research or Dean and Vice President, Faculty of Health Sciences) • Signatures can only be obtained through the Health Research Services Office • Agreements are not fully binding until everyone has signed

46. What if you need to change Something? • Changes to the terms of an agreement are done through amendments • Contact your agreements negotiator to prepare and negotiate the amendment • Amendments remove clauses from the original agreement and insert new language

47. Please Don’t • Start any work without checking to see if you need an agreement and without the agreement being finalized • Transfer any funds to an outside party without an agreement in place • Sign an agreement without McMaster Institutional review and approval

48. Agreements : Post Execution Management McMaster University Faculty of Health Sciences Health Research Services

49. Health Sciences Finance • Financial management of research accounts • Ensuring payments to and from accounts match with agreements • Ensuring accounts managed in compliance with Sponsors and McMaster policies • Each department has an assigned finance accountant in HSF

50. Accounts with Agreements • A fully executed original agreement is needed to open an account • An HRS Checklist and ethics is also required • Funds are not automatically transferred • Cheque requests should refer to the agreement and be in compliance with the terms of the agreement