1	DU Departmental Grants Administrator Spring Meeting Office of Sponsored Programs March 24, 2005
2	Agenda Introduction Research Compliance AAALAC Accreditation IRB and IBC Review OSP Project Administration PI Guide to OSP Sponsor Updates Digital Signature OSP Grants Accounting Grants Procurement Card (Frank Nowak) Effort Certification Process Cost Sharing Process Technology Transfer Review (Carley Pavelka) Upcoming Training NCURA webcasts Appendices Sample of OSP Award Information Sheet Sample Effort Certification Form Sample of Cost-Share
3	Office of Sponsored Programs: http://www.du.edu/orsp
4	Research Compliance IRB (Institutional Review Board for the Protection of Human Subjects) www.du.edu/orsp/irb.html Federal-wide Assurance Updated IRB application IACUC (Institutional Animal Care and Use Committee) www.du.edu/orsp/animal.html Federal wide Assurance Forms: Protocol for Use of Live Vertebrates for Research or Teaching Personnel Qualifications to Perform Animal Research Biohazard Material Information Questionnaire Protocol Revision Form for Use of Live Vertebrates Protocol Annual Review IBC (Institutional Biosafety Committee) www.du.edu/orsp/biosafety.html Charter Forms Cover Sheet for Review by Institutional Biosafety Committee IBC Annual Report for Approved Projects OSP Research Events Calendar http://ducal.du.edu Click on OSP Research Events under the Administrative Events Menu
5	What is AAALAC International? Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International A private nonprofit organization whose mission is to enhance the quality of research, teaching and testing by promoting humane, responsible care and use Accomplished through voluntary accreditation and evaluation programs More than 670 companies, universities, hospitals, government agencies and other research institutions in 24 countries have earned AAALAC accreditation AAALAC accredits active animal care and use programs including: animals; facilities; equipment; professional, technical and administrative support; and policies and programs for institutional responsibilities, animal husbandry and veterinary care All animals used in research, teaching or testing in the units are included and evaluated. This includes traditional laboratory animals, farm animals, wildlife, and aquatic animals. Nontraditional animals, including invertebrate species, are also included where they are relevant to the units mission.
6	Why accreditation counts! Symbolizes quality Promotes scientific validity Acts as a recruiting tool Demonstrates accountability Provides a confidential peer-review Impresses funding sources Shows real commitment to humane animal care
7	AAALAC Accreditation Process Submitting an application that includes a Program Description is the first step toward accreditation. This is the key document used by the Council on Accreditation to evaluate the animal care and use program. The process of conducting this internal review will help identify and address weaknesses, resulting in improved animal well-being and better science. The Program Description includes detailed information on: Animal care and use policies and responsibilities. Animal environment, housing and management. Veterinary medical care. Physical plant. Next, we will be evaluated by a team of visitors chosen by AAALAC International from among the members of and consultants to the Council. This will require that site visitors be permitted to enter any and, if necessary, all animal holding rooms, laboratory or use areas, and support areas. The site visitors are provided all relevant program information including protocols. After the site visit, the Council on Accreditation will make a final decision regarding accreditation. The Council meets three times a year (January, May and September), so our application and site-visit report will be considered during the first Council meeting that follows their visit. For more information: www.aaalac.org
8	Institutional Review Board Institutional Review Board for the Protection of Human Subjects in Research (IRB) All research projects conducted at the University of Denver by faculty, staff and students, whether funded or not, that involve human subjects must be reviewed. What constitutes research? This is not always an easy thing to define; however, Federal definitions follow: Research a systematic investigation designed to develop or contribute to generalizable knowledge. Human subject a living individual, about whom an investigator conducting research gains Data through intervention or interaction with the individual, or Identifiable private information. Intervention includes both physical procedures (example: venipuncture) and manipulation of the subjects environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.
9	What Needs IRB Review? Projects with or without funding Projects involving outside collaboration (i.e., information/data sharing and/or data gathering about people, their cells, tissues, etc.) All applications being reviewed by an outside ethics or review board Research involving oral history and ethnography Telephone or internet interviews, questionnaires or surveys Some assessments of academic programs Research conducted as part of classroom requirements Research on instructional strategies Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods Research involving the use of educational tests, survey procedures, interview procedures, or observation of behavior Research involving the collection or study of existing data, documents, records, etc. Taste and food quality evaluation and consumer acceptance studies Marketing surveys Focus groups and pilot studies Masters Theses, Dissertations, and Psy.D. Doctoral Papers Undergraduate projects including Partners in Scholarship (PINS) and Cherrington Global Scholars Changes to previously approved research Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development Exempt projects
10	What May Not Need IRB Review? Journalistic interviews Information gathering with the intention of reporting rather than drawing conclusions; for example, writing a report on the practices of a particular groups holiday activities Observational activities designed to increase a students understanding or knowledge related to classroom issues and topics; i.e., attending a political rally regarding gun control Classroom activities in which the intent and purpose is other than learning about and practicing research activities and/or methods; i.e., learning how to conduct interviews or administer an intelligence test If you are not sure whether or not IRB review is required for your research, please contact: Dawn Nowak, x14052, dnowak@du.edu
11	Types of IRB Review Exempt Category of research activity that the Federal government allows to be conducted without the usual IRB review process. Depending on the situation, requires from one reviewer to a full Board review Some classroom research activities Expedited Category of research that Federal regulations allow to be reviewed outside the regular IRB meeting cycle, by less than the IRB quorum. Requires two reviewers only. Some continuing review of minimal risk research Full Board Review Applications requiring review by a quorum of the convened IRB. Continuing Review Ongoing research is required to be reviewed at least yearly. Depending on level of risk (minimal or greater than minimal), continuing review would be by exempt, expedited, or full Board review.
12	International Research The newest version of the IRB application (link online at www.du.edu/orsp/irb.html) includes the following questions specifically for those researchers who plan to conduct all or part of their research outside the U.S.: Will an IRB in the host country review the protocol? What is the process for gaining approval/permission for conducting research in this setting? What is your relationship with, familiarity with, and/or experience in the community in which research participants will be recruited? What are the ethical challenges of conducting research in this country? Researchers should review at least one of the available guidelines for ethical research in developing countries or related guidelines. The ethics page of the American Anthropological Association includes not only the Associations ethics statements and deliberations, but also links to those of other organizations. Go to: http://www.aaanet.org/committees/ethics/ethics.htm. What is the standard method for obtaining informed consent in the host country? What is the current situation in the host country regarding freedom of speech, press, and interaction with researchers from American universities? What are the potential academic, legal, political, and social risks for participants in your study? What modifications may need to be made to DUs standard consent language regarding limits to confidentiality? What are the risks to U.S. and collaborating host-country researchers? Is capacity building in the host country an essential element of the research protocol?
13	IRB Decision Tree
14	IBC Membership Institutional Biosafety Committee (IBC) Please visit the following website address for forms and documents referred to in the information that follows: http://www.du.edu/orsp/biosafety.html IBC Membership Membership on the IBC consists of no fewer than five members who collectively have experience and expertise in recombinant DNA technology and who have the capability to assess the safety of recombinant DNA research and to identify any potential risk to public health or the environment. At least two members are not affiliated with the University of Denver (apart from their membership on the IBC) and represent the interest of the surrounding community with respect to health and protection of the environment. At least one member is a scientist with expertise in animal containment principles. When necessary for evaluating research involving plants, one member is a scientist with expertise in plant, plant pathogen, or plant pest containment principles. One member qualified to evaluate BSL3, BSL4, or Large Scale research is designated Biological Safety Officer.
15	IBC ~ 2 The Institutional Biosafety Committee (IBC) is responsible for ensuring that research involving recombinant DNA or select agents and other biological hazards at the University of Denver is in compliance with established National Institutes of Health (NIH) Guidelines. To carry out this oversight, the IBC has three main tasks that are more fully described below: Reviewing research proposals involving biological hazards Developing emergency plans for accidental biohazard spills Providing consultation to PIs on biosafety issues. Reviewing research proposals involving biological hazards: The IBC considers and approves, or prohibits, proposed research by assessing: Appropriate containment and biosafety (BSL) levels. Facilities, procedures, and practices to be used Training and expertise of the personnel who will be conducting the research. There are four classes of experiments. Each has specific approval requirements: Class A experiments require review by the NIH and the IBC before initiation. Class B experiments require IBC approval before initiation. Class C experiments require IBC review simultaneously with initiation. Class D experiments are exempt from NIH Guidelines and may commence prior to, but do require, IBC approval.
16	IBC ~ 3 Applying for IBC approval: For a research proposal involving recombinant DNA work and other biohazardous procedures, PI is required to electronically submit to OSP, the Cover Sheet for Review by Institutional Biosafety Committee along with supporting documentation. A preliminary assessment of the need for review is made by the IBC Chair. (PIs proposing research involving the use of human or animal subjects/materials should also consult the IRB and Animal Care websites) If IBC review is required, the Chair appoints primary and secondary reviewers with expertise appropriate to the proposed research. The full IBC also considers the research at its quarterly meeting and either approves it or recommends revisions. Proposals that require revisions are delegated to the primary and secondary reviewers and the Chair for final approval after the PI has responded to the IBC's concerns. IBC members are not allowed to be involved in review of their own proposals. OSP sends a letter to the PI and the proposed sponsor notifying them of the IBC's final decision. Approval periods are as follows: BSL1 projects -- the duration of the project BSL2 and higher projects -- until funding for the project comes up for renewal
17	IBC ~ 4 Requirements after IBC approval is received: Once approved, projects at all BSL levels are subject to the following requirements: Changes: Prior to instituting any changes in the biological materials used in a project, the PI is required to submit an amended Cover Sheet for approval. Annual reviews: The PI is notified prior to a project's annual approval date that an IBC Annual Report for Approved Projects must be submitted. If there are no changes to the project, the review is conducted by the IBC Chair. If there are changes, the review is conducted by the Chair and primary and secondary reviewers. Their unanimous approval is required for renewal of the project. NOTE: Research activities involving the use of non-biologic hazards, such as hazardous chemicals, are subject to requirements established by the Environmental Health & Safety Manager in the University of Denver Risk Management Department. Developing emergency plans for accidental biohazard spills: The IBC develops emergency plans covering accidental spills and personnel contamination and is required to report within 30 days to the Vice Provost for Graduate Studies and Research and to NIH any significant problems resulting from violations of the NIH Guidelines and any significant research-related accidents or illnesses. Any such incidents on the D.U. main campus should be immediately reported to Dr. Roger Clark, (303)871-3473. Incidents at Eleanor Roosevelt Institute should be reported to the ERI Safety Officer, Dr. Miles Brennan, (303)336-5690. Providing consultation to PIs on biosafety issues: PIs are encouraged to contact the IBC Chair with any questions they may have regarding biosafety issues: Dr. Bruce Bowler, Department of Chemistry and Biochemistry, (303)871-2985.
18	OSP Project Administration -- DU Department Assignments Crystal Streit Communications Daniels College of Business Graduate School of International Studies Graduate School of Professional Psychology Graduate School of Social Work History College of Law Psychology School of Engineering and Computer Science University College Undergraduate Studies Wellness Center Womens College
19	PI Guide to OSP Available to all Faculty/Departmental Administrators in a hard copy format Will be available online at: www.du.edu/orsp Includes information on: Proposal Development and Submission Grant Writing Tips EIN, DUNS, Human & Animal Assurance Numbers Signature Authority University Budgetary Policies Internal Proposal Review and Approval Form Award Negotiation and Acceptance Contract/Award Negotiation Grant/Fund Setup Distribution of Documentation Post Award Responsibilities Subcontract/Consultant Agreements Award Modifications Allowable/Unallowable Costs Cost Sharing Salary/Effort Reporting Award Closeout Reporting Requirements Award Closeout Process
20	OSP Award Notification Sheet Yellow form will be distributed to each Principal Investigator and their Departmental Administrator after new award is set up in Banner Includes the following information: Grant Number Fund Number Org Number Project Period Budget Period Current Budget Cost Share Commitments Future Year Funding Project Administrator Name & Contact Info Account Representative Name & Contact Info Supplemental Information Reporting Requirements IRB/IBC/IACUC Information Cost Share Activity Code Export Control Requirements See Appendix A for a sample form
21	Sponsor Updates Department of Health & Human Services Developing a common eRA system for all DHHS agencies called ONE-VIEW ONE-VIEW will consist of three parts: Single login for all DHHS eRA applications including NIH commons applications Single method for notification of actions from all DHHS Agencies to the Grantee Community Single interface to initiate and process a request within the DHHS Agencies and the Grantee Community National Institutes of Health New PHS 398 forms must be used for all proposal submissions after 5/1/05 http://grants1.nih.gov/grants/funding/phs398/phs398.html Centralized address for receipt of non-competing continuation progress reports Division of Extramural Activities Support, OER National Institutes of Health 6705 Rockledge Drive, Room 2207, MSC 7987 Bethesda, MD 20892-7987 (regular mail) Bethesda, MD 20817 (express mail delivery)
22	Sponsor Updates ~ cont. National Science Foundation No longer require cost-share on programs http://www.nsf.gov/pubs/policydocs/cspolicy1004.pdf Department of Education New grant making priority will permit departments to give preference to proposals that utilize randomized studies for quasi-experimental research designs State of Colorado Bids Procurement website: http://www.gssa.state.co.us/VenSols Contact Crystal Streit for login information to view bid specifications OSP is developing an online calendar of current funding opportunities
23	Digital Signatures OSP has developed a new Proposal Review and Approval Form in Adobe Acrobat that can be digitally signed Form can be completed and digitally certified by PI and then routed via email to other signatories such as Dean and Vice Provost Certification ensures that no changes have been made to the form since signature by the PI See instructions for creating and using digital signatures
24	Digital ID Create & Sign Creating a Digital ID in Adobe Acrobat On the menu bar at top of page, choose Document > Manage Digital Ids > My Digital ID Files > Select My Digital ID File Click New Digital ID File and then click Continue In Create Self-Signed Digital ID dialog box, do the following: Type a name for your Digital ID this name will appear in the Signatures panel of the signature filed Choose a key algorithm from menu 2048-bit RSA offers more security 1024-bit RSA is more universally compatible Under Use Digital ID for:, select Digital Signatures Type a password containing at least six characters (letters and/or numbers); passwords are case-sensitive Click Create, specify a filename and location and then click Save Signing an Adobe Acrobat Document Once you have finished making changes to the document, find the signature field where you are required to sign. Click on the signature field. In the Digital ID Selection dialog box, do the following: Select a Digital ID or Click Add Digital ID and find your ID. Once your ID is selected, click OK. Select a reason for signing the document Click Sign and Save As, specify a filename a location and then click Save Forward document to next in line for signature
25	OSP Grants Accounting Julie Cunningham Management of Grants Expenditure systems, including Payroll, Purchasing, Equipment, Travel, etc. Management of Billing and Payment systems; finalizing monthly deposits. Management of Accounts Receivable, Collections, Overruns, and Unallowable expenses. Management of period-end closing processes. Approval of all journal entries for research funds, gainshare/flowback funds, OSP clearing funds. Reconciliations of Grants Ledger to General Ledger Preparation of quarterly VCBFA reports Audit Liaison Billing and financial reporting for: IRS (Internal Revenue Service) Foundations/Non-profits Other Non-federal Sponsors
26	How to obtain a P-Card Any appointed University employee who has the responsibility for making purchases on behalf of his/her department may apply for a purchasing card Print the Purchasing Card Application http://www.du.edu/purchasing/forms/PurCard_Application.doc Submit to your Card Program Coordinator (usually the Budget Officer). The Coordinator will: Gain the necessary approvals for the application Identify a departmental FOAP number for charges Forward application to Purchasing Services Before receiving your card, you must complete the online Purchasing Card Questionnaire http://www.du.edu/purchasing/pcardquestions.html Print, review and sign a Cardholder Agreement http://www.du.edu/purchasing/forms/PurCard_Agreement.doc Mail signed agreement to Purchasing Services 2467 S. Vine St. Keep a copy for your records If you are interested in a P-Card for grants, please contact: Julie Cunningham, x14039, jcunnin2@du.edu
27	Effort Certification A report shall be generated based on payroll distributions for each employee who is: Paid monthly, AND Has been paid from a sponsored program fund sometime during the fiscal year, OR Has cost-shared effort towards a sponsored program (as indicated through Activity Code), OR Has an employee class code related to research OSP will distribute these reports to the employees Faculty will receive them semi-annually Non-faculty will receive them monthly Employees will review, indicate adjustments and certify by signing The supervisor (PI) will sign. If employee is PI, the Department Chair or Dean shall sign Reports will be returned to OSP promptly Faculty must complete the Payroll Redistribution form in order for OSP to make any adjustments Non-faculty - OSP will make any adjustments indicated through the Banner payroll system See Sample of Effort Certification (Appendix B) http://www.du.edu/orsp/effort_certification.html
28	Cost Sharing Cost share is defined as the project or program costs not borne by the sponsoring agency. In order to include an item as cost sharing it must be: Verifiable Not included as a cost share to another grant or contract account without agency approval Necessary and reasonable for project Allowable and allocable under applicable cost principles Not funded from another grant or contract without agency approval Incurred within the time frame of the project
29	Cost Share ~ Additional Guidelines Unrecovered indirect cost can be used as cost sharing only with agency written approval Tuition and waived IDC are the preferable methods of cost sharing because they are easily verifiable Cost sharing should be limited in proposal preparation to only those costs making a direct contribution to the project. Excessive cost sharing causes additional work on everyones part in verification and has an adverse effect on indirect cost rates. Voluntary cost sharing in strongly discouraged. Cost sharing identified in the text of the proposal must be listed in the budget All sources of university cost share should be easily identifiable in the budget. For example, differentiate between costs contributed by the department versus those contributed by the school or another unit. A letter of support, with specific reference to the cost sharing, from a third party source, must be included with the proposal. Written confirmation of third party support will be required at the time the final cost sharing report is prepared for the agency. The university is required by federal guidelines to account for all cost share associated with federal or federal pass through accounts. This is true regardless of the granting agency involved and whether the cost share is considered mandatory or voluntary.
30	Cost-Share ~ Procedures Proposal Stage Principal Investigator determines budget including mandatory cost share before proposal is submitted OSP Project Administrators review budget and sponsor guidelines to determine that cost share is mandatory Principal Investigator completes the Proposal Review and Approval form and lists the departmental FOAP that will be cost-shared towards the project Department Chair and/or Dean must approve Award Stage Office of Sponsored Programs sets up grant/fund and activates a Cost-Share Activity Code Example: Grant 36123 = Cost share activity code = CS6123 The Cost-Share Activity Code is used with a 10000 fund and departmental operating org This Cost-Share Activity Code will be needed on all transactions for salaries, supplies, travel and equipment. It will not be necessary to use the CS activity code on tuition, waived IDC or third party contributions Verification of Cost-Share forms will be sent to the Principal Investigators quarterly and must be signed and returned to OSP
31	Cost Share ~ Procedures Salaries Employees submit timesheets using departmental FOAP and Cost-Share Activity Code Salaried/monthly employees submit Salmon Timesheets each month Benefited/bi-weekly employees submit Blue Timesheets bi-weekly Contact Susan McTavish x14054 for more information Supplies items are purchased with direct pay vouchers or purchase orders Cost share activity code must be used on direct pay forms or purchase orders to tag supplies as cost share Third Party Signed statements from third parties entities certifying cost match amounts Closeout All cost-share must be accounted for and verified before the end of the project period. Cost-share will be reported on the final financial report sent to the sponsor. See Sample of Cost-Share (Appendix C) http://www.du.edu/orsp/costsharing.html
32	Inventions, Patents & Technology at DU http://www.du.edu/techtransfer Employee Patent Agreement The University owns all rights to any discovery or invention resulting from research carried on by a faculty member, employee or student If you have not signed an Employee Patent Agreement or you are unsure, please contact Human Resources or the Office of Technology Transfer Disclosure Requirement and Form Disclosure of any discovery or invention must be made promptly to the University Patent Rights Committee Inventor Assistance in License Identification Inventors knowledge of prior art and the market is invaluable in commercializing a patent Royalty Distribution
33	Upcoming OSP Training and Education OSP hosted NCURA webcasts Email: jcavende@du.edu to register Principles of R&D Contracting June 14, 2005 9:30am 1:30pm OSP Conference Area Best Practices in Research Compliance September 13, 2005 9:30am 1:30pm OSP Conference Area For more information: http://www.du.edu/orsp/Training_Education.html
34	Appendix