Page 1 of 6 Instructions for ORS Proposal Transmittal and Approval ...

Instructions for ORS Proposal Transmittal and Approval Form(form RS-001 (rev. 7/01))Page 1 of 6The principal investigator is responsible for completing and signing the transmittal form. By signing theform, the investigator certifies that the information contained in the proposal and on the transmittal form isaccurate and complete. For schools, other than the School of Medicine, once the proposal has been approvedand the transmittal form signed by the Dean(s) of the appropriate School(s), the original proposal andtransmittal form and one copy of the proposal for ORS files should be delivered to the Office of ResearchServices (3451 Walnut Street, Room P221 Franklin Building) for University approval and signature. In theSchool of Medicine, proposals may be signed by the ORS representative at the School, provided all humanand animal protocols are on file in Regulatory Affairs and the proposal is not in response to an RFP or doesnot require the execution of a contract.1. ORS NEEDS FILE COPY OF PROPOSAL: ORS requires the original and one copy prior to processing aproposal. ORS will not process a proposal without receiving an ORS file copy.2. PROPOSAL DUE DATE: Indicate the Sponsor's deadline for receiving the proposal.3. LETTER OF RESPONSIBILITY ATTACHED? Faculty Rank: It is the policy of the University that allresearch and training proposals carry as principal investigator or co-principal investigator at least one personholding the academic rank of professor, associate professor or assistant professor. Research and trainingproposals may be submitted by individuals who do not qualify under this policy requirement provided theproposal is approved in writing by the appropriate Department Chairperson and Dean, indicating theiraffirmative endorsement of the proposal, and the Chairperson's acceptance of the responsibility for theconduct and quality of the Work. The principal investigator must be an employee of the University or holdan adjunct or emeritus appointment.4. PI/FACULTY SPONSOR NAME: Faculty sponsor pertains to a fellowship application and refers to thefaculty member who is sponsoring the fellow identified under CO-PI/FELLOW NAME in the next block.The faculty sponsor takes responsibility for the fellow's work if the proposal is funded. Names of PI's, Co-PI's, and Fellows should be identical to those used for payroll.SOCIAL SECURITY #: Required for links from the ORS database and other campus data.PHONE #: Local campus extensionE-MAIL: Local e-mail addressSCHOOL/DEPARTMENT: Indicate the department in which the PI has his/her primary appointment.POSITION/TITLE: Indicate the investigator's academic rank. ORS will reference this title if atransmittal letter is required by the sponsor.5. DEPT. ADMINISTERING GRANT OR CONTRACT: If the proposal is funded, this block indicates thedepartment that will administer the grant. The department identified in this block will receive Digests issuedby ORS, have access to the account in the University's financial management system, and receive credit forthe proposal within the University. Fellowships are administered by the Faculty Sponsor's home department.School requirements vary regarding proposals being administered by other than the PI's primary department.

Page 2 of 66. HAS PI CHANGED?: If this grant is active under a different principal investigator, or if a proposal hasbeen submitted previously to the same sponsor by a different principal investigator (someone other than theperson listed under PI/FACULTY SPONSOR NAME), check "yes." Indicate the previous PI if applicable. Ifthis is a new proposal or the principal investigator has not changed, check "no."7. ORG NO.: As required for the Financial Management Information System (FINMIS), please provide the4-digit Organization code associated with the proposed project. Your school's senior business administratorwill have a complete list of your school's ORG value.8. PROGRAM NO.: As required for the Financial Management Information System (FINMIS), pleaseprovide the 4-digit Program code associated with the proposed project. Your school's senior businessadministrator will have a complete list of University Program values. If this field is left blank, the defaultvalue 2000 - Research, will be used.9. CENTER REF.: As required for the Financial Management Information System (FINMIS), please providethe 4-digit Center Ref. code associated with the proposed project. The Center Ref. Is a unique additionalreference specific to an individual school or center. It permits financial information to be aggregated at alevel other than organization or program.10. TYPE OF PROJECT: Check the appropriate box(es) using the following definitions:Research: Includes research projects under the direction of a PI with academic rank of Assistant Professor orhigher (or equivalent). Do not include fellowships, scholarships.Fellowship: Include projects where principal funding is for student stipends, tuition and fees. Include allfellowships and scholarships.Training: Include projects for new or expanded University curricula, training courses, teaching programs,general education support programs.Clinical Trial: Include programs which are investigations, sponsored and funded by a private sponsor(industry), of the effects of a drug, medical treatment, or device on a group of patients or non-patientvolunteers.Conference: Include programs which are entirely for support of a conference.Facilities and Equipment: Include programs which are entirely for procurement of new buildings andstructures, renovations of existing buildings, or equipment.RFP/RFA: Include proposals submitted in response to a specific Federal Government Request for Proposalsor Request for Application. The RFA/RFP Program number should be provided.Other: Include anything not identifiable in the above. Should be used only in unusual circumstances.

Page 3 of 611. TYPE OF PROPOSAL: Check the appropriate box using the following definitions:Pre-proposal: Information requested by sponsor prior to submission of complete proposal.Change of Grantee Institution: Transfer of an existing grant or contract to Penn by a new faculty member.New: Applications being submitted for the first time to a sponsor.Supplement: Applications for additional funds to supplement a currently funded project.Revision: Applications replacing a prior unfunded version of a new, competing continuation or supplementalapplication.Non-competing Continuation: Applications for continuation of a grant within its current project period.Revised Budget: Budget-only revisions.Competing Continuation: Applications to renew or extend a funded grant beyond its current total projectperiod.Terminology reflects NIH definitions and types, however, proposals to all sponsors should conformto the above categories.12. TITLE OF PROJECT: The title in this block must match the title on the proposal and IRB/IACUCprotocol. While specifications vary by sponsor, PHS requires that the title not exceed 56 typewriter spaces,including the spaces between words and punctuation. For sponsors who have no requirements, please limitthe title to no more than two lines of 50 characters each. ORS will reference the title listed in this block, ifthe sponsor requires a transmittal letter.13. IS THIS A TITLE CHANGE FROM LAST SUBMISSION?: Titles change frequently betweensubmissions. Indicating whether or not the title has changed will help ORS locate previous submissions andproperly record the proposal in the ORS database.14. SPONSORING AGENCY OR ORGANIZATION: This block should indicate the agency or institutionto which the proposal is being submitted along with the contact’s name and telephone. This sponsor andaddress will be used if ORS generates a transmittal letter, mails the proposal, or needs to negotiate terms andconditions. If, when the proposal is funded, the University of Pennsylvania will be a subcontractor underanother University or agency, list the sponsoring University or agency here, not the primary sponsor, e.g.NIH, NSF, etc.15. SPONSOR's GRANT #: If the grant is active and the sponsor has assigned a grant number, indicate thenumber here.16. UNIVERSITY ACCOUNT #: If the grant is active and the University has assigned an account number,indicate the number here.17. MAILING INSTRUCTIONS: ORS will mail the proposal by UPS ground service or First Class US Mailto the sponsor listed under SPONSORING AGENCY OR ORGANIZATION as long as the proposal is

Page 4 of 6approved and signed by ORS at least five business days prior to the sponsor's deadline. ORS will not sendproposals by overnight delivery and will not guarantee delivery by the sponsor's deadline date. In addition,due to the volume of proposals during deadlines, ORS may not have the personnel to mail proposals.18. SPECIAL INSTRUCTIONS: ORS will generate a transmittal letter if one is required by the sponsor.Also, please attach a separate sheet as needed for additional special instructions.19. PROPOSED PROJECT START DATE: Self explanatory.20. PROPOSED PROJECT END DATE: Self explanatory.21. INDIRECT COST RATE(S): The University's federally approved indirect cost rates should be usedunless the sponsor has a stated policy requiring a different rate and for projects involving clinical testing ofdrugs and devices which may be budgeted for indirect cost at 23.6% of total direct costs. The off-campusrate may be used for projects or portions of projects performed in other than University owned facilities for aperiod of four (4) or more months.22. FUNDS REQUESTED: Enter the direct and indirect cost amounts requested from the sponsor as well asthe amount of cost sharing or matching funds for both the initial budget period and the entire period of theproject. For clinical trials, the entire budget for the initial phase may be listed in one column. Also, pleaseindicate the location of the detailed budget within the proposal. If cost sharing or matching funds areproposed, please indicate the source of the funds. The requirements for committing University funds to costsharing or matching vary by school.23. SUBCONTRACTORS: If other universities, companies, or organizations will perform a portion of theproposed project and are included in the proposal budget to receive funds, please list the name of thatorganization here. In addition, ORS requires that documentation from the subcontracting entity (including aninstitutional signature) be included with the proposal.24. FACILITIES: The individual schools are responsible for monitoring space usage. Please contact theschool business office if you have questions concerning completion of this block.25. REGULATORY AND OTHER APPROVALS:The following review and approval procedures are mandated by federal statute and/or regulations. Failure tocomply with these requirements may delay submission of your proposal. University policy requires thesereviews for all projects, sponsored or un-sponsored.Human Subjects Review Proposals calling for the use of human subjects must be reviewed by theUniversity's Committee on Studies Involving Human Beings. Human subjects review and approval must beobtained either before the proposal is submitted or before a deadline set by the sponsoring agency. Noncompetingcontinuation proposals do not have a 60 day grace period and must have human subjects approvalprior to submission. ORS will not process a proposal until the human subjects protocol has been submittedfor review. If the grant is awarded, ORS will not assign a University account number and research cannotbegin until the human subjects protocol has been approved. Human subjects "Guidelines" are available fromthe Office of Regulatory Affairs (Ext. 8-2614).Animal Care Review Proposals involving the use of vertebrate animals must be reviewed by theInstitutional Animal Care and Use Committee (IACUC). Committee approval is required before the proposal

Page 5 of 6is submitted or before a deadline date set by the sponsoring agency. In the case of the National Institutes ofHealth, IACUC approval must be received within 60 days from the date of the proposal submission for newand competing continuation proposals. Non-competing continuation proposals do not have a 60 day graceperiod and must have IACUC approval prior to submission. ORS will not process a proposal until theAnimal Care and Use protocol has been submitted for review. If the grant is awarded, ORS will not assign aUniversity account number and research cannot begin until the Animal Care and Use protocol has beenapproved. Animal care and use "Guidelines" are available from the Office of Regulatory Affairs (Ext. 8-2614).Experimental Drug and Device Testing Clinical trial protocols must receive the approval of the Committeeon Studies Involving Human Beings, and if appropriate, the Radioactive Drug Research Committee. Forinformation, contact the Office of Regulatory Affairs (Ext. 8-2614).Radioactive Drug Research The research use of radioactive drugs is to be referred to the Radioactive DrugResearch Committee for clearance. "Guidelines" are available from the Office of Environmental Health andRadiation Safety (Ext. 8-7187).Radiation Safety The use of radio nuclides and radiation producing equipment at the University is under thesurveillance of the Radiation Safety Committee. The Radiation Safety Committee establishes policy withrespect to use of sources of radiation in the University of Pennsylvania and certain affiliated institutions.Under direction of the Committee, the Office of Environmental Health and Radiation Safety (OEHRS)provides consultation, technical support services, monitoring surveillance and administers a program toestablish compliance with federal, state and local regulations and laws governing use of sources of radiation.Due to government regulations and required licensure, the procurement and use of radioactive materialsrequires prior approval by the Radiation Safety Committee. Other sources of radiation (X-ray equipment,accelerators, electron microscopes for example) are subject to regulations and standards for the equipment,its installation (which may require substantial structural shielding), procedures for safe use, standards forpersonal exposure, and registration of the equipment with the Commonwealth of Pennsylvania.Information on radioactive licensing and the proper use of radioactive material is to be found in the Office ofEnvironmental Health and Radiation Safety "Users' Guide" which is available on the Office ofEnvironmental Health and Radiation Safety web site at http://www.ehrs.upenn.edu/. By using the "Users'Guide" and by consulting with the OEHRS during grant proposal preparation, a researcher is able tofacilitate the licensing process and to obtain other services such as advice about potential costs for thedisposal of radioactive materials and personnel dosimetry. Also, by having completed the OEHRS licensingprocess prior to the award of a grant, researchers will avoid delays that can occur in initiating a researchproject if licensing has not already been finalized. Please contact the Office of Environmental Health andRadiation Safety at extension 8-7187 for more information.Chemical and Biological Safety The Office of Environmental Health and Radiation Safety (OEHRS) is theoperational group of the Environmental Health and Safety Committee and its subcommittee the InstitutionalBiosafety Committee (IBC). As such, OEHRS facilitates compliance with proposed and existing laws,regulations and guidelines associated with the use of chemically and biologically hazardous materials andharmful physical agents. Proposals which involve the in vitro generation of recombinant DNA must beregistered and approved by the IBC through OEHRS. Proposals involving the use of teratogens, mutagens,carcinogens, or infectious agents (including human blood and tissues) in animals must be submitted toOEHRS for review, establishment of safety guidelines, and approval. Proposals involving the use of

Page 6 of 6carcinogens, reproductive hazards and acutely toxic chemicals must comply with guidelines described in theUniversity's "Chemical Hygiene Plan." Lists of carcinogens, reproductive hazards and acutely toxicchemicals are available in the "Chemical Hygiene Plan." Proposals involving the use of infectious agentsmust comply with guidelines in the University's "Biological Safety Manual." A list of infectious agents maybe found in the appendix of the "Biological Safety Manual." Investigators whose proposals involve the useof human blood, blood products, tissues and certain body fluids must complete the University's ExposureControl Plan. The completed plan must be readily accessible in the laboratory for all employees to reference.All documents are available from OEHRS. For more information, call OEHRS at 898-4453.26. APPROVAL CERTIFICATIONS:Principal Investigators are responsible for verifying that all proposal information is accurate and completeand agree to accept responsibility for scientific and technical conduct of this project and for provision ofrequired technical reports if a grant or contract is awarded as a result of the proposal. If an award is made asa result of the proposal the Principal Investigator is responsible for administering it in accordance with thepolicies of the sponsor and the University.Business Administrators are responsible for verifying that the financial and administrative informationcontained in the proposal is accurate and complete.Department Chairpersons have a general responsibility for promoting the scholarly and research activities oftheir departments. They review applications for research projects for their appropriateness and transmitapproved proposals through the appropriate dean to ORS, making sure that the human, fiscal and spacedemands of all projects are in the best interests of their departments and the University. A DepartmentalChair's signature is required for each department with significant involvement in the proposal.Dean of School: The Dean's review relates to the substance and merit of the proposal, as well as, the budget,the salaries and employment of present and proposed personnel, and any other aspect of the proposal whichmay effect the teaching, research, and use of space and facilities of the responsibility center and theUniversity. The Dean's approval of less than the negotiated indirect cost rate indicates his/her acceptance ofreduced indirect cost recovery to the responsibility center. Once approved and endorsed, the proposal istransmitted to ORS for University approval. A Dean's signature is required for each school involved in theproposal.