Frequently Asked Questions

If the proposal is to be submitted via paper upload the completed proposal application into Emory Proposal Express (EPEX). If it is to be submitted via Grants.gov or some other electronic system, submit the necessary proposal information in EPEX, then upload the completed proposal into the required electronic system. PIs and Co-PIs must electronically approve the proposal in EPEX. All of the following should electronically approve for each KEY PERSONNEL listed on the application:

• Division Chief(s) if applicable
• Department Chair(s)
• Deans Office(s)
• The Office of Sponsored Programs (OSP) receives last after all of the above have signed.

Please review the Sponsored Programs and Institutional Advancement Proposal Routing Procedures.

If you have routed your application and are curious to see if OSP has received it you can view it's approval status in EPEX. EPEX is restricted to those users in the Emory domain.

For assistance on application completion, refer to the table below.

1. Attach budget, work statement and any other forms that the sponsoring agency requires in EPEX and route.
2. Provide the name and address of the Institution and Principal Investigator that will be collaborating.
3. OSP will provide a consortium letter.

1. Follow the instructions under "How do I route a proposal?"
2. Additionally, include agency required forms for subcontractees (example, budgets, checklist, etc.)
3. Need consortium letter from subcontractee, signed by subcontractees' institutional official.

1. 10% on the Salary, Wage, & Fringe base
2. If NIH, only 8% of TDC minus equipment is allowed for foreign subs on an NIH grant.

1. Route proposal/contract information via EPEX
2. Budget (internal and/or external)
3. Protocol
4. Clinical Trial Agreement (if available)
5. IRB Approval (if available)
6. Name and phone number of the contact person at the agency

Note: You do not have to wait for IRB approval to route your clinical trial

1. Note instructions and decision tree for determining whether or not Office of Clinical Research review is needed per the OCR website.
2. If OCR review is needed, route the proposal to the OCR via EPEX and email the OCR information sheet plus attachments to clinicaltrials@emory.edu per the OCR website.
3. If OCR review is not needed, prepare the following set of documents for routing: *fully endorsed proposal via EPEX *budget (Siteminder and sponsor budget) *protocol *clinical trial agreement *draft informed consent form *draft HIPAA form (if applicable) The routing documentation should also indicate the name and email address of the sponsor's contact person for the contract. The routing package should be routed, via the standard process for routing proposals, as described above.

Note: The non-industry sponsored trials are routed the same as standard proposals.

Confidentiality agreements come in several flavors but are very similar. CA stands for Confidentiality Agreement. CDA stands for Confidential Disclosure Agreement, sometimes referred to as an NDA (Non-Disclosure Agreement) or an RDA (Restricted Disclosure Agreement). Generally speaking, these types of agreements outline what information is confidential, what and how information can be shared, and what information should be restricted from other parties. These agreements allow parties to discuss details of their business and inventions without the fear of important information being made public.

During the planning and preparation of a research project, there may be a need to exchange with or receive from a potential sponsor or collaborator confidential information (unpublished data, intellectual property, business practices, etc.). Depending on the nature of the situation, CDA/NDA’s are handled by varying offices.

• Any confidentiality agreements received from a third party pertaining to consulting/advising or committees will be routed to the respective Schools Business Offices for review and approval after the PI submits it as an external activity through eDisclose;
• non-clinical research related MTAs/DUAs should be routed to Office of Technology Transfer/OTT, ottmta@emory.edu; and
• vendor/procurement agreements should be routed to Procurement Service Center for review and signature.

 Any confidentiality agreements received from a third party pertaining to clinical research (trial or study)should be routed to Office of Sponsored Programs/OSP for review and signature at the following email address: OSP-CONTRACTS@LISTSERV.CC.EMORY.EDU.

Please ensure the following information is provided at the time of submission to the OSP listserv: 

• Principal Investigator
• Sponsor Contact Name
• Sponsor Contact Email Address
• Project Title
• Proposed or draft agreement (attached in Word format only (not pdf) in case edits are needed)
• Clearly identify any request that is urgent and require expedited review in subject heading
• Information about data sharing:
  • Emory will receive confidential information only; OR
  • Emory will share confidential information only; OR
  • Sponsor will share confidential information and Emory will or may share confidential information

If a sponsor or other third party does not have a template or draft CDA/NDA agreement, Emory’s CDA/NDA template can be provided as the proposed draft agreement.

1. Check agency guidelines for transferring policies. You may wish to consult your program officer and/or grants specialist at the sponsoring agency for further assistance.
2. Have previous institution prepare a relinquishing statement (for federal grants) to send to sponsoring agency.
3. Obtain a copy of the relinquishing statement for your records.
4. Route proposal through Emory with revised pages, i.e. EPEX, face page, budgets, resource pages, checklist, etc. and a copy of relinquishing statement from prior institution. As per #1 above, you will know the sponsor requirements.
5. Contact appropriate compliance committees here at Emory University and secure approval.
   • Institutional Review Board
   • Institutional Animal Care and Use Committee

1. Check agency guidelines for transferring policies. The PI should verify that transfers are possible and how to reapply for these funds at his/her new institution (i.e., NIH will require the PI to complete a PHS 398 or PHS 2590 with the new institutions signatures).
2. PI should write a letter to OSP stating:
   • Title
   • Grant Number
   • Date of Transfer
   • Any equipment associated with this grant that the PI wishes to take with them.
3. PI, department chair and dean must sign this letter.
4. For federal grants, PI must complete Final Invention Statement.
5. The signed letter and Final Invention Statement must be sent to OSP.
6. Upon receipt, OSP and the Office of Grants and Contracts Accounting will prepare a relinquishing statement (for federal grants) to be sent to the sponsoring agency.

In making the determination of whether a subrecipient or vendor (consultant) relationship exists, the substance of the relationship is what is heavily considered. There may be unusual circumstances or exceptions to the general characteristics listed below but these are the general criteria used. It is not expected that all of the characteristics below will be present and judgment should be used when determining whether an entity is a subrecipient or a vendor.

1. SUBRECIPIENT RELATIONSHIP
   A subrecipient relationship exists when a third party:
   • performs a substantive portion of the programmatic work, which is defined as project activities that are a primary purpose of the prime award;
   • has responsibility for programmatic decision making;
   • uses the funds provided to carry out a program of the subrecipient as opposed to providing goods or services for a program of Emory;
   • is responsible for helping Emory meet the requirements of its prime award;
   • potential for patentable or copyrightable technology;
   • potential for publication of results;
   • has its performance measured against whether the objectives of the prime program/award are met; or
   • has responsibility for adherence to applicable prime program/award compliance requirements.
2. VENDOR (Consultant) RELATIONSHIP
   A vendor relationship exists when a third party:
   • provides professional services or highly technical advice, such as a consultant;
   • provides goods or services as a part of its normal business operations;
   • provides similar goods or services to many different purchasers;
   • operates in a competitive environment;
   • no potential for publication or patentable/copyrightable technology;
   • is responsible only for meeting the requirements of the contractual services contract between Emory and the vendor;
   • provides goods or services that are ancillary to the operation of the Federal program; or
   • is not subject to compliance requirements of the Federal program.

If you have any compliance related concerns you can call the Trust Line for Compliance Concerns at 1-888-550-8850.