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The following pages / sections contain the term(s) .

Introduction

This electronic guide serves as a roadmap for researchers (new and existing) as they navigate the complex research environment at Emory. The Research Handbook provides instructions for getting
…
Where do I start?

Investigators new to Emory should refer to appointment letter for information related to financial considerations, space and department resources.

Policy 7.9
Guidelines for Responsible Conduct of…
What are the regulatory and institutional requirements?
When can I start enrolling subjects, working with animals, or conducting laboratory-based research?

1. IRB
a. Office of Quality (OoQ)
b. Fully Executed CT
c. Active Study Account (eNOA)
i. ERMS
d. EHC Nursing Staff Training (if…
How do I navigate research – Emory Affiliates?

4a. CHOA

4b. Georgia Tech

4c. Grady

4c. VA

4d. Yerkes
How do I manage awards and effort?
What are the Research Lifecycles?
How do I conducting responsible research?
What are the processes for hiring and supervising staff?
Transferring awards/specimens out of Emory
Leaving Emory
Who should I contact to get started?

If information not included in your faculty appointment letter, contact the Departmental Vice-Chair, Department/Division Administrator, and/or Senior Mentor in your hiring department. They are…
Applying for funding
External Funding
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Are there databases available for me to use to search for external funding?
There are several types of research funding: federal, state, corporations, foundations and internally at Emory. Emory has a…
Funding on any free [non-subscription] databases
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Opportunities from federal government sponsors are posted on Grants.gov and also on the individual agency’s website, such as:

· National Institute of Health (NIH) Essentials and funding…
Internal Funding
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Internal funding may be available from various sources on campus. The OSP has compiled a list of Emory University internal funding sources for research and teaching projects as a convenience for the…
What staff resources are available for grant development?
Is there someone available to help me with grant preparation?
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Many Department/division research administrators, Vice –Chair of Research and Sr. Mentors have dedicated and available to assist researchers with grant development, budget preparation, routing, etc…
How can I learn more about grant-related training opportunities?
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The Office of Research Administration departments are here to assist faculty in developing, writing and submitting proposals. The Office of Sponsored Programs offers workshops, grant application kits…
What resources are available for proposal preparations and routing?
Who can help?
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· Department/division research administrators, Vice –Chair of Research and Sr. Mentors may be available to assist with administrative components of the application.
· The Research…
Who is eligible to apply for external funding?
/pages/56

As highlighted in the Principal Investigator Eligibility Policy, Emory University permits any regular full-time or part-time faculty member in the School of Medicine is allowed to submit research…
What resources are available for proposal preparation?
/pages/56

The Investigator’s Guide provides links to online research administration content and tools for each stage of the grant life cycle. The Department of Medicine’s Office of Research webpage also offers…
What are my specific roles and responsibilities in proposal preparation?
/pages/56

The Emory proposal development process requires significant contributions from the researcher, department/division, the RAS units and OSP. As the researcher, you are responsible for ensuring the…
What is the routing process and who can help?
/pages/56

OSP provides guidance on Emory’s Routing Process on its website.

Emory University requires its faculty, staff, and students to route all proposals for external funding, along with all related…
What are my specific roles and responsibilities in the routing process?
/pages/56

As is the case in proposal preparation, proposal routing requires a collaborative effort.

The typical proposal routing process:
1. Faculty member identifies funding opportunity
2. Faculty…
What is the proposal submission process and who completes it?
/pages/56

Once a proposal has been completed and reviewed through the routing process, it must be submitted to the sponsoring agency. Agencies may differ in how they wish grant or contract proposals to be…
Tips for ensuring the application process goes smoothly
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· Work with your department/division early in the submission process and plan to complete your application at least 7 days in advance of the sponsor’s submission deadline.
· Follow the…
What should I consider when developing a budget?
Who can help me with budget development?
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The Principal Investigator (PI) works with the PreAward Administrator in the RAS unit to define the budget and develop and finalize the budget justification for each proposal. The Office of Sponsored…
What are F&A costs?
/pages/65

Indirect Costs (also known as Facilities & Administration Costs or F&A) ensure the proper indirect cost rate is used.
(Refer to current Emory F&A rates)
What should I include in my budget?
/pages/65

Budgets should include direct costs that are reasonably required to support the project and Facilities & Administration (F&A) costs.

Direct costs are directly identifiable project expenses. Major…
Do I need to include cost sharing in my proposal?
/pages/65

Cost sharing should only be included in a proposal when it is required by the sponsor and/or the perceived benefit of the proposed project is of sufficient strategic importance to warrant the…
What can’t be charged to grants?
/pages/65

The following items cannot be charged to a federal award and should not be included in the project budget submitted to a federal sponsor:

· postage unless the project has a separate and…
What needs to be included in a budget justification?
/pages/65

The Budget Justification is a narrative that provides additional detail on line items in the budget. Sections should be included for Personnel, Equipment, Travel, and any other budget categories that…
When do I use an NIH modular budget?
/pages/65

NIH requires that proposals requesting $250,000 or less in direct costs per year be submitted as “modular grants.” Funds are requested in $25,000 increments, or “modules,” based on an internal…
What should I consider when working with industry?
Whom do I contact for assistance?
/pages/73

The Office of Technology Transfer (OTT) is now responsible for the Emory industry contracting group (ICG). This will better align industry contract negotiations, both clinical and non-clinical, with…
What is a research contract?
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A research contract is a legal document detailing the obligations of two or more parties over the course of a research project. It usually has specific deliverables and milestones to be met and…
Where are research contracts with industry reviewed and signed?
/pages/73

As a single point of contact for industry OTT is responsible for negotiating industry clinical trial agreements, research agreements, and confidentiality agreements. The OTT Team handles agreements…
What authority does my signature have?
/pages/73

Grants, contracts, and other agreements with terms and conditions for research, sponsored training, clinical trials, patents and licensing, technology transfer, and research compliance are the…
What aspects of the contract am I expected to negotiate?
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Statement of Work (SOW) or protocol: As the subject matter expert, you are in the best position to know what work can and should be included in the project. Your familiarity with your resources and…
What F&A rate should be charged for Industry Agreements?
/pages/73

Emory proposals to industry are expected to include the University’s full costs of doing research, including the appropriate Facilities and Administrative (“F&A”) or indirect costs. The current F&A…
What should I expect during the contracting process?
/pages/73

Move to Budget/Consult Pam: Contracts that are negotiated and signed by OSP must be routed to the OSP. Be sure to include the agreement (if provided by sponsor), statement of work or protocol, and…
How do all the agreements terms impact my research? (Common differences between Federal and Industry Contracts)
/pages/73

Terms on sponsored research agreements potentially can impact any aspect of your work. A few examples include the record retention period; requests for compliance with corporate research standards…
What are the core facilities and resources?

A list of core facilities are available on the Emory Integrated Core Facilities (EICF) website.
Emory Integrated Core Facilities offers a list of core facilities that aid Emory researchers with access…
What licenses are needed for use of controlled substances/dangerous drugs? How do I obtain these licenses?

If your research requires the use of controlled substances and/or dangerous drugs, approvals from the Georgia Board of Pharmacy (GBP) and Drug Enforcement Agency (DEA) are required.

Different legal…
Obtaining regulatory approvals and requirements
Whom do I contact?
/pages/84

To work effectively within the university environment, you will collaborate with several regulatory offices on campus that have staff to assist you with the process.

Specific guidance on who to…
What are my responsibilities?
/pages/84

The university policies on research administration are grouped under four headings on the university Policies and Procedures website: General Policies, Research Compliance, Sponsored Programs, and…
What is included when disclosing financial interests related to research?
Whom do I contact?
/pages/87

The Conflict of Interest Review Office provides oversight, systemic safeguards, and regulatory expertise in managing individual and institutional financial interests that could impact research and…
How do I know if I need to submit a financial interest disclosure form? When do I submit the form?
/pages/87

All Emory investigators involved with research must disclose their Significant Financial Interests using the Investigator Financial Interest in Research Report component of the electronic Conflict of…
How do I get started?
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Emory's eCOI application is a University and Healthcare system-wide tool that helps to implement Emory's policies and procedures regarding financial interests and external activities. This application…
What are the training obligations? Are educational resources available?
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Investigators must receive training about Conflict of Interest policy when they begin research at Emory and again at least every 4 years thereafter. This training is currently part of the eCOI system…
How does the University determine if there is a conflict of interest related to research?
/pages/87

Institutional Responsibilities are defined by Emory Policy 7.7 (Policy for Investigators Holding a Financial Interest in Research) as activities related to an Investigator's Research, Teaching…
What should I expect if is determined that I have a conflict of interest? How do I get a management plan?
/pages/84

As outlined in Policy 7.7: Policy for Investigators Holding a Financial Interest in Research, Emory through its Conflict of Interest Review Committee (“the Committee”), or its delegates, will…
Will I be monitored after I receive a management plan?
/pages/87

The Conflict of Interest in Research Office will annually monitor whether you are following the terms of your management plan. All issued management plans are subject to monitoring. Therefore, it is…
What are my continuing obligations concerning conflict of interest?
/pages/87

Each year of a grant or contract, an Investigator must update his/her Investigator Financial Interest in Research Report. The form must be updated at the time of the annual progress report, twelve…
What are my responsibilities when using controlled substances?
/pages/87
Relevant policies, procedures, and links.
/pages/87

· Emory University Policy 7.7 - Researchers Holding Financial Interest in Research
·Emory University Policy 7.24 - Institutional Financial Interests Involving Human
…
What is the process when working with animals?
Whom do I contact?
/pages/99

The Division of Animal Resources (DAR) is an integrated team of animal care specialists, administrative professionals, veterinarians, veterinary technicians, logistics deliverers, and information…
What do I need to do when transferring animals into Emory?
/pages/99

Research animals are the property of Emory University and their exchange or transfer between institutions or investigators must be properly approved and accounted by the animal resources programs…
How do I know if I need to obtain approval?
/pages/99

Protocol Review and Approval
All researchers must obtain IACUC approval initiating any research, testing, or instructional project involving the use of live vertebrate animals.
To obtain approval…
What are training obligations? Are educational resources available?
/pages/99

Prior to working with animals, individuals must complete basic training components. The components are detailed in the 8th Edition of the Guide for the Care and Use of Laboratory Animals (Guide).
What should I do after I receive IACUC approval for my animal protocol?
/pages/99

Contact the Division of Animal Resources (DAR) to set up your accounts and arrange for ordering and housing your animals.

Be aware that all approved animal protocols must undergo complete review at…
What are my responsibilities related to animal subjects research compliance?
/pages/99

Emory University maintains a fully staffed veterinary surgery unit, health technicians and husbandry personnel. If your animal model requires special needs, contact the Division of Animal Resources…
Will IACUC monitor my research after approval?
/pages/99

IACUC is under federal mandate to monitor all research activities related to animal use. Pursuant to the 8th edition of “The Guide for The Care and Use of Laboratory Animals (Guide),” this includes…
How do I close a research study?
/pages/99

Contact the IACUC Office to close a research study.
Relevant policies, procedures, link, etc.
/pages/99
What is necessary when I am working with human subjects in research, including data and bio-specimens?
Whom do I contact?
/pages/109

Emory Institutional Review Board (IRB) facilitates ethically responsible human subjects research by assuring the rights and welfare of study participants.

Phone: (404) 712-0720
Toll Free: (877)…
How do I know if I need to obtain IRB approval?
/pages/109

If your research project meets the regulatory definition of “human subjects research”, you are required to obtain approval from the Institutional Review Board (IRB).

If you are unsure whether your…
Is it human subjects research and are you engaged in research at Emory?
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How do you obtain Investigational Drugs?
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How do you purchase drugs – the process?
/pages/109
Where is an acceptable place to store investigational drugs?
/pages/109
How do I obtain investigational Devices?
/pages/109
1. OCR Form for device negotiation
Where is an acceptable place to store investigational devices?
/pages/109
How do I get started if my research does require IRB approval? What are the recommended steps?
/pages/109

a. Review the IRB New Submission Guidance
b. Learn about Emory’s web-based IRB application and review system called eIRB
c. Review the general guidance on submitting a new study found in…
What are the training obligations? Are educational resources available?
/pages/109

All employees, faculty, staff, students and/or agents of Emory University engaged in the conduct of human subject research must have reviewed and be familiar with the principles of “The Belmont…
What should I expect after I submit?
/pages/109

a. Your application will be reviewed by the Administrative support staff prior to being sent to the IRB Chair or IRB convened board for final review and approval.

b. If the IRB has questions…
What are my responsibilities related to Human Subjects Research Compliance?
/pages/109

Investigators have a variety of IRB communication and record-keeping responsibilities after the research project is initiated. The Policies and Procedures define important terms (see the Glossary at…
What if I am using Emory Healthcare (EHC) clinical services in my human subjects research?
/pages/109

Section 7 of the eIRB application allows documentation your needs for EHC services. Clinical tools/checklist necessary for utilization of EHC clinical services (lab and radiology) are available on…
Will I be monitored after my approval?
/pages/109
1. Refer to 2015 IRB Investigational Guide
How do I close-out or terminate a research study in eIRB?
/pages/109

If all human subjects research activities have concluded, you may close out/terminate a study in eIRB. To do this, you must "create a Close-Out request” in eIRB.
Are registries available to help with volunteer recruitment?
/pages/109
Relevant policies, procedures, ethical statements, etc.
/pages/109
What is necessary when complying with research and export control regulations?
Who do I contact?
/pages/127

If you have questions regarding export controls, the Office of Compliance is available to provide guidance. You can contact the Office of Compliance at compliance@emory.edu or 404-727-2398.

If export…
What are export controls?
/pages/127

The United States regulates the exports of certain items, materials, equipment, software and technology in furtherance of national security interests and foreign policy objectives.
How can export controls apply to research?
/pages/127

Export controls can apply to a wide range of research activities, regardless of the source (or existence) of funding. The shipment of materials outside the U.S. can invoke export controls…
How will I know if export controls apply to my research?
/pages/127

For the export of physical items, while many things are not export-controlled, it is important to make sure to perform a diligence check to ensure that your export can be made.

With regard to…
If I think export controls may apply to my project, what do I do?
/pages/127

When routing a proposal or contract to start a project for which you think export controls may apply, indicate this by checking the “yes” box on the OSP routing form question about export controls…
What can I do to ensure compliance with export controls?
/pages/127
Is training available?
/pages/127

The Office of Compliance offers training on the Fundamentals of Export Control. In person training for groups available upon request. Information and resources regarding export controls is also…
Relevant policies, procedures, link, etc.
/pages/127

Policy 7.11: Policy on Export Controls
What is the process when working with biological materials/organisms?
Who do I contact?
/pages/136

The Research Safety Program in the Environmental Health & Safety Office (EHSO) is responsible for administration of programs in the research and non-research community regarding management of…
What approvals do I need prior to working with biological materials/organisms?
/pages/136

a. Recombinant DNA, Stem Cell, Select Agent and Toxin Research, Additional Approvals

Recombinant DNA (rDNA) Research
Authorization: As required by the NIH Guidelines, all rDNA research covered…
How do I get started if my research does require approval? What are the recommended steps?
/pages/136

For advice and guidance on the Biosafety Protocol Submission and Approval (BIORAFT) process, please contact the Biosafety Officer within the Environmental Health and Safety Office (EHSO).

Biosafety…
What are training obligations? Are educational resources available?
/pages/136

The EHSO offers http://www.ehso.emory.edu/training/index.htmlonline and in-person training for all Emory Employees.
Will I be monitored after my approval?
/pages/136
Relevant policies, procedures, link, etc.
/pages/136
What is the process when working with chemicals?
Whom do I contact?
/pages/143

The Research Safety Program in the Environmental Health & Safety Office (EHSO) is responsible for administration of programs in the research and non-research community regarding management of…
What approvals do I need prior to working with chemicals?
/pages/143

The Chemical Safety Protocol – Notice of Intent Guidelines outlines the submission and approval process for investigators working with chemicals. Investigators must complete a Chemical Safety…
How do I get started using chemicals and other hazardous materials in lab research?
/pages/143

Contact Kalpana Rengarjan at 404-727-8863to obtain information on the pertinent chemical health and safety program s as well as on the setting up a lab, and EHSO laboratory review process.
What are training obligations? Are educational resources available?
/pages/143

All personnel must complete the Lab Safety Training. EHSO training resources are available on the website: http://www.ehso.emory.edu/training/courses.html.
What are my responsibilities related to use of chemicals?
/pages/143

Guidelines and manuals for chemical safety are available on the EHSO website.

· The Chemical Hygiene Plan (CHP)
A CHP must be implemented in each lab by the Principal Investigator. EHS…
Will I be audited/monitored after my approval?
/pages/143
Relevant policies, procedures, link, etc.
/pages/143
What is the process when working with radioactive materials/radiation producing machines
Whom do I contact?
/pages/151

The Radiation Safety Office serves a dual role within the University. First, to help minimize occupationally related exposures to radiation, and second, to ensure that all radioactive materials used…
How do I obtain authorization for using radioactive materials/radiation producing machines for human and non-human research?
/pages/151

Research studies that involve radiation or radioactive materials must be approved by one or more Radiation Safety Committees. There are three Committees that review applications for human and…
What are training obligations? Are educational resources available?
/pages/151

Mandatory and recommended training sessions are available. Review the training requirements for Radiation Safety on the EHSO training website: http://www.ehso.emory.edu/training/courses.html.

The…
Will I be monitored after my approval?
/pages/151

Your safety advisor will conduct safety round observations, monitor the laboratory, and review the annual lab self-audit to assist lab staff with complying with safety regulations and University…
Relevant policies, procedures, link, etc.
/pages/151
What is the process when disposing of chemical, radioactive & biohazardous waste?
Whom do I contact?
/pages/157

The Environmental Compliance Program operates the chemical, radioactive and universal waste (i.e. lamps and batteries) disposal program for Emory University, Emory College, Oxford College, Emory…
What are my responsibilities as a waste generator?
/pages/157

Generators of chemical waste should collect waste in a suitable container, keep the container capped except to add or remove waste, label the container, store the waste properly, and contact EHS for…
What are training obligations? Are educational resources available?
/pages/157

Mandatory and recommended training sessions are available. Review the training requirements for Waste Management on the EHSO training website: http://www.ehso.emory.edu/training/courses.html.
Relevant policies, procedures, link, etc.
/pages/157

Waste Management Guidelines & Procedures
Waste Disposal: List of hazardous materials and disposal contacts
Request a pickup of chemical waste
Request a pickup of radioactive waste
Waste collection…
What is the process when working with Drug Enforcement Administration (DEA) materials?
Whom do I contact for questions related to the use of controlled substances?
/pages/162

For advice and guidance on the registration process and use of controlled substances/dangerous drugs at Emory and the Biosafety Protocol Submission and Approval (BIORAFT) process, please contact the…
How do I know if I need to register and/or obtain approval to work with controlled substance?
/pages/162

If your research requires the use of controlled substances and/or dangerous drugs, approvals from the Georgia Board of Pharmacy (GBP) and Drug Enforcement Agency (DEA) are required.

Different legal…
How do I get a Researcher Permit from the State of Georgia? What are the recommended steps?
/pages/162

A researcher must register with both the federal Drug Enforcement Agency (DEA) and the State of Georgia Board of Pharmacy (GBP). A practitioner that has a DEA registration for controlled substances…
What are the training obligations? Are educational resources available?
/pages/162

The Office of Compliance provides tutorials and offers a number of forms to assist investigators in the Emory research community conducting bench research or animal research using Controlled…
What should I expect after I submit?
/pages/162

After the application is approved by the GBP, the researcher must install a locker or cabinet where the controlled substances can be securely stored. Expect site visits by GBP/DEA personnel to…
What are my responsibilities related to compliance?
/pages/162

You, as the researcher (registrant), are ultimately responsible for the safe handling, use, control, security, disposal, and recordkeeping of the controlled substances procured under your…
Will I be monitored after my approval?
/pages/162

Yes, both the DEA, GBP and the Georgia Drugs and Narcotics Agency (GDNA) have the authority to oversee and inspect facilities before and after the registration is approved. The Division of Animal…
How do I close a research study that uses controlled substances?
/pages/162

After the completion of research study involving controlled substances, the researcher/registrant can arrange for a DEA reverse distributor to accept and dispose of the substances or, the…
Relevant policies, procedures, ethical statements, etc.
/pages/162

The following are Emory University policies that govern research use of Controlled substances and Dangerous Drugs.
Policy 7.25: Research Use of Controlled Substances
Policy 7.29: Research Use of…
What is the process when working with EHC Nursing, Clinics, Hospital and Office of Quality?
Fiscal Responsibility
Whom can I contact?
/pages/173

Contact your departmental/division research administrator, Vice-Chair of Research or Sr. Mentor for your hiring department. This individual(s) will serve as your primary contract for financial…
What is the Research Disct’d Fee Schedule (Pam Terry) Budget Considerations
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What financial principles do I need to know?
/pages/173

The successful administrative management of a sponsored project is a partnership shared by principal investigators and departmental/school/central administrators. Ultimately, however, the PI is…
What do I need to know in case of audit?
/pages/173

The University is audited on a regular basis. Audits fall into two categories – internal and external. The Internal Audit Division (IAD) carries out most internal audits and operational reviews at…
Spending / Apply costs
When can I start spending?
/pages/178

Once the terms of an award are acceptable, OSP will execute all necessary documents (e.g., contracts) on behalf of Emory University. Next, OSP will establish an account and alert you, your…
How do I purchase goods and services?
/pages/178

When you need goods and services for your research, utilize Procurement's Emory Express tool. Fisher Scientific is Emory's primary contract supplier for your lab supplies; however, Emory Express has a…
What cannot be charged to grants?
/pages/178

Fee Schedule Definitions

You must also ensure that all costs that are charged directly to a sponsored project are:
· Allowable – A cost is allowable if it is eligible under the terms and…
What are my responsibilities as the Project Director?
/pages/178

As the Principal Investigator (PI) of a project, you will probably be required periodically to supply information regarding the technical progress of your research. Pay careful attention to your award…
How do I monitor the fiscal status of my funds?
/pages/178
How do I get subjects reimbursed for travel – stipends?
/pages/178
What do I need to know about international travel?
/pages/178

Emory University Travel Policies require that all University business travel be arranged through one of three Emory air travel providers. Emory has a responsibility to provide travelers with…
How are Facilities & Administrative (F&A) costs charged to my award?
/pages/178

Facilities and Administrative (F&A) rates are used to recover costs spent on sponsored activities that cannot be directly attributed to a particular project. These are often called indirect costs. The…
Outgoing Subawards
Whom can I contact?
/pages/187

The Research Administration Services (RAS) will work with an investigator and OSP to request an outgoing subaward/subcontract.
Add: CAZ Exception/MOU/IPA
What is an outgoing subaward and Professional Service Agreement (PSA)? What offices are involved in these agreements?
/pages/187

An outgoing subaward is an agreement between Emory University and a separate legal entity in support of a sponsored project in which substantive programmatic activity is carried out.

For more general…
What is the difference between an outgoing subaward and a Professional Service Agreement (PSA)?
/pages/187
What offices are involved in processing an outgoing subaward, and what are their respective roles and responsibilities?
/pages/187

The Office of Sponsored Programs (OSP) is responsible for all formal negotiations with the subaward recipient during the development or performance of the subaward.

The role of the Post-Award…
How do I initiate an outgoing subaward?
/pages/187

Use the online system, COMPASS Financial System [insert correct hyperlink to new COMPASS system], to initiate and complete a request. (Do they apply to PSAs?)
What do I do if my Subawardee requires an advance payment?
/pages/187
How do I revise an existing outgoing subaward?
/pages/187
What is zero dollar subaward?
/pages/187
When do I need to file my technical report?
/pages/187

OGCA does not monitor, maintain, or require that copies of Final Technical Reports be submitted to OGCA. However, timely submission of the Final Technical Report is of great importance since Sponsors…
What is necessary when purchasing equipment?
Whom do I contact?
/pages/198

Asset Management – Equipment Team:
Renee Corsello, Mgr. Fixed Assets
Phone: 404-727-2287
Email: rcorsel@emory.edu
What do I need to know about equipment?
/pages/198

The Finance: Office of Grants and Contracts records and tracks University capital equipment within the PeopleSoft Asset Module.
Can I buy equipment?
/pages/198

a. If I leave, can I take it with me? Or can I give it to someone else?
b. Are there dollar limits to get approval?
c. Is this dependent upon funding source or chairs discretion?
d. When…
Reporting
How often do I need to file a progress report?
/pages/202

During the period of an award, most Sponsors require scientific and/or financial progress reports. Typically, Sponsors require progress reports on an annual basis, often 60-90 days prior to the end…
What is COMPASS?
/pages/202

COMPASS is Emory’s enterprise-wide PeopleSoft Financial system designed to track financial information, consolidate financial reports, and facilitate standardized financial processes.
Do I need to file a patent report?
/pages/202

All patent reports that indicate a disclosure and/or invention are coordinated with the Office of Sponsored Programs and the Office of Technology Transfer. The final patent reports for grants…
What is effort reporting?
/pages/202

OMB’s Uniform Guidance requires that institutions receiving federal awards maintain systems and procedures documenting the distribution of activity and associated payroll charges, to each individual…
Who is responsible for submitting financial reports?
/pages/202

Most sponsors require a full accounting to document how funding was spent. These reports might be due during regular intervals or at the completion of an award. The Financial Management of Sponsored…
What are property reports?
/pages/202

Some sponsors require Final Inventory Listing of Emory-owned equipment acquired with sponsor funds. Please be aware that even though not normally exercised, some Sponsors retain the right to transfer…
What are implications of not filing required sponsor reports?
/pages/202

Failure to submit required records could result in the sponsor withholding payment, terminating the award, or withholding future awards.
Changes to the project
OSP/OTT
/pages/210
FGC
/pages/210
OCR
/pages/210
IRB
/pages/210
Public Access
What is CT.gov
/pages/215
What is the NIH Public Access Policy?
/pages/215
Whom can I contact?
/pages/215
Is there training from the NIH?
/pages/215
What is PubMed Central and how is it different from PubMed?
/pages/215
Does the NIH Public Access Policy apply to me?
/pages/215
What must I do to comply with the NIH Public Access Policy?
/pages/215
My paper is based on research only partially funded by NIH. Is the paper required to be submitted to PubMed Central?
/pages/215
Am I responsible for papers that result from my NIH-funded project for which I am not an author?
/pages/215
How do I submit the final peer-reviewed manuscript to NIH/PubMed Central?
/pages/215
If I am not funded by NIH, how do I find out more information about the open access policies of other sponsors of research?
/pages/215
Links to relevant policies and procedures.
/pages/215
Training in the responsible conduct of research
Whom do I contact?
/pages/229

Training is required for those who are conducting or coordinating FDA-regulated clinical trials. Refer to the Clinical Research Education Requirements and Revised Training Letter for Emory’s…
How do I know if I need to complete Responsible Conduct of Research (RCR) Training?
/pages/229
How do I complete the RR Training?
/pages/229
Will my training be monitored?
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Yes, the Office for Clinical Research Education and Outreach staff track and monitor training for those conducting or coordinating research at Emory.
Relevant policies, procedures and links
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For training guidance, please visit OCR’s Training page or contact us at OCR@Emory.edu

Clinical Research Education Requirements
Revised Training Letter (May 23, 2016)
Introduction to Clinical Research…
Research Misconduct
Whom do I contact to report a concern?
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Emory University Chief Compliance Officer is:
Kristin West, JD, MS, Chief Compliance Officer
Research Integrity Officer (RIO) for Emory University
Office of the Vice President for Research
2660 UCC
(404)…
What are the responsibilities of the researcher?
/pages/235

Researchers, whether faculty members, staff members, or students, have the responsibility to be unfailingly honest in research; they must refrain from deliberate distortion or misrepresentation; and…
How is research misconduct defined?
/pages/235

Under the Policy, Research Misconduct is defined as:

o Fabrication - making up of Research data or results and recording or reporting them

o Falsification - manipulating Research materials…
Are there training opportunities available?
/pages/235

The Office of Compliance serves as a resource to the Emory research community for a variety of training and education needs.

Below are links to training materials provided by the Office of Compliance…
Relevant policies, procedures and links
/pages/235

At Emory, matters involving allegations of Research Misconduct are handled according to Emory University Policy 7.8, the Policy on Research Misconduct (the Policy). Emory personnel are encouraged to…
Authorship and publication
What is the university’s policy on authorship?
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Emory University’s Policy 7.9: Guidelines for Responsible Conduct of Scholarship and Research will address questions from faculty, students, and staff related to academic misconduct and authorship…
Who should be included as an author?
/pages/241

Standards for authorship vary between disciplines and journals. It is expected that all contributors to researchand/or scholarly work at Emory University shallconform to the specific, written…
What do I do in case of authorship dispute? Who do I contact?
/pages/241

It is recognized that when conflicts of opinion with regard to authorship arise, the disputing parties should make an attempt to resolve the matter amongst themselves through open discussion.

If the…
Additional publishing considerations?
/pages/241

Research Tools and Tips (Manuscript Development)
Authorship Guidelines
Confidentiality and privacy
What types of confidential information will I see as a researcher?
/pages/246

As a researcher, you may be asked to review grant proposals, scientific manuscripts, academic reviews of your colleagues. You may also see confidential records of your staff, collect human subjects…
HIPAA at Emory University - FAQ
/pages/246

a. Privacy Rules and the Health Insurance Portability and Accountability Act
/pages/246
Patient Protected Health Information HIPAA FAQs (Emory University)
/pages/246
HIPAA issues in Human Subjects Research at Emory
/pages/246
Human Subjects Office HIPAA FAQs by researchers (HHS.gov)
/pages/246
Staff Records
/pages/246

a. Guidelines for Personnel File Contents and Transfers Among University Departments
Confidential Disclosure Agreements
/pages/246

a. Sometimes one or both of the parties contemplating a research agreement will elect to execute a Confidential Disclosure Agreement, safeguarding the release or exchange of confidential…
Covered Entities
/pages/246

a. What does it mean if am a part of a covered entity or if I am not?
b. Business Assessment Agreement
Intellectual property
Whom do I contact?
/pages/256

Emory personnel should disclose the existence of any Intellectual to the Office of Technology Transfer (OTT).
Contact us at:
Office of Technology Transfer
1599 Clifton Rd, NE, 4th Floor
Atlanta, GA…
What is intellectual property?
/pages/256

Intellectual property (IP) is an asset created by intellectual effort and the owner of IP holds certain legal rights. Depending on the type of IP involved, IP protection may be afforded by patent…
How do I get started?
/pages/256
When should I contact Emory?
/pages/256
What is a Material Transfer Agreement (MTA)?
/pages/256

Material Transfer Agreements (MTAs) are used to transfer materials (generally biological) from one institution to another. An MTA is a contract between the owner of a material and the intended…
Relevant policies, procedures and links
/pages/256

Policy 4.121: Non-retaliation
Policy 7.8, the Policy on Research Misconduct
Policy 7.9: Guidelines for Responsible Conduct of Scholarship and Research
7.30: Policy on Authorship Guidelines and Dispute…
Data management: Research Records
What are Research Records?
/pages/263

Typically, research records refer to any type of records or materials that document your research effort. These can be electronic or hard copy as in various forms of logs, notebooks, correspondence…
Add: Duo Security: Ask Marc Overcash
/pages/263

a. Encryption Requirements for USBs
What points should I consider when managing my data?
/pages/263

The integrity of your data is dependent upon having and using a system of data management. When determining how data will be collected, recorded, and stored, you should consider the following:

·…
What am I responsible for?
/pages/263

As the PI, you should observe sound practices for the maintenance, oversight, and
storage of data as you have the final responsibility for the following:

· Validity and quality of the…
Who can help?
/pages/263

Emory University researchers can seek assistance in developing data management plans from various sources. The DMP Tool helps researchers create and manage data management plans. The Emory Libraries…
What are the relevant policies and procedures?
/pages/263

Emory University Policies, Procedures, and Resources:

Policy 10.13: Institutional Data Management

Partial list of Federal Policies, Procedures, and Resources:

NIH Data Sharing Policy/Data Safety…
Staff Hiring and Supervision
Getting started
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Whom do I contact?
/pages/271
What are the staff member types to which I can hire? (Ask Trish)
/pages/271
Where do I find job descriptions?
/pages/271

Click here for a listing of job descriptions.
What if the new employee has a Visa?
/pages/271
What is the process for onboarding a new employee?
/pages/271
What if my new employee wants to take a leave of absence – FMLA?
/pages/271
To be eligible for FMLA leave, an employee must:
- Have worked at least 12 month for Emory (need not be consecutive);
- Have worked at least 1,250 hours for Emory over the preceding 12 months (these hours…
Can a potential employee start working before being placed on payroll?
/pages/271
What are the restrictions on hiring family members or others with whom I have a significant relationship?
/pages/271
What do I need to know related to the hiring of a foreign national?
/pages/271
How do I make an offer of employment?
/pages/271
How do I determine salary and what benefits will my staff receive?
/pages/271
How do I anticipate salary and benefit costs for a multi-year grant or contract?
/pages/271
What happens when a staff member resigns?
/pages/271
What happens when a staff member retires?
/pages/271
What should I do when I anticipate no longer having sufficient funds to support my staff member(s) continued employment?
/pages/271
What if my staff member incurs a work-related injury?
/pages/271
What if my staff member has a health condition that affects his/her ability to work?
/pages/271
As a faculty member with a 9-month appointment, may I have a summer appointment related to my research?
/pages/271
Can I be paid extra compensation for working on an externally funded project?
/pages/271
Can I provide extra compensation to a staff member for exceptional performance?
/pages/271
Orienting you and your staff
/pages/270
What do I need to know to transition new staff members?
/pages/297
How can I prepare a staff member for their specific job responsibilities?
/pages/297
Performance management
/pages/270
What support is available if I have questions about the performance review process, conducting a review or working to develop a staff member’s performance?
/pages/300
What if I am experiencing challenges with my staff?
/pages/300
How can I show recognition and appreciate to staff members who are performing exceptionally well?
/pages/300
Professional growth and career development
/pages/270
Where can I find information about professional development opportunities for my staff?
/pages/304
What kind of fee assistance is available for professional development?
/pages/304
Where can I find information about professional development for myself?
/pages/304
How can I support my staff member’s career growth?
/pages/304
Closing the laboratory space
Closing animal research studies
Closing human research studies
Closing fund accounts, grants, and contracts
Transfer of grants to another institution

Proposals, contracts, awards and agreements are handled through the Office of Sponsored Programs (OSP) and the Office of Technology Transfer (OTT). When an investigator wishes to transfer a…
Transfer of biological specimens and protocols to another institution
Materials Transfer Agreements
/pages/314
Shipping
/pages/314
Are training and resources available?
/pages/314
Data ownership and transfer

Search Results

This electronic guide serves as a roadmap for researchers (new and existing) as they navigate the complex research environment at Emory. The Research Handbook provides instructions for getting