Frequently Asked Questions
What is fundamental research?
Fundamental research is basic and applied research in science and engineering, the results of which ordinarily are published and shared broadly within the scientific community, as distinguished from proprietary research and from industrial development, design, production, and product utilization, the results of which ordinarily are restricted for proprietary or national security reasons.
Source: NSDD-189 – 1985 National Policy on the Transfer of Scientific, Technical and Engineering Information.
What is the difference between a pre-proposal and a letter of intent?
A pre-proposal is a brief description, usually 2-10 pages, of research plans and estimated budget that is sometimes submitted to determine the interest of a particular sponsor prior to submission of a formal proposal. Pre-proposals may become awards depending upon agency specifications.
As most pre-proposals require a scope of work, budget justification and detailed budget information, pre-proposals are required to be entered and approved in RAMSeS
A letter of intent (LOI) is a short, usually no more than 2 page, letter stating intent to submit a proposal in response to a request for proposals. A LOI is not binding. The predominant reason for its use is to help agency program staff to gauge the size and range of the competition, enabling earlier selection and better management of reviewers and panelists. In addition, the information contained in a LOI is used to help avoid potential conflicts of interest in the review process.
A LOI normally contains the PI's and co-PI's names, proposed title, list of possible participating organizations (if applicable), and a synopsis of the work in sufficient detail to permit an appropriate selection of reviewers. A LOI is not externally evaluated or used to decide on funding. The requirement to submit a LOI will be identified in the program solicitation and such letters are submitted as specified in the program solicitation.
A letter of intent is not required to be entered and approved via RAMSeS.
Which agencies are using the PHS FCOI Regulations?
(From the FDP website) This list below constitutes agencies that have been reported to the FDP as using the PHS regulations (including FCOI) in their award terms. This list is provided as a convenience for FDP members and other institutions, but the accuracy of the list has not been verified by the FDP. Institutions are encouraged to independently verify the inclusion of PHS regulations in their award terms from these agencies. If you become aware of other agencies including PHS regulations routinely in their awards, please notify David Wright, FDP Executive Director, at firstname.lastname@example.org so that he can add that agency in the list.
Public Health Service (PHS) Agencies
- Office of Global Affairs (OG)
- Office of the Assistant Secretary for Health (OASH)
- Office of the Assistant Secretary for Preparedness and Response (ASPR)
- Agency for Health Care Research & Quality (AHRQ)
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Centers for Disease Control and Prevention (CDC)
- Food and Drug Administration (FDA)
- Health Resources and Services Administration (HRSA)
- Indian Health Service (IHS)
- National Institutes of Health (NIH)
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Administration for Children and Families (ACF)
- Alliance for Lupus Research (ALR)
- American Cancer Society (ACS)
- American Heart Association (AHA)
- American Lung Association (ALA)
- Arthritis Foundation (AF)
- Juvenile Diabetes Research Foundation (JDRF)
- Lupus Foundation of America (LFA)
- Susan G. Komen for the Cure
Does UNCW require different information to be entered into RAMSeS depending on whether I am seeking a grant versus a contract?
UNCW requires the same information be entered into RAMSeS and routed for approval for competitive awards as it does for the funding you seek by partnering with another institution or private organization for contractual research. At a minimum, a scope of work, detailed budget and a budget narrative are required to be uploaded into RAMSeS and all appropriate questions in RAMSeS be answered. ORSSP is available to help with review of documents and any issues you encounter with RAMSeS. A link to RAMSeS is located on the Research webpage www.uncw.edu/research.
For more information contact:
What is “Facilities and Administrative” costs (F&A) or “Indirect Costs” (IDC)?
Overhead is how university Facilities & Administrative cost are recovered. Each grant reimburses the university for a portion of the university F&A. F&A are cost incurred by the university. Office space, office supplies, clerical and administrative personnel, facilities, buildings are all cost incurred by the university. Grants are charged with direct cost which are cost unique to the research, and that are necessary to carryout research.
Source: OMB Circular A-21 Cost Principles for Educational Institutions. Link: http://www.whitehouse.gov/omb/circulars_a021_2004
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When planning a multi-year budget, what pay increase should I budget for?
Depending on the planned start-date and duration of the projet, you may need to include pay raise estimates to ensure that your budget will have sufficient funds to cover personnel costs. If project activities will take place after the current fiscal or academic year ends, calculate a 3-5% raise per person for each year of the project. (If next year's raise is known at the time you are developing a budget, include the known raise for next year then budget 3-5% pay increase for any subsequent years of the project.) While raises have been lower than 3-5% in recent years, budgeting for that level of increase is prudent so that any unpredicted costs (e.g., promotions, fellowships, etc.) can be covered.
When are MEALS/FOOD an allowable contract or grant expense?
Meals are an allowable expense when:
- in conjunction with conference
- Are included in the written agenda
- There is substantial dissemination of technical information
- Participants are non-UNCW employees
Meals are NOT allowable expense:
- If occur before and after conference
- If meeting is for UNCW staff
- Are deemed “socials” or “networking” events
For more information, please contact your grant officer.
Source: OMB Circular A-110, Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals and Other Non-Profit Organizations. Link: http://www.whitehouse.gov/omb/circulars_a110
What constitutes a “sub-recipient” for contract and grants?
Sub-recipient versus vendor relationship.
Sub-recipient means the legal entity to which a subaward is made and which is accountable to the recipient for the use of the funds provided. The term may include foreign or international organizations (such as agencies of the United Nations) at the discretion of the Federal awarding agency.
Source: Office of Management and Budget Circular A-110
A sub-recipient serves as a co-investigator, is responsible for the end results of the research effort equally with the principal investigator where federal funds are being passed through to another entity. By definition, a sub-recipient relationship can only be established where federal funds are involved.
A vendor provides ancillary goods or services that the principal investigator needs to conduct the research effort. A vendor is not responsible for the research results.
Source: ResearchOnline: http://osp.osu.edu/administration/vendorsubrecip.cfm
Is it permissible to have an employee start work on my sponsored project without Human Resources paperwork being completed?
No. Individuals cannot start work of any kind until UNCW’s Human Resources has received a completed I9 with appropriate backup documentation. It is illegal in North Carolina for an individual to start work without a completed I9.
The I-9 has been created by the Immigration and Naturalization Service (INS) to verify that an individual is indeed eligible to work in the U.S. Therefore, all employers are required by the government to obtain the information on this form before hiring an individual.
Source: NC Office of State Personnel Link: http://www.uscis.gov/files/form/i-9.pdf
What is the Umstead Act?
DEFINITION: In general, the Umstead Act (the "Act") prohibits North Carolina government agencies from competing with the private commercial activities of North Carolina citizens. NC State University and its employees must comply with the Act. Violations may be punished as a criminal misdemeanor. G.S. 66-58(a).
The Act specifically prohibits North Carolina government agencies from:
- directly or indirectly selling goods in competition with N.C. citizens;
- rendering services to the public that are ordinarily provided by private businesses;
- leasing space in a state owned or operated building for purposes of selling goods or rendering services in competition with private business;
- contracting with anyone to sell goods or render services in competition with private business.
EXCEPTIONS INVOLVING UNIVERSITY ACTIVITIES:
Five of the exceptions specifically permit the university to conduct certain commercial activities.
- The first statutory exception (G.S. 66-58(b)(8)) allows state universities to sell several things:
- utilities and other services operated prior to January 1, 2005;
- items that are incident to educational research or the operation of instructional departments;
- food, books, and minor merchandise to employees, students, and their families;
- food and merchandise to guests invited to the university for meetings or conventions;
- anything incident to operation of the coliseum;
- anything related to Centennial Campus operations;
- student health services;
- activities that serve students and employees and their immediate families or guests;
- activities that further the mission of the university;
- activities that provide university related services or market university related merchandise to alumni of the university and their immediate families;
- activities that enable the community or people of the state to utilize the university’s facilities, equipment or expertise; and,
- operation by the university of an inn or hotel and dining and other facilities connected to an inn or hotel.
- A second exception allows the sale of learned journals, works of art, books or publications of the university. G.S. 66-58(c)(2).
- A third exception allows state universities to operate campus stores where profits are used for student scholarships. Campus stores may sell educational supplies, gift items, and personal use items. However, a campus store may only sell to students and their families, employees and their families, and individuals who are on campus for a purpose other than just to buy goods from the university store. Only educational supplies, gift items, and personal use items may be sold. G.S. 66-58(c)(3).
- The General Assembly created the UNC Umstead Review Panel to review and determine whether or not a proposed activity violates the Umstead Act. The University may rely on the determination made by the panel. Therefore, if you want to start a new activity, please discuss with the Office of General Counsel to determine if a presentation to the Review Panel is appropriate. You may read more about the Umstead Act and the Review Panel.
- The simplest defense is to establish a clear connection between the goods sold or the service rendered and the University's educational purpose. In 1986, the NC Attorney General stated that activities which are incidental to the legitimate function of a state agency are not violations of the Umstead Act. (Attorney General's Opinion, March 4, 1986, 55 NCAG 101). The function of the university is to educate, so the law permits any sale of goods or services that are a function of educational operations.
- A federal court in North Carolina has ruled that the Umstead Act creates an exclusive remedy. This means that although an agency or employee may be found criminally guilty of a misdemeanor, a private citizen cannot sue in civil court. (See Bd. Of Governors v. Helpingstine, 714 F. Supp. 167 (M.D.N.C. 1989)).
- For employees of state institutions, the statute applies only when they act in their capacity as employees. G.S. 66-58(a).
IMPORTANT QUESTIONS TO ASK:
- Is the activity a direct or indirect sale of goods, wares or merchandise?
- Does the activity offer a service that is normally performed by private businesses?
- Is the activity directly related to the university's educational function?
- Would the activity fall under any other exception, such as a product of an experimental station or test farm, a learned journal or other exception?
**If the answer to 1 or 2 is "yes," then proceed to answer 3 and 4. If neither 3 or 4 is "yes," then the activity is likely prohibited by the Umstead Act.
MOST IMPORTANT: Consult with the NC State Office of General Counsel if there is any question about the applicability of the Umstead Act.
An activity that is acceptable under the Umstead Act may still be inappropriate or raise other legal issues. For example, revenue from an activity that is not substantially related to the educational mission, as determined by the IRS, may be subject to Unrelated Business Income Tax (UBIT).
What are the different levels of IRB Review?
There are three types of IRB review depending on the level of risk involved in the project: exempt, expedited and full IRB review. Projects that qualify for exempt review are projects having such a low level of risk to subjects that further IRB oversight is not required with the exception of protocol amendment forms. Amendment forms are required on exempt studies since a change to the study may alter its exempt status. Projects qualifying for expedited review are also minimal risk to subjects, but may involve other aspects that require continuing IRB oversight and annual renewal of protocol approval. A project may require full review for a number of reasons such as the subjects belonging to a potentially vulnerable population or a higher degree of risk to subjects. According to UNCW IRB policy, researchers may NOT make their own determination as to the appropriate type of review. Only the IRB Chair or designate, can determine which type of review is applicable.
Am I doing research as defined by the IRB?
The chart accessible from the link below may help you determine if you are conducting "research" as defined by IRB regulations. As you view this chart, please note the following definitions: Research is defined by the federal government as a systematic investigation, including development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Systematic Investigation is defined by the UNCW IRB as a cohesive approach involving data collection (quantitative or qualitative) from one or more individuals and analysis to address a question or test a hypothesis. Generalizable knowledge is defined by the UNCW IRB as the results or outcomes gained from systematic investigation that may be published, archived, presented, or viewed in some way as relevant beyond the specific participant population.
Research Decision Chart (PDF)
Am I working with human subjects as defined by the IRB?
The chart accessible with the following link may help you determine if your research involves the use of human subjects. As you review this decision chart, keep in mind the following definition: Human subject is defined as a living individual, about whom an investigator (whether professional or student) conducting research obtains: 1) data through intervention or interaction with the individual, or 2) identifiable private information.
What are the IRB training requirements for researchers?
Any person involved in the design and/or conduct of a human subject research project must complete the approved online human subject protections training program offered by the University of Miami's Collaborative Institutional Training Initiative (CITI). The IRB will not review a protocol until training documentation is on file at ORS. This requirement includes any faculty, staff, students, or collaborators from other institutions.
The CITI program automatically emails ORSSP when training is completed. You are no longer required to submit hard copies of training certificates to ORS if you complete training through CITI and identify the University of North Carolina Wilmington as the participating institution.
What is UNCW's Federalwide Assurance number?
FWA00001025, Expires 6/30/2014
A Federalwide Assurance is an agreement with the United States Department of Health and Human Services (DHHS) to conduct human subject research in accordance with certain principles. UNCW's Assurance agrees to comply with the principles outlined in the Belmont Report and the Code of Federal Regulations Title 45, Part 46 Protection of Human Subjects, Subparts A, B, C and D (PDF). UNCW has agreed to follow these regulations for all research involving human subjects, regardless of the funding source. See the DHHS website for more information about assurances.
Where do I get the forms? Where do I send my completed forms?
If you are unable to retrieve the forms below, all forms can be obtained by contacting the regulatory compliance officer in ORS (910-962-7774 or email@example.com). Researchers must submit to the IRB Chair a signed hard copy along with any supporting documentation (surveys, consent forms, etc.). Click here for UNCW's full mailing address and contact information.
What types of animals fall under IACUC regulation?
ALL live, vertebrate animals fall under IACUC regulations. This is stated in UNCW's Assurance of Compliance (FAQ #6 below) and in UNCW's IACUC policy.
Is IACUC approval required for vertebrate animals used in teaching, or just research?
UNCW IACUC policy requires IACUC approval for vertebrate animals used in research, research training, experimentation, teaching, biological testing or other purposes.
Why does my protocol expire after three years even though my grant is continuing?
PHS Policy and UNCW IACUC policy (PDF) require a complete review of ongoing activities at least once every three years. Like many other universities, UNCW requires this complete review to be conducted through the submission of a new protocol form. Therefore, all protocol forms expire after three years regardless of the grant cycle, so that a complete review of animal activities may be conducted.
What should I do if I change a procedure, change personnel, or change the species on an approved protocol?
If you make any change to an approved protocol, please submit something in writing explaining the change to the regulatory compliance officer (e-mail requests are acceptable, firstname.lastname@example.org). According to UNCW IACUC policy (PDF), the regulatory compliance officer and IACUC Chair will determine if the change is minor, moderate or significant. Minor or moderate changes such as the addition or deletion of a student assistant, a minor species change (from one rodent species to another, like mice to rats), or a small increase in the number of animals (less than 5%) can be approved very quickly by the IACUC Chair. Major changes to the protocol such as a major change in the approved activities, a major change in species (such as changing from rats to dogs) or a significant increase in the number of animals used (more than 5% of approved number) require a revision to the protocol itself and either designated or full review, depending on the original review received and the nature of the changes requested.
What are the IACUC training requirements for researchers?
The online training course, "Working with the IACUC", provided by the University of Miami's Collaborative Institutional Training Initiative (CITI) is required for all members of the research team. Other forms of training may be approved on a case-by-case basis by the IACUC chair or regulatory compliance officer.
IACUC committee members are required to complete a course specifically for IACUC members in addition to the basic "Working with the IACUC" course.
What is UNCW's OLAW Assurance number?
A3871-01, EXPIRES 6/30/14
An Assurance is an agreement with the Office of Laboratory Animal Welfare to operate an animal care program in accordance with certain policies and principles. UNCW's Assurance (PDF) of Compliance with Public Health Service Policy on Humane Care and Use of Laboratory Animals states that UNCW will follow the USDA Animal Welfare Act and Animal Welfare Regulations, the Public Health Service Policy on Humane Care and Use of Laboratory Animals and the National Research Council's Guide for the Care and Use of Laboratory Animals for ALL live, vertebrate animals. The Assurance also sets out the organization of the UNCW IACUC and lists certain procedures and policies of the IACUC.
Where do I get the forms? Where do I send completed forms?
There are now two versions of the main application form - a long form and a short form. If your activities include surgery, drug administration, dietary manipulation, pain and/or distress or prolonged restraint, you should use the long form. If your activities include none of those things or just one you should use the short form and attach an appendix if needed. Please submit an electronic copy of the completed form to the regulatory compliance officer (email@example.com) by the initial submission deadline posted on the IACUC homepage. All protocols submitted will be forwarded to the attending veterinarian (AV) for consultation. The AV will complete a consultation form and forward it to the principal investigator (PI) within a few days. The PI should take the comments under consideration and revise the protocol if appropriate. Please go to the IACUC home page for specific submission deadlines. Submit the fully revised, signed hard copy to: Regulatory Compliance Officer, Office of Research Services and Sponsored Programs, Hoggard Hall, Room 180 or Campus Mail box 5973 Click here for UNCW's full mailing address and contact information.