Uniformed Services University of the Health Sciences
4301 Jones Bridge Road
Bethesda, Maryland 20814
a. NIH: While USU does not prohibit investigators from receiving an honorarium for reviewing grants for NIH (if on leave), NIH has a policy that they will not pay an honorarium to reviewers from other government institutions. However, this policy apparently does not prevent NIH from paying for a reviewer from USU to have a hotel room to facilitate attending the study section meetings. All those arrangements should be made through NIH (or its contractor) via the pertinent study section such that the reviewer incurs no out-of-pocket expenses.
b. Other agencies: Grant reviewers may accept honoraria for reviewing grants from other institutions as long as there is no conflict of interest, they are on leave during the time the review is completed, and they have filled out the proper "outside activity" form.
Can I accept an Honorarium?
(Answer provided by Bradley S. Beall, Deputy General Counsel, 3-1-07).
If giving a research seminar related to your on-going unpublished research, investigators are not allowed to accept an honorarium. The speaker could still give the seminar with travel funded by the seminar sponsor (see the FAQ above about arranging travel). However, if 90% or more of the information contained within your presentation is based on your general subject matter expertise (including previously published information), you may be able to accept an honorarium. The speaker must submit an "outside activity" request to the Dean for approval (via the USU Ethics Official) and must be on leave to receive the honorarium. Note, if receiving an honorarium, preparation for the seminar must also be accomplished on "off-duty" time.
Employees may accept fees for outside activities as long as there is no conflict of interest, the outside work is done on their own time (or during leave) and they have completed the proper "outside activity" form. The subject matter of any writing for which an author is compensated must be based on general subject matter expertise which may include previously published information.
a. Investigators are required to complete an "outside activity" form for all activities conducted outside of the University. These activities may include, but are not limited to, being an officer in a professional society, consulting, grant reviewing, etc. Pay particular attention to compensated outside activities.
b. Regarding professional societies, no request is necessary for merely being a member of a professional organization or serving on a committee. With the exception of serving as an officer of a professional organization, involvement in a professional organization may occur during work time with the permission of the department chair.
When is a Material Transfer Agreement required and how is one prepared?
(Answer provided by Alyssa Shepard, Director HJF Services and approved by Jeb Baker and Mac McDaniel (General Councils for USU and HJF, respectively) and Carol Lavrich, who oversees MTAs), 4-23-07.
Research materials can be biological materials such as plasmids, hybridomas, or cell lines; chemical materials such as drugs, or even animals such as knock-out mice. For a variety of research purposes, research materials are often exchanged between and among academic institutions and commercial entities. Material Transfer Agreements (MTAs) define the legal rights of both the entity transferring the material and the entity receiving the material. MTAs also govern the use and distribution of any material or intellectual property derived from the material that has been transferred. MTAs are required for the transfer of ANY and ALL research material to or from USU, whether proprietary or not. Separate and apart from the material transfer, if the parties wish to keep certain information, knowledge, or data confidential between them, such information is generally transferred pursuant to a Confidential Disclosure Agreement (also known as a Nondisclosure Agreement).
USU's Joint Office of Technology Transfer (the "JOTT" - which is composed of HJF and USU personnel) is responsible for the negotiation and review of MTAs to ensure conformity with institutional policies and proper handling of intellectual property rights. USU researchers who plan to exchange any research materials with outside individuals or entities are required to contact the JOTT for assistance in preparing and executing the appropriate documents; this policy applies regardless of whether the USU researcher is receiving incoming materials or is transferring outgoing materials.
For material transfers with non-federal individuals or entities, an official at HJF signs the agreement. For transfers to federal institutions, an official at USU signs the agreement. For incoming materials, the faculty member involved in the research also will sign the agreement, acknowledging the terms of the transfer. For all transfers, the JOTT will provide the researcher with a Material Transfer Request (MTR) form, which is a checklist of questions to be completed by the PI to facilitate negotiation of the agreement.
For both incoming and outgoing transfer of human-derived material, or if human beings will be involved in the research related to the material transfer, Institutional Review Board (IRB) approval must be in place before the MTA can be executed. Likewise, Institutional Animal Care and Use Committee (IACUC) approval is necessary for incoming transfer of research animals, or if you plan to use the material in animal research. If you believe that your project is IRB or IACUC exempt, please obtain a waiver letter from the IRB and IACUC review officials, because this letter is required before the MTA can be executed. Some materials (hazardous or restricted agents) may be subject to additional regulations that will require coordination with USU's Environmental Health and Occupational Safety Office, as well as registration with the appropriate state or federal agency, before an MTA can be executed.
Materials Coming into the University:
Transfers between USU and another academic institution are facilitated by use of the Uniform Biological Materials Transfer Agreement (UBMTA), which provides standard terms that have been pre-negotiated. USU and many other institutions are signatories to this Agreement. When an academic institution is not a signatory to the UBMTA, or when materials are patented or involve human subjects, the providing institution may require the use of its own MTA model, which generally requires time for negotiation between the institutions. As a general rule, it is best to request the preparation of an MTA as far ahead of time as possible, well before you actually need to start using the material in your research. New faculty members coming to USU should ensure that MTAs are negotiated between USU and their prior institution for any materials that they wish to transfer to their USU research program for ongoing research. Similarly, exiting faculty members who are moving to another research position and wish to take materials with them from USU must have an MTA negotiated between USU and their new institution.
Transfers from commercial entities will generally require case-specific review of agreement terms to ensure that USU's and the faculty member's interests are adequately protected. Negotiation of MTAs with for-profit organizations usually take more time in order to ensure adequate protection of the various and sometimes competing commercial interests.
Materials Leaving the University:
For transfers of material to another academic institution, the UBMTA will be used as a starting point for negotiation, if the other academic institution is also a signatory to the UBMTA and agrees to use it.
If the material is being transferred across international boundaries or to a foreign national located in the United States, the material may be subject to export controls requiring a license from the Commerce Department (if the material appears on the Commerce Control List) or, in some cases, the State Department (if the material appears on the Munitions List).
For transfers of proprietary materials that you have developed to a commercial entity for its research purposes, the JOTT often can negotiate a limited use license agreement for internal research purposes. If the company wishes to resell the materials for research purposes to other researchers, the JOTT can negotiate a commercial license. Likewise, if the company wishes to make a diagnostic or therapeutic product from your materials, a commercialization license would be required.
If you have any questions, or to initiate an MTA or other type of agreement, please call the JOTT at 301-295-0450 or 301-294-1223 or email at firstname.lastname@example.org. The JOTT has a part-time office in the modular building behind Bldg A and a full-time office at HJF in Rockville.
How do I coordinate official travel to give a seminar if my department is not funding my TDY?
(Answer provided by Bradley S. Beall, Deputy General Counsel and Jim Wolff, Financial Services Officer, 3-1-07).
a. If giving a seminar for another Department of Defense organization, the speaker must obtain a letter from the sponsor that provides a line of accounting to be used on travel orders prepared by the speaker's USU department. If the sponsor is another government agency but not DOD, the speaker can travel on funded TDY orders that are processed through the inviting organization.
b. If giving a seminar while TDY that is funded by a non-Federal entity, the traveler must fill out an ethics travel form and submit it, via the department chair, to the USU Ethics Official in the General Counsel's office. Assuming no conflict of interest, the inviting agency can handle the speaker's travel in several ways. USU can make the arrangements and then be reimbursed by the inviting institution. Alternatively, the inviting institution can book the travel, hotel etc. such that the speaker incurs no out of pocket expenses.
Grant submission process at HJF
1. The first step for investigators at USU interested in submitting a proposal for extramural funding through HJF is to contact your departmental Sponsored Project Administrator (SPA). All departments have access to an SPA. If in doubt about who your SPA is, contact the USU Services Department (301-295-2991, USUServices@hjf.org). Your SPA will inform your HJF/OSP and USU/OSP grants specialists of your submission plans. The earlier you can inform you SPA, HJF/OSP and USU/OSP of your submission plans, the better (at least one month is ideal).
2. For extramural submissions for NIH opportunities, you will need to register for an NIH eRA Commons account 4 weeks prior to your submission deadline. HJF is already registered as a recipient organization (DUNS # 144676566); your HJF grants specialist (301-294-1276; email@example.com) can assist you with registering as a submitting Principal Investigator. Additional information about how to register is available on the following NIH websites: http://era.nih.gov/ElectronicReceipt/ and Grantee Registration Process in NIH eRA Commons.
3. Many federal funding opportunities now require electronic submission thru Grants.gov. HJF is already registered as an applicant organization. Principal Investigators DO NOT need to register in Grants.gov.
4. HJF uses a Service Provider that has a system-to-system interface with Grants.gov to submit applications - called Cayuse 424. Cayuse is a web-based application that supports most NIH, NSF and DoD funding opportunities. For other electronic submission opportunities that are not supported by Cayuse 424, a PureEdge viewer will be required for direct submission to Grants.gov. You may opt to delegate your electronic submission to your SPA and in that case you will not need to have either PureEdge (or adobe forms, once they are made available by Grants.gov) or a Cayuse account. Your SPA or HJF OSP Grant Specialist can assist you with Cayuse and/or Puredge installation and training.
5. Your SPA can assist you in budget preparation and the administrative sections of the proposal. HJF Grant Specialists can assist in reviewing the proposal for conformity with sponsor guidelines and can also advise on the appropriate fringe benefit and indirect cots rates to use. Moreover, Grant Specialists can also assist with any contemplated sub-recipient agreements or vendor contracts. For research activities conducted onsite at USU (onsite being defined as Buildings A, B, C and D at 4301 Jones Bridge Road, as well as AFRRI, and Buildings 28, 53, 59, and 79 on the NNMC campus) the applicable onsite indirect cost rate will apply.
6. Forms required for USU onsite research. USU/OSP requests that USU form 3208, the budget, and the administrative pages of the proposal be submitted at least 10 working days prior to the award submission deadline.
7. HJF/OSP also requires 10 working days lead-time to review each proposal and to make any necessary changes. Proposals are handled on a first-in, first-out basis. The USU/OSP and HJF/OSP grant specialists will work together with your SPA to review and provide comments and request modifications/clarifications. Your research proposal can still be modified during this review period.
8. Your SPA will assist you to respond to these comments, make any necessary revisions, and submit the revised application to both USU/OSP and HJF/OSP in order for the proposal to proceed to the remainder of the review process. The administrative sections of the proposal, including the budget and justification, should be finalized between HJF and SPA/PI at least two working days before the deadline to ensure timely submission.
9. In order for the proposal to receive site approval from the USU/OSP, you must submit the final revision of the research narrative to USU/OSP. Site approval is a written statement from USU to the Foundation affirming that your research may be conducted onsite at USU. The Foundation must receive this site approval before your proposal can be submitted.
10. Once you or your SPA have made all necessary changes to the budget and other administrative pages of the proposal, and you have submitted your final research narrative to USU/OSP, the complete proposal will be reviewed by the director and Vice President of USU/OSP, who may have additional comments. If no further revisions are necessary, your proposal will proceed to a final review and receive site approval from USU. At this point, the Foundation will submit the proposal to the funding agency.
11. Note: (a) The Foundation has a Contract Review Board that reviews all actions (including proposals, awards, modifications and subawards) that propose an annual amount of greater than $500,000 in any one year. This review usually adds at least a week to the Foundation's review time. (b) If the sponsor does not allow full indirect cost recovery, an under-recovery memo from USU's VP of Research should be provided to and approved by HJF's VP of Sponsored Programs, before the proposal can be submitted.
Steps for hiring an applicant using HJF administered funds:
1. Once a program has funding and has identified a need to hire personnel, the first step is to set up the personnel budget in the relevant award. The HJF Office of Sponsored Programs (301.294.1276; firstname.lastname@example.org) or Contracting Department (301.294.1230; email@example.com) can assist in setting up an appropriate personnel budget. HJF's Recruiting group (301-738-8720; firstname.lastname@example.org) will assist with appropriate salary ranges depending upon the specific position description (template pds are available from HJF's Recruiters that should be customized for the specific position needed). Questions about which fringe or indirect cost rates to apply should be directed to HJF OSP or Contracting.
2. Once budgeted, a Position Requisition Form (HJF form #211; http://www.hjf.org/forms) and a customized position description is submitted to HJF HR department. This document can be downloaded from HJFonline and the HR recruiters can guide you through the process. The salary range should not be any higher than the range submitted in the approved proposal budget.
3. Once the position requisition is entered into HJF's Talent Acquisition System and routed for budget approval, an approval may take up to 2 business days, but can be delayed if funding has not been received by HJF, or if rebudgeting is necessary. If permitted by the sponsor, an HJF grants specialist or contracting officer can set up pre-award funding to allow the posting of a position up to 90 days in advance of an award.
4. The position will be posted on HJF.org, and can be advertised in other venues upon request (and must be coordinated through HJF's HR department) and with applicable costs charged to the program. Per EEO guidelines, positions must be posted for 5 days before an offer of employment can be made. Temporary and summer positions are exempt from these guidelines.
5. Candidate resumes are screened by HJF Recruiters and forwarded to PI for review. Interviews are scheduled and conducted by PI and/or Recruiter if requested. HJF Recruiters can also perform reference checks at your request.
6. Once a candidate has been chosen and terms of employment negotiated, a completed Applicant Interview Form, which can be downloaded from HJFonline (HJF form #238; http://www.hjf.org/forms.html) and the resumes of all candidates interviewed are submitted to HJF HR.
7. Only HJF can make an official offer of employment. The HJF Recruiter will contact the chosen candidate to make an offer of employment, and the PI will be notified of the response. If accepted, an offer letter and package will be sent to the applicant. Candidates waiting for visa approval will receive a "pending the approval of your visa" offer letter as opposed to receiving an offer letter indicating a start date.
8. New employees will be required to attend a "New Employee Orientation" within the first month of employment. At this orientation, new employees will be introduced to the history of HJF, be informed of HJF's benefits package, complete the required paperwork for enrollment into the benefits programs, complete the necessary tax (federal and state) forms, be educated on issues such as how to complete timesheets and leave request forms, receive ethics training and sexual harassment training, receive information about registering for HJFOnline, and receive an overview of occupational health and safety from HJF's Safety Manager.
The basic requirements to become a Radionuclide Experimental Authorization (REA) holder at USU are:
(1) You must document 30 hours of formal radiation safety training. You can list 1.5 hours from attending the required USU initial radiation safety training. You can receive 8 hours for attending the independent user of radioactive materials course. You will receive 3 hours for attending a required PI specific training for new REA applicants. Years of experience using the radioisotopes and chemical forms requested for authorization can be substituted for up to 15 of the required 30 hours (1 year = 3 hours).
(2) You must document at least 6 months experience using each of the radioisotopes and chemical forms that you request authorization to use at USU under your REA. Any amount of experience past 6 months can be submitted in place of formal training for up to 15 of the required 30 training hours as stated above. You can document both your training history and work experience on USU Form 6042 Radiological Training & Experience. Please submit copies of training certificates if you have them, but they are not required.
In order to submit a complete application for an REA to the Radiation Safety Committee:
(1) Submit USU Form 6041 REA Application listing each of the radioisotopes requested for authorization to use at USU with the chemical forms and maximum activity limits to order at one time, store in the lab at one time and use in a single procedure and summaries of the experimental procedures for each. A sample completed REA application is also available to use as a guide.
(2) Submit USU Form 6042 for yourself and each individual you request to be listed as a Senior Investigator or Independent User on your REA. USU Form 6042 is not required for individuals you request to be listed as Supervised Users on your REA.
(3) Submit an updated Curriculum Vitae with all articles with a significant radiological component where you are listed as the first or second author highlighted. Published articles may also be considered by the Radiation Safety Committee as a substitute for formal training (1 article = 3 hours).
The complete REA application should then include the USU Form 6041, USU Form 6042 (for you and others requesting SI or IU status), summaries of all experimental procedures requested for authorization and an updated C.V.
(4) After submitting the REA application, REA will schedule a time to have the Radiation Safety Officer present the required PI specific radiation safety training for new REA applicants to you. After the training you will meet with the Radiation Safety Committee (RSC) Chairman before the next scheduled RSC quarterly meeting to review your application. Your REA application will then be reviewed and approved at the next scheduled quarterly RSC meeting.
All of the USU forms listed above are available on the EHS website link on the USU Homepage as well as the schedule of all radiation safety training through the academic year at http://www.usuhs.edu/ehs/ . The USU Radiation Safety Guide, November 2005, Section IV, lists the requirements for Principal Investigators to qualify to be authorized radioisotope use at USU. The RSC has set additional requirements for attending PI specific training and a meeting with the RSC Chairman prior to approval of the REA application. POCs for REA applications are LTC John P. Cuellar, USU RSO, 295-3390, email@example.com or Mr. Michael Woolbert, USU ARSO, 295-1906, firstname.lastname@example.org
A: In general, neither appropriated funds nor extramural federal awards can be used to purchase food. Meals and refreshments are considered a personal expense for Federal employees who are not on travel status. Moreover, food and beverages (even if consumed by non-federal employees) are considered unallowable expenses for federal awards as defined in OMB Circular A-122, which specifies cost principals for funds administered by the Henry M. Jackson Foundation.
However, there are some specific circumstances in which food/beverage expenses may be paid for with federal funds. If you have food costs which are fundamental to the performance of the award-such as providing coffee for members of the public who take part in your research, or using alcohol in a research project, or consuming meals associated with a meeting or conference where the primary purpose is the dissemination of technical information -such costs may be allowable federal expenditures. In making a determination as to whether or not a food or beverage expense is allowable, the Foundation and University officials will be looking at whether the activity/expense is essential to the original proposal and who the food is for, as well as applicable OMB Circular guidelines and any specific sponsor requirements.
In some specific situations, appropriated funds may be used to purchase food for events in which Federal employees are participating. Those limited circumstances are outlined in a Power Point presentation that can be found at: http://www.gao.gov/special.pubs/appforum2005/approfunds/index.html
If you are contemplating using federal funds for any food expense, you should consult both the USU Ethic?s Office as well as your HJF Grant Specialist for extramural awards (301.294.1276; email@example.com ).
A: Detailed rules concerning publication can be found in Instruction 5202.1 ("Clearance for Public Release of Information and Scientific Materials by USUHS Personnel").
As a general rule, "if the writing, editing, or electronic publishing is related to the employees official duties", then you must receive clearance before publication of your work. This clearance can be obtained by filling out USUHS Form 5230 (Manuscript Approval or Clearance form) and submitting it to the proper official. The form can be obtained within the 5202.1 instruction.
Many journals, publishers, etc. will ask that you sign over the copyright of your work to the specific publication. However, you should be aware that if the work was generated as an official part of your duties as a government employee there is no copyright to sign over and it is a violation of Federal law to claim a copyright that does not exist. The USU General Counsel's Office strongly suggests you execute an agreement similar to the one in the Government work section found on the release used by AMSUS.
Never sign a form that provides compensation for government produced work or that contains an indemnification clause. If you have questions about a specific agreement, the General Counsel's Office (295-3028) is available to answer your questions.
NOTE: Ordinarily Federal employees may not be reimbursed for monies spent on food, drinks, supplies, etc. Because of this rule, it is important to give sufficient time for the approvals required to take invited guests out for meals. You should also note that as a general rule, alcohol must be purchased separately and paid for by the participants.
You must first determine, by asking the department chair or AO, whether your department has non-federal unrestricted funds that can be used to pay for meals. Payment should be made directly to the vender. If yes, a "Use Of Non-Profit Funds by Federal Employees" form must be completed and submitted for approval. The form can be downloaded from http://www.usuhs.edu/usuhs_only/ogc/UseofNonProfitFunds.pdf.
In addition to the completed form, you must also include a detailed justification of how this activity will enhance education, faculty, and/or USU development. An example of a possible justification is given below. The completed form and justification must be signed by yourself, your department chair and then sent to the Office of General Counsel for approval. If approved, General Counsel will send the documents to HJF for their review and approval. At that point, you may make a restaurant reservation and HJF will arrange for payment to made by credit card directly to the restaurant.
I would like to have our USU fund at HJF pay for X Number of faculty members (Drs. XXX and YYY) to meet with Dr. ZZZ over dinner on DATE to discuss common expertise.
Seminar speaker in the AAA seminar series on DATE
"Title of Talk"
School from, etc.
Date of Seminar
Time of Seminar
Location of Seminar
Each of the faculty members who will be going to dinner with Dr. ZZZ has ongoing research that overlaps with the research of Dr. ZZZ. These opportunities for interaction with faculty are very important for continuing to bring in quality speakers for our Seminar Course since the speakers are more willing to come if they will have the opportunity to discuss the work with knowledgeable faculty in the same field of research. The informal interaction with the speaker on such an occasion is not only crucial for the work of USU faculty members, it also provides an additional venue for the speaker to discuss his/her unpublished, on-going work with USU faculty members, which is extremely beneficial and is one of the major reasons a speaker would consent to give a seminar.
Please let me know if you agree that it is an appropriate use of our USU Education Fund to pay for the dinner of these members of my laboratory to have the opportunity for scientific discussion. If so, please also advise me if I should forward your approval to HMJ to have prepayment set up.
Thank you for your help with this request.
Which items can be purchased on the Government Purchase Card and which must be ordered through CUFS?
(Answer provided by Brian Schaeffer and approved by Anthony M. Revenis, J.D. Director, Contracting on 4-15-07).
The short answer is that the Government Purchase Card (GPC) is limited to $3,000 per purchase. However, some items such as hazardous chemicals, radioactive materials and animals may only be purchased using an RX in CUFS. Note that, in general, these items also CANNOT be purchased with HJF funds - there is NO way to circumvent these restrictions! In addition to hazard items, some additional items are prohibited because they are personal items or are purchased centrally. Finally, some items may be purchased on the GPC, but only after prior approval is secured. Your department A.O. or GPC cardholder can provide individual guidance or call Terry Zimmerman the GPC coordinator at 295-3070.
For additional information regarding the use of the Government Purchase Card, see http://www.usuhs.edu/usuhs_only/avr/contractingdir.html
The prohibited list and prior approval items are listed at: http://www.usuhs.edu/usuhs_only/avr/docs/GPCQuickReference.doc
No, your cardholder can not split the order to evade the $3000 limit!
How do I obtain approval to work with animals?
(Answer complied by Russell M. Peckham MAJ, MC, and approved by LTC Jim Sheets, Director, Center for Laboratory Animal Medicine, and Brian Cox, Chair IACUC 1-28-08).
The IACUC review and approval process for proposed animal use at USUHS involves a number of steps. These include the following:
The USUHS IACUC website contains helpful information as well as the necessary forms to begin the submission of an animal protocol: http://www.usuhs.edu/usuhs_only/iacuc/index.html.
The website also contains a detailed FAQ page to answer many specific questions: http://www.usuhs.edu/usuhs_only/lam/lamfaqs.html#iacuc.
Helpful information to keep in mind when planning and preparing your protocol:
All investigators must complete the Investigator Training Course. This is offered every 1-2 months. If you have not attended the Investigator Training Course you may complete on-line training (see the IACUC Office in G169 for the required courses). This on-line training does not substitute for the USU course but can be used to gain temporary approval for access to the animal facility; you must also attend the next scheduled course at USU.