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Research Compliance News





 

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NIH Administrative Supplements  

NIH recently announced the implementation of a new electronic submission process for administrative supplement funding requests. These supplemental funds may be available to meet increased costs that are within the scope of an approved award, but were unforeseen when the new or renewal application or the grant progress report for the noncompeting continuation support was submitted.  All applicants must discuss potential requests with the awarding institute or center (IC) and receive confirmation of the availability of the funds prior to the supplement submission.  (Refer to either the parent award’s assigned Grants Management and Program Staff or the contact persons listed in Section VII of the specific Administrative Supplement FOA.)  Additionally, prior to submission, applicants must review their awarding IC's web site to ensure they meet the IC's requirements.  Click here for a list of those web sites.  

There are two ways to submit an electronic version of the administrative supplement request.  
- eRA Commons:   Look for an “Administrative Supplements” link in the action column on your funded project’s Status page.   
- Grants.gov portal.:  Find the “Apply for Grants Electronically” button in the FOA PA-12-100.  It will lead you to the appropriate application package.   

The eRA Commons streamlined process option is fast and easy.   You will find much of the application pre-populated with information from the parent grant data, while you are guided step-by-step through the rest of the process.  If you decide to submit through Grants.gov, you will find the SF424 package similar to that used for a regular proposal submission.  Users will be able to track the administrative supplement requests submitted via either of these methods in eRA Commons.   

Administrative Supplements will not receive peer review. The staff of the NIH awarding component will evaluate requests to determine overall merit.  

If you have any questions regarding the submission of an administrative supplement, please contact your College Grants Officer.
New NIH search tool helps principal investigators determine which study section is best for their grant submission.

If you are a Principal Investigator focused on the next R01 submission deadline and are considering which NIH Institute and study section to list as a preference in your cover letter, a new eRA search tool called "LikeThis" can help.  Click here to check out LIkeThis.

How to calculate effort of students working on R-series NIH grants for inclusion on the All Personnel Report of an Annual Progress Report (eSNAP)

Any person who has worked on the project during the current budget period (the period covered by the report) for one person month or more needs to be included on the report, regardless of his/her role on the project.

NIH doesn’t allow payment of stipends from R-series grants. Any students working on an R-series NIH grant project must be paid a salary or hourly wage.

Graduate Student Research Assistants (RA's) are employed by University departments and units and receive compensation via a salary for their work. This is an allowable expense on R-series NIH grants. Per UK policy, research assistants who are also full-time graduate students may be assigned responsibilities requiring no more than 50 percent of their time. Responsibilities for RA's will vary with the fraction of time for which they are employed, but normally a one half-time appointment should require no more than 20 hours per week of assignable duties, for a .50 (full) RA, or 10 hours per week for a .25 (half) RA.

The University’s HR system (SAP) reflects "full-time" Research Assistant appointments as 50%, or .50 FTE.

Per NIH policy, for any part-time employees or students who do not have regular academic appointments, if the level of part-time work is already classified as a percentage, e.g., 50% for a half-time appointment, you can consider it an appointment based on a 12-month year – 50% of 12 months would be a 6 month appointment -- and multiply the percent of effort associated with the project times the number of months of the appointment. For example, if someone has a 50% appointment – like a full-time Graduate Student Research Assistant as noted in the UK policy -- and works 20% of their 50% on the project, you would calculate that they work 1.2 months (20% x 6 = 1.2) on the project and should be reported on the All Personnel Report. For example:

50% (half-time appointment) x 12 months = 6-month appointment

20% x 6 months = 1.2 calendar months

For students or other employees who are paid at an hourly rate, since 1 person month equals approximately 160 hours, you can use payroll information to determine if a student works on a project for 1 person month or more.

To comply with UK policy, Graduate Student Research Assistants work time should be no more than 20 hours per week, and their effort reported on an NIH All Personnel Report, should never be greater than 6 calendar months.

UK Graduate School policy on research assistant appointments:
UK | Graduate School | Teaching and Research Assistantships

NIH Frequently Asked Questions on All Personnel Reports, C. Level of Effort http://grants.nih.gov/grants/funding/all_personnel_report_faq.htm#556

Laboratory Staff Strongly Encouraged to Attend a Review Session on Laboratory Safety

Lack of sufficient training has been blamed for a recent lab acquired infection at another institution which resulted in a Salmonella typhimurium outbreak that affected 109 people in 38 states.  It is imperative that adequate safety precautions are taken in the planning, execution, and termination of research utilizing biohazardous materials.  Biohazarous materials include but are not limited to infectious agents (viral, bacterial, fungal, parasitic, or prion), recombinant nucleic acids (ex: plasmids with inserts, viral vectors, etc. or whole animals and plants with introduced recombinant materials), infected animal blood and/or tissues, human blood/blood products/fluids, human derived cell lines or tissues, and live vaccines. This training will focus on definitions of biohazards, risk groups, biosafety containment levels, best practices and proper disposal methods, as well as requirements set forth by the University of Kentucky for researchers using biohazards.

The training entitled "Laboratory Safety Training Procedures" will take place on May 21 from 10:30 to 12:00 in MN263. 
University Deadlines Associated with the Upcoming NIH RO1 Deadline

The next standard NIH R01 deadline is Tuesday, June 5.  OSPA expects to receive your fully completed proposal ready to submit 3 business days in advance of that date – Friday, June 1.  Your CGO needs sufficient time prior to this 3-day deadline to review the proposal package and allow time for edits to be made.  Please provide it as soon as possible prior to June 1.    Also, per the new policy as announced by the VPR, your eIAF must be fully routed 3 business days in advance of the sponsor deadline.  For this R01 deadline of 5 p.m. on Tuesday,  June 5, OSPA must have your fully routed eIAF by 8 a.m. on Friday, June 1.  The COM recommends that eIAF routing be initiated at least 10 business days ahead of the University deadline (Friday, May 18).   This interval should be extended for complex grant submissions.  Initiation means routing the eIAF and required attachments to your CGO.     Remember – you are not the only one submitting for this deadline!  And, there is a holiday on Monday, May 28, so that is one less business day for items to be reviewed and certified.  
Have you checked the access to your shower and eyewash stations lately?

According to UK EHS policy, monthly inspections of your shower/eyewash stations are required. Any area which deals with corrosive, flammable or otherwise hazardous material is required to have immediate access to eyewash and drench shower facilities. All showers and eye wash equipment must be in full operational order and unobstructed. Eye wash bottles are not adequate equipment.   For more detailed information on Emergency Eyewash and Shower Equipment, please follow the link to the information on the Environmental Health and Safety website.
NIH Announces New Just-in-Time Submission Process

Click on the link to see the new guidelines announced by NIH.

Contact your CGO if you have further questions.

Supreme Court Ruling Throws Doubt Over Countless Life-Sciences Patents

The Chronicle of Higher Education reported on the U.S. Supreme Court decision related to life-sciences patents in a March 21, 2012 article.  To read the article, click here.  To read the full Supreme Court opinion, click here.
Do your grant’s expenses look like this?

If so, you may be inviting some attention from audit agencies. Spending out a grant at its end is an audit flag to many sponsor’s audit entities. The second graph below is NSF’s graph showing what activities are items that draw their interest. Even if you don’t have an NSF award, you should consider their information as true for other awards!

Expense Graph

NIH Graph
Don’t wear gloves in the hallway

Don’t wear gloves it the hallway per the EH&S policy!  The need to wear gloves indicates you are being protected from something that is potentially harmful.  Wearing the gloves into general service areas, like hallways, could be a potential source for exposing other people to harmful substances.  Occupational Health and Safety should be contacted with any questions. 
Citations for Noncompliance with NIH Public Access Policy

Recently, investigators have been cited by NIH for noncompliance with the NIH Public Access Policy related to the submission of their annual NIH progress reports.  This policy, which also applies to new proposals, ensures that the public has access to the published results of NIH funded research. Annotations demonstrating compliance with the NIH Public Access Policy should be placed at the end of each applicable publication citation in every application, proposal or report. Included in this policy is a requirement that scientists submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication.  To help advance science and improve human health, the Policy requires that these papers are accessible to the public on PubMed Central no later than 12 months after publication. Potential consequences for non-compliance may be proposal rejection or funding delays.  

Refer to these sites for further information:  http://publicaccess.nih.gov/index.htm and http://publicaccess.nih.gov/FAQ.htm.

One of the three following items must be listed for any publication citation: 1)  PubMed Central (PMC) reference number 2)  NIH Manuscript Submission reference number (e.g., NIHMS97531) 3)  PMC Journal – In Process (if the Journal submits articles directly to PMC)        

Also, per NIH policy, for each publication that results from NIH grant-supported research, grantees must include an acknowledgment of NIH grant support and a disclaimer stating the following: “This publication was made possible by Grant Number ________ from _________” or “The project described was supported by Grant Number ________ from ________” and “Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the [name of awarding office or NIH].”
Plagiarism Prevention - Access to "iThenticate" software now available

The University of Kentucky College of Medicine has arranged for trial access to a software called "iThenticate".  This software compares your literature/publication/abstract content against a massive database providing in-depth reports on originality.  This will provide you with a tool to determine how similar or original your work is before publication - http://www.ithenticate.com/.

In order to access this web-based system, you will need to request login permission by sending an email to COM.SADR@uky.edu.  Your login ID and password will then be established and sent to you by email.
Personal Protective Equipment and Apparel in Laboratories  

Appropriate attire and personal protective equipment are required any time someone is in a laboratory area.  Shorts, short skirts, sandals and open-toed or high-heeled shoes are not allowed while working in a laboratory.  Personal Protective Equipment (PPE) such as lab coats and protective eyewear are required when in a laboratory area.  Other equipment such as gloves may be required based on the task.  To learn more about appropriate lab apparel and PPE, see the UK EH&S Fact Sheets on PPE and Apparel and the UK Laboratory Safety website.
Standardized Budget Template Available for Use with eIAF

As the April 2 deadline approaches, when an eIAF must be fully routed three days in advance of a sponsor’s proposal deadline, we are looking for ways to facilitate and expedite the review of eIAFs by the College Grant Officers (CGO).  One way we are making the process easier is to encourage depts./units to use a standard budget template. Click here to access the template.   You can also find one on the College’s Research Support and Development page: http://www.mc.uky.edu/medicine/research/supportdev.asp    

Please note: the form is an Excel 97-2003 file.  Current fringe rates are included, with recommended escalation formulas included for salaries, fringes, and other costs.  It uses the standard research F&A rate of 48.5%, but this can be easily changed  for other types of submission.   There is a tab for both a detailed and modular submission, if the proposal will be submitted to NIH. 

Contact your CGO for assistance.
Required Effort on NIH Grants During a No-Cost Extension Period

If an NIH grant is in a no-cost extension period, NIH expects the effort of all key personnel to remain the same. As the extension is “no-cost,” with this extension effort must be committed absent any additional funding from the sponsor. Any effort committed and not paid for by the sponsor is considered cost share, and must be tracked accordingly.

In general, effort of the PI and any key personnel named in the notice of grant award may reduce their effort by up to 25% without sponsor approval. If effort needs to be reduced by 25% or more, advance notice must be obtained from NIH. The request for this reduction can be made via email, through the Office of Sponsored Projects Administration as institutional official. (NIH policy regarding prior approval requirements is at this link.)

Contact your CGO for assistance.

DEA-License Related to Research

Per discussions with the regional DEA Diversion Agent, Pam Bixler, University researchers should be individually applying for this license using form DEA-225, and, as an employee of the University of Kentucky, a state governmental entity, would be exempt from paying the license fee.

As part of the application process, the applicant should provide his/her department chair’s name as the one who can certify the exemption status. If a chair is applying for the license, he/she may provide Alan Daugherty, Sr. Associate Dean for Research, as the person who can certify the exemption. Be sure the work address provided is a University of Kentucky address.

If the individual leaves the University, and chooses to keep the license as an employee in the private sector, then the fee exemption would no longer apply. There may also be certain circumstances, if a project is funded by a for-profit entity, where the fee payment may be required. In those situations, the private company should be covering the cost.

Contact your CGO if you have further questions.

Implementation of University IAF Processing

IMPORTANT INFORMATION ON REQUIRED GRANT ROUTING   Please read the memo from the Vice President for Research.   The important message – Routing of IAFs (Internal Approval Forms) will need to be completed (submitted to OSPA) for new, competing, and non-competing applications 3 business days before a grant deadline.   For IAF routing to be completed in this time frame, we are making the following recommendations: IAF routing to be initiated a minimum of 13 business days ahead of the grant submission deadline  (10 business days ahead of the OSPA deadline)   Please note – limited sections of the grant are needed to initiate this process.  The information needed to initiate IAF routing is listed on the COM Research site - http://www.mc.uky.edu/medicine/research/supportdev.asp.   Please note – for complex proposals involving multiple Investigators and/or Multiple Colleges, it is recommended that the process be initiated earlier that this deadline.  College of Medicine College Grant Officers (http://www.mc.uky.edu/medicine/research/grantsofficers.asp) are experts on this topic if you have questions or need assistance.
Office of Inspector General released it work plan for 2012

The Office of Inspector General released its work plan for 2012 that includes emphasis on the review of university charging indirect cost items as a direct cost.  Previous audits of universities found this to be a problem.  The review will encompass both labor and non-labor expenses.  The UK guidelines on determining if a cost is normally considered direct is here.  If you have any questions about what your grant or contract will allow as an expense, please contact your CGO.
The Leahy-Smith America Invents Act

The Leahy-Smith America Invents Act is one of the most significant job creation bills enacted by Congress this year.  The Act implements a first-inventor-to-file standard for patent approval, creates a post-grant review system to weed out bad patents and helps the Patent and Trademark Office (PTO) address the backlog of patent applications. The enactment of H.R. 1249 is a victory for America’s innovators and job creators who rely on our patent system to develop new products and grow their businesses. The America Invents Act brings our patent system into the 21st century, reducing frivolous litigation while creating a more efficient process for the approval of patents.  These reforms will help the innovators and job creators of today launch the products and businesses of tomorrow.  

The UK office of Intellectual property is available to help any UK employee or student navigate the complex set of rules associated with patents.  If you believe you may have an invention, please contact their office.   http://www.uky.edu/econdev/econdev/faculty-staff-clinicians/intellectual-property-development
Including a collaborator on an NIH proposal without committing any salary support for that person

If you’d like to include an individual who will contribute to the scientific development or execution of the project but they’re not committing any measurable effort (in person months) – no direct salary support in the grant budget and no cost share commitment – they should be identified in the proposal as “Other Significant Contributors.” NIH has specific guidance in the SF424 (R&R) Application guide on the appropriate way to include them in this role. Your CGO can also advise you on the appropriate way to do this.
Summary of Findings from a Recent DHHS OIG Audit of a Large University

A recent DHHS OIG audit of a large university focused on direct reimbursement of normally indirect administrative costs charged directly to DHHS agreements.  They were found to generally be in compliance.  Three hundred thirty-two (322) expenditures were reviewed and 85% were found to be allowable and compliant.  The remaining 47, however, were found to be unallowable.  Thirty of these were found to be unallowable as they did not “solely benefit” the sponsored agreement to which they were charged – this included the purchase of information technology supplies like computers, printers, and digital cameras.  Also, nearly half were purchases that occurred at the end of a project period.   In addition to the institution having to repay the questioned costs, they were directed to “establish adequate controls to ensure consistent compliance with the costs principles applicable to charging administrative, clerical, and extra service compensation expenditures to sponsored agreements.”              

A focus of the DHHS OIG for audits in 2012 will be on how universities are meeting their cost share commitments.  The UK cost sharing policy is found here:  http://www.uky.edu/EVPFA/Controller/files/BPM/E-50-2.pdf

Children in the Workplace   (Memo from COM Dean's office)     

Children should not be brought to the workplace in lieu of daycare.  
Children should not be brought into research labs.
Children should not be brought into clinical environments (unless the child is a patient or accompanying a parent to a personal clinical visit).  
NIH Updated Electronic Application Forms - ADOBE-FORMS-B2

The ADOBE-FORMS-B2 packages will be used with new funding opportunity announcements (FOAs) posted on/after July 22, 2011. In addition, NIH will reissue R01, R03, and R21 parent announcements with the new forms on July 22 and expire the current parent R01, R03, and R21 FOAs on January 8, 2012 . Applicants may use either the current parent FOAs with ADOBE-FORMS-B1 or the new parent FOAs with ADOBE-FORMS-B2 packages for deadlines on/before January 7, 2012, but NIH strongly encourages applicants to use ADOBE-FORMS-B2 whenever possible.  For further details, the full notice appears at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-096.html.
Reminder of what constitutes a sponsored activity proposal (grant, contract, clinical trial agreement)

As we work toward a deadline of when IAFs must be completed prior to a proposal being submitted, this is to remind you of what constitutes a proposal –

Per University policy a proposal includes: all New, Competing Renewal, Noncompeting, Continuation, Revised applications, Supplemental (REUs, Minority, etc.) and Administrative requests, and any Response to an RFP or RFQ. This includes UKRF’s proposed role as a subcontractor on any of these types of submissions from another entity (i.e., when another University is submitting an NIH proposal on which UKRF is a proposed subcontractor, the internal IAF should be routed prior to obtaining a signed letter of commitment/intent from UKRF and prior to the lead institution submitting a proposal to the funding agency).

If no formal proposal was submitted (i.e. certain industry or foundation funding such as pre-proposals that do not include budget details), an IAF must be completed before an agreement is signed or an account number is established.

Only certain R mechanisms are eligible for “continuous submission” per NIH policy. 

Only certain R mechanisms are eligible for “continuous submission” per NIH policy.  This includes R01, R21, and R34.  Any proposal submitted under this policy must include a cover letter that identifies the study section(s), Council, and/or Board on which the individual served, as well as the period of his/her service.  Check the NIH website on Continuous Submission (http://grants.nih.gov/grants/peer/continuous_submission.htm) to check your eligibility and to review the additional requirements to comply with this program.  If you are interested in a Multiple PI submission through this process, be sure to review the FAQs on the NIH Multiple PI site (http://grants.nih.gov/grants/multi_pi/faq.htm#2969) as well.
Guidance on completion of an NIH All Personnel Report.

The All Personnel Report is part of the Non-competing Continuation Progress Report (PHS 2590).  For awards subject to the Streamlined Noncompeting Award Process (SNAP), the report may be submitted through the eRA Commons using the eSNAP module.  If grantees are using the paper PHS 2590 to submit a progress report, the All Personnel Report is Form Page 7.  Directions for completing the All Personnel Report appear in the PHS 2590 instructions at Section 2.2.8.

In addition, FAQs are available at this link:  http://grants.nih.gov/grants/funding/all_personnel_report_faq.htm#551

Please work with your business office staff to make sure your report corresponds to the information in the University’s HR system.  Your CGO will compare these two items as part of your progress report review before it is submitted by OSPA.
 
Laboratory Security

Laboratory security measures are necessary to minimize the risk of theft of hazardous materials (anti-bioterrorism) as well as to protect University property, intellectual property and personal property.  Click on the link to see the University's adaption of the CDC/NIH requirements for laboratory security.

New On-Line Subagreement Request Form

When a sponsored project award includes a collaborating entity, the Office of Sponsored Projects Administration prepares and issues a subaward agreement to the other party. The Principal Investigator (PI) begins the process by submitting a completed Subagreement Request Form to OSPA. The form includes the necessary information to prepare the subagreement such as the scope of work, budget and collaborating investigator contact information. In the past, the form was in pdf format and required a live signature. It has now been converted to an on-line form with an electronic signature. The PI is identified by logging into the site with his or her MyUK logon ID and password.

The new format is available for immediate use at the OSPA website on the Forms page http://www.research.uky.edu/ospa/forms.html. Directly below the form is a document with instructions.

If you have questions, please contact Steve Jacoby, OSPA Subaward Administrator, 257-9420, hsjaco2@uky.edu.

How Tuition Appears on Monthly Ledger Reports

When reviewing your monthly ledgers for accuracy, remember that tuition is included within the Direct Current Expense category/sponsored class, but is exempt from the base when calculating indirects/F&A costs. As tuition isn’t budgeted in its own separate line, it may not be readily apparent that this cost has been excluded from the F&A calculation. If a tuition expense isn’t charged to the grant after all, but another type of cost is incurred that is subject to F&A, then this will negatively impact the overall budget, causing a short fall that would need to be covered by departmental funds.

Other costs exempt from F&A are equipment, rent, patient care, and subcontract amounts in excess of $25,000. Each of these costs, however, would have a separate line item in the budget.

Communications Converged Fee

As of July 1, communication charges for the following will be assessed as a lump sum per FTE:  Network access,  Basic Phone Line charges, Features – call waiting, call forwarding, auto busy, Voice Mail, and Domestic Long Distance.  

Previously, these costs were itemized to four different general ledger expense codes.  At that time, some of these could be charged to grants with sufficient justification.  With the implementation of this new program, it will not be possible to charge this converged fee directly to grants. 
Senior and Key Personnel as defined by NIH

Senior and Key Personnel are defined by NIH as follows:  “The program director/principal investigator (PD/PI) and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they request salaries or compensation.”  It’s expected they will have measurable effort on the project.  

NIH also allows the option to identify someone as key personnel but without effort, provided they are designated as an “Other Significant Contributor.”  

For internal approval purposes, all faculty and any staff identified as a co-Investigator in the proposal or in a leadership role on a project (like project director or program manager) with measurable effort – whose salary will be either a direct charge or cost shared – need to complete and certify the Internal Approval Form (IAF) and provide a Financial Disclosure Conflict of Interest (COI) form.  In addition, if the PI identifies anyone else working on the project that could impact the project outcomes, they should complete a COI form.
Changes to Conflict of Interest Regulations

The U.S. Department of Health and Human Services recently released the Final Rule on changes to the conflict of interest regulations regarding research.  UK Administration is reviewing the changes and will provide more information before the rule takes affect. (WEBSITE)
Good Practices for Laboratory Notebooks

Notebooks should err on the side of completeness. Someone from outside your lab should be able to read what was done without your verbal interpretation.  General guidelines for lab notebooks include:
•  Permanently bound book (not spiral), with acid-free paper
•  Pages should be consecutively numbered
•  Dated entries
•  Signed entries
•  Record entries chronologically
•  Recorded in English
•  Each entry should stand on it's own
•  Organize material with sections and headings
•  If a page is left blank draw a line through it
•  Identify material sources (e.g. manufacturer, lot number, expiration date)
•  Identify and describe reagents and specimens
•  Include instrument serial numbers and calibration dates
•  Explain nonstandard abbreviations
•  Use permanent ink – don't remove pages or obliterate original entries
•  Use glue to permanently attach graphs computer printouts etc. to the notebook (sign & date)
•  Outline new experiments, include objectives & rationale
•  Include periodic factual summaries of findings
•  Enter observations immediately
•  Summarize discussions from lab meetings and ideas made by others citing the person's name

For more information on laboratory notebook management, see this Responsible Conduct of Research site. sponsored by the Office of Research Integrity.
Postdoctoral Scholar versus Postdoctoral Fellow.  How do you know which title to choose?

When hiring a person with a PhD for a post-doctoral position, it is very important to assign the correct title.  The information below provides general guidelines for making the correct choice.  If you need more information, refer to the Administrative Regulation (AR II-4.0-1).

Postdoctoral Scholar Definition:  An individual who has earned a doctoral degree and is pursuing an individualized program of advanced training in research, in teaching or other important aspects of academic work, or in any combination of these activities for which the University has assumed a measure of responsibility. Although participation in the program provides advanced training, service is required as a condition of appointment with salary. A postdoctoral scholar has status both as a non-regular academic staff employee and as a postdoctoral student.
Payroll:  Monthly
Benefits:  Basic Life, Optional Life, ADB Insurance, Health Insurance, Health Plan Credit, Voluntary Retirement, Workers’ Compensation, Long Term Disability, Vacation, Temporary Disability Leave, Holiday Leave
Payroll Charges:  Base+Health Insurance+ Life Insurance+ FICA+ Misc. Benefits
Taxes: Tax withholding depends on the deductions the individual lists on their tax forms.

Postdoctoral Fellow Definition:  an individual who has earned a doctoral degree and is a recipient of a fellowship or training award. Through such an award, a postdoctoral fellow receives a stipend or living allowance (not considered as salary) from grant funds provided specifically for a particular field of study or training. No service to the University is required as a condition of receiving the stipend, although service may be rendered incidentally as part of the training or fellowship program. A postdoctoral fellow has status as a postdoctoral student, but not as an employee.
Payroll:  Monthly
Benefits:  Basic Life, Optional Life, Health Insurance, Health Plan Credit
Payroll Charges:  Base+Health Insurance+ Life Insurance
Tax: Although no taxes are withheld by the University on the fellowships the individual may be responsible for federal, state, or local taxes depending on their annual filing status.  It is up to the individual to comply with federal and state laws.
Office/Workstation Space for Academic, Research and Academic Support Functions.

New guidelines for office/workstation space for academic, research and academic support functions became effective July 1, 2011.  Click here to view the guidelines.
Mapping Publications to Grants.

A recent article by Dr. Sally Rockey, Deputy Director, NIH, Office of Extramural Research outlined the SPIRES system for mapping publications to NIH grants.  The SPIRES database uses automated text manipulation methods to find NIH references in publications and reformat the references into a standard traceable format.  This function is important to NIH because outcomes of NIH support often are demonstrated through publications.  To read more of Dr. Rockey’s comments about mapping publications to grants, click here
NIH notice reminds investigators of page limits for grants.

The notice was issued to remind investigators that an Appendix or certain sections of an application can not be used to circumvent page limits.  NIH’s electronic submission system enforces page limits for grant submissions by rejecting the electronic submission.  NIH staff manually validate page limits for paper application and will withdraw the application from consideration if certain sections are too long.  Not all sections of a grant have page limits.  Therefore, it is important for investigators to be familiar with the appropriate application guide or instructions in the funding opportunity announcement.  For more information, click here to see the entire NIH Reminder.
Be certain the required signage on your laboratory door is current.

The University’s chemical hygiene plan requires that signage information be updated at least every six months and in the event of any change in the emergency contacts or special hazard, be updated immediately.  Federal law requires that any lab that uses hazardous chemicals must comply with the University’s chemical hygiene plan. 

This plan provides includes the following signage requirements:
Each laboratory door must be legibly marked with the following information:
    Room number
    Department
    Laboratory Supervisor's name
    Emergency contacts, including names, office location, and office and emergency telephone numbers
    Special hazards/instructions (e.g. location of large quantities of flammables or the presence of a "local alarm" system)

They also provide a form that can be used for this purpose at this link
Additional University environmental health and safety resources can be found at this link
Does ORI regularly pursue cases of sabotage?

The Curious Case of Vipul Bhrigu (more information: ORI website)

The recent research misconduct finding on Vipul Bhrigu is one of the more interesting cases ORI has handled.  Bhrigu, a former postdoctoral fellow at the University of Michigan, was caught on video engaging in the sabotage of a graduate student’s research.

This leads to a question that some people may raise–Does ORI regularly pursue cases of sabotage? The answer is “It depends.” ORI pursues cases involving plagiarism, falsification, and fabrication in PHS-funded research. The sabotage, itself, was not the reason that ORI made findings of research misconduct in the case against Bhrigu. In this case, ORI’s jurisdiction stemmed from false results that were recorded in the research record and were caused by Bhrigu’s intentional tampering with the graduate student’s PHS-funded research.
Advertising Employment

A position doesn’t have to be vacant in order to be posted on the Online Employment System (OES).

In fact, if an employee is retiring or has given ample notice, the incumbent and the new hire can be employed in the same position number for up to six weeks. This allows the incumbent time to potentially train the new hire before leaving the position, making for a smoother transition. You will want to work with your budget officer to ensure your department can financially support paying both individuals simultaneously.
REMINDER There is a Three-Day Internal Deadline for submission of proposals and the associated Internal Approval Form.  

The Vice President for Research has established a deadline to receive final proposals THREE BUSINESS DAYS in advance of the sponsor deadline.  This deadline applies to both electronic and paper submissions. You should contact your CGO well in advance of the three day deadline so that he/she can assist you. Submission by the sponsor’s deadline may not occur if this three-day deadline is not met. 

UK Policy requires the completion of the Internal Approval Form (IAF) and financial conflict of interest form (COI) for all key personnel prior to proposal submission. Please see the IAF instructions here
Warm Weather Lab Attire

EH&S would like to remind everyone in the coming warm weather season that shorts, dresses, sandals are not appropriate attire in the lab. Long pants and fully covered feet are acceptable. Complete personal protective equipment is a federally required best practice for your own safety. Please refer to the Chemical Hygiene Plan on the EH&S website for further information.
Volunteers in the workplace 
 
As summer approaches, please be sure to review the UK HealthCare Volunteer Services policy regarding volunteers in the workplace (this applies to research areas in the College of Medicine).  More information at UK HealthCare website.
Incomplete labeling of hazardous waste

Hazardous Waste must always be labeled as “Hazardous Waste” and the contents listed.  UK’s office of Environmental Health and Safety provides training materials here due to the enforcement of federal policy from the US EPA.
Chemical Hygiene Plan Annual Update

The Chemical Hygiene Plan manual needs to be updated annually. The ID page (pages ii-iii), chemical inventory and lab specific training all need to be updated.  The UK policy on this requirement is due to Federal Law.  The hygiene plan, related documents and help on this can be directed to Environmental Health and Safety (EH&S).
Storage of Flammables in refrigerators/freezers 
     
Flammables are not to be stored in refrigerator or freezers unless it is an explosion proof or flammable safe.  Explosion proof items are designed for use in an area where flammable vapors or gases may be present.  Typical lab operations would not warrant an explosion proof frigerator.
If you need to cool/chill flammable products, please consult with EH&S for advice.  (Website) (PDF)   
Is overtime allowed on Grants?

Because UK has so many types of grants, it depends.
First and foremost, if a non-exempt (hourly) employee works the hours, they do have to be paid.
Second, Employees are not authorized to work overtime without supervisor prior approval.

Overtime pay is earned for total hours worked in excess of 40 (for hourly employees) in the regular 7 day work week and compensated at one and one-half times the hourly wage rate.

Overtime is only allowed on federal grants (or federal flow through) if preapproved through OSPA. A Prior Approval Request for Action/Revision form must be completed with the appropriate approvals provided. Your CGO can provide assistance with this process and offer advice on the justification.

Non-federally funded projects do not require a specific budget for overtime, but if a sponsor does not allow it, the department will be responsible for those costs.
Departments may have to process journal vouchers after the payroll posts to make sure the overtime costs are assigned to the project where the overtime hours were worked.
How to respond to a request for recommendation and employment verification.

Any and all requests for verification of past University employment shall be directed to the Lexington Campus Employee Records Office. That office releases information including the fact of past or present employment, verification of dates of employment and position or title.  See Human resources policy 6.1.3.1  

Nothing in this policy shall be construed as a prohibition against a letter of recommendation.  Warning:  Statements within a letter of recommendation could be determined as a defamation of character or slander.  Because of the potential legal risk associated with these letters, the Human Resources department highly recommends that all employment verifications be sent to Human Resources Records

Do not provide references over the phone whenever possible, as they tend to be less formal. There is much more potential to make false claims about the comments made when providing a reference when there is no official record of the conversation.
Potential consequences for PMCID omission – including proposal rejection or funding delays.    
NIH Literature Citation Requirements for New Applications, Renewals, Progress Reports and Biosketches.
(Click here for notice.)

One of the three following items must be listed for any publication citation:
1)  PubMed Central (PMC) reference number
2)  NIH Manuscript Submission reference number (e.g., NIHMS97531)
3)  PMC Journal – In Process (if the Journal submits articles directly to PMC)      
Loaner and donated equipment.  What you need to know.

If any department receives a donated piece of equipment that will not be entered into the UK Equipment Inventory and that the University is required to provide insurance then they need to contact Risk Management (257-3708) to have the piece(s) covered. Information required by Risk Management includes:  Name of the vendor, description of the equipment, building the equipment will be kept, value and the dates equipment will be kept. UK risk management
Do individuals certifying effort in your department have suitable means of verification?

Per federal guidance (OMB Circular A-21): “Reports will reasonably reflect the activities for which employees are compensated by the institution. To confirm that the distribution of activity represents a reasonable estimate of the work performed by the employee during the period, the reports will be signed by the employee, principal investigator, or responsible official(s) using suitable means of verification that the work was performed.”  
Further, “…the signature of the employee or of a person having direct knowledge of the work, confirming that the record of activities allocable as direct costs of each sponsored agreement is appropriate.
(for more information click here.)
Legal Implications of NIH Applications

When a grant proposal is submitted to NIH, the applicant is actually the University of Kentucky Research Foundation (UKRF), not the Principal Investigator.  As part of the electronic submission process, all applications are “signed” by UKRF’s Authorized Organizational Official (AOR), Deborah Davis.   

Per NIH Policy, “The signature of an AOR on the application certifies that the organization will comply with all applicable assurances and certifications referenced in the application. The applicant organization is responsible for verifying conformity with the most current guidelines for all administrative, fiscal, and scientific information in the application, including the F&A cost (indirect cost) rate. The AOR’s signature further certifies that the applicant organization has the ability to provide appropriate administrative and scientific oversight of the project and agrees to be fully accountable for the appropriate use of any funds awarded and for the performance of the grant-supported project or activities resulting from the application.”  

For further details, refer to this link.

Good Laboratory Practice for Nonclinical Laboratory Studies

Good Laboratory Practice for Nonclinical Laboratory Studies prescribes good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products. (PDF)

Are you following the HIPAA requirements for your research subjects?

If your research is subject to the Health Insurance Portability and Accountability Act (HIPAA) and your approved protocol includes a HIPAA Authorization Form to describe use and disclosure of subject’s protected health information (PHI), you must utilize this form as indicated in the IRB approved protocol.

HIPAA Authorization Forms need to be signed by research subjects and the IRB form itself cannot be altered without IRB approval.

A research authorization form should be signed by each subject upon enrollment in a research study. Standard clinical HIPPA authorizations do not cover use and disclosures associated with research.

Failing to comply with HIPAA Authorization regulations is considered non-compliance. As a federal regulation, non-compliance with HIPAA could result in associated penalties from the federal government, depending on the nature of the infraction.

For additional information see the Office of Research Integrity website or contact Joe Brown at 859-257-9428, or e-mail.
Are your images altered or manipulated? Be very careful!

Taken from the Journal of Clinical Investigation, we advise the following Best Practice.

No specific feature within an image may be enhanced, obscured, moved, removed, or introduced. The groupings of images from different parts of the same gel, or from different gels, fields or exposures must be made explicit by the arrangement of the figure (e.g. using dividing lines) and in the text of the figure legend. Adjustments of brightness, contrast, or color balance are acceptable if and as long as they do not obscure or eliminate any information present in the original. Nonlinear adjustments (e.g. changes to gamma settings) must be disclosed in the figure legend.

The Editors reserve the right to consult the Office of Research Integrity or the appointed official at the authors' home institution if the figures appear to have been manipulated.
Are diagnostic analysis tests patentable?  The US Court of Appeals thinks so.

Click here for more.
NIH Error Correction Window for Grant Submission has been ELIMINATED!

Beginning with due dates on or after January 25, 2011, NIH, AHRQ and NIOSH will eliminate the error correction window from the application submission process. This change was announced in August, via notice # NOT-OD-10-123.

Accommodations will still be made related to Federal system issues, provided they are appropriately documented and verified by NIH support staff.

Per NIH, a “system issue” is defined as follows: Systems issues are technical problems with federal systems used for electronic submission of grant applications (Grants.gov or eRA Commons) that keep an applicant from successfully submitting their grant application on time. Please note: Problems with computer systems at the applicant organization are not considered system issues nor is a failure to complete any required registration by the submission deadline. System issues must be reported to the eRA Helpdesk on or before the deadline and will be investigated on a case by case basis.

To be appropriate documented, through your Research Administrator in OSPA, You MUST follow the steps below to document your issues on or before the submission deadline:
1. Contact the Grants.gov Contact Center to document and help resolve any Grants.gov related submission issues.
2. Document issue preventing submission with the eRA Commons Help Desk and be sure to include your Grants.gov support ticket number(s).
Plagiarism- guidance from DHHS.

Plagiarism "...taking over the ideas, methods, or written words of another, without acknowledgment and with the intention that they be taken as the work of the deceiver." American Association of University Professors (September/October, 1989).

As the above quotation states, plagiarism has been traditionally defined as the taking of words, images, ideas, etc. from an author and presenting them as one’s own. It is often associated with phrases, such as kidnapping of words, kidnapping of ideas, fraud, and literary theft. Plagiarism can manifest itself in a variety of ways and it is not just confined to student papers or published articles or books. For example, consider a scientist who makes a presentation at a conference and discusses at length an idea or concept that had already been proposed by someone else and that is not considered common knowledge. During his presentation, he fails to fully acknowledge the specific source of the idea and, consequently, misleads the audience into thinking that he was the originator of that idea. This, too, may constitute a case of plagiarism.  

In sum, plagiarism can be a very serious form of ethical misconduct. For this reason, the concept of plagiarism is universally addressed in all scholarly, artistic, and scientific disciplines. In the humanities and the sciences, for example, there are a plethora of writing guides for students and professionals whose purpose, in part, is to provide guidance to authors on discipline-specific procedures for acknowledging the contributions of others. Curiously, when it comes to the topic of plagiarism, many professional writing guides appear to assume that the user is already familiar with the concept. In fact, while instruction on attribution, a key concept in avoiding plagiarism, is almost always provided, some of the most widely used writing guides do not appear to offer specific sections on plagiarism. Moreover, those that provide coverage often fail to go beyond the most basic generalities about this type of transgression.

Although plagiarism can take many forms there are two major types in scholarly writing: plagiarism of ideas and plagiarism of text.

For more information:  http://ori.hhs.gov/education/products/plagiarism/3.shtml Avoiding plagiarism, self-plagiarism, and other questionable writing practices: A guide to ethical writing.
Reminder- xTRAIN Required as of January 1, 2011 (relevant to T programs (T32) and F programs).

Beginning January 1, 2011, the use of xTrain, NIH’s electronic appointment system, will be required for nearly all NIH institutional research training grants, fellowships, education and career development awards.  A notice was first released in March 2010 with this information.  http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-072.html

xTrain provides program directors, university administrators and trainees the ability to electronically process and submit appointment forms and termination notices associated with institutional research training grants and career development awards. The xTrain system speeds up the NIH approval process and reduces the chance of data entry errors associated with paper appointment forms. In addition, once a training appointment has been initiated in xTrain, the system provides institutional and NIH users with an ongoing record of its status.

Further information is available in the article from the April 2010 OER/Extramural Nexus (http://nexus.od.nih.gov/nexus/nexus.aspx?ID=425&Month=04&Year=2010) .  NIH offers some excellent instructional materials at this site:  http://era.nih.gov/ and there is also a demonstration site available on eRA Commons to help familiarize PI with how to use this system.  Certain tasks can be delegated by the PI to an assistant.  If you have any questions, contact your CGO for assistance.

NIH list of Reviewers Eligible for Continuous Submission.

As part of our continuing commitment to recognize outstanding service in the NIH peer review process and on NIH Advisory Groups, and to minimize disincentives to such service, the NIH has implemented policy and procedures to allow appointed members of NIH review and Advisory Groups, and peer reviewers with recent substantial service (six times in 18 months), to submit their research grant applications (R01, R21, or R34) on a continuous basis and to have those applications undergo initial peer review in a timely manner. ·        
Lists of Reviewers Eligible for Continuous Submission:
Individuals may determine their eligibility for the continuous submission option, by accessing the list below. Because of the potential for multiple reviewers to have the same name, please check your Commons profile to confirm your individual eligibility. The term of eligibility is shown after the name.
(Website)  (PDF)

Important Reminder Regarding Upcoming Change in NIH Proposal Packages.

NIH (as well as ARHQ, CDC, FDA, and NIOSH) is transitioning to updated electronic application form packages, known as ADOBE-FORMS-B1.  All applicants submitting for the following programs must use the B1 package on or after January 25, 2011:  Individual Research Career Development Award Programs (Ks), Institutional Training and Career Development Programs (Ts and Ds), or Individual National Research Service Awards (Fs).  On or after May 7, 2011, the B1 package will be required for all programs using electronic submission.  Be sure you are accessing the correct application package from the most current program announcement. 

Refer to this notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-007.html for details.  Your CGO is also available to answer questions.
Protecting Sensitive Data and Information Used in Research.

Recipients of NIH funds are reminded of their vital responsibility to protect sensitive and confidential data as part of proper stewardship of federally funded research, and take all reasonable and appropriate actions to prevent the inadvertent disclosure, release or loss of sensitive personal information. NIH advises that personally identifiable, sensitive, and confidential information about NIH-supported research or research participants not be housed on portable electronic devices. If portable electronic devices must be used, they should be encrypted to safeguard data and information. These devices include laptops, CDs, disc drives, flash drives, etc. Researchers and institutions also should limit access to personally identifiable information through proper access controls such as password protection and other means. Research data should be transmitted only when the security of the recipient’s systems is known and is satisfactory to the transmitter.
For detailed information on this topic, click here.
If you need assistance with encrypting your devices, contact MCIS 3-8586.  
Reminder of Clinical Trials.gov mandatory registration.

Notes about ClincalTrials.gov http://prsinfo.clinicaltrials.gov/  
ClinicalTrials.gov facilitates registration of trials in accordance with the International Committee of Medical Journal Editors (ICMJE) initiative requiring prior entry of clinical trials in a public registry as a condition for publication.  

Trials can be registered at any time, but many policies require registration prior to the enrollment of the first participant.  

Multi-site trials and multi-sponsor trials are susceptible to duplicate registration, thus care must be taken in how the trials are registered. For multi-sponsor trials it is the lead sponsor who should take responsibility for registration. It is critical that investigators and sponsors work together to ensure that a trial is registered once and only once.  

A registration and reporting FAQ document is available here: http://prsinfo.clinicaltrials.gov/registering.pdf  

To obtain an access code to the UK Organizational Account on ClinicalTrials.gov, send a request with Name, Department and Email address to:      
Laura Ashe laura.ashe@uky.edu Clinical Research Associate II room C300 UKMC, Lexington, KY 40536-0293 (859) 323-2782
How will the vertebrate animal section of your NIH grant application be evaluated?

There is a NIH notice to clarify how the Vertebrate Animal Section (VAS) of applications for grants, fellowships, and cooperative agreements is evaluated as part of the NIH peer review process and is considered as part of the overall scoring.
Reviewers rate the application as Acceptable or Unacceptable with respect to the proposed use of vertebrate animals and include specific comments assessing the information provided in the application.  (Click here to see full notice.)
Is there a difference between “Research Support” on my NIH biosketch and “Other Support?”

Yes, there is a difference.

The “Research Support” section of an NIH-formatted biosketch should include selected on-going and completed (in the last three years) research projects (Federal or non-federal support).  Think of this section as highlighting your accomplishments as a scientist.  List those projects first that are relevant to the current proposal.  Briefly state the overall goals of the projects and your responsibilities on the project.  Do not include effort information or direct costs.

In contrast, “Other Support” information is required for all applications that are selected to receive grant awards.  NIH staff will request complete and up-to-date “other support” information from you after peer review. This information will be used to check that the proposed research has not already been Federally-funded. Information on active and pending grants should be provided – details should include a project number, funding source (agency, foundation, institute, etc.), a brief statement of the overall objectives of the project, the dates of the approved/proposed project (for NIH projects, provide dates of the approved/proposed competitive segment), the annual direct costs, the level of actual effort in person months for the current or proposal initial budget period, and a summary of any potential overlap with the active or pending projects and this application in terms of the science, budget, or your committed effort. 
Top 10 Laboratory Facility Safety Watch List   (PDF version)

  1. Shorts, sandals, tank tops, and clogs are not appropriate lab attire.
  2. Improper use of lab coats, gloves, and respirators.
  3. Improper disposal of lab waste—pipettes, broken glass, biohazards, chemicals, dry ice, radiation.
  4. Fire hazards—covered lab doors, extension cords, worn out wiring, rotted tubing, poor housekeeping, personal work area clutter, too much storage at ceiling level.
  5. Use/consumption of food and drinks and chewing gum, and applying lip gloss or hand lotion in lab spaces.
  6. Improper transportation of lab research animals— far too many people carry animals in their cages, uncovered, through the Kentucky Clinic.
  7. Use of MP3 players and other electronic distractions—interferes with the ability to hear alarms, chemical or experimental mistakes.
  8. Improper use of biosafety/tissue culture rooms and hoods.
  9. Lab doors continue to be left open—it is not permitted.  It affects the negative air flow into the lab, runs the risk of biohazards or radiation backwashing into corridors, or contamination to tissue culture.  Closed doors help contain spills or potentially dangerous situations.  If a lab is unoccupied, the door needs to be locked.
  10. Improper disposal of broken or outdated equipment.  Do not defrost freezers in corridors, especially if they have contained biohazards or radiation.  They must be cleared first, taken to the dock to defrost by MCPPD and then brought back when defrosted.

 

For further assistance related to general University lab safety, refer to this link:  http://ehs.uky.edu/ehs/ohs/labsafe.html.

Do you know when you can use the work of others? When Fair Use permits you to use a work, and when you must get permission.

See this COPYRIGHT BASICS document developed by University of Kentucky legal counsel (PDF)
Fly America Act

Fly America Act: a federal regulation that requires the use of U.S. carriers for travel that will be reimbursed by federal grants and contracts.   http://www.uky.edu/EVPFA/Controller/files/BPM/E-5-1.pdf -- section VI. 3. a. (PDF)

  • Airtran Airways (FL)
  • Alaska Airlines (AS)
  • America West Airlines (HP)
  • American Airlines (AA)
  • American Trans Air (TZ)
  • Continental Airlines (CO)
  • Delta Airlines (DL)
  • Frontier Airlines (F9)
  • Hawaiian Airlines (HA)
  • Midwest Express (YX)
  • Northwest Airlines (NW)
  • Southwest Airlines (WN)
  • Spirit Airlines (NK)
  • United Airlines (UA)
  • US Airways (US)
Hiring Enhancement Program - The Dos, Don'ts and Whys of Interview Questions. (PDF)

Even the most experienced interviewer can find themselves asking potentially inappropriate questions in an interview. Click on the above PDF for more information regarding information for the interview and hiring process. 
C
ourtesy of the Hiring Enhancement Program at UK.  UK HR website.
NIH New Investigator vs. Early Stage Investigator - which one are you?
In general, a Program Director/Principal Investigator (PD/PI) is considered a New Investigator if he/she has not previously competed successfully as PD/PI for a substantial NIH independent research award.  NIH provides a useful link, http://grants.nih.gov/grants/new_investigators/, with specific details on eligibility for New Investigator status. 

Note regarding grants with Multiple PD/PIs: In the case of a grant application that involves more than one PI, all PD/PIs must meet the definition of New Investigator in order for the application to have the New Investigator designation.

An Early Stage investigator is a New Investigator who has completed his or her terminal research degree or medical residency—whichever date is later—within the past 10 years and has not yet been awarded a substantial, competing NIH research grant. The dates that start the period of classification as an Early Stage investigator are entered in the investigators eRA Commons Profile (https://commons.era.nih.gov/commons/). 

There are several programs and initiatives for scientists just beginning their independent careers.  Refer to the link provided above for more information on these programs and initiatives. 

Please note the importance of keeping your NIH Commons profile current to ensure any proposal submission accurately reflects your new investigator or early investigator status. 
Overtime.

Overtime pay is earned for hours worked in excess of 40 (for hourly employees) in the regular work week and compensated at a wage rate of one and one-half times the hourly wage rate.
Departments may have to process journal vouchers after the payroll posts to make sure the overtime costs are assigned to the project where the overtime hours were worked.
Overtime is only allowed on federal grants (or federal flow through) if preapproved through OSPA. A Prior Approval Request for Action/Revision form must be completed (http://www.uky.edu/eForms/forms/action.pdf), with the appropriate approvals provided. Your CGO can provide assistance with this process and offer advice on the justification.
Non-federally funded projects do not require a specific budget for overtime, but if a sponsor does not allow it, the department will be responsible for those costs.
The Office of Environmental Health and Safety (EH&S) provides help with Research Waste Disposal

EH&S has a flow chart available to assist with determining how to dispose of laboratory research waste here.
NIH Nonhuman Primate Enrichment and Social Housing Resources

The Office of Extramural Research has recommendations for use by the wider grantee community in enhancing the care and well-being of chimpanzees and other nonhuman primates. Resources to enable a better understanding of various aspects of social housing and positive reinforcement training for these animals are now available including:
·         a prerecorded online seminar with slides and transcripts by NIH OLAW and United States Department of Agriculture staff (see OLAW Special Seminars);
·         new OLAW Frequently Asked Questions (FAQs) – FAQ F14 and FAQ F15;
·         a new Web site focused on Nonhuman Primate Enrichment and Social Housing.
Funding from the American Recovery and Reinvestment Act (ARRA) of 2009 - Stimulus Funds.  Important reminders for University faculty and staff.

On July 29, 2010, a meeting was sponsored by the Office of Sponsored Projects Administration (OSPA) to provide important guidance and reminders related to funding received via ARRA.  A copy of the handout can be found here.
How do you hire a Post Doc or Grad Student on my NIH R01 grant?

It’s important to discuss your plans with your Dept. Administrator and/or the HR contact in your department about what sort of compensation and work/service responsibilities this individual will undertake.  The offer letter needs to be accurate (a template offer letter is available on the COM website here).  When you intend to use research award funds (R01, R21, etc), it’s important to understand that NIH has clear guidelines that the individual must be compensated for services provided – and must receive a salary/wage rather than a stipend per the NIH definition.  The NIH policy states, “Stipends are not allowable under research grants even when they appear to benefit the research project.”  (for more NIH policy information, click here)  To follow UK policy (for more UK policy information, click here), this means a Graduate Student would have to be hired as a Research Assistant and a Post Doc as a Scholar (not a Fellow).  There are significant financial implications if the appointment is not established correctly.  Please consult your CGO if you have questions.
Responsible Authorship Quick Guide

Did you know the DHHS provides a quick guide to help detect common mistakes when preparing manuscripts for submission?  This source provides examples with a brief introductory scenario followed by a sample paper excerpt.  (Click here for more information

Supreme Court Opinion on research documentation...did you know?

"A ruling...by the United States Supreme Court (Melendez-Diaz v. Massachusetts, 129 S.Ct. 2527(2009) requires forensic lab analysts providing evidence in criminal matters to be available to appear in court to be cross-examined about their test results. A written report of results, without the lab technician’s availability to provide testimonial support, is no longer sufficient evidence of the results. The opinion, written by Justice Antonin Scalia, allowing criminal defendants to confront forensic lab analysts at trial pursuant to the confrontation clause in the sixth amendment to the U.S. Constitution, should remind research scientists that the techniques and operational decision-making of everyone in their laboratory, not just their test results and conclusions, can be subject to scrutiny and lab analysts may need to be at-the-ready to defend them.
If required by peer reviewers, journal editors, and publishers, would you or your technicians be able to communicate and document the quality of the work performed?
Should peer reviewers of grants and publications, journal editors and publishers, and the public at large continue to assume the reliability of research results without evidence of the quality of the techniques and procedures used?
If you or a member of your lab was accused of research misconduct, would you have sufficient documentation to support your claimed results?"
John Galland, Ph.D.
Director, Division of Education & Integrity, Office of Research Integrity, US DHHS
(Click here for more information)

EH&S DOD safety plan and cert of environ compliance related to Department of Defense Grants

The Occupational Health and Safety department issues the Certificate of Environmental Compliance for the DOD Just in Time process. For OH&S to do this in a timely manner please contact Jan Hamon within two (2) weeks before deadline. (more information)
Are you shipping dangerous goods?  

Anyone who ships dangerous materials must comply with federal and, in some cases, international, regulations. (more information)
NIH Office of Extramural Research conversation:  Postdocs Thinking About Independence

The Office of Extramural Research (OER) presents conversations with NIH staff members. Designed for investigators, fellows, students, research administrators, and others, we provide insights on grant topics from those who live and breathe the information.  Information on the June 4 topic is available here.
Required information on statements and press releases related to federal funding.

Acknowledgment of Federal Funding (Section 506) "When issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money, all grantees receiving Federal funds included in this Act, including but not limited to State and local governments and recipients of Federal research grants, shall clearly state: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) percentage and dollar amount of the total costs of the project or program that will be financed by non-governmental sources."  Additional information available here.
NIH Public Access Policy and Publications

NIH Grantees are reminded to demonstrate compliance with the Public Access Policy when submitting an application, proposal, or progress report to the NIH. Grantees should include the PubMed Central (PMC) reference number (e.g., PMC234567) for each paper that was authored or co-authored by the applicant or arose from their NIH award, and that falls under the Policy.  http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-119.html
Data Ownership.  Who's data is it?

·UK owns data resulting from scholarly activities in certain university units whose specific mission includes the production of works for instructional, public service administrative use (see UK ORI website for overview of “Data Retention & Ownership” here) . 
UK Administrative regulations AR 7:6 defines traditional products of scholarly activity.  The full university administrative regulation regarding intellectual property ownership and disposition is available here.

Where can I find information about Research & Human Subjects?


Any activity that meets the federal definition of both "Research" and "Human Subjects" or the Food and Drug Administration (FDA) definition of "Clinical Investigation" requires review and approval by the University of Kentucky (UK) IRB. Additional information is available on the ORI website: http://www.research.uky.edu/ori/index.htm Any questions or concerns should be addressed to the ORI staff.

Effort reporting - why is it required?

Federal regulations issued by the Office of Management & Budget (OMB) require employees performing work on sponsored agreements to certify university work efforts as a distribution of 100% of total compensated time worked. UK has chosen the After-the-Fact effort reporting method described in Section J.8 of OMB Circular A-21 to meet the requirement for certifying effort on sponsored project agreements.  http://www.whitehouse.gov/omb/rewrite/circulars/a021/a021.html 

Federal regulations for "after the fact activity records" requires that confirmation of the effort on Effort Reports be signed by the employee, principal investigator, or responsible official(s) using suitable means of verification that the work was performed. Having first-hand knowledge of the work performed and the ability to make a reasonable estimate of the effort expended on each sponsored project is key to fulfilling this requirement.

Would your lab documentation and data withstand an audit? 

NIH Office of Research Integrity has educational material available on the important aspects of laboratory management.  Additional information available here.
Biological Safety Registration and Usage of Infectious Agents and Toxins (additional info)
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