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How to Design a Memorandum of Understanding
Provides directions on designing a memorandum of understanding (MOU) which is a written agreement (not a contract) between two or more parties meant to support the collaborative partnership. An MOU offers a detailed and comprehensive understanding of the collaborative partners’ roles and expectations to assure fairness and mutually satisfactory outcomes. |
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How to Pretest a Survey Questionnaire
Provides directions on how to conduct pretesting of survey questionnaires for research, outlines the advantages and disadvantages of different pretesting methods, and describes the pretesting process used by the Los Angeles County Department of Health Services Care Connections Program. |
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How to Translate Research Documents for Non-English Speaking Participants
Presents basic information on how to translate research documents into languages other than English. It also highlights different translation approaches, translation methods, and important considerations. |
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How to Design a Partnered Consent Form
Provides a guide to develop a community partnered research consent form which reflects the views of community members, while still meeting requirements for IRB approval. |
How to Include Community Partners in Data Collection
Describes the process used by the Healthy Community Neighborhood Initiative research project to incorporate staff from community partners in data collection to increase trust and success of the project. |
An introduction for community organizations with minimal research experience
Aziza Lucas-Wright, M.Ed.
Community Engagement Specialist/ Project Associate IV, The RAND Corporation;
Community Instructor, Charles R. Drew University of Medicine and Science;
Program Manager/Research Assistant, Lundquist/Harbor-UCLA
This presentation assesses an organization’s readiness for working in research by asking questions to a potential research partner.
Aziza Lucas-Wright, M.Ed.
Community Engagement Specialist/ Project Associate IV, The RAND Corporation;
Community Instructor, Charles R. Drew University of Medicine and Science;
Program Manager/Research Assistant, Lundquist/Harbor-UCLA
This presentation highlights the importance of clinical research and the protections offered to research participants.
Keith C. Norris, M.D. – University of California, Los Angeles
Loretta Jones, Th.D., M.A. – Founder and CEO of Healthy African American Families II
Aziza Lucas-Wright, M Ed. – Healthy African American Families II
This presentation provides an overview of the ethical standards for research.
Loretta Jones, Th.D., M.A. - Founder and CEO of Healthy African American Families II
Aziza Lucas-Wright, M.Ed. – Healthy African American Families II
Episocopal Health Foundation CCBR Community Training Program: Boot Camp
Summary: Training program for community members who are being introduced to research. Their training includes a pre & post test, a presentation with talking points as well as handouts. Training teaches the following skills: research design, interviewing and data gathering, data analysis, and Implementation & dissemination of plans and interventions.
(NOTES, 1. Presentation is 155 slides in length. 2. If used, please cite CES4Health.info as source, along with resources listed in presentation.)
St. Luke Episcopal Health Charities
Citation: King K, Pardo YJ, Norris KC, Diaz-Romero M, Morris DA, Vassar SD, Brown AF. A Community-Academic Partnered Grant writing Series to Build Infrastructure for Partnered Research. Clin Trans Sci 2015; Vol 8: 573-578 http://onlinelibrary.wiley.com/doi/10.1111/cts.12327/full
Click here to see the Grant Writing poster.
Detailed information about training session content is available upon request. Please contact cerp@mednet.ucla.edu.
Created by: Maria Diaz-Romero (CDU), Matt Kirk (Cedars-Sinai), Brittney Lee (UCLA CERP), Arturo Martinez (UCLA CERP), Homero del Pino (CDU), Allison Weber (Lundquist/Harbor-UCLA). With contributions by: Rosie Cardenas (UCLA), Andrea Jones (HAAF), Elizabeth Lizaola (UCLA), Norma Mtume (Community Partner), Cristina Punzalen (UCLA).
There are four steps in creating a partnered research project budget: pre-proposal, pre-award, post-award and closeout. In the below sections, you will find helpful processes, terms and tips to help you navigate the process.
Project Timeline: 12 weeks – this timeline goes through the last ten weeks prior to a proposal submission
Budget Timeline: in development
NCURA YouTube Channel: short videos describing all aspects of applying for and managing research funds.
This step describes the search for opportunities, organizational eligibility, pursuing opportunities, review and selection of proposals.
Once a funding opportunity has been screened for both principal investigator (PI) and organizational eligibility, the development of a complete proposal will include adhering to sponsor content and format specifications, complying with sponsor requirements, obtaining necessary organizational approvals, and transmitting the compiled proposal for review and submission.
Most funding agencies have their own proposal forms or formats and provide specific instruction on content, page limitations, and numbers of copies of proposals that are to be submitted. In most instances, proposals contain most or all of the following elements:
http://ora.research.ucla.edu/OCGA/Pages/Proposal-Preparation/proposal-preparation-home.aspx
Applications submitted to the Sponsoring Agencies or Foundations will normally be evaluated by a peer review process to ensure a fair, competent and objective assessment of their scientific and technical merit. The peer review of grant applications frequently involves an assessment conducted by panels of experts established according to scientific disciplines or medical specialty areas. Applications for Federal funding (including sub-award applications submitted as part of a prime applicant’s proposal) can take from nine months to one year to be completely evaluated and considered for award. After so much time has passed since submission, the Sponsor may reach out to the proposer and request updated information, referred to as the "Just-in-time" (JIT) process (see here for additional detail: http://grants.nih.gov/grants/glossary.htm#J). Applications submitted from Community-Based Organizations directly to a UCLA CTSI funding opportunity generally have a somewhat more informal evaluation process and can be fully evaluated in a much shorter timeframe. During a Sponsor’s review process, it is common for revised proposal documents to be requested by the Sponsor (e.g. revised budget in response to limited funding availability or revised work plan in response to reviewers’ concerns).
Any cost incurred prior to the beginning date of the project period or the initial budget period of a competitive segment (under a multi-year award), in anticipation of the award and at the applicant's own risk, for otherwise allowable costs. If for any reason an award cannot be made after an application is preliminarily identified for funding, all pre-award costs become the responsibility of the organization that incurred the cost. A prime applicant is NOT responsible to reimburse pre-award costs incurred by their sub-award/consortium partners in anticipation of an award to the prime. Costs can only be reimbursed once there is a fully executed sub-award/consortium agreement in place between the prime and sub-award organizations. (The short answer is that any costs for the project before you have a contract or award document are at your own risk.)
http://grants.nih.gov/grants/glossary.htm#P
The official, legally binding document provided to the prime applicant, signed (or the electronic equivalent of signature) by an authorized official of the sponsor that:
https://era.nih.gov/grantees/view-notice-of-award.htm
Establishment of a formalized agreement whereby a research project is carried out by the prime grantee and one or more other organizations that are separate legal entities. Under the agreement, the (prime) grantee must perform a substantive role in the conduct of the planned research and not merely serve as a conduit of funds to another party or parties. These agreements typically involve a specific level of effort from the consortium (sometimes called a sub-award or subcontractor) organization's PD/PI and a categorical breakdown of costs, such as personnel, supplies, and other allowable expenses, including F&A costs (see section Key Terms & FAQs). Until this agreement is in place, consortium participants (sub-awardees or subcontractors) are responsible for all pre-award spending, and will not be reimbursed unless/until a consortium agreement is executed by both organizations.
The total time for which sponsor support of a project has been programmatically approved as shown in the NOA; however it does not constitute a commitment by the sponsor to fund the entire period. For example, the project period may be for five years, but the funder may be unhappy with the grantee’s progress and so decides to stop funding the project after year two. The total project period comprises the initial budget period, any subsequent budget periods resulting from a renewal award(s), and extensions. Federal awards are often made in 2, 3 or 5 year project periods. The single award year is considered the Budget Period (below) and all other years may be called “out” years. All together, these years constitute the Project Period.
http://grants.nih.gov/grants/glossary.htm#P
The intervals of time (usually 12 months each) into which a project period is divided for budgetary and funding purposes.
http://grants.nih.gov/grants/glossary.htm#B
Periodic, usually annual, report submitted by the grantee and used by NIH or other sponsor to assess progress and, except for the final progress report of a project period, to determine whether to provide funding for the budget period subsequent to that covered by the report. This report may also be called the non-competing continuation progress report. Sometimes referred to as “non-competing continuation” to indicate that evaluation for next funding increment is only for programmatic progress; it is not scored and evaluated against other proposals (c.f. “renewal”). Generally, all reports generally go to the sponsor from the prime grantee. If you are a subcontract on a grant then your progress report information should be coordinated with the prime grantee. That Prime grantee then incorporates your updates or data or report into their report for submission to the sponsor.
http://grants.nih.gov/grants/glossary.htm#P
A financial report normally due 30-90 days after the end of each budget period showing the status of awarded funds for that period. All reports generally go to the sponsor from the prime grantee. If you are a subcontract on a grant then your progress report information should be coordinated with the prime grantee. That prime grantee then incorporates your updates or data or report into their report for submission to the sponsor.
http://grants.nih.gov/grants/glossary.htm#F
The process by which a sponsor determines that all applicable administrative actions and all required work (often referred to as ‘deliverables’) under an award have been completed by the grantee. Typically, this includes submission of a Final Progress Report and Final Financial report. This may also require disclosure of any inventions (sometimes called “Final Invention Statement”) which were conceived or first actually reduced to practice during the course of work under the grant (especially for funding initiated by the federal government).
http://grants.nih.gov/grants/glossary.htm#C
A report to the sponsor that communicates the work accomplished with the funds provided. It should include:
If a renewal has been submitted, the progress report contained in that application may sometimes serve in lieu of a separate Final Progress Report and will likely be used (in part) to evaluate request for continued funding.
http://era.nih.gov/erahelp/commons/Commons/status/closeout/final_progress_rpt.htm
A financial report normally due 30-90 days after the end of the project period showing the status of awarded funds for the entire award. If an organization is participating as a sub-awardee, the Final Financial report will take the form of a Final Invoice, stating expenses incurred for the final billing period, as well as for the entire budget period that is ending. Final invoices are normally due 30-60 days after the end of the project period to allow time for the prime awardee to review and pay Final Invoices and then file their prime Final Financial report to the Sponsor.
http://grants.nih.gov/grants/glossary.htm#F
Report disclosing any inventions which were conceived or first actually reduced to practice during the course of work under the grant.
http://grants.nih.gov/grants/glossary.htm#F
A Financial Conflict of Interest exists when the Institution, through its designated official(s), reasonably determines that an Investigator’s Significant Financial Interest is related to a NIH-funded research project and could directly and significantly affect the design, conduct or reporting of the NIH-funded research.
Source: http://grants.nih.gov/grants/policy/coi/coi_faqs.htm#3180
Group of collaborative investigators/institutions; arrangement can be formalized with specified terms and conditions.
Source: https://www.research.uci.edu/compliance/human-research-protections/docs/glossary-of-terms.html (provided by UC Irvine)
An individual who provides professional advice or services for a fee, but typically not as an employee of the engaging party. In unusual situations, an individual may be both a consultant and an employee of the same party, receiving compensation for some services as a consultant and for other work as a salaried employee. To prevent apparent or actual conflicts of interest, grantees and consultants must establish written guidelines indicating the conditions of payment of consulting fees. Consultants may also include firms that provide paid professional advice or services.
Source: http://www.grants.nih.gov/grants/policy/senior_key_personnel_faqs.htm?print=yes#1661
An award instrument used to acquire from a non-federal party, by purchase, lease, or barter, property or services for the direct benefit or use of the Federal government. The same term may be used to describe a vendor relationship between a recipient and another party under a grant (to acquire routine goods and services); however, the recipient may use subaward to describe the contract under a grant relationship.
Source: http://grants.nih.gov/grants/glossary.htm#C
Costs that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy.
Source: https://grants.nih.gov/grants/developing_budget.htm#difference
A unique, nine-digit identifying number that an organization is provided free of charge by the commercial company Dun & Bradstreet, and is required by the federal government to track how federal grant money is distributed. (See SAM)
Source: http://fedgov.dnb.com/webform/pages/dunsnumber.jsp
A nine-digit number that the IRS assigns in the following format: 12-3456789. The IRS uses the number to identify taxpayers who are required to file various business tax returns. This is a type of taxpayer identification number.
Source: http://www.irs.gov/Businesses/Small-Businesses-&-Self-Employed/Employer-ID-Numbers-EINs
Costs that are incurred by a grantee for common or joint objectives and therefore, cannot be identified readily and specifically with a particular sponsored project, program, instructional activity or any other institutional activity. These costs also are known as "indirect costs." (e.g., may include Human Resources & Accounting, & general administrative costs) Each grant opportunity has its own budget restrictions. When considering budget items, it is advised to include some of the common expenses such as, rent, supplies, utilities, phones, meeting costs, transportation, and other additional costs. Frequent contact with your partner institution is recommended to determine if the costs you propose can be covered by the grant.
Source: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.3_direct_costs_and_facilities_and_administrative_costs.htm
Allowable as part of overall compensation to employees in proportion to the amount of time or effort employees devote to the grant-supported project, provided such costs are incurred under formally established and consistently applied policies of the organization. For more information, contact your partnering institution.
Source: http://grants.nih.gov/grants/policy/nihgps_2013/nihgps_ch7.htm#Fringe_Benefits
Contributions or assistance in a form other than money. Equipment, materials, or services of recognized value that are offered in lieu of cash (and salaries/fringe/indirect).
Source: https://grants.nih.gov/grants/policy/nihgps/html5/section_1/1.2_definition_of_terms.htm
A consolidated resource of policy requirements that serve as the terms and conditions of NIH grant awards. It also provides general information about NIH-its organization, staff, and grants process. Current and historical versions of the NIHGPS can be found on the OER Grants Policy and Guidance webpage at http://grants.nih.gov/grants/policy/policy.htm#gps
Source: http://grants.nih.gov/grants/glossary.htm#N
The metric for expressing the effort (amount of time) that the Principal Investigator(s), faculty and other senior personnel devote to a specific project. The effort is based on the type of appointment of the individual with the organization; e.g., calendar year (CY), academic year (AY), and/or summer term (SM); and the organization's definition of such. For instance, some institutions define the academic year as a 9-month appointment while others define it as a 10-month appointment. See the NIH person-month calculator: http://grants.nih.gov/grants/policy/person_months_conversion_chart.xls
The individual responsible for the conduct of research or other activity described in a proposal for an award.
Source: https://grants.nih.gov/grants/multi_pi/faq.htm#2952
The System for Award Management (SAM) is a combination of the federal procurement systems and the Catalog of Federal Domestic Assistance into one new system. To be eligible to receive grants or contracts from the federal government, your organization must be registered in SAM. This consolidation is being done in phases. The first phase of SAM includes the functionality from the following systems:
Sources: https://www.transportation.gov/osdbu/system-award-management-sam (Department of Transportation)
https://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/registration/org-representative-registration/sam-org-registration.htm (NIH)
The personnel considered to be of primary importance to the successful conduct of a research project. The term usually applies to the senior members of the project staff. The Senior/Key Personnel section should include any senior or key personnel from the applicant organization who are dedicating effort to this project. “Other Significant Contributors” who dedicate negligible effort should not be included. Some common significant contributors include: 1) CEOs of companies who provide overall leadership, but no direct contribution to the research; and 2) mentors for K awardees, who provide advice and guidance to the candidate but do not work on the project. Likewise, any consultants or collaborators who are not employed by the applicant organization should not be included in section A, but rather should be included in section F.3 of the budget (for consultants) or in section A of the consortium/subaward budget page (for collaborators). If primary leadership of a CBO is added as senior/key personnel, additional requirements may need to be fulfilled.
Source: https://www.research.ucsb.edu/toolbox/definitions-and-acronyms
An identification number used by the Internal Revenue Service (IRS) in the administration of tax laws. It is issued either by the Social Security Administration (SSA) or by the IRS. A Social Security number (SSN) is issued by the SSA whereas all other TINs are issued by the IRS. Both Social Security Numbers and Employer Identification Numbers are forms of TINs
Source: https://www.irs.gov/individuals/international-taxpayers/taxpayer-identification-numbers-tin
The process for obtaining an ERA commons user names varies depending on the academic institution with which your organization is collaborating. For guidance on the process, contact the academic institution with whom you are collaborating.
Before you can bid on government proposals, you need to obtain a Dun & Bradstreet, or D-U-N-S Number, a unique nine-digit identification number for each physical location of your business. DUNS Number assignment is free for all businesses required to register with the federal government for contracts or grants. Therefore, technically you need one. In the past, a proposal could go through with putting nine zeroes in the DUNS field – but that may change.
When registering for your DUNS Number, you will need the following on hand:
DUNS numbers can be obtained from: http://fedgov.dnb.com/webform/pages/CCRSearch.jsp
obtaining a new DUNS number takes about a day.
Read the Eligibility Criteria in the Funding Announcement.
It may be possible for your organization to apply for a proposal on its own; however, this depends on the eligibility requirements of the Funding Announcement. Be sure to read the Funding Announcement, and then contact your partner institution for additional questions.
Generally, organizations without an established agreement are entitled to claim a certain percentage for F&A, this percentage might vary depending on the academic institution with which you partner. The process for obtaining an F&A Rate is arduous. Per NIH:
"F&A costs are determined by applying your organization’s negotiated F&A rate to your direct cost base. Most educational, hospital, or non-profit organizations have negotiated their rates with other Federal (cognizant) agencies such as the Department of Health and Human Services or the Office of Naval Research. If you are a for-profit organization, the F&A costs are negotiated by the Division of Cost Allocation (DCA), Division of Financial Advisory Services (DFAS) in the Office of Acquisition Management and Policy, NIH."
The total costs requested in your budget will include allowable direct costs (related to the performance of the grant) plus allowable F&A costs. If awarded, each budget period of the Notice of Award will reflect direct costs, applicable F&A, and in the case of SBIR or STTR awards, a "profit" or fee. Direct costs can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy. While indirect costs are costs incurred by a grantee for common or joint objectives and that, therefore, cannot be identified specifically with a particular project or program (e.g., may include Human Resources & Accounting, & general administrative costs)
The Office of Human Research Protection, at the US Department of Health and Human Services oversees the issuing of FWAs. For more information on this, please view the information that the OHRP has on the subject: http://www.hhs.gov/ohrp/assurances/index.html.
It is very likely that in this instance, you will need a Single Audit (formerly known as an A-133 Audit), your partner institution will be in contact with you.
The budget is your best guess of the cost (e.g. staff, supplies) to implement a project. Please see Sample Budgets and Justifications in Section 4.
All listed costs in your budget need to be your best estimation. If you already have staff, determine the amount of effort, or percentage of their time will be devoted to the project and use their current salary. If you will be hiring new staff for the project, follow your own organization’s human resource policies.
For the most part, effort is based off a 40-hour workweek, or 2080 hours per year. If your staff will be working 10 hours a week on the project, then effort = 25% (10 hours per week working on project/40 hours worked per week). The person-months calculator may be of assistance when determining effort: http://grants.nih.gov/grants/policy/person_months_conversion_chart.xls
Person months assist in determining effort, which is based on the type of appointment of the individual with the organization; e.g., calendar year (CY), academic year (AY), and/or summer term (SM); and the organization's definition of such. For instance, some institutions define the academic year as a 9-month appointment while others define it as a 10-month appointment. To calculate person months, multiply the percentage of your effort associated with the project times the number of months of your appointment.
For example:
The person-months calculator may be of assistance when determining effort:
http://grants.nih.gov/grants/policy/person_months_conversion_chart.xls
Costs necessary to achieve your specific aims and scope of work. In general, all costs must be: 1) allowable under federal regulations; 2) specifically allocable to the research project (not providing general support to multiple projects); 3) reasonable (you would purchase the same or similar good or service if you were funding the project yourself); and 4) consistently applied (whatever methods you use to allocate expenses to the project are used across all projects, regardless of the funding source for each project). This link from the National Institutes of Health provides general guidance on the allowability of some of the most commonly requested budget items:
http://grants.nih.gov/grants/policy/nihgps_2012/nihgps_ch7.htm#selected_cost_items
Fringe benefits are part of a the overall compensation to employees in proportion to the amount of time or effort employees devote to the grant-supported project, provided such costs are incurred under formally established and consistently applied policies of the organization. So, for a subcontractor, that will mean calculating the cost of Paid Medical Leave, Paid Vacation, Health (Dental, Vision), life, Disability Insurance, Retirement paid by the company as well as the employer’s portion of Social Security and Medicare Tax.
One may do this by adding the work hours of a hear (typically 2,080 hours per year), add together the sum of these costs of benefits. Divide that sum by the total wages earned while working on the job. That percentage is the Fringe Benefit Rate for that employee. The NIH does not have a pre-set limit on fringe benefits. More information on what is included as fringe benefits can be found in the Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2013/nihgps_ch7.htm#Fringe_Benefits. If you have questions about what rate to use, consult the partnering institution’s sponsored programs office.
The Scope of Work is the specific description within the contract for services that includes those actions and deliverables for which the party will be contractually obligated to produce.
These are all elements needed to fulfill the requirement for recipients of Federal grant awardees (grants) and contractors (procurements) to be registered in the System for Award Management (SAM). For a quick guide to all required elements and timelines for registration, as well as additional resources, click here:
https://www.sam.gov/SAM/transcript/SCR_QSG.pdf
***This is a growing resource, if you feel other questions should be added, please contact Stefanie Vassar (svassar@mednet.ucla.edu), Administrative Specialist of the Community Engagement & Research Program***