Introduction to Sponsored Programs

Preliminary Distinctions

Sponsored programs (SPs) are projects or sets of projects that aim to advance knowledge and/or serve a specified population.  In the health care setting, research studies seek to improve the future of health care for all, and service programs provide needed services.  Their populations are research participants and patients.  All SPs are funded by sponsors whose requirements must be met as a condition of funding – and, often, because it's the law.

Research/service: Most of BMC's SPs are research programs but, in recent years, other programs' funding has risen,* prompting use of the more encompassing "sponsored program." BMC's service programs are typically clinical initiatives sponsored by governmental agencies. Occasionally BMC receives also receives funds for administrative initiatives. All SPs must follow sponsor rules and applicable laws and regulations.

External/internal: An SP is usually funded by an external sponsor, such as a federal or other governmental agency, a non-profit foundation, or a biotech company, but the term also applies to projects that are internally sponsored, i.e., are supported by BMC funds alone.  Both types require diligence; both types pose risks. 

Research: As defined by the "Common Rule" (45 CFR 46), the federal regulation governing protection of human research participants, research is "a systemic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge."

An individual research SP may or may not directly improve health outcomes of BMC patients, but health care research is responsible for the astonishing advances in medicine that we provide every day.

Service programs: Often funded by the Commonwealth of Massachusetts or the City of Boston, historical champions of public health, these SPs provide standard care but in extraordinary ways, reaching out, e.g., to our patients who don't have (sufficient) insurance or whose healthcare needs extend beyond present healthcare norms. 

*In fiscal year 2023, SP funding not devoted to a research plan amounted to 32% of BMC's SP portfolio.

Sponsor Types

See also Finding Funding for more detail on funding types.

Federal: Many federal agencies serve as sponsors, across a number of institution types.  Healthcare research is a common focus of SPs; the NIH is the largest healthcare research sponsor.  As its name implies, the NIH is a grouping of several individual national institutes devoted to specific areas of health care.  Other federal sponsors also fund SPs.

Other governmental:  All public non-federal funding fits in this category.  BMC receives significant funding from both the Commonwealth of Massachusetts and the City of Boston for research and service grants.

Foundation: Non-profit foundations, e.g., the American Heart Association, frequently provide grants to healthcare institutions. They stipulate grant proposal and SP conduct requirements.

Industry: In most cases, an "industry" SP is a research study funded by a biotech company that has its own protocol and is conducting the study at multiple sites, sometimes hundreds of sites.  In rarer cases, a BMC investigator may develop a protocol and receive funding from a biotech company.

BMC (aka "Internal"): In general, we can view BMC as a sponsor of all its SPs, since BMC resources support SPs.  However, when a project has no external funding and yet BMC approves its conduct, BMC is funding sponsor.

Funding Mechanisms

Introduction

By funding “mechanism” or “instrument,” we mean simply a way by which a sponsor funds the work that they sponsor. To some extent, though not entirely, those ways align with different sponsor types.

What they have in common is an agreement* between sponsor and BMC that identifies required deliverables and related terms and conditions governing the SP. An award may be in the form of a letter, sent by an authorized agent of the sponsor, or it can be a detailed research agreement. Grants are the paradigmatic award; cooperative agreements are also awards. A contract* must always have a fully executed agreement.

Below are listed the three most common funding mechanisms used by sponsors to reimburse institutions for sponsored program (SP) activities.

*The term "agreement" is synonymous with "contract." For example, a clinical trial agreement (CTA) is a contract or legally binding agreement. Sometimes, however, the term "agreement" is used without implying a legal obligation.

Grants

Government agencies, non-profit organizations (foundations) and, occasionally, private industry* award grants to institutions. Grant funders stipulate terms and conditions to which BMC agrees. Typically, a grant requires that the applicant develop a unique proposal, eg, a scientific research plan that is judged for scientific merit against other applicants. Usually, the funder publishes a request for applications (RFA), funding opportunity announcement (FOA), or request for proposals (RFP) that provides stipulations that narrow the topic, specify a date span, and otherwise limit the scope of the grant opportunity.

Government grants, among others, aim to provide improvements for the public good. Most BMC grants fund research, but a substantial portion go to service programs.  Occasionally, a grant may be issued for an administrative or capital improvement program.

The NIH is BMC’s largest funder.  It has many types of grant programs, for investigators at every level.

Contracts

SP contracts can be distinguished by the agreed type of remuneration and by type of sponsor. SP contracts are nearly always procurement agreements, although the term "procurement" is not commonly used to describe industry contracts.

Remuneration Arrangement

Fixed-Price contracts commits BMC to a defined scope of work for an agreed amount, paid in increments or "milestones." They place BMC at full responsibility for all costs and resulting funding excess or loss. If project completion costs less than the contract price, BMC retains the funds. However, accurate budgeting is critical. Auditors seek to identify intentional misrepresentation of costs.  The deliverables in a fixed-price contract may be tangible, such as a prototype or a component for implementation in a product or system.

Cost-Reimbursable contracts allow the sponsor to pay for all allowable costs incurred by BMC in the process of project performance, in the amount prescribed in the contract. If the project costs less to complete than the original amount budgeted, the sponsor is obligated to reimburse BMC only up to the allowable incurred costs of the project.  If the project costs more, the sponsor may choose to require a smaller portion of the work completed, or to provide additional funding for the remainder. The recipient is obligated to inform the sponsor in advance if the funding will not be sufficient. Deliverables in a cost-reimbursable contract are often theoretical or intangible, such as data and project reports.

Sponsor

Industry contracts are those that research sites negotiate with biotech companies, almost always a developer and manufacturer of drugs or devices. The most common type is a clinical trial agreement (CTA). The industry sponsor, not the principal investigator (PI), develops the CT protocol and contracts with multiple sites to conduct the study. The CTA is negotiated and the research site has more freedom to adjust the terms and conditions of the agreement with the sponsor. At BMC, CTAs are usually of the fixed-price variety, whereby milestone payments are made at pre-determined intervals. 

In some cases, a biotech company will coordinate with a BMC investigator on a protocol that the investigator develops.  Although the term "grant" is sometimes used in these cases, much depends upon the intellectual property rights negotiated in the contract.  By and large, the SP is categorized as an industry-negotiated contract.

Government contracts involve an exchange of funding for stipulated services, or “procurement” (wherein the sponsor is “procuring” goods and/or services at the primary direction and benefit of the sponsor). They can be fixed-price or cost-reimbursable.   

Cooperative Agreements

A third form of government funding, cooperative agreements differ from grants primarily by the degree of programmatic involvement of the funder.  Agency staff may contribute to the protocol, data collection and analysis, and/or training, among other activities.

Sponsored Program Roles

Several individuals work together to secure funding, initiate the sponsored program (SP), and see it through to completion. Below we introduce them by role and provide a brief description.  

Principal Investigator/Program Director 

The PI/PD is centrally involved throughout the stages of an SP.  They are responsible to provide intellectual and programmatic oversight, including finances.  BMC is the awardee of all BMC programs; the PI/PD, the primary agent tasked with SP management. 

Department Administrator

The DA assists the PI/PD in securing funding and managing the SP and is able to conduct much of the required administrative tasks as the PI/PD's designee. The DA, however, may not be delegated oversight responsibilities.  One or more DAs may support SPs and their titles may vary.  In some cases, the PI/PD has no DA and must conduct all administrative tasks.  

The staff of Foundation Relations and Government Grants (FRGG) acts as specialized DAs, providing proposal submission services on behalf of a department or division, when requested to do so, as time allows.

Department Chair or Division Chief

The chair or chief has an oversight role for all SPs proposals issuing from and awarded to their department or division. They assess alignment of SP objectives and department or division goals, including impact on their patients and medical practice and the availability of resources need for SP completion.  

Co-investigators and other Key Personnel

Key personnel are members of the PI/PD's SP team. Typically, their specific scientific expertise is crucial to the project and cannot be readily replaced. 

Study Team

In addition to key personnel, the PI/PDs study team may include personnel who manage crucial SP tasks but whose expertise is not considered to be potentially irreplaceable. These include but are not limited to lab and data technicians and project coordinators.  Some departments have study staff who conduct specialized services, such as budgeting or regulatory support across departmental SP, while clinical research coordinators (CRCs) enroll participants and manage and document their study visits. Some CRCs are assigned to conduct all of the above. Depending upon their role, a CRC or other team member may be identified as key personnel.

Central Administrators

Central administrators are Research Operations (RO) staff, assigned to one of three RO teams: Sponsored Programs Administration (SPA), Sponsored Programs Finance (SPF), and the Clinical Trial Office (CTO). They support all PI/PDs and DAs in SP requirements and activities, from proposal submission or contract negotiation through SP closure. They represent BMC and act as BMC's signatory officials.  

SPA and SPF together oversee all SPs that are awarded to BMC. SPA is responsible to review and submit proposals on behalf of BMC, conduct post-submission pre-award activities, and oversee post-award administrative requirements.  SPF oversees all central post-award finances; conducts and supports audits; and provides metrics and analytics that are crucial for indirect cost rate (IDC) negotiation.

The CTO oversees industry-sponsored clinical trials, from protocol review through study-closeout.  When awarded SPs include prospective clinical services, the CTO collaborates with SPA, SPF, and PI/PD/DAs on patient-related billing and finance requirements, as applicable.

All three RO teams provide metrics and analytics to support institutional strategic goals.

Institutional Partners

Administrative and infrastructure requirements of SPs involve collaborations with many different BMC departments, including but not limited to: Accounts Payable, Supply Chain Operations, Human Relations, Financial Information Services, Information Services, Pharmacy, Office of General Counsel, Corporate Compliance, Marketing and Communications, as well as medical departments that supply services, e.g., Radiology and Pathology.

Sponsor Officials and Staff

All externally sponsored programs require collaboration with sponsor personnel at multiple intervals from proposal submission or protocol review through closure.  Their officials act as guides to a wide range of funder requirements. In addition, industry sponsors assign clinical trial monitors to ensure the integrity of study data and to support participant safety.

Communicating with Sponsors

Because the recipient of every award –  or the institutional party to any research contract – is BMC, most sponsor communications are led by BMC's authorized officials. The principal investigator/program director (PI/PD) is the agent of BMC, responsible for scientific and technical oversight.  BMC assigns signatory authority over sponsored programs to Research Operations (RO).

Scientific Communications

The PI/PD and the awarding body's program officers do communicate with each other informally. Open dialogue between scientists is essential as the project evolves; new techniques and tools become available; and the course of scientific study progresses.

All Other Communications

Sponsors generally prefer to communicate with a single administrative point of contact. The PI/PD or their designated department administrator (DA) should work directly with the applicable RO team and avoid contacting sponsor staff directly for anything extra-scientific. The DA regularly communicates with Sponsored Programs Administration (SPA) for administrative matters related to award management and the Clinical Trial Office (CTO) for research contracts and all awards that include provision of one or more protocol-specified services. 

An awarding sponsor’s administrative staff, such as a Grants Management Specialist (GMS), may also communicate informally with SPA; analogously, an industry sponsor's agent and the CTO typically connect over clinical trial details.

All of these communications are essential for project management and administration. 

Formal Administrative Requests

If an administrative change is necessary (e.g., change in key personnel, a no-cost extension, and other modifications to the existing award agreement), BMC must submit a formal request to the sponsor. NIH grants policy specifies reporting and communications requirements. Requests should be initiated by the PI/PD, working in collaboration with their DA, and sent to SPA, who will review, sign, and then forward the request to the sponsor on behalf of BMC. RO also receives numerous sponsor requests for an “institutional signature.”

By following each step in the process, BMC demonstrates its commitment to meet sponsors' grants policy and to fulfill all sponsor requirements.

Communications with Subrecipients

Subrecipients are accountable to BMC, just as BMC is accountable to the sponsor. The PI/PD/DA should monitor subrecipient performance throughout the term of the project.

Acronyms and Abbreviations

Acronyms are challenging in everyday life, but sponsored programs and health care are rife with confusing sets of initials.  The links below may help.

NIH Abbreviations  

The vocabulary of the largest SP funder in the United States (and at BMC) dominates the language of central and department SP administrators. 

Commonly Used Abbreviations and Terms in Clinical Trials 

Original source is not attributed.

Research Dictionary 

The University of Florida Clinical Research Hub generously supplies 888 acronym or terms.

Medical Abbreviations and Terms 

This list is published by the National Library of Medicine and is not SP-specific.

Whom Should I Contact and When?

Your primary contact for central SP support depends upon several factors, especially the type of sponsor and/or the activity for which you need assistance.  

Contact the:

Clinical Trial Office when:

• an industry sponsor seeks to activate a clinical trial protocol at a BMC or BUMC site
• a BMC grant proposal involves clinical services as early as possible to ensure accurate and compliant budgeting

Clinical Research Network, when:

• your study team seeks specific services (e.g., regulatory, finance)
• you seek support on community and/or sponsor engagement and/or participant partnership

Sponsored Programs Administration for all proposal submission, subawards, and post-award needs exclusive of finances, including:

• all grant and contract proposals that are not industry projects
• all award-related tasks, exclusive of industry trials and financial management

Sponsored Programs Finance, for all:

• award finances, including equipment management and effort reporting
• finance-related compliance (audit, indirect costs, equipment management, effort)