- Any officer of the institution or any person holding a full-time faculty appointment at the level of Assistant Professor or above in any school of the institution may serve as a PI.
- An employee who does not have a faculty appointment may collaborate with an experienced investigator who agrees to oversee the study as the PI.
- Employees may apply to the Vice President for Research Affairs (VPRA) to be authorized to serve as a PI. After reviewing the application, the VPRA will recommend an action to the Research Oversight Committee, which will make the final decision.
A faculty member who is a candidate for a degree may not be the PI of record for IRB, IACUC, or grant applications that pertain to the degree.
The PI acts in the name of the institution in directing a research program. The PI will work under the oversight of the institutional officers and with the approval of the VPRA. Loma Linda University expects that the PI will:
- Be responsible for directing and identifying the resources necessary to complete the project;
- Have a working knowledge of applicable institutional and governmental policies and regulations;
- Be solely responsible for the ethical and professional conduct of the research and safety of the research personnel as defined in the University's administrative handbook.
Follow LLU Guidelines
Use the following guidelines to provide the best possible estimate of costs for each phase or year of the proposed project:
FOLLOW ALL REGULATIONS AND POLICIES. The proposal must conform to government regulations and all LLUH policies and procedures for sponsored projects.
*** Policy Coming Soon***
As described under Plan the Proposal, a subaward is an award issued under the prime award (the formal agreement with an external sponsor to obtain research funding) to procure specific services or program-related tasks from a third party, usually because the resources or skills are not readily available at the primary institution. The third party is known as the subrecipient (or "sub").
Proposals arriving at Financial Management that have subawards in the budget must have a Subrecipient Commitment form that illustrates the subrecipient's intent to support the award, signed by the sub's authorized organizational official. Indicate in the justification the reasons why a portion of the technical or programmatic effort must be contracted and provide an explanation of the method used to select the subaward (i.e. sole source, competitive bid, etc) as well as the reasons why the subrecipient was selected. For a sole source selection, describe why the selection has to be a sole source.
If an award is made, the institution will enter into a written agreement with each subrecipient. LLU will be responsible for monitoring subrecipients for compliance with all federal regulations and grant conditions. The institution may recover indirect costs on only the first $25,000 of the subrecipient's total budget expenditures (direct and indirect costs) to cover administrative expenses
Data Safety and Monitoring Plans (DSMPs) are meant to assure that each clinical investigator has a system for appropriate oversight and monitoring of the conduct of clinical investigation. This oversight ensures the safety of the participants and the validity and integrity of the data.
Requirements for a DSMP are commensurate with the risks involved with the study. The DSMP can be as simple as the investigator annually submitting his/her safety and adverse event (AE) information to the LLU Institutional Review Board (IRB), or as complex as having a Data Safety and Monitoring Board.
NIH requires a Data Safety and Monitoring Plan to be submitted with all proposals using human subjects. Funding is being withheld from investigators who have not submitted a DSMP. In most cases, a proposal submitted without a DSMP will not even be considered. A copy of the DSMP must also be submitted to Research Affairs for record-keeping. Contact the Research Administration for more details.
Data Management and Sharing Plan (DMSP) was implemented on January 25, 2023 and the NIH expects its researchers to maximize the appropriate scientific data. The NIH requires all applicants to generate scientific data to prepare a DMS Plan that describes how scientific data will be managed and shared. The NIH recognizes that making data accessible and reusable for other researchers may incur costs. For that reason, investigators may request funds toward data management and sharing. For additional guidance on how to budget, click here.
Most proposal submissions are electronic and can be submitted in various ways, e.g., as email attachments, through the Grants.gov portal or Proposal Central, or directly to a sponsor website.
For the majority of submissions to federal sponsors via the Grants.gov portal, Loma Linda University uses the LLeRA (Loma Linda electronic Research Administration) system-to-system (S2S) software.
Helpful Links and Tools for Electronic Submissions
- infoEd login
- LLeRA Proposal Development Instructions
- For more information, contact a Pre Award Specialist
Check the announcement to see if the sponsor limits the number of proposals that can be submitted from an institution. If it does, the proposal must be submitted to Research Affairs - Contact Pre Award.
Whether you’re a researcher, educator, or service provider you will find proposal development resources in this section of our webpage.