Key Personnel

When should I list a person on my grant as key? 

Key personnel are defined as, and should be limited to, individuals who contribute in a substantive way to the scientific development or execution of the project, whether or not salaries are requested. Typically, these individuals have doctoral or other professional degrees, although individuals at the masters or baccalaureate level should be included if their involvement meets the definition of key personnel.

PIER/DEI/Community Benefits Plans

More information and resources for writing these plans can be found on the ESE Hub here

Human and Animal Use Approvals

1. Who is responsible for getting Human Subjects and Animal Use Approval? 

PIs are directly responsible for determining their own human subjects and animal use approval requirements. The assistance of Kelsey Miller in the Human and Animal Regulatory Committees (HARC) office may be sought as needed.

PIs are responsible for getting approval or exemption from further review for ALL projects involving human subjects and/or animal use, including projects using already approved protocols from other grants and projects where the actual animal work or human subjects interactions occur at another site. Researchers should bear in mind that human subjects approval may be required for projects using only human-derived DNA, cell lines, tissue cultures, and existing data. More complete definitions can be found on the HARC website or in Chapter 22 of the Berkeley Lab Health and Safety Manual, Pub 3000. Departmental administrative staff  are often called upon to help PIs with the required paperwork. The following will provide a very brief overview of what is required.

2. When is human subjects or animal use approval required? 

Separate human subject or animal use approval is required for each new experiment (protocol) and funding proposal. Annual renewal is required for all nonexempt protocols and proposals/projects. Funding may be interrupted for projects in which approval is allowed to lapse.

Human Subjects – Please note that if an exemption for human cell lines is granted, it is assigned to a proposal, not to the cell lines themselves. Thus every project using human cell lines requires approval. Once exempted, however, there is no requirement for annual review.

Animal use – Cell lines, or purchased animal tissue or products, are not subject to Animal Welfare regulations so do not require any kind of approval (ex: stock antibodies purchased from a chemical supplier). But research-derived tissues and antibodies that are custom-made ARE considered animal use and require approval.

3. What is the approval process and timeline? 

PIs are responsible for submitting the required paperwork to the HARC office in time to allow for appropriate review prior to the funding agency deadline; the HARC approval process takes up to eight weeks depending on the level of review required. HARC deadlines for given review dates are posted on their website. Evidence of approval of the project by the Berkeley Lab HARC is usually required by sponsors; consult with your proposal specialist for filing guidance and agency deadlines. 

Note: NIH recently delayed review of a proposal for months when the required approval was not received by their deadline. Regardless of funding agency deadlines, approval must be in place before a new proposal is funded or work with human subjects or animals is begun.

4.  How do I get documentation of animal or human use approval for my grant?

The HARC office must compare new, competing, or modified grant proposals to the protocols identified by the researcher as covering the work.  Only after that review can the HARC office certify the proposal to Sponsored Projects and the sponsor. The HARC website describes the process for use of Animals and Human Subjects.

For clarification and more information, review the HARC websites or contact Chris Byrne or Dianna Bolt in the HARC office, 486-5399 or harc@lbl.gov.

Be honest. Some investigators may budget below their actual need in the belief that this improves their chances for funding. Reviewers have expert knowledge of the funds required to do research in the field. Underestimating your costs can be as damaging as inflating costs and putting in ‘fat’. In many cases, it is wiser to calculate a real budget, and request that amount. Every item on the budget, particularly personnel, must be clearly justified.

Describe the role of all personnel, professional and nonprofessional, regardless of whether salary is requested. Specify each individual’s unique qualifications and role in the project, including percent time (now expressed as months) and effort.

Thoroughly justify all proposed purchases of major equipment. If supplies appear unnecessary or redundant, they will most likely be disallowed.

The research plan is the heart of the grant application. A good research plan is usually based on a meaningful hypothesis. The hypothesis should have a subset of specific project aims and scientific questions. The questions and aims, in turn, should have a focused subset of research methods to accomplish or answer them. A creative, exciting, and significant hypothesis is often the first step in a sound and well-received research plan; a sound research plan is necessary to a successful application.

The applicant, in describing their research plan, should not assume that the reviewer will “know what they mean.” While the applicant may assume that the reviewers are experts in the field and up-to-date with current methodology, the reviewers will not make the same assumption of the investigator. In other words, the burden is on the applicant to clearly display their knowledge of methodology by detailing the specific experimental design, materials, techniques, and rational to accomplish the aims of the project.

While writing the entire proposal, but most crucially while developing the research plan, keep in mind the review criteria of the funding organization. The following mandated NIH research project review criteria, announced on May 5, 1997 by the NIH Peer Review Oversight Group, are applicable to most research proposals: 

• 1. Scientific, Technical, or Medical Significance 

  2. Appropriateness and Adequacy of Experimental Method 

  3. Innovative Science 

  4. Qualifications of the PI and Staff

  5. Availability of Needed Resources

Although these criteria may serve as a guideline, be aware of and address all review criteria of the funding organization, including such points as reasonableness of budget/research timeline and adequacy of human, animal, and environmental protections. These criteria are further detailed in the following discussion of the Research Plan sections.

• • Project Aims - As stated above, the project aims should clearly address a problem or need. If applicable, the project aims should explain how the research eliminates or decreases gaps in the current knowledge in the field. In other words, this section should include a hypothesis and objectives: a concise wording of overall purpose, and statements of intended accomplishments through the project.

  • Background and Significance - The study question or hypothesis should be reiterated in this section. Also include a statement of the importance of the proposed research on the experimental level and in the larger scope of the field. In other words, explicitly describe how your research will advance knowledge or otherwise significantly impact the research area.

This is also the section where the PI can demonstrate their knowledge and assessment of the relevant literature. This section should include a thorough, critically reviewed collection of data/events that justifies the next step: your current proposal.

• • Preliminary Studies - If available, preliminary data should be included. Such data can indicate the viability of the hypothesis and the proposed methodology. It can also reveal the PI’s qualifications by giving the reviewers a preview of the PI’s methods of research and interpretation of results. This section allows an unestablished researcher to demonstrate experience and competence to do the research in the proposed project area. Relate the preliminary study with the proposal at hand, describing the expansion, continuation, or progression of the research from the pilot data. If the research methods are to change significantly, this section provides an opportunity to explain such changes.

The applicant may include preliminary studies published or in-press in the appendix to demonstrate the feasibility of the hypothesis and their qualifications as an investigator.

• • Research Design - Good science is paramount to a successful application.

From this section, reviewers judge if the investigator understands the proposal’s methodology and limitations. The experimental design, including technical methodology, should be mapped out clearly for each phase of the project. Each experiment should be tailored to a specific aim within the framework of the entire project. The framework of the project should include a realistic estimate of the work the PI can accomplish during each funding year requested. Justify as well as describe research designs and methods chosen and, if applicable, provide a comparison with alternative methods not chosen. If human or animal subjects are involved, address the characteristics of the subject population and evaluate the risk/benefit ratio. For animal subjects, indicate appropriate care before, during, and after the research period.

Describe the assumptions in the planned research. Along this line, mention likely potential limits or pitfalls and ways to work around such problems. This is particularly key should later experiments depend heavily on results from an initial phase of research.

Demonstrate appropriate and available controls, and a critical assessment of the proposed work. Define the criteria for evaluating whether a given test is a success or failure. Be certain to use correct statistical analyses if applicable. In some cases, the assistance of an expert statistician may be required for demonstrating proper statistical analyses in the proposal write-up, as well as providing assurance of proper statistical analyses of future research results.

• • Literature - Literature cited should be thorough, thoughtful, current, and relevant. In some cases, project hypotheses have been built on misinterpreted literature, an obvious red flag to a reviewer.