CHAPTER FOUR

PROPOSAL REVIEW, APPROVAL, AND PROCESSING

4.1 Review and Approval Responsibilities

Each proposal must be reviewed and approved prior to submission to the funding agency. The review and approval may vary depending upon the nature of the proposal and the extent upon which the proposed project needs additional review by Health Science Center regulatory committees (e.g., human subjects, animals, biohazards, etc.)

4.2 Certificate of Proposal * 2

 When the proposal is submitted to Grants Management for final review and signature, but prior to submission to the funding agency, a completed and signed Certificate of Proposal (Appendix G) must accompany it. The Certificate of Proposal) represents a review of administrative, policy and fiscal issues affecting the proposal and consists of a series of information items and questions to assist the Investigator and Health Science Center reviewers in assessing potential risks and obligations which could be assumed if the proposal is funded. In addition to the signatures of the department chair and dean, other pre-submission approvals are also required as detailed in Section 4.4 below.

Where there are faculty from more than one academic department who will participate in the proposed project, signatures of their appropriate department chairs and deans are also required prior to Grants Management institutional signoff.

The Certificate of Proposal is also required when an agreement or contract is received and no formal proposal has been submitted. Grants Management will also advise Investigators and administrators at all other times when the Certificate of Proposal is required.

Instructions for completing the Certificate of Proposal can be found at Appendix H.

4.3 Other Pre-Submission Approvals and Requirements

Health Science Center and funding agency policy requires certain other approvals to be in place prior to the submission of a proposal. These are also noted on the Certificate of Proposal and include:
  • Institutional Review Board (IRB) Approval for Human Research . The Institutional Review Board must review all proposals using human subjects. Use of human subjects in research is defined as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge…" using "living individual(s) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information." (Code of Federal Regulations, Title 45, Part 46.102(d) and (f). The IRB approval form must be appended to the Certificate of Proposal. If approval is still pending, documentation from IRB must be attached. Some sponsors will not accept pending review status; sponsor instructions should be consulted.

  • Institutional Animal Care and Use Committee (IACUC) Approval for the Use of Animals in Research. The Institutional Animal Care and Use Committee must review all proposals using animals. The IACUC approval form must be appended to the Certificate of Proposal. If approval is still pending, documentation from the IACUC must be attached. As with human subjects, some sponsors will not accept pending review status; consequently, sponsor instructions should be carefully reviewed.

  • Institutional Biohazard Committee for Replicating or Recombinant DNA Experiments. Federal regulations required approval by this Committee when research involves the use of replicating agents, radioactive drugs, or recombinant DNA, whether funding is required or not.

  • Institutional Chemical Safety Subcommittee. Approval by this Committee is required when research involves the use of chemical carcinogens and extremely toxic substances.

  • Off-Campus Projects. For those projects taking place in facilities other than those owned by the Health Science Center, the University Health System, or the Veteran's Administration Hospital, a letter of support from an authorized official of that facility must accompany the Certificate of Proposal.

  • Statement of Significant Financial Interests. In accordance with the Health Science Center's "Policy and Procedure for Promoting Objective in Research by Managing, Reducing, or Eliminating Conflicts of Interest" as well as federal policy, a Statement of Significant Financial Interests for each listed key personnel must also be submitted to Grants Management at the time of final proposal review. Note that this policy applies to federal research proposals only. (See Appendix M.)

    • 4.4 Proposal Review

     All applications for support for external funding must be reviewed by the Office of Grants Management prior to submission to the funding agency. Grants Management reviews the proposal for consistency with agency guidelines and compliance with Health Science Center policies.

    In particular, the budget will be reviewed carefully to ensure the correct application of rates, proper format, and verification of any institutional cost-sharing commitments. Investigators are encouraged to submit draft copies of the budget well in advance of the proposal due date for review.

    The Director of the Office of Grants Management has been delegated signature authority for all proposals submitted to external sponsors by the Health Science Center.

    NOTE: ITEMS NEEDED PRIOR TO GRANTS MANAGEMENT SIGNATURE ON A PROPOSAL: 1
    Grants Management is not authorized to provide institutional sign-off without the following items:
  • Completed and signed Certificate of Proposal
  • Human Subjects Approval or Pending letter (if applicable)
  • Animal Subjects Approval or Pending letter (if applicable)
  • Institutional Safety Office Sign-off (if applicable)
  • Statement of Significant Financial Interest for Each Listed Key HSC Investigator (all federal proposals)
    • A copy of the proposal for Grants Management files should either be submitted at time of proposal review or within two weeks after submission.

    4.5 Protection of Proposal Information

     Should a PI/PD wish to protect ideas, information and data presented in a proposal against improper use by others and premature disclosure, he/she may wish to include the following or a similar general statement on the face page of the proposal:
    "The contents of this proposal may not be disclosed to the public beyond the normal distribution necessary for proper review and evaluation for possible funding, nor used by the Government [or Sponsor] for any other purpose, without the express written approval of the Principal Investigator (or the Project Director) and an authorized official of the Health Science Center."
    Alternatively, specific portions of the proposal may be prefaced on each page containing individual salary information or proprietary scientific information or data with a legend similar to the following:
    "Following is information that The University of Texas Health Science Center at San Antonio considers proprietary and which it requests not be released to persons outside the Government [or Sponsor] except for evaluation purposes."

    4.6 Mailing the Proposal

     In general, the Principal Investigator/Project Director's academic department is responsible for making the necessary copies of the proposal and for mailing. Grants Management will mail the proposal upon receipt of the necessary copies (and a copy for Grants Management) prior to ten (10:00) a.m. of the day on which the proposal should be mailed. Costs for priority or overnight mailing will be assessed to the Principal Investigator/Project Director's academic department.

    4.7 Site Visits

     A site visit may be part of a sponsor's review of the proposed research. Site visits are generally made for very large and expensive projects, such as for program projects and center grant proposals. Normally, the site review team will be made up of scientific and administrative officers from or representing the sponsoring agency, occasionally a fiscal consultant, and a varying number of scientists specializing in the field with which the proposal is concerned. The site visit team generally reviews the following criteria:
  • scientific merit of each component of the program and of the overall program;
  • requested budget;
  • use of human/animal subjects (notify the IRB or LAR of the visit as appropriate);
  • contributions of subawardees and collaborators;
  • administrative structure;
  • resources and project environment; and
  • overall strength of the Health Science Center and its commitment to the project.
    • The agenda for a site visit is the responsibility of the Principal Investigator/Project Director and should be submitted to the Sponsor's site visit administrative officer one month prior to the visit. This will give the administrative officer an opportunity to review the agenda, as well as to review it with the site visit chair. They may suggest revisions based on their experience. These revisions should be accepted if at all possible. The following strategies are provided as further assistance:

    Strategies
    Place yourself in the site visitors' roles and remember that their task is to acquire additional information. Make it easy for them to write their reports by:

  • Providing a handout at the beginning of the site visit that includes copies of all slides and materials to be used at the site visit, organized and tabulated according to the agenda. The site visitors will use these directly to write program descriptions and their critiques.
  • Having all presenters available at all times throughout the site visit (in the room or on call).
  • Understanding that careful and critical rehearsal of presenters is essential.
  • Using an ample-sized conference room, preferably one with an oval or u-shaped table, and make sure that presentation equipment is working.
  • Being prepared to follow-up on questions in writing. Do not assume that because you may have a specific comment during the site visit that it will become a part of the formal written record.
    • Points to be Avoided
  • Do not change budget requests the night before the visit. A changed budget constitutes a new application.
  • Do not call or write individual site visitors or the site visit chair before or after the site visit unless requested specifically to do so.
    • Grants Management should be contacted if a representative from that office is either necessary or could be useful in attendance at a forthcoming site visit or if you need assistance with preparations for a site visit.

    4.8 Pre-Award Audits

     Where a proposal submitted to a federal agency is likely to result in the award of a contract and the budget exceeds $500,000 per year, a pre-award audit will be undertaken by the federal funding agency. This audit will occur prior to an award being issued. If an audit (often referred to as a Field Pricing Report) is required, the federal sponsor generally requests DHHS to review the proposal budget to ensure that it is adequately documented and that all rates are current.

    Pre-award audits may either be conducted in person or via telephone and fax by the sponsor and should be coordinated through Grants Management. Assistance will be needed from the PI/PD and the academic department on specific cost or pricing issues.

    4.9 Unfunded Proposals

    Should the principal investigator/project director receive notification from the prospective funding agency that the submitted proposal will not be funded, a copy of the notification should be sent to Grants Management.

    It is the policy of the Office of Grants Management to retain copies of unfunded proposals for one year following notification that the proposal will not be funded. After one year, Grants Management will inform the Investigator that the file will be discarded unless the Investigator wishes to personally retain the file in which case the file will be forwarded to the Investigator.