Frequently Asked Questions for Mechanisms and Management of Cardiovascular and Metabolic Complications of HIV/AIDS (R01) HL-08-003

Q: What is the budget cap? Is it the same whether the application is for a clinical research site or a Data Coordinating Center?

A: The cap for direct costs in each year is $650,000 and applies to clinical site and DCC applications. The maximum project period that can be requested is 5 years. Direct costs include total costs (direct plus indirect) for all subcontracts. The indirect or Facilities & Administration (F&A) costs will vary among different institutions and may vary within one institution on the basis of the type of research.

Q: How many research aims should be proposed?

A: There is no limit, but the applicant should present at least the minimum requirement described in the RFA of one clinical study aim and one mechanistic aim. Each aim should be developed sufficiently for reviewers to judge it by the review criteria that are clearly outlined in the RFA. The aims do not have to address the same topic. All aims should be chosen to take advantage of any current collaborations and resources of the applicant, as well as any institutional resources such as patient populations, other academic and clinical departments that are interested in collaborating, clinic/lab/imaging facilities, experience in specific areas of research, etc.

Q: What are the required elements of a clinical research budget beyond the usual line items of personnel, materials and supplies, publication costs, consultant services, etc.?

Travel costs for the PI (s) and 2 key collaborators to attend 3 meetings in Bethesda, MD during Year 1 and one meeting per year in Years 2 through 5. Each meeting will last 1.5 days.
Protocol-related research costs calculated on a per-patient basis. These should include drug and device costs. If support is expected from Industry, letters to that effect should be included with the application, as well as contingency plans.
Unit and total costs for biological specimen processing, temporary storage, and preparation for batch shipping to the NHLBI Biological Specimen Repository. (The DCC will cover the actual shipping expenses to the Repository.) If foreign subcontracts are planned, the research site budget must also include shipping costs for specimens from the foreign country to the NHLBI Repository in Gaithersburg, Maryland.
Anticipated costs necessary to meet regulatory requirements. For instance, costs of preparing an application for an IND or IDE, if the proposed research mandates it.

Q: What are the required elements of a Data Coordinating Center budget beyond the usual line items of personnel, data collection and management, materials and supplies, website development and maintenance, statistical support, publication costs, consultant services, DCC member travel, etc.?

Funds for a meeting room and other support for the grantees’ meetings, each lasting 1.5 days, in Bethesda, MD. Estimates should include 3 such meetings in Year 1 and one meeting in each of Years 2-5.
Funds to cover travel and honoraria ($200 per meeting day) for a maximum of 8 DSMB members who will meet once annually in Bethesda, MD for one day.
Costs of teleconferences: 3-4 per year with DSMB and investigators and 4 per year for investigators alone.
Shipping costs for biological specimens from all domestic clinical research sites to the Repository. For purposes of estimation, assume a total number 50,000 blood-derived 2 milliliter specimens shipped from within the U.S. per year for 4 years.
Costs, calculated on a per unit basis, for centralized, standardized readings of cardiovascular assessments such as ECGs, carotid IMTs, coronary calcium EBCTs, cardiac echocardiograms. Assume 150 patients per site at each of 7 clinical research sites.

Q: When must I ship my biological specimens to the Repository and will they be openly available to outside investigators as soon as they are received at the Repository?

A: You may ship the biological specimens from your study anytime during the period of the grant. The specimens should be processed and made ready for storage at the research site prior to shipping. It is preferred that the research site ship specimens when there is a sufficient quantity to fill a standard shipper, which will be provided to the research site. Access to biospecimens from a particular study (“Collection Study”) is restricted during the “Proprietary Period,” which lasts until the data from the Collection Study are made available following the NHLBI Limited Access Data Policy. Non-collection Study investigators may access biospecimens from a collection during the study “proprietary period” by establishing collaboration with the study investigators and applying per Collection Study procedures. The Collection Study investigators may access biospecimens from the collection using procedures described in the Collection Study’s Manual of Procedures.

The “Open Period” for access to Collection Study biospecimens starts when the study data are made available following the NHLBI Limited Access Data Policy. During this “Open Period,” all qualified investigators may access biospecimen collections by contacting the NHLBI Biologic Specimen Repository Project Officer and following the NHLBI Repository procedures.

Q: What is the receipt date for applications?

A: The correct receipt date for applications to RFA HL-08-003 is March 25, 2008.

Last update: January 18, 2008