National Institute of Diabetes & Digestive & Kidney Diseases

FREQUENTLY ASKED QUESTIONS AND NEW INFORMATION

A. As the RFA notes, the potential studies listed are examples only. From the RFA "THESE ARE EXAMPLES ONLY. APPLICANTS SHOULD NOT FEEL LIMITED TO THE SUBJECTS MENTIONED BELOW AND ARE ENCOURAGED TO SUBMIT OTHER TOPICS PERTINENT TO THE OBJECTIVES OF THE RFA. " This could include a randomized clinical trial, keeping in mind the budgetary and other constraints of the RFA.

A: There are NO investigators or consortia that have been given assurances of funding for the Bariatric Surgery Clinical Research Consortium. Individual applications for clinical centers and data coordinating centers will be reviewed for scientific merit by a special scientific review group convened by NIDDK, and for programmatic relevance and other funding criteria by NIDDK, as described in the RFA. The only official sources of information regarding this RFA are the program, review, and grants management staff listed as contacts within the RFA, and potential applicants are STRONGLY encouraged to contact these NIH staff for questions regarding their applications.

A: No. A successful consortium will require investigators in multiple disciplines. Although a bariatric surgeon obviously needs to be an active participant in the RFA, it is not necessary that he or she be PI. From the RFA :

"Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

All current policies and requirements that govern the research grant programs of the National Institutes of Health (NIH) will apply to grants awarded under this RFA. Among the disciplines and expertise that may be appropriate for this program are surgery, internal medicine, nutrition, behavioral science, and clinical trials management."

A: The proposals should be contained within the page limit of the PHS 398 form.

A: The purpose of the sample protocols is to allow NIDDK to evaluate the potential range of studies that might be carried out by the BSCRC, and to allow the IRG (study section) to evaluate scientific thinking of individual investigators and their likely ability to contribute to protocol and database development. These areas relate primarily to the "approach" and "significance" criteria for review. Information on your qualifications as a productive CC would be also expected to be important in the review. (See investigator, environment, and "other review criteria" in the RFA)

A: If you believe that investigators from more than one institution might wish to collaborate to form a single center, this is permissible. It is important to consider logistics, however, including how the institutions will interact as a single center, methods for coordination, how you will share the limited number of staff allotted for a single center, etc. This is particularly important if the collaborating institutions are not located within the same local geographic area. The study section will be likely to view the logistics of such a collaboration with particular scrutiny, to see if the collaborative center offers advantages over a single center.

Collaborations between CCs within the BSCRC: For those applicants that propose collaborative efforts between two groups to form a single CC, additional factors to be considered would include the advantages of the collaboration in terms of cost, recruitment, or facilities; the commitment of the participants to the collaboration; and the adequacy of plans to coordinate efforts.

Because of the lack of data on the safety of bariatric surgical procedures in pediatric populations, children and adolescents under age 18 will not be included in this protocol; however, it is expected that patients between the ages of 18 and 21 would be studied, if they are appropriate surgical candidates.

A: According to the RFA, domestic for-profit or not-for-profit organizations as well as public or private institutions, such as universities, colleges, hospitals, and laboratories are permitted to submit an application (see wording from RFA). Although a private practice could, theoretically, be the applicant organization, there would likely be disadvantages to this arrangement. For example, obtaining assurances. IRB approvals, etc. would be much more cumbersome when initiated by a private practice. The PI may wish to consider partnering with an institution that has experience with obtaining federal grants, such as a university or hospital, and having the partnering institution serve as the applicant organization.

A: Although individual clinical centers are not excluded from working together to develop agreements and common protocols prior to the submission of the proposals, this might potentially be a disadvantage in review. The purpose of the sample protocols is to allow NIDDK to evaluate the potential range of studies that might be carried out by the BSCRC, and to allow the IRG (study section) to evaluate scientific thinking of individual investigators and their likely ability to contribute to protocol and database development. The actual protocols will be developed after study funding.

"The criteria of Significance, Approach, and Innovation will relate primarily to the two protocols submitted as a part of this application, as well as to the recommendations for information to be acquired in the database. The protocol and database descriptions are being requested in order to allow reviewers to evaluate the scientific thinking of the investigators, and their likely ability to contribute to protocol and database development. The actual protocols and database will be developed by the Steering Committee after study funding."

In addition, the protocols are only one aspect of the review criteria; it is unlikely that all CC will be equally strong in all areas important in review (see review criteria). Thus, it is unlikely that all CCs coming in with a common protocol will receive similar priority scores, and therefore, the applicants cannot make the assumption that, even with submission of common protocols any or all of the cooperative group of centers would be selected for funding.

A: The review criteria specify that both the Investigator as well as the Environment will be evaluated by the IRG. The individual preparing the application (PI) should note not only his/her expertise, but also the experience and expertise of others in the applicant organization, as both will be considered in the review.