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Except as otherwise noted below, the provisions of IIA apply to all CDA programs. This includes all Public Policy Requirements, Objectives, and Other Appropriation Mandates such as civil rights; the protection of human subjects, including data and safety monitoring requirements; the humane care and use of live vertebrate animals; human embryonic stem cells; and/or recombinant DNA and human gene transfer research. See Subpart IIA for a complete list of applicable requirements.
In addition, all Administrative Requirements described in IIA also apply to CDA program unless an exception is noted below. These include requirements such as prior approvals; availability of research results, publications, NIH Public Access policy, invention reporting, and program income. See IIA for a complete list of applicable administrative requirements.
Since CDA awardees are employees of the institution, applicable institutional leave policies for leave such as vacation, sick, parental, etc. apply to individuals supported by NIH CDAs.
CDAs are expected to be for continuous support of an individual; however, in certain circumstances, candidates will be permitted to take a leave of absence. Circumstances include personal or family situations such as parental leave, child care, elder care, medical conditions, or a disability. A leave of absence or sabbatical greater than three months must be requested and approved in writing by the NIH awarding IC. A leave of absence less than 3 months only requires institutional prior approval.
For some CDAs additional information is required as part of any prior approval request:
Leave without award support may not exceed 12 months. Such leave requires prior written approval of the awarding component and will be granted only with justification. When approved, the K award will be placed in a no-cost extension for the duration of the unpaid leave and no charges to the grant will be allowed during that period, although continued coverage of health insurance would be allowable if in accordance with institutional policy. Such leave does not reduce the total number of months of program support for which an individual is eligible.
At the time of the initial appointment of K12 or KL2 scholars, the Program Director may submit a Statement of Appointment (Form PHS 2271) for each scholar to the NIH awarding IC to document the appointment of scholars to institutional CDAs. This policy varies with ICs. Contact the CGMO of the awarding IC to confirm their policy on submitting a PHS 2271. When 2271s are required, this information must be submitted using the xTrain feature in the eRA Commons.
Consultation with the applicable NIH program staff and/or grants management staff is strongly encouraged when a termination is being considered before the scheduled project end date. When an institution plans to terminate an award, the awarding IC must be notified in writing at the earliest possible time, so that appropriate instructions can be given for termination. NIH will issue a revised NoA to specify the changed period of support.
NIH may terminate a CDA before its normal completion date if it determines that the recipient has materially failed to comply with the terms and conditions of the award or to carry out the purpose for which it was made. If an award is terminated for cause, NIH will notify the recipient in writing of the determination, the reasons for the determination, the effective date, and the right to appeal the decision.
The NIH awarding IC should be notified immediately if a sponsoring institution wants to terminate a K12 scholar, or if the scholar decides to terminate the appointment before the scheduled completion date.
CDA awardees may retain royalties and fees from activities such as scholarly writing, service on an advisory group, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation, or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of the CDA, and provided that the retention of such pay is consistent with the policies and practices of the recipient institution. No other income or fees may be retained by the CDA recipient and must be assigned to the recipient institution for disposition by any of the following methods:
Adequate records regarding the source, receipt and disposition of fees and other income are to be maintained by the institution for the time period(s) specified in 45 CFR 75.307.