During the peer review, auditors are asked to comment on the genomic data sharing plan, but they do not incorporate it into the overall impact assessment unless the announcement of funding opportunities indicates this. After an initial peer review, NIH program officials may accept the plan as planned, recommend changes to the applicant, or request additional information. Once the application is made, the Senior Auditor (IP) should contact the Human Protection Authority (OPHS) to discuss next steps to ensure that it has an approved protocol including the submitted data sharing plan and that informed consent documents allow for the sharing of the resulting data, as outlined in the plan presented. If PI does not have an existing protocol covering the proposed work, it should cooperate with OPHS staff to have a new protocol or amendment in the works to allow for the rapid development, submission and approval of the CPHS if the institution and IP are informed that the proposal is in the due process (JIT). The SMD Directive applies to all competing NIH grant applications and NIH contract proposals submitted under the January 25, 2015 deadline and beyond, where the proposed research will produce important genomic data for humans or humans or use this data for future research. In such cases, the MDS directive applies regardless of the level of funding. Note: If an examiner uses only anonymized cells/data without identifiers or codes (i.e., does not involve any human subject), the CPHS will conduct a “non-human subject research” and inform the IP and OPS that nih does not need to provide institutional certification. The NIH encourages the patenting of technologies that can be patented for future private investments and that can lead to the development of products that meet the needs of the public without hindering research. However, it is important to note that DNA sequences naturally present in the United States are not patentable. Therefore, basic sequential data and some related information (genotypes. B, haplotypes, p values, aisle frequencies) are pre-competitive.