Timing for Release of Data to PharmGKB - Retired on March, 2003
This policy has been superceded by a more recent version.
Many kinds of information will be deposited into the PharmGKB, encompassing all of the data types necessary to define genotype and phenotype, including genomic, genetic, molecular, cellular, and clinical data. In order to promote the timely release of this information, policies for the four main categories of data that the Network believes will be deposited are outlined below. In general, the data should be deposited within 90 days of discovery. This will allow for the validation necessary for submission of provisional patents.
- Genotype data for a given gene (e.g., SNPs in a form suitable for acceptance into the PharmGKB) should be deposited within 90 days of completion of the sequence analysis of a set of DNA samples.
- In vitro phenotype data for variants of a given gene (e.g., from banked tissue samples, recombinant expression systems, etc.) should be deposited within 90 days of completion of the analysis of a set of variants.
- In vivo pharmacokinetic data (including that from human subjects) should be deposited within 90 days of completion of the analysis of a set of variants.
- Clinical research phenotype data (e.g., information derived from measurements taken from subjects who have received drugs or treatment) should be submitted within 90 days of the point of completion of analysis of a set of measurements. If considered appropriate by the investigator, quarterly deposition of summaries of information as subjects and results are accumulated in long-term trials is encouraged.
In cases where investigators have concerns about issues relating to the submission of data from human subjects, they can contact the PharmGKB and/or their IRB to discuss appropriate alternatives to deposition of individual subject data. A Pharmacogenetics Research Network PI may request to delay deposition of data beyond the 90 day limit under special circumstances involving the need to protect the identities of human subjects. Such a waiver may be granted by the NIH Program Director after consultation with the Executive Committee.
Other versions of this policy are also available: