Revised March 2012
Guidelines for PIs to consider if submitting human genetics application to NIDA:
When preparing an application, researchers are strongly encouraged to present a rationale that carefully balances important substantive, methodological, and budgetary issues. In particular, applicants are advised to address each of the following, when appropriate:
- Substantive focus with clear hypothesis (e.g., specific heritable phenotypes, alternative phenotypes, endophenotypes)
- Sample selection (e.g., particularly informative sub-samples and subgroups, understudied valuable populations) and generalizability (i.e., population to which findings can be applied)
- Research design (e.g., genetically-informative, birth cohort, multi-generational, selection by prenatal exposure, case-control)
- Statistical power (e.g., ability to detect effects within the proposed study or in combination with other studies) and population stratification
- Number and timing of assessments when applicable (e.g., multiple waves ranging from pre- to post-drug exposure, or from disorder onset to remission)
- Selection and quality of assessments (e.g., diagnostic and/or symptom-based scales, detailed measurement of salient individual and environmental factors)
- Comorbidity (e.g., psychiatric, polysubstance, physical illness)
- Flexibility for future use of the data (e.g., consent forms have potential for subsequent inquiry).
- Cost effectiveness
- Biomaterial collected to isolate genetic information (e.g., blood, buccal cells, etc.)
- Compatibility/overlap with extant studies in the NIDA Genetics Consortium (description of studies)
- The NIDA Genetics Consortium has developed a series of core elements for assessing and harmonizing demographic information and substance use history for genetic studies. The core elements can be accessed here. NIDA strongly encourages all applicants to discuss how these core elements are addressed in their data sharing plan by either assessing them directly or indirectly by proxy measures.
For studies requesting access to the NIDA Genetics Consortium, the following additional points need to be addressed:
- Samples obtained can be combined with other samples within the NIDA Repository and the study will have the minimal required dataset to increase and obtain sufficient statistical (as outlined in Answer 13, subpart c, of the FAQ power: Frequently Asked Questions About the NIDA Genetics Consortium and All Human Genetics Studies at NIDA.).
- Eligibility and plans to join the NIDA Genetics Consortium (for details see Frequently Asked Questions About the NIDA Genetics Consortium and All Human Genetics Studies at NIDA and Frequently Asked Questions About the NIDA Center for Genetic Studies).