AACR Project GENIE: New Institution Open Call 2022
Project GENIE Open Call for New Participants
AACR Project GENIE is accepting applications for up to five new consortium participating institutions.
Focus of this new participant call: Cancer affects all populations, but due to social, environmental, and economic disadvantages, certain minority and underserved/rural populations bear a disproportionate burden of cancer.
To provide a resource for the scientific community to address this important issue, the second expansion of the GENIE consortium will focus on onboarding centers and institutions with diverse patient populations.
Open Call Schedule
- The New Applicant Pre-submission Webinar was held on Tuesday, May 10, 2022. Access the recording or download the presentation.
- Open: May 16, 2022
- Close: July 15, 2022
- Review applications: Summer 2022
- New member announcement: Winter 2022
Requirements for New Participating Institutions
- For US applicants, patient demographics (race, ethnicity) in line with national average of minority and underrepresented patients treated for cancer (14%; cancer.org). Rural populations as defined as cities and towns that are not located in urban areas (population greater than 50,000) or urban clusters (population between 2,500-50,000). Different criteria will be considered for non-US applicants.
- Provide 500 genomic records to start; 500 each subsequent year of participation:
- Data must be CLIA- or ISO-certified
- Limited Data sets as defined by 45 C.F.R. § 164.514(e) can be provided
- If de-identified datasets are provided, the process must adhere to the project’s established protocol
- Maintain IRB approval
- Meet data standards and deadlines
- Participate in meetings
- Participate in committees and subcommittees
- Execute the Master Participation Agreement and agree to all exhibits, including the Data User Agreement
- Each participant agrees to return to the electronic health records (EHRs) of select patients as necessary to gather deeper clinical data as part of various sponsored research projects. Funds to offset costs associated with manual chart abstraction are provided and agreed to as part of each project proposal.
- The data within GENIE are made publicly available every 6 months. Your institution must agree to this as part of the Data Use Agreement.
AACR Project GENIE Participation Evaluation Criteria
Applicants interested in joining AACR Project GENIE will be scored in three different categories (quality, feasibility, value add) as well as an overall score. Numerical values are on the following five-point scale: 1 Outstanding; 2 Excellent; 3 Very Good; 4 Good; 5 Satisfactory were assigned to each category.
- Significance. Does the site provide a key technology and or data type(s) that would enhance the registry? Is there evidence in the application that the applicant will significantly advance the goals of the consortium?
- Investigator(s). Is the applying team capable of providing both administrative and scientific leadership to the further development and operations of the consortium? Is there evidence that an appropriate level of effort will be devoted by the applicants to ensure the consortium’s goals are accomplished? Is there evidence that the applicants have the necessary experience to contribute both technical and leadership roles?
- Approach. Are the applicants developing or utilizing innovative approaches and latest best practices to collect and analyze clinical genomic and patient outcomes data? Are the participants using the latest clinical sequencing methodologies? Do they have novel best practices that could be shared to enhance the entire consortium?
- Environment. Is there tangible evidence of institutional commitment? Is there evidence that the faculty have sufficient institutional support to create a sound environment for inter-institutional collaboration among the participants? Where appropriate, is there evidence of collaboration and buy-in among participating programs, departments, and institutions?
This section determines if the applicant can meet the baseline requirements:
- Genomic Data. The site can provide clinical-grade genomic data in the required formats. In addition to missense mutations and indels, the site can provide CNA and fusion data. Are the data of significant quality in terms of coverage, panel size, and sequencing pipeline? Is the site willing and able to provide new data on the required schedule?
- Baseline Clinical Data. Can the site provide the required tier 1A data with the exception of race and ethnicity where prohibited? Is there any indication that this will be difficult and/or costly for the site? Is the site willing to provide new data on the required schedule?
- Deeper Clinical Annotation. Can the site go back to the required EHRs and curate the necessary clinical data fields? Is there any indication that they have been previously successful in doing so? Is there any indication that they have the necessary clinical infrastructure in place to perform this task?
- Legal. Are there any major tenants of the existing legal infrastructure that will prevent the site from executing a version of our legal agreements?
III. Diverse populations
This section evaluates the diversity of the patient population at the applicant’s cancer center and the genomic samples that will be provided to the GENIE consortium:
- What are the demographics of the population seen or treated at your center relative to the demographics of the catchment area (state and city/town) surrounding your center?
- What are the demographics of the population genomically sequenced at your center relative to the demographics of the catchment area (state and city/town) surrounding your center?
- Is your center/institution located in an urban or rural area?
- Are there community outreach programs at your cancer center or institution to address the disparity in genomic sequencing of minority or underserved populations in your catchment area in place or under development.
IV. Value Add
This section evaluates any additional expertise an applicant brings to the consortium:
- Does the addition of this site bring additional skills to the consortium?
- Panel size
- Structural variants
- Additional novel tumor types
- Research data and/or unique data sets
- Number of sequenced and able to be submitted to GENIE per year
- Technical expertise