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Affiliate Membership Policy

Date Approved: May 17, 2023

Date of Last Update: March 4, 2024

Version: 2.1

Table of Contents

  1. Scope
  2. Applicant information
    1. PRIMED Affiliate Tiers
    2. Criteria
      1. Primary Criteria for Expertise Only Applications
      2. Primary Criteria for Data Affiliate Applications
    3. Benefits
    4. Responsibilities
      1. Additional Responsibilities of Expertise Only Affiliate
      2. Additional Responsibilities of Data Affiliate
  3. Application Process
  4. Related Policies
  5. Definitions and Abbreviations
  6. Change Log
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Scope

This policy establishes “expertise only” and “data affiliate” Affiliate Membership tiers in PRIMED, to enable subject matter experts and data contributors otherwise not eligible for Core Membership (see “Related Policies” below) to actively participate in the PRIMED Consortium. Applicant information, selection criteria, benefits, responsibilities, and application process for both tiers are described in this policy document. Additional tiers of Affiliate Membership may be defined in future iterations of this policy.

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Applicant information

Applicants for PRIMED Affiliate Membership are typically individuals (see Definitions section for Affiliate Member Applicant) that are interested in actively contributing to the development and evaluation of polygenic risk scores (PRS) to estimate disease risk and enabling improved applicability of PRS in diverse ancestry populations. Affiliate Membership is conditional on agreement and adherence to the criteria for participation described below.

Note that trainees may submit an Affiliate Membership application, indicating their direct supervisor/mentor on their application and noting that the supervisor/mentor won’t be directly involved in Consortium activities. If the trainee’s direct supervisor/mentor will also participate in PRIMED activities, the mentor should instead apply for Affiliate Membership and indicate the trainee on their application. 

PRIMED Affiliate Tiers

PRIMED Affiliate Membership has two tiers, summarized in the table below:

 

Expertise only

(“Non-Data” Affiliate)

Data Affiliate

Benefits
  • Access to PRIMED-developed resources (e.g. internal website, Consortium meetings)
  • Shared expertise in a rich, collaborative environment 
  • Participation in PRIMED Working Groups and Working Group products
  • Opportunity for co-authorship on PRIMED manuscripts
  • Opportunity to access PRIMED Consortium data (e.g. dbGaP via PRIMED Coordinated process, PRIMED-SAG via CDSA)

Eligibility criteria for participation
  • Abide by Consortium policies, guidelines, and agreements
  • Commitment to engage with PRIMED investigators and actively participate in Consortium activities
  • Ability to contribute relevant expertise that is of interest to and within scope of the PRIMED Consortium
  • Has genotype or phenotype/outcome data related to one or more existing PRIMED projects underway
  • Ability to sign onto CDSA (or equivalent) as DATA AFFILIATE to bring data into PRIMED-SAG (this will also provide access to PRIMED-SAG Data)

Approval criteria for Steering Committee review
  • Applicant’s expertise is unique, of interest to and within scope of PRIMED
  • Quality, diversity, relevance, and timeliness of applicant’s data
  • Applicant’s ability to join PRIMED-SAG by signing onto CDSA as DATA AFFILIATE

Application and review process
  • Pre-review by PRIMED Coordinating Center to ensure application completeness and scope
  • Review by PRIMED Executive Committee and recommendation to Steering Committee, optional consultation with Working Group(s)
  • Decision by Steering Committee
  • Annual review by Executive Committee

Expertise Only Application

Data Affiliate Application

Responsibilities
  • Adhere to Consortium policies, guidelines, and agreements.
  • Submit PRIMED proposals to solicit input and participation from other Core and Affiliate Members in proposed projects and analyses
  • Not to disclose confidential information obtained from Consortium members.
  • Participate in PRIMED Consortium activities (e.g. WG calls)
  • Substantial intellectual contributions to the Consortium and projects, bringing expertise to accomplish goals in a timely manner 
  • Bring in data to accomplish Consortium goals in a timely manner
  • Sign onto CDSA (or equivalent) as DATA AFFILIATE to bring data into PRIMED-SAG

Criteria

Applications from those who wish to become PRIMED Affiliate Members will be assessed on a case-by-case basis.

Primary Criteria for Expertise Only Applications

  • Willingness to engage with other PRIMED investigators and actively participate in Consortium activities
  • Contribution of relevant expertise that is of interest to and within scope of the PRIMED Consortium
  • Willingness to abide by the Consortium policies related to data sharing and publication of results activities and products

Primary Criteria for Data Affiliate Applications

  • Required genomic and/or phenotype/outcome datasets are available or will be available in time for use 
  • Quality and accessibility of data is commensurate with current members 
  • Participant or population diversity significantly enriches the Consortium activities and products
  • Willingness to abide by the Consortium policies related to data sharing and publication of results activities and products
    • Ability to sign onto CDSA (or equivalent) as DATA AFFILIATE to bring data into PRIMED (this will also provide access to PRIMED-SAG Data).

Applications to either tier from individuals in the private sector and/or for-profit entities to participate or provide cost-free or in-kind services to PRIMED will be assessed separately by National Human Genome Research Institute (NHGRI) staff and the PRIMED Executive Committee to ensure compliance with applicable NHGRI, National Institutes of Health (NIH) and federal government legal-, ethical-, and conflict of interest-related policies. 

Benefits

Benefits for Affiliate Members may include:

  • Access to PRIMED-developed resources (e.g. internal website, Consortium meetings)
  • Shared expertise in multidisciplinary areas 
  • A rich, collaborative environment with multiple sites 
  • Participation in PRIMED Working Groups and Working Group products when appropriate
  • Co-authorship on PRIMED manuscripts, when merited by contributions and arranged early in manuscript development
  • Opportunity to access PRIMED Consortium data (via addition to the PRIMED Eligibility List), as described in the PRIMED Consortium Data Sharing Agreement, Data Sharing Policy, and Instructions for PRIMED Coordinated dbGaP Applications. 
    • An Affiliate Member who wishes to use PRIMED data will need to enter into one or more PRIMED data sharing circles, as described in the Data Sharing Policy (e.g. enter into the PRIMED Coordinated dbGaP sharing circle or the PRIMED-SAG)
      • Expertise Only (Non-Data) Affiliates who wish to enter into the PRIMED-SAG would do so by signing onto the Consortium Data Sharing Agreement as NON-DATA AFFILIATES.
      • Data Affiliates will sign onto the Consortium Data Sharing Agreement (or equivalent) as DATA AFFILIATES to bring data into the PRIMED-SAG (this will also provide access to PRIMED-SAG Data).

Responsibilities

Responsibilities and expectations of Affiliate Members include:

  • Agreement to adhere to Consortium policies, guidelines and agreements, including the PRIMED Consortium Code of Conduct, Publications Policy, and Data Sharing Policy.
    • Includes agreement to submit PRIMED proposals to solicit input and participation from other Core and Affiliate members in proposed projects and analyses. Submission of PRIMED proposals applies to all Expertise Only Affiliates; applies also to Data Affiliates who are engaging in projects and analyses using PRIMED data.
  • Agreement from each participant that they will not disclose confidential information obtained from other members of the Consortium.

Additional Responsibilities of Expertise Only Affiliate

  • Agreement to participate in PRIMED Consortium activities, including attending calls for the Working Group(s) they choose to join and contributing to the products of these groups.
  • Agreement from each participant to contribute significantly to the project, bringing their particular expertise to bear on accomplishing the goals of the Consortium in a timely manner. Participation should include substantial intellectual contributions to the Consortium.

Additional Responsibilities of Data Affiliate

  • Agreement from each participant to contribute data to accomplish the goals of the Consortium in a timely manner.
  • Sign onto Consortium Data Sharing Agreement as DATA AFFILIATE (or equivalent) to bring data into PRIMED-SAG.

Additional responsibilities and criteria for membership may be added upon recommendations of the PRIMED Steering Committee, PRIMED Executive Committee, and/or NIH program staff.

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Application Process

Expertise Only Affiliate Membership Application Data Affiliate Membership Application

An investigator who is interested in applying for Affiliate Membership to the PRIMED Consortium should provide the required information in no more than two pages.

The application will be submitted to the PRIMED Coordinating Center for pre-review to ensure that the application is complete and that the expertise, research interest, and/or proposed project ideas appear to be in scope for the PRIMED Consortium.

The application will then be reviewed by the PRIMED Executive Committee, optionally in consultation with relevant Working Group(s). The Executive Committee will then make a recommendation to the Steering Committee on whether to approve the application. The Steering Committee then votes on whether to approve the applicant as an Affiliate Member and additionally to participate in the PRIMED-SAG.

A recommendation for approval will be based on the following criteria: 

Expertise Only Applications

  • Applicant has relevant expertise to participate in the Consortium; 
  • Applicant clearly states their reasons for applying and their planned contributions;
  • Proposed research is of interest to and within scope of PRIMED;
  • Investigator has time and commitment to contribute to one or more PRIMED projects

Data Affiliate Applications

  • Quality, diversity, relevance, and timeliness of applicant’s data
  • Applicant’s ability to join the PRIMED-SAG by signing onto the Consortium Data Sharing Agreement as a DATA AFFILIATE

Applicants will be notified as quickly as possible, typically within 2 months, once a determination has been made or if there are questions from the Executive Committee, Steering Committee, or relevant Working Group(s) that must be addressed to move forward.

Affiliate Members will be reviewed annually, at the start of the Consortium fiscal year (April 1), by the Executive Committee to ensure continued interest; contribution; engagement; and adherence to Consortium policies, guidelines, and agreements. Affiliate Member groups who were approved less than one year prior to the start of a given April 1 review cycle will not be expected to submit an annual review form for the given cycle.

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Definitions and Abbreviations

  1. Affiliate Member Applicant - An individual not eligible for Core Membership who wishes to actively participate in and contribute to the scientific activities and mission of the PRIMED Consortium can apply to become a PRIMED Affiliate Member as a subject matter expert (via Expertise only tier) or data contributor (via Data Affiliate tier). An application can come from (1) ​​an individual researcher or a contact PI on behalf of a single institutional research team/lab in the case of Expertise only tier or (2) a contact PI on behalf of a single- or multi-institutional study/cohort or consortium in the case of Data Affiliate tier.
  2. Affiliate Member - An approved Affiliate Member Applicant. The Affiliate Member is permitted to enter into any of the same data access and sharing opportunities available to Core Members as described in the PRIMED Data Sharing Policy (e.g. can enter into PRIMED data sharing circles such as dbGaP or PRIMED-SAG).
    1. Data Affiliate Member - Affiliate Members (e.g. studies or consortia) contributing data (via the CDSA or equivalent) for use by and to carry out the scientific goals of the PRIMED Consortium. Data Affiliate Members have genotype or phenotype/outcome data related to one or more existing PRIMED projects underway.
    2. Expertise Only (Non-Data) Affiliate Member - Affiliate Members contributing relevant expertise that is of interest to and within scope of the PRIMED Consortium.
  3. CDSA - PRIMED Consortium Data Sharing Agreement
  4. SAG - PRIMED Consortium Data Sharing Agreement Group (PRIMED-SAG or SAG) refers to the data sharing circle established by CDSA signatories (MEMBERS, DATA AFFILIATES, NON-DATA AFFILIATES, and their respective COMPONENTS) as defined in the CDSA.
  5. PRIMED Eligibility List (EL) - The list of investigators eligible to enter into PRIMED Consortium-wide data sharing mechanisms (e.g., eligible to submit a PRIMED Coordinated dbGaP application or eligible to be an investigator signatory on the PRIMED Consortium Data Sharing Agreement, CDSA).
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Change Log

  • V2.1 - Clarying path for trainees to apply. Adding details on the Annual Review process.
  • V2.0 - Add Data Affiliate tier, specify options for data access for both Expertise Only (Non-Data) and Data Affiliate tiers - as required by the Consortium Data Sharing Agreement. Approved by PRIMED Steering Committee on May 17, 2023.
  • V1.1 - Link to expertise only application form added
  • V1.0 - Initial Policy. Approved by PRIMED Steering Committee on April 20, 2022.
  • V0.1 - Based on CSER and eMERGE Affiliate Member Policies
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