Maintaining MIREC Platform Resources: Biobank, Data, Research Community, and Participant Engagement

ADVANCE CONTRACT AWARD NOTICE (ACAN) Title: Maintaining MIREC Platform Resources: Biobank, Data, Research Community, and Participant Engagement. Solicitation Number: 1000266964 1. The Purpose and Explanation of an ACAN An Advance Contract Award Notice (ACAN) allows Health Canada to post a notice for no less than fifteen (15) calendar days, indicating to the supplier community that a goods, services or construction contract will be awarded to a pre-identified contractor. If no other supplier submits, on or before the closing date, a Statement of Capabilities that meets the minimum requirements identified in the ACAN, the Contracting Authority may then proceed to award a contract to the pre-identified contractor. 2. Rights of Suppliers Suppliers who consider themselves fully qualified and available to provide the services or goods described in this ACAN may submit a Statement of Capabilities demonstrating how they meet the advertised requirement. This Statement of Capabilities must be provided via e-mail only to the contact person identified in Section 12 of the Notice on or before the closing date and time of the Notice. If the Bidder can clearly demonstrate they possess the required capabilities, the requirement will be opened to electronic or traditional bidding processes. 3. Proposed Contractor CHU Sainte-Justine 3175 chemin de la Cote-Sainte-Catherine Montreal QC 4. Definition of Requirements or Expected Results Under the Canadian Environmental Protection Act Health, Canada is mandated to study the levels of health effects of hormone disrupting chemicals in the environment. The proposed work is to maintain the Maternal-Infant Research on Environmental Chemicals (MIREC) research platform. The main objectives of the work are: 1. Retaining the experienced MIREC study coordinating center staff; 2. Maintaining the MIREC Data and Biospecimen Bank (Biobank); 3. Keeping MIREC participants up to date, engaged, and safeguarding the potential of the MIREC cohort for future longitudinal research: 4. Managing MIREC Biobank access in a manner that meets with the Biobank access policies, including communication with the MIREC Biobank Management Committee and investigators & supporting researchers’ access and work with MIREC data; More specifically, the main tasks for the requirement are related directly to the objectives of the requirement, and are as follows: 1. Retaining the experienced MIREC study coordinating center staff: a. Support all ongoing activities/objectives listed below b. As required, renew human studies research ethics committee certificates annually for all MIREC Research Platform studies; c. Organize and participate in MIREC teleconferences with the Scientific and Technical Authority and document any decisions; d. Liaise with site investigators and site research staff; e. Contribute expertise and administrative support to the preparation of any research grants involving the MIREC participants. f. Maintain and update the bilingual MIREC website to support researcher interaction, including information on progress and results of follow-up studies, publications, and how to access the MIREC Biobank g. Maintain and monitor MIREC website, MIREC e-mail addresses, and MIREC toll free phone numbers to receive and respond to public inquiries h. Develop, produce and distribute updates for stakeholders including MIREC investigators and Biobank investigators. 2. Maintaining the MIREC Data and Biospecimen Bank (Biobank); a. Safeguard and track all biospecimens b. Maintain and update databases from all the MIREC studies c. Store study materials including empty biospecimen collection containers, blank questionnaires, and testing equipment from all MIREC studies; d. Provide secure storage facilities for all paper questionnaires and consent forms separate from any directly identifying information. e. Respond to requests to access Data and Biospecimens from the MIREC Biobank f. Provide Health Canada researchers with approved Data and Biospecimen access requests with access to data from the MIREC Biobank for no additional cost and biospecimens from the MIREC biobank at no, or reduced cost. 3. Keeping MIREC participants up to date and engaged, and safeguarding the potential of the MIREC cohort for future longitudinal research: a. submit all participant communications for approval by the Scientific and Technical Authority and ethics committees when required; b. continue regular communications with the participants (at least twice annually), and summarize those communications in the biannual reports; c. communicate with MIREC youth, directly or through their parent (at least once annually), and summarize communications in the biannual reports; d. develop and send by e-mail or Canada Post copies of newsletters and birthday cards for MIREC youth; e. respond to participant inquiries; f. maintain and update the bilingual MIREC website with new content, including: g. continue other participant engagement activities, including social media posts, sharing MIREC results, and receiving participant feedback; h. update and manage the original MIREC study participant contact information database 4. Managing MIREC Platform and MIREC Biobank activities in a manner that meets with the established data use and access policies: a. communication with the MIREC Biobank Management Committee; b. Collect information from MIREC Platform researchers and Biobank users about the status of their ongoing and future projects. c. provide administrative and coordination support for MIREC Platform data access requests for internal research questions, including reviews of data requests, and contacting theme leaders; d. provide administrative and coordination support for the MIREC Biobank Management Committee, including budget, scheduling and taking notes at meetings, and records of status of all biobank applications; e. update/renew MIREC Governance documents and information collection tools as needed, in consultation with the Scientific and Technical Authority 5. Minimum Requirements Any interested supplier must demonstrate by way of a Statement of Capabilities that it meets the following minimum requirements: A) The Supplier must demonstrate that they either already have access to, or have a detailed plan to obtain access to, the MIREC Biobank and MIREC Cohort. This includes seeking participant consent to have custody of and/or access to the personal identifiers, and if applicable, the ability to transfer the biological specimens to the supplier’s facility without damage. B) The Supplier must demonstrate they can provide the appropriate infrastructure (safe long-term storage to protect data and biospecimens from loss due to equipment failure) and maintenance for a biobank with over 100,000 aliquots of biological material, servers and software to store collected data from approximately 1900 mother-child pairs. C) The Supplier must demonstrate previous successful interactions with at least three (3) Canadian Research Ethics Boards. Previous successful interactions are defined as the submission of an ethics application for least one (1) research study involving the collection of personal information, biological samples, and questionnaire data from study participants in the past 10 years which was approved and maintained in good standing for at least two (2) years, and either continues to be in good standing, or a final report was accepted by the Research Ethics Board. D) The Supplier must have a research Coordinating Centre site with at least five (5) years of experience in the past 10 years providing logistical, technical, and personnel support, including administrative, data management, IT and accounting services for a Canadian pregnancy cohort study where: • At least 1000 women were followed and biological specimens (blood and urine) collected from first trimester pregnancy through delivery; • At least one follow-up health study of at least ¼ of the cohort for data and biological specimen collection from both the mother and child after birth of the child; • Multi-center, with participant recruitment at 5 or more sites from at least 3 Canadian provinces, in large urban population centers (populations over 100,000). • The Supplier must demonstrate it has personnel capable of communicating study information verbally and in writing in both English and French, for the purposes of training study site personnel in standard study procedures, communicating with research ethics boards and site staff, and communicating with study participants. • The Supplier must have a lead investigator or investigator team with: i. a doctoral or medical degree; and ii. a current, or recent (at least 3 years in the past 10 years) academic appointment at a University, Research Hospital or Research Institute, where an academic appointment is defined as a Teaching & Research Appointment in the Professorial Ranks (Professor, Associate Professor, Assistant Professor) including Tenure Track, Tenured, Adjunct or Clinical appointments; and iii. Minimum 3 years’ experience as an investigator for a Canadian pregnancy cohort study as defined under section 3.4; and iv. Minimum 5 published peer reviewed papers related to a pregnancy cohort in the past 5 years. E) The Supplier must demonstrate it has a network of clinical and academic research experts to provide advice on the handling, analysis, and storage of the biobank materials, including: • Blood • Teeth • Urine • Hair 6. Reason for Non-Competitive Award Section 6 of the Government Contracts Regulations contains four exceptions that permit the contracting authority to set aside the requirement to solicit bids. For the proposed procurement, the following exception applies: (d) Only One Person or Firm is capable of performing the contract 7. Applicable trade Agreements and Justification for Limited Tendering This procurement is subject to the following: • Canadian Free Trade Agreement • Canada-Chile Free Trade Agreement • Comprehensive and Progressive Agreement for Trans-Pacific Partnership • Canada-Colombia Free Trade Agreement • Canada-European Union Comprehensive Economic and Trade Agreement • Canada-Honduras Free Trade Agreement • Canada-Korea Free Trade Agreement • Canada-Panama Free Trade Agreement • Canada-Peru Free Trade Agreement • Canada-Ukraine Free Trade Agreement • Canada-United Kingdom Trade Continuity Agreement • World Trade Organization-Agreement on /Government Procurement 8. Ownership of Intellectual Property Contractor will own the Intellectual Property. 9. Period of the Proposed Contract The contract period shall be from the 1st of April 2026 until the 31st of March 2027, with four (4) option periods. 10. Estimated Value of the Proposed Contract The estimated value of the proposed contract is $1,600,000.00 including all applicable taxes plus four (4) option years 11. Closing Date and Time The Closing Date and Time for accepting Statements of Capabilities is the 14th of November at 2 p.m. 12. Contact Person All enquiries must be addressed by e-mail to: Name: Eryn Mathers E-Mail: contact@example.gov