Maternal-Infant Research on Environmental Chemicals (MIREC) – Maintaining and Supporting MIREC Research Platform Infrastructure

TITLE: Maternal-Infant Research on Environmental Chemicals (MIREC) – Maintaining and Supporting MIREC Research Platform Infrastructure

SOLICITATION NUMBER: 1000215287

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 believe that they are fully qualified and available to provide the services or goods described in this ACAN may submit a Statement of Capabilities clearly 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

Centre hospitalier universitaire Sainte-Justine

3175 Chemin Côté Ste Catherine

Montréal, Québec J3T 1C5

4. Definition of Requirements or Expected Results

The Maternal-Infant Research on Environmental Chemicals (MIREC) Research Platform was started in the 2007 with the initiation of the original MIREC Study: a national-level multi-year research study that recruited approximately 2,000 pregnant women from ten cities across Canada. The last MIREC baby was born in the fall of 2011. MIREC has the most extensive biomonitoring data on environmental chemicals for pregnant women in Canada and is a collaborative effort among Health Canada scientists, the Sainte-Justine Hospital in Montreal, and clinical and academic researchers across Canada. Another key component of the MIREC Research Platform is the MIREC Biobank. The Biobank is the repository for both the electronic data collected from all aspects of the MIREC Research Platform and additional biospecimens (maternal urine and blood, umbilical cord blood, infant first stools, breast milk, neonatal dried blood spots, maternal hair and child blood and urine) that are available for future research on the health of the mothers and their children. This future research could include measuring new environmental chemicals, markers of disease, or markers of susceptibility to disease.

Given the major investment in the MIREC Research Platform by the Government of Canada, its academic and clinical partners and Canadian families, it is critical that this unique, extremely valuable and complex resource be maintained to enable forthcoming analysis of the already collected data and biospecimens and further contacts with MIREC families to invite their participation in new research.

The proposed work supports the MIREC Research Platform infrastructure by:

• retaining the experienced coordinating center MIREC staff and key relationships with the MIREC recruitment sites (e.g., Vancouver, Edmonton, Winnipeg, Sudbury, Ottawa, Kingston, Toronto, Hamilton, Montreal and Halifax);
• maintaining the MIREC freezers and biospecimens and micro-aliquotting biospecimens as needed;
• maintaining the MIREC datasets;
• maintaining contact and interest with MIREC participating families;
• providing storage for study materials, questionnaires and equipment used in the MIREC Research Platform studies.

Maintaining this unique and valuable resource will allow the conduct of future research to assess the impacts that fetal, early-life and childhood exposures have on child development and early onset chronic disease.

5. Minimum Essential Requirements

Any interested supplier must demonstrate by way of a Statement of Capabilities that it meets the following minimum requirements:

1. Access to and extensive knowledge of the study population and data collected from the trans-Canada MIREC Research Platform is required. This includes the MIREC Study, the various follow-up studies of mothers and children and the MIREC Biobank.
2. The supplier must demonstrate capacity to establish/maintain research collaborative relationships with 10 clinical recruitment sites across Canada that were part of the MIREC Study (Vancouver, Edmonton, Winnipeg, Sudbury, Ottawa, Kingston, Toronto, Hamilton, Montreal and Halifax) for the recruitment of 2,000 women in the first trimester of pregnancy. Because CHU Sainte-Justine was identified as the study coordinating center for the MIREC Study, they are the only supplier with consent for custody of electronic data and personal identifiers that are a part of the MIREC Research Platform.
3. The supplier must demonstrate capacity to access to the MIREC Biobank. CHU Sainte-Justine maintains the MIREC Biobank, and in the only supplier with consent for custody of the information in the biobank. The biospecimens held in the Biobank cannot be moved to another supplier without seeking participant consent for the change in custody. The cost of moving the biospecimens to a facility with the experienced staff and all the same telecommunications and computer equipment, materials, freezers and associated alarm systems, security, software and space would be prohibitive, if not greater than the value of the proposed contract. Seeking consent from the original 2000 MIREC families to move the data and bio specimens from another supplier would be cost prohibitive. Moving the more than 100,000 biospecimens would also increase the likelihood that the samples would be lost or damaged. MIREC Biobank specimens are being accessed as a part of ongoing MIREC Biobank Projects. Additional specimens are being added to the MIREC Biobank as part of ongoing and future research. 
4. The supplier must demonstrate having the necessary experienced staff with knowledge of the history of the MIREC Research Platform and telecommunications and computer equipment, materials, software and space to plan, develop or modify survey instruments, conduct training, manage the data collected and contribute to communication of the scientific results in peer-reviewed journals.
5. The supplier must demonstrate a proven track record in supporting and conducting multi-site clinical research studies as proven by an extensive publication record. The CHU Sainte-Justine research team and network has both expertise in clinical research, child development and environmental exposure studies necessary for the current study.
6. The supplier must demonstrate capacity to establish/maintain relationships with MIREC investigators and MIREC Biobank project investigators to ensure that the data access and usage polices are followed, and that updates to the policies are recorded and communicated to the investigators. 
7. The supplier must demonstrate the capacity to meet the proposed work requirements by April 1, 2020.
8. The supplier and its proposed personnel must hold a valid Reliability status, granted or approved by Health Canada/PHAC or the Canadian Industrial Security Directorate (CISD), Public Works and Government Services Canada (PWGSC) by April 1, 2020.

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.

CHU Sainte-Justine is the only institute that meets all of the minimum requirements. CHU Sainte-Justine has consent for custody of the contents (data and biospecimens) of the MIREC Biobank.

CHU Sainte-Justine is the study coordinating center for the MIREC Research Platform and is the only research group with the unique blend of technical expertise, knowledge and experience to meet the technological requirements needed to support the MIREC infrastructure.

7. Applicable trade agreements and justification for limited tendering or the Procurement Strategy for Aboriginal Business

This contract is not subject to either the North American Free Trade Agreement (NAFTA) or World Trade Organization - Agreement on Government Procurement (WTO-GPA). It is however subject to the Canadian Free Trade Agreement (CFTA). This requirement is subject to limited tendering procedures in accordance with:

•  CFTA, Article 513.1 (b) (iii)

- NAFTA, Article 1016.2 (b)

• WTO-AGP, Article XV

which allows for contracts to be directed to a particular firm when the products or services can be supplied only by a particular supplier and no reasonable alternative or substitute exists.

8. Ownership of Intellectual Property

Copyright shall vest with the Contractor, although the Contractor shall grant the Crown a license to exercise all Intellectual Property Rights in the Materiel for any public purpose.

9. Period of the proposed contract

The contract period shall be from April 1, 2020 until March 31, 2021, with the irrevocable option to extend the contract up to four (4) one-year option periods.

10. Estimated value of the proposed contract

The estimated value of the proposed contract is $290,860.00, including all costs, taxes exempt. However, this contract will have four (4) option years built into it, dependent upon the availability of funding, worth a combined total of $1,234,080.00, making the total potential value of this contract over five years $1,524,940.00.

11. Closing date and time

The closing date and time for accepting Statements of Capabilities is October 8, 2019 at 2 p.m. (EDT).

12. Contact Person

All inquiries with regard to this Notice must be addressed by e-mail to:

Name: Darlene Fisher

E-Mail: Darlene.Fisher2@canada.ca