Maternal-Infant Research on Environmental Chemicals – Pubertal Timing and Metabolic Function (MIREC-ENDO)

1. Advance Contract Award Notice (ACAN)

An ACAN is a public notice indicating to the supplier community that a department or agency intends to award a contract for goods, services or construction to a pre-identified supplier, thereby allowing other suppliers to signal their interest in bidding, by submitting a statement of capabilities. If no supplier submits a statement of capabilities that meets the requirements set out in the ACAN, on or before the closing date stated in the ACAN, the contracting officer may then proceed with the award to the pre-identified supplier.

2. Definition of the requirement

The Department of Health has a requirement to study the effects of environmental chemicals on human health. The primary objective of this research (MIREC ENDO) is to determine whether prenatal exposure to elevated levels of various environmental chemicals are related to the onset and progression of puberty, child metabolic function and growth. A second objective will be a study of the mother's health to assess the potential effects of exposure to chemicals during pregnancy on her future health.

The proposed study will leverage the MIREC research platform, which represents a significant investment by the Government of Canada of over $15 million since 2008, into research on exposure to and potential health effects of environmental chemicals during pregnancy and early life. The MIREC Research Platform includes:

• the original MIREC Study - a pregnancy cohort study of 2,000 women from 10 sites across Canada;
• the MIREC Biobank - the repository of all data and biospecimens from the MIREC Research Platform;
• MIREC follow-up studies including:
  • MIREC-ID - assessment of infant development at birth and six months of age;
  • MIREC-CD3 - an online survey of child development and behavior at 3 years of age;
  • MIREC-CD Plus - biomonitoring, anthropometry and neurodevelopment ages 2-6 years. 

 The proposed work will involve the following:

• Research ethics approvals and any amendments required at Health Canada and at all study sites;
• Recruitment of participants from the existing MIREC cohort from 9 of the 10 study sites (Vancouver, Winnipeg, Sudbury, Ottawa, Kingston, Toronto, Hamilton, Montreal, and Halifax);
• Data and biospecimen collection from MIREC participants including the logistics (home, site visits, survey/questionnaire administration; clinical testing, processing, shipping and management of biological specimens), in accordance with the study protocol and the project operating procedures;
• Laboratory analysis of new and existing biological specimens in the MIREC Biobank;
• Providing progress reports to the Technical Authority including recruitment and questionnaire completion rates; 
• Data entry, cleaning and validation and follow-ups on any queries generated from data entry and the validation process (e.g., missing data and illogical results);
• Providing advice on the analysis, interpretation, communication and dissemination of the study results for presentation at scientific conferences, publication in scientific journals, and government agencies.

The proposed contract would be completed in three phases:

a. Phase 1: study of girls and boys ages 7 to 10 from contract award to March 31, 2021.

It is essential the work for Phase 1 start spring 2017 in order to collect data in the younger population for assessment of early puberty. If there is any delay some of the MIREC children will have already reached puberty and it will be too late to determine the effects of chemicals on the start time of puberty.

b. Optional Phase 2: study of girls ages 11 to 12 and boys ages 12 to13 from April 1, 2021 to March 31, 2024; and

c. Optional Phase 3: study of girls ages 13 to 14 and boys ages 14 to 15 from April 1, 2024 to April 1, 2028.

3. Criteria for assessment of the Statement of Capabilities (Minimum Essential Requirements)

Any interested supplier must demonstrate by way of a statement of capabilities that it or its subcontractors meet the following requirements:

3.1 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.

3.2 The Supplier must demonstrate it 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 at least 1000 mother-child pairs.

3.3 The Supplier must provide a work plan schedule demonstrating that they have the ability to meet the timelines for the three phases of the Work.

3.4 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.

3.5 The Supplier must have a clinical 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, 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-centre, with participant recruitment at 5 or more sites from at least 3 Canadian provinces, in large urban population centres (populations over 100,000).

3.6 The Supplier must demonstrate that it has validated methods for the 24 phthalate metabolites listed in table 1 (attached) and can achieve the limit of detection (LOD), and the analysis permits comparison of the results to the results of a nationally (Canadian) representative biomonitoring survey that has measured phthalate metabolites in the Canadian population (such as the Canadian Health Measures Survey). Proof of comparability would include: (i) having acted as the reference laboratory for nationally representative biomonitoring survey at least once in the past three (3) years; or (ii) validation of the comparability of the methods used and results of the analyses with a laboratory that has acted as a reference laboratory for a nationally representative biomonitoring survey.

3.7 The Supplier must currently have the following ISO certifications:

a. ISO/IEC 17025:2005 with a scope which specifically includes competence in the detection of: Elements and Trace Metals in urine, blood, tissues and meconium (specifically M-571; M572; M-580; M-589); Organic Contaminants including pesticides, flame retardants, perfluorinated compounds, and chemicals used in plastic manufacturing (specifically E-446, E-475, E-490, E-491, E-495, E-501);

b. ISO/IEC 17043:2010 with specific accreditation for: Inter-laboratory Comparison Program for Metals in Biological Matrices for the detection of the following metals, with lower limits of detection as noted: blood Cadmium (5.0 nmol/L), serum Copper (1.0 µmol/L); blood Lead (0.050 µmol/L), inorganic blood Mercury (5.0 nmol/L), organic blood Mercury (5.0 nmol/L), serum Selenium (0.50 µmol/L), serum Zinc (2.0 µmol/L). Inter-laboratory Comparison Program for AMAP Rings test for Persistent Organic Pollutants in Human Serum, specifically proficiency testing for Flame Retardants, Pesticides, and the following six (6) Perfluorinated Compounds (lower limits of detection in µg/L): PFHxA (0.50); PFHxS (0.50); PFNA (0.20); PFOA (0.50); PFOS (1.0), PFUdA (0.20).

3.8 The Supplier must demonstrate capacity and expertise to develop assays for and complete the measurement of (1) by Liquid Chromatography Mass Spectrometry in serum: estradiol, progesterone, testosterone, Dehydroepiandrosterone Sulfate, total and free triiodothyronine and thyroxine; (2) by immunoassay in serum and urine: follicle stimulating hormone and luteinizing hormone. 

3.9 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.

3.10 The Supplier must have a lead investigator with:

a. a doctoral or medical degree; and

b. 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

c. Minimum 3 years’ experience as the lead investigator for a Canadian pregnancy cohort study as defined under section 3.5; and

d. Minimum 10 published peer reviewed papers related to a pregnancy cohort in the past 5 years.

3.11 The Supplier must demonstrate it has a network of clinical and academic research experts, including the following expertise:

• A Paediatric Endocrinologist with 5 peer reviewed publications in the past 5 years on the subject of pubertal staging and timing of puberty; and
• A Perinatal Epidemiologist with 5 peer reviewed publications in the past 5 years on the subject of maternal determinants of fetal and infant health outcomes; and
• An Epidemiologist or Public Health professional with 5 peer reviewed publications in the past 5 years on the subject of developmental effects of environmental chemicals on children's health.
   

4. Applicability of the trade agreements and Comprehensive Land Claims Agreements
This procurement is subject to the Agreement on Internal Trade (AIT).

This procurement consists of services related to a medical/health study which is excluded from the application of the North American Free Trade Agreement (NAFTA) as per Annex 1001.1b-2, Class B - Special Studies and Analysis - not R&D, B503 - Medical and Health Studies, and is not listed under the World Trade Organization Agreement on Government Trade (WTO-AGP). 

The Comprehensive Land Claims Agreements (CLCAs) are not applicable to this procurement, as work will not be delivered to, nor conducted within CLCA areas.

5. Justification for the Pre-Identified Supplier

It is proposed to issue a sole-source contract to the Centre hospitalier universitaire (CHU) Sainte-Justine, Montreal, Quebec, on the collective basis indicated below:

5.1 CHU Sainte Justine currently has MIREC participant consent for custody of the biological samples; and either CHU Sainte Justine only, or both CHU Sainte Justine and the applicable hospital study site, currently have participant consent for custody and use of the personal information.

Changing suppliers could cause significant negative impacts on not only the proposed MIREC ENDO study but also the entire $15M MIREC Research Platform. A new supplier would need to seek Research Ethics Boards’ (REB) approval to transfer the personal information from the current supplier’s coordinating centre to their coordinating centre. If the REBs approve, the supplier would need to contact all MIREC cohort participants to obtain permission for the transfer. Seeking approval to transfer the personal information to a new supplier would cause a significant delay during which vital study data will be lost. This will negatively affect Health Canada’s ability to deliver data to contribute to the completion of the assessment of chemicals that are of a public health concern.

A new supplier also may need to seek approval and consent for the transfer of data and biospecimens from the MIREC Biobank in order to ensure that MIREC ENDO data and biospecimens can be stored in the Biobank. At this time there is valid contact information for only approximately 1300 of the 2000 MIREC participants. This means 700 participants cannot be contacted to request permission to transfer their banked data and biological samples, and these could not be transferred. This represents a loss of 35% of the samples available in the MIREC Biobank for future research, such as testing stored samples for new chemicals of interest. Not all participants are expected to consent to the transfer, and there is a risk of loss or damage to the biological samples if transferred, further reducing the number of samples available for future research. This cumulative loss significantly reduces the scientific value of the Biobank, and would negatively impact Health Canada’s ability to deliver data to contribute to the assessments of chemicals of concern.

5.2 CHU Sainte Justine has the facility and equipment necessary to perform the work and meet all of the work requirements. As such, no transfer of facility, equipment and associated items would be required thereby protecting the research and results done to date and furthermore maintaining the ability to complete the required work with a satisfactory level of integrity. Risks in changing suppliers include following.

1. Lack of interoperability of supplier system/database causing damage to the existing MIREC Research Platform and MIREC Biobank including all existing research performed and data collected to date;
2. Lack of interoperability of supplier system/database thereby compelling Canada to purchase additional items to make operability possible and/or to recover data/goods.
3. Loss of data/goods that are non-recoverable and thereby lessen and/or destroy the merits/integrity of the required work. 
4. Additional time respecting all aspects associated with the transfer of supplier that would impact the timelines for the work, in particular Phase 1, and ultimately the required work. 

5.3 CHU Sainte Justine has the necessary qualifications and experience to perform the work and to meet all of the work requirements. They have formed valuable research collaborations over the past 10 years with leading scientific experts in Canada required for the MIREC studies. In addition, CHU Sainte Justine has the established study relationship with the participants of the MIREC study and each of the applicable REBs. 

6. Government Contracts Regulations Exceptions

The following exception to the Government Contracts Regulations is invoked for this procurement under subsection 6(d) - only one person is capable of performing the work. The reasons are given in article 5.

7. Exclusions and/or Limited Tendering Reasons

The following exclusion(s) and/or limited tendering reasons are invoked under the Agreement on Internal Trade (AIT) – Article 506, paragraph 12(a): to ensure compatibility with existing products, to recognize exclusive rights, such as exclusive licenses, copyright and patent rights, or to maintain specialized products that must be maintained by the manufacturer or its representative. As stated in article 5, integrity and value of the data relies on the work/research undertaken to date.

8. Cost estimate of the proposed contract

The costs for the proposed work are as follows:

• Phase 1: $6,686,857, Applicable Taxes included
• Optional Phase 2: $4,157,291, Applicable Taxes included
• Optional Phase 3: $4,724,963, Applicable Taxes included

9. Statement of Capabilities

Suppliers who consider themselves fully qualified and available to provide the services described above may submit a statement of capabilities in writing to the contact person identified in this notice on or before the closing date of this notice. The statement of capabilities must clearly demonstrate how the supplier meets the advertised requirements.

The closing date and time for accepting statements of capabilities is: April 12, 2017.

Inquiries and statements of capabilities are to be directed to:

Brooke Taylor

Supply Team Leader

Telephone: 873-469-4792
E-mail: brooke.taylor@tpsgc-pwgsc.gc.ca