The Ontario Birth Study (OBS) is a research platform developed by the Lunenfeld-Tanenbaum Research Institute and Sinai Health System (SHS) with support from Ontario Institute of Cancer Research (OICR) and the Fraser Mustard Institute for Human Development at the University of Toronto. Core material includes self-administered questionnaire data, pregnancy-related clinical and outcome data housed on a database managed by the Applied Health Research Centre of St. Michael’s Hospital (collectively, the “Database”) as well as biospecimens including blood samples and vaginal swabs which are stored at the Mount Sinai Hospital Biospecimen Repository (the “Biobank”).
All new research proposals which seek to access data from the Database (“OBS Data”) and/or samples from the Biobank (“OBS Samples”) shall require approval from the OBS Steering Committee (the “Committee”) before the study is commenced.
Researchers will complete the Data Access Application Form (the “Application Form”), attached hereto, that will be e-submitted to the OBS Steering Committee for review. This process will allow the Committee to assess the viability of the project and the availability of existing OBS Data and/or OBS Samples to fulfill the project objectives. The Application Form also allows the Committee to identify any potential overlap with currently approved projects, and proposed studies. The Committee may offer suggestions for combining substantially similar proposals and will prioritize Data Access Applications on scientific merit if multiple requests are received at the same time.
The OBS Steering Committee will review Application Forms and supporting documentation and will endeavor to provide a response within 30 days of submission of the Application Form. Approved projects requiring renewal for extended access of OBS Data will require completion and submission of the Data Access Renewal Form to the OBS Steering Committee for review.
Both internal (i.e. from within SHS) and external applications to access the Database and Biobank will be treated in the same manner, using the steps and guidelines outlined in this OBS Application Procedure.
If OBS Steering Committee approval is required for a grant application, the applicant should plan accordingly and allow adequate time to seek Committee approval in advance of the grant application deadline. Furthermore, if funding is required to complete the proposed study, applicants may want to delay applications for funding until a recommendation for approval or non-approval of the proposed study is received from the OBS Steering Committee.
Once the required funding is received, the applicant should then apply to their local Research Ethics Board (REB) and the SHS REB for approval of the proposed study. Once both REB approval letters are received by the investigator, copies must be forwarded to the OBS Steering Committee to complete the Data Access Application Form. Investigators will only be provided with data and/or specimens in accordance with the REB application which should be outlined in the Data Access Application Form. Investigators may only contact OBS Subjects for the purpose described in the Data Access Application Form and in accordance with the terms of the OBS Steering Committee approval as applicable.
Ancillary Studies are studies that are proposed to the OBS Steering Committee that intend to use the same subject pool that has consented to participate in the OBS (“Ancilliary Studies” and “OBS Subjects”, respectively). Since many OBS Subjects have consented to be approached for future studies in their executed informed consent forms, applicants may submit a Data Access Application Form to seek approval for the collection of additional information from OBS Subjects through questionnaires, physical measures, or environmental or biological samples. All studies wishing to contact OBS subjects to determine their interest in the Ancillary Study must have a SHS personnel as the principal investigator. Upon approval of applications for Ancillary Studies, the OBS Recruitment Personnel will contact OBS Subjects to determine their interest in participating in the Ancillary Study and to gain OBS Subject’s permission to share her contact information to the approved investigator, as required. At no time will OBS Subject personal contact information be transferred directly to the approved researcher without explicit approval from the OBS Subject to do so.
Applicants proposing Ancillary Studies that require additional OBS Subject participation will provide the OBS with all relevant study materials and tools. These can include data collection instruments (e.g. questionnaires, medical record abstraction forms) and/or a description of the additional measurements or samples that will be collected, as well as a letter of informed consent developed for the Ancillary Study. The consent form for the Ancillary Study must clearly stipulate that it is ancillary to the OBS and that OBS Subject participation in the Ancillary Study is not required for continued participation in the OBS.
Investigators will have exclusive access to the data that they have collected under an approved study for an agreed period of time following data collection. This time period for exclusive access will be determined by the OBS Steering Committee following approval of the Study and shall be defined clearly in the terms of the legal instrument that will be executed following approval. Once this period of exclusive access to study data has elapsed, ongoing collection of the new data as part of the Ancillary Study, as well as any derived data or test results, shall become part of the OBS database. Regardless of whether said study has been published, the study data will be available to other investigators for inclusion in future studies
There are two situations where resubmission is possible. Firstly, when the OBS Steering Committee decides that the submitted application is incomplete, the applicant will be allowed to resubmit his/her Data Access Application Form with the necessary information/documentation/approvals. Secondly, resubmission is possible after the OBS Steering Committee has refused approval of the Data Access Application Form submitted. The applicant will be permitted to submit a revised Data Access Application Form, which should address the comments relayed by the OBS Steering Committee.
Responsibilities of the OBS Steering Committee:
Required Acknowledgement Information
The authors acknowledge the contribution and support of Ontario Birth Study Team members and the participants. We are extremely grateful to all the women who took part in this study and the whole research team. Funding for the Ontario Birth Study has been provided by Mount Sinai Hospital Foundation, Lunenfeld-Tanenbaum Research Institute, Ontario Institute for Cancer Research and the Fraser Mustard Institute of Human Development at the University of Toronto.