OVERVIEW

mSTUDY collaborates with investigators who are interested in working with the cohort participants on exploration of further research questions (prospective studies) and/or in analyzing specimens donated by the cohort participants into the mSTUDY Biorepository (retrospective studies).

For prospective studies:

A standard concept sheet will be available for the interested investigators to describe their research goals, details of their proposal, and their reasons for studying the mSTUDY cohort. The investigators will complete the desired eligibility criteria which will be evaluated by the mSTUDY investigators who will ultimately decide whether the concept conforms to the overall goal of the project. Once the decision is made to allow the prospective study to go forward, the prospective study investigators will obtain IRB approval before any participant contact can be made, complete the Material Transfer Agreement if any specimens are accessed from the Biorepository, and sign the Data Use Agreement.

In order to ensure that the mSTUDY cohort participants’ confidentiality is appropriately maintained, the prospective study investigators will work with the designated data manager and the mSTUDY sites’ staff to establish contact with the participants. The data manager will sort the data collected during the routine study visits according to the desired eligibility criteria for the prospective studies and inform the mSTUDY site staff which participants are eligible; the mSTUDY staff will then distribute the approved recruitment materials from the prospective study, such as flyers and letters, to the selected participants. The participants will then contact the prospective study staff directly if they are interested in participating. The prospective study staff will then have a responsibility to maintain an appropriate relationship with these participants and ensure to complete the appropriate informed consent process applicable to their study. The primary data collected during the prospective studies is required to be reported to the mSTUDY investigators, as will be outlined in the mSTUDY Data Use Agreement.

For retrospective studies:

Similarly to the prospective studies, the investigators who are interested in using specimens from the bio-repository and/or any questionnaire, self-report or other type of data collected in mSTUDY for retrospective studies will complete a concept sheet, outlining their proposals. The request for desired bio-specimens and potential analyzes will be reviewed and evaluated by the mSTUDY investigators. Once the retrospective study is approved and all the required agreements are in place (i.e. Material Transfer Agreement, Data Use Agreement, and/or IRB approval or exemption), the concept study investigators will work with the mSTUDY data manager and the bio-repository lab staff to identify specimens and the accompanying data needed for the study. The designated bio-repository lab techs, supervised by the lab manager, will retrieve the desired specimens and work with the retrospective study staff to deliver them to the appropriate labs/research facilities, ensuring the integrity of the specimens in the process.