Conducting Research with TMA
Q: I am either 1) a contractor working with TMA; or 2) a researcher within TMA or Department of Defense (DoD) who would like to get access to the Military Health System (MHS) data for a project. What do I need to do to be able to start the project?
A: The first thing that you need to do is to figure out whether or not your project qualifies as human subjects research. Your project is considered human subjects research if:
the activity involves collecting data about living people through an intervention/interaction;
the activity involves identifiable, private information.
the activity is a systematic investigation and is designed to contribute to generalizable knowledge.
A lot of research done with TMA qualifies as human subjects research because it involves obtaining data that includes identifiable, private information (i.e. name, social security number, birth date, geographic location, medical diagnosis) and can be considered generalizable (i.e. datasets including very large numbers of cases, plans to publish or present findings). If you are unsure whether or not your project qualifies as human subjects research, contact your local Institutional Review Board (IRB) or the TMA Exempt Determination Official.
Q: My project does not qualify as human subjects research, what do I do next?
A: Your project is not subject to the human subjects regulations, but other regulations may apply. For example, if you are requesting individual level data from TMA, then you need to submit a TMA Data Use Agreement (DUA) to the TMA Privacy Office http://www.tricare.osd.mil/tmaprivacy/default.cfm. Please note that the TMA Privacy Office will review these materials and you will be contacted if additional information is needed. TMA reviewers will make the final determination as to whether or not your project is human subjects research based on the information submitted.
If TMA agrees that your project does not qualify as human subjects research and your DUA is approved, the data can be released to you and you are ready to start your project!
Q: My project does qualify as human subjects research, what do I do next?
A: You will need to create a Research Protocol for the study only if you do not already have a research protocol written. You will also need to submit a TMA Data Use Agreement (DUA) if you are requesting or using individual level data from a Military Health System dataset.
If you do not work within TMA, your research study will need to be submitted to an Institutional Review Board (IRB) for review.
Questions #4-#9 contain additional information about what to do if your project qualifies as human subjects research.
Q: What is an IRB?
A: An IRB is any board, committee, or other group formally designated by an institution (or company) to review, to approve the initiation of, and to conduct periodic review of research involving human subjects. The primary purpose of such a review is to assure the protection of the rights and welfare of the human subjects.
Q: So I have to submit my study to an IRB for review. What if I don't have an IRB as part of my institution or company-what IRB should I use?
A: There are IRBs called Independent IRBs that you can use. Independent IRBs are companies that have constituted IRBs but do not require affiliation in order to submit research to be reviewed (unlike University IRBs). Independent IRBs charge a fee for their review services.
If you work within DoD, you should contact your department to find out where you need to submit your study for IRB review.
Q: I have an IRB as part of my institution/company or I have found an independent IRB, and have submitted my study for review, what now?
A: The IRB will review the study and determine whether the study is exempt (meaning that it meets certain criteria and does not require continuous IRB oversight), can be reviewed and approved via expedited review (meaning that it is minimal risk and meets certain criteria that allows the study to be reviewed and approved by a designated IRB member), or must be reviewed by the IRB at a convened meeting (full review).
Q: The IRB reviewed my study and determined it was exempt or approved it. What do I have to do now?
A: You should follow the directions in the TMA Submission Instructions document under (B.) Secondary Review or (C.) Administrative Review, depending on what best describes your role. Once you submit all of the required information, TMA will review your study and make a determination as to whether or not TMA concurs with the IRB's decision. If TMA concurs with the IRB's decision, you will be issued a TMA approval so that your study can begin. If TMA does not concur with the IRB's decision, you (and possibly the IRB) will be contacted to discuss any questions/concerns.
Q: What if I work within TMA, what kind of review does my study need?
A: You will need to submit the Research Protocol to TMA. Follow the directions in the TMA Submission Instructions document under (A.) Primary Review. TMA will make a decision as to whether or not your study is exempt from IRB oversight. If it is exempt, you will be issued a TMA approval so that your study can begin. If your study is determined not to be exempt, the study will need to be submitted to an IRB for review. TMA will contact you and work with you to identify the IRB to submit the study to.
Q: I have received approval from TMA to start my study, is there anything else I need to do?
A: If your study includes use of TMA data, you will need to complete a DUA. You will need to submit this DUA to the TMA Privacy Office. The DUA must be approved by the Privacy Office before any data is released to you. If your study requires IRB review, typically the Privacy Office will not approve the DUA until you have receives IRB approval for the study. Once you have TMA approval and your DUA is approved, you are ready to start your study!
If your study does not include use of TMA data and you have approval from TMA, you are ready to start your study!