9. Submit Documents to an Institutional Review Board (IRB)
The protection of the rights and welfare of all human research participants continues to be an important element in the conduct of research. All researchers are responsible for considering the risks to which research participants are exposed, and for protecting them against all foreseen hazards, be they physical, psychological or social. IRBs review research studies and evaluate whether they adhere to agreed-upon principles for the responsible conduct of research. In accordance with this, they are concerned with the ethical elements of a study, emphasizing safety and protection of research participants, the application of informed consent, the selection of research participants and the assurance of privacy and confidentiality.
All research activities, whether they directly involve human research participants or not, must be reviewed and approved by the IRB. This includes research projects conducted by all students at the IHP. The approval is required even if the project is being conducted at another facility and that facility has already received approval for the project. Projects involving secondary data analysis or review of medical records must also be submitted, although they will usually receive an expedited review.
Application for Approval: In many cases the thesis student’s research project is covered by an existing IRB approval obtained by the advisor, but in other cases the student must prepare a new IRB application or an amendment, in consultation with the advisor. The advisor will be the Principal Investigator (P.I.) for the submission. Materials are submitted to the MGB IRB electronically, through Insight.
NO DATA COLLECTION CAN BEGIN UNTIL FULL IRB APPROVAL HAS BEEN RECEIVED.
Complete Human Research Affairs (HRA) training
Human Research Affairs (HRA) training must be completed by all researchers, including students, prior to submitting an application to the IRB or being added to an IRB protocol. This is an online training program about the protection of human research participants. It is available through Healthstream (link; MGB login required) and consists of two required modules: HRA Clinical Research Boot Camp and HRA Good Clinical Practice. Information about HRA training is available here.
Students will complete this training when they are enrolled in CD-724-01 in the Spring of Year 1.
Quality of Proposals: Institutional Review Boards may look closely at the quality of the research in addition to the risk and benefits of the research. Proposals can be returned for clarification of methods, design, or data analysis procedures. To facilitate timely review of proposals, students should be sure that all aspects of the proposal are clear and have a complete rationale.