9. Submit Documents to an Institutional Review Board (IRB)
The protection of the rights and welfare of all human subjects 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 most cases the thesis student’s research project may be 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 Partners IRB electronically, through Partners Insight.
NO DATA COLLECTION CAN BEGIN UNTIL FULL IRB APPROVAL HAS BEEN RECEIVED.
IRBs will monitor all ongoing projects by requesting progress reports on a regular basis. Any substantive changes in protocol should be reported to the responsible committee prior to their initiation.
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.
Informed Consent Forms (ICF)s: All projects that directly involve human research participants require the use of informed consent prior to the participation of any individual. The MGB IRB requires use of their approved template when developing an informed consent form. Approval of proposals can be delayed because of needed changes in the ICF. Students should work with their readers to develop a form that is complete, uses appropriate language, and is clear in the specification of risks and benefits. All signed ICFs must be maintained in a file by the P.I. and a copy must be provided to the research participants.
Although all projects must be approved by the appropriate IRB, those that are limited to analysis of existing data either in databases or past medical records may not require informed consent. The review process in these cases is intended to assess the provisions for privacy and confidentiality.