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 some 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 an annual basis. Any substantive changes in protocol should be reported to the responsible committee prior to their initiation.
Obtain CITI certification
The Collaborative Institutional Training Initiative (CITI) program must be completed by all researchers including students prior to submitting their application to the IRB. This is an online training program about the protection of human subjects that takes approximately 4 to 6 hours to complete.
Information about the CITI program is available here.
Students will complete their CITI training when they are enrolled in CD-724-02 in the Spring of their first year.
Quality of Proposals: Institutional Review Boards have begun to look more closely at the quality of the research in addition to the risk and benefits of the research. Many proposals have been 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 Partners affiliates have approved a template to guide the development of informed consent forms and should be followed for all projects. The first part of the form written by the investigator details the purpose and methods of the study for the research participants, explaining all procedures, risks and benefits. The second part of the form should contain specific standard language, assuring the rights of the research participants.
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 do not require informed consent. The review process in these cases is intended to assess the provisions for privacy and confidentiality.