The following are the essential elements of the IRB process. Please read through and familiarize yourself with these elements before submitting a proposal; it will make the process quicker, easier and more coherent.
If you wish to conduct a research study at Smith College that has been approved by another institution (primary IRB), you must also receive approval from the Smith College IRB. The review performed by the primary IRB must meet the human subject protection requirements of the Smith IRB. Approval by the primary IRB does not guarantee approval by the Smith IRB.
Prior to seeking approval from the Smith IRB, see sections 1 and 2 above, and then submit the following to email@example.com or via campus or U.S. mail to Bass Hall, room 302:
You may be asked to provide other documentation, as needed.
While conducting your research, you are responsible for reporting any deviations from the approved protocol and/or adverse events to the IRB. If in the course of conducting your research you need to change the procedures, you are required to submit a Research Project Change of Protocol Form to the IRB for approval. You are required to respond in a timely fashion to the annual renewal notices sent by the IRB to every researcher with an open project. When you have completed your research, you must notify the IRB of the completion of your project. Please keep the IRB abreast of any changes in your contact information while your project remains active.
Proposals approved under Full and Expedited Review must be renewed annually. The IRB will initiate contact with the primary investigator to inquire about the status of the research project. Application forms for Continuing Review are also available for download on this site. If you are a Primary Investigator and will no longer be affiliated with the College at that time (e.g. graduation, end of employment, etc.), you must contact the IRB prior to your departure with alternative contact information for your project.
Deviations from Approved Protocol
A Protocol Deviation is an incident involving non-compliance with the approved proposal, but typically does not have a significant effect on the integrity of the research or on the participants' rights, safety or welfare. As the Primary Investigator (PI), it is your responsibility to report any action taken by a researcher that goes beyond or outside what has been approved by the IRB. You can download a Protocol Deviation Report for this purpose.
Adverse/Unanticipated Events and Findings
During the conduct of your research, you may have findings whose nature, severity and/or frequency are not described in the proposal approved by the IRB. Examples include, but are not limited to, unexpected complications in a subject, missteps in the study procedures or consent documentation, or breaches of confidentiality. Alternatively, you may encounter problems or events that are potentially harmful to either the participants or the researcher. In either case, you must report these facts immediately to the IRB using an Adverse/Unanticipated Events Report.
Changes of Protocol
If at any time you wish to make any change to the research procedures you originally submitted to the IRB, you must submit a Research Project Change of Protocol form. Make sure to fill in the correct information about the project's primary investigator, title and project number. Once these changes have been approved, the IRB will forward a copy of the signed form to you.
When data collection and analysis have been completed, you must report this using a Research Proposal Continuation/Completion Form.
Documentation and Record keeping
Investigators must store signed consent documents in a way that ensures confidentiality of participants' information. Smith College will prepare and maintain documentation of IRB activities. This documentation is kept on file for at least 3 years after completion of the research and includes: copies of all research proposals reviewed, evaluations, approved sample consent documents, progress reports, and reports of injuries to subjects; minutes of IRB meetings; copies of IRB correspondence; a list of IRB members; and copies of policies and guidelines.