Steps in the HSRB Process
The main purpose of the Human Subjects Review Board (HSRB) is to ensure the safety of people who voluntarily participate as subjects in research projects.
Regardless of the presence or absence of institutional review, an investigator has a personal responsibility to human subjects and is liable for harm resulting from conduct that disregards the rights of human subjects during the research process.
The legal authority for the HSRB comes from the Federal Policy for the Protection of Human Subjects (described in 45 CFR Part 46, or The Common Rule).
What is Research?
According to federal regulations, "research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge."
What is a Human Subject?
Federal regulations define a human subject as “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information."
All Monmouth College faculty, staff, or student research projects that engage human subjects must be submitted for review. Student researchers should have their faculty sponsor review their completed application and application materials before submission to the HSRB.
- Prior to completing an application for review, please read the HSRB guidelines. The Informed Consent page provides guidelines as to what should be included in an informed consent and an example of an informed consent that you may use as a framework.
- Complete an application for review (including requested email attachments). The application can be found at the Online Submission Form page. This form is automatically submitted to the chair of the HSRB. Please do not send paper copies.
- The application will be reviewed by the chair and the complete project application will be placed in one of three categories; exempt from full-board review, subject to expedited review, or requiring full-board review. The categories are described on the Review Categories page.
- If the project is rejected, the principal investigator may revise and resubmit the proposal.
- Either the board or the investigator can request that the investigator be present at the part of the HSRB meeting when a specific project is being considered.
- If you are seeking an external grant for research, upon request a letter to a prospective funding agency will be issued stating that the proposed research protocol is under review and that the HSRB will make a decision within 60 days. If required and requested, a letter describing the decision of the HSRB will be addressed to the funding agency. Normally, these letters are forwarded to the agency by the investigator and not the HSRB.
- If a project is approved, it will usually receive a one year expiration date. If the research is not completed in a year, the researcher should submit a request for extension. If, at any time after the project is approved, the researcher wishes to make changes to the materials or procedures, an addendum should be submitted to the HSRB for consideration.