Research Involving Human Subjects
Research is defined by federal law 45 CFR 46 as
“a systematic investigation designed to develop or contribute to generalizable knowledge.
A “systematic investigation” is any methodical collection of data. This includes interviews, surveys, tests, observations, or other experiments, regardless of content, even if it is a pilot study.
Research is designed to “contribute to generalizable knowledge,” when it is aimed at adding something new to a field of knowledge (e.g., the field of psychology, the field of biology).
A research project is considered to have human subjects if it involves “a living individual about whom an investigator . . . obtains data through intervention or interaction with the individual or identifiable private information.” §46.102
How Do I submit a proposal to the IRB?
- E-mail Amy Emmert to get your IRB Sakai Account.
- Complete Ethics Training Course.
- Prepare Your Application
- Submit all of your application materials in one PDF document to your Sakai Dropbox. Once placed in your Dropbox, send an e-mail notification so IRB members will know it is there.
IRB Submission Process
Once the Scripps College IRB has received your proposal, the IRB Chair will conduct a preliminary review to determine the review status of your proposal. The review status will affect you only in that each type of review — Exempt, Expedited, and Full — requires a different amount of time between proposal submission and final approval. For information purposes, the approximate length of reviews are listed below.
Exempt Review: 5 business days
Federal regulations limit the categories of research that qualify for exemption. “Data obtained in person, or that are coded and linked to name, record number, social security number or other identifiers do not qualify for exempt review status.”
Expedited Review: 7-14 business days
Research that falls into certain categories and that meets conditions of minimal risk may qualify for Expedited Review status.
Full IRB Review: 14-30 business days
IRB reviews are guided by the ethical principles set forth in The Belmont Report: Ethical Principles and Guides for the Protection of Human Subjects of Research of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.