The IRB at Scripps is a group of people from Scripps College, from the wider Claremont College community, and from the surrounding community, generally invited by the Dean of Faculty. The IRB is directed by the President and Dean of Faculty at Scripps to review research involving human participants in order to safeguard participant welfare and autonomy. IRB review is required for all research with human participants that is led by researchers at Scripps under the auspices of Scripps College, as stated in the Faculty Handbook (2014):
The Scripps College Institutional Review Board (IRB) shall be responsible for the protection of the rights and welfare of participants in research activities carried out by persons acting under the auspices of Scripps College. All such research activities involving human participants shall be reviewed to determine whether the participants are at risk, and, if risk is involved, whether:
- The risks to the participant (or to groups with which s/he may be identified) are minimized,
- The risks are reasonable in relation to anticipated benefits,
- The selection of participants is equitable, or
- Informed consent is sought from each participate and is appropriately documented.
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
For further information, please contact the Scripps College IRB Administrator Gretchen Edwalds-Gilbert, Dean of Faculty Office, or Scripps College IRB Chair Michael Spezio.
What is Minimal Risk?
“Minimal Risk” means that the probability and magnitude of harm or discomfort anticipated in the research (BOTH the chance of something occurring AND its severity if it in fact occurs) are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (Taken from CFR 46.102(i))
Note that all protocols involving greater than minimal risk require review by the convened Board, in accordance with OHRP guidelines.
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
- Once you have obtained a personal user Dropbox on the Scripps College IRB Sakai site, please use the following online form to complete and send in your protocol: https://www.formstack.com/forms/scrippscollege-irbnewproposalform
- Please send an email to the IRB Administrative Officer anytime you submit something via your IRB DropBox. Thanks!
How Do I submit my revised proposal to the IRB?
- First be sure to look carefully at the IRB’s response letter and take note of all of the requested changes.
- Write your own response letter in which you address each of the requested changes and whether you made them and where they occur in your proposal. If you did not make requested changes, please also note that and provide justification.
- Finally, submit everything via this link: https://scrippscollege.formstack.com/forms/irbrevisedproposalform
IRB Submission Process
The IRB works to regularly receive and review research proposals only during Fall and Spring semesters. Researchers who wish to submit a proposal outside of an academic term (e.g., after finals, over the summer, over winter break) are requested to please contact the IRB Chair to ask if this is possible and if so, to receive information about possible time frames.
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: 10 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: Minimum 15 business days
Research that falls into certain categories and that meets conditions of minimal risk may qualify for Expedited Review status.
Full IRB Review: Minimum 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.