We expect that investigators are changing their procedures to conduct their project remotely or online instead of in-person to reduce COVID-19 transmission risks. In these situations, investigators must report those changes to the Scripps IRB before the changes are implemented. If necessary, however, investigators may implement changes to approved research prior to IRB review and approval, if the changes are necessary to eliminate apparent immediate hazards to the subject (45 CFR 46.108(a)(3)(iii) under the 2018 Requirements and 45 CFR 46.103(b)(4)(iii) under the pre-2018 Requirements). Such necessary changes should then be reported to the Scripps IRB as soon as possible.
And as you plan such changes, please be sure to consider new potential issues related to data confidentiality, especially if one plans to conduct the project remotely via video or audio conferencing platforms (e.g., Zoom, Microsoft Teams, FaceTime, etc.) as the security and privacy of these platforms or where participants may be when participating in studies may be different than when studies are conducted in person.
Scripps College maintains an Institutional Review Board (IRB) in order to ensure the protection of the rights and welfare of human participants in research activities carried out by faculty, students and staff acting under the auspices of the College.
In compliance with College policy, all proposals for research conducted by Scripps faculty, students or staff that involves human participants must be submitted to the IRB for review.
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 participant 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 IRB
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 for a new project to the IRB?
- Email the Scripps College Institutional Review Board to get your IRB Sakai account.
- Read the Belmont Report and complete Ethics Training Course. NOTE: The NIH ethics training system mentioned on this website (and in the IRB proposal template) will no longer be operational after Wednesday, September 26th, 2018. If you have already completed the NIH training, we will continue to honor the resulting completion certificate to show that you have successfully completed the Ethics Training requirement (Question #4 on the IRB proposal template). After the 26th, you can complete the FHI ethics training to satisfy the Ethics Training requirement. This website will be updated soon to reflect alternatives to the NIH training that satisfy our ethics training requirement
- Complete an IRB proposal for your project. (Please note the IRB proposal template has changed to comply with changes to the Common Rule, do not use an older version.)
- Once you have obtained a personal user Dropbox on the Scripps College IRB Sakai site, upload your completed application and proof of Ethics Training Completion to your dropbox.
- Please send an email to the IRB anytime you submit something via your IRB DropBox. Thanks!
How do I submit a renewal request for an existing IRB approved project?
- 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, upload your revised proposal to your dropbox, saving it with a file name that indicates it is the revised proposal.
IRB Review Process
- Write a renewal request letter. Your request for renewal should include 1) the original project title, 2) a request to renew your project’s IRB approval, 3) a description of the progress/status of the project currently (e.g., how many participants currently run, whether or not there have been any adverse events, etc.), and 4) a description of any changes, if any, that you would like to make to the originally approved project at that point.
- Upload your renewal request to your Sakai IRB dropbox.
- Please send an email to the IRB alerting us to your submission.
Full Board IRB Meetings:
The IRB works to regularly receive and review research proposals only during the 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 appropriate 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 appropriate 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 is listed below.
Exempt Review: 10 business days
Federal regulations limit the categories of research that qualify for an exemption. “Data obtained in person, or that are coded and linked to a 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.
Scripps College Survey Administration, Use, and Reporting Guidelines
Proposals requiring full review need to be submitted to the IRB at least one week in advance of a meeting to be considered at a particular meeting.
There will be no full board reviews until the fall and other reviews may take a little longer than the time frames listed above.
To read more about Scripps College’s survey administration, use, and reporting guidelines please visit the Office of Assessment and Institutional Research.
Read more about Scripps College’s policies and procedures related to research integrity here.