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The IRB governs the field of research with human subjects. "Research" and "human subjects" are legally defined as follows:
Research: "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge" (Federal Policy for the Protection of Human Subjects)
Human subjects: "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" (Federal Policy for the Protection of Human Subjects)
If you are a faculty member requiring student research with human subjects in a course and the students will not present the findings of their research outside of the course:
Fill out and submit the Faculty Assurance Form (Google Form linked).
Provide evidence that you, the faculty member, have completed CITI training (upload CITI Certificate on the linked Google Form).
If you are a faculty member, student, or staff member conducting research with human participants, with the intention of external dissemination of results, you should submit the following items via email to irb@eckerd.edu
A completed Research Proposal Form (provided below).
A sample Consent Form (optional template provided below).
Evidence that you and all researchers affiliated with the study have completed CITI training.
(If your research will be in a language other than English) A completed Verification of Translated Research Documents form (GoogleForm linked)
Note: Approvals are for one year, please submit a renewal form each year that you continue the research.
If you are a faculty member, student, or staff member conducting research with human participants, with the intention of external dissemination of results and you wish to renew or modify a project that has previously received IRB approval, you should fill out and submit the IRB Renewal and Modification Form (GoogleForm linked).
CITI stands for Collaborative Institutional Training Initiative. To go through the appropriate training (good for three years), which consists of a number of information modules with short quizzes at the end:
Go to citiprogram.org.
Set up a username and password.
Choose "Add a Course or Update Learner Groups."
Choose "Social & Behavioral Research Investigators" Biomedical Research", or "Students conducting no more than minimal risk research" as appropriate. That will generate the courses needed.
Unless directed to do so, you do not need to enroll in the Responsible Conduct of Researchers course.
Researchers who are not affiliated with Eckerd and would like to use Eckerd as a research site and/or include populations at Eckerd, faculty and/or staff) are required to have an Eckerd affiliated researcher as a co-Investigator and be approved by the Eckerd IRB.
If you are an investigator who is unaffiliated with Eckerd College, you must have permission from the IRB before recruiting participants via email, fliers/posters or other campus spaces (virtual and physical). Researchers who are unaffiliated investigators should contact us at irb@eckerd.edu and include the following materials:
A description of the recruitment materials and a justification for recruiting Eckerd participants,
A copy of the IRB approval, and
Copies of the instruments, surveys, etc and the consent form.
If your request is approved, we will send you a letter providing you permission to recruit on campus.
Timeline for Approval: Please provide the IRB adequate time to review your materials. Proposals classified as expedited are typically reviewed within two weeks. Proposals requiring full board review will be discussed at the next monthly IRB meeting, which are only held during the academic year (The IRB does not meet during the summer or during Winter Term). Proposals must be received the week prior to the meeting. Proposals submitted during the summer will not be reviewed until the Fall term and proposals submitted during the Winter term will be reviewed in the Spring.
Timeline for Approval: Please provide the IRB adequate time to review your materials. Proposals classified as expedited are typically reviewed within two weeks. Proposals requiring full board review will be discussed at the next monthly IRB meeting, which are only held during the academic year (The IRB does not meet during the summer or during Winter Term). Proposals must be received the week prior to the meeting. Proposals submitted during the summer will not be reviewed until the Fall term and proposals submitted during the Winter term will be reviewed in the Spring.
The use of campus email lists is not within the purview of the IRB and IRB approval does not guarantee approval to administer survey via college email lists. For more information, please contact Jacqueline MacNeil, Executive Director of Institutional Effectiveness, at macneijm@eckerd.edu.
Use of Giftcards as incentives: Please see the FAQ section for guidelines on the use of giftcards.
Use of Giftcards as incentives: Please see the FAQ section for guidelines on the use of giftcards.
Use of Materials in Languages other than English: If you are conducting research in a language other than English, please complete and submit this form to verify that the translated materials are accurate. The person who translates/approves the translation must sign a declaration attesting to their qualifications to serve as a translator. Please Note: Please submit the materials to be translated in English first, so that the translated materials are based on the approved materials. If the investigator or a member of the project team may translate the materials if they are qualified to do so.
Anonymity and confidentiality: During human subjects research, data collected and the methods of data collection may be either anonymous, confidential, or neither. They cannot, by definition, be both. Definitions are as follows;
Anonymous: Data are recorded such that no identifier whatsoever exists to link a subject's identity to that subject's response. No one can link an individual person to the responses of that person, including the investigator.
Confidential: There exists a documented linkage between a subject's identity and his/her response in the research, and the investigator provides assurance in the protocol and in the informed consent form that the identity of any individual subject will not be revealed in any report of the study. Confidential means that the investigator can (or could) identify individuals who participated in a study, perhaps through a code. If you collect a consent form (either in person or online) where participants sign their name, your study is confidential, not anonymous. The majority of proposals submitted through the Eckerd IRB are for confidential protocols.
IRB FORMS
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