- Animal Subjects
- Human Subjects
- Recombinant DNA Molecules
- Collaborative Institutional Training Initiative
4200 54th Avenue South
St. Petersburg, FL 33711
toll-free: (800) 456-9009a>
Instructions for Researchers Using Human Subjects
These principles govern whether or not your research will be subject to Full Review by the IRB:
- If it involves children or other vulnerable populations (e.g., the disabled); OR
- If it involves procedures that might cause stress, discomfort, or adverse reactions, including psychological harm (e.g., embarrassment, emotional distress, breach of confidentiality), economic harm, and legal jeopardy beyond levels encountered in daily life; OR
- It involves the deception of participants.
All forms should be submitted via e-mail to firstname.lastname@example.org. Forms that require signatures should be scanned and e-mailed via multi-function copiers located in collegial offices. If you require assistance scanning and e-mailing documents, contact email@example.com.
A. If the research to be conducted is a course-related assignment that does NOT involve any of the principles stated above and has met the conditions stated in "Review by a Supervising Faculty Member, please follow these procedures:
- If you are the instructor for a class AND if no student's research will involve any of the three stated principles that govern Full Review AND if no student's research will be presented in a forum outside of an Eckerd classroom, then please submit (using the instructions above), the Faculty Assurance Form. The Faculty Assurance Form singly seeks approval by the instructor for course-related research projects for all students in one section of one course during one semester. (This form must be re-submitted for each section of the same course each semester that research is a required part of the course.)
Each student's proposed project must have been reviewed and approved by the supervising faculty member. The faculty member must maintain for at least three years a file of these submitted Faculty Assurance Forms for each section of a course in which course-related research was required to be conducted by the students.
B. If the research to be conducted is believed NOT to involve any of the three principles stated above and has met the conditions stated in the Exempt/Expedited Review, then the student researcher must submit to the IRB (using the instructions above) ALL of the fully completed forms listed below:
- The fully completed form, Proposal for IRB Exemption;
- The fully completed form Information About This Study;
- A full copy of the actual questionnaire or survey or research design; and
- A copy of a certificate that the student researcher has completed the College-prescribed training for research with human subjects; this certificate must have been signed and dated by the faculty member who is supervising the research.
The Chairperson of the IRB or his/her designee will review the content of these forms and notify the supervising faculty member and the student if the research proposal has been approved for Exempt/Expedited Review.
C. If the proposal does NOT meet the standards for an Exempt/Expedited Review OR the research involves one of the three stated principles that require a Full Review, i.e., vulnerable populations, potential harm or deception, then the review process continues under Full Review, as follows:
- If, after review by the IRB Chairperson of his/her designee, the Exempt/Expedited Review is not approved, the student must complete and submit (using the instructions above) the full IRB Proposal Form at least one week prior to the intended date for commencement of the research, as well as the completed Informed Consent for Research Involving Human Subjects Form that will later be signed by participants.
- The IRB will meet within five working days of the student's submission of essential forms (named above) for Full Review and return a decision as soon as possible to the student and supervising faculty member whether or not the research has been approved.
- If approved, the research may begin immediately. If not approved, the Board will present a written explanation of why approval has been denied. At that point, the student may revise the proposed research so as to address the reason for denial OR choose another research design. In either case, the student must re-submit the proposal through the review process above.
If the research involving human subjects is to be conducted by a faculty member, the above procedures must also be followed (with the exception of submission of the Faculty Assurance Form).