HUMAN
RESEARCH PROTOCOL
Rev. 8/21/2013 1
The Galileo School is pleased to partner with researchers wishing to conduct human subjects research that is mutually beneficial to both the researcher and the school. Researchers interested in conducting human subjects research must complete this protocol and submit electronically to . Requests for research will reviewed on a rolling basis as described within the Galileo Human Subjects Research Procedures. Researchers can usually expect a decision on the status of their research within three weeks from the date of submission. Please note: Research at the Galileo School will not be considered unless and until it has received approval from an institution that adheres to Federal Policy (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm) (most colleges and universities, such as UCF, which receive federal funding adhere to this federal policy). Please include a copy of the IRB approval letter or indicate when the research was submitted for approval.
Questions about conducting research at the Galileo School can be directed to .
Please Note: Depending on the nature of your research, certain sections below may not be applicable. Indicate this as appropriate.
GENERAL INFORMATION1. Protocol Title
2. Primary investigator and affiliation
3. Email address of primary investigator
4. Phone number of primary investigator
5. Co-investigator(s) and affiliations
6. Objectives of the research
7. Background (i.e., theoretical/conceptual framework) [please attach a complete literature review to this document and summarize here]
8. Resources available to conduct the human research
9. Setting of the human research
a. Number and type (e.g., grade level) of teacher participants desired (if a specific grade level is desired, please indicate)
b. Number and type (e.g., 3rd grade only) of student participants desired
c. Anticipated class time required (if multiple dosages are required, indicate the number of days and amount of class time per day)
d. School facilities needed ((briefly list space, materials, equipment, etc. necessary for the proposed research, indicating those that the researcher will be providing—also list the purpose or use intended for each item listed)
10. Study Design
a. Recruitment methods
b. Inclusion and exclusion criteria
c. Study endpoints
d. Procedures involved in the human research [this must be extremely comprehensive so that the who/what/where/when/why/how of the research process is completely transparent; if an intervention is involved, the procedures for the intervention must be thoroughly detailed]
e. Data management
f. Provisions to monitor the data for the safety of participants (required when human research involves more than minimal risk to participants)
g. Withdrawal of participants
11. Risks to participants
12. Potential benefits to participants
13. Provisions to protect the privacy interests of participants
14. Provisions to maintain the confidentiality of data
15. Medical care and compensation for injury
16. Cost to participants
17. Consent process
18. Process to document consent in writing
19. Vulnerable populations (pregnant women, minors, others)
20. Drugs or devices
21. If this study is part of multi-site human research, please explain and indicate the other sites at which research will occur
22. Sharing of results with participants
23. Any and all research conducted at the Galileo School must be mutually beneficial. Please indicate what the Galileo School will be provided in return for conducting research at the school (e.g., no-cost teacher professional development, classroom resources, no-cost programs for students, monetary donation to the school).
24. Has your research been approved by another institution’s IRB office (e.g., UCF or other college or university)?
Please include a copy of the approval letter or indicate when the research was submitted for approval. Research at the Galileo School will NOT be considered unless and until it has received approval from an institution that adheres to federal policy regarding the protection of human subjects research.
ENCLOSURE CHECKLIST
Completed Galileo Human Research Protocol (this form).
Completed literature review.
Copies of all instruments to be used.
Copies of all correspondence, consent (e.g., parent, teacher, student), and other documentation used with participants.
Copy of IRB approval granted to conduct this human subjects research that has been obtained from any other institutions (e.g., college or university).
By signature and date below, I certify that I have read and will adhere to the Galileo School for Gifted Learning’s Human Subjects Research Procedures.
Signature / DateRev. 8/21/2013 1