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Additional FSU Information for Human Subjects Participants
Below is a list of questions that individuals should think about and ask FSU researchers before deciding to take part in research:
- Is this study of interest to me?
- When does this study take place?
- Where does this study take place?
- How long does this study last?
- Does this study have FSU IRB approval?
- Is this study safe?
- Is this study confidential or totally anonymous?
- How is my privacy being protected?
- How will I be notified if risks or benefits to the study were to change?
- Do I learn anything from participating?
- Who gains from my participation in the study?
- Do I feel pressured or obligated to participate in the study?
- May I quit the study at any time?
- Whom may I contact with questions or concerns about the study?
- Whom may I contact with questions or concerns that is not involved in the study?
FSU Human Subjects Participant Rights
If you are asked to consent (that is, you asked to agree or to provide permission) to be a subject in a research study, you have the right to:
- Learn about the nature and purpose of the study, experiment, or clinical trial
- Receive an explanation of the procedures, and any drug or device that may be used
- Learn about any benefits you might expect from the study
- Receive a description of any discomforts and risks that you may experience from the study
- Learn about the risks and benefits of any other available procedures, drug, or devices that may be helpful to you
- Learn what medical treatment will be made available to you if you should be injured as a result of the study
- Decide to consent or not to consent to a study without feeling force, obligation, pressure, or coercion
- Receive a copy of the signed and dated consent form
- Quit the study at any time, you decision may not be used as an excuse to hold back necessary medical treatment
- Ask any questions about the study or the procedures involved
FSU Investigator Responsibilities
The Principal Investigator ("PI") is the individual who assumes full responsibility for a research study. The PI, together with other research study staff, are required to:
- Conduct the FSU IRB approved research protocol
- Obtain legally effective informed consent
- Maintain subject confidentiality
- Quickly respond to all participant concerns and questions
- Inform participants of changes to risks or benefits in a study
- Obtain approval from the FSU IRB for any proposed changes, additions, or deletions to the study
- Promptly report all unanticipated problems or injury to the IRB
- Retain research records for 3 years after the study completion date
- Effectively train/mentor student researchers in ethical conduct of research
- Comply with all FSU procedures for the ethical conduct of human subject research
Research Participant Responsibilities
- Completely read the consent form and ask the Principal Investigator ("PI") any questions that you may have. You should understand and comprehend what procedures will occur before you agree to participate.
- Know the beginning and ending dates of your participation
- Carefully weigh potential benefits of participation (if any) and risks of participation
- Contact the Principal Investigator if you desire to terminate, end, or quit your involvement in any research study
- Contact the PI and/or the FSU IRB with complaints or concerns about study participation
- Report any and all unanticipated problems to the PI immediately
- Comply with the responsibilities of participation as described on the consent forms unless you are discontinuing participation in the study
- Confirm receipt of extra-credit points or monetary compensation
- Request study results, if desired
- Retain a copy of the consent form for your records
Office for Human Subjects Protection (OHSP)
2010 Levy Avenue
Bldg. B Suite 276
Tallahassee FL, 32306-2742
Ph: (850) 644-7900 (automated call answering with voice menu system allowing callers to be routed quickly and efficiently to needed points of contact)
Fax: (850) 644-4392