Informed consent is required if your project involves more than minimal risk, or involves an at-risk population (e.g., minors, prisoners, pregnant women). The IRB may also require that you obtain informed consent under other circumstances. Whether informed consent is required or not, all subjects must be debriefed on the purpose of the research, and provided with a means to view the results of the research when available.
If informed consent is required, it must include:
- A statement that the study involves research.
- An explanation of the purpose of the research, an invitation to participate and
explanation of why the participant was selected, and the expected duration of the
- A description of procedures to be followed and identification of which procedures are
investigational and which might be provided as standard care to the participant in another
setting. Use of research methods such as randomization and placebo controls should be
- A description of any foreseeable risks or discomforts to the participant, an estimate of
their likelihood, and a description of what steps will be taken to prevent or minimize
them; as well as acknowledgment of potentially unforeseeable risks.
- A description of any benefits to the participant or to others that may reasonably be
expected from the research, and an estimate of their likelihood.
- A disclosure of any appropriate alternative procedures or courses of treatment that
might be advantageous to the participant.
- A statement describing to what extent records will be kept confidential, including
examples of who may have access to research records such as hospital personnel, the
FDA, and drug sponsors.
- For research involving more than minimal risk, an explanation and description of any
compensation and any medical treatments that are available if participants are injured
through participation; where further information can be obtained, and whom to contact in
the event of research-related injury.
- An explanation of whom to contact for answers to questions about the research and the
research participant's rights (including the name and phone number of the Principal
- A statement that research is voluntary and that refusal to participate or a decision to
withdraw at any time will involve no penalty or loss of benefits to which the participant is
- A statement indicating that the participant is making a decision whether or not to
participate, and that his/her signature indicates that he/she has decided to participate
having read and discussed the information presented.