INFORMATION TO BE INCLUDED IN THE CONSENT DOCUMENT
(adapted from 45CFR.46.116)

1. A statement that the study involves research;
   
   
2. 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 participant's participation;
   
   
3. 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 explained;
   
   
4. 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;
   
   
5. 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;
   
   
6. A disclosure of any appropriate alternative procedures or courses of treatment that might be advantageous to the participant;
   
   
7. 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;
   
   
8. 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;
   
   
9. 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 Investigator (PI));
   
   
10. 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 otherwise entitled;
    
    
11. 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.