2. A description of any reasonably foreseeable risks or discomforts to the participant.
3. A description of any benefits to the participant or to others which may reasonably be expected from the research.
4. A disclosure of appropriate alternative procedures or courses of treatment, if applicable, that might be advantageous to the subject.
5. A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained. If data obtained will be made available to any person or organization other than the participant, the investigator, and the investigator's staff, then the person or agencies to whom information will be furnished, the purpose of disclosure, and the nature of the information to be furnished must be described. Participants should be informed that observations warranting concern for the well-being of the participant will be shared with the appropriate authorities.
6. If tape recordings, photographs, movies, or videotapes are made, they should be described, regardless of whether they will be shown to others. The time they will be retained before erasure should be specified. Use of such data for other purposes must be disclosed and permission obtained in a special portion of the consent form.
7. An explanation of whom to contact for answers to pertinent questions about the research and research participant's rights, and whom to contact in the event of a research-related problem. A telephone number should be included.
8. A statement that participation is voluntary, the participant may refuse to participate, and may discontinue participation at any time without penalty or loss of benefits to which he/she is otherwise entitled.
9. The reason for participant's selection.
10. Length and frequency of procedures, including an estimate of the total amount of the participant's time.
11. If specific human specimens (e.g. blood, urine) are to be collected, they must be specified along with the frequency of such collections, and the period during which they will be collected.
12. An offer to the participant of a copy of the consent form.
13. Space for the signatures and date. The consent form must be signed and dated by the participant and/or by those who are responsible for the care of the participant. If applicable, there should be space for signature by one other than the participant (e.g., parent), along with a space for the signer to indicate his/her relationship to the participant. The signature of the investigator or person conducting the research is also required in order that it can be established who discussed the study with the participant. If any information relevant to risks of participation is to be presented orally to the participant, there should be space for the signature of a witness who must be someone other than the person obtaining or providing the signed consent.
15. Anticipated circumstances under which the participant's participation may be terminated by the investigator without regard to the participant's consent.
16. Any additional costs to the participant that may result from participation in the research.
17. The consequences of a participant's decision to withdraw from the research and procedures for orderly termination of participation by the participant.
18. A statement that significant new findings developed during the course of the research which may relate to the participant's willingness to continue participation will be provided to the participant.
19. The approximate number of participants involved in the study.
20. Oral or written consent of minors depending on age and maturity.
Last updated: August, 2006
If you have any comments or suggestions about this web site, please send them to wsvelmoe@saintmarys.edu.
This site was authored by Dr. Catherine Pittman and Zhou Zhu as the product of a faculty / student special project.