A description of the consent process and a copy of all consent
documents must be attached to the IRB application. Informed consent
must be sought from each prospective participant or the participant's legally
authorized representative. A copy of the consent form must be given
to the participant.The following consent elements must be provided to
the participant in clear non-technical language.
| 1. |
The fact that this is a research study. |
| 2. |
The purposes of the research. |
| 3. |
The expected duration of the participation. |
| 4. |
The procedures to be followed. |
| 5. |
Any reasonably foreseeable risks or discomforts. |
| 6. |
The benefits to the participant or to others which may reasonably
be expected from the research. |
| 7. |
Appropriate alternative procedures or courses of treatment,
if any, that might be advantageous to the participant. |
| 8. |
The extent to which confidentiality of data and privacy of
the participants will be maintained. |
| 9. |
For research involving more than minimal risk of if injury
occurs as a direct result of the research, the type of compensation
and that medical treatment will be available and the financial
costs that the University will be responsible for are specified. |
| 10. |
Who to contact for answers to pertinent questions about the
research, participants' rights, and research related injury to the
participant. |
| 11. |
The fact that participation is voluntary and that the participant
may withdraw his or her consent at any time without penalty
or loss of benefits which will be prorated to the time of withdrawal. |
| 12. |
Notification that if participants are between the age of 12
and 18, they may sign the consent form in addition to parents
when appropriate. |
