IRB guidelines for Informed Consent
The purpose of informed consent is to inform research participants about the nature of the research, the procedures involved and the risks and benefits associated with participation.
The following elements are required in the consent document:
- A statement that the study involves research
- An explanation of the purpose of the research
- The expected duration of the participant’s participation
- A description of the procedures
- A description of any foreseeable risks or discomforts the participant might experience
- A description of any benefits to the participant or to others
- A description of how confidentiality will be maintained
- A statement that participation is voluntary
- A statement that refusal to participate will involve no penalty or loss of benefits
- A statement that the participant may discontinue participation at any time without penalty or loss of benefits
Informed consent is to be documented by the use of a written consent form approved by the IRB and signed by the participant or participant’s legally authorized representative.
All participants or legally authorized representatives must be given adequate time to read the consent form before it is signed.
A copy of the signed consent form must be given to the participant.
Informed Consent Procedures
Any research using human subjects requires informed consent. For the majority of studies this will involve developing an informed consent form and obtaining written informed consent by the participants in the study.
- For studies that involve no physical risk an abbreviated informed consent form may be used.
- For studies involving anonymous surveys that do not contain items related to sensitive matters (i.e., drug use, sexual behavior, and illegal activities) a letter of invitation with implied consent may be used.
INFORMED CONSENT FORM INSTRUCTIONS
- The consent form must be written in lay language at the sixth-grade level.
- Participants must be invited to participate and assured that their participation is voluntary.
- Investigator(s) must be identified
- The procedures of the study must be explained to the participant so that the person would be able to understand the exact procedures.
- All measures to ensure confidentiality must be explained.
- All potential risks and precautions that will be taken to reduce the potential risks must be explained.
- The approximate number of participants involved in the study must be identified.
- Consent form must be written in second person using “you” throughout.
- Font should be black, non-italicized, and 12-point (or larger if appropriate).
Please use standard wording that is provided wherever possible; however, you must adapt the forms as appropriate to your study.