Informed Consent

Informed Consent ensures that prospective human subjects understand the nature of the research as well as the ability to decide to participate with the full knowledge of possible risks. Informed Consent reflects the principles of respect for persons, which is an important part of research.

Tailor each Informed Consent process to the individual project keeping in mind the prospective participation population, the risk(s) involved in the research, the sensitivity of the research, and the research procedures.

Consider the Following when Developing Informed consent Procedures:

1. Will prospective participants be old enough to provide legal consent? If not Investigators will need to obtain consent from a parent/guardian as well as assent from the minor. For more information, please review the IRB's Suggestions on Informed Consent for Research with Minors.

2. Will prospective participants be literate?

3. Will prospective participants be able to speak and read English or another language?

4. Will prospective participants need a specific reading comprehension level in order to participate?

5. Will prospective participants be part of another cultural group? If so, what are the proper procedures for Informed Consent forms?

Provide the following to the IRB along with Informed Consent Procedures:

* At what time will participants be given the information about Informed Consent?
* What format will participants receive the information about Informed Consent?
* How will the participants review the information about Informed Consent - individually or with the Investigator?
* which member of the research team will administer the Informed Consent process?

* Will the consent process be administered separately to each individual or in a group with other participants?
* How much time will prospective participants have to review the information before they are asked to decide if they will participate in the research?
* How will participants indicate they consent to participate?
* If prospective participants will be signing Informed Consent Forms, how will they return the forms to the Investigator?