Informed Consent Checklist

(Excerpt from the Checklist for Proposed Research Involving Human Subjects)

Informed consent is recommended for all research studies but is required for Category II projects (full review). Every informed consent should include all of the following as they apply.

    1. Clearly invites the participant to take part in the study.
    2. Presents a clear statement that the study is for research purposes (e.g., thesis, under supervision of advisor)
    3. Gives a clear description of study's purpose.
    4. Describes the procedures.
    5. States all possible risks, including psychological and social
    6. States benefits that are "hoped for," but not guaranteed.
    7. States financial consequences to the participant, or any payment to be given to the participants
    8. States how confidentiality of responses and respondents will be secured
    9. States that participants are free to ask questions
    10. States participation is voluntary and indicates how the subject may withdraw from the study and the consequences of the withdrawal, if appropriate.
    11. States how participants will be informed of or may have access to any summary of the findings or conclusions for the study.
    12. Uses simple lay language.
    13. Includes parental/guardian consent.
    14. Name and number of the IRB chair to be contacted if desired.

If full informed consent is impractical or would alter the results of the study, the principal investigator may request modifications to or a waiver of this requirement. To do so, the principal investigator must provide the IRB with sufficient justification for excluding this step. If full informed consent is to be waived the principal investigator must , at a minimum, provide the participants with information about how to contact the investigators for additional information.