ELEMENTS OF INFORMED CONSENT

Researchers must obtain the informed consent of participants. For participants less than 18 years of age, the researcher must obtain the informed consent of parents or legal guardian and all reasonable attempts must be made to obtain each participant's assent. *

For Exempted Requested and Expedited Review, the informed consent must include the following in sequential order and in language which participants can understand:

1. Statement of purpose of the study.
2. Short description of methodology and duration of participant involvement.
3. Statement of risks/benefits to the participants.
4. Statement of data confidentiality.
5. Statement that participants may withdraw from the study at any time without negative consequences.
6. An offer to answer any questions the participant may have.
7. Name, title, address and phone number of all principal researchers.
8. Line for signature of participants and/or parents or legal guardian except for questionnaire research in which return of questionnaire gives implied consent.
9. Statement that participant is 18 years of age or older unless parent or legal guardian has given consent.

If an item does not apply, you may omit the item, but it should be obvious to the HSC reviewer(s! why the item has been omitted in your description of the purpose of the study. (See Sample Informed Consent)

For Pull Review, the informed consent must include the following in sequential order and in language that participants can understand:

1. Statement of purpose of the study.
2. Short description of methodology and duration of participant involvement.
3. Statement of risks/benefits to the participants.
4. Statement of data confidentiality.
5. Statement that participants may withdraw from the study at any time without negative consequences.
6. An offer to answer any questions the participant may have.
7. Name, title, address and phone number of all principal researchers.
8. Statement that any effective treatment will be offered to all participants, if a treatment is included. The cost of the treatment or renumeration should be specified.
9. Description of alternate treatments that are available.
10. Declaimer of responsibility for anything not caused by the treatment of personnel involved in the study. (If this applies, contact the HSC for advice.)
11. A short description, by the participant/parent or legal guardian, describing the procedures to be followed and potential risks.
12. Statement that participant will be given a copy of the informed consent form.
13. Line for signature of participant and/or parent or legal guardian except for questionnaire research in which return of questionnaire gives implied consent.
14. Statement that participant is 18 years of age or older unless parent or legal guardian has given consent. (See pp. 14-15 for Sample Informed Consent)

*Assent is defined as the participant's agreement to participate in the study. (To be used for persons under 18 years of age or those who have legal guardians assigned for whatever reason.)

In situations where participants will be deceived, regardless of the type of review, the following must be included and must be presented to the participants before they engage in the study:

1. Omit steps 1 and 2 (purpose and description of methodology) substituting a statement, if possible, indicating that full disclosure of the purpose of the study could bias the outcome. Have participants sign the form.
2. Following the study, present participants with a full description of the study and methodology which the participants are to sign.