University of Chicago s2

University of Chicago Social Service Administration Institutional Review Board

Consent Form Instructions (May. 2011)

Informed consent of the human research participant is one of the fundamental principles of ethical research. Informed consent is also mandated by Federal regulations and University policy for research with human participants.

Informed consent is the knowing and voluntary consent of an individual or his/her legally authorized representative that is obtained without undue inducement or element of force, fraud, deceit duress, or other forms of constraint or coercion. An informed consent form documents voluntary informed consent and is designed to provide information to the potential participant about the research and the participant’s involvement in the research.

The SSA/Chapin Hall IRB must review and approve the informed consent forms before any participants may take part in the research. One of the most common reasons for delay in IRB approval is an inadequate consent form. Please follow these guidelines for developing an informed consent form.

Only participants whose consent has been obtained on an IRB approved informed consent form may serve as research participants.

If changes are made to a previously approved consent form, the new informed consent form must receive IRB approval before it can be used.

The informed consent form should not include a waiver of legal rights of the research participant or release of others from liability for negligence.

The informed consent form is written in the form of a statement to prospective participants and should be worded in the second person (you). Example: “You will be asked to watch a 5 minute video clip from a popular movie and then answer a series of questions about the video clip.”

The informed consent form should be written in language that the subject can understand. This means avoiding technical jargon and adapting the form to fit the educational background of the participants. Generally aiming for a 6th to 8th grade reading level is appropriate.

Bad Example: “This study is designed to assess the cognitive and language capabilities of pre-schoolers who have been exposed to environmental hazards which have been shown to result in the early onset of ADD or ADHD.”

Better Example: “This study will look at how children between 3 and 5 years of age talk and learn. The study will look at how being around lead paint or carbon dioxide from cars might affect learning problems such as attention deficit disorder or attention deficit disorder with hyperactivity.”

Separate forms should be used to obtain consent from adults, assent from children age 12 to 17, and to obtain parental permission for participation of children age 17 or under. Elements of Informed Consent according to 45 CFR 46 116(a)

Informed consent must include the following elements:

1. An investigator’s statement that the protocol involves research and that the purpose of this form/process is to fully inform the participant.

2. A brief explanation of the purpose of the research.

3. A description of the procedures the participant will experience, the duration of the participant’s involvement, and the identification of any procedures that are experimental.

4. The approximate number of subjects for the study.

5. A description of any foreseeable risks or discomforts to the participant.

6. A description of any benefits, both personal and scientific, that may result from the participant’s involvement in the study. Payment is not a benefit.

7. A description of payment or other gifts to the participant. You must also state whether or not the participant will forfeit the payment/gifts if they don’t complete the study, or if payments are prorated.

8. A statement describing the extent, if any, to which confidentiality or records identifying the participant will be maintained.

9. A statement about the final disposition of the data and personal identifiers (e.g., disposed of after thesis completion, held for 3 years and shredded, archived in Library of Congress).

10. A statement about what plans you have for the data (e.g., thesis, publication).

11. A statement about the participant’s rights which include, but are not limited to, these: 1) participation is voluntary; 2) refusal to participate or discontinuing participation will involve no penalty; 3) you may choose not to answer a question.

12. A statement about the participant’s agreement to participate and a signature line: I agree to participate in this study. Name:______Date:______

13. A statement about who to contact for answers to pertinent questions about the research. This should be a contact person from the study who can answer the questions. Include a name, phone number, e-mail address, and full address.

14. A statement about who to contact if the participant feels his/her rights have been violated. This should be the Chapin Hall/Social Service Administration IRB office, (773) 702-0402, 969 E. 60th Street RM, University of Chicago, Chicago, IL 60637 [email protected]

15. The participant is given a copy of the informed consent form to take with them. When appropriate, the following elements should be included in the informed consent:

16. If audio/video taping is part of the procedure, tell the participant they will be audio/video taped, explain what will become of the tapes after use (shown at scientific meetings, archived, destroyed), describe the final disposition of the tapes (will be destroyed after transcribed, archived for 3 years).

17. If audio/video taping is optional, explain the above information and then have an extra consent line: Please sign below if you are willing to have this interview recorded. You may still participate in this study if you are not willing to have the interview recorded.

18. If your study involves participants under the age of 18 (in some states the age of majority is 21), you must have separate parental permission form. If the participant is old enough to understand assent (generally over 7 years), you must get clear assent from the child.

19. If your participants are recruited from places such as work sites, treatment sites, or detention centers, clearly state that their decision whether or not to participate in this study will not affect their employment, treatment, legal or detention status.

20. If the study may cause the participant discomfort, state that a list of resources is available if their participation in the study results in a need for the resource.

21. If the researcher wishes to quote a participant in publications or presentations a separate line is needed for the participant’s signature indicating his or her consent.

22. If there is a possibility of subpoena or legal investigation of the participant or information gathered the researcher should request a Certificate of Confidentiality and reference it in the informed consent form.