Question: What is the difference between the sample consent procedures?
- Signed Consent form: The most common type of consent form. Participants sign their name to verify their consent in a project. Investigators provide a copy of the consent form for participants. For example, a signed consent form may be used to consent when identifying participants (i.e., audio or video recorded activities), sensitive topic information, clinical studies, etc.
- Tear-off Consent form: Participants sign their name to verify their consent; however, the certification information is de-attached from the study information. The project title should be included on the certification page of the consent form for document verification if you are planning to use a tear- off version. There is not a legal problem with having the signer tear off the form and send the signed form in, so long as the researcher can show that the signed consent goes with the informational piece about the specific research study. Therefore, the tear-off or secondary certification part should identify the research study in the last paragraph that is sent to the researcher, so there is evidence that the signature of the signer was for that research study. For example, researchers using many participants for a study and providing a signed consent form.
- Parent - Guardian Consent form: A parental or guardian consent form is used when participants cannot legally sign consent for themselves (e.g., research involving children or cognitively-impaired individuals).
- Assent Procedure: In research with children or other participants for whom the ability to give informed consent may be otherwise compromised, it is usually appropriate to obtain some form of agreement, or "assent" to participation in the data collection sessions. For example, even though children or individuals with developmental disabilities may not be able to provide informed consent for participation in research, a researcher should still describe the procedures in language that can be understood by the subjects, and obtain their verbal "agreement" to participate. If an assent procedure is to be used, a prototype of the "script" of this procedure should be included with the HSCL application.
If your research presents no risk to participants and involves no procedures for which written consent is normally required outside of the research context HSCL may waive the requirement for a signed consent form (45 CFR 46.117 (b) (2). A potential problem for researchers is that there is no documentation of consent. See consent form examples below:
- Information statement (e.g., use of anonymous surveys or questionnaires): You may use an information statement instead of a consent form. Participants do not sign an information statement and so this option would reduce your copies by one-half, since participants would keep their copy and not sign one to give to you. This would also further protect anonymity of participants. However, you may decide to use a consent form for your own records.
- Internet Information Statement: An information statement to be used via the Internet. It provides the following statement for participants regarding data security: "Your name will not be associated in any way with the research findings. It is possible, however, with internet communications, that through intent or accident someone other than the intended recipient may see your response."
- Oral Consent Procedure: An oral consent procedure is used for different types of recruiting (i.e., short interviews or questionnaires by word of mouth, telephone interviews). Oral consent procedures may be used with illiterate populations or where signing one's name may have negative consequences or have a different meaning for the participants. Also, an oral consent procedure may be most suitable in research where informality is the best way to set participants at ease and where documented consent is not required.
Question: What other document must I submit for deception project other than the participant consent form(s)?
A debriefing form is required for participants. Participants should be informed that deception took place, and should be appropriately informed as to the actual purpose of the research, and the role of the deception in protecting the integrity of the research, that is, an explicit statement as to why the deception was necessary. Participants should also be reminded of their right to withdraw from the study at the time of the debriefing. A debriefing form sample is provided on the HSCL website.
Please note: HSCL makes the final determination of consent form approval.
Questions? Please contact:
David Hann
785-864-7429 | dhann@ku.edu
Coordinator | Human Subjects Committee of
Lawrence (HSCL)
— or —
Mary Denning
785-864-7385 | mdenning@ku.edu
Associate Coordinator |Human Subjects Committee of
Lawrence (HSCL)
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