IRB Guidelines: Informed Consent

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The purpose of informed consent (along with debriefing) is to help protect the rights and well being of people who take part in research.  Past abuses of the rights and dignity of research participants has led to the development of disciplinary codes of research conduct, federal guidelines, and institutional guidelines.  While most researchers scrupulously protect the welfare of their research participants, IRBs or other mechanisms provide an additional safeguard by reviewing the procedures and materials in research, and help insure that people's rights are protected.

Human participants in research have the right to be informed about the nature of the research in which they may take part, and about their rights during and after participation.  These include the right to withdraw from participation at any time without penalty, the right to information about whom to contact with questions, as well as the right to have concerns addressed. Participants also have the right to know whether and to what extent their confidentiality will be protected. Finally participants have a right to be informed about the results of research and to have the research explained to them.

Informed consent procedures may take a variety of forms, but participants in research must be informed of their rights, and give their consent before a researcher collects data from them.

At DePauw, a written informed consent sheet must be submitted to, and approved by the IRB for nearly all research with human participants. An approved written informed consent sheet must be provided to participants in research, and researchers must obtain signatures that indicate participants have received the informed consent document, understand their rights as participants in research, and consent to participate in the research. Although oral informed consent procedures may be used, oral consent procedures that meet federal guidelines are generally more complicated than written informed consent.

There are some cases where research does not require written informed consent and signatures of participants, for example some types of  field studies that employ only observation .  In addition, a modified version of informed consent that does not require researchers to obtain signatures of participants is acceptable for some anonymous surveys and telephone surveys/interviews .

Written Informed Consent Guidelines

Participants in research should receive (always before participation) a written informed consent sheet (that they will sign and return to the researchers) that contains all of the following elements:
 

1. A statement that the study involves research, and at least a general description of the topic of the research, the procedures used, and the duration of the research.
2. A statement of the risks and/or benefits of participation, if any.
3. A statement that participation is voluntary, and that the participant may discontinue participation at any time without penalty.
4. A statement about the extent to which a participant's data and participation will be confidential.
5. Information (names, phone numbers and/or email addresses) about how to contact the researcher(s) and the faculty sponsor(s), and a statement that participants may contact researchers with questions.
6. Information about how, when, and where participants maybe more fully informed about the nature of the research and the results of the study.
7.  A statement that the study has been reviewed and approved by the DePauw Institutional Review Board.

You can look at a sample informed consent document here.



There are special procedures for consent when minors are participants, or when studying any category of participants who are not able to provide consent for their own particpation.  Specifically, Researchers must obtain signed consent from parents or legal guardians, and in addition obtain signed assent from the participants themselves (when plausible).  The parent/guardian consent form and the participant assent form should both include the 7 components listed above, written in language appropriate for the person who is providing consent or assent.

Email questions and comments to bwallace@depauw.edu