Human Subjects Research, Informed Consent and the Consent Form
One of the most important components of ethically and legally acceptable research is that the participants have provided informed consent. In almost all cases, you will obtain informed consent by having participants sign a written consent form approved by the IRB (if the participant is a child, a legally authorized representative such as a parent or guardian signs the form). Give a copy of the form to the person signing it. A legally acceptable consent form must include ALL of the following elements:
- A statement that the study involves research
- An explanation of the purposes of the research
- An estimate of the expected length of participation
- A description of the procedures to be followed or activities to be carried out
- A description of any reasonably foreseeable risks or discomforts to the participant
- A description of any reasonably expected benefits to the participant or to others (e.g., contribution to your academic discipline)
- An explanation of how you will keep participant records confidential and otherwise protect participants’ privacy
- Your contact information (in case a participant has questions about the research or about their rights, or in the event of a research-related problem for the participant)
- A statement that participation is voluntary
- A statement that refusal to participate does not involve any penalty or loss of benefits to which the participant is otherwise entitled
- A statement that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled
- A statement that the participant is not being asked to voluntarily give up any of their legal rights. Note that any research with legal ramifications requires full Board approval and cannot therefore be reviewed on an expedited basis.
The Colorado College IRB has developed a consent form template that covers all legally required components as long as you incorporate all of the template’s components in your finalized consent form. Because it uses the simplest possible language to cover the legal issues, the IRB recommends that you develop your consent form from the template rather than from this document.
To make sure that consent is truly informed, the following steps or elements are also required:
- When a participant’s first language is not English, translators and/or a translated form must be used so that the form is in the participant’s native or first language, unless the participant and researcher are both fluent in a second language, in which case the form may be in the second language.
- The writing level of the consent form should match the reading level and background of the participants.
- Use simple declarative sentences and avoid abstract, academic words and phrases.
- The consent form should be as short as possible while still meeting all of the requirements listed here, as participants are more likely to read a short document completely and carefully.
- Construct the consent form using “you” rather than “I” because it may be unclear whether “I” refers to the investigator or the participant.
- Use large print and wide margins for readability while still keeping the form to one page if at all possible.
- Give the participant or their representative adequate time to read the form before signing it.
- Be sure to take cultural values into account if you are carrying out research in a setting where the local culture might understand “informed consent” differently. For example, there might be settings where consent must be given communally rather than by individuals, or must first be received from a political or religious leader.
In some situations, you may receive permission from the IRB to obtain consent without the use of a signed consent form. The following four conditions must all be met for the IRB to approve such a process:
- The only record linking the participant and the research would be the consent form itself, and
- The principal risk would be potential harm resulting from a breach of confidentiality; and
- The research presents no more than minimal risk of harm to participants; and
- No research procedures would normally require written consent outside of the research context.
If your research fits these four criteria, you must still provide participants with a written statement regarding the research, an information form that is identical to a consent form but without the signature line on the bottom.
You must also give participants a copy of the consent form when they sign the copy to return to you.
There may be some situations in which obtaining written consent is culturally insensitive or inappropriate. If you believe that your research project will involve such a situation, it is your responsibility to explain why this is the case in your IRB proposal. You do not need to draft a consent form in such a situation. The IRB will review your proposal and either approve your project or ask for further clarification about the consent context.
If you have any questions about consent form requirements or how to modify the consent form template on the IRB website for your personal use, please contact Amanda Udis-Kessler, firstname.lastname@example.org.
The IRB supports human subjects research with no or minimal harm, good consent processes, no deception or debriefed deception, confidentiality or anonymity and the use of fairly chosen participants who can refuse to participate if they choose.
Amanda Udis-Kessler, PhD, Chair