IRB Concerns: Consent
A legally and ethically appropriate research project involves a well-designed process to obtain the consent of the participants in most cases (exceptions are discussed below). Consent in the context of human subjects research is based on:
- Voluntariness (the complete freedom of the participant to refuse to participate if they want);
- Information (about the research, provided on the consent form or in some other way as part of the consent process); and
- Comprehension (the consent process, whether a form or not, uses language that the participant can understand fully so that they are completely able to decide whether or not to participate.
In most cases, the consent process involves a consent form to which the participant almost always signs their name (again, there are exceptions, more on which below). In some cases, a verbal consent script is more appropriate, as when participants cannot read. It is important to understand that the form is not equivalent to the consent process; instead, it is the way many participants go through that process. Reading and filling out the form should always be supplemented by the opportunity for the participant to ask questions and otherwise make sure they feel comfortable participating.
The below refers to the consent process when participants are adults. When participants are children, they can legally only assent to participate in research and a parent or guardian must grant permission for the child to participate. This issue is covered on the subpage about research with children.
Give a copy of the form to the person signing it.
Following changes in IRB regulations, a legally acceptable consent form must begin with "a concise and focused presentation of the key information that is most likely to assist a participant in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension."
More broadly, the consent form must provide "the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information." And: "Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the participant's understanding of the reasons why one might or might not want to participate.
A legally acceptable consent form must include ALL of the following elements unless otherwise noted, though they are not always in this order:
- A statement that the study involves research
- An explanation of the purposes of the research; in plain English, what the research is about
- An estimate of the expected length of participation
- A complete description of the procedures to be followed or activities to be carried out
- An identification of any procedures that are experimental [primarily intended in a biomedical context so rarely relevant at CC]
- A description of any reasonably foreseeable risks or discomforts to the participant, whether psychological, physical, or social (e.g., financial, criminal, or academic)
- 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
- For research involving more than minimal risk, an explanation as to whether any compensation and/or medical treatments are available if injury occurs, and, if so, what they consist of, or where further information may be obtained
- A description of what will happen to the information collected after the research has concluded
- 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)
- Contact information for the Colorado College IRB, including the chair's name, email address, and phone number in case the participant has concerns about whether they have been treated unethically or illegally
- 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.
- [NEW] One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens
- A statement that identifiers might be removed from the identifiable private information or biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the participant if this might be a possibility, OR
- A statement that the participant's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies
The Colorado College IRB has developed consent form templates that cover all legally required components as long as you incorporate all of the template’s components in your finalized consent form. Because the forms use 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. These templates have all been updated to reflect the regulatory changes.
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 language and avoid abstract, academic words and phrases.
- Construct the consent form using “you” rather than “I” because it may be unclear whether “I” refers to the investigator or the participant.
- Give the participant or their representative adequate time to read the form before signing it and encourage them to ask any questions they have.
- 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 carry out research without the use of a standard consent process ("waiver" of consent) or with some alteration to the required elements of the process. The following five conditions must all be met for the IRB to approve such a change:
- The research involves no more than minimal risk to participants.
- The research could not realistically be carried out without the waiver or alteration.
- If the research includes identifiable biological specimens or private information, the research could not realistically be carried out without using such specimens or information in an identifiable format. (This condition is a new extension of #2 above.)
- The waiver or alteration will not adversely affect the rights or welfare of the participants.
- Whenever appropriate, participants or their legally authorized representatives will be provided with additional pertinent information after their participation.
The IRB can also waive the requirement for you to obtain signed consent forms for some or all participants if it finds any of the following:
- 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 [in this instance, each participant decides whether they want documentation linking their name with the research].
- The research presents no more than minimal risk of harm to participants; and no research procedures would normally require written consent if they took place outside of the research context.
- The participants or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm and the research presents no more than minimal risk of harm to participants and there is an appropriate alternative mechanism for documenting that informed consent was obtained.
Finally, the issue of consent is connected to the use of incentives for participation; this topic is discussed on a separate subpage.
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.