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:
(1) A statement that the study involves research
(2) An explanation of the purposes of the research
(3) An estimate of the expected length of participation
(4) A description of the procedures to be followed or activities to be carried out
(5) A description of any reasonably foreseeable risks or discomforts to the participant
(6) A description of any reasonably expected benefits to the participant or to others (e.g., contribution to your academic discipline)
(7) An explanation of how you will keep participant records confidential and otherwise protect participants’ privacy
(8) 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)
(9) A statement that participation is voluntary
(10) A statement that refusal to participate does not involve any penalty or loss of benefits to which the participant is otherwise entitled
(11) A statement that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled
(12) 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:
1. The only record linking the participant and the research would be the consent form itself, and
2. The principal risk would be potential harm resulting from a breach of confidentiality; and
3. The research presents no more than minimal risk of harm to participants; and
4. 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, .
Standard Consent Form Template
Keep all text as is while addressing the issues in brackets as appropriate to your study, then delete brackets and this paragraph. Be sure to address every area in brackets on the form. Bolded sections should remain bold. Adapt the form as needed so your participants will understand the language used, but do not leave out any sections. Keep the consent form to one side of one page.
[Project title] Consent Form
[Researcher’s name]
[Supervisor’s name if applicable (e.g. thesis advisor)]
Colorado College Department of [fill in department name]
[Phone number of department secretary, beginning with “719”]
[Your email address]
You are invited to take part in a research study of [state your topic clearly here].
What the study is about: [Provide a one-sentence description of the study]
What you will be asked to do: [Briefly describe what participants will do, including all activities or tasks. NOTE: Include the approximate amount of time it will take for participants to complete the task(s).]
Risks and benefits: [List any known emotional, physical or other risks. If none, use the following text: “There are no anticipated risks to you if you participate in this study, beyond those encountered in everyday life.” Do not include the quotation marks if you use this sentence.]
[Briefly explain any benefits to the participant or otherwise. This may include incentives such as compensation or entry in a drawing for a prize if relevant; it may also include contributions to the researcher’s field of knowledge.]
Taking part is voluntary: Taking part in this study is completely voluntary. If you choose to be in the study you can withdraw at any time without consequences of any kind. [Indicate that participants can choose to skip any question, participate in only some tasks, etc. as appropriate to the study.] Participating in this study does not mean that you are giving up any of your legal rights.
Your answers will be confidential: The records of this study will be kept private. [Describe how this will be done: will data be kept in a locked drawer? Kept on a personal computer? Will recordings be destroyed after transcription? Other methods?] Any report of this research that is made available to the public will not include your name or any other individual information by which you could be identified.
If you have questions or want a copy or summary of the study results: Contact the researcher at the email address or phone number above. You will be given a copy of this form to keep for your records. [NOTE: please provide each participant with their own copy of the form.] If you have any questions about whether you have been treated in an illegal or unethical way, contact the Colorado College Institutional Research Board chair, Amanda Udis-Kessler at 719-227-8177 or .
Statement of Consent: I have read the above information, and have received answers to any questions. I consent to take part in the research study of [topic of research]
______/ ______Participant’s Signature Date