Informed Consent Checklist
The consent form must be expressed in clear, simple language that participants can easily understand. Be sure to include these elements in your consent form or script.
_____The name of the researcher and his or her institutional and departmental affiliation
_____Statement that this is a research activity (e.g., use the word “experiment”)
_____The purpose of the study
_____Why the participant has been invited to participate
_____What the participant is expected to do
_____How long it should take to participate
_____Potential inconveniences, discomforts, and risks
_____The extent to which and the means by which confidentiality will be maintained
_____Potential benefits
Statement(s) specifying:
_____participation is voluntary
_____the individual may refuse to participate
_____the participant may skip questions or tasks
_____the participant can discontinue participation at any time without penalty
_____the participant has had the chance to ask questions and that any questions have been answered
_____contact information for the primary researcher, faculty advisor(s), and the IRB chair ([email protected])
_____When applicable, notification that the participant will receive a copy of the consent form
_____When applicable, a statement verifying that the participant is at least 18 years old
_____When applicable, signatures of participant and primary investigator
Components of Consent Forms
A standard consent form must include:
- A statement that the study involves research
- An easy to understand explanation of the purpose of the study
- How long it takes to participate
- A simple description of the procedures to be followed
- Identification of any procedures which are experimental
- If deception is involved, there should be an indication that the research cannot be fully described at this time, but that at the end of the subject's participation an explanation will be provided
- A description of any reasonably foreseeable risks or discomforts to the subject.
- These include not only physical injury, but also possible psychological, social or economic harm
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- A description of any benefits to the subject or to others which may reasonably be expected from the research
- If there is no direct benefit, this should be stated. Please note that payment is not considered a benefit.
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- A statement concerning costs or compensation to the subject, if any.
- Contact information for those who can answer questions about the research and the subject's rights, and (if applicable) for whom to contact in the event of a research-related injury to the subject. For senior projects, normally participants should be invited to contact the principal investigator or faculty advisor if they have any questions about the research, and to contact the the IRB if they have questions about their own rights as research participants.
- Description of the extent, if any, to which confidentiality of records identifying the subject will be maintained
- A statement that participation is voluntary, that neither refusal to participate nor participation discontinued at any time will invoke penalty or loss of benefits to which the subject is otherwise entitled
- Information about access to the results of the research.
- For senior projects, you should disclose that the final project will be permanently and publicly available in the Bard College library and online. In most cases, this disclosure is a courtesy.
- The participant's signature, as well as their printed name and date should appear on the consent form.
If you would like to see the expanded federal Office of Human Research Protections checklist from which the previous checklist was adapted, please click here.
Verbal Description of Consent Forms
In all cases, you should prepare a verbal script that you will say to each participant just before you hand them a consent form or ask for their verbal consent.Example Verbal Consent
(This is an example script of what you say to participants when you hand them a consent form for your study. Material in brackets [ ] should be altered to apply to your study.)
Thank you for agreeing to participate in this study. Your participation is expected to take about [45 minutes]. During this time you’ll [brief and honest description of the experimental procedures and tasks].
If you’re ever uncomfortable for any reason and would like to stop participating, that is OK, just say so. [Optionally, if payment or compensation is provided:] You will still be paid for your time. Your data will be stored according to a coding number, so your responses will remain confidential.
Before we start you need to read this consent form carefully. Consent forms are necessary so that you are accurately informed about the research process and you understand your rights. If you have any questions, just ask me. Then, if you agree with the content of the consent form, sign at the bottom. If you’d like a copy of the consent form, you can take a copy with you.
Also, in all cases, you should provide each participant with a copy of the consent form, so they can refer to it later if they have any questions or would like to contact you. If the participants decline a copy of the consent form for their own records, you should provide as an alternative a printed slip of paper that has contact information for you, your advisor, and the IRB so the participant has this contact information.
Circumstances in Which a Written Consent Form May Not Be Required
There are some situations where a written consent form may not be required:
- if the principal risks are those associated with a breach of confidentiality concerning the subject's participation in the research (e.g., studies on potentially sensitive topics such as illegal drug use, other illegal conduct, or sexual behavior);
- if the consent document is the only record linking the subject with the research; or
- if the research presents no more than minimal risk and involves procedures that do not require written consent when they are performed outside of a research setting.
If there is no written consent form, an oral presentation of the research should be provided to the subjects by the investigator, with documentation that such a presentation was made to the subjects.
Visit this link for the conditions under which waiver or alteration of informed consent can be applied.
If you will be photographing or videotaping your participants, the participants must, in addition, sign a photo release form or a video consent form.
This description will occur elsewhere on the IRB website, before researchers click on a link to access this form: “A standard consent form may include statements regarding video and audio recording that will be viewed and coded only by the investigators who were specified in the project proposal as approved by the IRB. Video Image release forms are necessary if and only if the goal of your research is to create a film, photographic stills, or video art in which participants’ images will be publicly displayed. Such purposes include photographic and video installations or web pages viewed by individuals other than the project investigators (some types of documentary film may be exempt). The video image release form is separate from the consent form. The consent form must be presented first. A video image release form should be signed by the participant before video recording begins. It may also be advisable to present the same form again at the end of the recording period so that the participant may change his or her mind about the image release authorization. Example Video Image Release Form
Video Image Release Form for Without Words, a project by Eudora Welty, supervised by Rosalind Franklin.
USAGE: Without Words is a film and/or video project. The resulting product will be a film and/or video, Internet web pages, stills for publication, promotional materials, distribution materials, art installation, or other creative work that will be available to the public.
I, the undersigned participant, hereby give Eudora Welty and Rosalind Franklin specific permission to publish, copyright, distribute and/or display images (motion and still) of my likeness created as part of the Without Words project.
By signing below, I acknowledge that 1) I have read this agreement carefully; 2) any questions I have about the use of my image have been answered satisfactorily; 3) any additional assurances or verbal qualifications that have been made to me have been added in writing to this document; 4) I have been given a copy of this form, including any changes or restrictions, initialed by me and by Eudora Welty.
I understand and agree to the conditions outlined in this video image release form. I hereby allow Eudora Welty and Rosalind Franklin to use this recording, and I give up any and all of my own future claims and rights to the use of this recording.
Participant’s signature: ______________________________
Date: _________________
Participant contact information (optional): ________________________________
Filmmaker’s Contact Info: Eudora Welty; Bard College, 845.758.xxxx.
Rosalind Franklin, Ph.D., Film Program; Bard College, 845.758.xxxx.