Consent Form & Process
Develop a Consent Form
Consent Form Template.pdfInstructions
- Consent documents submitted for IRB review must contain certain required elements. See Consent Form Checklist for the required elements. Also, see Consent Form Template for an example of how the consent document should be formatted.
- Consent document must not contain grammatical or typographical errors. The submitted document will be approved as is and the IRB office will date stamp each page of the document with IRB approval. The IRB-approved consent document must be the only version of the form signed by subjects.
- Direct the language in the consent form to the subject.
- The language of the consent form must be appropriate for the age, mental capacity and maturity of the subject. Adult consent forms = 8th grade reading level; child assent forms = appropriate grade level.
- Any exculpatory language in the consent form through which the subject is made to waive or appear to waive any of the subject’s rights is prohibited.
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Additional Information to Include in a Consent Form for Research Involving...
Additional information to provide in your consent document(s) if your study involves students and extra credit:
Compensation Section
- Amount of extra credit given for completion of each study procedure and for completion of the entire study; and
- The impact this extra credit will have on students’ grades.
Procedures Section
- Inform subjects that the study will involve audio and/or video recording;
- Inform subjects whether or not these recordings are required to participate in the study procedures (if recording is optional, provide a space at the end of the consent document where subjects initial to consent specifically for the audio and/or video recording).
Anonymity / Confidentiality Section
Provide an explanation of the following:
- How the study will ensure the security of the recordings;
- Who will be transcribing the recordings;
- Who will have access to the recordings; and
When the recordings will be erased / destroyed.
Risks Section
- Be specific regarding potential risks including psychological, social, legal, economic, dignity and physical. Remember the potential of emotional distress while completing these surveys;
- Provide an explanation of the study’s efforts to reduce the potential risks.
Anonymity / Confidentiality Section
- Provide subject with contact information of professional counselors within the area that he/she may contact;
- Inform subjects that any expense from the counselor will be incurred by the subject;
- Inform subjects that if he/she provides responses to the survey that indicate the potential of harm to themselves or others, the researcher is obligated to report to the appropriate authorities; and
- Provide a thorough explanation of how the study will ensure confidentiality of this sensitive information.
When is Signed Consent Required?If feasible, researchers are advised and may be required to obtain signed consent from each participant. Written, signed consent should be sought unless there are compelling reasons for the IRB to grant a partial or full waiver of consent.
Signed consent may not be required if...
- Obtaining signatures leads to an increase of risk for participants (e.g., the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting in a breach of confidentiality).
- The research is exempt (the IRB may request the development of a consent form for some exempt studies on an individual, per study, basis). Examples of exempt research include low risk or anonymous surveys, public observation, and analysis of existing data.
The IRB will make final determinations regarding the requirement of researchers to obtain signed consent from research participants.
If not obtaining signed consent, participants must, in most cases, be supplied with consent information in a different form (e.g., in recruitment document, at the beginning of survey instrument, read to participant over the phone, information sheet physically or verbally provided to participant). Researchers may be required to obtain verbal consent (see below section) from participants in lieu of obtaining signed consent.
What to Do with Signed Consent FormsMake sure you give a copy to each subject. Do not throw them away after the study is initiated. Federal laws indicate that you must save them for three years after the termination/conclusion of your research. Store signed consent forms in a confidential manner.
Verbal ConsentWhat is Verbal Consent?
Verbal consent means that subjects are read a verbal version of a consent consent form (i.e., an information sheet - see below section) and give their verbal consent in place of written consent to participate.
When is it Used?
Obtaining verbal consent in place of written consent may be the only feasible method to obtain consent from subjects. For example, this method may be helpful when recruiting subjects and completing screening surveys over the phone.
In order to use verbal consent in place of written consent, your study must meet one of the criteria for a waiver of written consent (see below section) (not required for exempt research).
What is Required if Using Verbal Consent
When this method is used, the IRB must approve a written summary (i.e., information sheet - see below section) of what is to be said to the subject or the representative. The researcher obtaining verbal consent must sign and date the information sheet to document each subject's consent. Note: the information sheet should include the required elements found in a consent document. View the Consent Form Checklist to review the required elements.
If verbal consent is the only method for obtaining consent for a particular study (i.e., study will not obtain written consent from subjects at a later date), there must be a witness to the oral presentation and verbal consent. Both the witness and researcher obtaining verbal consent must sign and date the written summary (i.e., information sheet) to document each subject's consent.
Internet-Based ConsentThe IRB understands that because of the two different methods (electronic versus paper) avaiable for collecting data, the processes of providing information to potential subjects and obtaining documentation of consent will not be the same. Nevertheless, the IRB wants to encourage subjects to read the consent document or a written summary of the study (i.e., information sheet - see below section) first, before being able to actually participate in the study.
Options for Obtaining Internet Consent
- Provide an information sheet (see below section) to subjects before the completion of online study instrument. This information sheet must contain the required elements of consent. View Consent Form Checklist for required elements. Note: to use this method, the research must qualify for a waiver of written consent (see below section) and the IRB must grant this waiver.
- Obtain documentation of consent from subjects. Provide participants with an online consent form. After the participant reads the online consent he/she clicks an "agreement" button, which contains a message indicating that clicking the button means the subject has read the statement, printed a copy for their files, and agrees to participate in the study and accepts that personal information will be electronically supplied to the researcher to document their participation (such as name, e-mail name, and date). To use this method, there must be a mechanism by which information is returned to the researcher that identifies the person who is participating. This documentation must be kept by the researcher for at least the standard three years beyond the end of the study. The IRB might require this method, unless obtaining signatures leads to an increase of risk for participants (e.g., the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting in a breach of confidentiality).
Information SheetAlthough consent documents / signed consent are not required (by the IRB) for some studies (see above section, "When is Signed Consent Required?"), it may be helpful to develop an information sheet (not to be signed by the subject) that is handed out to study participants. The purpose of the information sheet is to provide subjects with a general description of the study. The information sheet may cover many of the required elements of a typical consent document. In particular: contact information, the study procedures, purpose of the research, confidentiality / anonymity issues, etc. Note: an information sheet may be required by the IRB.
The Consent Process
Informed consent of the subject is one of the fundamental principles of ethical research for human subjects. Informed consent is also mandated by Federal regulations (45 CFR 46, Section-46.117) and University policy for research with human subjects.
The development of a consent document with the required elements (see Consent Form Checklist) is only the first step to obtaining informed consent from study participants. Informed consent is a process, not merely a document with the subject’s signature. It is the knowing consent of an individual or his/her legally authorized representative that is obtained without undue inducement or element of force, fraud, deceit, duress, or other forms of constraint or coercion. Informed consent is designed to provide information to the potential subject about the research and the subject’s involvement in the research. The process must assure that the potential subject understands the study and its risks and benefits and can certify his or her willingness to participate.
The informed consent process is different from the consent form. It involves meeting with a potential subject, finding out whether he or she is capable of giving consent, and discussing the purpose, risks, and benefits of participation. The consent form formalizes the agreement to participate and should be designed to document the process. Obtaining informed consent is not just giving a prospective subject a consent form and getting it signed. If consent by the subject involves their being truly informed, the subjects must genuinely understand the study. Hence researchers should strive to convey information to subjects, not merely disclose it to them. Subjects should be able to say what they are consenting to (i.e., be able to describe the project and their involvement in their own terminology).
A clear oral explanation, a demonstration of the procedures, showing an informative video, and eliciting and answering questions are other means to obtain informed consent.
A consent form should be only one of many means used to obtain informed consent. Although a dated signature certifies the subject’s willingness to participate, it is not equivalent to assuring that the subject has understood the research. Including a date with the signature avoids confusion about whether the subject began to participate before giving informed consent. A researcher may need to prepare several consent forms, depending on who the subjects are likely to be. For example, a single project may require a permission form for the guardian or parent of a child, a consent form for the competent adult subject, and a simplified assent form for the 8- to 18-year-old or for the adult who is not competent to give consent alone. Foreign-language versions of consent forms will be needed if people who do not speak English are to be enrolled.
To achieve understanding, potential subjects should not be presented information all at once or only at the last minute. People need time to think about whether or not they want to participate. They may wish to discuss the decision with family, close friends, or religious advisors. They should not feel rushed or coerced. They need time, especially if the information is disturbing or particularly complex, to digest the information and come to terms with it. Researchers should be prepared to give adequate time to the Subjects for review – one day, a week, or more, depending upon the level of risk and complexity of the subject’s involvement in the research.
- Write the consent document at an 8th grade (or lower) reading level;
- Use short sentences and keep details separate;
- Use bullets to emphasize key points;
- Emphasize important information by repeating or bolding text;
- Format the document to increase comprehension (e.g., use headers, white space, charts, pictures, diagrams, etc.);
- Define terms in lay language;
- If possible, discuss the consent form with the subject. Highlight key points and ask open-ended questions of the participant to access comprehension;
- Allow ample time for subjects to read, review and make a decision regarding participation. Allow the individual enough time to discuss the study with others;
- Be specific in the consent document & consent process. Subjects need to be fully aware of each step of the study procedures;
- Use the consent document/process as an opportunity to inform subjects as much about the study as possible (as it pertains to him/her). This will help to empower subjects to make his/her own determinations about the research, including the risks and benefits and whether or not he/she would like to participate; and
- If applicable (i.e., long-term studies), continue to emphasize the key points of the consent document/process throughout the study. Keep the subject informed of which point in the study process he/she is, what will happen next and ensure he/she is comfortable to continue.
The burden of ensuring that someone who might participate genuinely understands the research falls upon the researcher, not upon the prospective subject. Hence it is critical to the consent process that the researcher not only field questions but also ask questions. Asking questions can further the discussion, elicit questions from the prospective subject, prompt the prospective subject to think more carefully about the project, and help the researcher decide whether the person has adequately understood the project. These questions need to be prepared in advance.
Useful questions will be open-ended and non-directive. Rather than asking for yes or no answers, they ask for explanation because these questions often can be answered in a variety of ways, and do not already contain the correct answer. Open-ended questions are often introduced with “what,” “where,” “how often,” “when,” and “please describe.” Examples of open-ended questions to be used to assess subject's understanding are:
- “Just so that I’m sure you understand what is expected of you here, would you please explain to me what you think we’re going to ask you to do?”
- “Describe in your own words the purpose of the study.”
- “What more would you like to know?”
- “What is the possible benefit to you in participating in this experimental procedure? What are the possible risks?”
In contrast, examples of closed-ended and far less useful questions are: “Do you understand?”, “Do you have any questions?”, “Do you see that there are some risks in participating in this experimental procedure?”. Instead of furthering the discussion, closed-ended questions tend to bring it to a stop.
It is important to note that federal regulations do not support the concept of passive consent.
Example of passive consent – A research study involves participation from elementary school students. After obtaining appropriate permission from the school system, the researcher would like to send a letter to students’ parents. The letter explains that if parents do not register an objection to the study, it will be assumed that they are giving the researchers permission to ask their child to participate.
To approve the use of a passive consent procedure, the researcher must request a waiver of informed consent.
Waivers of ConsentThe IRB is responsible for granting waivers of consent. The researcher does not specifically need to request a waiver of consent during the application process; however, it is helpful. The IRB does not need to grant waivers of consent for exempt research.
There are three types of waivers. The IRB may waive the requirement for researchers to:
Researcher does provide subjects with the required elements of consent; however, does not obtain signed consent forms from subjects.
To qualify for a waiver of written consent, the research must meet one of the following criteria:
- Criteria 1: The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern (typically used for anonymous studies); OR
- Criteria 2: The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context (e.g., calling someone at home and asking everyday questions, mall survey, mail survey, internet survey, etc.).
Subjects are unaware of participation.
To qualify for a waiver of informed consent, the research must meet all of the following criteria:
- Criteria 1: The research involves no more than minimal risk to the subjects; AND
- Criteria 2: The waiver will not adversely affect the rights and welfare of the subjects; AND
- Criteria 3: The research could not practicably be carried out without the waiver; AND
- Criteria 4: If appropriate, the subjects will be provided with additional pertinent information after participation.
To use a consent document which does not include, or which alters, some of all of the elements of informed consent (required for the use of deception), the research must meet all of the following criteria:
- Criteria 1: The research involves no more than minimal risk to the subjects; AND
- Criteria 2: The alteration will not adversely affect the rights and welfare of the subjects; AND
- Criteria 3: The research could not practicably be carried out without the alteration; AND
- Criteria 4: If appropriate, the subjects will be provided with additional pertinent information after participation.
Definition of ConsentConsent involves the act of the will, based upon legal rights of the consenter, which requires the individual to be 18 years of age or older. Individuals who have appropriate decisional capacity and legal empowerment can give their informed consent. Consent embodies judgments about proposed interventions and, more importantly, consent (literally "to feel or sense with") expresses something for one's self: a person who consents responds based on unique personal beliefs, values, and goals.