Informed Consent
Frequently Asked Questions (FAQ)
& Tips

Tips for Creating Consent Forms

The process of obtaining informed consent must comply with the requirements of 45 CFR 46.116. Informed consent is a process, not just a form. Information must be presented to enable persons to voluntarily decide whether or not to participate as a research subject.

Sample language for the items explained below can be found on the standard IRB cover letter and consent form templates. For more information and other forms needed for your IRB application, please visit IRB on the web at:

http://www.jmu.edu/sponsprog/irb/irbforms.html

Faculty Guide to IRB Approval
(print version - pdf)

Student Guide to IRB Approval
(print version - pdf)

Identification of Investigators-Identify all of the researchers participating in this research project, also identify for what class the research is being conducted.

Purpose of Study- Identify the reason the study is being performed and briefly state the research objectives.

Potential Risks-List any potential risks that may arise during the study, if there are no foreseeable risks then state that the investigator does not perceive more than minimal risks from any subject's involvement in this study.

Potential Benefits-These benefits might include having the participant directly benefit from the research themselves or at the very least expanding the level of knowledge in a certain field.

Research Procedures-Describe exactly what the participant will be asked to do in the study: from signing the consent form to how they will submit their completed responses. If the researcher plans to contact participants with the final results or otherwise make them available, then the method for accomplishing this should be stated.

Confidentiality-Include all of the following points under this section:

• What audience will view the data results, (i.e. presentation, paper, published research, classroom project etc.).
• In what format the data results will be presented, (i.e. aggregate form only).
• How the data will be secured throughout the study (i.e. in a locked metal filing cabinet available only to the researcher or his/her advisor).
• What will happen to the data upon completion of the study (i.e. shredded or destroyed in another responsible manner).

Participation & Withdrawal- The cover letter/consent form should emphasize that the subject's participation is entirely voluntary. Furthermore, the researcher should inform the participant that they can halt the survey/interview (etc.) and withdraw from the study at any point, without consequences of any kind.

Contact Information-State to the participant how they can reach the researcher/investigator at the time of the study and after the study is completed in case they have any questions. JMU students should identify their faculty advisor. Please provide the participant with a ways to contact the researcher (by e-mail) and advisor, if applicable (preferably by e-mail and work phone).

The contact information for the IRB Chair MUST be included on EVERY cover letter and/or consent form in addition to the investigator contact information listed above. The sample consent form on the IRB web site contains sample language for this statement.

JMU Students Information-Identify the type of student research activity the investigator will be conducting, and how it relates to their academic program at JMU.

• Symposium
• Conference
• Senior Thesis
• Honors Thesis
• Classroom Project
  

Other items to consider when creating a consent form or cover letter:

Surveys should not be administered by an individual in a position of authority over the research subjects.

Please state how the researcher will obtain consent from the telephone subjects. When conducting telephone interviews, please obtain proper consent and note such on the consent or survey form submitted for IRB review, and/or part of the script at the beginning of the telephone interview,

Anonymity v. Privacy: There are many circumstances where a researcher may choose to protect a subject's identity by not referring to them by name in their research. This serves to make their responses confidential, but is not the same as conducting an anonymous study. The following research activities would not be considered anonymous: If interviewing subjects they cannot be considered 'anonymous' because the investigator is talking to them directly. If the subject's images/voice are recorded by the investigator on audio or videotape. The subject is known personally to the investigator.

Consent forms must be written at an eighth grade reading level.

Provision of Consent-

Include a statement that explicitly states the human subject:

• Understands what is being asked of them as a participant in the study
• Has no outstanding questions regarding his/her participation
• Is willing to participate
• For situations where a consent form signed by the participant and investigator is used, the consent statement should also indicate that both parties will retain a signed copy of the form.

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Anonymous Survey Research

• A cover letter may be used for anonymous studies instead of a consent form.
• The researcher still signs this letter but does not obtain the signature of the participant.
• Address the following confidentiality issues in the cover letter:
  • What audience will view the data results, (i.e. presentation, paper, published research, classroom project etc.).
  • In what format the data results will be presented, (i.e. aggregate form only).
  • How the data will be secured throughout the study (i.e. in a locked metal filing cabinet available only to the researcher or his/her advisor).
  • What will happen to the data upon completion of the study (i.e. shredded or destroyed in another responsible manner).
• A study can only be considered truly anonymous if the researcher cannot identify the participants.
• To ensure the confidentiality of the participant, the researcher must provide a method of dissemination and collection so the participants cannot be identified.
  • Some methods of accomplishing dissemination and collection follow:
    • Provide a blank envelope or ballot box and allow each participant to submit their survey there individually.
    • The participant must remain anonymous to the researcher.
    • Surveys should not be administered with the researcher present.
• Interview subjects cannot be considered anonymous if the process involves dialogue and personal interaction.

Confidential Interview Research

Unlike anonymous surveys, when participants are interviewed the investigator must obtain a consent form signed by both parties (researcher and participant). Both parties retain a copy of this signed form.

• Details must be provided as to how participants' answers will be kept confidential. This includes the following:
  • What audience will view the data results, (i.e. presentation, paper, published research, classroom project etc.).
  • In what format the data results will be presented, (i.e. aggregate form only). How the data will be secured throughout the study (i.e. in a locked metal filing cabinet available only to the researcher or his/her advisor).
  • What will happen to the data upon completion of the study (i.e. shredded or destroyed in another responsible manner).
  • What will happen to audio-tape or video recordings of subject responses, (i.e. erased or destroyed).

Web-Based Survey Research

Web-based survey research requires the researcher to obtain participant consent.

Sample Methodology:

• Send a preliminary e-mail to request participation.
• Include a confidentiality section on the consent form that covers how the participants will remain anonymous. This statement will guarantee the participant's e-mail address or other identifying information is not included when the survey is submitted. Provide the subjects with the link to the consent form, and not the survey itself.
• Typically there will be a line that states, "I certify that I am at least 18 years of age" and "By clicking on the following link I consent to participating in this study."
• Should the subjects consent they will then click on the link to the survey normally located at the bottom of the consent form.

Telephone Survey - Consent Script

Sample Dialog follows: (sample form)

(The following written consent serves as signed documentation for oral informed consent (such as telephone surveys) for the protection of the participant.  Federal requirements mandate that informed consent shall be documented by the use of a written consent form and in the case of oral presentation must also be witnessed.)

VERBAL CONSENT DOCUMENTATION FOR PARTICIPATION.

SUBJECT:  Project Title

This signed written consent serves as documentation that the required elements of informed consent have been presented orally to the participant or the participant’s legally authorized representative.

Verbal consent to participate in this telephone survey has been obtained by the participant’s willingness to continue with the telephone survey by providing answers to a series of questions related to what the participant has heard about air quality.

                                                                                                                                                           
Surveyor’s Name (Printed)                                           Surveyor Witness’s Name (Printed)     

                                                                                                                                                           
Surveyor’s Signature                                                     Surveyor Witness’s Signature   

                                                                                                                       
Date                                                                             Date

Personal Interview - Consent Script

A recruitment script is what one follows when making initial contact with potential interview subjects. This should be very similar to the consent form. The goal of the script is to let potential subjects understand that the investigator is asking them to participate in a research project, that their participation is voluntary and what, precisely they are being asked to do.

Sample script follows:

Research Involving Youth/Minors

Research that involves minors must include the following:

1. Child Assent Form (Ages 7-12)
2. Youth Assent Form (Ages 13-17)
3. Parental Consent Form
4. Site Permission if outside of the child's home, i.e. Nursery School, Public School, Private School, etc.

Research Conducted off JMU's campus (Letter of Permission required)

• Conducting research at a site other than JMU researchers must receive written permission from the site coordinator of that business/institution/agency. A letter of permission is required from any private organization such as the Valley Mall. If researchers want to send completely anonymous surveys to an organization and have provided a self-addressed stamped envelope then advance permission from the site is not required.
• If the researcher is going to an agency and interviewing only the senior member of the staff then it is not necessary to gain a letter of permission from the site coordinator. In this case, the person being interviewed would sign a consent form.
• Research studies conducted at another Educational institution require approval from the Institutional Review Board of JMU as well as the institution where the study is performed.

Research Involving Participants with Limited English Skills

There will be occasions when the researcher wishes to study a group of human subjects who have limited English skills. In those situations, the researcher is responsible for ensuring that the participants truly comprehend the purpose of the study, and what will be required for their participation.

• If the research subject's native language is not English, please provide assurance in your protocol (not the consent form) that they will only interview subjects with good English speaking/reading/writing skills. Otherwise the consent form must be translated.
• Consent forms must be written at an eighth grade reading level as well in the research subject's native language.