Informed Consent

The goal of obtaining informed consent is to provide information so that prospective subjects understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate.

At the bottom of the page is a Sample Informed Consent Form and a Sample Template for an Online Survey Informed Consent Form.

Informed consent is one of the primary ethical requirements of research with human subjects. Informed consent is not a single event or just a form to be signed; it is an educational process that takes place between the investigator and the prospective subject. The basic elements of the consent process include:

  • full disclosure of the nature of the research and the participant’s involvement,
  • adequate comprehension on the part of the potential participant, and
  • the participant’s voluntary choice to participate.

It is the investigator’s responsibility to document that the informed consent process has taken place, and an informed consent form is the standard for documenting the process for research projects involving human subjects.

When the participant population is not homogeneous, different consent documents may be required for different groups of people. If the research population will include participants under 18 years of age, then the HSRB will expect investigators to use an assent form and a parental permission form instead. Similarly, research with cognitively or decisionally-impaired individuals will require documented consent from another party—namely that person’s legally authorized representative.

The HSRB also recognizes that there are instances when documenting written informed consent is not appropriate to a research project. A request should be made to the HSRB for a waiver of informed consent with justification in your HSRB proposal. Regardless of the method of documenting informed consent, however, the process of obtaining informed consent should always contain the same required components.

In seeking informed consent, the following information shall be provided to each subject:

  1. A statement that the study involves research, an explanation of the purposes of the research, and the title of the research project.
  2. An explanation of what will be happening to the participant during the study, and an indication of the participant’s time commitment for each component.
  3. A description of any reasonably foreseeable risks or discomforts to the subject. For social science, educational, and behavioral research, though risks usually do not extend beyond the possible loss of confidentiality and/or mild emotional distress, these should also be made clear to prospective participants. If it appears that there are no real risks to participation, state, “We do not anticipate any risks to you participating other than those encountered in daily life.”
  4. A description of any benefits to the subjects or to others that may reasonably be expected from the research, if applicable. These should be limited to direct benefits: information about better coping skills, awareness of available support or resources, or any other personal gain other than financial rewards. Thus, learning about how experiments are conducted, receiving a gift, or earning extra credit for being a research participant are NOT recognized as benefits (they are compensation). If there are no direct benefits, simply indicate that there are none.
  5. A statement describing how confidentiality of information (data) will be protected.
  6. A statement that participation is voluntary, and that refusal to participate or discontinuation of participation will involve no penalty or loss of benefits to which the subject is otherwise entitled.
  7. A statement that the participant is allowed to ask questions concerning the study, both before agreeing to be involved and during the course of the study.
  8. A description of what will be done with the data once the study is completed.
  9. An indication that recording devices, audio or visual, are being used (when applicable).

    Be sure to describe what will be done with the any video or audio tapes upon the completion of the study (destroyed, erased, archived, etc.), and when (after transcription, 1 year, 3 years, etc.).

    Also, provide a separate signature line on the consent form for the participant to agree to be video/audio taped or photographed, if the recording is optional for participation. For example:

    Please sign below if you are willing to have this interview recorded on tape (specify audio or video). You may still participate in this study if you are not willing to have the interview recorded.

    I am willing to have this interview recorded on tape:

    Signed: __________________________________________

    Date: ____________________________________________

  10. Conclude with a statement such as “I am making a decision whether or not to participate. My signature indicates that I have read and understand the information presented above, that I have decided to participate, and that I consent to the procedures or treatment described above”. Include an 18 year or older statement, if applicable.

     

  11. Provide a space for signatures and the date of signature.

    Signed: __________________________________________

    Date: ____________________________________________

  12. The name(s) of the investigator(s) and contact information.
  13. For on-line data-gathering: Since a signature will not be possible, the investigator can confirm concurrence with the informed consent by, for example, including a sentence at the end of the consent stating that by continuing with the questionnaire, the individual indicates that he or she understands the consent and agrees to participate. Alternatively, the investigator may set up the on-line questionnaire so that the potential participant must check an “I agree” button at the bottom of the consent before being able to continue.

    If data is collected online through a service like Amazon’s Mturk, additional information must be provided, such as “We do not have control over how Amazon (the owner of Mturk) uses data you already provided them to become an Mturk worker. For example, if you are both an Amazon customer and Mturk worker, your worker ID is likely linked to your personal Amazon account, rendering it non-anonymous.”

Sample informed consent form:

(Title of Research Project)

I consent to serve as a participant in the research investigation entitled (title of project) being conducted by (name of researcher/s) as part of (a senior research project/a class project/a research project) for (name of class or department) at Monmouth College. This investigation has been approved by the Monmouth College Human Subjects Review Board with project number XX-XX (include project number after approval).

I understand that this study is investigating (include a brief description of the study topic). As a participant in this study, I will be asked to (describe all of the tasks that participants in the study will complete). This study will last approximately (include a high estimate of how long your study will take).

I understand that the potential benefits of this study to participants are (describe the potential benefits of participating in your study here, including any compensation for participation) OR there are no direct benefits or compensation for my participation in this study. The potential risks to participants in this study are not greater than one may encounter in everyday life (OR describe any risks here). I understand that the information that I provide is confidential and my identity will not be revealed (include an explanation of how confidentiality will be ensured and what will be done with the data once the study is completed).

I understand that my participation is voluntary and that I am free to withdraw consent and to discontinue participation in the project at any time without penalty. If I have any questions about the project, either before it begins or after I have participated, I may ask the researcher directly (or contact the researcher’s advisor) using the contact information below. I am at least 18 years old.

My signature indicates that I have read and understand the information presented above, that I have decided to participate, and that I consent to the procedures or treatment described above.

Participant’s Signature:
Date:

Researcher’s Name:
Researcher’s Email Address:
Researcher’s Phone number:

Faculty Advisor’s Name:
Faculty Advisor’s Email Address:
Faculty Advisor’s Phone number:

Sample Template for Online Survey Informed Consent Form:

(Title of Research Project)

[Include all the standard informed consent document content here and add the following:]

I understand that I will complete this study anonymously online. Because information is being transmitted via the internet, complete anonymity cannot be guaranteed; however, all reports based on my responses will combine my data with other participants’ data and will not reveal my identity or my participation in this project. [If participants are students receiving extra course credit for participation, explain how this will be done to maintain confidentiality.]

I understand that my participation is voluntary and that I am free to withdraw consent and to discontinue participation in the project at any time without penalty by closing the survey prior to completion. Because this is an online survey, I understand that once I have completed the study and submitted the data, it will not be possible to withdraw my data. If I have questions about the project either before it begins or after I have participated, I may ask the researcher directly, or contact the researcher’s advisor, using the contact information below. I am at least 18 years old.

Clicking the “I agree” box and providing my online signature indicates that I have read and understand the information presented above, that I have decided to participate, and that I consent to the procedures described above.

____ I agree to the terms and conditions above.

Researcher’s Name:

Researcher’s Contact Information:

Faculty Advisor’s Name:

Faculty Advisor’s Contact Information: