Informed Consent & Other Considerations
The goal of the informed consent process is to ensure that the research participant is treated with respect and human dignity.
This is achieved by safeguarding the participant’s right to deliberate and make a knowing decision whether to cooperate with the investigator’s research interest. It communicates to the prospective research participant the purpose, procedures, risks and benefits of the study; the participant’s rights in participating in the research; and the freedom to decline to participate without penalty. The consent document also allows the participant to obtain further information and answers to questions related to the study. The consent form, therefore, serves as a written summary of the proposed research and provides a reference for both the participant and the researcher.
All research participants must give their express consent to participate in a research study. Consent is a necessary element for all research studies, including expedited research. Consent is only considered valid if the participants are given enough information to allow them to weigh the study’s risks and benefits and if the information is told to them in terms that they can understand. Participants always have the right to decline or even withdraw from any study.
Marlboro College requires that every researcher (whether student, faculty or staff) secure the informed consent of any human participant before involving that participant in the research project.
Every potential participant who is a physically and mentally able adult (at least 18 years old) must provide consent to participate in the research prior to the initiation of the actual research. The ideas of mental and physical normalcy revolve around the ability of the participant to provide truly informed and voluntary consent. Populations who do not meet this description, whether due to age or disability or other protected status, must be afforded additional safeguards.
Description of the Consent Process
The consent process is typically made up of two parts:
- a discussion that takes place between the researcher and the participant
- a written document (for example, a consent form) that captures the nature of the consent discussion
The consent process should be specific to each participant population as well as the individual participant. There may be some participants who require special considerations, such as children, prisoners, cognitively impaired individuals, economically/educationally disadvantaged individuals and others. The IRB will always look to see that the study and consent process provide additional protections for these “vulnerable populations.”
The consent form/information sheet must be written in language “understandable to the participant”. The IRB reviews consent forms very carefully to ensure that they would be understandable to a wide audience. Key elements to consider when filling in the details of your informed consent form are:
- It should be written at no higher than an 8th grade level (similar to a popular magazine or newspaper; language copied out of a grant or proposal is not appropriate).
- It should be written in the second person (“you are invited to participate, you will be asked to participate in an interview about your favorite colors, lasting approximately 30 minutes…”)
- It should be written as if the author and the reader are engaged in conversation.
Information Sheet vs Consent Form
The consent discussion that takes place between a researcher and participant must be captured in a document called an “informed consent form” or “consent form.” Unless the IRB gives an investigator permission to alter the consent process (i.e. through an oral consent form), all research participants must indicate in writing their willingness to participate by signing the consent form.
However, written consent may not be necessary or appropriate in certain studies, such as surveys (print or online) where the participants are to remain anonymous. In these cases, the investigator should prepare an “information sheet” appropriate for the study. This assures that the criteria for obtaining informed consent are met and understood by all parties involved in the study.
Each participant must be given a complete copy of the consent form. The investigator should also keep one copy of the consent form. Investigators should keep consent forms on file for 3 years following the completion of the research. Consent forms should be kept in a secure location, accessible only to the researcher. All electronic information should be coded and secured using a password protected file.
Anonymous and Confidential Data
Participants should not be promised anonymity unless the research data is truly anonymous. Anonymity cannot be guaranteed unless there is no method by which the investigator can connect the research results with individual participants providing the data. If there are codes or a master list that would enable the investigator to identify participants, the research is not anonymous even though the participants’ names do not appear in the research data. Similarly, interview and ethnographic research can never be anonymous, since the researcher knows who the participants are. This data could be considered confidential if the participant’s identity is not discernable.
Consent and Assent for Minor (under 18) Research Participants
All research participants under the age of 18 must provide written parental (or guardian) consent in order to participate in College-sponsored research projects. In addition, an assent form must be signed by those participants capable of understanding a simplified version of the consent form, and of signing their names. A copy of both the consent and assent forms must accompany the proposal. For participants too young to read, but who are capable of understanding an oral explanation of the procedures, a copy of the oral explanation (a script) must accompany the proposal. The age, maturity, and psychological state of the participants must be taken into account by the researcher when creating an assent form or an oral explanation for minors.
Written Assent: From age 7 and up, a child’s written assent is needed (in addition to parental or guardian consent). The assent form should be written in a way the minor participant can understand. There are sample forms for children ages 7-13, and ages 14-17. The researcher should use supplementary verbal explanations as needed.
Oral Explanation: For participants who are 6 and younger, the researcher should obtain the child’s assent to participate, but a signature is not required. The explanation to the child should contain elements of consent expressed in a way the child can understand. A conversational question/answer setting is often the most useful form of communication. With very young children, the child’s nonresistant behavior may be interpreted as assent, but the researcher must use special care to discontinue the participation of any child who appears to experience undue stress from the research procedure.