Instructions for Informed Consent Documents or Information Sheets
Students should use the letterhead/masthead provided on the IRB website. Faculty must use their own department letterhead. Title your form "Informed Consent" or "Information Sheet", depending on which you are preparing, followed by the title of your project. Include all the sections below as appropriate.
It is recommended that you use short paragraphs, sub-heads for each paragraph, and language appropriate to your population. Write in a conversational style as if you are talking to the participants.
Invitation to Participate
In this first section, introduce yourself with your name and title or affiliation; always list that you are associated with CSU—San Marcos. Then, briefly list the primary aim(s) of your study. Follow this with rationale as to why subjects are being recruited for the study i.e. inclusion criteria, etc.
Requirements of Participation (What you will be asked to do)
In this section, in layman’s terms describe what participants will undergo during his/her participation in the study. Describe all procedures used as part of your protocol, including all surveys/questionnaires, interviews, audio/videotaping, as well as physical measurements such as heart rate, blood pressure, blood draws, etc. As you describe these procedures, try and list them chronologically and make sure to denote the estimated time commitment of each component of the study. Subjects should be able to understand exactly what their responsibilities are after reading this section.
If there is more than 1 day of participation, describe what subjects will need to do between trials, etc. to maintain the validity of your study. Also, it may be warranted to briefly describe the rationale for each test or interaction.
Risks
Next should be a bulleted section labeled, in which you list all potential risks experienced through participation in the study. Remember, risks can be emotional (survey responses, etc.), financial (loss of income), physical (harm or injury), personal (loss/jeopardization of relationships, excess time commitment, coercion, etc.) as well as loss of anonymity and confidentiality that we as Investigators strive to maintain.
Safeguards
Include a section in which each safeguard denoted responds to a corresponding risk listed above. Sample safeguards can be found on the sample consent forms linked to at the end of this document.
Incentives for Participation
List any incentives for participating that you are offering; if you are not offering incentives, do not include this section. Keep in mind, monetary compensation, extra credit, etc. are incentives and not benefits. If there are strict criteria for receiving incentives, such as completion of the study, list that here also.
Benefits The Benefits section lists the potential benefits to participants for enrolling in the study. Sometimes, there may be no direct benefits to individuals; rather, the benefits are to the field in regards to additional content knowledge; this is fine.
Voluntary Participation and Contact Information
These sections must use text very similar to the sample consent forms. Subjects need to be informed that they can withdraw their participation at any time without consequences (we no longer use the word penalty). Make sure that you provide your email address and phone number. Students must also provide contact information for their faculty advisor. It is recommended too that you maintain a ‘professional’ email address that reflects appropriately on you, your research, and the University. Your CSUSM email address is preferred.
The final line should state that participants agree to participate in the study. Signature lines must be included unless a waiver of signed consent is being requested in the IRB application.
When participants are under 18 years of age, parent signatures must also be obtained. If the language level of both parent and child are similar, one form must be used. Otherwise appropriate supplemental forms must be used. This may be a child assent form written at the child’s level of understanding or a parent consent form written in the primary language of the parent.
Please Note! Consent is a process that should include an adequate discussion of the research with the potential participants (and parents as appropriate), time for consideration such that there is no pressure to decide immediately, and a printed document (consent form) that a participant may take with them.
