Researchers should use the letterhead/masthead provided on the IRB website. 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. Use short paragraphs for each section and language that a layperson can understand. 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. Explain why subjects are being recruited for the study i.e. inclusion criteria, etc.
Briefly, list the primary aim(s) of your study. Avoid jargon and research terminology such as "factors", "variables", etc.
Procedures of the Study
In this section, describe what participants will be asked to do if they agree to participate 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. List the procedures 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.
Risks and Incoveniences
Next should be a bulleted section labeled, in which you list all potential risks and inconviences experienced through participation in the study. Remember, risks can be emotional (survey responses, etc.), financial (loss of income), physical (harm or injury), personal (loss/jeopardy to relationships, excess time commitment, etc.).
Include a section in which each safeguard denoted responds to a corresponding risk listed above.
Explain whether the data is confidential or anonymous. Explain where and how you are going to store the data collected. If confidential, explain how you are going to protect the real identity of the participants, e.g. you might assign ID numbers or give pseudonyms.
Subjects need to be informed that they can withdraw their participation at any time without consequences.
Benefits of Taking Part in the Study
The Benefits section lists the potential benefits to participants for enrolling in the study. There may be no direct benefits to individuals; rather, the benefits are to the field in regards to additional content knowledge.
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.
Contact Information and Signatures
Research participants should be able to contact the study investigators at any time to answer questions about their participation and to report any problems or unanticipated consequences. Make sure that you provide your email address and phone number. Students must also provide contact information for their faculty advisor. Use your CSUSM email address. At the end of your contact paragraph include the following statement:
|“This study has been approved by the California State University San Marcos Institutional Review Board. Questions about your rights as a research participant should be directed to the Institutional Review Board at firstname.lastname@example.org or (760) 750-4029. You will be given a copy of this form to keep for your records.”|
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. You should also include check boxes or additional signature lines to indicate explicit permission to photograph, audiotape, or videotape participants. You should include an explanation of what will become of those recordings in the section where you discuss confidentiality.
IMPORTANT: People under 18 years of age cannot give consent. You need to obtain parent signatures on the consent form, and create a separate child assent form for children older than 7. The child assent form must be written at the child’s level of understanding.