Researchers must use CSUSM letterhead provided on the IRB website. Provide the title of your project at the top of the page. Title your form "Informed Consent" or "Information Sheet" , depending on which you are preparing. Include all the federally required sections in the order listed 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 section, address the participants and introduce yourself with your name and title or affiliation. Provide a general statement about the study in one sentence. Explain why the participants were selected and are being recruited for the study.
Key Information about this Research Study:
In this section, provide a short summary of the study to help participants decide whether to be a part of this study in a paragraph. Include the purpose of the study (avoid jargon and research terminology such as "factors," "variables," etc.) procedures, the duration of participation, primary risk, and main benefit.
Briefly, explain the purpose of the study.
Number of Participants:
Provide the total number of participants in the study. It may also be appropriate to clarify the number of participants in different cohorts, sites, or groups, if applicable.
Procedures for 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.
Risks and Incoveniences:
This section should be a bulleted list, 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.).
In this section, explain what measures you will take to minize each risk and inconvenience you identified using bullet points.
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. Also, include how long you are going to store the data and how you will dispose it.
Participants 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 the participants; rather, the benefits are to the field in regards to additional content knowledge.
Payment or Incentive:
Indicate whether or not participants will receive payment or any other form of compensation for participating in the study. If payment involved, explain the amount and the conditions under which the participant will receive compensation. If instead of payment the participants receive credit or other forms of compensation (e.g. gift card), this should be mentioned here. If participants receive compensation for different parts of the study, the compensation schedule needs to be mentioned here as well.
Alternatives to Taking Part in the Study: (Include this section only if there is an alternative activity for those who decide not to participate in the study- this usually applies to survey and curriculum/design studies)
Explain how those who decline to participate will spend their time while participants of the study engage in the research activities. For example, if you are giving out surveys in a classroom, explain how those who do not want to take the survey will spend their time.
Study Related Injuries: (Include this section only if your study is full review)
You must explain whether any medical treatment are available if injury occurs and, if so, what they consist of, or where further information may be obtained. Consent forms cannot include any exculpatory language that which the sibject is made to appear to waive any legal rights or releases the researcher or institution from liability for negligence.
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.|
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.