Participant Consent Information
Informed Consent Is A Process
- The Investigator should explain the study to the potential participants verbally, providing all pertinent information (purpose, procedures, risks, benefits, etc.), and must allow the potential subject ample opportunity to ask questions.
- Following this verbal explanation, the potential participant should be provided with a written consent form and afforded sufficient time to consider whether or not to participate in the research. "Sufficient time" can range from hours to days, depending on how long it reasonably takes to evaluate the procedures, risks, potential benefits, etc.
- The potential participant should be provided an opportunity to ask any questions they may have about their participation in the research.
- It is important to continue the informed consent process during the research, ensuring the participants continue to understand pertinent information about the study and are making a voluntary decision to continue their participation.
Suggestions for Preparing Consent Forms
The IRB has developed templates for the informed consent and assent process. These templates are offered as tools to support you in your research, and you should adapt these templates to the specific needs of your research project. You are not required to use the templates and are welcome to design your own informed consent forms.
- Assent Form Template
- Informed Consent Template
After you have completed your consent form, please proofread for:
- Accuracy
- Completeness and inclusion of required statements
- Spelling and readability: You may wish to use a readability tool to ensure the accessibility of your form. These tools are available in most word processing applications, and some online tools are also available.
Documenting Institutional Permission
If you are conducting your research at a non-Minnesota State University, Mankato site you must obtain permission from the appropriate authority to conduct the research at their site. This permission must be obtained prior to IRB approval, documented, and submitted with your application.
