Informed consent is the term given to the communication process that allows individuals to make an informed decision about participation in a research study. This process begins with the recruitment materials and is described in an informed consent document that contains specific, required information about the research study.
The human subjects in a research study must be adequately informed about the research and must participate willingly.
If the human subjects in a project are part of a vulnerable population (i.e. prisoners, cognitively impaired individuals, or children), special protections are required. Contact the IRB Office at (734) 763-5084 for more information.
The IRB provides consent templates that can be adapted for specific research projects. These templates contain the regulatory elements required for informed consent. Be sure to click the download arrow on the upper right side of the screen and the template will open in Word.
If the study is more than minimal risk or is not eligible for an Exempt Determination please use the Standard Consent Template and adapt it to the conditions of the research project.
PI's who are conducting studies utilizing the UM-Dearborn Psychology Department Subject Pool will use one of the Subject Pool Consent Templates and adapt it to the specifics of their study.
The Informed Consent Templates, contain all required elements of informed consent. Except where noted, written informed consent must contain all sections described in the template.
- The consent form should be able to be written at a 5th to 8th grade reading level.
- It should be formatted to separate required elements of the informed consent process (i.e. Risks & Benefits, Explanation of the Research Study, etc).
- The IRB recommends that researchers modify the consent template, save it and upload it to the IRB application.
If informed consent will be obtained in a language other than English, please include a copy of the consent document in that language, as well as a copy of the English version.
Informed Consent is not required for studies that are Exempt from IRB Oversight. However, obtaining informed consent is is important component of the ethical conduct of human subjects research.
Informed Consent is not required for studies that are Exempt from IRB Oversight. However, obtaining informed consent is is important component of the ethical conduct of human subjects research. The Dearborn IRB recommends that all researchers obtain informed consent using the templates.
IMPORTANT: Applications for international studies are more complex than applications for domestic studies so expect that the approval process will take longer and submit the application as early as possible.
- The consent form must be written in the language that the subject reads or speaks and must contain all of the required consent form elements.
- The application must contain contact information for the PI and for the Dearborn IRB; the mandatory language on the Consent Form contains this contact information.
- Please verify that the country code for the United States is included with the contact information.
- If your study has been reviewed by a local IRB or ethics committee please provide the local contact information (email, telephone, and address as applicable.)
- IRB Dearborn may require you to provide contact information for a local individual or organization that can assist subjects in relaying questions or complaints to the IRB - Dearborn particularly for projects involving more than minimal risk to the subjects.
Please note that all waivers or alterations must be requested at question 10.1 of the eResearch IRB application. Additional sections of the application will open to collect the detailed information needed for IRB approval.
Request for Alteration of Informed Consent Requirement.
Researchers that utilize deception in their research must apply for a "Request for Alteration of Informed Consent Requirement". In order for this request to be approved the study must:
- present is no more than minimal risk to the subjects AND
- the subjects are debriefed and offered the chance to withdraw their data at the end of the research interaction.
Request for Waiver of Documentation of Informed Consent
The consent process takes place before the research begins but the subject's signature is not collected. There are 2 conditions where this request can be approved
- The consent form is the only thing that links the identity of the subject to the research. This is especially useful for studies where there could be risk to the subjects should their identity become known. For example, studies that ask about illegal activities or immigration status would benefit from a Waiver of Documentation of Informed Consent.
- Studies that present no more than minimal risk to the subject. The Waiver of Documentation is especially useful for on-line studies where the subjects can not sign a consent document.
Waiver of Consent
When a Waiver of Consent is requested there is no consent process at all. In order for this request to be granted the following 4 conditions must be present:
- The research involves no more than minimal risk to the subjects.
- The waiver or alteration will not adversely affects the rights and welfare of the subjects.
- The research could not practicably be carried out with out the waiver or alteration.
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Examples of studies where a Waiver of Consent is required are: studies where questions are asked about 3rd parties who are not part of the original data collection, studies where subjects who are 18 years old live in a state where the age of majority is 21 a waiver of parental consent may be approved.