Consent Form Template

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The Department of Health and Human Services requires all researchers conducting human subjects research to provide prospective subjects with informed consent.
In most cases, federal regulations require written informed consent. The consent form should be written in clear, everyday language that prospective volunteers can easily understand. Ordinary language should replace technical terms. A consent form should have the following components:

Introductory Statement: In the first paragraph of the consent form, provide a brief statement which includes the general topic of investigation and identifies the sponsoring agency (if any) and the Principal Investigator(s).

Background Information/Purpose of Study: State the purpose of your research. The principle of respect for persons requires researchers to clearly inform prospective participants of research objectives in an honest and forthcoming manner (if research involves deception this must be justified in your IRB application). The statement of purpose should be concise, but must provide sufficient information to allow the individual to make an informed decision about whether or not to participate.

Explanation of Procedures to be Followed: Clearly state the nature and duration of the subject's participation in the research study. Describe the procedures employed by the study, state any physical requirements and indicate as accurately as possible the volunteer's anticipated time commitment to the project.

Description of Risks/Discomforts & Benefits: In lay terms, describe any foreseeable risks or discomforts to the volunteer. Individuals who may be placed at increased risk of physical discomfort or psychological distress must be clearly warned of the nature of their risk and informed of precautionary measures employed by the investigator to minimize risks and ameliorate negative effects. Also describe any benefits to the participant or others which may be reasonably expected from the research.

Compensation: If the participant is to receive compensation for participation, state the nature and amount of compensation and the terms of payment.

Confidentiality/Anonymity: Describe the extent to which the project will maintain the privacy of information. Confidentiality means the researcher will maintain records with personal identifiers but will not release information to unauthorized personnel. Anonymity means that records will not include any personal identifiers or code numbers that may link a participant to specific information.

Voluntary Nature of the Study: Include the following statement: Participation in this study is completely voluntary; refusal to participate involves no penalty or loss of benefits to which I am otherwise entitled. I understand that I may discontinue participation without penalty or loss of benefits to which I am entitled. I also understand the investigator has the right to withdraw me from the study at any time.

Contact Information: Provide the name and telephone number of the person available to answer questions about the research. This is usually the Principal Investigator. Also include the following statement: "If you have other questions or concerns regarding the study and would like to talk to someone other than the researcher(s), you may also contact Dr. John Schmitt, Chair of the St. Catherine University Institutional Review Board, at (651) 690-7739."

Signed Consent to Participate: Include the following statement: "You are making a decision whether or not to participate. Your signature indicates that you have read this information and your questions have been answered." Include a line for the participant to sign and date the form.



Use our template as you construct your own Informed Consent Form!

Please note that any area of this form marked with XXXXXX or parentheses indicates that you should provide your own information. Please use the entire form and modify it to fit your needs.

Use the following checklist to ensure that all elements of informed consent are included:

___ A statement that the study involves research.
___ For student research, a statement that the study is being undertaken by students under the supervision of a faculty member. The name of the department should be indicated as well as the name of the faculty member.
___ An explanation of the purposes of the research.
___ The duration of the subject's participation.
___ The number of subjects involved in the research.
___ A step by step description of the procedures to be used.
___ A description of the expected or foreseeable risks or discomforts to the subject.
___ A description of any benefits to the subject or to others which may reasonably be expected from the research.
___ A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
___ A description of the measures that the researcher will follow to assure confidentiality of records that identify each subject by name and/or identification number.
___ An explanation of how to contact the researcher and the sponsor for questions about the study.
___ If physical contact is involved, an explanation of whom to contact regarding the research, the subject's rights, and research-related injury.
___ A statement that the subject is free to choose to participate in the study, and that by refusing to participate, the subject will not be penalized or lose any benefits to which the subject may otherwise be entitled.
___ A statement that clearly indicates that the subject may discontinue participation at any time, even after the consent form is signed, without any loss of benefits.
___ A statement indicating that the subject will be offered a copy of the form to keep.
___ A line for the signature of the subject followed by the date(do not make an "x" to show where to sign)
___ A line for the signature of the investigator followed by the date of the signing