Creating Consent Forms
[printable version]

Basic Federal Requirements:

• A statement that the study involves research.
• An explanation of the purposes of the research.
• The expected duration of the subject's participation .
• A description of all study procedures, including the timing and sequence of procedures as well as the time required for completion.
• Identification of any procedures which are experimental.
• A description of any reasonably foreseeable risks or discomforts to the subject.
• A description of any benefits to the subject or to others (i.e., society) which may reasonably expected from the research.
• For studies that offer treatment: A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject (includes standard of care). In addition, consider stating the relative risks and benefits of therapeutic alternative vs. the research. In non-therapeutic research, the consent form should state any "Alternative(s) to Participation" that may be advantageous to the subject. For example, if the subjects are UConn students, who will receive academic credit, the consent form should describe the alternatives available to earn equivalent academic credit (e.g. research paper). Be sure to rename this section of the consent form to "Alternatives to Participation".
• A statement describing how the confidentiality of records identifying the subject will be maintained.
• For research involving more than minimal risk: An explanation as to whether compensation and medical treatment are available if injury occurs, including a description of each and where the subject may obtain further information.
• A statement that subjects may ask questions about the research and contact information for both the researchers and the IRB.
• A statement that participation is voluntary and that the subject will not be penalized for declining to participate or withdrawing from the study.

Additional Elements (generally used in biomedical and/or treatment studies)
The following additional elements should be included, as appropriate:

• A statement that the particular treatment or procedures may involved risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable
• Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent
• Additional costs to the subject that may result from participation in the research
• The consequences of a subject's decision to withdraw from the research and the procedures for orderly termination of participation by the subject
• A statement that significant new findings developed during the course of the research, which may relate to the subject's willingness to continue participation will be provided to the subject
• The approximate number of subjects involved in the study

Refer to the consent form/information sheet checklist for detailed guidance in how to prepare and format the consent form.

General Instructions & Formatting:

• Leave plenty of "white space"
• Make sure you have at least 1" margins on all sides
• Do not use anything smaller than size 12 font

Consent Form Validation
Investigators are required to use an approved, validated (with the IRB's stamp) consent form or information sheet to consent each subject.

Specific Instructions for Using the IRB Template or Creating Your Own Consent Form

The IRB has provided the Consent Form Template to make it easier for researchers to include all of the necessary information. The template should be downloaded and modified to suit the individual study.

• If you choose NOT to use the IRB template, skip to the Section 1 instructions and include all of the required information as addressed by Sections 1 - 11, as well as the federal & IRB required elements listed in the above section.

For ease of use, the template downloads as a locked document. Simply tab through and fill out the gray sections or cut and paste into the shaded areas to complete the information sheet.

• Download the Template Now
• To unlock the document in Microsoft Word, go to Tools --> Unprotect Document. This will allow you to edit the document fully.
• Any text appearing in the gray shaded areas of the Template should be replaced with your own words and explanations.
• Follow the detailed instructions listed below to complete the sections of the template.
• The Basics of Using RTF files.

** Note - never list students as the Principal Investigators; list them instead as student researcher. **

Section 1: Invitation to Participate
Tell your subject why s/he is being asked to be in the study. The information sheet must be written in the second person ("You are invited to be in this study…") Do not use the first person ("I understand that …")

Section 2: Purpose
Describe WHY you are conducting the study.

Section 3: Description of Procedures
Describe all study procedures so that the subject knows what her/his participation will consist of. You should include the length of time the study will take, the timing and sequence of the study procedures, the time required for each procedure and whether the subject will be contacted again in the future.

Section 4: Risks and Inconveniences
Describe any risks (could be physical, psychological, social, or economic) or inconveniences the subject may experience. Inconveniences could be the amount of time it takes to do the study.

Section 5: Benefits
If there are no benefits to the individual subject, you should identify the benefits to society. DO NOT include $$$ here.

Section 6: Economic Considerations (if appropriate to the study)
Tell the subject whether s/he will be charged for any part of the study and/or whether s/he will be given any compensation for participation. Compensation may not be coercive in amount or method of distribution.

Section 7: Alternative Treatment or Alternative(s) to Participation
If the study offers treatment then you must include a section that tells the subject what other alternatives exist to the treatment offered per the study (could be no therapy, standard therapy or other experimental therapies). State the relative risks and benefits of the therapeutic alternative(s) vs. the research. If the study involves UConn students, describe the alternatives available to earn equivalent academic credit.

Section 8: Confidentiality
Describe how you plan to preserve the subject's confidentiality. Remember that there is a difference between confidentiality and anonymity. Confidentiality means that the subject's identity is known and linked to the data, even if not included in publications. Anonymity means that there is no way you can ever link the data to the subject. You must also include the following statement:

You should also know that the UConn Institutional Review Board (IRB) and the Office of Research Compliance may inspect study records as part of its auditing program, but these reviews will only focus on the researchers and not on your responses or involvement. The IRB is a group of people who review research studies to protect the rights and welfare of research participants.

Section 9: In Case of Injury
Only applicable for studies that present greater than minimal risk to subjects:
If the study is greater than minimal risk to the subjects, you must include a statement telling subjects what they should do if injured (go to ER, call PI, etc.). If funds exist to reimburse the subjects for the cost of their medical treatment, state that here. If no funds exist to reimburse subjects, you must state that as well. In addition, the following statement must be included:

The University of Connecticut does not provide insurance converge to compensate you if you are injured during the research. However, you may still be eligible for compensation. If you are injured, you can file a claim against the State of Connecticut seeking compensation. For a description of this process, or available compensation options, please contact the Office of Research Compliance at the University of Connecticut at 860-486-8802.

Section 10: Voluntary Participation
Include the following statement:

You do not have to be in this study if you do not want to. If you agree to be in the study, but later change your mind, you may drop out at any time. There are no penalties or consequences of any kind if you decide that you do not want to participate."

Section 11: Questions
Include the following statement:

Take as long as you like before you make a decision. We will be happy to answer any question you have about this study. If you have further questions about this project or if you have a research-related problem, you may contact the principal investigator, (insert name and phone number) or the student researcher (insert name and phone number). If you have any questions concerning your rights as a research subject, you may contact the University of Connecticut Institutional Review Board (IRB) at 860-486-8802. An IRB is a group of people that reviews research studies and protects the rights of people involved in research.