Elements of Informed Consent
Informed consent forms should include the following elements. (You may change the order in which items 5 through 12 appear, or consolidate two or more of these items if it enhances the readability of your form).
- Heading: All informed consent forms should start with the following heading: Saint Xavier University Consent to Participate in a Research Study "Title of Study"
- 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).
- 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. 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. Do not attempt to mask or hide the purposes of the study. Researchers who believe the use of deception is essential for their project must justify the deception. All investigators employing deception must justify its use in the IRB application.
- 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, identify any procedures that are experimental, state any physical requirements and indicate as accurately as possible the volunteer's anticipated time commitment to the project. If applicable, state whether the subject will be expected to return for follow-up exams, interviews or procedures. Also include a statement of any randomization procedures which may influence the participant's chances of placement into any of the experimental/treatment or control groups. If applicable, explain placebo treatments, amount of blood to be drawn, specific clinical procedures and so on.
- Description of Risks and Discomforts: 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. Per 45 CFR 46.116.a.6, "For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
- Description of Benefits: Describe any benefits to the participant or others which may be reasonably expected from the research. (In many instances, it is appropriate to incorporate the description of benefits in the statement of the Purpose of the Study.)
- Disclosure of Alternatives: Describe any alternative procedures, treatments or resources that might be appropriate and advantageous to the participant.
- 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.
- Identifiable Private Information: A statement of whether a subject's private information or biospecimens could be used for future research studies or distributed to another investigator for future research studies, with or without identifiers.
- Costs to Participant: Explain any costs for which the volunteer will be responsible, such as costs for medical treatment, laboratory testing or psychological counseling.
- Monetary Compensation/Honorarium: If the participant is to receive compensation for participation, state the nature and amount of compensation and the terms of payment (for example, on completion of participation).
- Availability of Compensation for Injury: Include the following statement regarding compensation for injury: I understand that in the event of physical injury resulting from this research there is no compensation and/or payment from Saint Xavier University for such injury, except as may be required of the University by law.
- Noncoercive Disclaimer: 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 at any time without penalty or loss of benefits to which I am otherwise entitled. I also understand the investigator has the right to withdraw me from the study at any time.
- Project Liaison and IRB Administrator: Provide the name, telephone number and email address of the person available to answer questions about the research and research subjects' rights, and next steps in the event of a research-related injury to a human participant. This is usually the Principal Investigator, although larger projects may wish to name the Program Director, Research Director. The contact information for the IRB Administrator must be included in the informed consent form as an additional point of contact concerning participants' rights and next steps in the even of injury. The IRB Administrator's contact information can be found on the IRB Membership page.
- Signed Consent to Participate: Include the following statement: I acknowledge that the investigator has explained
to me the need for this research, identified the risks involved and offered to answer
any questions I may have about the nature of my participation. I freely and voluntarily
agree to participate in this study. I understand all information gathered during the
interview will be completely confidential (or anonymous). I also understand that I
may keep a copy of this consent form for my own information.
Signature of Voluntary Participant
Note: Requests for alterations to or waivers of the informed consent process may be requested, but all such requests must be justified on the basis of the criteria stipulated in 45 CFR 46.116.c-d and Section F of SXU's IRB Application Form (DOC).