Research that involves living human beings as research subjects is fundamentally different from all other kinds of research. When conducting such research we are morally and ethically bound to love our brothers and sisters, whom we are using as research subjects, as we love ourselves. We must protect their privacy and treat them with respect and dignity, seeking only what is best for them, not what is best for our own research. Informed consent is the concept under which care and concern lives itself out. Much has been written on the need for informed consent and its origins in modern ethical thought. The following gives some idea of the background and urgency of the issue.
“All modern codes of ethics concerning research with human subjects affirm the moral importance of a principle of informed consent. It is a principle born of outrage at the atrocities committed by German physicians and scientists under the Hitler regime. As is well known, thousands of concentration camp prisoners were used as human guinea pigs against their will in experiments that were typically excruciatingly painful and generally led to death or permanent disfigurement. As a part of its written decision, the war crimes tribunal that convicted several of the notorious “Nazi Doctors” produced what has since become known as the Nuremberg Code (1), widely regarded as the first international code of human experimentation ethics. The code begins simply, with one statement set apart from all the rest:
‘The voluntary consent of the human subject is absolutely essential.’ “
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A note to student researchers: A well thought out and carefully constructed consent document is a vital part of any research involving human subjects. This web page is intended to give you a very basic introduction to the informed consent concept and the required elements of the consent form. We recommend working closely with your faculty advisor as you compose the consent form for your research project and have written an informed consent template that can be modified to meet the specifications of your research project.
About Informed Consent
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. Informed consent is a process, not a document. The first part of the process consists of you informing prospective research volunteers about the research. This is commonly done through an “information sheet”. The majority of this document addresses this part of informed consent.
The consent form (information sheet) should be written in clear, everyday language that prospective volunteers can easily understand. Ordinary language should replace technical terms. The Readability Scoring feature of Word can be used to determine the reading level of your document. A 7th to 8th grade reading level is commonly used. See the instructions for measuring readability in this web site.
In the special case of an informed assent document, the wording must be age appropriate. For pre-literate children, illiterate adults or non-English readers, the information sheet must be read to the research volunteer and a second person, who has no connection to the research project, must provide a signed statement that the volunteer has been informed and has indicated understanding of the information.
Components of Informed Consent
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. Roger Wiemers, Chair of the Lipscomb University Institutional Review Board, at email@example.com."
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.
REMEMBER: (1) A minor, anyone under the age of 18 years, is not a legal person and cannot give consent. For research involving minors a parent or legal guardian must sign the Informed Consent Form. The participating child must sign a corresponding Informed Assent Form. This detail of the regulations increases the amount of work a researcher must do if children are the subjects of the research in order to provide them the full protection the law gives.
(2) The wording of the Informed Assent Form may have to be substantially different from that of the Informed Consent Form in order to be “age appropriate”.
(3) Research involving pre-literate children, infants and adults or children with limited cognitive ability present additional challenges in complying with the regulations. Your research advisor is responsible for guiding you to information on best practices in all of these cases.
Lipscomb Informed Consent Resources
The Lipscomb IRB has two tools designed to help researchers with informed consent.