Informed consent is one of the primary ethical requirements of involving human participants in any research activity. It assures that participants understand the research and what they will be expected to do so that they can make an informed decision about whether they want to participate in it. Informed consent reflects the basic principle of respect for persons.

Heartland IRB informed consent page: school child

It is essential that researchers think of informed consent as an educational process that takes place between the investigator and the prospective subject, and not just as a form that must be signed. No one can guarantee that another person has understood the information presented; one must inform prospective subjects as clearly as possible. The researcher also must ensure that participants understand all information that is presented. In some cases, it may be necessary to ask the participants to explain the research procedures to verify their understanding.

Examples of Heartland IRB’s informed consent forms and other consent forms can be found under the Forms tab.

Basic Components of Informed Consent,
Anonymous versus Confidential Data, and
Additional Requirements for Specific Research Methods/Populations
are the three components of our informed consent requirements.

Basic Components of Informed Consent

Federal regulations require that certain information must be provided to each subject [Federal Policy §46.116(a)]:

  1. 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 the procedures to be followed, and identification of any procedures that are experimental,
  2. A description of any reasonably foreseeable risks or discomforts to the subject,
  3. A description of any benefits to the subject or to others that reasonably may be expected from the research,
  4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject,
  5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained,
  6. For research involving more than minimal risk, an explanation as to whether any compensation and any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained,
  7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject,
  8. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

These regulations further provide that the following additional information be provided to subjects, where appropriate [45 CFR 46.116(b)]:

  1. A statement that the particular treatment or procedure may involve risks to the subject that are currently unforeseeable,
  2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent,
  3. Any additional costs to the subject that may result from participation in the research,
  4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject,
  5. A statement that significant new findings developed during the course of the research that may be related to the subject's willingness to continue participation will be provided to the subject, and
  6. The approximate number of subjects involved in the study.

Investigators may seek consent only under circumstances that (a) provide the prospective subjects or their representative sufficient opportunity to consider whether or not to participate, and (b) that minimize the possibility of coercion or undue influence. Furthermore, the information must be written in language that is understandable to the subject or representative. The consent process may not involve the use of exculpatory language through which the subject or representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, sponsor, institution, or agents from liability for negligence [45 CFR 46.116].

Anonymous versus Confidential Data

In the consent form, researchers should explain clearly how they will use the collected data and how it will be handled. The most secure procedure is not to ask for names or any other identifying information—to keep the identity of the subjects completely anonymous. Only those studies that do not ask for names or any easily identifiable information may be described as anonymous. Anonymity means that the researcher cannot link the data to individually identifiable subjects.

Although anonymity may be useful for some studies, it is not practical for others. In studies that are not anonymous, subjects' data should be confidential. A coding procedure should be used in which each subject's identifying name or number is linked to a code number. The code number should be used on all data. A list linking the identifier to the code number should be kept secure, and a limited number of people should have access to the list. Researchers must tell subjects who will have access to the code list and what will happen to it upon completion of the study. When data are not anonymous, consent forms should include a statement such as, "We will take all reasonable steps to protect your identity." Researchers should not promise that they will maintain confidentiality, because any data could be obtained by court order.

Additional Requirements for Specific Research Methods/Populations

Some research methods and some populations of research studies create unusual problems in obtaining informed consent. To ensure that participants understand the risks and requirements of various research methods, Heartland Institutional Review Board uses the following guidelines for these specific methods and populations.

A) Audio/Videotaping

If participants are to be audio/videotaped, there are several additional requirements to safeguard the privacy and confidentiality of the data. Explicit consent must be obtained for any public use of the tapes, such as use in the classroom or as part of a public presentation of the research results. This constitutes a waiver of the normal confidentiality of research data.

In the consent form, researchers should:

  • Include a statement describing the recording procedures.
  • Indicate how confidentiality will be maintained
  • Include a statement similar to, "I agree to participate in this activity and know that my responses will be recorded on audio/videotape."
  • Describe how the tapes will be stored, who will be allowed to hear/view the tapes, and when or if the tapes will be erased. If the tapes will not be erased, you must get the participants' written permission to keep the tapes and tell them where the tapes will be kept, who will view the tapes, and how the tapes will be used in the future (e.g., future research, valuable historical data.)

Each participant must sign the consent form, indicating approval for the taping. If taping is planned in a group setting, the consent of all members of the group must be obtained for taping to take place.

Sometimes recordings are made with participants who are willing to be a research subject, but are reluctant to sign a consent form. Federal regulations allow the IRBs to waive signed consent forms, and the researcher may obtain verbal consent on the tape. Participants must be informed of their rights, confidentiality, and all other aspects of consent. The researcher must provide to Heartland Institutional Review Board, a commercial IRB, a written script of the verbal consent process in their protocol documentation and application forms.

B) Incentives

Researchers should not offer students or employees any academic or professional advantage over others who do not volunteer, nor should they pose any penalty to those who choose not to volunteer. If students are offered extra-credit course points for volunteering, those who do not volunteer must be offered alternatives to earn the same number of extra-credit points; the alternatives must require an equal time and effort commitment. For example, completing a research questionnaire that takes thirty minutes is not comparable to writing a two-page critical review of a journal article. Incentives should be compensatory to time and effort that participants invest in the research, and not so substantial that they constitute coercion to participate.

Individuals who accept money for participation in research projects paid by an outside company or source should be informed that their confidentiality may be compromised because of reporting requirements at said company and the IRS.

C) Possibility of Physical Harm

Describe any physical risks to the subject that might arise from participating in the research and the steps you will take to minimize those risks. When visual or auditory or muscular stimuli or other measures might affect the health of subjects, the researcher must provide Heartland Institutional Review Board, with a statement from a person qualified to evaluate risks for such conditions.

In some cases, participants should be told that a medical questionnaire must be completed, and that they may be excluded from participation based on their responses.

The following paragraph should be included in the consent form:

"Federal regulations require that you be advised as to the availability of medical treatment if a physical injury should result from research procedures. The researchers do not have funds specifically dedicated to compensate you for any adverse effects that you may experience by participating in this research. Nevertheless, you retain all your legal rights to seek compensation in the event of injury or other adverse event. Immediate medical treatment will be made available at usual and customary fees at ____________ Hospital. In the event you believe you have suffered any injury as a result of participating in the research program, please contact the Administrator of the Heartland IRB, who will review the matter with you. Contact information:

Heartland Institutional Review Board, 4226 Woodfield Place, Suite 100, Belleville IL 62226, Phone: 866.618.HIRB, Fax: 866.414.0517