Human Research Protection Program: Guidance

Informed Consent

Informed consent is the agreement of an individual to participate in a research project that he or she understands. Typically, researchers explain to prospective participants, in easy-to-understand language, all that they need to know about participating in a research project before the project begins. In many cases, federal regulations require researchers to document individuals' agreements to participate in research by providing written explanations of the project and obtaining the prospective participants' signatures. In other cases, oral consent or a waiver of consent will be appropriate. The informed consent process should not end with an individual's initial agreement to participate in a research study. Researchers should be sensitive, throughout the conduct of the research, to participants' understanding of the project and willingness to participate.

Eight Elements of Consent

The federal Common Rule contains requirements for the process of obtaining and documenting informed consent. Although the requirements vary depending on the nature of the research project, the general requirement is that a written consent form (or the language in the oral consent procedure) must contain the following elements (45 CFR 46.116):

 

(a) Basic elements of informed consent:

 

1. A statement that the study involves research, an explanation of the purpose(s) of the research, the expected duration of the subject's participation, and a description of the research procedures (e.g. interview, observation, survey research).

 

2. A description of any reasonably foreseeable risks or discomforts for the subjects. Risks should be explained to subjects in language they can understand and be related to everyday life.

 

3. A description of any benefits to the subject and/or to others that may reasonably 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 the confidentiality of records identifying the subject will be maintained.

 

6. For research involving more than minimal risk, a statement whether compensation is available if injury occurs and, if it is, what it consists of and from whom further information may be obtained.

 

7. An explanation of whom to contact for answers to pertinent questions about the research and research subject's rights. The name and phone number of the responsible faculty member as well as contact information for an IRB must be included for these purposes. In addition, if the project involves student research, the name and phone number of the student's advisor/mentor must also be included.

 

8. A statement that research participation is voluntary and the subject may withdraw from participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. If the subject is a patient or client receiving medical, psychological, counseling or other treatment services, there should be a statement that withdrawal will not jeopardize or affect any treatment or services the subject is currently receiving or may receive in the future. If the subject is a prisoner, there should be a statement that participation or nonparticipation in the research will have no effect on the subject's current or future status in the prison. If a survey instrument or interview questions are used and some questions deal with sensitive issues (including but not limited to illegal behavior, mental status, sexuality or sexual abuse, drug use, or alcohol use) the subjects should be told they may refuse to answer individual questions.

 

(b) The IRB may also require, in appropriate cases, one or more of the following additional elements of informed consent:

 

1. A statement that the particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or becomes pregnant) that are currently unforeseeable (e.g., when the research involves procedures that have limited experience in humans and in all research protocols that involve an investigational drug or device).

 

2. The anticipated circumstances under which the participant's participation may be terminated by the investigator without regard to the participant's consent (e.g., when the protocol describes situations where participants should be withdrawn from the research or if it is reasonable to expect that participants will be withdrawn from the research without their consent).

 

3. Any additional costs to the participant that may result from participation.

 

4. The consequences of a participant's decision to withdraw from the research and procedures for orderly termination of participation by the participant (e.g., when withdrawal from the research might place a participant at risk of harm).

 

5. A statement that significant new findings developed during the course of the research that may relate to the participant's willingness to continue participation will be provided to the participant.

 

6. The approximate number of participants involved in the study (e.g., when a reasonable person would find the information useful in making a decision to participate in the research).

Appropriate Language

The consent form or script should be worded so that potential participants can readily understand it. A general recommendation is to use an eighth-grade reading level for the writing style, but investigators should adjust the language to an appropriate level for the particular participant population.

Obtaining Signatures and Retaining Records

Signatures on the consent forms should be placed immediately below the text of the form. Each participant must be given a complete copy of the consent form. Investigators must also keep a copy of the signed consent form. UW-Madison’s policy requires investigators to keep signed consent forms on file for seven years following the completion of the research.

Image and Audio Recording of Participants

It is the policy of UW-Madison's IRBs that if the research involves the use of image or audio recording of participants, the consent form should clearly state that fact. In addition, there should be a statement about how the recordings will be used and how long they will be kept. This statement should include who will see/hear the recording and where the recording will be used (e.g., in a classroom, professional meeting).

 

For SBS IRB and ED IRB protocols, if the investigator wants permission for the recording to be viewed or heard by anyone other than the research staff, or, if it involves sensitive material, participants should also be given an opportunity to view, or listen to, the recording after it is completed. Permission for the tape to be used should then be obtained.  See, Protecting Privacy and Confidential Data Policy.

Anonymity

Participants should not be promised anonymity unless the research data is truly anonymous. Anonymity cannot be guaranteed unless there is no method by which the investigator can connect the research results with individual participants providing the data. If there are codes or a master list that would enable the investigator to identify participants, the research is not anonymous, even though the participant names do not appear in the research data.

Create a Consent Form

Consent Form Wizard

 

For the Health Sciences IRBs, see, Consent, Assent and HIPAA Authorization Forms

 

Combined Consent/HIPAA Authorization Wizard (in the case of health science protocols, this form should only be used only for minimal risk and non-interventional studies)