Informed Consent Is a Process

The purpose of informed consent is to ensure that research subjects fully understand the nature of their proposed participation in research and consent willingly to take part. Informed consent addresses the "respect for persons" principle of the Belmont Report. As stated in the Belmont Report " Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied. While the importance of informed consent is unquestioned, controversy prevails over the nature and possibility of an informed consent. Nonetheless, there is widespread agreement that the consent process can be analyzed as containing three elements: information, comprehension and voluntariness." The informed consent process provides the researcher with a legally effective record of the consent of subjects.

University of Richmond researchers who work with human subjects will have access to a variety of CITI training programs on the subject of informed consent. In addition, this website provides examples of informed consent model forms and forms that have been approved by the IRB.

Informed consent is not just a form, but a process whereby the researcher knows that potential participants are fully informed, willingly agree to participate, and the project is carried out in accordance with the description provided to participants.

The consent process effectively begins with the recruitment of subjects, wherein potential participants are provided with an overview of the research and a brief summary of their potential involvement.

When a potential subject presents himself or herself to the researcher, it is the obligation of the researcher to determine that the subject is competent to provide informed consent. Typically, a researcher will lead a subject through a consent form, answering questions and ensuring that the subject understands his or her potential role in the research and the basic elements of consent. The usual practice is for the researcher to document this process by having a subject sign a consent form. The researcher must remember that a subject always has the right to opt out of the research activity at any time, without penalty, even after the subject has completed providing the data requested.

Consent Process for Persons Under 18

Only an adult can provide legal consent for himself or herself. In Virginia the legal age of consent is 18. If a subject is under 18 years of age, the parent of the subject must give consent and the subject must provide assent. There are very detailed laws and regulations on obtaining the assent of minors and the consent of their parents or guardians. University of Richmond researchers should note that some students will be under 18 years of age. Most often, researchers are advised to include in their consent forms a statement similar to the following. "By signing this form, I am providing my consent to participate in this study and I attest that I am 18 years of age or older." Individuals who are not 18 years of age can, however, be recruited in certain types of studies--such as studies of classroom teaching methods and studies that are exempted from compliance with regulatory requirements.

Acquiring Consent for Research Conducted Online or by Mail

OHRP provides for situations where an electronic signature can be used; it also provides that an IRB can establish procedures for circumstances where an signature cannot be obtained. When research is conducted under circumstances where the researcher will not have personal contact with a subject, the consent form becomes even more important, because potential subjects will typically not be able to ask questions. The researcher must balance the need to provide the necessary level of detail with brevity, as persons will often skip to the end of a lengthy consent form. The University of Richmond IRB has determined that researchers can conduct minimal risk research using online consent forms. Examples of online consent forms are provided at this website.

Consent for Vulnerable Populations

Research is sometimes carried out where a subject lacks the capacity to provide informed consent. Also, there are special populations, such as prisoners, which require special consent procedures. Employees are also viewed as a vulnerable population, as they may think their jobs are at risk as a result of their participation or non-participation in a research project. The IRB will require additional training of researchers performing research with vulnerable populations. The research proposal will need to provide detail on the procedures for obtaining legally effective consent.

Waiver of Some Element of Informed Consent

There are times when research cannot be performed without the waiver of some element of informed consent. For example, the IRB may approve the use of minimal risk deception in some studies. (Studies involving deception cannot be reviewed using the expedited process, so researchers need to plan their research so that the convened IRB can review the study at a regularly scheduled meeting.)

Under 45 CFR 46.116(d) the IRB may waive the requirement for obtaining informed consent or approve a consent procedure that leaves out or alters some or all of the elements of informed consent, provided that the IRB finds and documents that all of the following four criteria are met:

  1. the research involves no more than minimal risk to the subjects;
  2. the waiver or alteration will not adversely affect the rights and welfare of the subjects;
  3. the research could not practicably be carried out without the waiver or alteration; and,
  4. whenever appropriate, the subjects will be provided with additional pertinent information after participation.

If a researcher is seeking a waiver of some element of informed consent, the researcher's proposal must address all of the above criteria.

Consenting Students

Students are often used as research subjects on university campuses, either for convenience samples or because the research may focus on student learning or some other aspect of student behavior. A concern about the use of students as subjects is the possibility that the student may feel some level of "undue influence" or coercion, especially if his or her professor is conducting the research. Consequently, OHRP has developed guidance on the use of students of students in research. The policy of the University of Richmond IRB is that students can be used as research subjects, provided that the researchers conduct the research without coercion and in accordance with OHRP guidance. Students may not be penalized for not participating in research, but may be given extra credit for participation. Generally, a professor should administer a survey in a manner where the identity of participants or non-participants cannot be determined.

Consent Forms Required for Video/Photographic and Audio Recording

Additional steps are required for recordings of research subjects, as recordings always entail the collection of individually identifiable information. An IRB consent form for recordings can be found at with other consent form templates on this site. Note: This research consent form differs from the Communications Office Photo/video Releaset Form.