Informed Consent Process
An underlying ethical principle of the federal regulations is that human participants enter into research voluntarily and with adequate information. (See The Belmont Report on Ethical Principles and Guidelines for the Protection of Human Subjects of Research, 1979.) Thus, consent must be informed and voluntarily given. A participant’s consent is “informed” if he/she has a reasonable comprehension of that to which he/she is consenting. The investigator must use language appropriate to the participant’s ability to comprehend. Generally, consent information should be provided at no more than an 8th grade reading level. Information may not be withheld from participants simply to assure their participation in the research.
Consent should be considered a process, not an event. Although consent is typically documented by the participant signing a form, the form itself is not the consent (although it is often referred to in that way). The consent is the individual’s decision to participate and/or to continue participation. It is the researcher’s responsibility to ensure that the participant is consenting throughout the study procedures. Participants have the right to withdraw consent and terminate participation at any point, and researchers must be attuned to the participants’ state of mind and allow for this to occur, particularly when participants may find it difficult to express their feelings if they believe it will make the researcher unhappy.
Coercion and Undue Influence
Any legally competent adult can give consent; but said adult cannot give valid consent if he/she is under the influence of alcohol or drugs, or if the consent is obtained under duress or undue influence. To ensure that participants’ consent is voluntary, the IRB considers whether any undue pressures or coercion will be brought to bear on potential participants. Excessive compensation or no payment for withdrawals can be viewed by the participants as pressure to participate or continue participation. Other pressures may be more subtle as, for example, when individuals request that family members, friends, or colleagues participate in a study they are conducting. An indirect method of recruitment (e.g., email) may be best in these situations. (See Recruitment chapter.)
Deception or Omission
Deception and/or omission should be employed only when there are no viable alternative procedures. Where deception is a necessary part of a study, the IRB may require that a preliminary consent be obtained, if possible, in which the investigator informs the participant that the study activities or purpose cannot be described fully in advance. After the study, the participant should be informed of the deception and its purpose. The IRB recognizes that there are rare instances in which no consent can be obtained or debriefing done, such as when the debriefing would cause more harm to the participant than the deception itself.
The consent process involves the researcher or key personnel providing the consent information – the information participants need to make an informed decision – and then the individual decides whether or not to proceed. There are several “elements” of consent that reviewers are looking for in consent materials, which are all listed on an Informed Consent Checklist. Sample consent forms are also available to assist investigators in the preparation of their own consent materials. The samples reflect both requirements of the federal regulations and customary language adopted by the IRB. Use of the Checklist and samples will facilitate IRB review. Thus, it is highly recommended that all researchers consult the Informed Consent Checklist before finalizing their consent documents and submitting them for review.
Consent information may be provided orally, in written form, and/or by electronic text or display, according to the nature of the study. Providing consent information in written form is the standard preferred method, and thus researchers should provide a justification when proposing other methods. The justification is often inherent in the method, however. For example, oral consent makes more sense in telephone interviews, rather than mailing the consent information or asking participants to return a signed form. Likewise, online or email surveys will typically provide the consent information in the email text or on the webpage (electronic display). There are other situations, however, when a written consent process is not best for the participants, such as when language or literacy issues are present. Oral consent is obviously more appropriate for young children and for individuals with certain significant communication problems. In some communities and countries, there may be cultural concerns. In these cases, the investigator should explain the justification on the IRB application form when proposing an alternative to written, signed consent.
Waiver of Consent
Certain studies can only be undertaken if the potential participants are not aware of the nature of the study, or that the study is even taking place. In these cases, the PI must request a waiver of consent (or some of the elements of consent). It is also possible to request that the consent requirements be waived in cases where the research is important but consent would be impossible or highly impractical to obtain. This type of waiver is unusual and must not only be justified by the requirements of the study design, but also well-balanced by its benefits. Waivers can be requested by checking the appropriate box on the application form and providing a written justification on the form as to why the waiver is appropriate.
Documentation of Consent (Consent Forms)
The standard consent process is for the PI to develop and provide a written informed consent document to a potential participant that includes signatures lines for participants as well as the PI and Advisor (if the PI is a student). If the individual is interested in participating in the study, s/he signs the form as well as the PI (or other key personnel), the participant is provided a copy, and the PI or Advisor keeps it in a secure location, separate from the data, for at least 3 years. Each participant must be offered a copy of the consent form when written consent is obtained.
Researchers should not provide signed consent forms to the IRB. They should be kept in a private, locked filing cabinet and not provided to anyone outside of the study team, unless specifically requested by the IRB as part of a study audit or other review process. PIs should notify the IRB if an outside agency or court of law requests to see the consent forms.
Waiver of Documentation of Consent (Waiver of Signatures on a form)
The standard written informed consent agreement provides the PI with documented evidence that participants gave informed consent, and it partially protects the PI and the University of Northern Iowa from later charges of misconduct. The IRB recommends that written documentation of informed consent be obtained whenever it is appropriate and possible to do so. However, if in the PI’s judgment obtaining signed consent is inappropriate or risky in itself, and thus the consent method being proposed is oral, electronic, or by mail, the PI may propose this alternative method by by checking the appropriate box on the IRB application. Note that this is not a waiver of consent, but a waiver of the standard requirement to obtain documentation of consent from the participant (the signatures on a form).
When a waiver of documentation of consent is granted, it is nevertheless highly advisable for investigators to document in some other fashion that consent was obtained. One alternative is to tape record the interview, or at least the informed consent procedures. A second procedure is to have a witness (e.g., a research assistant) record in written notes that the participant was fully informed, and gave consent. Under some circumstances the IRB will accept the most minimal documentation: a note in the PI’s own records stating that he/she followed informed consent procedure and obtained fully informed consent. If the researcher chooses to use this minimal documentation procedure, he/she should explain why no other form of documentation is appropriate. The greater the risk is to the participant, the greater the burden on the researcher to justify a less conventional means of documenting consent.
Consent for Research with Children
See the chapter on Research with Children and Youth for procedural guidance on obtaining Youth Assent and Parental Permission.