Informed Consent Essentials
- The Consent Process
- Principles Guiding Informed Consent
- Documentation of Informed Consent
- Essential Elements of Informed Consent
- Policy for Date-Stamping Approved Consent Forms
- Assent of Children and the Consent of their Parents
- Informed Consent in Ethnographic Research
- Confidentiality and the Consent Process
The process of obtaining informed consent involves more than just getting someone to sign a form. Central to the process is the subject's understanding of the research protocol and their prospective involvement in it. Their willingness to participate in the study should then be decided freely and without any form of coercion on the part of the investigator. The consent process must therefore educate the participant about the studythe purpose, procedure, risks, benefits, and confidential treatment of dataand then ask for their voluntary participation only after they fully understand what's involved.
A written or verbal description of a research study can only educate those who are capable of understanding what is written or said. It cannot be overly stressed that a consent form or script must be understandable to the subject or their representative. Investigators should write for their participant audience, keeping in mind the 8th grade reading level of the average American adult, and being careful to avoid technical language or terminology.
The consent process also should involve answering questions that arise before, during, and after the subject's participation. Investigators who are willing to fully address questions that arise are more likely to retain volunteers. Consent documents should make it easy for participants to contact an investigator and should also provide contact information for the IRB Office that approved the research.
The consent process also involves keeping subjects informed of changing facts or circumstances related to the study, both during and after the participation period. This is especially important if new information related to the risks or benefits of participation become available.
The major ethical principles outlined in the Belmont Report should be used to guide investigators who are asking for study volunteers. The principle of respect for persons focuses on individual autonomy, which is essential to volunteerism. Autonomous persons are fully informed and are able to freely decide whether they wish to participate as research subjects. The principle of beneficence drives the risk/benefit assessment that should be done for every research study. This principle goes beyond the maxim of "do no harm," and stresses that benefits must be maximized in human subjects research. The potential benefits of the research should always be explained during the consent process, whether or not they are expected to accrue to the subjects directly. The principle of justice demands that the benefits and burdens of the research are fairly distributed among potential subject groups. This principle applies to the recruiting of subjects, to ensure that subject groups are not being unfairly included in or excluded from studies. In evaluating consent documents, the Belmont principles provide essential guidance.
No investigator may involve a human being as a subject in research unless legally effective informed consent is first obtained from the subject or from their legally authorized representative. Investigators must seek consent only under circumstances that provide sufficient opportunity for the subject or their representative to consider whether or not to participate.
The IRB may consider a waiver or alteration of the informed consent requirement only if all four of the following are true:
- The research involves no more than minimal risk to the subjects;
- the waiver or alteration will not adversely affect the rights and welfare of the subjects;
- the research could not practicably be carried out without the waiver or alteration; and
- whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Under federal regulations, informed consent must be documented by the use of a written form approved by the IRB and signed by the subject or their legally authorized representative. The consent form may be a comprehensive written document that embodies the federally required elements of informed consent, or a short form stating that the required elements of informed consent have been presented orally to the subject or their representative. In either case, a copy of the form must be given to the subject or their representative.
The IRB may consider a waiver or alteration of these requirements only if it finds either
- that the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality; or
- that the research presents no more than minimal risk of harm and involves no procedures for which written consent is normally required outside the research context.
Within federal guidelines, the methods used to obtain consent may vary. They should be designed to fit the nature of the research, the nature and magnitude of the risks involved, the research setting, the nature of the subjects who will participate, and the requirements of applicable policies, laws, and regulations. If appropriate justification is given, an oral process may be approved by the IRB.
The required elements of a consent document follow (printable version available in Word, pdf), though not all items will be applicable to every project. It cannot be overly stressed that the language used in every consent form or script must be understandable to the subject or their representative. Commonly, IRB approval of research is delayed over inadequate consent forms that have either too much or too little information, that are confusing, or that are written above the average subject's reading level. Consent forms should be written for the average participant's level of understanding, by keeping in mind the 8th grade reading level of the average American adult, and by being careful to avoid technical language or terminology. Every form should contain the following essential elements:
Consent forms must bear a stamp showing the expiration date of the project's approval. The expiration date is determined by the reviewing body and applied to an original copy of each approved consent form. The stamped form(s) are sent to the responsible project investigator and copies of these date-stamped forms must be used in obtaining informed consent, then retained for a period of at least three years after the research is finished. It's possible that consent forms might contain information (e.g., names, phone numbers, locations) that will vary with time or with the circumstances of the project. The IRB Office must be informed in writing of any such variables in consent forms and must approve revisions before new forms are used.
Children must provide assent to participation when, in the judgment of the IRB the children are capable of providing assent. Assent is defined as the voluntary agreement of a person not legally able to give consent. In determining whether children are capable of assenting, the IRB takes into account the age, maturity, and psychological state(s) of the children, either individually or as a group. Children under age 8 may give assent orally or by the act of participating in cases involving infants or very young children. Children who can read, generally thought to be those 8-18 years old, should provide assent by signing a written form unless a UIUC IRB approves a different process.
In addition to the assent of the children, regulations require legally effective informed consent from the parents or the legally appointed guardian of all children who are subjects in research. The consent of just one parent is allowed if the research presents no greater than minimal risks or if it holds out the prospect of providing direct benefits to the child. If the research presents greater than minimal risks and no prospect of direct benefit to individual subjects, the consent of both parents is required, unless one parent is deceased, unknown, incompetent, not a legal custodian, or not reasonably available.
Fieldwork and ethnographic research typically involve observation of and interaction with groups of subjects in their own environment, often over long periods of time. It may not be possible to specify in an informed consent statement the detailed contents of the experimental protocol, as the research itself may involve continuing interactions between the researcher and hosts that are difficult to describe prior to initiation of the research. Differences in language or culture may preclude the use of a written or formal consent agreement. If appropriate justification is given, the IRB may waive the requirement for formal, written consent in these cases. The American Sociological Association (www.asanet.org) and the American Anthropological Association (www.aaanet.org) have developed guidelines that address ethical issues in research, including informed consent. Investigators conducting research in these disciplines should consider those guidelines when designing their protocol.
In all research involving human subjects, confidentiality of identifiable information is presumed and must be maintained unless the investigator obtains the express permission of the subject to do otherwise. That is, the anonymity of the subjects must be preserved in the disseminated research results. The more sensitive the material, the greater the care that must be exercised. Ordinarily, the following requirements must be met and should be understood by the research subject. Consent documents should therefore explain specifically how the following confidentiality requirements will be met:
- Questionnaires, inventories, interview schedules, and other data-gathering instruments and procedures should be carefully designed to limit the personal information to be acquired to that which is essential, and should be administered using procedures that will protect the subject's privacy.
- Information that could reveal a subject's identity should be securely stored in files accessible only to the project investigator and authorized staff.
- As early as feasible, data should be coded to remove identifying information, and identifiers destroyed.
- The identity of subjects must not be released except with their express permission. This includes through the use of audio tapes, videos, photos, or other images (e.g., MRI, CT scan) that either show the subject's face or would divulge unique or identifying features. Subjects should always be told during the informed consent process if their likeness or other unique or identifying features will be imaged and how the images will be used. Explicit consent must be obtained for any public use of such images (including uses in the classroom, on the World Wide Web, or as part of a presentation of the research results), since publication would otherwise constitute a breach of the basic confidentiality requirement.
- Use of existing data that were originally obtained for different purposes and that involve identifiable subject information requires examination of the risks involved. There should be a determination of whether the new use is within the scope of the original consent or whether it is necessary or feasible to obtain additional consent. Anonymity of the subjects must be preserved in these cases.