Informed consent is one of the primary ethical requirements underpinning research with human subjects; it reflects the basic principle of respect for persons. Informed consent is an ongoing process, not a piece of paper or a discrete moment in time, per the federal guidelines from OHRP. Informed consent assures that prospective human subjects will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate. This assurance protects all parties, both the subject, whose autonomy is respected, and the investigator. A primary ethical responsibility of the Principal Investigator is to ensure that potential participants have been provided with all the information they might reasonably need to know. Any research protocol utilizing human participants requires the informed consent of those participants. Potential participants have the right to know what they are being asked to do prior to voluntary participation, no matter what the nature of the protocol and no matter how innocuous it may seem. The procedure of advising potential participants and obtaining voluntary agreement is known as the informed consent process.
The Nuremberg Code states in pertinent part:
"The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment."
All subsequent codes and regulations regarding informed consent, insofar as they pertain to competent, adult subjects, follow these principles closely. The federal regulations governing the protection of research subjects require that certain information must be provided to each prospective subject as part of the informed consent process. There are eight (8) basic minimum requirements that must be a part of the informed consent:
In addition to these basic elements of consent, when appropriate, one or more of the following elements of information shall also be provided to each subject:
Investigators may seek consent only under circumstances that provide the prospective subject or his or her representative sufficient opportunity to consider whether or not to participate, and 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.
Other Important Topics regarding Informed Consent:
Exculpatory Language in Informed Consent Documents:
Federal policy provides that no informed consent, whether oral or written may include any exculpatory language, through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence. OHRP and the FDA have applied a broad interpretation to the exculpatory language prohibition, as opposed to a narrow reading. In general, exculpatory statements relate to the releasing of liability or fault for wrongful acts. An example of an acceptable clause in a consent form would be:
An example of unacceptable language would be the following:
I understand that I will not sue the sponsor or investigator for any negligence; or Subjects agree to hold harmless the institution, investigators, and sponsors affiliated with or in any way a part of this research protocol.
Waiver of Informed Consent:
The federal regulations do permit the IRB to approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:
A waiver of informed consent may also be approved on certain research and demonstration projects designed to study public benefit or service programs as specified in the regulations. A sample waiver form is provided on the webpage, and should be submitted at the time of IRB application submission.
Waiver of Documentation of Informed Consent:
The IRB is also permitted by federal regulations to waive the documentation of informed consent (the use of a written consent form), provided 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 as described in the regulations; or that the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context. In cases in which the documentation requirement is waived, the IRB may require the researcher to provide subjects with a written statement regarding the research.
Waiver of Consent in Emergency Medicine Research:
Federal regulations provide criteria for the waiver of consent in emergency medicine research. The regulations are applicable to only a narrow class of research activities, and the waiver is explicitly excluded when the research involves certain protected research populations such as fetuses and pregnant women.
Parental Permission and Child Assent:
The consent process for research involving children requires that parents or legal guardians give permission for their children to become research subjects. The children, as appropriate for their developmental stage, provide assent. Assent is an individual's voluntary, affirmative agreement to participate in research. A participant's failure to object cannot be construed as assent. As with all consent processes, the parental permission and child assent processes must include all of the information that potential participants need to make an informed decision. Permission and assent forms/materials must be presented in the appropriate language and reading level and the voluntary nature of participation must be made clear.
In Florida, the legal age of consent for research is 18 years of age (there is an exception in the emancipated minor laws - see section entitled "Florida Law"). Usually, children aged seven (7) or above have the ability to read a simple assent form, adjusted for developmental stage, to agree to participate in a research project. A verbal script is permitted by the IRB whenever children are involved, as appropriate. Assent scripts should be brief, to the point, and at a language level appropriate to the participant. Examples of parental permission forms and assent forms are provided.
Waiver of Parental Permission:
Federal regulations provide four basic criteria for waivers of any of all of the elements of informed consent. The same criteria apply to waivers of parental permission (and also to child assent). In order to waive or alter any or all of the elements of informed consent, the IRB must find and document that all of the following criteria have been met:
"Passive" Consent and Parental Notification:
"Passive Consent" has been used in school based research in response to the challenges of securing prior written permission from parents. The passive consent process involves notifying parents that research will take place and giving them an opportunity to state that they do not want their children to participate. Thus, if parents do not remove their children in response to the notification, they have provided permission. However, the passive consent process is not equivalent to informed consent. Passive consent is strongly disfavored by the FSU IRB. The federal regulations require that parental or guardian permission for children to participate in research must be secured or waived in accordance with the four criteria provided in the regulations. On a very practical level, sending notice does not mean that notice is received for a variety of reasons, including parents' inability to read. The parental notification process can be used to provide parents with the option to remove their children from research, but only if the requirement for parental permission has been waived by an IRB.
Child Abuse and Neglect:
Some research has the potential to reveal child abuse and neglect. A study about behaviors for at-risk children might do so, and study about art and reading abilities would probably not touch on this possibility. If the potential does exist, then researchers should inform parents and older children during the informed consent process that the confidentiality they can provide is limited by Florida's child abuse reporting requirements.
Witness Signature on the Consent Form:
Federal regulations do not require a witness signature when the research uses a standard informed consent document that embodies all of the required elements of informed consent. Nor do the regulations require the investigator's signature when a standard consent document is used. Federal policy only requires that the consent document is signed by the subject or the subject's legally authorized representative. However, a witness is required when the IRB authorizes the use of a short form written consent document. In this situation, the witness should observe the oral presentation, sign the short form consent document, and sign a copy of the summary of the oral presentation approved by the IRB. In addition, the subject or legally authorized representative must also sign the summary and the short-form consent document. FSU follows this same federal policy.
Deception of Research Subjects:
Deception relates to research in which the subject is intentionally deceived about research participation. Deception is often used in studies that evaluate fundamental aspects of human behavior. The rationale for deception is that it is not possible to obtain accurate information about how people behave when they know that they are being observed or evaluated. The American Psychological Association explicitly states that:
Psychologists do not deceive prospective participants about research that is reasonably expected to cause physical pain or severe emotional distress. APA Ethical Principles of Psychologists and Code of Conduct. Effective June 1, 2003.
The IRB will review whether the procedures are potentially of a nature such that they would cause distress sufficient to cause a participant to withdraw from the study if they were known in advance. The fact that all participants are informed that they may choose to withdraw from a study at any time for any reason does not reduce the responsibilities of the researcher. At the conclusion of the experiment, it is the researcher's responsibility to institute procedures to alleviate any discomfort that was experienced during the course of the study. Although participants may not be fully informed, they should be informed of as much as possible without compromising the ability of the research to test the true hypothesis of the study. A recommendation is that the consent form should never be used as part of the deception and should not include anything that is untrue. In some research, it may be advisable to reveal to participants that possibility of deception in the consent form.
Research Involving Decisionally Impaired Persons:
The researcher needs to provide a consent form to ask the research subject's legally authorized representative for consent to the participation of the research subject. An assent form should also be provided to the research subjects, depending on whether the subjects are capable of assenting. Under Florida law, several classes of persons can consent for incapacitated/incompetent adults. See the section entitled Florida State law for the list, which is in order of who has the greatest legal authority to consent for an incompetent adult. Consent should be sought first from the person at the top of the list. If the first reasonably available person refuses consent, that refusal is final.
Confidentiality in the Consent Form:
After the IRB has decided that there are adequate provisions in the research plan to protect the privacy and confidentiality of the subjects, it must also ensure that the consent form accurately provides the subject with information concerning the confidentiality of the research records. This allows the subject to make his/her own determination of whether the provisions for protecting privacy and confidentiality are adequate to participate in the proposed research. A basic element of consent is that each subject be provided with a statement describing the extent if any, to which confidentiality of records identifying the subject will be maintained. The FDA also requires the subject be provided with a statement also describing the possibility that the FDA may inspect the records.
Certificate of Confidentiality:
Certificates of Confidentiality can serve to promote recruitment in studies requiring disclosures of sensitive personal information, and the IRB can suggest that investigators apply for them when appropriate. An investigator should consider applying for a certificate on a topic which is likely to be subject to legal proceedings. The website of the OHRP contains information about contacting different agencies to obtain Certificates of Confidentiality. As long as a certificate is in place when a subject enrolls in a study, the protection provided by the certificate is permanent. Information identifying the subject will never be disclosed unless it is volunteered by the subject or investigator.