Perhaps the most important ethical tenet in human studies is the individual's ability to agree to participate with full understanding of what will happen to him. The informed consent process and all of its elements address the basic principles of autonomy, beneficence and justice. The components of the process consist of information elements, including disclosure of information and the subject's comprehension of that information, consent elements, ensuring the voluntary nature of participation and the subject's competence to consent and authorization to use data in a manner specified in the protocol.15,17
Subjects Must Be Fully Informed
The informed consent process begins with an invitation to participate. A statement of the purpose of the study permits potential subjects to decide whether they believe in or agree with the worth and importance of the research. The process then requires that the researcher provide, in writing, a fair explanation of the procedures to be used and how they will be applied. This explanation must be complete, with no deception by virtue of commission or omission. Subjects should know what will be done to them, how long it will take, what they will feel, what side effects can be expected, and what types of questions they may be asked. If subjects cannot read the informed consent document, it should be read to them. Children should be informed to whatever extent is reasonable for their age. Subjects should also know why they have been selected to participate in terms of inclusion criteria for the study, such as clinical condition or age. If the subjects are patients, they should understand the distinction between procedures that are experimental and procedures, if any, that are proposed to serve their personal needs.
An ethical dilemma occurs when complete disclosure of procedures might hinder the outcomes of a study by biasing the subjects so that they do not respond in a typical way. When the risks are not great, review boards may allow researchers to pursue a deceptive course, but subjects must be told that information is being withheld and that they will be informed of all procedures after completion of data collection. For example, when the research design includes a control or placebo group, subjects will not know what treatment they are receiving. They should know that they will be told their group assignment at the completion of the study.
An important aspect of informed consent is the description of all reasonable foreseeable risks or discomforts to which the patient will be subjected, directly or indirectly, as part of the study. Risk refers to physical, psychological or social harm that goes beyond expected experiences in daily life. The researcher should detail the steps that will be taken to protect against these risks and the treatments that are available for potential side effects. For example, if a patient is likely to become fatigued as a result of performing maximal physical exercise, the researcher may include rest periods during the experimental trial. If a patient were receiving electrical stimulation, the researcher would explain the risk of shock and how that risk is minimized by proper grounding and by regular inspection of the equipment. The subject should be advised against such behaviors as taking certain medications or driving a car, which could be hazardous during or after the experimental period. A statement should be included whereby subjects agree to exercise appropriate caution. They are not bound by this, but they should understand the potential harm of not honoring the agreement. If the research involves more than a minimal risk, a statement should be included concerning the availability of medical care and whether compensation will be provided. Subjects should also be informed of new information, such as the identification of previously unknown risks that becomes available during the course of the study. This may affect their willingness to continue participation.
The researcher also delineates the potential benefits of participation. Some studies may result in a beneficial reduction of symptoms. For example, subjects who participate in a study to test the effectiveness of treatment for migraine headache may find their pain relieved by the experimental treatment. The subject should be advised that such a benefit is possible but is not guaranteed. Studies that are geared more toward theory testing may provide no direct benefits. The researcher should explain the potential application of theoretical findings and how the findings will contribute to future research or future patient care.
When a study involves a form of therapeutic intervention, subjects must be informed that alternative treatments are available and that they have the right to choose among them instead of accepting the experimental intervention. Patients must also be told if "standard" treatments to which they are entitled are being withheld as part of the study. This information is essential if a patient is to make an informed decision about accepting the experimental conditions.
Subject Information Should Be Confidential and Anonymous
Research subjects should be told what steps are being taken to ensure confidentiality of all information, including descriptive and experimental data. Whenever possible, a subject's anonymity should be protected. This becomes an issue with surveys, for example, when respondents wish to remain unidentified. In experimental situations anonymity is often not feasible, but the researcher can code the data without using names. Identifying codes can be kept separate from the rest of the data. Researchers should also be aware of this responsibility when disseminating results. Researchers also have a responsibility to know the requirements of the Privacy Rule15,17 and the procedures established by their Institutional Review Boards.
If the subject is to be videotaped or photographed during the study, this should be disclosed in the consent form. The subject should know who will have access to tapes or photographs, who will keep them, and how they will be used. Subjects retain the right to review such material and to withdraw permission for its use at any time. Subjects should also be informed if one-way windows will be used and who the observers will be.
The Informed Consent Form Must Be Written in Lay Language
Informed consent is more than telling subjects about the research; the process implies that they understand what they are being told and what they are reading. The language must be clear and basic so that the average reasonable individual can follow it. Professional jargon is unacceptable. Instead of "perform a maximal isometric contraction," the subject should be told to "pull up as hard as you can without moving." This is the language that clinicians use routinely in patient education. As a rule of thumb, language should be written for the lowest educational level that would be expected for subjects.
The Researcher Must Offer to Answer Questions at Any Time
The researcher is responsible for ensuring that the subject understands all relevant information. A verbal description is almost always a part of the process, so that the researcher can "personalize" the information for each subject. The subjects should have sufficient time to assimilate the details of the proposed project, prior to making their decision to participate. They should feel free to question the procedures at any time during the course of the study, and should be provided with the name and telephone number of an appropriate contact person.
Consent Must Be Voluntary
Subjects should participate in a research project of their own free will. Patients are usually quite motivated to help, but they must be informed that there is no penalty to them if they refuse. Some studies may involve monetary compensation for participation. It should be clear if such compensation will be received whether or not the subject completes the study.
Special Consideration Must Be Given to Subjects Who Are Particularly "Vulnerable"
Some individuals cannot give informed consent because they may not be able to understand the information. In cases of mental illness, developmental disability, or diminished mental capacity, the ability of the subject to consent must be evaluated by the researcher and others who know the subject well. If the subject is not competent, consent must be provided by a legal guardian or advocate.6
The regulations regarding children as research subjects require that parents or guardians give permission for participation. Furthermore, if a child is considered competent to understand, regardless of age, his or her assent, that is, his or her affirmative agreement to participate must be obtained and documented. Researchers should be particularly cautious about influencing subjects who are considered "captive."7 For example, there are specific regulations regarding research involving prisoners.9 More subtle circumstances exist with the use of students or nursing home residents. In both cases, the sense of pleasing those in authority may affect the subjects' decisions.
Subjects Must Be Free to Withdraw Consent at Any Time
The informed consent document must indicate that the subject is free to discontinue participation for any reason at any time without prejudice; that is, the subject should be assured that no steps will be taken against him, and, if he is a patient, that the quality of his care will not diminish. This can occur before or during an experiment, or even after data collection when a subject might request that his data be discarded. It should also be clear that the researcher would discontinue the experiment at any time if necessary for the subject's safety or comfort.
The Informed Consent Form
All subjects must give informed consent prior to participating in a project. This is done by providing a written informed consent form that is signed and dated by the subject, researcher and a witness. Subjects should receive a copy of this form and the researcher must retain a signed copy. Although it is a general contractual agreement, the informed consent form is not binding on subjects. Subjects never waive their rights to redress if their participation should cause them harm. The form should not contain language that appears to release the researcher from liability. The required elements of an informed consent form are listed in Table 3.1. A sample informed consent form can be found in Appendix E. The format of this sample informed consent form is used in many institutions. It specifically identifies and acknowledges all of the elements of informed consent. Of special note, the signature page should not stand alone, but must contain some of the text of the document to show that the signatures are applied in the context of the larger document.
TABLE 3.1ELEMENTS OF INFORMED CONSENT ||Download (.pdf) TABLE 3.1 ELEMENTS OF INFORMED CONSENT
Purpose of the research project
Risks and discomforts
Alternatives to participation
Statements of the procedures used to ensure the anonymity of the individual in collecting, storing, and reporting information and who (persons or agencies) will have access to the information
What information may be used?
Who may use the information?
For what purpose? (May be referred to the description of the study)
Is there an expiration date? Is so, what is it?
This authorization must be signed as part of the informed consent document or as a separate document.
Request for more information
Refusal or withdrawal
Although written consent is preferable, some agencies allow oral consent in selected circumstances. In this case, a written "short form" can be used that describes the information presented orally to the subject or his or her legally authorized representative.6 This short form is submitted to the review committee for approval.
Informed Consent and Usual Care
Clinical research projects are often designed to test specific treatment protocols that are accepted as standard care, and subjects are recruited from those who would receive such treatments. Therapists often ask if informed consent is necessary for a research project when the procedures would have been used anyway. The answer is yes! Even where treatment is viewed as usual care, patients are entitled to understand alternatives that are available to them. Patients must always be informed of the use of the data that are collected during their treatments, and they should have sufficient information to decide to participate or not, regardless of whether treatment is viewed as experimental or accepted clinical practice.
COMMENTARY A Patient Care Perspective
The concepts of informed consent for human research have also been applied to medical practice.18,19 Patients entering hospitals are asked to sign standard consent forms that indicate agreement to routine medical care and tests. Additional forms are signed for surgery or special tests. This practice has not been applied as readily to clinical situations in allied health, although the concepts of disclosure and voluntary participation are becoming more important to the protection of patients' rights. Although the idea of explaining treatments to patients is by no means unusual, the structure and formal requirements of informed consent have important implications for the patient-provider relationship. The clinician can give the patient a description of the planned treatment and available alternatives and explain inherent risks, consequences, advantages and disadvantages. Clinicians recognize the possibilities of inflicting harm on patients through thermal modalities, resistive exercise, or mobilization and should identify these potential effects prior to treatment. It is not necessary for the average patient to understand the physiological rationale for treatment, but clinicians should be able to explain things in reasonable detail and within the scope of the patient's understanding. With sufficient information, the patient can participate in the setting of treatment goals, consider whether or not he or she wants to be treated, and express a preference for particular types of treatment. In this manner, patients, like research subjects, can assume an appropriate role in making decisions about the activities that affect their lives.