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The Consent Process
Consent is only viable when the subject has been given all pertinent information about the study's procedures and risks so that the subject's ultimate decision is truly an informed one.
5.1 - What Subjects Need to be Told About the Research
5.2 - Information Sheet vs. Consent Form: Documenting the Consent Process
5.3 - How to Assess Subjects' Understanding of the Research
5.4 - Assent
5.5 - When the Consent Requirement Can be Waived
5.6 - Barriers to Consent (language & physical)
5.7 - Consent in Foreign Countries
5.8 - Certificate of Confidentiality
5.9 - Samples and Templates
5.1 What Subjects need to be Told About the Research
All research subjects must give their express consent to participate in a research study. Consent is necessary element for all research studies, even exempt research. Consent is only considered valid if the subjects are given enough information to allow them to weigh the study's risks and benefits and if the information is told to them in terms that they can understand. Subjects always have the right to decline or even withdraw from any study.
The consent process is made up of two parts: 1) the discussion that takes place between the investigator and the subject and 2) a written document (either a "consent form" or "information sheet") that captures the nature of the consent discussion. The consent process should be specific to each subject population as well as the individual subject. There may be some subjects who require special considerations, such as children, prisoners, cognitively impaired individuals, economically/educationally disadvantaged individuals and others. The IRB will always look to see that the study and consent process provide additional protections for these "vulnerable populations".
5.2 Information Sheet vs. Consent Form: Documenting the Consent Process
The consent discussion that takes place between an investigator and subject must be captured in a document called an "informed consent form" or "consent form." Unless the IRB gives an investigator permission to alter the consent process, all research subjects must indicate in writing their willingness to participate by signing the consent form. However, written consent may not be necessary or appropriate in certain studies, such as surveys, interviews and other minimal risk research or in research where the subjects are to remain anonymous. In these cases, the investigator should prepare an "information sheet" appropriate for the study. Federal regulations identify certain specific elements required for informed consent, and, depending on the nature of the research, the IRB may require additional elements. This assures that the criteria for obtaining informed consent are met and understood by all parties involved in the study.
Consent Form
Researchers are encouraged to use the consent form template provided, however, deviations from this format are allowed on a case by case basis in order to best suit the individual research study. If your consent form/information sheet deviates from the Templates, you will have to explain why in the IRB-1, SECTION VI, Documentation of Consent or in IRB-5, #5. Informed Consent. Regardless of the format, all consent forms must adhere to the regulations and formatting detailed in the guidelines below.
Information Sheet
An information sheet is similar to a consent form in every way except it is not signed by the subject. An information sheet should be used when the study seeks anonymous data and/or when the IRB has granted the study a waiver of signed consent. (Note: For studies involving anonymous focus groups or surveys, you might want to use the Focus Group/Survey Information Sheet Template instead)
The following elements must be considered and applied as needed to each study:
Language Level
The consent form/information sheet must be written in language "understandable to the subject". The IRB reviews consent forms very carefully to ensure that they would be understandable to a wide audience. Key elements to consider when writing a consent form are:
- It should be written at no higher than an 8th grade level (similar to a popular magazine or newspaper -- language copied out of a grant or protocol is not appropriate).
- It should be written in the second person ("you are invited to participate, you will be asked to give a blood sample…")
- It should be written as if the author and the reader are engaged in conversation.
Video and Audiotaping
The consent form should clearly state if the research involves the use of video or audiotaping of subjects. In addition, there should be a statement about how the recordings will be used and how long they will be kept. This statement should include who will see/hear the recording and where it will be used (e.g., in a classroom, professional meeting). If the investigator wants permission for the recording to be viewed/heard by anyone other than the research staff, or if it involves sensitive material, subjects should also be given an opportunity to view (or listen to) the recording after it is completed. Permission for the tape to be used should then be obtained. The consent form must also clearly state who will transcribe the tapes and, if third-party transcriptionists will be used, what steps will be taken to protect subject confidentiality.
Recordkeeping
Each subject must be given a complete copy of the consent form. The investigator should also keep one copy of the consent form. Investigators are required to keep consent forms on file for 3 years following the completion of the research.
Anonymous and Confidential Data
Subjects should not be promised anonymity unless the research data is truly anonymous. Anonymity cannot be guaranteed unless there is no method by which the investigator can connect the research results with individual subjects providing the data. If there are codes or a master list that would enable the investigator to identify subjects, the research is not anonymous even though the subject names do not appear in the research data. In this case the IRB would consider the data to be confidential.
5.3 How to Assess Subjects' Understanding of the Research
The subjects must genuinely understand what is being asked of them if there is to be informed consent. Therefore, researchers should strive to convey information to subjects and not merely disclose it to them. Subjects should be able to say what they are consenting to. It is the investigator's responsibility to ensure that he subject understands the research, not the subject's. Therefore, it is critical that the investigator not only answer questions, but ask them so as to further the discussion and prompt the subject to think more carefully about her/his participation in the research.
Useful questions will be open-ended; rather than asking for yes or no answers, they ask for explanations. Such answers are, therefore, more indicative of what the subject truly understands. Some examples of open-ended questions:
- Just so that I'm sure you understand what is expected of you here, would you please explain to me what you think we're going to ask you to do?
- Describe in your own words the purpose of the study.
- What more would you like to know?
- What is the possible benefit to you of being in the study? What are the possible risks?
In contrast, examples of closed-ended and less useful questions are:
- Do you understand?
- Do you have any questions?
- Do you see that there are some risks to being in this study?
5.4 Assent
In the State of Connecticut only individuals who are 18 years or older (the age of majority) may legally consent to participate in research. This legal authority may be withheld from some classes of individuals with limited decision-making or cognitive ability. Further, some individuals voluntarily give over this authority to another through a power of attorney or a health care proxy.
Individuals who do not have the authority to consent to participate in research must still provide their assent. "Assent" is an active affirmation of a desire to participate and differs from "consent" which is recognized as being granted from an individual with the legal authority to do so. Even very young children or those with limited cognitive ability can assent and they can certainly indicate a desire not to participate, which must be honored. If the individual giving assent is able to read and write then assent should be documented using an assent form, otherwise assent should be obtained though a conversation with the subject. Both the assent discussion with the subject and the assent form should be in language especially tailored for the subject class and should describe the following:
- Tell why the study is being conducted;
- Describe what will happen and for how long or how often;
- Say its up to the child/individual to participate and that its ok to say no;
- Explain if it will hurt and for how long and how often;
- Say what the child's/individual's other choices are;
- Describe any good things that might happen;
- Say whether there is any compensation for participating; and,
- Ask for questions.
The assent form should be limited to one page. Illustrations might be helpful and larger type makes it easier for some individuals to read. In studies involving older children or adolescents it may be possible for the child to read and indicate assent on the assent form.
5.5 When the Consent Requirement can be Waived (Oral Consent vs. No Consent)
Federal regulations allow the conditions for informed consent to be altered to either 1) waive the requirement for written consent and allow the study to proceed on the subject's oral consent or 2) waive the requirement for consent entirely. Only the IRB can waive or modify the consent process. Researchers are not authorized to make this decision.
In order for written consent to be waived the investigator must rely on oral consent from the subject. Oral consent is only allowed under conditions that would normally only require oral consent or where subject confidentiality is paramount and the subjects written record of participation would place him/her in jeopardy. Written consent can only be waived under the following conditions (45 CFR 46.117(c):
"[T]he 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. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; 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 of the research context."
In studies where the subject will not sign a consent form, the investigator must give the subject an information sheet containing all the same information as a consent form would, except that it is not signed by the subject.
The IRB can waive the requirement for consent altogether, but only under the following specific circumstances:
- The research involves no greater than minimal risk to subjects;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects;
- The research would be impracticable without the waiver or alteration; and,
- The subjects will be informed of the study when it is over (if possible).
5.6 Barriers to Consent (language and physical)
Investigators should prepare both English-language and translated consent forms for protocols involving non-English speaking subjects. An explanation of the translations and the expertise of the translator should be provided for IRB review.
In the event that a subject has a physical limitation that could affect the consent process the investigator should provide alternate means to obtain consent and should consider asking the IRB to waive or alter some of the elements of consent.
5.7 Consent in Foreign Countries
Field research done outside of the United States, especially in non-western societies or places where the subjects do not speak English poses some problems in obtaining written documentation of informed consent. In these situations, it is sometimes impossible, for a variety of reasons, to obtain written consent. If that is the case, the investigator must provide the IRB with a statement of the reasons why it should waive written consent, and also provide an acceptable alternative method of obtaining oral consent, which is appropriate to both the subjects and their culture.
If the subjects may be economically or educationally disadvantaged, the investigator should pay particular attention to these issues and ensure that appropriate safeguards have been implemented.
5.8 Certificate of Confidentiality
A certificate of confidentially protects the subject's confidentiality by protecting research records from subpoena. The certificate goes beyond the consent form in ensuring confidentiality and anonymity. Without the certificate, researchers can be required by a court-ordered subpoena to disclose research results (usually as part of a criminal investigation of the subjects). Certificates of Confidentiality are provided by the federal Department of Health and Human Services, however, the study's funding source is not relevant to the granting of a certificate.
The following language is typical of Certificate of Confidentiality requirements. Either this, or other similar language must be present in the consent form.
"To help protect your privacy, the researchers have obtained a Certificate of Confidentiality from the National Institutes of Health. With this certificate, the researchers cannot be forced to disclose the information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The researchers will use the Certificate to resist any demands for information that would identify you, except as explained below. The Certificate cannot be used to resist a demand for information from personnel of the United States Government that is used for auditing or evaluation of federally funded projects or for information that must be disclosed in order to meet the requirements of the Federal Food and Drug Administration (FDA).
You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself and your involvement in the research. If an insurer, employer or other person obtains your written consent to receive research information, then the researcher may not use the Certificate to withhold that information.
The Certificate of Confidentiality does not prevent the researchers from disclosing voluntarily, without your consent, information that would identify you as a participant of the research project under the following circumstances the present danger of child abuse, suicide, and/or homicide."
5.9 Samples and Templates
The investigator must provide copies of all consent and assent forms. If the investigator believes that written consent is not appropriate, he or she should provide the IRB with a statement of the reasons why written consent should be waived. A script that includes all the elements of consent is sometimes used in obtaining oral consent from the subject. If this is the case, a copy of the script should also be provided to the IRB.
The IRB has provided Templates & Samples for investigators and researchers to use and adapt as necessary.
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