Purpose of Consent Process and Documentation
Informed consent is understood as an on-going process which starts with the initial presentation of a research activity to a prospective subject by the investigator and continues through the research activity until the subject ends his/her participation or the study closes. Research subjects are rarely aware of research activities prior to an initial presentation by the principal investigator or a member of a principal investigator’s research team. The initial phase of consent requesting participation in a research activity commonly begins with the first contact between the subject and the investigator. Many subjects make their decision regarding whether to participate in research during this initial contact. As a result, the greatest potential for misunderstanding exists in the initial consent process. Researchers must provide sufficient time for a potential subject to reflect on the nature of participation during the important initial presentation of a research activity. When subjects are presented with numerous research and clinical options, the consent process must include a clear description of the possible known ramifications resulting from each option presented. Subjects must also be made aware of the possibility of unforeseen risks resulting from participation in the research project. The presentation must not include specific “leading” information about whether to participate in any particular project.
By providing a potential subject with information understandable to the subject in an initial session regarding complex research issues, potential subjects should have an improved comprehension of the elements within the consent form and provide a more informed consent for participation in the research.
The second step in the consent process is the presentation of the consent forms to the subject. In biomedical research the investigator should separate the research consent form from any other clinical information or hospital admission forms. Subjects should not be asked to sign hospital admission paperwork or hospital consent documents for clinically indicated procedures at the same time as the presentation of the research consent form. Individuals who have already received pre-op medication or anesthesia should not be asked to sign a consent to participate in human research. The presentation of the research consent form should be a separate process. The principal investigator or a member of the research team should ensure that the subject or legally authorized representative (LAR) reads the consent form or has it read to them. After the subject or LAR reads the consent form or has it read to them, the principal investigator or member of the research team should ask the subject or LAR if he/she has any questions regarding the information contained in the consent form. Please note that the IRB must approve the use of an LAR or surrogate prior to obtaining their assent.
In situations where the ability of the subject to understand the form is in question, for example, the subject is possibly educationally or mentally challenged, the investigator or member of the research team may wish to ask questions of the subject to ensure an understanding of the basic elements of the consent form. In performing an assessment of the subject’s comprehension of the consent form, an investigator should request that the subject indicate the risks of participation, how the subject may withdraw, and what alternatives exist to participation in the research. The decision-making capacity of subjects with psychiatric disorders or cognitive deficits (such as dementia) should be evaluated by a practitioner with expertise in the area.
All efforts should be made to offer the potential subject or LAR sufficient time to consider the information contained in the consent form. The potential subject or LAR should be given the opportunity to take the consent form home and sign the form on a return visit or be left alone to consult about enrollment with family or friends. If the individual decides to participate, he/she is asked to sign the consent form. The person obtaining the subject’s informed consent must also sign the form. The subject must be given a copy of the form the subject signed. The FDA (drug or device studies) explicitly requires that consent forms be dated as well as signed by the subject or the subject's legally authorized representative. The original consent is retained in the investigator’s files.
The consent form should be a statement addressed to the subject that gives reasonable information about the study, its procedures, benefits, risks, and alternatives, to enable him/her to make an intelligent decision about participation. The consent form should be written in a language and level which the prospective subject can be expected to understand. It should be concise, literate and be proofread carefully for errors in spelling and grammar.
The consent form must not be overly encouraging or coercive. It may not include any language through which a subject is made to waive or to appear to waive any legal rights or to release the institution or its agents from liability for negligence.
All subjects invited to participate in a research protocol must be given the opportunity for informed consent or refusal. For these purposes, control subjects are always viewed in the same way as other subjects, even if the research plan is to treat control subjects with standard accepted diagnostic and therapeutic maneuvers.
Standardized research consent forms have been developed by the IRB which indicate the elements of informed consent required by the federal regulations and require the Principal Investigator to insert the study-specific information.
If a procedure is performed solely for purposes of identifying a population of future research subjects, consent is required. Investigators may wish to present prospective subjects with a consent form describing only this procedure and stating as its purpose a determination as to whether the subjects will be eligible for participation in further studies. If the screening involves access to, or creation of, prospective subjects’ protected health information, a HIPAA authorization will also be required. A separate consent/authorization form may then be presented to those who are found to be suitable. In such situations, while soliciting consent to the qualifying tests, the Principal Investigator is expected to show potential subjects the consent/authorization form they will be asked to sign if they prove to be suitable subjects for further study.
It is highly encouraged that spell-check/grammar check is used on your consent form(s) prior to submitting to the IRB.
The consent form signed by the subject in the original must be kept in the study files. A copy of the signed consent form must be given to the subject. If the research involves protected health information, a HIPPA authorization is required. At UVa, the HIPAA authorization is combined with the research consent form.
If there are two or more consent forms, each should be clearly labeled as to which subject population is addressed (i.e., subject/ subjects, normal controls, family members). Type must be clear and readily legible, in standard size, which is 10 to 12 points. Twelve (12) point-type is preferred.
Principal Investigators may not make any changes to the text of the informed consent and authorization form approved by the IRB without the IRB’s prior written approval. In cases where a Principal Investigator is requested to change the text of the informed consent documentation by other third parties, the revised informed consent document must be resubmitted to the IRB for approval prior to initiating the study.
If videotapes are to be made for research purposes, the consent form should state when the tape will be erased, that the subject has the right to demand erasure at any time, and the circumstances, if any, under which the tape might be used for purposes other than the research described in the protocol (e.g., educational purposes).
It is the policy of the IRB that the consent process shall be conducted by the investigator or other professional staff listed on the protocol who are knowledgeable about the protocol.
The primary goal of a consent form is to provide all required information about a study in language and format that is comprehensible to the subject population. Everyday vocabulary and simple sentence structure should be used throughout the form. While Principal Investigators always have the option of describing the study in more detail during the consent process itself, the written description of the study should be simple and straightforward so that subjects will have a consent form to take home with them and refer to over the course of their participation in the study. Unless the subjects are themselves medical professionals, scientific or technical terms should either be replaced with or defined in lay language.
For example, “blood draw” is preferable to “venipuncture,” “X ray” to “radiographs”, “upset stomach” to “GI upset,” “obstruction” to “occlusion.”. A list of technical terms and lay language for lab tests can be obtained from links on the IRB-HSR website. Legalistic sounding language such as “you hereby agree”, “you certify that”, “you the undersigned, do acknowledge that” should not be used. Phrases similar to the following should be: “you have been told that”, “It has been explained to you that”. These phrases do not assure a subject’s comprehension and lend the appearance of a legal document to the consent form.
Some useful tips in making a consent more readable include:
The person-tense in which the form is written should be consistent throughout the form. The second person (i.e., “you are being asked”) is preferable, but not required.
- Using short sentences
- Using works with a lower number of syllables