Informed consent is an integral component of research insuring that participants are aware of and understand fully the consequences of participation. Informed consent is the process by which participants are provided the information necessary to make a decision about participation. Current Federal regulations (45 CFR 46.116) describe nine basic elements of informed consent that are necessary to provide an individual with adequate information for making such a decision. Unless the IRB has approved a waiver or alteration of informed consent, the following information must be provided to each subject or the legally authorized representative:
- A clear statement that the project involves research. The informed consent explains the purposes of the research, as well as the expected duration of the participant's participation. The informed consent must include a description of the procedures to be followed and identification of any procedures that are experimental. Descriptions must be clear and detailed enough for the participants to understand their involvement.
- A description of any reasonably anticipated risks or discomforts the participant may experience.
- A description of any benefits to the participant or to others that may reasonably result from participation in the study.
- A disclosure of any appropriate alternative procedures or treatments, if they exist, that may benefit the participant.
- A statement describing the extent to which confidentiality of identifying data will be maintained.
- In the case of research involving more than minimal risk, an explanation as to whether any compensation is involved, and whether medical treatment is available if injury is sustained.
- Identification of whom to contact to answer pertinent questions, to explain participants' rights, or to contact in the event of an emergency.
- A statement that participation is voluntary: Refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled. The participant may discontinue participation at any time without penalty or loss of benefits.
- One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens: (i) A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or (ii) A statement that the subject's information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies
Informed consent is more than a form, it is an ongoing process. It is crucial to consider the participant's specific involvement in a project and a participant's abilities to assure proper informed consent. Often involvement in a research project may occur over the course of several weeks or months. In these instances it is important to review informed consent issues from time to time in order to reaffirm the participant's understanding. The need for renegotiating informed consent will vary from study to study. As with many aspects of IRB review, this issue must be considered on a case by case basis. The IRB will make a final determination as to the extent to which an investigator will need to reaffirm consent. This could range from reminding the participants of what will be expected at each session to a formal review of the informed consent document. Regardless of the determination by the IRB, the investigator bears the responsibility for assuring that participants have a full understanding of the nature of their involvement in the research throughout the project.
Special Population Issues
A special issue in consent arises when participants are unable to give consent for themselves, as with children or cognitively impaired individuals. In such cases consent is generally given by “proxy.” However, this proxy consent is not the same as true consent, and thus raises other ethical questions. In the event proxy consent is obtained, the subject should be given veto power whenever feasible. Such is often the case with children involved in research activities. While they are unable to give legal consent, they may still be able to grasp at least basic aspects of the research project. When this is the case, assent of the subject is necessary. While there is no clear rule regarding the age at which children can adequately give assent to participate, the rule of thumb is that assent should be obtained from children seven years and older. In general, if the participants have the cognitive ability to understand what they will be asked to do in a project, they should be asked if they would like to participate. Again, this issue must be assessed on a case by case basis, and the IRB will make a final determination as to whether both assent from participants and consent from guardians are necessary. (See also Chapter 4.)
Many research questions cannot be adequately addressed when full informed consent is required. In many cases incomplete disclosure or deception is necessary to obtain essential information. This presents a “Catch 22” in the informed consent process. The first solution should be to attempt to design a study which can answer the research question without any form of deception. The IRB will expect an explanation as to the necessity of deception in any project. When it is not possible to answer the research question without deception, the IRB will assess the risks to participants and make a decision as to what is necessary to protect them. With any research utilizing deception, a thorough debriefing procedure is necessary. The debriefing allows the investigator to explain tactfully what happened and why deception was necessary. At times deception may generate ill feelings among research subjects. It is the responsibility of the investigator to address the ill will and attempt to restore subjects to the pre-testing state of feeling and mind that was disrupted by deceptive methodology. (For a more complete discussion of deception in research, refer to Section 3.10 - Deception, in this manual.)
Placebo, Randomizing, and Blind Clinical Trials
A related issue is that of placebo, randomized, and blind clinical trials. When these types of designs are utilized it is impossible to inform the participants concerning which treatment they will receive. The informed consent document should define single and double blind procedures in a way participants can understand. They should be informed of all the possibilities which may occur if they agree to participate.
Language Used in Consent Forms
Many special circumstances can arise when developing an adequate informed consent procedure. One of the most important factors to consider is the language of the document. While investigators have complete control over the language contained in the document, they have limited control over the prospective participants' comprehension levels. It is crucial that investigators consider the possible variation in comprehension levels of subjects in their sample and write informed consent documents that reflect the subjects' reading abilities. While this is a difficult task to accomplish, there are several rules of thumb to follow:
- Avoid technical jargon; rephrase in lay terms.
- Do not include any language that implies that subjects may waive any rights based on their participation in the research.
- Do attempt to write documents at a sixth grade level.
Many consent forms contain extensive amounts of technical information and are written at a college/graduate level. Reducing the reading level and complexity of the document does not guarantee comprehension, but it does provide a better opportunity for participants to understand their involvement in the research project.
Although the IRB has a standard consent form format, there are situations when this format may be counterproductive for a given group of subjects. Researchers are encouraged to contact the IRB if they believe an alternate format would be more appropriate. (See Appendix 6.5 for sample consent forms.)