A Discussion Of Issues With Informed Consent
A Discussion of Issues Related to Informed Consent
Purpose, Contents, and Signed Consent Form vs Oral Consent
Purpose
Informed consent is a process, not just a form. Information must be presented to enable potential participants to voluntarily decide whether or not to participate in a research project. It is a fundamental mechanism to ensure respect for persons through provision of thoughtful consent for a voluntary act. The procedures used in obtaining informed consent should be designed to educate the participant population in terms that they can understand. Therefore, informed consent language and its documentation (especially explanation of the study's purpose, duration, experimental procedures, alternatives, risks, and benefits) must be written in "lay language", (i.e. understandable to the people being asked to participate) at a reading level no higher than fifth grade.
Contents
For a participant to be thoroughly informed certain information must be included in the presentation.
Describe the overall experience that will be encountered. Explain the research activity and exactly what the participant will be expected to do. Inform the participants of the reasonably foreseeable harms, discomforts, inconvenience and risks that may be associated with the research activity. If additional risks are identified during the course of the research, the consent process and documentation will require revisions to inform participants as they are recontacted or newly contacted. (Remember: most all research with human participants has the potential risk of loss of confidentiality.)
Describe the benefits that participants may reasonably expect to encounter. There may be none other than a sense of helping the public at large (or the student!). If payment is given to defray the incurred expense for participation, it must not be coercive in amount or method of distribution.
Describe any alternatives to participating in the research project. For example, in studies involving
Purpose, Contents, and Signed Consent Form vs Oral Consent
Purpose
Informed consent is a process, not just a form. Information must be presented to enable potential participants to voluntarily decide whether or not to participate in a research project. It is a fundamental mechanism to ensure respect for persons through provision of thoughtful consent for a voluntary act. The procedures used in obtaining informed consent should be designed to educate the participant population in terms that they can understand. Therefore, informed consent language and its documentation (especially explanation of the study's purpose, duration, experimental procedures, alternatives, risks, and benefits) must be written in "lay language", (i.e. understandable to the people being asked to participate) at a reading level no higher than fifth grade.
Contents
For a participant to be thoroughly informed certain information must be included in the presentation.
Describe the overall experience that will be encountered. Explain the research activity and exactly what the participant will be expected to do. Inform the participants of the reasonably foreseeable harms, discomforts, inconvenience and risks that may be associated with the research activity. If additional risks are identified during the course of the research, the consent process and documentation will require revisions to inform participants as they are recontacted or newly contacted. (Remember: most all research with human participants has the potential risk of loss of confidentiality.)
Describe the benefits that participants may reasonably expect to encounter. There may be none other than a sense of helping the public at large (or the student!). If payment is given to defray the incurred expense for participation, it must not be coercive in amount or method of distribution.
Describe any alternatives to participating in the research project. For example, in studies involving