Consent of Subjects Included in Biomedical Research

¶ … Consent of Subjects Included in Biomedical Research

Informed Consent is the basis of the transfer of information to a subject who is a candidate to participate in a clinical trial. The process of obtaining informed consent is a moral and ethical component of clinical trials conducted under Good Clinical Practices (GCPs). A subject is informed of all aspects of a clinical trial that are determined relevant to their decision to participate including risks, trial purpose, and safety documentation so that the subject can make a decision and confirm their willingness to participate. Informed consent precedes enrollment in a clinical trial and is documented by means or a written, signed and dated consent form.

Purpose of Informed Consent

Except in a few narrow instances such as life threatening situations, all research involving any drug including biological products, food additives, medical devices, or color additives must take place with legally effective informed consent of the subject of the clinical trial (21CFR 1998). All informed consent must take be documented by means of an approved, written, signed and dated informed consent form (ICH GCP E6 1996). The informed consent should consist of a template form that clearly identifies any research purpose for a study and include any information the subject needs to know to decide whether or not they will participate in a study. This information has to include any potential risks and benefits related to participating in the study. The subject should be able to completely understand all of the background information and the purpose cannot be to ask a subject to waive any legal rights. After reviewing the information contained in an IRB-approved informed consent document a subject should be able to weigh all risks and/or benefits and decide whether or not to participate in the study.

Requirements for an Informed Consent Document

The informed consent form (ICF) must be approved by the IRB for the site where clinical research is to take place. It is important to understand that the ICF is not a static document but must be revised any time new information is available that is relevant to subjects consent (ICH GCP E6 1996) and any revisions must be reviewed and approved by the IRB. It is critical that none of the ICF documentation can cause a subject o waive any legal rights or release the investigator or sponsor from liability for negligence (21 CFR 1998, ICH GCP E6 1996). The ICF must be written in a language that subjects can understand with medic al and technical terms explained and for patients who do not speak the language of the written ICF, a reviewed and documented translation must be provided (ICH GCP E6 1996). The following elements are required elements for GCP (21CFR 1998):

A. A statement that the study involves research

B. An explanation of the purpose of the research

C. The expected duration of a subject's participation

D. A description of any procedures to be followed during the trial

E. Identification of all parts of the trial that are experimental

F. Description of any foreseeable risks or discomforts to the subject

G. A description of any benefits to the subject or others that can be expected from the research

H. A disclosure of appropriate alternative procedures or courses of treatment that might be advantageous to the subject

I. A statement describing the extent of confidentiality of records and notes that the FDA may inspect records

J. Explanation of any compensation any potential injury that may occur and where further information may be obtained

K. Explanation of subjects rights and whom to contact in the event of a research-related injury

L. A statement that participation is voluntary and refusal will result in no penalty.

Some additional elements may be appropriate for the ICF of clinical trial depending on circumstances and may include the following (21CFR 1998):

A. A statement that the particular treatment may involve risk to the subject or fetus should the subject be or become pregnant

B. Circumstances under which the subject's participation may be terminated by the investigator without the consent of the subject

C. Any additional costs to the subject that may result from participation in the research

D. The consequences of a decision by the subject to withdraw from the research

E. The approximate number of subjects involved in the study

The investigator should provide a signed and dated copy of the approved ICF to each subject with any supplemental documents or amendments to the information prior to and during participation in the research.