Informed Consent: New Recommendations Aim to Simplify Documents, Improve Quality

The National Cancer Institute (NCI) has unveiled new recommendations for informed consent documents that aim to make the forms more understandable and more useful to people who are considering participation in a cancer clinical trial.

Consent forms are a critical part of the informed consent process, through which an individual decides whether or not to participate in a trial. The need to improve this part of the process has become a major issue in oncology in recent years, as the forms have grown increasingly long, complex, and difficult to understand.

In a mailing to thousands of Institutional Review Boards (IRBs), hospitals, cancer centers, patient groups, and individual researchers this week, NCI offers specific guidelines for simplifying and clarifying informed consent documents, and providing information essential to informed decision making. Included with the recommendations is a computer disk with a template a fill-in-the-blanks model form that investigators can use in developing their own documents.

The packet is intended both to support researchers who write consent forms and to assist local IRBs in reviewing the documents. "The ultimate goal is to increase patients' understanding of studies, and provide them with a sound foundation for decision-making," said Mary McCabe, R.N., director of the Office of Clinical Research Promotion at NCI, which is part of the National Institutes of Health (NIH).

The guidelines were developed by the Comprehensive Working Group on Informed Consent in Cancer Clinical Trials, which included representatives of NIH's Office for Protection From Research Risks and the Food and Drug Administration, as well as research physicians and nurses, patient advocates, IRB members, communications and legal experts, ethicists, and representatives of the pharmaceutical industry. Once developed, the recommendations and model template were evaluated and refined through a series of focus groups with patients, physicians, nurses, IRB members, and clinical research associates.

The Working Group made recommendations regarding specific elements in the consent form, such as the study's objectives, risks, and benefits. It also made general recommendations concerning readability and information access. Some examples:

The consent form should clearly and simply explain the research study and state why the potential research participant is eligible to enroll. The main objective of the proposed study should be placed in the context of standard care. Risks should be presented for the entire regimen rather than listing the risks for each specific drug or procedure that comprise the intervention. No investigational approach should be identified as the only chance for cure or contrasted with standard approaches that offer no chance of cure. Informed consent documents should be understandable to the patient population at the local facility. Documents should be written at an eighth grade or lower reading level. The research participant should be informed about and provided access to supplemental information during the initial decision-making process and throughout the research trial.

In addition to the recommendations, the Working Group developed sample consent forms for four current NCI-sponsored studies. The samples are included in the packet along with the guidelines and the template.

The new informed consent materials are available on the NCI's Web site for clinical trials, http://cancertrials.nci.nih.gov.

For more information about cancer visit NCI's Web site for patients, public and the mass media at http://rex.nci.nih.gov or NCI's main Web site at http://www.nci.nih.gov.