Safeguards

Informed Consent and the Larger System of Protections

Informed consent for clinical trials is just one part of a larger system in place to safeguard people who want to help researchers evaluate new practices that may improve treatment, supportive care, screening, and prevention, while perhaps benefiting from these new methods. This system ensures that clinical trials are conducted ethically, without undue risk to participants. What follows are links to some of the resources that contribute to this system of protections.

Simplification of informed consent documents

The informed consent process can be effective only if patients understand the study information presented by the medical team. After both participants and investigators voiced concerns that informed consent documents for clinical trials were becoming too long, complicated, and difficult to understand, the National Cancer Institute issued recommendations and other guidance for the documents' developments (see Simplification of Informed Consent Documents ¹). The recommendations had three goals in mind:

• to make the forms more useful and understandable to people who want to participate in clinical trials;
• to aid investigators in developing better informed consent documents; and
• to assist Institutional Review Boards (IRBs) in reviewing the documents and ensuring their quality.

Office of Human Research Protections (OHRP)

This OHRP ², which is part of the U.S. Department of Health and Human Services (DHHS), is responsible for:

• guiding the medical community on ethical issues in biomedical or behavioral research, and
  
  
• implementing DHHS's Regulations for the Protection of Human Subjects ³ (Title 45, Part 46 of the Code of Federal Regulations, Protection of Human Subjects; also referred to as 45 CFR 46).

These federal regulations set standards for the informed consent process; the formation and function of Institutional Review Boards (see below); the involvement of prisoners, children, and other vulnerable groups in research; and many other protective measures.

The regulations apply to any federally funded research that involves people (which includes NCI-sponsored clinical trials). Participating institutions must provide OHRP with a written assurance that they will comply with the regulations. In addition, many research institutions conducting independent (i.e., not federally funded) trials have volunteered to adhere to these regulations.

Human Subject Protection Program, FDA

The U.S. Food and Drug Administration (FDA), through its Office of Health Affairs, has developed its own set of regulations on the protection of human subjects (Title 21, Parts 50 and 56 of the Code of Federal Regulations; also referred to as 21 CFR 50, 56).

The regulations apply to any clinical trial that involves an investigational drug, biological product, or other device that is regulated by the FDA under the Food, Drug, and Cosmetics Act -- regardless of whether or not the trial receives Federal funding. If a trial is supported by the Department of Health and Human Services and involves an FDA-regulated drug or device, then it is subject to both organizations' regulations. (For more information, see Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors ⁴).

The American Hospital Association and "The Patient Care Partnership"

The American Hospital Association (AHA) first adopted a "patient's bill of rights" in 1973, which was later revised into a brochure called The Patient Care Partnership: Understanding Expectations, Rights and Responsiblities ⁵. This brochure (available in multiple languages) lists a patient's rights to considerate and respectful care, privacy, confidentiality, information about options, and access to medical records, among others. The AHA expects hospitals to use the brochure to ensure quality care and encourages them to adapt its contents to meet the needs of the communities they serve.

Institutional Review Boards

Institutions have an Institutional Review Board (IRB) made up of medical specialists, nurses, social workers, medical ethicists, and patient advocates. The IRB reviews all clinical trial protocols and approves only those that address medically important questions in a scientifically and ethically responsible manner. It also reviews all informed consent documents to make sure that they provide clear and complete information for those who may wish to take part.

You might be interested in taking a look at the IRB Guidebook ⁶ issued by the NIH's Office of Human Research Protections.

Peer review

Before a clinical trial gets under way, it also may be reviewed by experts chosen by the sponsoring organization (such as the National Cancer Institute, the Food and Drug Administration, or pharmaceutical company) for scientific merit, patient safety, and ethical considerations.

For more information about peer review at the National Institutes of Health (NIH), including NCI, see the Office of Extramural Research:  Peer Review Policy and Issues ⁷ or the NIH Center for Scientific Review ⁸.

Patient representatives

Many hospitals and clinical centers employ patient representatives, who work to make sure that those who receive care (including clinical trial participants) are informed of and understand their rights and responsibilities.

Other organizations

Groups such as Public Responsibility in Medicine and Research (PRIM&R) ⁹ help to educate medical personnel and the public about the ethical, legal, and policy issues involved in clinical research.