By Amy Davis

PRIM&R recently filed comments on the FDA’s proposed rule to amend the informed consent regulations at 21 CFR 50 that apply to most clinical investigations.

PRIM&R’s Board of Directors has a Public Policy Committee (PPC) that works with content experts to develop comments on proposed guidance or regulations that might negatively impact the ethical conduct of research by limiting protections for human subjects or by negatively impacting the welfare of animals used in research.

The regulation change, required by the Food and Drug Administration Amendments Act of 2007, states that all informed consent documents and processes must inform subjects that certain information from the clinical trial is included in the government’s clinical trial registry databank , which contains information about federally registered clinical trials.. The proposed change is to 21 CFR 50.25 , the regulation that lists the basic elements of informed consent for clinical trials. The new provision would require all informed consent documents and written processes to include the following uniform statement, which serves to ensure consistency among the information that clinical trial participants receive:

“…clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank under paragraph (j) of section 402 of the Public Health Service Act: Information, that does not include personally identifiable information, concerning this clinical trial has been or will be submitted, at the appropriate and required time, to the government-operated clinical trial registry data bank, which contains registration, results, and other information about registered clinical trials. This data bank can be accessed by you and the general public at www.ClinicalTrials.gov. Federal law requires clinical trial information for certain clinical trials to be submitted to the data bank.”

According to the Federal Register announcement, the purpose of the rule change is to:

• Increase public awareness of the existence of the database, thereby allowing subjects to make more fully informed decisions about participating in a clinical trial;
• Provide greater accountability and responsibility of investigators for outcomes and adverse events, and improve transparency of all clinical trial outcomes information by creating a system of checks and balances for the research community;
• Increase public confidence in the validity of the research process; and
• Give sponsors, physicians, and patients access to more information, thus enabling them to make more educated treatment decisions.

PRIM&R solicited input from its members and Board, and the PPC developed comments on this proposed regulation that raised two objections:

• The requirement that specific language be included in the informed consent document is inconsistent with the other provisions of 21 CFR 50.25 that do not dictate the wording of the essential elements of the informed consent document, and
• The required wording is too complex and exceeds the reading level that would be necessary to ensure understanding on the part of all subjects in violation of 21 CFR 50.20.

What are your thoughts on PRIM&R’s response to the FDA? We welcome any comments and discussion on this issue!