The 519-page Notice of Proposed Rulemaking (NPRM) released Wednesday will make protections for human research subjects more uniform by streamlining some informed consent rules and using other means to reduce ambiguity around clinical trials.
The move by HHS and 15 other governmental departments and agencies is part of a plan to overhaul what is known as the Common Rule, which was originally published in 1991 and outlines the basic provisions for institutional review boards (IRBs), informed consent and assurances of compliance for human research conducted or supported by the federal agencies.
The idea for the NPRM to overhaul the Common Rule comes as a range of stakeholders raised concerns about shifts in science, technology, and public engagement expectations in the 21st century that have altered the fundamental principles of the Common Rule.
As part of that shift, the NPRM says that some low-risk categories of research, such as research involving "benign interventions in adult subjects," will no longer be covered by the Common Rule. But the NPRM would also extend the scope of the Common Rule to cover all clinical trials, regardless of funding source, conducted at a US institution that receives federal funding for non-exempt human subjects research.
One of the main focal points of the NPRM is on informed consent, which the NPRM says would be "significantly tightened to make sure that the process becomes more meaningful." For example, consent forms for potential subjects would no longer be "unduly long" and the documents would need to give pertinent details about the research upfront to help potential participants decide more quickly on whether to enroll in a study.
In addition, there will be a new requirement whereby consent forms for clinical trials will have to be posted publicly.
Informed consent would also be required for secondary research with a biospecimen, which the NPRM says includes "part of a blood sample that is left over after being drawn for clinical purposes, even if the investigator is not being given information that would enable him or her to identify whose biospecimen it is."
The NPRM also seeks to avoid requirements that do not enhance subject protections and impose burdens that can decrease efficiency, waste resources, erode trust, and obscure ethical challenges that require careful deliberation and stakeholder input.
"Cumbersome and outdated regulatory standards overwhelm and distract institutions, IRBs, and investigators in ways that stymie efforts to appropriately address the real risks and benefits of research," the NPRM says.
Meanwhile, the NPRM would mandate that US institutions engaged in cooperative research rely on a single IRB for that portion of the research that takes place within the US, with certain exceptions. To encourage the use of IRBs that are otherwise not affiliated with or operated by an assurance holding institution ("unaffiliated IRBs"), this NPRM also includes a proposal that would hold such IRBs directly responsible for compliance with the Common Rule.
Some studies that currently require IRB review would also now become exempt, and the NPRM says that it will determine which studies are exempt from IRB review with a web-based "decision tool."
The agencies say that it "is expected that in many instances the tool would be used by the investigators themselves, thus obviating both the need for further review and the concern that the institution might be subjecting itself to future liability by allowing investigators to use the tool."
Notice of Proposed Rulemaking