Informed Consent Common Rule Revisions Delayed for Six Months, But Certain Changes Can Continue

The federal government pushed back its revisions to the Common Rule for an additional six months — making the announcement less than 36 hours before the changes were set to take effect Jan. 19 — and warned the public to expect additional delays down the line.

The Common Rule encompasses the federal regulations and policies that govern the protection of human research subjects, including informed consent procedures and institutional review boards, and spans at least 16 departments and agencies.

The new implementation date is currently set for July 19 — but HHS, the Consumer Product Safety Commission and the Environmental Protection Agency, as well as the departments of Veterans Affairs, Defense, Commerce and others, are all currently developing a new proposed rule to further delay the changes, which were first announced in January 2017.

Until then, sponsors must continue to comply with current regulations, until the so-called “2018 regulations” finally go into effect — causing disruptions with companies participating in Common Rule-agency funded research that planned to comply with the Jan. 19 implementation date.

However, companies can begin implementing certain new elements of informed consent before July 19 — because they are not prohibited by current law, according to the HHS Office of Human Research Protections. 

“Institutions may begin implementing provisions of the revised Common Rule that do not conflict with the pre-2018 Common Rule,” OHRP said in announcing the delay this week.

However, certain new provisions cannot be implemented early, such as the elimination of the need for continuing review in certain circumstances.

“Because the pre-2018 regulations require continuing review at least annually for all ongoing non-exempt human subjects research, halting continuing review for such research before that date would be considered non-compliance,” OHRP said.

Oracle Survey Polls Challenges for Implementing Digital Trial Management Systems

A new survey described the main challenges for clinical trial professionals using current randomization and trial supply management and interactive response technology systems — with over 70 percent of respondents pointing to a lack of flexibility, integration with other platforms and the time burden it takes to deploy new trials as their major frustrations. The online survey, conducted by Oracle Health Sciences and Informa Engage, found that 92 percent reported having to make changes to their RTSM/IRT systems due to study changes, and at least twice per study on average. The most anticipated change in the next five years is the integration of IRT into the platform, followed by accelerated trial builds and self-service solutions, according to the study, which polled 254 professionals in clinical operations, trial management and related areas