Initially scheduled due to be introduced on January 19, 2018, amendments to the Common Rule – The Federal Policy for the Protection of Human Subjects have been put back for six months, allowing research groups additional time to comply with the new provisions.
July 19, 2018 is the new date for the change to be introduced,however the provision covering cooperative research still has an introduction and enforceable date of January 20, 2020.
Many healthcare groups, including the American Medical Informatics Association (AMIA), the Associated of American Medical Colleges (AAMC), and the Association of American Universities (AAU), asked for the compliance date to be delayed due to uncertainty in relation to the final rule. Such a delay was required to give institutions additional time to ensure compliance and would allow federal agencies more time to release guidance to researchers to help them adapt to the updated regulations.
Sixteen federal departments, including the Department of Health and Human Services, made changes to the Common Rule. In a notice of proposed Rulemaking, the requirement for the delay to the compliance date was outlined. “Without a delay, and without guidance, institutions that have expected a delay who hastily attempt to implement the revised rule without adequate preparation are bound to make mistakes, the consequences of which may jeopardize the proper conduct of research and the safety and well being of human subjects.”
While the new date will be welcomed by many groups, those that had already prepared to adhere with the new provisions of the Common Rule ahead of the January 19 compliance date will now need to continue with their old policies and processes for another six months, which may cause some issues.
Amendments to the Common Rule
The final rule amendment to the Common Rule was released on January 19, 2017 on the final day of the Obama administration. One of the main factors behind the update was since the Common Rule was introduced in 1991, there have been many alterations to how research is conducted.
At the time, research was mainly carried out in universities and medical institutions, with studies taking place at a single location. Nowadays, the scale of research studies has risen, they often involve many sites, data is now digital, and the research is now more varying. Due to this an rethinking of the Common Rule was long overdue.
The changes will enhance privacy protections for researchers. The updated Common Rule is closely linked to the HIPAA Privacy Rule and introduces further security measures to safeguard the privacy of research participants, while also improving the availability of health information for secondary research.
The update sees consent requirements amended to require information about research studies to be listed on consent forms in language that a reasonable individual would understand. The changes also make it possible for broad consent for secondary research to be achieved, which will enhance the availability of patient-reported data and biospecimens for research. The amendments will also help research institutions download up-to-the-minute data from mobile applications and devices used by clients.
These updates clarify that specific public health surveillance activities are not included in Common Rule restrictions, which will help with monitoring the spread of disease in the USA. Certain low-danger studies carried by HIPAA Covered bodies will also be exempt.
The HHS has also stated that the oversight system will not add an unnecessary administrative requirement and the update has introduced greater flexibility to match the current dynamic research environment.
March 23 2018 is the deadline for feedback on the Interim Final Rule to be submitted. Guidance to assist institutions adhere with the Common Rule changes will be published soon.