The Federal Policy for the Protection of Human Subjects was supposed to take effect on January 19, 2018. But its implementation was delayed by 6 months. Compliance date was changed to July 19, 2018. The updated common rule was uncertain so several healthcare organizations such as the Association of American Medical Colleges (AAMC), the American Medical Informatics Association (AMIA) and the Association of American Universities (AAU) requested for the delay of compliance date. The delay will give research organizations extra time to comply with the updated Common Rule. It would also give federal agencies the chance to issue guidance regarding the changes so that researchers can comply.
The revisions to the Common Rule were contributed by 16 federal departments, one of which was the Department of Health and Human Services. If the compliance date was not delayed, it’s likely that a hasty attempt to implement the revised rules could lead to mistakes. The mistakes could further lead to the improper conduct of research affecting the safety and wellbeing of human subjects. Many organizations liked the idea of the delay, but those that are already prepared to comply with the updated Rule ahead of the original compliance date may have to implement the old policies for 6 months more, possibly causing some conflicts.
The final changes to the Common Rule were approved on the last day of Obama’s administration – January 19, 2017. The update was long overdue as the last update was way back in 1991. Since then, the way to conduct research has changed a lot. Research is no longer limited to doing it in one site – like in universities or medical institutions. It can now be done using multiple sites using digital data.
So what were the changes to the Updated Common Rule?
- Improved privacy protection for research participants and better health data availability for secondary research.
- Consent requirements included detailed information about the research studies that a reasonable person can understand.
- It’s possible to use broad consent to get secondary research that improves the availability of biospecimens for research and patient-reported data.
- Allows research institutions to get real time data from patient’s mobile apps and devices
- Exemption of certain public health surveillance activities from Common Rule restrictions. An example is the monitoring of disease in the United States.
- Exemption of low-risk studies conducted by HIPAA covered entities.
- Greater flexibility in today’s dynamic research environment.
Comments regarding the interim final rule can still be submitted until March 23, 2018. The HHS issued guidance for helping institutions comply to the Common Rule will follow.