For more than 25 years, the rules and regulations governing the protection of human subjects in research (the “Common Rule”) have gone largely unchanged. As we reported earlier this year, 16 federal agencies and departments promulgated a final rule in 2017 to update and modernize the Common Rule (the “2017 Final Rule”).
The 2017 Final Rule was originally slated to become effective on January 19, 2018, and institutions were required to comply with its new requirements by that same date. However, on January 20, 2017, President Trump issued an executive memorandum freezing all regulations that had been published but were not yet effective. On October 7, 2017, the Office of Management and Budget (OMB) received a proposal from the Department of Health and Human Services (DHHS) that, by its title, seeks a “1-Year Delay of the General Implementation Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Year.”
While the title of the proposed rule implies that the compliance date for institutions to implement the 2017 Final Rule requirements will be delayed by one year, no actual proposed rule was attached to the OMB posting, and neither OMB nor DHHS has issued an official statement announcing a one-year delay. Thus, until a formal delay is published by final rulemaking, institutions should continue to prepare with the assumption that January 19, 2018, remains the required the compliance date.
To that end, below are the seven key Final Rule takeaways for individuals and institutions involved with clinical research that we highlighted earlier this year:
- Non-identified biospecimens are not considered “human subjects.” Researchers do not need to obtain informed consent from patients to use non-identified biospecimens in secondary research.
- Informed consent forms must contain key information (risks, benefits, alternative treatments) that a person would want to know at the beginning of the document. Institutions should update template informed consent forms to meet this requirement.
- Research studies involving multiple institutions generally should be overseen by a single institutional review board.
- Researchers may obtain broad consent from participants to conduct future research on stored identifiable data and identifiable biospecimens.
- Researchers involved in low-risk studies may be exempt from institutional review board oversight. For example, the Final Rule expands the list of exemptions to include most non-clinical research, benign behavioral interventions, consumer preference surveys and research involving identifiable private information on subjects otherwise protected by HIPAA.
- Continued institutional review board oversight is not required when enrolled subjects are no longer at risk (e.g., the data analysis and standard of care follow-up stages).
- Consent forms for some federally funded clinical trials must be posted on a public website.
If you have any questions about the implications of the 2017 Final Rule on the Common Rule or its potential delay, please contact the authors or any member of Drinker Biddle’s Health Care team.