Biomedical research practitioners should be aware of the important changes in federal regulation governing the “Common Rule,” a federal policy that protects people who volunteer for federally funded research studies. On January 19, 2017, the Department of Health and Human Services (“HHS”), as well as the 16 federal departments and agencies to which the Common Rule applies, issued a final update to the regulation, which has remained static since 1991. The update is meant to strengthen the rule and modernize it to better reflect the significant transformations in biomedical research that have occurred over the past 25 years. The United States has undergone a clinical research revolution since 1991, recording a growth from fewer than 4,000 clinical trials to more than 235,000 currently registered on ClinicalTrials.gov[1]. This spectacular growth has brought about the need for greater oversight and more transparent rules regarding human subject protection in the era of big data.
The process of reviewing the rule began in September of 2015, when the agencies issued a Notice of Proposed Rulemaking (NPRM) in an attempt to “reduce burden, delay, and ambiguity for investigators” as well as “modernize, simplify, and enhance the current system of oversight.” Researchers and patient advocates filed more than 2000 comments on the plan, with scientists and investigators raising strong objections that certain new requirements would impose added regulatory burdens on research institutions and study sponsors. One particularly contentious rule would have placed restrictions for using blood, urine, tissue, and other specimens leftover from clinical care or a specific research study. The revised final Rule, which will come into effect in January 2018, drops a number of these controversial proposals. The key takeaways are as follows:
- Non-identified bio specimens are not considered “human subjects.” Research can be performed using previously collected bio specimens without informed consent as long as the specimens are not linked to an individual.
- Clinical investigators may obtain broad consent from participants to conduct future research on stored identifiable data and identifiable bio specimens.
- Informed Consent Forms should be shortened and make it easier for research subjects to locate the key information (risks, benefits, alternative treatments) necessary to make informed decisions regarding their participation in research studies.
- In general, research studies involving multiple institutions should be overseen by a single Institutional Review Board.
- 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).
- Researchers involved in low-risk studies (e.g., non-clinical research, benign behavioral interventions, consumer preference surveys) may be exempt from institutional review board oversight.
Sources
https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html
https://en.wikipedia.org/wiki/Common_Rule
https://news.aamc.org/research/article/5-things-you-need-know-about-revised-common-rule/
[1] ClinicalTrials.gov
ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world
