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The MedStar Health Research Institute (MHRI) Office of Research Integrity (ORI) would like to provide some details on recent changes to the Common Rule and how it may affect you.
The U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule on January 18, 2017, to update regulations that safeguard individuals who participate in research. Most provisions of the new rule will go into effect on January 19, 2018.
What is the Common Rule and Why Should I Care?
Regulations that govern institutional review boards (IRBs) and human subjects research is often referred to as the “Common Rule” because they were adopted by the HHS and 15 other federal agencies. Changes to the Common Rule will affect how IRBs, including the MHRI IRB, will operate. These changes also affect investigators who conduct research with human subjects.
Why Was this Done?
The Revised Common Rule represents the first systematic reform to the Common Rule since its promulgation in 1991. These regulations were developed at a time when the research was conducted predominantly at universities and medical institutions, and each study generally took place at a single site. Since then, the research enterprise has changed dramatically. Research involving human participants has grown in scale and become more diverse and the data have become digital.
To address these changes, the HHS undertook a nearly decade-long process to overhaul and update the Common Rule. Goals of the Revised Final Rule include the following:
- To more thoroughly address broader types of research issues, such as behavioral and social science research.
- To harmonize human subject policies across federal departments and agencies.
- To improve the oversight system to reduce unnecessary regulatory burden and enhance protections for research participants, particularly for low-risk studies.
What are the Key Changes to the Revised Common Rule?
Important elements in the final rule include the following:
- To require, in many cases, use of a single IRB for multi-institutional research studies. This change mirrors recent changes to NIH policy for single IRB review of multi-site research.
- To authorizes Common Rule departments and agencies to enforce the Common Rule against independent IRBs. It is expected that this change will ease liability concerns of institutions that rely on independent IRBs, because HHS can now direct its enforcement action against an independent IRB for noncompliance. This change likely will increase the use of commercial, independent IRBs, consistent with both industry and National Institutes of Health policy.
- To require consent forms to provide potential research subjects with a better understanding of a project’s scope, including its risks and benefits, so they can make a more fully informed decision about whether to participate.
- To allow researchers the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement for studies on stored identifiable data or identifiable biospecimens. As under the current rule, researchers will not have to obtain consent for studies on unidentified stored data or biospecimens.
- To establish new exempt categories of research based on the level of risk they pose to participants. For example, to reduce unnecessary regulatory burden and allow IRBs to focus attention on higher risk studies, there is a new exemption for secondary research involving identifiable private information if the research is regulated by and participants are protected under the HIPAA rules.
- To remove the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects.
- To require that consent forms for certain federally funded clinical trials be posted on a public website.
What is the MRHI ORI Doing to Prepare for These Changes?
Changes to prepare for the January 19, 2018, compliance date are underway. The 2018 Requirements have been reviewed in detail and the changes have been classified as easy, medium, hard and those that can be implemented now (before January 19, 2018, compliance date) and later (after January 19, 2018).
Whether a policy or procedure has been updated to reflect the 2018 requirements can be identified from the reference section of the policy, which will include (1/19/2017) after the regulation citation to indicate its compliance with the Revised Common Rule.
During July, August and September, our changes have focused on updating policies/procedures that affect only the internal operations of the IRB and can be implemented now. Intensive planning for the 2018 requirements to be implemented by January 19, 2018, will begin in October.
Where can I get more information about these upcoming changes?
Stay tuned. From now until January, regular announcements and training opportunities will be presented as various elements of the 2018 Requirements are implemented.
Come Join Us. Training sessions will be provided for various key topics between now and January. Additional information on these sessions will be forthcoming.
Keep Communications Open. If you have any questions, please do not hesitate to contact MHRI's Office of Research Integrity at MHRI-ORIHelpDesk@MedStar.net.