The federal government has revised its Common Rule, a 2005 policy for the protection of human subjects who participate in federally funded research. The revisions are being incorporated into the regulatory provisions of 16 federal agencies and will become effective January 19, 2018, except for a provision covering cooperative research, which takes effect January 20, 2020. Agencies subject to the revisions include the EPA, the Departments of Energy, Homeland Security, Transportation, Health and Human Services, and the National Science Foundation.
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Protection of People and Information
One of the major goals of the revisions is to bring the Common Rule up to date with current research practices involving human subjects. The agencies describe the need for the revisions as follows:
“Evolving technologies—including imaging, mobile technologies, and the growth in computing power—have changed the scale and nature of information collected in many disciplines. The sheer volume of data that can be generated in research, the ease with which it can be shared, and the ways in which it can be used to identify individuals were simply not possible, or even imaginable, when the Common Rule was first adopted. Biospecimen repositories and large databases have made it easier to do research on existing (stored) biospecimens and data.
“At the same time, the level of public engagement in the research enterprise has changed. More people want to play an active role in research, particularly related to health. As technology evolves, so does the nature of the risks and benefits of participating in certain types of research. Many studies do not involve interaction with research subjects, but instead involve secondary analysis of data or biospecimens. Risks related to these types of research studies are largely informational, not physical; that is, harms could result primarily from the inappropriate disclosure of information and not from the research interventions themselves. Nonetheless, those harms can be significant.”
Improved Consent Forms
One of the key changes involves consent forms. The final rule will now generally expect consent forms to include a concise explanation—at the beginning of the document—of the key information that would be most important to individuals contemplating participation in a particular study, including the purpose of the research, the risks and benefits, and appropriate alternative treatments that might be beneficial to the prospective subject.
Other changes include:
- Allowing the use of broad consent (i.e., seeking prospective consent to unspecified future research) from a subject for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens.
- Establishment of new exempt categories of research based on their risk profile. Under some of the new categories, exempt research would be required to undergo limited review by an institutional review board (IRB) to ensure that there are adequate privacy safeguards for identifiable private information and identifiable biospecimens.
- Removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects.
- A requirement that consent forms for certain federally funded clinical trials be posted on a public website.
Nonfederally Funded Clinical Trials
The final rule differs in significant ways from the agencies’ September 2015 proposal. Proposed provisions that were not finalized include a requirement that research involving nonidentified biospecimens be subject to the Common Rule and a requirement that consent would need to be obtained to conduct research to cover clinical trials not federally funded.
The revised Common Rule was published in the January 19, 2017, FR.