Editor’s Note: After over five years of discussion from the advance notice of proposed rulemaking and two implementation delays, it appears that changes to the Common Rule regulations overseeing human subjects research (45 CFR 46) are finally set to go into effect Jan. 21. Heather Cathrall, MBE, CIP, assistant director of Institutional Review Board (IRB) Operations at Children’s Hospital of Philadelphia, explains what researchers need to know about the revised Common Rule. Protecting human participants in biomedical research is a top priority at CHOP Research Institute, and the IRB team is revising its electronic IRB system, standard operating procedures, templates, and webpage to comply with these new regulations. Also, the IRB is leading a series of trainings for CHOP investigators, study staff, IRB members, and IRB staff. All researchers should work directly with their local institutions and IRBs to prepare for the revamped Common Rule provisions that modernize protections for human participants.
The Common Rule regulations overseeing human subjects research (45 CFR 46) have not had any major revisions since 1991. However, the research landscape has changed greatly in the past 28 years, in light of advances in science and technology. Today’s research involves combining big data sets, registries and repositories, genomic studies, social media research, and a rise in multi-institutional collaborative projects. To help modernize the regulations and to decrease administrative burden, the federal government has been working on revising the Common Rule.
The main changes to the revised Common Rule include updates to categories of research which qualify for exempt review, informed consent requirements, continuing review requirements, and single IRB review for multi-center studies. For exempt research, researchers should take note of two primary changes:
- A new exempt category covers studies involving benign behavioral interventions with adults (e.g. interventions which are brief, harmless, painless, not invasive, not offensive, not embarrassing, and not likely to have a significant adverse lasting impact on the subjects)
- An expanded exempt category No. 4 includes prospective research on secondary data, even if the data is linked to identifiers. This means that chart-review studies, which under the previous regulations required expedited review, could now be exempt.
The main updates to informed consent include a required “concise summary” at the beginning of the consent form that includes the main information a prospective subject would want to know. Additional elements of consent are also required related to future use of non-readily identifiable data, whether the research will involve whole genome sequencing, whether biospecimens may be used for commercial profit and, if so, whether subjects will share in the profit, and whether clinical results will be returned to subjects.
In addition, there is a new requirement that for clinical trials: a copy of an approved consent form must be posted to a “publicly available, federal website” after the last subject is recruited. Another change to help facilitate research is that certain recruitment efforts, such as simply asking subjects questions to gain eligibility, will no longer require a screening consent in the future.
Another change to reduce administrative burden is that continuing review of non-FDA regulated federally funded minimal risk studies is no longer required. While CHOP still has an obligation to know what research is ongoing, this will be met by a one- or two-question prompt that the principal investigator will complete every two years from their last submission asking if they are still conducting human subjects research for the study. If human subjects research is being conducted, then they will have another two years until an update is requested. If not, the study will be automatically closed. This two-year check-in will be required for both expedited and exempt research reviewed under the revised regulations.
The revised Common Rule also expands the requirement for single-IRB review to all multi-center federally funded studies. This means that when the same study is conducted at multiple sites, one IRB needs to be chosen to provide the regulatory review for all sites. Each institution will still retain institutional responsibilities (such as investigator training and ancillary reviews). At CHOP, a brief submission in the electronic system is required if CHOP is engaged in the research, even if the study will be reviewed by an outside IRB.
These regulatory changes will affect all federally funded research studies reviewed and approved after Jan. 21, 2019, as well as non-federally funded studies where CHOP has decided to apply similar human subjects protections. For existing studies at CHOP, most will be converted to the updated Common Rule regulations at the time of next review — for example, with an upcoming amendment or continuing review — however, the decision to apply the new regulations can be discussed on a case-by-case basis depending on the study.
The regulatory changes must be applied in an all or none fashion. In order to request to not have to submit continuing reviews, all other updates such as informed consent requirements need to be made. Please note that any CHOP study which has an expiration date must still submit their next continuing review prior to expiration. If the new regulations are applied to a study, then no expiration date will be given from the IRB.
A long and distinguished tradition of research has positioned CHOP Research Institute as a world-renowned pediatric research center. We will continue to uphold excellence in research by ensuring that we protect the rights and welfare of the patients and families who volunteer to participate in our innovative and pioneering studies.
Find out more details about these Common Rule changes by visiting the Federal Register’s website. CHOP researchers are invited to join a combined Research Affinity Group event hosted by the Qualitative Methods, Health & Behavior; Clinical Trials; and Global Health RAGs Friday, Jan. 11, in the Roberts Center for Pediatric Research, conference room 1120 AB from 11 a.m. to 12:30 p.m., where I will review the changes and be available for questions.