Policies & Procedures
office for research protections
Update on the Final Rule and Introduction of the BC IRB Flexibility Policy
Update on the Final Rule
The Final Rule (a change in the regulations governing IRB activities, called the Common Rule) was initially slated to go into effect in January 2018, but its implementation was delayed just before the official-roll out and postponed until July 18th, 2018. On June 19th, U.S. Department of Health and Human Services released a notice delaying the implementation of the Final Rule once again until January 21st, 2019, while allowing institutions to implement, at their discretion, three of the burden-reducing provisions of the Final Rule beginning on July 19th for all new studies. These provisions include:
· Use of the revised definition of “research,” which deems four categories of activities as not research (certain journalistic, public health surveillance, and criminal justice or intelligence activities)
· Eliminating continuing review for expedited studies and any full board studies that are in the Data Analysis Only phase
· Eliminating the requirement for IRB review of grant applications for research
Boston College will adopt these provisions for all new studies submitted on or after July 19th, 2018, regardless of funding source.
Additionally, institutions have some options for handling ongoing studies that were approved before July 19th, 2018. For example, they can continue to treat them under the “old rules” that were previously applied, wait until January 21st, 2019 to apply any changes, or begin to implement the burden-reducing provisions on July 19th, 2018.
We have decided that all existing expedited Boston College studies (submitted before July 19th, 2018), will undergo one final continuing review, after which they will no longer require continuing review in subsequent years, unless the IRB determines on a case-by-case basis that they require additional monitoring (due to the risk profile of the protocol).
New Boston College IRB Flexibility Policy
The Office for Research Protections at Boston College engaged in a benchmarking process over the past few months to see how our IRB’s policies matched up against those of some peer institutions. At BC, a small proportion of our active IRB protocols are federally funded, which are the only protocols that must follow the federal regulations (the Final Rule). As an institution that has never “checked the box” on our Federal Wide Assurance with the Federal Office for Human Research Protections, Boston College has flexibility in how to treat our non-federally funded protocols. To date, the Boston College Office for Research Protections has chosen to treat all federally funded protocols in the same way as all other protocols, i.e., federal guidelines have been applied to all protocols.
In general, the fact that BC has chosen to treat all projects as if they were federally funded is burdensome for researchers. In response, we have decided to implement a more flexible set of IRB policies to be applied to all non-federally funded research protocols, launching on July 19th, 2018.
What is changing under the BC IRB Flexibility Policy?
We plan to incorporate a number of changes proposed in the Final Rule and apply them to all non-federally funded studies, including:
Broadening existing categories of exempt research
o The existing categories of surveys, interviews, educational tests, observations of public behavior (already exempt) will be expanded to include the collection of some kinds of sensitive and identifiable data. However, the following are still not allowed: interventions that do not fall into the definition of “benign behavioral intervention” (see below); the collection of biospecimens; linking to other personally-identifiable data; and research with children (except for educational tests)
o The scope of secondary data research (already exempt) will be expanded to allow: maintenance of identifiers if all study data is protected health information (PHI), and prospective data review (meaning data do not need to be “on the shelf” at the time of the study, as required pre-2018).
Implementing a new category of exempt research
o The new “benign behavioral intervention” category permits data collection via an interaction (e.g., survey, interview, audio/visual recording) from adult subjects with prospective agreement. A “benign behavioral intervention” is defined as one that is brief in duration, harmless, not physically invasive, painless, not embarrassing or offensive, and not likely to have a lasting adverse impact. Example: having subjects solve puzzles under various noise conditions.
o However, the following are not included in this exempt category: research with children, deception, physiological data collection methods, linking to additional personally-identifiable data
Implementing minor changes to informed consent
o These are already implemented on our consent templates on the ORP website
Eliminating continuing review for most new studies
o Research that qualifies for expedited review will typically not need annual continuing review
o Studies in the Data Analysis Only phase will typically not need annual continuing review
o In rare cases, the IRB may require continuing review due to the risk profile of a protocol
o In the place of continuing reviews, we have developed a Quality Assurance Program which is detailed here.
Additionally, the Department Chair’s signature will no longer be required for protocol submission. The Department Chair will still receive notification of all submissions, but will not need to log into Cyber to electronically sign them. We expect this change to reduce delays in the submission process.
Please note that the amendment process for staff changes or any other protocol alteration has NOT changed.
We are excited about these changes and expect the new Flexibility Policy to reduce the administrative burden associated with research involving human subjects. As always, please contact us at any time with questions or feedback, and feel free to visit us during office hours or make an appointment with our staff.