THE IMPLEMENTATION AND EFFECTIVE DATE OF THE NEW “COMMON RULE” DELAYED
The date on which the changes of the Common Rule where to take effect (July 19, 2018) has been pushed back an additional 6 months to January 21, 2019. This delay was prompted by requests from 16 federal agencies. The details of the request and the decision are detailed in the announcement entitled, “Federal Policy for the Protection of Human Subjects: Six Month Delay of the General Compliance Dateof Revisions While Allowing the Use of Three Burden Reducing Provisions During the Delay Period."
What does this mean for you? Nothing will be changing for UCSB investigators during this six month period, however effective January 21, 2019 you will see slight changes to the online application system ORahs to meet the new Common Rule requirements.
We will keep you updated on changes to ORahs as the implementation date nears.
NIH’S SINGLE IRB (SIRB) POLICY FOR MULTI-SITE RESEARCH
This new policy takes effect for all NIH competing grant applications with due dates on or after January 25, 2018. This policy covers all studies that are wholly or partially funded by the NIH.
The NIH’s sIRB policy applies to grant applications that involve multiple domestic sites where each site will conduct the same research protocol involving non-exempt human subject research. This means if the research protocol that would be submitted to each of the individual sites’ IRB in the past is essentially the same, you now need to use a sIRB for these domestic sites.
The NIH excludes foreign sites and career (K), institutional training (T), and fellowship (F) awards from this requirement.
Additionally, the NIH allows for limited exceptions:
- Sites for which federal, state, or tribal laws, regulations or policies require local IRB review; and
- Other exceptions may be considered by the NIH based on “compelling justification”. These types of exceptions must be reviewed and approved by the NIH. These will not be granted often.
If you have questions about the exceptions, please contact the NIH Program Officer for her/his input.
In order to help facilitate the process, the Office of Research (O.R.) is adding a new question to the proposal Data Sheet to capture whether a research project will need to utilize a sIRB for a NIH proposal containing human subjects research. Additionally, the researcher will need to address this in her/his application on the new FORM-E.
The reason O.R. is trying to capture this up front is because setting up a sIRB may be very time consuming - the more sites, the more complicated it becomes.
We urge you to reach out to the Human Subject staff (email@example.com) with any questions about this policy. This may be complicated and the sooner OR staff can start developing a plan, the sooner the researcher will get the funds for the study if awarded.
For more information, please visit the NIH website that describes the sIRB policy.
NIH PUBLISHES NEW CERTIFICATE OF CONFIDENTIALITY POLICY
In order to comply with Section 2012 of the 21st Century Cures Act, P.L. 114-255, the NIH has released a new policy on issuing Certificates of Confidentiality (CoC) - NOT-OD-17-109. Implementation of this policy begins October 1, 2017.
In the past, if you wanted to protect identifiable, sensitive information collected in the course of your human subject research project, you had to apply to the NIH for a Certificate of Confidentiality. This is no longer necessary in most cases.
If your research is NIH-funded (in part or in whole) and the research project meets certain criteria, your project is automatically granted a CoC. HSC staff will be developing language to be used in consent forms moving forward.
To determine if this Policy applies to your NIH-supported research, you first need to answer the following question:
- Is the activity biomedical, behavioral, clinical, or other research?
If the answer to this question is “No”, then the activity is not issued a CoC. If the answer is “Yes”, then you need to answer the following questions:
- Does the research involve Human Subjects as defined by 45 CFR Part 46?
- Are you collecting or using biospecimens that are identifiable to an individual as part of the research?
- If collecting or using biospecimens as part of the research, is there a small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual?
- Does the research involve the generation of individual level, human genomic data?
If you answer “Yes” to any of the questions above, your research project is automatically covered by a CoC.
CoC and non-federally funded human subjects research
For non-federally funded research, you may still apply to the NIH for a CoC. In this case, you will need follow the previous application procedure.
Please contact us with any questions concerning this new policy.
NIH’S EXPANDED DEFINITION OF “CLINICAL TRIAL” AND NEW PROCEDURES
Several years ago, the NIH revised their definition of “clinical trial” (NOT-OD-15-015) to the following:
“A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”
More information on this revised definition, including a tool to determine whether a particular project qualifies as a clinical trial, can be found here.
Recently, the NIH has started a big push to address several concerns they have regarding the reproducibility, transparency, and timely reporting of results of their funded trials.
The following timeline outlines the steps that the NIH has and is taken to address their concerns:
January 1, 2017 - All NIH-funded clinical investigators and clinical trial staff involved in the design, conduct, oversight, or management of clinical trials are required to be trained in Good Clinical Practice.
January 18, 2017 - All NIH-funded clinical trials are expected to register and submit results information to Clinicaltrials.gov. See NOT-OD-16-149
January 25, 2018 – All NIH applications proposing research that meets the definition of clinical trials must be submitted through a funding opportunity announcement (FOA) designated specifically for clinical trials.
January 25, 2018 – In concert with the above requirement, a new Human Subjects and Clinical Trial Information form (Form-E) will be required for all human subjects and/or clinical trial research. This is an expanded form that tries to capture more information about the proposed human subject research.
For some, these requirements will be seen as a slight change in how you fill out your NIH application and add new required training. However, for others, especially researchers who have been performing human subjects research which the NIH now defines as a clinical trial (e.g., those in the fields of social and behavioral science), these requirements are a marked change.
To help out during this time, UCSB’s Sponsored Projects Office and Human Subject research program staff will be reaching out to our researchers to best help minimize the burden that these new requirements may impose.
The NIH’s main page for these changes is quite informative, and we suggest you go and look it over - Clinical Trial Requirements for Grants and Contracts.
Additionally, you should reach out to your NIH Program Officer to seek guidance on whether s/he thinks your project falls under the revised definition of clinical trial. Talking to the PO is a great way to voice your concerns about these new requirements.
We will update this site with information as it becomes available.
If you have any concerns, please reach out and contact us. We are here to help.
FINALLY, THE REVISED “COMMON RULE”
Note: The implemention date has been pushed back to January 21, 2019.
The revised Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in the Federal Register on January 19, 2017. The final rule is supposed to go into effect starting January 21, 2019.
While waiting for the official start date to be announced, we will summarize some of the biggest areas that may affect you.
New and expanded “Exempt” research categories – Previously exempt research categories will remain and additional categories will be added to the list. Under some of the new categories, exemptresearch would still be required to undergo Limited IRB review. The determination of whether a study is eligible for exemption will still be made by the IRB.
Annual review of certain low-risk research no longer required – For certain types of low-risk research, annual IRB review will no longer be required. All modifications still will require review.
Mandated Single IRB (sIRB) - The implementation date of this requirement is not expected until 2020. This requirement is separate from the NIH’s sIRB requirement which has an implementation date of 2018. This regulation allows federal agencies to require single IRB review on human subject research projects. However, it also allows any federal agency to waive the requirement if they so choose.
Overall, the revised Common Rule appears to have reduced some the administrative burden associated with human subjects research, without compromising the safety and well-being of the human research participants.
We will be updating ORahs to deal with the new Exempt categories and develop a process to capture the fact that annual review will no longer be required for many protocols moving forward.
We will update this site with new information as it comes available.