Compliance Updates and Information
Export Control Training Update
It is the policy of USA to fully comply with U.S. export control laws. Therefore, to best facilitate basic understanding and knowledge regarding the subject matter, USA offers an online Export Control training module through CITI (Collaborative Institutional Training Initiative). Completion of training is required for specified users including research faculty in the professions of science and engineering; research administration; human resources; purchasing; and international programs. Additionally, a module designed for students is also available and may be added to any course syllabus as required training.
Training modules have been tailored to best fit each designated target audience. An email was disseminated regarding the training requirement, in addition to posting information in several research newsletters. The ROC was asked to help reminder faculty in their departments to complete the required training. Additionally, ROC members fall within research administration, and should also complete training.
Human Subjects Protection Training
The USA IRB requires human subjects protection training for all persons involved in the conduct of human subjects research. The USA IRB has utilized the NIH Office of Extramural Research training course to fulfill this requirement; however, the government released a notice on August 28th announcing they will no longer offer the online training module.
The IRB is transitioning to the Collaborative Institutional Training Initiative (CITI) platform for completion of the required human subjects training. Two basic courses will be offered, as applicable to scientific disciplines (biomedical vs. non-biomedical). The Office of Research Compliance website, Human Subjects - Training tab, will be updated to reflect these changes.
NSF's New Award Terms and Conditions, Effective October 1, 2018
The final version of NSF’s award term and condition entitled, “Notification Requirements Regarding Findings of Sexual Harassment, Other Forms of Harassment, or Sexual Assault” was published on September 21, 2018 in the Federal Register. A link to this Federal Register notice, as well as other important information regarding this important topic (including Frequently Asked Questions regarding the term and condition), is available at: www.nsf.gov/harassment.
On February 8, 2018, the National Science Foundation released Important Notice No. 144. The notice articulates the Foundation’s policy that it will not tolerate sexual harassment, or any kind of harassments within the agency, at grantee organizations, field sites, or anywhere NSF research is conducted. The notice is a reminder to research community of its obligations to fully investigate complaints of sexual or other harassment and for complying with federal nondiscrimination law.
NSF plans to add a new award term and condition that identifies obligations for awardees and new reporting requirements. A notice and request for comment was published on March 5, 2018 in the Federal Register.
NSF Notice on Harassment
The National Science Foundation has issued Important Notice No. 144: Harassment. NSF is working to make certain NSF’s awardee organizations respond promptly and
appropriately to instances of sexual and all other forms of harassment.
This notice describes a new award term that includes the following new requirements:
- Grantee organizations will be required to report findings of sexual harassment, or any other kind of harassment regarding a PI or co/PI or any other grant personnel.
- Grantees also will be required to report the placement of the PI or co-PI on administrative leave relating to a harassment finding or investigation.
NSF will be soliciting feedback on this term through an announcement in the Federal Register within the next few weeks.
Changes affect National Institutes of Health applications:
- NIH applications submitted on or after January 25, 2018 requires all sites participating
in multi-site studies, which involve non-exempt human subjects research funded by
the NIH, will use a single Institutional Review Board (sIRB) to conduct the ethical
review required for the protection of human subjects. This policy applies to the domestic
sites of NIH-funded multi-site studies where each site will conduct the same protocol
involving non-exempt human subjects research. The requirement does not apply to career
development, research training or fellowship awards.
Applicants must include a plan for the use of a sIRB in the grant application. For more information: Single IRB Policy for Multi-site Research The USA Human Subjects website provides Institutional Policy and Procedures for compliance with the NIH sIRB mandate.
- NIH will require all applications involving one or more clinical trials be submitted
through a Funding Opportunity Announcement (FOA) specifically designed and designated
for clinical trials.
For more information: Reminder: Policy on Funding Opportunity Announcements (FOA) for Clinical Trials Takes Effect January 25, 2018 (NOT-OD-18-106)
- NIH applicants must use FORMS-E application packages for due dates on or after January 25, 2018.
The U.S. Department of Health and Human Services and 15 other federal departments and agencies have announced an Interim Final Rule (IFR) that delays by six months the effective date and general compliance date of the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule) originally published in the Federal Register on January 19, 2017 (82 FR 7149). Most provisions in the revised Common Rule were scheduled to go into effect on January 19, 2018.
The IFR delays the effective date and general compliance date to July 19, 2018, providing regulated entities additional time to prepare to implement these revisions.
Human Subject's Protection: Changes to the Common Rule
The effective date of compliance is set to take effect on January 19, 2008. The previous rule applies to research approved prior to January 19, 2018 and will not transition to the new rule.
See "Changes to the Common Rule" for summary of updates.
The 2017 Final Rule was originally slated to become effective on January 19, 2018, and institutions Required to comply with its new requirements by that same date. However, on January 20, 2017, President Trump issued an executive memorandum freezing all regulations that had been published but were not yet effective.
On October 7, 2017, the Office of Management and Budget (OMB) received a proposal from the Department of Health and Human Services (DHHS) that, by its title, seeks a “1-Year Delay of the General Implementation Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Year.”
Until a formal delay is published by final rulemaking, we will continue to prepare for the implementation to comply with the updated changes by January 19, 2018.
NIH Changes to Certificates of Confidentiality
Effective October 1, 2017, NIH will automatically issue Certificates of Confidentiality to all research funded by NIH that is collecting or using identifiable sensitive information. Additional information can be found on the NIH Certificates of Confidentiality Kiosk at https://humansubjects.nih.gov/coc/NIH-funded. In part, the new policy reads:
"For the purposes of this Policy, consistent with subsection 301(d) of the Public Health Service Act (42 U.S.C 241), the term "identifiable, sensitive information" means information about an individual that is gathered or used during the course of biomedical, behavioral, clinical, or other research.
Consent document wording related to the NIH Certificate of Confidentiality has been provided by NIH consent sample language.
Guidance on Exceptions to the NIH Single IRB Policy
Notice Number: (NOT-OD-18-003) National Institutes of Health
Guidance on Implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
Notice Number: (NOT-OD-18-004) National Institutes of Health
NIH is launching a series of initiatives that are rolling out in 2017-2018 to enhance the accountability and transparency of clinical research. These initiatives target key points along the whole clinical trial lifecycle from concept to results reporting. Learn more about these changes and how they will affect your research.