NIH Grant Recipients: A new NIH Human Subjects System (HSS) will replace the current NIH Inclusion Management System (IMS) for the reporting of data about human subjects and clinical trials. NIH will launch this new system on June 9, 2018 and it will be available within the eRA Commons site. More information can be found here.
The National Institutes of Health (NIH) Policy on the use of a single Institutional Review Board (sIRB) of record for multi-site research became effective January 25, 2018. This policy establishes the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the NIH will use a single Institutional Review Board (sIRB) to conduct the ethical review required by the Department of Health and Human Services regulations 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, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. It does not apply to career development, research training or fellowship awards.
This policy applies to domestic awardees and participating domestic sites. Foreign sites participating in NIH-funded, multi-site studies will not be expected to follow this policy.
Investigators are encouraged to consult with the Office of Research Integrity and Compliance (ORIC) prior to including an sIRB plan in their application if they have questions about whether or not ECU should cede IRB review to another IRB or assume the responsibility of being the IRB of record (Reviewing IRB).
You may review the NIH posting regarding sIRB review by clicking here.
If you have additional questions about the sIRB review process or IRB reliance agreements, please call the ORIC at 252-744-2914, or email your question to firstname.lastname@example.org.
Clinical Practice (GCP) is the international ethical and scientific
standard expected in the design, conduct, performance, monitoring,
auditing, recording, analysis, and reporting of clinical trials.
Compliance with GCP provides assurance that data are reported, results
are credible and accurate, and that the rights, safety, confidentiality,
and well-being of trial participants are protected.
NIH has issued a policy on Good Clinical Practice training for NIH Awardees involved in NIH-funded clinical trials. This policy requires that PIs and clinical trial staff involved in all new and ongoing NIH-defined clinical trials
complete Good Clinical Practice (GCP) training by January 1, 2017. GCP
principles help assure the safety, integrity, and quality of clinical
trials by addressing elements related to trial design, conduct, and
reporting. GCP training is in addition to, and different from, Human
Subject Protection training, which is required by the UMCIRB. Some
specifics about the policy:
Link to the CITI Online Course - http://www.citiprogram.org/
Link to the Society of Behavioral Medicine (SBM) Online Course - http://www.sbm.org/training/good-clinical-practice-for-social-and-behavioral-research-elearning-course
All key research personnel involved in NIH-funded clinical trials are
expected to document the completion of GCP training. Key research
personnel include principal investigators, sub-investigators, research
coordinators, and any other research team members who are involved in
the design, conduct, or reporting of clinical trials involving human
Select the following course applicable to the research in which you are involved to satisfy the requirement for GCP training:
For new NIH-funded clinical trials, you must provide documentation of
training completion as part of the Just-in-Time process. It is not yet
clear how NIH will implement this requirement for ongoing awards. The
new NIH policy requires GCP training be refreshed every three years in
order to remain current with regulations, standards and guidelines.
This will depend on your experience with human research issues. Most
modules will take about 10-20 minutes to complete. Researchers familiar
with these topics may require three hours or less to complete all of the
required modules. You do not have to complete all the modules at once.
Both the CITI and SMB training sites are designed for you to work at
your own pace, and allow you to exit and return at a later date to where
you left off.
The required passing score if you are taking the CITI modules is 70%.
The score is based on the overall score from all the required modules.
You may check your grade by selecting the grade book link on the welcome
page or at the end of the course. If you do not pass, you can return to
the modules and re-take the quizzes.
The required passing score if you are taking the SBM modules is 100% (this has been set by the Society for Behavioral Medicine who sponsors/administers the training site). If you do not pass the quizzes with a score of 100% you will be given the option to retake the quizzes until you score 100%.
If you are a new faculty, staff or student at ECU and have completed the
same GCP CITI training modules at another institution within the last
three years, you may log into the CITI site with the CITI username and
password you created when you registered to use CITI and you may choose
to "affiliate with another institution". When you do this, select East
Carolina University. If you have completed the SBM modules within the
last three years at another institution you should upload a copy of the
certification of completion in your ePIRATE profile.
If you have successfully completed GCP training through another site
within the past three years we will accept this training. When you
update your ePIRATE profile with your GCP training information please
upload a copy of the certificate of completion.
To make full use of the features of the CITI site, and to do so
securely, use a current browser version when accessing CITI Program. The
vast majority of browsers made available within the last 3-4 years will
support all CITI Program features. Older versions may not, as they are
often less secure and provide less functionality.
Individual users who are taking the CITI or SBM GCP training as required by NIH are not assessed a fee for the training.
You may contact ORIC at 252-744-2914 or contact us via email at UMCIRB@ecu.edu.