- Changes to the federal rule governing human research (Common Rule) were announced on January 18, 2017. Many of the Common Rule changes go into effect January 19, 2018.
- The changes to the Common Rule do not apply to FDA-regulated studies.
- ORIC is working to roll out these changes at ECU. The announcements section of the ORIC > UMCIRB webpage and the ePIRATE homepage will be your main source of information and updates about the revised Common Rule roll out.
- Studies submitted on or after January 19, 2018 will be reviewed under the revised Common Rule. We are currently evaluating whether the changes will apply to studies existing prior to January 19, 2018.
- The definition of "human subject" has been altered to now include identifiable biospecimens. Identifiable biospecimens and identifiable private data are treated the same in the final rule.
- Consent forms will need to include an introductory paragraph which provides a clear and easy to understand summary of the key information that will be helpful to a potential participant or their legally authorized representative in the understanding of reasons why they might or might not want to take part in the research.
- Overall, there are four new elements of informed consent; one new required element and three new optional (i.e."if applicable") elements. These new elements are generally related to the secondary use of data and samples and genomic research.
- The revisions to the Common Rule broaden the types of research that can be reviewed under the exempt categories. For example, secondary research involving identifiable private information that is protected by HIPAA can be reviewed under an exempt category; currently this type of research requires review under an expedited category. As has always been the case at ECU, only the IRB may determine what research may be reviewed under the exempt categories.
- Some minimal risk studies will no longer be required to undergo annual continuing review.
- Changes to the Common Rule mandate the use of a single IRB for multisite, cooperative studies. This requirement will be effective January 19, 2020.
- The revisions to the Common Rule go into effect January 19, 2018 and UMCIRB will begin reviewing new studies under the revised Common Rule on that date.
- New document templates will be posted on both the UMCIRB website and within ePIRATE. Be sure to use these new templates for any new research studies submitted on or after 01.19.18.
- Revised SOPs will be posted on the UMCIRB website.
- For existing studies; ORIC is evaluating whether the changes will apply to these studies after the effective date.
- Keep our website and the ePIRATE homepage checked for continuing and updated information.
- Contact UMCIRB with any questions. You are welcome to email us at UMCIRB@ecu.edu.
- Remember, the revised Common Rule does not apply to FDA-regulated studies.
Good Clinical Practice (GCP) Training for
NIH-Funded Clinical Trials
Good 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:
- This Policy applies to
investigators and clinical trial staff who are responsible for the
conduct, management and oversight of NIH-funded clinical trials.
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.
GCP Training for Clinical Trials Involving Drugs, Biologics and Devices
Link to the CITI Online Course - http://www.citiprogram.org/
GCP Training for Social Behavioral Research
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:
- CITI Program - GCP for Clinical Trials with Investigational Drugs, Biologics and Devices - Basic Course - for NIH-funded research involving drugs, biologics and/or devices.
- SBM eLearning Course - GCP for Social Behavioral Research - GCP training that is more relevant to the Social and Behavioral Researcher PI and other key personnel involved in all new and ongoing clinical trials.
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.