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Announcements

  • 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. 
Users will now select "Final Report" on the left side of each study's workspace to close a research study. This option was added to help users navigate to the correct application more easily when they are ready to close a study. Brief tutorials have also been added to the website.
The short form consent (both the English and Spanish versions) has been updated. The new version date for the short form is 10/09/2017. In addition, an attestation of translation has been obtained for the Spanish translated version of the short form and is available on the UMCIRB website under "Forms, Docs & Templates". Please be sure to use this new template when submitting a short form for IRB review and approval.

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.

  • 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.

 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 participants.

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.
If you are involved in biological, drug or device research as well as social and behavioral research you are required to complete the CITI GCP training. If you have taken the CITI GCP training for biologics/drugs and devices you do not have to take the additional social and behavioral GCP training if you are involved in social/behavioral research.
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.

 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.

In order to verify successful completion of the required GCP training you must log the completion date in your ePIRATE profile. Click on the following link for instructions How to Add Your IRB Training Completion Date to Your ePIRATE Profile (PPT). Once a person's CITI or SBM training date is logged in their ePIRATE profile it will be automatically populated in any new study submission received by the UMCIRB. Do not forget to update your ePIRATE profile when you complete the required refresher course every three years.

 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.