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Announcements

ORIC has received a high volume of calls from Vidant ePIRATE users reporting they are not receiving notifications from ePIRATE. This seems to be the case particularly for new Vidant users who are registering in ePIRATE for the first time. We believe this is due to a recent roll out of a new spam filter by Vidant IT. Some callers have been able to find the notifications in their email spam folder. It is likely that the current Vidant spam filter does not recognize umcirb@ecu.edu as a safe email address therefore is segregating it. If you believe you are not receiving ePIRATE notifications and should be, please check your email spam folder. In addition, you may wish to call Vidant's IT support office to inquire whether or not they can mark umcirb@ecu.edu as a safe email address therefore allowing the email to pass through to you. 
Effective October 1, 2017, the NIH began automatically issuing CoCs to all ongoing or new research funded by the NIH as of December 13, 2016 that is collecting or using identifiable, sensitive information. NIH awardees no longer have to apply for a CoC. Language to include in consent documents have been added to the consent templates on the UMCIRB's website. More information about CoCs can be found on the NIH website.
The following UMCIRB informed consent templates have been revised:
Consent Letter for Expedited Survey Research v. 02.05.18
Consent for More than Minimal Risk Research v. 02.16.18
Consent for No More than Minimal Risk Research v. 02.05.18
Genetic Testing Addendum v. 02.05.18
Language for Use in a Sponsor's Consent Template v. 02.05.18
Parent Permission Form Template: No More than Minimal Risk Research v. 02.05.18

Please begin using these templates immediately and discard any old templates you may have stored on your desktop. 

The revisions involve primarily changes to Vidant Health contact information and minor grammatical/editorial changes as needed. These revised templates can be found on our website as well as in ePIRATE. 

 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 umcirb@ecu.edu.

  • 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 July 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 July 19, 2018 will be reviewed under the revised Common Rule. Currently approved studies will continue to fall under the pre-2018 Common Rule requirements. 
  • The revisions to the Common Rule go into effect July 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 07.19.18. 
  • Revised SOPs will be posted on the UMCIRB website. 
  • Existing expedited studies approved prior to January 19, 2018 will continue to follow pre-2018 requirements including required renewal at least annually. Upon request by the investigator and after discussion with ORIC, an existing study may be revised to meet the new federal requirements. An amendment would need to be submitted and approved within the electronic IRB submission system to document this transition.  
  • 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.

  • 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.