ePIRATE
Click the ePIRATE icon to work
on your electronic IRB submission.


Announcements

  • Changes to the federal rule governing human research (Common Rule) were announced on January 18, 2017. Many of the Common Rule changes went into effect January 21, 2019. 
  • The changes to the Common Rule do not apply to FDA-regulated studies. 
  • UMCIRB SOPs, templates, and the ePIRATE electronic IRB submission system have been revised accordingly. 
  • Click on the tab labeled Common Rule Changes in the UMCIRB website for more information about the changes.  
  • Studies submitted on or after January 21, 2019 will be reviewed under the revised Common Rule. Studies approved prior to January 21, 2019 will continue to fall under the pre-2018 Common Rule requirements. 
The following UMCIRB informed consent templates have been revised:
Consent Letter Template for Expedited Survey Research v. 1.21.19
Consent for More than Minimal Risk Research v. 1.21.19
Consent for No More than Minimal Risk Research v. 1.21.19
Genetic Testing Consent Template v. 1.21.19
Language for Use in a Sponsor's Consent Template v. 10.1.18
Parent Permission Form Template: No More than Minimal Risk Research v. 1.21.19

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

The revisions primarily involve changes to consent elements that will be required under the revised regulations, effective January 21, 2019. These revised templates can be found on our website as well as in ePIRATE. 

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.

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 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.

  • The revisions to the Common Rule go into effect January 21, 2019 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 01.21.19. 
  • Revised SOPs will be posted on the UMCIRB website. 
  • Existing expedited studies approved prior to January 21, 2019 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. 

Final Common Rule 

The Revised Common Rule

Click here to read a copy of the revised Common Rule which contains tracked changes. 


New UMCIRB SOP for Applying Common Rule Changes (01.21.19)

Application of Final Common Rule (2018 Requirements): Protection of Human Subjects


UMCIRB Review of the Upcoming Common Rule Revisions 

The UMCIRB staff recently presented an overview of the upcoming Common Rule revisions. The overview consisted of two one-hour Power Point presentations which were video recorded so that investigators, key study personnel and others in the local research community to could view them at their convenience. Click below to view the presentations. Each of the presentations requires a password (provided below) in order to view them. 

Common Rule Revisions Overview - Part 1 (password - Mc3JWPy*) 

  • Understand the revisions to definitions contained in the Common Rule;
  • Understand the new concept of 'Limited Review' and its application; and
  • Understand the changes to the categories of exempt research contained in the revisions to the Common Rule
  • Changes to expedited research contained in the revisions to the Common Rule;
  • Changes related to elements of consent and waiver of consent and documentation of consent;
  • Requirements of new local SOP related to the application of the revised Common Rule;
  • ePIRATE changes related to the revision of the Common Rule


The following table provides a basic summary of the upcoming Common Rule changes:

Revised "Human Subject" Definition
  • The definition of "human subject" has been altered to now include identifiable bio-specimens. Identifiable bio-specimens and identifiable private data are treated the same in the final rule. 
 Informed Consent Changes
  • 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. Click here to view samples of a concise summary introductory paragraph.
  • 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. 
Revised Exempt Categories 
  • 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. 
Continuing Review Requirement Changes
  • Some minimal risk studies will no longer be required to undergo annual continuing review.
Single IRB Requirement for Cooperative Research
  • Changes to the Common Rule mandate the use of a single IRB for multi-site, cooperative studies. This requirement will be effective January 19, 2020. 
 How do these changes affect you?
  • The revisions to the Common Rule go into effect January 21, 2019 and UMCIRB will begin reviewing new studies under the revised Common Rule on that date. 
  • Remember, the revised Common Rule does not apply to FDA-regulated studies.
  • New document templates will be posted on both the UMCIRB website and within ePIRATE. Be sure to use these new templates for any new studies submitted on or after 01.21.19. 
  • Revised SOPs will be posted on the UMCIRB website.
  • Existing expedited studies approved prior to 01.21.19 will continue to follow pre-2018 requirements including required renewal at least annually. Upon request by the investigator and after discussion with UMCIRB office, 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 the UMCIRB 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. 

OHRP Education Links

OHRP Revised Common Rule Q&As

OHRP has developed a list of common questions about the revised Common Rule with answers. These Q&As are being made available to the public as an educational resource. Click here to view the Q&As. 

OHRP Revised Common Rule Videos

OHRP has produced a set of videos to help IRB personnel, researchers and others in the research community learn about and understand the revised Common Rule. These videos are for educational purposes. Please refer to the text of the Common Rule (link above) for a complete and accurate description of the regulatory requirements. Click here for the selection of education videos.