Common Rule Changes - OHRP DELAYS Effective Date and General Compliance Date - New Effective Date - 07.19.18
- 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.
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.
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.
Investigators & Coordinators
- Fundamental Information for New Investigators and Key Research Personnel
- Glossary of Lay Terms
- Consent Elements
- Expedited & Exempt Categories
- Criteria for IRB Approval of Research
- Fast Fact Sheet
- UMCIRB Quick Start Reference Guide for Investigators
- Fee Schedule
- Guidelines to Waive Consent for Emergency
- Protocol Template
- Storing Research Data
Other ECU Links Related to Human Research
- Brody School of Medicine – Clinical Trials Office
- REDCap - a secure, HIPAA-compliant, web-based application for building and managing online research surveys and databases.
- ECU - Survey Review & Oversight Committee - a committee established to oversee scheduling of surveys with less overlap; avoid duplication of data collection efforts improve the quality of surveys with an overarching, goal of preventing "survey fatigue" on the ECU campus. Please visit the SROC web site if your research involves surveying ECU faculty, staff, or students.
- Institutional Biological Safety Committee (IBC) – The IBC is the core of the biosafety program at ECU. Any research project that involves the use of potentially infectious materials must be declared and registered with the IBC. This also includes projects involving gene therapy. The IBC reviews the protocols and ensures that the materials are handled properly and that appropriate training takes place. Biological safety specific training is also offered for blood borne pathogens, infectious materials shipping, and biological safety cabinet use.
- Identity Theft Protection Committee (ITPC) - In order to implement and ensure compliance with legal requirements governing SSNs and PII, ECU established the Identity Theft Protection Committee (ITPC) to oversee ECU's compliance with this regulation in regard to the collection, segregation, disclosure and security of SSNs and PII and the development of related policies/regulations.
The ITPC is also responsible for approving the collection and use of SSNs and PII.
Questions concerning the requirements of this regulation should be directed to the Identity Theft Protection Committee (ITPC) at ITPC@ecu.edu
- Clinical Information Steering Committee - The Clinical Information Steering (CIS) Committee oversees the adoption and use of healthcare-related information technologies. CIS's partnership with ITCS provides a uniform process for the Brody School of Medicine, ECU School of Dental Medicine, ECU Allied Health, ECU College of Nursing and ECU Physicians to request and receive guidance in the selection, development and implementation of hardware, software systems, databases and third party IT services that support clinical research and operations for the purposes of assuring compatibility with existing East Carolina University and Vidant Health healthcare-related information technology systems, promoting operational efficiency, limiting storage of patient information outside of the university's designated Electronic Health Record (EHR) system(s), and ensuring both patient and university data are protected within the scope of applicable university policies, government regulations and state laws.
Research Ethics, History and International Protections
- Nuremburg Code
- The Belmont Report - Ethical principles and guidelines for the protection of human participants of research.
- The Declaration of Helsinki
- OHRP International Compilation of Human Research Standards – a listing of the laws, regulations, and guidelines that govern human participant research in countries around the world.
- Presidential Commission for the Study of Bioethical Issues—Researcher Primer: Incidental and Secondary Findings
- OHRP Website
- Food & Drug Administration (FDA)
- FDA – Warning Letters
- 21CFR50 – FDA regulations for protection of human participants
- 21CFR56 - FDA regulations governing IRBs
- FDA Information Sheets: Guidance for IRBs, and Clinical Investigators and Sponsors
- FDA Guidance on Adverse Event Reporting to IRBs
- FDA Guidance on IND Safety Reports
- Investigational Device Exemption (IDE)
- FAQs about Medical Devices
- NIH Website
- Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule
- Institutional Review Boards and the HIPAA Privacy Rule
- NIH FAQs: HIPAA Privacy Rule for Researchers
- ClinicalTrials.gov – a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.
- Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials
- Centers for Disease Control and Prevention (CDC)
- U.S. Department of Education
- Department of Health and Human Services (DHHS)
- Office for Civil Rights - HIPAA
- Office of Research Integrity
- Public Responsibility in Medicine & Research (PRIM&R) - Group dedicated to the education of the public on the conduct of ethical research.
- Association for Clinical Research Professionals (ACRP) - Organization dealing with ethical practice, regulations and policies regarding research and clinical practice
- American Society of Bioethics and Humanities - Group fostering communication and learning in the area of bioethics and humanities
- American Medical Association (AMA) - Information regarding health and learning resources