Investigators and Key Study Personnel Resources

The following resources are available for human research investigators and key study personnel.

General Information

• Fundamental Information for New Investigators and Key Research Personnel (PDF)
• Glossary of Lay Terms (PDF)
• Consent Elements (PDF)
• Expedited and Exempt Categories of Human Research (PDF)
• Criteria for IRB Approval of Human Research (PDF)
• Class Projects versus Human Research: ECU Guidance (PDF)
• Guidelines to Waive Consent for Emergency (Word)
• Protocol Template (PDF)
• Storing Research Data (PDF)
• Procedure for requesting data on East Carolina University students, faculty, or staff to be used in a human research project

Data Use Agreements

• Is an Activity Human Subject Research Requiring IRB Review and Approval? (PDF)
• NIH Information About Limited Data Sets and Data Use Agreements (DUA) (PDF)
• NIH: How Can Covered Entities Use and Disclose PHI for Research and Comply with the Privacy Rule?
  • The contact for DUAs related to grants and contracts is your Sponsored Programs Officer, Research Administration, Office of Research, Economic Development and Engagement.
  • The contact for DUAs related to unfunded research is Becky Welch, Assistant Vice Chancellor for Research Administration and Compliance and Institutional Official, Office of Research, Economic Development and Engagement.
• Local Limited Data Set Policies
  • ECU HIPAA Privacy Policy: Limited Data Set
  • Vidant Health Policy and Procedure: Disclosure of a Limited Data Set (PDF)

Determination Worksheets

• Worksheet: Case Reports Using Existing Data (Word)
• Human Research Determination Worksheet (Word)
• Worksheet: Emergency Use (Word)

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 and Oversight Committee (SROC): ECU’s established committee to oversee scheduling of surveys with less overlap to 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, including gene therapy, must be declared and registered with the IBC. This also includes projects involving gene therapy. The IBC reviews human subject protocols and ensures that 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 social security numbers and personally identifiable information, ECU established the ITPC to oversee the university’s compliance with this regulation in regard to the collection, segregation, disclosure and security of social security numbers and personally identifiable information and the development of related policies and 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 ITPC at ITPC@ecu.edu.
• Clinical Technologies and HIPAA Compliance: The Office of Institutional Integrity (OII), in conjunction with the University healthcare data steward, oversee the adoption and use of healthcare-related information technologies. OII’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, ECU Health and Student Health Services 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 ECU 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.
  The scope of OII and the healthcare data steward is the review of departmental uses of ITCS approved technologies.

  To initiate the purchase and/or implementation (including “free”) of a new technology or upgrade of an existing technology, contact ECU Materials Management or visit ITCS’s Technology Purchase Process webpage https://ecu.teamdynamix.com/TDClient/1409/Portal/Requests/ServiceDet?ID=31689 

  For questions related to ECU’s HIPAA Privacy or Security Rule compliance, please contact the Office of Institutional Integrity:

  Phone: 744-5200
  Email: integritycompliance@ecu.edu

Research Ethics, History and International Protections

• Nuremburg Code (PDF)
• The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Participants of Research
• The Declaration of Helsinki (PDF)
• OHRP International Compilation of Human Research Standards
• Presidential Commission for the Study of Bioethical Issues (PDF)

Government Agencies and Commissions

• Office for Human Research Protections
  • OHRP Policy & Guidance Index Webpage
  • OHRP Mini-Tutorials: Human Subjects Regulations and Policy 
  • OHRP Human Participant Regulations Decision Charts
  • OHRP Clinical Trial Informed Consent Posting Requirements
  • OHRP Informed Consent Checklist
  • Differences between DHHS and FDA
• Food and Drug Administration
  • FDA Warning Letters
  • FDA Regulations for Protection of Human Participants (21CFR50)
  • FDA Regulations Governing IRBs (21CFR56)
  • FDA Information Sheets: Guidance for IRBs, Clinical Investigators and Sponsors
  • FDA Guidance on Adverse Event Reporting to IRBs
  • FDA Guidance on Investigational New Drug (IDN) Safety Reports
  • Investigational Device Exemption
  • FAQs About Medical Devices
• National Institutes of Health
  • NIH Clinical Trial Informed Consent Posting Requirements
  • Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule (PDF)
  • Institutional Review Boards and the HIPAA Privacy Rule
  • NIH FAQs: HIPAA Privacy Rule for Researchers
  • ClinicalTrials.gov
  • Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-Funded Clinical Trials

Other Applicable Websites

• Centers for Disease Control and Prevention
• U.S. Department of Education: Protection of Human Subjects in Research
• U.S. Department of Education: Protecting Student Privacy
• Department of Health and Human Services
• Office for Civil Rights: HIPAA
• Office of Research Integrity

International Agencies

• International Conference on Harmonisation

Organizations

• Public Responsibility in Medicine and Research
• Association for Clinical Research Professionals
• American Society of Bioethics and Humanities
• American Medical Association