Supplemental Training Resources for Key Study Personnel

Supplemental training resources are available for investigators and key study personnel.

General Information

• Belmont Report – English Version
• Belmont Report – Spanish Translation (PDF)
• Fundamental Information for New Investigators and Key Research Personnel (PDF)
• Glossary of Lay Terms (PDF)
• Protocol Template (PDF)
• Storing Research Data
• Procedure for requesting data on East Carolina University students, faculty, or staff to be used in a human research project
• Expedited and Exempt Categories (PDF)

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)

Office for Human Research Protections (OHRP)

The OHRP offers an assortment of educational videos developed by its Division of Education and Development. These videos provide information on a variety of topics regarding the Department of Health and Human Services (HHS) regulations for the protection of human participants of research described at 45 CFR 46. Each video is approximately 20-25 minutes in length. Video topics include, but are not limited to, the following:

• Biobanking: When Issues with Tissues Come a Knockin’
• When PIs Come a Knockin’: Everything Investigators Want to Know but are Afraid to Ask
• OHRP: Research Use of Human Biological Specimens and Other Private Information
• OHRP: Reviewing and Reporting Unanticipated Problems and Adverse Events
• OHRP Research Involving Vulnerable Populations
• OHRP: General informed Consent Requirements
• 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

Office of Research Integrity: The Research Clinic

The Office of Research Integrity (ORI) and the OHRP present The Research Clinic. The interactive training video educates clinical and social researchers on the importance of appropriately protecting research subjects and avoiding research misconduct. The Research Clinic allows the viewer to assume the role of one of four characters and determines the outcome of the storyline by selecting decision-making choices for each playable character.

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 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

Other Online Resources

• National Institutes of Health (NIH)
• NIH FAQs: HIPAA Privacy Rule for Researchers
• Presidential Commission for the Study of Bioethical Issues – Research Primer: Incidental and Secondary Findings (PDF)
• Public Responsibility in Medicine and Research
• Association for Clinical Research Professionals
• American Society of Bioethics and Humanities
• American Medical Association
• International Conference on Harmonisation
• 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