Several major research institutions have been cited by the federal Office for Human Research Protection (OHRP) for non-compliance with federal regulations regarding the use of human subjects in research. Subsequently, the privileges to conduct research using human subjects and to expend federal funds were temporarily suspended for these institutions. To avoid non-compliance, OHRP strongly recommends that educational programs are completed by anyone involved in human subject research. Other agencies, such as the National Institutes of Health (NIH) requires proof of human subject research education for all key personnel on any NIH funded projects. National Science Foundation (NSF) requirements mandate NC State University undergraduate students, graduate students, and postdoctoral researchers to complete training in the Responsible Conduct of Research (RCR).
The NC State Institutional Review Board (IRB) supports recommendations and requirements of federal agencies and encourages everyone involved in human subject research to complete educational programs. Below are links to well-established programs which should be utilized to avoid research problems and ultimately make IRB interactions more efficient.
If you have any questions or comments, please feel free to contact the IRB office at 919-515-7515.
- Collaborative Institutional Training Initiative (CITI), a comprehensive ethics training program for researchers conducting research with human subjects. Click here for instructions on setting up your CITI account and accessing the training.
- Research Compliance eLearning Page, on this landing page you can find Research Compliance training including an IRB for the Protection of Human Subjects Overview.
- NC State Responsible Conduct of Research
Readings for Discussion: Research Ethics and Compliance
Many issues related to research ethics and compliance are new, ever growing, complex, and nuanced. Just as each study is unique, the ethical considerations and issues of compliance are as well. The NC State IRB office has selected some readings for your research team to read through and discuss. Reading these articles and discussing them with your team(s) and/or students will help illuminate some nuances regarding ethics and compliance related to research activities. We suggest reading through them and talking about issues of informed consent, participant selection, research design, analysis of risks, and understanding of national and local contexts related to the issues brought up.
- Questions for Consideration:
- What were researchers trying to solve, why were they trying to solve it, was it an appropriate research question to be asking?
- Did the study put their participants in harm’s way? Why or why not? How?
- What could have been different about the study design – that could have better protected participants?
- If you were participating in this study, what would you want the Informed Consent process to look like? What information would you want to include?
- Discuss the nature and reasoning behind each of the court’s findings.
- In your research, what are your intentions and why?
- In your research, where can risk manifest throughout your research design and process?
- In your research, have you communicated clearly with your participants?
- Questions for Consideration:
- Define primary participants and third party participants.
- In your research, who are your primary participants and who may be your third party participants?
- In your research, who of your participants are vulnerable and why are they vulnerable?
- In your research, what are ways to mitigate risks to your primary participants and your third party participants?