UK Human Research Protection Program Questions/Answers
Investigators are familiar with the institutional Human Research Protection Program, regulatory framework and ethical standards for protecting human subjects.
Questions
What rules or guidelines are you expected to follow?
What ethical standards or guides do you follow?
If you propose research be conducted at an international location, what do you inform the IRB regarding applicable local regulations, ethics review requirements, or cultural norms?
How does UK ensure the rights and welfare of participants are protected when the investigator is operating at a non-UK facility, in conducting collaborative research, or when oversight is shared with or deferred to another organization or IRB?
Does UK research have an emergency preparedness and response plan?
Answers
What rules or guidelines are you expected to follow?
Federal Regulations that Apply to All UK Human Subject Research
Department of Health and Human Services (DHHS) 45 CFR 46:
- Subpart A – “Common Rule” IRB Operations, Approval Criteria, Informed Consent
- Subpart B - Fetuses/Pregnant Women/Neonates
- Subpart C - Prisoners
- Subpart D - Children
Regulations that are applicable to select protocols:
A. Food and Drug Administration regulations
B. Health Insurance Portability Accountability Act (HIPAA), Family Educational Rights and
Privacy Act (FERPA) or General Data Protection Regulation (GDPR)
Funding Agency Requirements:
- Department of Defense (DoD)
- US Department of Education (DoED)
- Environmental Protection Agency (EPA)
- US Department of Justice (DOJ); National Institute of Justice (NIJ); Bureau of Prisons (BOP)
- Department of Energy (DOE)
State Law
University of Kentucky Policies and Procedures and Regulations
A. President Level Administrative Regulations (AR):
- AR 7:1 Research Misconduct
- AR 7.2 Research Conflict of Interest and Financial Disclosure Policy
- AR 7:4 Human Research Subject Protection and Institutional Review Boards
- AR 7.9 Institutional Conflict of Interest
B. Vice President for Research (VPR): University of Kentucky Human Research Protection
Program Comprehensive Plan
C. IRB/ORI:
- Standard Operating Procedures
- Application Forms
- IRB SURVIVAL HANDBOOK – Guidance Documents by Topic
What ethical standards or guides do you follow?
The above research regulations are based on the ethical principles set forth in the Nuremberg Code, Declaration of Helsinki, and the Belmont Report issued by the National Commission for the Protection of Human Subjects 1979. Belmont outlines three ethical principles that are central to human subject protection.
- Respect for persons involves recognition of the personal dignity and autonomy of individuals and special protection of those persons with diminished autonomy.
- Beneficence entails an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm.
- Justice requires that the benefits and burdens of research be distributed fairly.
If you propose research be conducted at an international location, what do you inform the IRB regarding applicable local regulations, ethics review requirements, or cultural norms?
Identify Applicable Requirements/Protections:
For research conducted at an international location, the investigator identifies local regulations, laws, or ethics review requirements for human subject protection. He/she may refer to the annual International Compilation of Human Research Standards or the National Institutes of Health ClinRegs website. If the project has been or will be reviewed by a local Ethics Committee or IRB, the investigator provides the UK IRB with a copy of that review.
Cultural Consultation:
In addition, the investigator informs the IRB of any relevant cultural norms or customs particularly regarding recruitment or informed consent. The IRB obtains a cultural consultant to assist in the review of issues which require expertise beyond or in addition to that available on the IRBs. Cultural consultants provide comments, concerns, translations, in writing to the IRB on protocols involving non-English speaking subjects, and/or subjects from a foreign culture.
How does UK ensure the rights and welfare of participants are protected when the investigator is operating at a non-UK facility, in conducting collaborative research, or when oversight is shared with or deferred to another organization or IRB?
In the IRB application, investigators include letters of support approving the conduct of research at non-UK facilities.
If research involves collaboration with any sites and/or personnel outside UK, then it is considered multisite research and IRB reliance issues will need to be addressed.
UK has procedures to define the responsibilities of collaborating institutions and to coordinate communication among responsible IRBs. UK IRB requires a written agreement to be completed between organizations involved in a reliance relationship. A Reliance (or Authorization) Agreement identifies and describes the respective authorities, roles, responsibilities, and methods of communication between an institution/organization providing the IRB review of research and a participating site relying on the institution/organization.
Federal policies require review by a single IRB for select multi-site research. Studies using an external IRB MUST register with the UK IRB.
The ORI Single IRB Reliance website provides tools, checklists, forms, sample agreements and guidance for navigating single IRB review.
Prior to allowing investigators to cede research to an external IRB, the IRB (with assistance from ORI):
- verifies initial and continuing training of investigators regarding human subjects research. Information about ensuring initial and ongoing qualifications and Human Subjects Protection Training; and
- verifies the external IRB is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). UK may agree to defer responsibility for IRB review to a non-AAHRPP accredited institution’s IRB for research that is not greater than minimal risk. To defer responsibility, the non-UK IRB must have an OHRP-registered IRB.
Does UK research have an emergency preparedness and response plan?
Yes, the Emergency Preparedness Response Plan [PDF] provides guidance for initiating a response to an emergency/disaster situation impacting the UK Human Research Protection Program (HRPP) including plans to enable sustainability of the HRPP and continuing protection of participants in research during emergencies.
