Research
Department
All research is conducted under the review, approval, and ongoing oversight of the Western Reserve Health Education (WRHE) Institutional Review Board (IRB).
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The WRHE IRB is committed to upholding the highest ethical standards for research involving human participants, as established by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
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In addition, the IRB follows all applicable federal regulations of the Department of Health and Human Services (DHHS), including:
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Office for Human Research Protections (OHRP) for regulations involving human subjects
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U.S. Food and Drug Administration (FDA) regulations for clinical investigations involving investigational drugs, devices, and biologics
The WRHE IRB also complies with all relevant state and local laws while supporting the responsible advancement of scientific knowledge.
Research Resources
for Principal Investigators
The The Belmont Report is a foundational set of ethical principles that guide research involving human participants. Created to protect individuals and ensure responsible scientific practices, it outlines three core ideas: respect for persons (treating individuals with autonomy and informed consent), beneficence (maximizing benefits while minimizing harm), and justice (ensuring fairness in who participates in research). These principles help ensure that research is conducted safely, ethically, and with the well-being of participants as a top priority.
The research protocol renewal form is available for clinical investigators to download and submit when continuing an approved study beyond its current review period. This form allows investigators to provide updates on study progress, enrollment status, and any changes to the protocol or research team.
“Common Rule”—is a set of federal regulations that protects people who participate in research studies. It requires researchers and institutions to follow clear safeguards, including informed consent, independent review by an Institutional Review Board (IRB), and additional protections for vulnerable populations. In simple terms, these rules help ensure that research is conducted responsibly, with respect for participants’ rights, safety, and well-being.
FDA Form 3455 is used to report financial interests and arrangements of clinical investigators involved in studies submitted to the U.S. Food and Drug Administration. This disclosure helps identify and manage potential conflicts of interest that could influence study outcomes.
Training through the CITI Program is widely recommended for Institutional Review Board (IRB) members and principal investigators involved in human subjects research. These courses provide essential education on research ethics, regulatory requirements, and best practices for protecting participants. By completing this training, research teams stay current with federal guidelines and institutional expectations, helping ensure studies are conducted responsibly, ethically, and with a strong commitment to participant safety.
The termination of study report form is available for clinical investigators to download and submit when a research study has been completed or discontinued. This form provides a structured way to document final outcomes, participant status, and any issues encountered during the study. Submitting a termination report ensures proper closure, maintains regulatory compliance, and supports accurate institutional records of research activities.
From the Research Department Staff
Our Research Department is dedicated to advancing knowledge, fostering innovation, and supporting resident physicians throughout every stage of the research process. From study design and regulatory guidance to data analysis and dissemination, the department provides the resources and mentorship needed to conduct high-quality, ethical research. With a strong emphasis on collaboration, education, and compliance, the program equips residents to contribute meaningful insights to their fields while upholding the highest standards of scientific integrity and patient-centered care.